Annual Report on Statistics of Production by ... · Annual Report on Statistics of Production by Pharmaceutical Industry in 2015 Health Policy Bureau, Ministry of Health, Labour and

Annual Report on Statistics of

Production by Pharmaceutical

Industry in 2015

Health Policy Bureau, Ministry of Health, Labour and Welfare

Section in charge: Statistics Section, Economic Affairs Division

Tel: +81-3-5253-1111 (Ex. 2532)

+81-3-3595-2421 (direct dialing)

Contents

Overview of Research ........................................................................................................................... 1

Overview of Results .............................................................................................................................. 5

I Drugs .................................................................................................................................... 5

1. Status of production of drugs ................................................................................................ 5

2. Status of production by therapeutic category of drugs ........................................................ 10

(1) Cardiovascular agents ................................................................................................. 10

(2) Central nervous system agents .................................................................................... 10

(3) Other agents affecting metabolism .............................................................................. 11

(4) Digestive organ agents ................................................................................................ 11

(5) Blood and body fluid agents ....................................................................................... 12

(6) Dermatologic preparations .......................................................................................... 12

(7) Biological preparations ............................................................................................... 13

(8) Sensory organ agents .................................................................................................. 13

(9) Extracorporeal diagnostic agents ................................................................................ 14

(10) Allergic agents ............................................................................................................ 14

(11) Antineoplastics ............................................................................................................ 15

(12) Antibiotics ................................................................................................................... 15

(13) Vitamins ...................................................................................................................... 16

(14) Hormones (including antihormones)........................................................................... 17

(15) Traditional Chinese medicines .................................................................................... 17

3. Status of production by drug form category, by classification according to use and by

therapeutic category of drugs .............................................................................................. 18

(1) Drug form category ..................................................................................................... 18

(2) Classification according to use ................................................................................... 19

(3) Therapeutic category ................................................................................................... 19

4. The amount of production by region of drugs .................................................................... 22

5. Composition of drugs by employee size and by production size ........................................ 23

(1) Composition by employee size ................................................................................... 23

(2) Composition by production size ................................................................................. 24

6. Status of import and export of drugs ................................................................................... 24

(1) Export .......................................................................................................................... 25

(2) Import .......................................................................................................................... 28

II Sanitary materials ............................................................................................................... 32

1. Status of production of sanitary materials ........................................................................... 32

2. Status of production of sanitary materials by region ........................................................... 33

III Medical devices .................................................................................................................. 34

1. Status of production of medical devices ............................................................................. 34

2. Status of production of medical devices by region ............................................................. 36

3. Composition of medical devices by production size ........................................................... 38

4. Status of import and export of medical devices .................................................................. 38

(1) Export .......................................................................................................................... 38

(2) Import .......................................................................................................................... 41

IV Quasi-drugs ......................................................................................................................... 44

1. Status of production of quasi-drugs .................................................................................... 44

2. Status of production of quasi-drugs by region .................................................................... 46

(Statistics)

○Amount of shipment by therapeutic category of drugs and by classification according to use ······· 47

○Amount of shipment by main category of medical device ················································ 49

1

Overview of Research

1. Purpose of research

These research aims at clarifying the status of production, import etc. of drugs, quasi-drugs, sanitary

materials and medical devices and regenerative medicine and similar products.

2. Scope of research

Offices that market and/or manufacture drugs, quasi-drugs, medical devices, and/or regenerative

medicine and similar products, authorized as marketing authorization holders of the relevant products;

and manufacturers that manufacturer drugs, quasi-drugs, medical devices, and/or regenerative medicine

and similar products, authorized or registered as manufacturers of the relevant products; as per

provisions of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices,

Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (“PMD Act”);

Note that establishments that are categorized in the following business types are excluded from the

scope of this research.

(1) A manufacturer, or marketing authorization holder, of drugs that are produced by proprietors of

pharmacies, using their own pharmacies’ equipment and/or apparatuses;

(2) A marketing authorization holder of condoms and/or corrective lenses (excluding the import of

packed products), which only market packed products, or such manufacturer which only

undertakes packing of such products; and

(3) A marketing authorization holder of absorbent cottons and/or gauzes, (excluding the import of

packed products), which only market packed products, or such manufacturer which only

undertakes packing of such products, as well as a marketing authorization holder, or manufacturer

of sanitary treatment products (excluding products that only comprise absorbent cotton), which

only market or manufacture large products.

* The research results concerning regenerative medicine and similar products are not disclosed for

confidentiality reasons, because the disclosure may allow the identification of reported establishments.

3. Period of research

From January 1 to December 31, 2015

4. Items of research

Quantity, monetary amount etc. of production, import, shipment, export and inventory of drugs,

quasi-drugs, sanitary materials and medical devices and regenerative medicine and similar products; also,

employees (including temporary ones) at manufacturing plants that relate to drugs.

5. Methods of research and reporting duties

(1) Manufacturing plants

The Ministry of Health, Labour and Welfare conducts research by way of prefectural

governments, by online, and by electromagnetic recording media and questionnaire sheets that are

distributed to business establishments who are obliged to report.

2

MHLW

Distribute electromagnetic

recording media / questionnaire sheets

Submit / online reporting

Prefectures

Distribute electromagnetic

recording media / questionnaire sheets

Submit / online

reporting

Establishments that are obliged to

report

(Review and tabulate)

(Sort out and review)

(Enter required information)

(2) Marketing authorization holder offices

The Ministry of Health, Labour and Welfare conducts research, by online, and by electromagnetic

recording media and questionnaire sheets that are distributed to business establishments who are

obliged to report.

MHLW Distribute electromagnetic recording media /

questionnaire sheets

Submit / online reporting

Establishments that are obliged to

report

(Sort out, review and tabulate) (Enter required information)

6. Tabulation of results

Tabulation of results was undertaken by the Health Policy Bureau, Ministry of Health, Labour and

Welfare.

7. Precautions for use

(1) Symbols

- : a value that is below the smallest unit, or there is no available data

0 / 0.0: a value for mean, proportion etc. that does not correspond to “1” in the lowest digit of

indication after rounding

(2) Regions

Hokkaido: Hokkaido

Tohoku: Aomori, Iwate, Miyagi, Akita, Yamagata and Fukushima

Kanto Etsusei: Ibaraki, Tochigi, Gunma, Saitama, Chiba, Tokyo, Kanagawa, Niigata, Yamanashi,

Nagano and Shizuoka

Tokai Hokuriku: Toyama, Ishikawa, Gifu, Aichi and Mie

Kinki: Fukui, Shiga, Kyoto, Osaka, Hyogo, Nara and Wakayama

Chugoku: Tottori, Shimane, Okayama, Hiroshima and Yamaguchi

Shikoku: Tokushima, Kagawa, Ehime and Kochi

Kyushu: Fukuoka, Saga, Nagasaki, Kumamoto, Oita, Miyazaki, Kagoshima, Okinawa

(3) Terms

Amount of production: The amount of production of final products (large products in the case

of absorbent cottons and/or gauzes in sanitary materials) that are

produced at a manufacturing plant during the period of research, which

is given by multiplying production quantity by the selling price of the

marketing authorization holder (including consumption tax).

3

Production quantity: Production quantity of final products (large products in the case of

absorbent cottons and/or gauzes in sanitary materials) that are

produced at a manufacturing plant during the period of research;

Conforming quantity is used as production quantity for products for

national assay.

Amount of shipment: Amount of shipment during the period of research (including shipment

by selling, as well as shipment to other manufacturing plants, business

offices, warehouses in separate locations etc. within the same business

entity), given by multiplying shipment quantity by the selling price of

the marketing authorization holder (including consumption tax).

The number of manufacturing plants / the number of marketing authorization holder offices:

Number of manufacturing plants / marketing authorization holder

offices, at which there were changes in production / import, shipment

and/or month-end inventory of final products (large products in the

case of absorbent cottons and/or gauzes in sanitary materials) during

the period of research (monthly average)

Prescription drugs: Drugs that are supplied to be used by physicians and/or dentists, or

under the prescription or instruction of these

Other drugs: Drugs other than prescription drugs

OTC drugs: Of other drugs, drugs other than drugs for household delivery

Drugs for household delivery:

Of other drugs, drugs that are supplied to be used mainly as drugs for

household delivery

Import*: Refers to drugs that are produced mainly from imported drug materials

(including raw powder, raw liquid, bulk products and preparation

materials)

Contract production: Manufacturing process of a final product that is contracted from a

marketing authorization holder office of another company, whether the

contracted process covers the whole or part of the manufacturing

process of the relevant product; contracting of only packaging, labeling

and/or storage processes is excluded from this research.

Employees: Refers to employees who are regularly engaged in actual production /

import, management or other activities pertaining to drugs, as of the

end of a month of research; even executive officers and directors are

included in regular employees, if they are engaged in specified tasks

related to production / import of drugs (monthly average).

Large products: Products that are made from raw cotton, raw fabric etc., and are ready

to be packed after refining, drying etc.; With regards to absorbent

cottons and gauzes in sanitary materials, reporting is required not for

final products, but for large products before packing.

8. Notes for figures concerning import and export

Figures for import and export in this research are used for statistics aimed at the clarification of

Japan’s production power and other conditions, but are not suitable for use to identify the trade

conditions. Please take care when using the figures concerning import and export.

[Below is provided a specific example of pharmaceuticals. The case is the same with medical

4

devices.]

◦ Tabulation in this research includes marketing authorization holders and manufacturers that are

authorized under the PMD Act in Japan, and import and export are respectively defined as

follows:

Export = Exported final products (direct exports only)

Import = Imported final products + Imported preparations that are subdivided in Japan

◦ Products that are sold from marketing authorization holders to exporters (e.g. trading firms) in

Japan, and then shipped to other countries by exporters, are counted as “domestic shipment” at

the stage of sale to exporters in Japan, and are therefore excluded from the scope of export in

this research. Preparations that are exported from Japan and then processed into final products in

foreign countries are also excluded from export, because it does not constitute “export of final

products”.

◦ Because the scope of tabulation in this research only includes marketing authorization holders

and manufacturers in Japan, products that are locally produced and marketed in foreign

countries are excluded from the scope.

As described above, please note in advance that the data of this research are not suitable for use aimed

at the identification of trade conditions.

5

Overview of Results

I Drugs

The amount of production of final products of drugs in Japan in 2015 stood at 6,820.4 billion yen,

while the amount of import from other countries was 4,022 billion yen. The combined amount was

10,842.5 billion yen.

Domestic amount of shipment stood at 10,478.5 billion yen, while export to other countries was 153.5

billion yen.

1. Status of production of drugs

(1) The amount of production of final products of drugs in 2015 stood at 6,820.4 billion yen, down

230.7 billion yen (3.5%) from 6,589.8 billion yen in 2014. By classification according to use, the

amount of production of prescription drugs stood at 5,996.9 billion yen, up 2.2%, while the

amount of production of other drugs was 823.5 billion yen, up 14.2%. With regards to the

proportion, prescription drugs make up 87.9% of total, with the share of other drugs at 12.1%.

Year-on-year changes over the past ten years were: up 0.7% in 2006, up 0.2% in 2007, up 2.6% in

2008, up 3.0% in 2009, down 0.6% in 2010, up 3.1% in 2011, down 0.2% in 2012, down 1.2% in

2013, down 4.4% in 2014, and up 3.5% in 2015.

(2) Trends in the amount of production of prescription drugs over the past ten years are indicated in

Table 1.

(3) The amount of production by main therapeutic category of drugs is indicated in Table 2 and other

tables. The top ten categories make up 5,016.2 billion yen (73.5%).

(4) The amount of production by sub therapeutic category of drugs, at or above 25.0 billion yen per

year, is indicated in Table 3.

6

Table 1. Trends in the amount of production of drugs

Year

Production Prescription drugs Other drugs OTC drugs Drugs for household delivery

Amount Year-

on-year Proportion Amount

Year-


Year-


Year-


Year-

on-year Proportion

Mil. yen % % Mil. yen % % Mil. yen % % Mil. yen % % Mil. yen % %

2006 6,438,082 0.7 100.0 5,803,581 1.1 90.1 634,501 -2.3 9.9 599,259 -2.0 9.3 35,243 -7.1 0.5

2007 6,452,166 0.2 100.0 5,828,086 0.4 90.3 624,080 -1.6 9.7 592,963 -1.1 9.2 31,117 -11.7 0.5

2008 6,620,091 2.6 100.0 5,992,765 2.8 90.5 627,327 0.5 9.5 598,438 0.9 9.0 28,889 -7.2 0.4

2009 6,819,589 3.0 100.0 6,174,202 3.0 90.5 645,387 2.9 9.5 616,601 3.0 9.0 28,786 -0.4 0.4

2010 6,779,099 -0.6 100.0 6,148,876 -0.4 90.7 630,223 -2.3 9.3 602,193 -2.3 8.9 28,030 -2.6 0.4

2011 6,987,367 3.1 100.0 6,344,512 3.2 90.8 642,855 2.0 9.2 617,231 2.5 8.8 25,624 -8.6 0.4

2012 6,976,712 -0.2 100.0 6,263,010 -1.3 89.8 713,702 11.0 10.2 689,018 11.6 9.9 24,684 -3.7 0.4

2013 6,894,014 -1.2 100.0 6,193,983 -1.1 89.8 700,031 -1.9 10.2 677,407 -1.7 9.8 22,624 -8.3 0.3

2014 6,589,762 -4.4 100.0 5,868,927 -5.2 89.1 720,835 3.0 10.9 700,376 3.4 10.6 20,459 -9.6 0.3

2015 6,820,413 3.5 100.0 5,996,890 2.2 87.9 823,523 14.2 12.1 804,561 14.9 11.8 18,962 -7.3 0.3

7

Table 2. Amount of production by main therapeutic category of drugs

Ranking Main therapeutic category of drugs Amount of production Year-on-year change Percent distribution

2015 2014 Change Proportion 2015 2014

Mil. yen Mil. yen Mil. yen % % %

Total 6,820,413 6,589,762 230,651 3.5 100.0 100.0

1 Cardiovascular agents 1,088,475 1,157,221 -68,746 -5.9 16.0 17.6

2 Central nervous system agents 784,182 793,493 -9,311 -1.2 11.5 12.0

3 Other agents affecting metabolism 690,568 633,860 56,708 8.9 10.1 9.6

4 Digestive organ agents 464,073 484,331 -20,258 -4.2 6.8 7.3

5 Blood and body fluid agents 461,825 448,987 12,838 2.9 6.8 6.8

6 Dermatologic preparations 450,583 377,811 72,772 19.3 6.6 5.7

7 Biological preparations 328,161 296,681 31,480 10.6 4.8 4.5

8 Sensory organ agents 278,773 264,245 14,528 5.5 4.1 4.0

9 Extracorporeal diagnostic agents 235,797 220,120 15,677 7.1 3.5 3.3

10 Allergic agents 233,739 219,157 14,582 6.7 3.4 3.3

11 Antineoplastics 227,490 161,913 65,577 40.5 3.3 2.5

12 Antibiotics 219,483 236,305 -16,822 -7.1 3.2 3.6

13 Vitamins 203,883 183,221 20,662 11.3 3.0 2.8

14 Hormones (including antihormones) 182,902 158,691 24,211 15.3 2.7 2.4

15 Traditional Chinese medicines 154,678 146,395 8,283 5.7 2.3 2.2

16 Urogenital and anal organ agents 147,680 152,239 -4,559 -3.0 2.2 2.3

17 Nutrients, tonics 146,492 146,785 -293 -0.2 2.1 2.2

18 Respiratory organ agents 119,017 98,066 20,951 21.4 1.7 1.5

19 Chemotherapeutics 116,031 117,109 -1,078 -0.9 1.7 1.8

20 Intracorporeal diagnostic agents (excluding extracorporeal diagnostic

agents) 53,742 57,699 -3,957 -6.9 0.8 0.9

21 Radioactive drugs 46,797 41,498 5,299 12.8 0.7 0.6

22 Dialysis agents 43,404 46,172 -2,768 -6.0 0.6 0.7

23 Peripheral nervous system agents 30,085 27,900 2,185 7.8 0.4 0.4

24 Public health agents 19,345 16,794 2,551 15.2 0.3 0.3

25 Other agents not mainly for therapeutic purpose 18,901 34,991 -16,090 -46.0 0.3 0.5

Others 74,306 68,076 6,230 9.2 1.1 1.0

(Note) The ranking in the main therapeutic category of drugs is based on the order of amounts of production in 2015.

8

Figure 1. Amount of production by main therapeutic category of drugs

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Figure 2. Proportion of the amount of production by main therapeutic category of drugs

2014

2015

Allergic agents

3.4%

Cardiovascular

agents

16.0%

Central nervous system agents

11.5%

Other agents affecting

metabolism

10.1%

Digestive organ

agents

6.8% Blood and body

fluid agents 6.8%

Biological preparations

4.8%

Dermatologic

preparations

6.6%

Sensory organ agents

4.1%

Extracorporeal diagnostic agents

3.5%

Others

26.4%

9

Table 3. Amount of production by sub therapeutic category of drugs

Rank

ing Sub therapeutic category of drugs

Amount of production Year-on-year change Percent distribution



Total 6,820,413 6,589,762 230,651 3.5 100.0 100.0

1 Antihypertensives 529,804 572,987 -43,183 -7.5 7.8 8.7

2 Agents affecting metabolism, not elsewhere classified 420,224 400,851 19,373 4.8 6.2 6.1

3 Analgesics, anti-itchings, astringents, anti-inflammatory agents 309,116 254,227 54,889 21.6 4.5 3.9

4 Other blood and body fluid agents 282,800 271,790 11,010 4.1 4.1 4.1

5 Peptic ulcer agents 255,203 274,192 -18,989 -6.9 3.7 4.2

6 Ophthalmic agents 231,942 221,876 10,066 4.5 3.4 3.4

7 Other allergic agents 226,155 210,912 15,243 7.2 3.3 3.2

8 Human blood preparations 207,912 197,436 10,476 5.3 3.0 3.0

9 Psychotropics 196,609 185,002 11,607 6.3 2.9 2.8

10 Hyperlipidemia agents 179,259 182,227 -2,968 -1.6 2.6 2.8

11 Antipyretics and analgesics, anti-inflammatory agents 174,420 175,913 -1,493 -0.8 2.6 2.7

12 Antidiabetic agents 171,501 130,631 40,870 31.3 2.5 2.0

13 Other antineoplastics 164,762 100,806 63,956 63.4 2.4 1.5

14 Other central nervous system agents 163,057 167,282 -4,225 -2.5 2.4 2.5

15 Vasodilators 162,279 179,600 -17,321 -9.6 2.4 2.7

16 Traditional Chinese medicines 154,678 146,395 8,283 5.7 2.3 2.2

17 Antibiotics acting mainly on gram-positive and gram-negative

bacteria 146,434 158,042 -11,608 -7.3 2.1 2.4

18 Other urogenital and anal organ agents 130,669 136,359 -5,690 -4.2 1.9 2.1

19 Biochemical testing reagents 109,504 110,689 -1,185 -1.1 1.6 1.7

20 Anticoagulants 100,833 99,050 1,783 1.8 1.5 1.5

21 Other hormones (including antihormones) 97,869 74,680 23,189 31.1 1.4 1.1

22 Serum-immunological testing reagents 92,664 82,335 10,329 12.5 1.4 1.2

23 Common cold drugs 86,030 84,254 1,776 2.1 1.3 1.3

24 Other cardiovascular agents 85,990 91,036 -5,046 -5.5 1.3 1.4

25 Protein and amino acid preparations 79,212 77,148 2,064 2.7 1.2 1.2

26 Other digestive organ agents 69,789 70,746 -957 -1.4 1.0 1.1

27 Vaccines 69,521 59,155 10,366 17.5 1.0 0.9

28 Blood substitutes 68,066 67,127 939 1.4 1.0 1.0

29 Vitamin B preparations (excluding Vitamin B1 preparations) 59,727 52,207 7,520 14.4 0.9 0.8

30 Antiarrhythmic agents 59,667 69,117 -9,450 -13.7 0.9 1.0

31 Vitamins A and D preparations 59,080 52,918 6,162 11.6 0.9 0.8

32 Hypnotics and sedatives, anxiolytics 56,325 69,827 -13,502 -19.3 0.8 1.1

33 Multivitamin preparations (excluding Vitamins A and D

mixtures) 55,080 51,364 3,716 7.2 0.8 0.8

34 Antiparkinsonian agents 52,688 57,955 -5,267 -9.1 0.8 0.9

35 Antiepileptics 51,018 48,210 2,808 5.8 0.7 0.7

36 Other nutrients, tonics 48,562 51,109 -2,547 -5.0 0.7 0.8

37 Radioactive drugs 46,797 41,498 5,299 12.8 0.7 0.6

38 Antivirals 43,398 41,394 2,004 4.8 0.6 0.6

39 Diuretics 41,070 33,973 7,097 20.9 0.6 0.5

40 Antibiotics acting mainly on gram-positive bacteria and

mycoplasma 41,055 40,317 738 1.8 0.6 0.6

41 Thyroid and para-thyroid hormone preparations 40,562 40,309 253 0.6 0.6 0.6

42 Synthetic antibacterials 40,270 56,775 -16,505 -29.1 0.6 0.9

43 Expectorants 39,813 37,828 1,985 5.2 0.6 0.6

44 X-ray contrast media 38,675 42,508 -3,833 -9.0 0.6 0.6

45 Suppurative dermatosis agents 36,930 23,243 13,687 58.9 0.5 0.4

46 Purgatives, clysters 35,726 29,486 6,240 21.2 0.5 0.4

47 Metabolic disease preparations & combinations 35,500 37,764 -2,264 -6.0 0.5 0.6

48 Antimetabolites 35,473 31,377 4,096 13.1 0.5 0.5

49 Gout preparations 35,471 34,901 570 1.6 0.5 0.5

50 Otic and nasal agents 35,117 30,531 4,586 15.0 0.5 0.5

51 Antimicrobial agents 31,415 35,788 -4,373 -12.2 0.5 0.5

52 Other chemotherapy agents 31,032 17,676 13,356 75.6 0.5 0.3

53 Mixed biological preparations 29,191 19,830 9,361 47.2 0.4 0.3

54 Kidney dialysis agents 28,791 31,182 -2,391 -7.7 0.4 0.5

55 Gastrointestinal agents and combinations 27,424 27,159 265 1.0 0.4 0.4

(Note) The ranking in the sub therapeutic category of drugs is based on the order of amounts of production in 2015.

The amounts are over 25.0 billion yen.

10

2. Status of production by therapeutic category of drugs

(1) Cardiovascular agents

The amount of production of cardiovascular agents stood at 1,088.5 billion yen, which made up 16.0%

of the amount of gross drug production, down 68.7 billion yen (5.9%) from the previous year.

Breakdown is indicated in Table 4. The amount of production was the largest with antihypertensives,

which makes up 48.7% of total, followed by hyperlipidemia agents vasodilators (16.5%), vasodilators

(14.9%).

Table 4. Amount of production of cardiovascular agent

Sub therapeutic category of drugs Amount of production Year-on-year change Percent distribution



Total 1,088,475 1,157,221 -68,746 -5.9 100.0 100.0

Cardiotonics 19,300 16,341 2,959 18.1 1.8 1.4

Antiarrhythmic agents 59,667 69,117 -9,450 -13.7 5.5 6.0

Diuretics 41,070 33,973 7,097 20.9 3.8 2.9

Antihypertensives 529,804 572,987 -43,183 -7.5 48.7 49.5

Capillary stabilizers 32 32 - - 0.0 0.0

Vasoconstrictors 11,074 11,906 -832 -7.0 1.0 1.0

Vasodilators 162,279 179,600 -17,321 -9.6 14.9 15.5

Hyperlipidemia agents 179,259 182,227 -2,968 -1.6 16.5 15.7

Other cardiovascular agents 85,990 91,036 -5,046 -5.5 7.9 7.9

(2) Central nervous system agents

The amount of production of central nervous system agents stood at 784.2 billion yen, which made up

11.5% of the amount of gross drug production, down 9.3 billion yen (1.2%) from the previous year.

Breakdown is indicated in Table 5. The amount of production was the largest with psychotropics, which

made up 25.1% of total, followed by antipyretics and analgesics, anti-inflammatory agents (22.2%), other

central nervous system agents psychotropics (20.8%).

Table 5. Amount of production of central nervous system agents




Total 784,182 793,493 -9,311 -1.2 100.0 100.0

General anesthetics 3,338 4,262 -924 -21.7 0.4 0.5

Hypnotics and sedatives, anxiolytics 56,325 69,827 -13,502 -19.3 7.2 8.8

Antiepileptics 51,018 48,210 2,808 5.8 6.5 6.1

Antipyretics and analgesics, anti-inflammatory agents 174,420 175,913 -1,493 -0.8 22.2 22.2

Stimulants 697 788 -91 -11.5 0.1 0.1

Antiparkinsonian agents 52,688 57,955 -5,267 -9.1 6.7 7.3

Psychotropics 196,609 185,002 11,607 6.3 25.1 23.3

Common cold drugs 86,030 84,254 1,776 2.1 11.0 10.6

Other central nervous system agents 163,057 167,282 -4,225 -2.5 20.8 21.1

11

(3) Other agents affecting metabolism

The amount of production of other agents affecting metabolism stood at 690.6 billion yen, which made

up 10.1% of the amount of gross drug production, up 56.7 billion yen (8.9%) from the previous year.

Breakdown is indicated in Table 6. The amount of production was the largest with agents affecting

metabolism, not elsewhere classified, which made up 60.9% of total, followed by antidiabetic agents

(24.8%), metabolic disease preparations & combinations (5.1%).

Table 6. Amount of production of other agents affecting metabolism




Total 690,568 633,860 56,708 8.9 100.0 100.0

Liver disease agents 6,743 6,354 389 6.1 1.0 1.0

Antidotes 12,425 13,389 -964 -7.2 1.8 2.1

Habitual intoxication agents 183 161 22 13.7 0.0 0.0

Gout preparations 35,471 34,901 570 1.6 5.1 5.5

Enzyme preparations 8,521 9,809 -1,288 -13.1 1.2 1.5

Antidiabetic agents 171,501 130,631 40,870 31.3 24.8 20.6

Metabolic disease preparations & combinations 35,500 37,764 -2,264 -6.0 5.1 6.0

Agents affecting metabolism, not elsewhere classified 420,224 400,851 19,373 4.8 60.9 63.2

(4) Digestive organ agents

The amount of production of digestive organ agents stood at 464.1 billion yen, which made up 6.8 % of

the amount of gross drug production, down 20.3 billion yen (4.2%) from the previous year.

Breakdown is indicated in Table 7. The amount of production was the largest with peptic ulcer agents,

which made up 55.0% of total, followed by other digestive organ agents (15.0%), purgatives, clysters

(7.7%).

Table 7. Amount of production of digestive organ agents




Total 464,073 484,331 -20,258 -4.2 100.0 100.0

Antidiarrheals, intestinal regulators 23,980 28,093 -4,113 -14.6 5.2 5.8

Peptic ulcer agents 255,203 274,192 -18,989 -6.9 55.0 56.6

Stomachics and digestives 11,069 10,955 114 1.0 2.4 2.3

Antacids 24,891 24,299 592 2.4 5.4 5.0

Purgatives, clysters 35,726 29,486 6,240 21.2 7.7 6.1

Cholagogues 15,992 19,401 -3,409 -17.6 3.4 4.0

Gastrointestinal agents and combinations 27,424 27,159 265 1.0 5.9 5.6

Other digestive organ agents 69,789 70,746 -957 -1.4 15.0 14.6

12

(5) Blood and body fluid agents

The amount of production of blood and body fluid agents stood at 461.8 billion yen, which made up

6.8% of the amount of gross drug production, up 12.8 billion yen (2.9%) from the previous year.

Breakdown is indicated in Table 8. The amount of production was the largest with other blood and body

fluid agents, which made up 61.2% of total, followed by anticoagulants (21.8%), blood substitutes

(14.7%).

Table 8. Amount of production of blood and body fluid agents




Total 461,825 448,987 12,838 2.9 100.0 100.0

Blood substitutes 68,066 67,127 939 1.4 14.7 15.0

Hemostatics 10,126 11,022 -896 -8.1 2.2 2.5

Anticoagulants 100,833 99,050 1,783 1.8 21.8 22.1

Other blood and body fluid agents 282,800 271,790 11,010 4.1 61.2 60.5

(6) Dermatologic preparations

The amount of production of dermatologic preparations stood at 450.6 billion yen, which made up 6.6%

of the amount of gross drug production, up 72.8 billion yen (19.3%) from the previous year.

Breakdown is indicated in Table 9. The amount of production was the largest with analgesics,

anti-itchings, astringents, anti-inflammatory agents, which made up 68.6% of total, followed by

suppurative dermatosis agents (8.2%), antimicrobial agents (7.0%).

Table 9. Amount of production of dermatologic preparations




Total 450,583 377,811 72,772 19.3 100.0 100.0

Antimicrobial agents 31,415 35,788 -4,373 -12.2 7.0 9.5

Skin protectants 1,659 1,743 -84 -4.8 0.4 0.5

Suppurative dermatosis agents 36,930 23,243 13,687 58.9 8.2 6.2

Analgesics, anti-itchings, astringents, anti-inflammatory agents 309,116 254,227 54,889 21.6 68.6 67.3

Antiparasitic dermatosis agents 22,435 16,344 6,091 37.3 5.0 4.3

Emollients (including caustics) 11,508 12,450 -942 -7.6 2.6 3.3

Hair remedies (hair growing agents, depilatories, hair dyes, hair

tonics) 16,998 16,339 659 4.0 3.8 4.3

Bath preparations - - - - - -

Other dermatologic preparations 20,522 17,677 2,845 16.1 4.6 4.7

13

(7) Biological preparations

The amount of production of biological preparations stood at 328.2 billion yen, which made up 4.8% of

the amount of gross drug production, up 31.5 billion yen (10.6%) from the previous year.

Breakdown is indicated in Table 10. The amount of production was the largest with human blood

preparations, which made up 63.4% of total, followed by vaccines (21.2%), Mixed biological preparations

(8.9%).

Table 10. Amount of production of biological preparations




Total 328,161 296,681 31,480 10.6 100.0 100.0

Vaccines 69,521 59,155 10,366 17.5 21.2 19.9

Toxins, toxoids 749 931 -182 -19.5 0.2 0.3

Antitoxins, anti-leptospiral sera 58 101 -43 -42.6 0.0 0.0

Human blood preparations 207,912 197,436 10,476 5.3 63.4 66.5

Biological test preparations - - - - - -

Mixed biological preparations 29,191 19,830 9,361 47.2 8.9 6.7

Other biological preparations 20,730 19,227 1,503 7.8 6.3 6.5

(8) Sensory organ agents

The amount of production of sensory organ agents stood at 278.8 billion yen, which made up 4.1% of


Breakdown is indicated in Table 11. The amount of production was the largest with ophthalmic agents,

which made up 83.2% of total, followed by otic and nasal agents (12.6 %), and vertigo agents (4.2%).

Table 11. Amount of production of sensory organ agents




Total 278,773 264,245 14,528 5.5 100.0 100.0

Ophthalmic agents 231,942 221,876 10,066 4.5 83.2 84.0

Otic and nasal agents 35,117 30,531 4,586 15.0 12.6 11.6

Vertigo agents 11,683 11,805 -122 -1.0 4.2 4.5

Other sensory organ agents 31 33 -2 -6.1 0.0 0.0

14

(9) Extracorporeal diagnostic agents

The amount of production of extracorporeal diagnostic agents stood at 235.8 billion yen, which made

up 3.5% of the amount of gross drug production, down 15.7 billion yen (7.1%) from the previous year.

Breakdown is indicated in Table 12. The amount of production was the largest with biochemical testing

reagents, which made up 46.4% of total, followed by serum-immunological testing reagents (39.3%),

blood testing reagents (7.5%).

Table 12. Amount of production of extracorporeal diagnostic agents




Total 235,797 220,120 15,677 7.1 100.0 100.0

General testing reagents 10,962 9,113 1,849 20.3 4.6 4.1

Blood testing reagents 17,577 13,595 3,982 29.3 7.5 6.2

Biochemical testing reagents 109,504 110,689 -1,185 -1.1 46.4 50.3

Serum-immunological testing reagents 92,664 82,335 10,329 12.5 39.3 37.4

Bacteriological testing reagents 3,012 3,460 -448 -12.9 1.3 1.6

Patho-tissue testing reagents 2,078 928 1,150 123.9 0.9 0.4

(10) Allergic agents

The amount of production of allergic agents stood at 233.7 billion yen, which made up 3.4% of the

amount of gross drug production, down 14.6 billion yen (6.7%) from the previous year.

Breakdown is indicated in Table 13. The amount of production was the largest with other allergic agents,

which made up 96.8 of total, followed by antihistamines (2.0%), and stimulation therapy agents (1.2%).

Table 13. Amount of production of allergic agents




Total 233,739 219,157 14,582 6.7 100.0 100.0

Antihistamines 4,767 5,094 -327 -6.4 2.0 2.3

Stimulation therapy agents 2,818 3,151 -333 -10.6 1.2 1.4

Nonspecific immunogen preparations - - - - - -

Other allergic agents 226,155 210,912 15,243 7.2 96.8 96.2

15

(11) Antineoplastics

The amount of production of antineoplastics stood at 227.5 billion yen, which made up 3.3% of the

amount of gross drug production, up 65.6 billion yen (40.5%) from the previous year.

Breakdown is indicated in Table 14. The amount of production was the largest with other

antineoplastics, which made up 72.4% of total, followed by antimetabolites (15.6%), antitumor plant

extract preparations (8.0%).

Table 14. Amount of production of antineoplastics




Total 227,490 161,913 65,577 40.5 100.0 100.0

Alkylating agents 1,015 1,348 -333 -24.7 0.4 0.8

Antimetabolites 35,473 31,377 4,096 13.1 15.6 19.4

Antitumor antibiotics 7,941 8,241 -300 -3.6 3.5 5.1

Antitumor plant extract preparations 18,299 20,141 -1,842 -9.1 8.0 12.4

Other antineoplastics 164,762 100,806 63,956 63.4 72.4 62.3

(12) Antibiotics

The amount of production of antibiotics stood at 219.5 billion yen, which made up 3.2% of the

amount of gross drug production, down 16.8 billion yen (7.1%) from the previous year.

Breakdown is indicated in Table 15. The amount of production was the largest with antibiotics

acting mainly on gram-positive and gram-negative bacteria, which made up 66.7% of total, followed

by antibiotics acting mainly on gram-positive bacteria and mycoplasma (18.7%), antibiotics acting

mainly on mold (7.2%).

Table 15. Amount of production of antibiotics




Total 219,483 236,305 -16,822 -7.1 100.0 100.0

Antibiotics acting mainly on gram-positive bacteria 6,212 6,222 -10 -0.2 2.8 2.6

Antibiotics acting mainly on gram-negative bacteria 2,911 2,691 220 8.2 1.3 1.1

Antibiotics acting mainly on gram-positive and gram-negative

bacteria 146,434 158,042 -11,608 -7.3 66.7 66.9

Antibiotics acting mainly on gram-positive bacteria and

mycoplasma 41,055 40,317 738 1.8 18.7 17.1

Antibiotics acting mainly on gram-positive bacteria,

gram-negative bacteria, rickettsia and chlamydia 2,474 2,282 192 8.4 1.1 1.0

Antibiotics acting mainly on acid-fast bacteria 2,627 2,200 427 19.4 1.2 0.9

Antibiotics acting mainly on mold 15,697 22,138 -6,441 -29.1 7.2 9.4

Other antibiotics (including antibiotic combinations) 2,073 2,414 -341 -14.1 0.9 1.0

16

(13) Vitamins

The amount of production of Vitamins stood at 203.9 billion yen, which made up 3.0% of the amount of

gross drug production, up 20.7 billion yen (11.3%) from the previous year.

Breakdown is indicated in Table 16. The amount of production was the largest with Vitamin B

preparations (excluding Vitamin B1 preparations), which made up 29.3% of total, followed by Vitamins A

and D preparations (29.0%), and multivitamin preparations (excluding Vitamins A and D mixtures)

(27.0%).

Table 16. Amount of production of vitamins




Total 203,883 183,221 20,662 11.3 100.0 100.0

Vitamins A and D preparations 59,080 52,918 6,162 11.6 29.0 28.9

Vitamin B1 preparations 8,373 7,562 811 10.7 4.1 4.1

Vitamin B preparations (excluding Vitamin B1 preparations) 59,727 52,207 7,520 14.4 29.3 28.5

Vitamin C preparations 6,494 5,597 897 16.0 3.2 3.1

Vitamin E preparations 2,598 3,251 -653 -20.1 1.3 1.8

Vitamin K preparations 2,528 3,081 -553 -17.9 1.2 1.7

Multivitamin preparations (excluding Vitamins A and D

mixtures) 55,080 51,364 3,716 7.2 27.0 28.0

Miscellaneous vitamins 10,003 7,241 2,762 38.1 4.9 4.0

17

(14) Hormones (including antihormones)

The amount of production of hormones stood at 182.9 billion yen, which made up 2.7% of the amount

of gross drug production, up 24.2 billion yen (15.3%) from the previous year.

Breakdown is indicated in Table 17. The amount of production was the largest with other hormones

(including antihormones), which made up 53.5% of total, followed by thyroid and para-thyroid hormone

preparations (22.2%), adrenal hormone preparations (10.0%).

Table 17. Amount of production of hormones




Total 182,902 158,691 24,211 15.3 100.0 100.0

Pituitary hormone preparations 17,828 16,952 876 5.2 9.7 10.7

Salivary gland hormone preparations - 160 -160 - - 0.1

Thyroid and para-thyroid hormone preparations 40,562 40,309 253 0.6 22.2 25.4

Anabolic steroids and preparations 27 27 - - 0.0 0.0

Adrenal hormone preparations 18,298 19,004 -706 -3.7 10.0 12.0

Androgen preparations 556 618 -62 -10.0 0.3 0.4

Estrogen and gestagen preparations 7,012 6,233 779 12.5 3.8 3.9

Mixed hormone preparations 751 708 43 6.1 0.4 0.4

Other hormones (including antihormones) 97,869 74,680 23,189 31.1 53.5 47.1

(15) Traditional Chinese medicines

The amount of production of traditional Chinese medicines stood at 154.7 billion yen, which made up 2.3% of


Table 18. Amount of production of traditional Chinese medicines




Total 154,678 146,395 8,283 5.7 100.0 100.0

Traditional Chinese medicines 154,678 146,395 8,283 5.7 100.0 100.0

18

3. Status of production by drug form category, by classification according to use and by therapeutic

category of drugs

(1) Drug form category

Breakdown of the amount of production of drugs by drug form category is indicated in Table 19.

The amount of production was the largest with tablets, which made up 47.4%, followed by external

solutions (6.7%) and capsules (6.5%). These three categories made up 60.6% of total.

With regards to changes from the previous year, increase was indicated in external solutions (102.3

billion yen, 28.6%), injectable solutions (45.3 billion yen, 13.1%), and capsules (33.5 billion yen, 8.2%).

On the other hand, decrease was shown in injectable powders (22.9 billion yen, 8.5%), oral liquid

preparations (5.9 billion yen, 3.4%), and tablets (3.8 billion yen, 0.1%).

Table 19. Amount of production by drug form category of drugs

Drug form classification Amount of production Year-on-year change Percent distribution


Mil. Yen Mil. yen Mil. yen % % %

Total 6,820,413 6,589,762 230,651 3.5 100.0 100.0

Powders and granules, etc. 382,505 371,010 11,495 3.1 5.6 5.6

Tablets 3,230,842 3,234,652 -3,810 -0.1 47.4 49.1

Pills 14,952 14,618 334 2.3 0.2 0.2

Capsules 442,634 409,149 33,485 8.2 6.5 6.2

Oral liquid preparations 165,346 171,200 -5,854 -3.4 2.4 2.6

Injectable solutions 390,366 345,097 45,269 13.1 5.7 5.2

Injectable powders 245,996 268,894 -22,898 -8.5 3.6 4.1

External solutions 459,913 357,631 102,282 28.6 6.7 5.4

Aerosols 16,781 14,069 2,712 19.3 0.2 0.2

Ointments and creams 170,963 158,268 12,695 8.0 2.5 2.4

Suppositories 12,577 13,541 -964 -7.1 0.2 0.2

Plasters, cataplasms and dermatologic pastes 219,583 210,838 8,745 4.1 3.2 3.2

Others 1,067,955 1,020,795 47,160 4.6 15.7 15.5

19

(2) Classification according to use

Breakdown of the amount of production by classification according to use of drugs is indicated in Table

20.

The amount of production of prescription drugs stood at 5,996.9 billion yen, which made up 87.9% of

total, up 128.0 billion yen (2.2%) from the previous year. On the other hand, the amount of production of

other drugs was 823.5 billion yen, which made up 12.1% of total, up 102.7 billion yen (14.2%) from the

previous year.

Table 20. Amount of production by classification according to use

Classification according to use Amount of production Year-on-year change Percent distribution



Total 6,820,413 6,589,762 230,651 3.5 100.0 100.0

Prescription drugs 5,996,890 5,868,927 127,963 2.2 87.9 89.1

Domestic drugs 4,413,942 4,301,373 112,569 2.6 64.7 65.3

Import drugs * 1,582,949 1,567,554 15,395 1.0 23.2 23.8

Other medicines 823,523 720,835 102,688 14.2 12.1 10.9

OTC drugs 804,561 700,376 104,185 14.9 11.8 10.6

Drugs for household delivery 18,962 20,459 -1,497 -7.3 0.3 0.3

(3) Therapeutic category

Breakdown of the amount of production by main therapeutic category of drugs is indicated in Table 21.

Except Dermatologic preparations and public health agents, the proportion of prescription drugs is larger

than that of other drugs.

The proportion of other drugs is also relatively high in vitamins (38.6%), nutrients, tonics (33.2%), and

sensory organ agents (31.9%) etc.

20

Table 21. Amount of production by main therapeutic category

Ranking of

amount of

productions Main therapeutic category of drugs

Total Prescription drugs

Sub-total Domestic

Amount of

production Proportion

Amount of


Amount of


Mil. yen % Mil. yen % Mil. yen %

Total 6,820,413 100.0 5,996,890 87.9 4,413,942 64.7

1 Cardiovascular agents 1,088,475 100.0 1,078,794 99.1 595,916 54.7

2 Central nervous system agents 784,182 100.0 648,450 82.7 336,428 42.9

3 Other agents affecting metabolism 690,568 100.0 646,752 93.7 524,957 76.0

4 Digestive organ agents 464,073 100.0 381,439 82.2 301,796 65.0

5 Blood and body fluid agents 461,825 100.0 461,734 100.0 344,318 74.6

6 Dermatologic preparations 450,583 100.0 224,032 49.7 190,398 42.3

7 Biological preparations 328,161 100.0 328,161 100.0 328,081 100.0

8 Sensory organ agents 278,773 100.0 189,894 68.1 169,721 60.9

9 Extracorporeal diagnostic agents 235,797 100.0 228,878 97.1 228,567 96.9

10 Allergic agents 233,739 100.0 230,057 98.4 107,211 45.9

11 Antineoplastics 227,490 100.0 227,490 100.0 166,855 73.3

12 Antibiotics 219,483 100.0 219,483 100.0 181,113 82.5

13 Vitamins 203,883 100.0 125,120 61.4 121,689 59.7

14 Hormones (including antihormones) 182,902 100.0 182,614 99.8 125,080 68.4

15 Traditional Chinese medicines 154,678 100.0 126,614 81.9 126,401 81.7

16 Urogenital and anal organ agents 147,680 100.0 140,375 95.1 96,490 65.3

17 Nutrients, tonics 146,492 100.0 97,821 66.8 97,734 66.7

18 Respiratory organ agents 119,017 100.0 94,361 79.3 80,037 67.2

19 Chemotherapeutics 116,031 100.0 115,583 99.6 84,726 73.0

20 Intracorporeal diagnostic agents (excluding

extracorporeal diagnostic agents) 53,742 100.0 53,742 100.0 21,038 39.1

21 Radioactive drugs 46,797 100.0 46,797 100.0 46,797 100.0

22 Dialysis agents 43,404 100.0 43,404 100.0 43,404 100.0

23 Peripheral nervous system agents 30,085 100.0 29,526 98.1 26,168 87.0

24 Public health agents 19,345 100.0 3,874 20.0 3,874 20.0

25 Other agents not mainly for therapeutic

purpose 18,901 100.0 16,519 87.4 11,189 59.2

Others 74,306 100.0 55,378 74.5 53,954 72.6

(Note) The ranking in the main therapeutic category of drugs is based on the order of amount of production in 2015.

21

and by classification according to use of drugs

Other drugs

Import* Sub-total OTC drugs Drugs for household delivery

Amount of


Amount of


Amount of


Amount of


Mil. yen % Mil. yen % Mil. yen % Mil. yen %

1,582,949 23.2 823,523 12.1 804,561 11.8 18,962 0.3

482,879 44.4 9,681 0.9 8,888 0.8 793 0.1

312,022 39.8 135,733 17.3 130,510 16.6 5,222 0.7

121,795 17.6 43,816 6.3 41,901 6.1 1,915 0.3

79,643 17.2 82,634 17.8 79,754 17.2 2,880 0.6

117,416 25.4 91 0.0 91 0.0 - -

33,634 7.5 226,551 50.3 224,809 49.9 1,742 0.4

80 - - - - - - -

20,173 7.2 88,879 31.9 87,976 31.6 903 0.3

311 0.1 6,919 2.9 6,919 2.9 - -

122,846 52.6 3,682 1.6 3,647 1.6 35 -

60,635 26.7 - - - - - -

38,370 17.5 - - - - - -

3,431 1.7 78,763 38.6 75,018 36.8 3,745 1.8

57,533 31.5 289 0.2 289 0.2 - -

213 0.1 28,065 18.1 27,139 17.5 926 0.6

43,885 29.7 7,305 4.9 7,304 4.9 1 0.0

87 0.1 48,671 33.2 48,414 33.0 257 0.2

14,323 12.0 24,656 20.7 24,186 20.3 471 0.4

30,857 26.6 448 0.4 448 0.4 - -

32,705 60.9 - - - - - -

- - - - - - - -

- - - - - - - -

3,358 11.2 559 1.9 555 1.8 4 0.0

- - 15,471 80.0 15,471 80.0 - -

5,330 28.2 2,383 12.6 2,383 12.6 - -

1,424 1.9 18,928 25.5 18,858 25.4 70 0.1

22

4. The amount of production by region of drugs

The amount of production by prefecture of drugs is indicated in Table 22. Production increased in 22 of 47

prefectures. Increase was the largest in Tokyo at 62.6 billion yen (18.9%), while decrease was the largest in

Sizuoka at 137.4 billion yen (22.1%).

Table 22. Amount of production by prefecture

Ranking Prefecture Amount of production Year-on-year change Percent distribution



All Japan 6,820,413 6,589,762 230,651 3.5 100.00 100.00

1 Toyama 732,544 616,256 116,288 18.9 10.74 9.35

2 Saitama 604,101 641,721 -37,620 -5.9 8.86 9.74

3 Tokyo 555,407 393,867 161,540 41.0 8.14 5.98

4 Osaka 495,375 510,234 -14,859 -2.9 7.26 7.74

5 Sizuoka 455,063 483,488 -28,425 -5.9 6.67 7.34

6 Kanagawa 317,689 319,327 -1,638 -0.5 4.66 4.85

7 Tochigi 281,624 291,258 -9,634 -3.3 4.13 4.42

8 Hyogo 250,668 252,128 -1,460 -0.6 3.68 3.83

9 Tokushima 239,373 218,677 20,696 9.5 3.51 3.32

10 Shiga 213,266 214,146 -880 -0.4 3.13 3.25

11 Yamagata 203,813 200,682 3,131 1.6 2.99 3.05

12 Yamaguchi 198,667 199,929 -1,262 -0.6 2.91 3.03

13 Aichi 185,616 173,891 11,725 6.7 2.72 2.64

14 Ibaraki 180,513 180,662 -149 -0.1 2.65 2.74

15 Chiba 157,197 142,326 14,871 10.4 2.30 2.16

16 Gifu 145,304 173,801 -28,497 -16.4 2.13 2.64

17 Fukuoka 120,549 129,724 -9,175 -7.1 1.77 1.97

18 Iwate 117,711 115,058 2,653 2.3 1.73 1.75

19 Saga 117,677 108,232 9,445 8.7 1.73 1.64

20 Mie 101,824 108,232 -6,408 -5.9 1.49 1.64

21 Ishikawa 97,494 86,119 11,375 13.2 1.43 1.31

22 Fukui 89,566 81,489 8,077 9.9 1.31 1.24

23 Kyoto 87,906 79,994 7,912 9.9 1.29 1.21

24 Nagano 87,763 86,791 972 1.1 1.29 1.32

25 Fukushima 86,220 105,144 -18,924 -18.0 1.26 1.60

26 Akita 82,784 79,483 3,301 4.2 1.21 1.21

27 Gunma 78,459 84,390 -5,931 -7.0 1.15 1.28

28 Yamanashi 78,350 82,216 -3,866 -4.7 1.15 1.25

29 Kagawa 69,580 60,049 9,531 15.9 1.02 0.91

30 Okayama 66,923 62,907 4,016 6.4 0.98 0.95

31 Kumamoto 61,204 55,544 5,660 10.2 0.90 0.84

32 Hokkaido 55,961 58,066 -2,105 -3.6 0.82 0.88

33 Nara 47,638 40,048 7,590 19.0 0.70 0.61

34 Ehime 32,982 27,153 5,829 21.5 0.48 0.41

35 Niigata 29,350 32,611 -3,261 -10.0 0.43 0.49

36 Hiroshima 24,432 21,138 3,294 15.6 0.36 0.32

37 Miyagi 24,162 24,885 -723 -2.9 0.35 0.38

38 Oita 18,481 21,561 -3,080 -14.3 0.27 0.33

39 Miyazaki 9,828 10,428 -600 -5.8 0.14 0.16

40 Shimane 9,010 7,583 1,427 18.8 0.13 0.12

41 Wakayama 3,585 3,583 2 0.1 0.05 0.05

42 Okinawa 2,486 2,488 -2 -0.1 0.04 0.04

43 Kagoshima 1,110 1,080 30 2.8 0.02 0.02

44 Nagasaki 542 628 -86 -13.7 0.01 0.01

45 Kochi 310 425 -115 -27.1 0.00 0.01

46 Aomori 299 311 -12 -3.9 0.00 0.00

47 Tottori 10 10 - - 0.00 0.00

(Note) The ranking of prefectures is based on the order of amounts of production in 2015.

23

5. Composition of drugs by employee size and by production size

(1) Composition by employee size

1) The number of manufacturing plants by employee scale (monthly average) is indicated in Table 23,

which shows that 1,210 (71.7%) of 1,687 manufacturing plants had fewer than 50 employees. The

number of manufacturing plants with 50 or more and below 300 employees stood at 402 (23.8%),

and 75 (4.4%) of all manufacturing plants had 300 or more employees.

Table 23. The number of manufacturing plants by employee size (monthly average)

Employee size The number of manufacturing plants Percent distribution

2015 2014 2015 2014

% %

Total 1,687 1,693 100.0 100.0

9 or below 631 643 37.4 38.0

10 - 49 579 576 34.3 34.0

50 - 99 181 182 10.7 10.8

100 - 299 221 218 13.1 12.9

300 - 499 55 53 3.3 3.1

500 - 999 18 20 1.1 1.2

1,000 and over 2 2 0.1 0.1

2) The amount of production by employee size (monthly average) is indicated in Table 24, which

shows that the amount of production at manufacturing plants with employees fewer than 50, which

make up 71.7% of all, only stood at 295.6 billion yen (6.4%). In contrast, manufacturing plants with

50 or more and below 300 employees produce 2,623.3 billion yen (57.1%), and those with 300 or

more employees produce 1,674.9 billion yen (36.5%).

Table 24. Amount of production by employee size (monthly average)

Employee size Amount of production Percent distribution

2015 2014 2015 2014

Mil. yen Mil. yen % %

Total 4,593,816 4,516,911 100.0 100.0

9 or below 31,504 26,799 0.7 0.6

10 - 49 264,046 280,833 5.7 6.2

50 - 99 507,723 471,604 11.1 10.4

100 - 299 2,115,625 2,113,483 46.1 46.8

300 - 499 1,176,513 1,027,154 25.6 22.7

500 - 999 454,316 555,880 9.9 12.3

1000 and over 44,088 41,158 1.0 0.9

24

(2) Composition by production size

Table 25 indicates the number of manufacturing plants and the amount of production by production size

of drugs. While the number of manufacturing plants whose internal production and/or contract the amount

of production in a month stood below 100 million yen stood at 1,350 (80.0%), their amount of production

was 126.9 billion yen, which made up only 2.8% of total internal production and/or contract production.

In contrast, the number of manufacturing plants whose amount of production reached or exceeded 100

million yen was only 337 (20.0%), but their amount of production reached 4,466.9 billion yen, which

made up 97.2%.

Table 25. The number of manufacturing plants and amount of production by production scale

Monthly amount of production

The number of manufacturing plants with

production etc. Amount of production

Monthly average Percent distribution Amount Percent distribution

2015 2014 2015 2014 2015 2014 2015 2014

% % Mil. yen Mil. yen % %

Total 1,687 1,693 100.0 100.0 4,593,816 4,516,909 100.0 100.0

Less than 1 million yen 784 781 46.5 46.1 867 850 0.0 0.0

1 million - less than 5 million yen 233 236 13.8 13.9 6,816 6,682 0.1 0.1





500 million - below 1 billion yen 59 59 3.5 3.5 502,149 507,385 10.9 11.2

1 billion yen and over 104 102 6.2 6.0 3,448,473 3,375,548 75.1 74.7

6. Status of import and export of drugs

Statistics of import of drugs have been clarified based on reports from marketing authorization holder

offices of drugs, and from manufacturing plants of drugs, with regards to import of final products and to

domestic packing production from imported preparations. Statistics of export are also based on reports from

marketing authorization holder offices of drugs, and from manufacturing plants of drugs, which signifies that

trades by way of trading companies etc. are not identified. Research does not cover import and export of drugs

other than final products (e.g. bulk, raw powder). Therefore, use of the following figures requires relevant

precautions.

25

(1) Export

As indicated in Table 26, export amount of drugs in 2015 stood at 153.5 billion yen, up 27.5 billion yen

(21.8%) from the previous year.

Trends in export amount by geographic region are indicated in Table 27. The amount was the largest

with Asia at 76.1 billion yen (49.6%), followed by North America (51.9 billion yen, 33.8%), and Europe

(18.3 billion yen, 11.9%).

Export amount by major country, and by major country and by sub therapeutic category of prescription

drugs, is respectively indicated in Table 28 and Table 29.

Total 26. Trends in the amount of exported drugs

(Index 2011 = 100)

Year Amount of export

Year-on-year change

Index Change Proportion


2011 138,402 -6,061 -4.2 100.0

2012 137,624 -778 -0.6 99.4

2013 129,686 -7,938 -5.8 93.7

2014 126,046 -3,640 -2.8 91.1

2015 153,512 27,466 21.8 110.9

Table 27. Trends in the amount of exported drugs by geographic region

(Index 2011 = 100)

Geographic

region

2011 2012 2013 2014 2015

Amount of

export Index

Amount of

export Index

Amount of

export Index

Amount of

export Index

Amount of

export Index

Mil. yen % Mil. yen % Mil. yen % Mil. yen % Mil. Yen %

Total 138,402 100.0 137,624 99.4 129,686 93.7 126,046 91.1 153,512 110.9

Asia 59,802 100.0 64,401 107.7 59,270 99.1 64,713 108.2 76,142 127.3

Europe 13,182 100.0 14,122 107.1 14,471 109.8 15,049 114.2 18,253 138.5

North America 61,466 100.0 51,357 83.6 47,296 76.9 39,805 64.8 51,924 84.5

South America 1,228 100.0 1,350 109.9 1,645 134.0 910 74.1 663 54.0

Africa 346 100.0 298 86.1 398 115.0 204 59.0 217 62.7

Oceania 74 100.0 81 109.5 72 97.3 12 16.2 171 231.1

Others 2,303 100.0 6,016 261.2 6,534 283.7 5,354 232.5 6,143 266.7

(EU Regrouped) 9,715 100.0 11,473 118.1 12,044 124.0 12,936 133.2 16,119 165.9

26

Table 28. Amount of exported drugs by major country

Ranking Country name

Amount of export Percent distribution

2015 2014 2015 2014


Total 153,512 126,046 100.0 100.0

1 USA 51,473 39,469 33.5 31.3

2 China 24,987 23,149 16.3 18.4

3 Korea 18,127 15,879 11.8 12.6

4 Taiwan 15,331 9,877 10.0 7.8

5 Hong Kong 7,790 6,174 5.1 4.9

6 Germany 6,597 6,355 4.3 5.0

7 Thailand 2,458 2,009 1.6 1.6

8 Spain 2,339 1,059 1.5 0.8

9 UK 2,235 1,473 1.5 1.2

10 Vietnam 1,709 1,998 1.1 1.6

Others 20,466 18,604 13.3 14.8

27

Table 29. Amount of export by major country and by sub therapeutic category of

prescription drugs

Ranking Therapeutic category Amount of export

Percent

distribution Major exporters and the amounts of export

(top 5 nations) 2015 2014 2015 2014

Mil. yen Mil. yen % % Mil. yen

Total 138,871 112,110 100.0 100.0 -

1 Biochemical testing reagents 36,687 32,799 26.4 29.3 USA 33,408 France 802 China 519

Germany 493 Switzerland 171

2 Agents affecting metabolism, not

elsewhere classified 13,789 10,421 9.9 9.3

USA 5,160 China 2,537 Korea 2,202

Taiwan 1,808 Ireland 433

3 Other antineoplastics 11,869 925 8.5 0.8 USA 6,569 Taiwan 4,374 Germany 373

Korea 236 Turkey 109

4 Local anesthetics 7,268 5,119 5.2 4.6 Germany 4,179 USA 3,005 Singapore 47

Switzerland 23 Korea 13

5 Ophthalmic agents 5,848 5,757 4.2 5.1 Korea 2,227 China 1,925 Vietnam 769

Taiwan 228 Thailand 25

6 Antibiotics acting mainly on

gram-positive and gram-negative bacteria 5,727 6,123 4.1 5.5

China 2,556 Taiwan 1,480 Vietnam 600

Korea 341 Malaysia 292

7 Serum-immunological testing reagents 5,448 5,165 3.9 4.6 Spain 1,235 China 431 France 356 Korea

290 Thailand 140

8 Antitumor antibiotics 5,051 4,731 3.6 4.2 UK 2,117 Germany 1,196 China 222

Russia 206 Turkey 171

9 Antibiotics acting mainly on mold 4,263 3,532 3.1 3.2 China 1,426 USA 1,174 Ireland 327 Taiwan

264 Brazil 200

10 Other urogenital and anal organ agents 3,526 3,697 2.5 3.3 Korea 2,962 Taiwan 504 China 60

11 Other dermatologic preparations 3,480 2,493 2.5 2.2 China 1,564 Ireland 888 Korea 254 USA

193 Saudi Arabia 187

12 Other blood and body fluid agents 3,294 1,845 2.4 1.6 China 1,953 Taiwan 687 Korea 599

Pakistan 39 Thailand 9

13 Vitamin B preparations (excluding

Vitamin B1 preparations) 3,139 2,529 2.3 2.3

China 1,963 Saudi Arabia 524 UAE 198

Jordan 135 Thailand 89

14 Antimetabolites Peptic ulcer agents 2,836 1,951 2.0 1.7 China 2,085 Korea 507 Taiwan 147

Netherlands 54 UK 43

15 Hyperlipidemia agents 2,595 2,314 1.9 2.1 Korea 867 Taiwan 742 China 538 Thailand

428 Indonesia 20

16 Other digestive organ agents 2,183 1,621 1.6 1.4 Korea 1,589 Russia 156 China 147

Malaysia 57 Thailand 25

17 Antitumor plant extract preparations 2,125 1,777 1.5 1.6 China 785 Russia 363 Turkey 332

Germany 234 Korea 178

18 Peptic ulcer agents 1,884 2,148 1.4 1.9 Korea 1,105 China 456 Hong Kong 204

Taiwan 119

19 Antibiotics that mainly affect acid-fast

bacilli 1,431 1,346 1.0 1.2 India 204 Netherlands 43

20 Blood test reagents 1,312 939 0.9 0.8 Spain 915 China 292 Korea 5 Italy 5

Taiwan 2

Others 15,116 14,878 10.9 13.3 -

28

(2) Import

As Table 30 indicates, import amount of drugs in 2015 stood at 4,220.0 billion yen, up 833.6 billion yen

(26.1%) from 3,188.4 billion yen in 2014.

Import amount by geographic region is indicated in Table 31. The amount was the largest in Europe at

2,884.8 billion yen (71.7%), followed by North America (928.3 billion yen, 23.1%) and Asia (189.5

billion yen, 4.7%).

Import amount by major country, and by major country and by sub therapeutic category of prescription

drugs, is respectively indicated in Table 32 and Table 33.

Table 30. Trends in the amount of imported drugs

(Index 2011 = 100)

Year Amount of import Year-on-year change

Index Change Change ratio


2011 2,531,292 214,740 9.3 100.0

2012 2,817,411 286,119 11.3 111.3

2013 3,077,303 259,892 9.2 121.6

2014 3,188,419 111,116 3.6 126.0

2015 4,022,045 833,626 26.1 158.9

29

Table 31. Trends in the amount of imported drugs by geographic region

Geographic region Amount of import Percent distribution

2015 2014 2015 2014


Total 4,022,045 3,188,419 100.0 100.0

Asia 189,532 137,395 4.7 4.3

Europe 2,884,787 2,226,655 71.7 69.8

North America 928,286 805,148 23.1 25.3

South America 2,637 1,704 0.1 0.1

Africa 1,919 607 0.0 0.0

Oceania 14,871 16,883 0.4 0.5

Others 14 28 0.0 0.0

(EU Regrouped) 2,262,232 1,633,542 56.2 51.2

30

Table 32. Amount of imported drugs by major country

Ranking Country name

Amount of import Percent distribution

2015 2014 2015 2014


Total 4,022,045 3,188,419 100.0 100.0

1 USA 691,510 595,424 17.2 18.7

2 Ireland 666,381 58,496 16.6 1.8

3 Germany 621,917 547,468 15.5 17.2

4 Switzerland 613,326 585,123 15.2 18.4

5 France 214,783 222,016 5.3 7.0

6 Puerto Rico (USA) 189,083 168,589 4.7 5.3

7 Belgium 164,456 184,223 4.1 5.8

8 UK 155,895 140,782 3.9 4.4

9 Singapore 123,576 82,678 3.1 2.6

10 Sweden 103,646 98,000 2.6 3.1

Others 477,471 505,620 11.9 15.9

31

Table 33. Amount of imported drugs by major country and

by sub therapeutic category of drugs

Ranking Therapeutic category Amount of import

Percent

distribution Major importers and the amounts of import

(top 5 nations) 2015 2014 2015 2014


Total 3,999,838 3,169,208 100.0 100.0 -

1 Antivirals 869,177 157,209 21.7 5.0 Ireland 601,201 USA 124,054 Germany 65,714

Switzerland 24,351 UK 10,296

2 Other antineoplastics 551,545 487,404 13.8 15.4 Switzerland 310,381 USA 89,016 Germany

61,020 UK 37,882 Belgium 23,285

3 Agents affecting metabolism, not

elsewhere classified 241,398 224,186 6.0 7.1

Germany 89,807 Puerto Rico (USA) 50,279

Switzerland 35,173 USA 28,836 Spain 17,078

4 Antidiabetic agents 218,104 203,726 5.5 6.4 Singapore 60,644 Switzerland 36,961 Denmark

31,305 USA 28,667 Germany 26,206

5 Ophthalmic agents 148,729 118,303 3.7 3.7 Germany 54,991 Belgium 51,174 Switzerland

28,814 Finland 5,854 USA 4,795

6 Other hormones (including

antihormones) 136,864 135,118 3.4 4.3

Switzerland 35,977 UK 27,284 Germany

26,837 Denmark 18,903 USA 14,351

7 Psychotropics 126,491 132,837 3.2 4.2 Spain 33,938 USA 33,867 UK 27,241

Canada 9,363 Netherland 5,113

8 Hyperlipidemia agents 123,919 119,705 3.1 3.8 Puerto Rico (USA) 72,750 Singapore 51,148

Taiwan 21

9 Anticoagulants 112,850 104,279 2.8 3.3 Germany 63,676 Puerto Rico (USA) 38,970

India 8,871 Singapore 658 France 450

10 Other central nervous system

agents 105,891 86,404 2.6 2.7

Germany 84,292 India 7,212 France 5,217

Italy 4,580 USA 4,414

11 Other respiratory organ agents 89,622 96,160 2.2 3.0 France 34,274 Sweden 24,367 UK 16,456

Australia 6,685 Switzerland 5,484

12 Other digestive organ agents 88,206 93,372 2.2 2.9 USA 73,425 Korea 4,782 Ireland 3,777

Switzerland 2,589 Czech 1,708

13 Other allergic agents 82,845 66,943 2.1 2.1 Switzerland 38,910 USA 21,807 France 13,797

UK 4,114 Suriname 2,633

14 Vaccines 70,841 88,006 1.8 2.8 USA 48,316 France 12,251 Belgium 10,274

15 Other cardiovascular agents 68,118 66,464 1.7 2.1 Switzerland 20,739 Italy 16,174 Ireland 9,382

Canada 9,084 France 4,388

16 Peptic ulcer agents 64,333 56,648 1.6 1.8 Sweden 55,469 USA 7,647 UK 526 Spain

356 Switzerland 172

17 Human blood preparations 56,891 59,954 1.4 1.9 Belgium 21,709 USA 11,600 Denmark 8,998

Switzerland 4,875 Austria 4,006

18 Serum-immunological testing

reagents 53,869 64,614 1.3 2.0

USA 32,202 Germany 11,847 Sweden 5,172

UK 3,327 France 923

19 Pituitary hormone preparations 49,831 41,835 1.2 1.3 Denmark 14,453 Belgium 13,238 France 8,657

Sweden 6,288 Switzerland 4,828

20 Thyroid and para-thyroid

hormone preparations 46,144 50,546 1.2 1.6 France 46,144

Others 694,170 715,495 17.4 22.6 -

32

II Sanitary materials

1. Status of production of sanitary materials

As Table 34 indicates, the amount of production of sanitary materials in 2015 stood at 56.8 billion yen, up

2.2 billion yen (4.1%) from 54.6 billion yen in 2014. Breakdown by product is indicated in Table 35. Large

products increased by 1.9% and final products increased by 4.2%.

Table 34. Trends in the amount of production of sanitary materials

(Index 2011 = 100)

Year Amount of

production

Year-on-year change

Index

Monthly average of

the amount of

production Change Change ratio


2011 51,804 -207 -0.4 100.0 4,317

2012 51,306 -498 -1.0 99.0 4,276

2013 52,719 1,413 2.8 101.8 4,393

2014 54,567 1,848 3.5 105.3 4,547

2015 56,790 2,223 4.1 109.6 4,733

Table 35. Amount of production of sanitary materials

Products Amount of production Year-on-year change Percent distribution



Total 56,790 54,567 2,223 4.0 100.0 100.0

A Large products 3,116 3,057 59 1.9 5.5 5.6

A1 Medical absorbent cotton 1,054 1,078 -24 -2.2 1.9 2.0

A2 Quasi-drug absorbent cottons 72 75 -3 -3.6 0.1 0.1

A3 Medical gauzes 1,989 1,903 86 4.5 3.5 3.5

B Final products 53,674 51,510 2,164 4.2 94.5 94.4

B1 Sanitary treatment products 53,674 51,510 2,164 4.2 94.5 94.4

Notes: 1) “Medical absorbent cottons” and “Medical gauzes” respectively refer to absorbent cottons and gauzes that are medical devices.

2) “Quasi-drug absorbent cottons” and “sanitary treatment products” respectively refer to absorbent cottons and sanitary treatment napkins that

are quasi-drugs.

33

2. Status of production of sanitary materials by region

The amount of production of sanitary materials by region is indicated in Table 36, which shows that the

amount was the largest in Kanto Etsusei at 28.9 billion yen (50.9%), followed by Shikoku (24.1 billion yen

42.4%), and Hokkaido Tohoku (3.5 billion yen, 6.1%). These three regions make up 99.4% of total.

Table 36. Amount of production of sanitary materials by region

Region

The number of

manufacturing plants Amount of production Percent distribution

(monthly average) 2015 2014 2015 2014


Total 25 56,790 54,567 100.0 100.0

Hokkaido Tohoku 3,464 3,341 6.1 6.1

Kanto Etsusei 7 28,880 27,867 50.9 51.1

Tokai Hokuriku 3 46 98 0.1 0.2

Kinki - - - -

Chugoku 187 185 0.3 0.3

Shikoku 10 24,086 23,000 42.4 42.2

Kyushu 3 126 77 0.2 0.1

34

III Medical devices

Domestic amount of production of medical devices in 2015 stood at 1,945.6 billion yen, and import amount

was 1,424.9 billion yen. The combined amount was 3,370.5 billion yen. Domestic amount of shipment stood at

2,717.3 billion yen, while export amount stood at 622.6 billion yen. The combined amount was 3,339.9 billion

yen.

1. Status of production of medical devices

(1) Trends in the amount of production of medical devices over the past ten years are indicated in Table 37.

The amount of production decreased in 2015 by 43.9 billion yen (2.2%) from the previous year. Trends

over the past ten years showed that the amount increased by 7.4% in 2006, dropped by 0.2% in 2007,

went up again by 0.5% in 2008, and decreased by 6.9% in 2009 again, alternately repeating increase and

decrease. While the amount increased consecutively by 8.7% in 2010, by 5.5% in 2011, by 4.8% in

2012, by 0.5% in 2013, and by 4.4% in 2014, the figure went down again by 2.2% in 2015.

Table 37. Trends in the amount of production of medical devices

(Index 2006 = 100)

Year Amount of production Year-on-year change

Index Monthly average

of the amount of production Change Proportion


2006 1,688,344 115,943 7.4 100.0 140,695

2007 1,684,465 -3,879 -0.2 99.8 140,372

2008 1,692,352 7,887 0.5 100.2 141,029

2009 1,576,198 -116,154 -6.9 93.4 131,350

2010 1,713,439 137,241 8.7 101.5 142,787

2011 1,808,476 95,037 5.5 107.1 150,706

2012 1,895,239 86,763 4.8 112.3 157,937

2013 1,905,492 10,253 0.5 112.9 158,791

2014 1,989,497 84,005 4.4 117.8 165,791

2015 1,945,599 -43,898 -2.2 115.2 162,133

(2) Table 38 indicates the amount of production of medical devices by main therapeutic category. The

amount was the largest with operating equipment and supplies at 520.8 billion yen (26.8%), followed by

diagnostic imaging system (292.0 billion yen, 15.0%), artificial internal organ apparatus and assist

device (271.4 billion yen, 14.0%).

35

Table 38. Amount of production by main therapeutic category of medical devices

Ranking Main Category Amount of production Year-on-year change Percent distribution



Total 1,945,599 1,989,497 -43,898 -2.2 100.0 100.0

1 Operating equipment and supplies 520,845 522,497 -1,652 -0.3 26.8 26.3

2 Diagnostic imaging system 291,958 290,456 1,502 0.5 15.0 14.6

3 Artificial internal organ apparatus and assist

device 271,417 265,450 5,967 2.2 14.0 13.3

4 Measuring and monitoring system for

biophenomena 205,351 260,616 -55,265 -21.2 10.6 13.1

5 In vitro clinical test equipment 180,700 169,450 11,250 6.6 9.3 8.5

6 Dental material 132,794 127,813 4,981 3.9 6.8 6.4

7 Medical apparatus for home use 94,243 88,147 6,096 6.9 4.8 4.4

8 Dental equipment 55,203 52,288 2,915 5.6 2.8 2.6

9 Ophthalmic goods and related product 49,985 52,272 -2,287 -4.4 2.6 2.6

10 Related device and tool for diagnostic X-ray

equipment 49,180 53,507 -4,327 -8.1 2.5 2.7

11 Therapeutic and surgical equipment 38,212 46,432 -8,220 -17.7 2.0 2.3

12 Clinical equipment and supplies 27,167 34,265 -7,098 -20.7 1.4 1.7

13 Steel product for medical use 20,597 18,705 1,892 10.1 1.1 0.9

14 Surgical dressing and hygienic product 7,948 7,600 348 4.6 0.4 0.4

(Note) The ranking in the main therapeutic category is based on the order of amounts of production in 2015.

(3) Table 39 indicates the amount of production of medical devices by sub-sub therapeutic category at 10 billion

yen or above annually. The amount was the largest with sterile tube and catheter for blood vessel at 214.1

billion yen (11.0%), followed by clinical chemistry automated analyzer (87.5 billion yen, 4.5%), dental

gold-silver-palladium alloy (76.6 billion yen, 3.9%).

36

Table 39. Amount of production by sub-sub therapeutic category of medical devices

Ranking Sub-sub Category Amount of production Year-on-year change Percent distribution



Total 1,945,599 1,989,497 -43,898 -2.2 100.0 100.0

1 Sterile tube and catheter for blood vessel 214,144 195,908 18,236 9.3 11.0 9.8

2 Clinical chemistry automated analyzer 87,549 88,975 -1,426 -1.6 4.5 4.5

3 Dental gold-silver-palladium alloy 76,621 70,592 6,029 8.5 3.9 3.5

4 Whole body X-ray CT scanner 69,419 68,143 1,276 1.9 3.6 3.4

5 Dialyzer 68,219 66,499 1,720 2.6 3.5 3.3

6 Blood collecting and transfusion device 66,479 84,953 -18,474 -21.7 3.4 4.3

7 Video image endoscope 50,694 83,558 -32,864 -39.3 2.6 4.2

8 Ultrasonic diagnostic imaging equipment for general use 41,354 42,871 -1,517 -3.5 2.1 2.2

9 Other contact lens 39,328 38,994 334 0.9 2.0 2.0

10 Operating equipment and supplies, not elsewhere classified 38,618 30,629 7,989 26.1 2.0 1.5

11 Sterile injection needle 36,355 35,726 629 1.8 1.9 1.8

12 Photographic film for medical use 35,352 37,272 -1,920 -5.2 1.8 1.9

13 Artificial joint, bone and related device 33,978 32,848 1,130 3.4 1.8 1.7

14 Ophthalmic camera 32,228 19,571 12,657 64.7 1.7 1.0

15 Blood purifier 30,706 24,296 6,410 26.4 1.6 1.2

16 Blood cell counter 29,629 21,077 8,552 40.6 1.5 1.1

17 Infusion device 28,068 29,692 -1,624 -5.5 1.4 1.5

18 Stent 27,361 33,212 -5,851 -17.6 1.4 1.7

19 Hemodialysis apparatus 26,835 28,040 -1,205 -4.3 1.4 1.4

20 Medical electrical equipment for endoscope 26,445 42,078 -15,633 -37.2 1.4 2.1

21 Electric therapy apparatus for home use 24,350 19,852 4,498 22.7 1.3 1.0

22 Digital radiographs 24,160 20,778 3,382 16.3 1.2 1.0

23 Infusion apparatus 22,514 23,227 -713 -3.1 1.2 1.2

24 Superconducting MRI system 22,471 20,138 2,333 11.6 1.2 1.0

25 Immune reaction measuring device 20,840 16,671 4,169 25.0 1.1 0.8

26 Radiographic fluoroscopic X-ray equipment 19,528 18,444 1,084 5.9 1.0 0.9

27 Dental unit 18,380 16,087 2,293 14.3 0.9 0.8

28 Artificial heart-lung machines 17,934 17,454 480 2.8 0.9 0.9

29 Visual function testing equipment 16,888 16,001 887 5.5 0.9 0.8

30 The devices for oxygen supplier 16,214 17,382 -1,168 -6.7 0.8 0.9

31 Sterile puncture needle 15,849 16,768 -919 -5.5 0.8 0.8

32 Other ultrasonic diagnostic imaging equipment 15,613 16,960 -1,347 -7.9 0.8 0.9

33 Sterile gastrointestinal tube and catheter 15,134 20,360 -5,226 -25.7 0.8 1.0

34 Continuous electrolytic water makers 14,027 8,991 5,036 56.0 0.7 0.5

35 Angiographic X-ray equipment 13,862 13,079 783 6.0 0.7 0.7

36 Dental filling material 13,047 13,139 -92 -0.7 0.7 0.7

37 Dental drive units and hand pieces 12,860 11,195 1,665 14.9 0.7 0.6

38 Blood coagulation analyzer 12,592 10,998 1,594 14.5 0.7 0.6

39 Sterile syringe 12,323 13,709 -1,386 -10.1 0.6 0.7

40 Computed radiography 11,613 11,435 178 1.6 0.6 0.6

41 Diagnostic imaging systems, not elsewhere classified 10,998 8,497 2,501 29.4 0.6 0.4

42 Electrocardiographs and related instruments 10,944 11,026 -82 -0.7 0.6 0.6

43 Operating and treatment tables for clinical use 10,636 11,827 -1,191 -10.1 0.6 0.6

44 Non-active treatment device for endoscope 10,467 20,073 -9,606 -47.9 0.5 1.0

45 Sterile blood access for blood purification 10,151 10,617 -466 -4.4 0.5 0.5

46 Special purpose clinical chemistry analyzers 10,033 11,889 -1,856 -15.6 0.5 0.6

(Note) The ranking in the sub-sub therapeutic category of medical devices is based on the order of amounts of production in 2015.

The amounts are over 10 billion yen.

2. Status of production of medical devices by region

Table 40 indicates the amount of production of medical devices by prefecture. The amount increased in 26

prefectures from the previous year.

37

Table 40. Amount of production of medical devices by prefecture

Prefecture Amount of production Year-on-year change Percent distribution



All Japan 1,945,599 1,989,497 -43,898 -2.2 100.00 100.00

1 Shizuoka 369,970 386,540 -16,570 -4.3 19.02 19.43

2 Tochigi 201,278 191,871 9,407 4.9 10.35 9.64

3 Ibaraki 120,214 118,076 2,138 1.8 6.18 5.93

4 Saitama 115,902 117,307 -1,405 -1.2 5.96 5.90

5 Tokyo 113,623 120,860 -7,237 -6.0 5.84 6.07

6 Chiba 92,215 99,065 -6,850 -6.9 4.74 4.98

7 Oita 91,051 96,591 -5,540 -5.7 4.68 4.86

8 Fukushima 77,567 130,344 -52,777 -40.5 3.99 6.55

9 Aichi 66,286 64,244 2,042 3.2 3.41 3.23

10 Hyogo 60,789 53,960 6,829 12.7 3.12 2.71

11 Osaka 59,479 42,450 17,029 40.1 3.06 2.13

12 Yamanashi 52,651 54,001 -1,350 -2.5 2.71 2.71

13 Yamagata 45,315 26,453 18,862 71.3 2.33 1.33

14 Kyoto 41,773 36,469 5,304 14.5 2.15 1.83

15 Akita 35,319 34,011 1,308 3.8 1.82 1.71

16 Shiga 32,298 36,678 -4,380 -11.9 1.66 1.84

17 Gunma 31,488 30,328 1,160 3.8 1.62 1.52

18 Gifu 31,463 34,830 -3,367 -9.7 1.62 1.75

19 Iwate 29,392 19,226 10,166 52.9 1.51 0.97

20 Aomori 26,764 51,220 -24,456 -47.7 1.38 2.57

21 Kanagawa 24,925 31,849 -6,924 -21.7 1.28 1.60

22 Ishikawa 22,287 13,875 8,412 60.6 1.15 0.70

23 Kochi 21,581 20,193 1,388 6.9 1.11 1.01

24 Nagano 17,902 17,922 -20 -0.1 0.92 0.90

25 Miyagi 16,798 17,991 -1,193 -6.6 0.86 0.90

26 Miyazaki 15,673 15,401 272 1.8 0.81 0.77

27 Shimane 15,322 14,204 1,118 7.9 0.79 0.71

28 Yamaguchi 12,520 12,737 -217 -1.7 0.64 0.64

29 Fukuoka 11,868 10,674 1,194 11.2 0.61 0.54

30 Okayama 11,203 11,063 140 1.3 0.58 0.56

31 Kumamoto 11,032 10,464 568 5.4 0.57 0.53

32 Nara 10,426 9,643 783 8.1 0.54 0.48

33 Tokushima 8,463 8,247 216 2.6 0.43 0.41

34 Hiroshima 8,394 10,012 -1,618 -16.2 0.43 0.50

35 Tottori 6,735 9,027 -2,292 -25.4 0.35 0.45

36 Hokkaido 6,254 6,320 -66 -1.0 0.32 0.32

37 Niigata 6,013 5,853 160 2.7 0.31 0.29

38 Ehime 5,912 2,703 3,209 118.7 0.30 0.14

39 Mie 4,467 4,139 328 7.9 0.23 0.21

40 Toyama 3,742 3,935 -193 -4.9 0.19 0.20

41 Kagawa 3,470 3,503 -33 -0.9 0.18 0.18

42 Fukui 2,000 2,079 -79 -3.8 0.10 0.10

43 Saga 1,712 1,342 370 27.6 0.09 0.07

44 Kagoshima 972 906 66 7.3 0.05 0.05

45 Nagasaki 789 764 25 3.3 0.04 0.04

46 Wakayama 300 128 172 134.4 0.02 0.01

47 Okinawa - - - - - -

38

3. Composition of medical devices by production size

Table 41 indicates the number of manufacturing plants and the amount of production by production size.

Monthly amount of production was below 100 million yen at 1,234 manufacturing plants (88.0%), though

their combined amount of production only made up 153.5 billion yen (8.5%) of total internal and contracted

amount of production. In contrast, the number of manufacturing plants whose amount of production reaches

or exceeds 100 million yen was only 169 (12.0%), but their amount of production stood at 1,652.1 billion yen

(91.5%).

Table 41. The number of manufacturing plants and amount of production

of medical devices by production size

Monthly amount of

production

The number of manufacturing plants

with production Amount of production

Monthly average Percent distribution Amount Percent distribution

2015 2014 2015 2014 2015 2014 2015 2014

% % Mil. yen Mil. yen % %

Total 1,402 1,417 100.0 100.0 1,805,583 1,762,113 100.0 100.0

Less than 1 million yen 601 608 42.9 42.9 915 934 0.1 0.1

1million - less than 5 million yen 220 223 15.7 15.7 6,607 6,729 0.4 0.4





500 million - below 1 billion yen 18 18 1.3 1.2 160,079 157,555 8.9 8.9

1 billion yen and over 34 31 2.4 2.2 1,179,438 1,129,243 65.3 64.1

4. Status of import and export of medical devices

(1) Export

1) Export amount of medical devices over the past five years is indicated in Table 42.

Export amount in 2015 stood at 622.6 billion yen, up 50.2 billion yen (8.8%) from 572.3 billion

yen in 2014. Table 43 indicates export amount by main category. The amount was the largest with

diagnostic imaging system at 147.8 billion yen (23.7%), followed by in vitro clinical test

equipment (142.7 billion yen, 22.9%), and operating equipment and supplies (109.1 billion yen,

17.5%). These three products make up 64.1% of total.

2) As Table 44 indicates, export amount of medical devices by geographic region has been increasing

since 2011.

3) Table 45 indicates export amount of medical devices by country. The proportion was the largest

with the United States of America at 19.2%, followed by People’s Republic of China (13.1%),

Germany (10.3%), and the Netherlands (5.7%).

39

Table 42. Trends in the amount of exported medical devices

(Index 2011 = 100)

Year Amount of export Year-on-year change

Index Change Proportion


2011 480,851 27,491 6.1 100.0

2012 490,057 9,206 1.9 101.9

2013 530,496 40,439 8.3 110.3

2014 572,333 41,837 7.9 119.0

2015 622,584 50,251 8.8 129.5

Table 43. Amount of export by major country and by main therapeutic category

of medical devices

Ranking Main Category Amount of export Percent distribution

Major exporters and the amounts of export

(top 5 nations) 2015 2014 2015 2014


Total 622,584 572,333 100.0 100.0 -

1 Diagnostic imaging system 147,764 134,509 23.7 23.5 USA 31,136 China 20,184, Netherlands

19,658 Germany 6,299 Australia 4,636

2 In vitro clinical test equipment 142,680 132,354 22.9 23.1

Germany 37,764 Korea 21,457 USA

15,258 China 14,034 HongKong

1,168

3 Operating equipment and supplies 109,102 99,346 17.5 17.4 USA 35,415 China 11,326 Belgium

7,387 Germany 3,149 Thailand 2,263

4 Measuring and monitoring system

for biophenomena 70,946 66,845 11.4 11.7

USA 14,710 Netherlands 11,410 China

8,262 Germany 6,682 Shingapore

3,016

5 Artificial internal organ apparatus

and assist device 59,224 52,739 9.5 9.2

China 12,381 USA 5,213 Belgium

4,760 Germany 3,200 Taiwan 1,744

6 Related device and tool for

diagnostic X-ray equipment 36,590 34,057 5.9 6.0

China 11,058 India 3,894 Netherlands

3,334 USA 2.058 Vietnam 1,378

7 Dental equipment 21,120 19,377 3.4 3.4 USA 5,491 Germany 3,113 China 2,243

Switzerland 1,186 Korea 901

8 Dental material 9,223 9,408 1.5 1.6 Germany 1,675 USA 1,548 Korea 798

Russia 525 China 419

9 Therapeutic and surgical equipment 7,129 6,659 1.1 1.2 USA 1,954 Belgium 917 Germany 592

China 509 North America 366

10 Steel product for medical use 6,238 5,615 1.0 1.0 Germany 1,535 USA 1,150 Brazil

407 China 398 Russia 396

Others 12,568 11,423 2.0 2.0 -

40

Table 44. Trends in the amount of exported medical devices by geographic region

(Index 2011 = 100)

Geographic

region

2011 2012 2013 2014 2015

Amount of

export Index

Amount of

export Index

Amount of

export Index

Amount of

export Index

Amount of

export Index

Mil. yen % Mil. yen % Mil. yen % Mil. yen % Mil. yen %

Total 480,851 100.0 490,057 101.9 530,496 110.3 572,333 119.0 622,584 129.5

Asia 110,331 100.0 119,823 108.6 136,124 123.4 152,387 138.1 186,705 169.2

Europe 136,069 100.0 140,199 103.0 146,507 107.7 154,928 113.9 146,011 107.3

North America 95,514 100.0 99,836 104.5 110,043 115.2 112,958 118.3 130,662 136.8

South America 15,371 100.0 15,144 98.5 16,043 104.4 18,513 120.4 17,684 115.0

Africa 7,055 100.0 7,845 111.2 8,904 126.2 10,736 152.2 9,584 135.8

Oceania 6,348 100.0 6,515 102.6 7,645 120.4 8,669 136.6 9,802 154.4

Others 110,161 100.0 100,694 91.4 105,230 95.5 114,142 103.6 122,137 110.9

(EU Regrouped) 123,517 100.0 126,369 102.3 130,871 106.0 139,572 113.0 132,180 107.0

Table 45. Amount of exported medical devices by major country

Ranking Country name Amount of export Percent distribution

2015 2014 2015 2014


Total 622,584 572,333 100.0 100.0

1 USA 119,256 101,719 19.2 17.8

2 China 81,262 68,714 13.1 12.0

3 Germany 64,263 74,106 10.3 12.9

4 Netherlands 35,714 35,146 5.7 6.1

5 Korea 32,330 22,156 5.2 3.9

6 Belgium 13,628 12,139 2.2 2.1

7 India 9,880 7,999 1.6 1.4

8 Australia 9,034 8,168 1.5 1.4

9 Brazil 8,445 9,103 1.4 1.6

10 Taiwan 8,065 6,679 1.3 1.2

Others 240,706 226,402 38.7 39.6

41

(2) Import

1) Table 46 indicates import amount of medical devices over the past five years.

Import amount in 2015 stood at 1,424.9 billion yen, up 56.3 billion yen (4.1%) from 1,368.5 billion

yen in 2014. Table 47 indicates import amount by main category. The amount was the largest with

artificial internal organ apparatus and assist device at 356.1 billion yen (25.0%), followed by

operating equipment and supplies (339.9 billion yen, 23.9%), ophthalmic goods and related product

(199.2 billion yen, 14.0%). These three products make up 62.9% of total.

2) As Table 48 indicates, import amount of medical devices by geographic region has been increasing

since 2011.

3) Table 49 indicates import amount of medical devices by country. The proportion was the largest

with the United States of America at 43.8%, followed by Ireland (11.3%), and Germany (8.1%).

Table 46. Trends in the amount of imported medical devices

(Index 2011 = 100)

Year Amount of import

Year-on-year change

Index

Change Change ratio


2011 1,058,373 2,955 0.3 100.0

2012 1,188,388 130,015 12.3 112.3

2013 1,300,816 112,428 9.5 122.9

2014 1,368,535 67,719 5.2 129.3

2015 1,424,871 56,336 4.1 134.6

42

Table 47. Amount of import by major country and

by main therapeutic category of medical devices

Ranking Main category Amount of import Percent distribution

Major importers and the amounts of import

(top 5 nations) 2015 2014 2015 2014


Total 1,424,871 1,368,535 100.0 100.0 -

1 Artificial internal organ apparatus

and assist device 356,132 355,074 25.0 25.9

USA 143,162 Ireland 43,007

Netherlands 28,482 Switzerland 27,281

Germany 19,530

2 Operating equipment and supplies 339,854 312,341 23.9 22.8

USA 219,625 China 31,214

Thailand 13,227 Ireland 12,922 UK

9,817

3 Ophthalmic goods and related

product 199,203 187,660 14.0 13.7

Ireland 89,905 Puerto Rico (USA)

22,282 Singapore 19,639 USA

17,806 Taiwan 17,603

4 Diagnostic imaging system 122,920 140,027 8.6 10.3

USA 71,609 Germany 29,081

China 14,338 Finland 1,992

Korea 1,917

5 Therapeutic and surgical

equipment 98,140 96,906 6.9 7.1

USA 67,235 Germany 15,598

UK 5,104 China 2,794 Sweden 1,618

6 Measuring and monitoring system

for biophenomena 83,682 80,004 5.9 5.8

USA 37,064 China 22,594

Germany 11,335 Dominican Republic

3,591 Israel 1,744

7 Medical apparatus for home use 53,937 48,189 3.8 3.5

China 25,912 Denmark 8,278

Switzerland 8,069 Singapore 4,534

Malaysia 3,358

8 Dental material 41,832 36,317 2.9 2.7

Ireland 10,199 USA 9,801

Switzerland 6,836 Sweden 6,504

Germany 3,166

9 Steel product for medical use 35,197 32,236 2.5 2.4

USA 18,170 Switzerland 5,326

Germany 2,391 Ireland 1,917

Netherlands 1,571

10 Surgical dressing and hygienic

product 23,605 12,811 1.7 0.9

Malaysia 16,645 China 3,059

Thailand 2,566 USA 718 UK 223

Others 70,369 66,970 4.9 4.9 -

43

Table 48. Trends in the amount of imported medical devices by geographic region

(Index 2011 = 100)

Geographic

region

2011 2012 2013 2014 2015

Amount of

import Index

Amount of

import Index

Amount of

import Index

Amount of

import Index

Amount of

import Index

Mil. yen % Mil. yen % Mil. yen % Mil. yen % Mil. yen %

Total 1,058,373 100.0 1,188,388 112.3 1,300,816 122.9 1,368,535 129.3 1,424,871 134.6

Asia 146,336 100.0 184,506 126.1 224,060 153.1 243,317 166.3 277,406 189.6

Europe 355,181 100.0 381,210 107.3 422,793 119.0 466,322 131.3 468,840 132.0

North America 540,981 100.0 611,313 113.0 644,511 119.1 648,076 119.8 667,716 123.4

South America 539 100.0 1,969 365.3 2,161 400.9 2,448 454.2 2,676 496.5

Africa - - 12 - 19 - 12 - - -

Oceania 14,901 100.0 8,895 59.7 7,164 48.1 8,217 55.1 8,082 54.2

Others 434 100.0 482 111.1 108 24.9 144 33.2 149 34.3

(EU Regrouped) 313,333 100.0 342,403 109.3 382,519 122.1 416,660 133.0 416,464 132.9

Table 49. Amount of imported medical devices by major country

Ranking Country name Amount of import Percent distribution

2015 2014 2015 2014


Total 1,424,871 1,368,535 100.0 100.0

1 USA 624,705 612,235 43.8 44.7

2 Ireland 160,460 158,739 11.3 11.6

3 China 114,828 102,100 8.1 7.5

4 Germany 103,741 118,818 7.3 8.7

5 Switzerland 51,758 48,953 3.6 3.6

6 Netherlands 38,552 46,248 2.7 3.4

7 Singapore 37,711 35,583 2.6 2.6

8 UK 35,716 33,503 2.5 2.4

9 Malaysia 31,719 19,739 2.2 1.4

10 Thailand 31,387 27,381 2.2 2.0

Others 194,294 165,236 13.6 12.1

44

IV Quasi-drugs

1. Status of production of quasi-drugs

(1) Table 50 indicates trends in the amount of production of quasi-drugs over the past five years.

The amount of production in 2015 stood at 921.8 billion yen, down 1.4 billion yen (0.2%) from 923.2

billion yen in 2014.

(2) Table 51 indicates the amount of production of quasi-drugs by therapeutic category. The amount was the

largest with medicated cosmetics at 358.3 billion yen (38.9%), followed by hair remedies (156.5 billion

yen, 17.0%), medicated toothpastes (134.6 billion yen, 14.6%).

Table 50. Trends in the amounts of production of quasi-drugs

(Index 2011 = 100)

Year Amount of

production

Year-on-year change Index

Monthly average of

the amount of production Change Proportion


2011 814,123 4,877 0.6 100.0 67,844

2012 800,577 -13,546 -1.7 98.3 66,715

2013 925,299 124,722 15.6 113.7 77,108

2014 923,245 -2,054 -0.2 113.4 76,937

2015 921,808 -1,437 -0.2 113.2 76,817

45

Table 51. Amount of production by therapeutic category of quasi-drugs

Ranking Therapeutic category Amount of production Year-on-year change Percent distribution


Mil. yen Mil. yen Mil. Yen % % %

Total 921,808 923,245 -1,437 -0.2 100.0 100.0

1 Medicated cosmetics 358,311 356,060 2,251 0.6 38.9 38.6

2 Hair remedies 156,476 155,171 1,305 0.8 17.0 16.8

3 Medicated tooth pastes 134,626 123,433 11,193 9.1 14.6 13.4

4 Vitamin preparations

(multiple vitamins) 100,327 117,901 -17,574 -14.9 10.9 12.8

5 Insecticides 47,012 42,963 4,049 9.4 5.1 4.7

6 Bath preparations 43,733 42,251 1,482 3.5 4.7 4.6

7 Axillary deodorants 22,606 26,787 -4,181 -15.6 2.5 2.9

8 Disinfection agents 9,633 7,715 1,918 24.9 1.0 1.1

9 Vitamin preparations 9,089 9,744 -655 -6.7 1.0 1.0

10 Insect repellent 7,446 4,346 3,100 71.3 0.8 0.8

Others 32,548 36,874 -4,326 -11.7 3.5 4.0

(Note) The ranking in the therapeutic category of drugs is based on the order of amounts of production in 2015.

Table 52. Amount of production of medicated cosmetics

(Special grouped items)

Items Amount of production

Unit Production quantity

2015 2014 2015 2014

Mil. yen Mil. yen

Medicated creams 58,754 64,094 Tons 13,312 14,832

Medicated lotions 84,472 85,660 1,000 L 13,178 16,026

Medicated emulsions 63,921 54,323 1,000 L 4,969 4,512

Medicated shampoos 43,115 48,283 1,000 L 38,495 40,801

Medicated rinses 8,855 9,056 1,000 L 7,591 6,914

Medicated soaps 36,918 36,697 Tons 51,088 47,736

46

Table 53. Amount of production of hair remedies

(Special grouped items)

Items Amount of production

Unit Production quantity

2015 2014 2015 2014

Mil. yen Mil. yen

Hair growing liquids 24,068 24,528 1,000 L 3,379 4,231

Depilatories 404 346 tons 213 186

Hair dyes 100,022 98,869 tons 21,787 22,853

Depigmenting agents, de-dyeing agents 1,472 1,372 tons 837 844

Permanent wave agent 1 containing thioglycolic acid

(permanent wave agents) 1,791 2,239 1,000 L 1,193 1,307

Permanent wave agent 1 containing cysteine

(permanent wave agents) 1,164 1,368 1,000 L 745 825

Japanese straight perm agent 1 (permanent wave agents) 1,745 1,881 1,000 L 580 559

2. Status of production of quasi-drugs by region

The amount of production of quasi-drugs by region is indicated in Table 54, which shows that the amount

was the largest in Kanto Etsusei at 390.9 billion yen (42.4%), followed by Kinki (295.4 billion yen, 32.1%).

These two regions make up 74.5% of total.

Table 54. Amount of production of quasi-drugs by region

Region

The number of

manufacturing plants Amount of production Percent distribution

(monthly average) 2015 2014 2015 2014


Total 675 921,808 923,245 100.0 100.0

Hokkaido 5 926 613 0.1 0.1

Tohoku 13 17,058 14,951 1.9 1.6

Kanto Etsusei 278 390,877 397,473 42.4 43.1

Tokai Hokuriku 94 137,980 135,975 15.0 14.7

Kinki 204 295,444 281,367 32.1 30.5

Chugoku 18 42,640 55,627 4.6 6.0

Shikoku 34 22,408 23,275 2.4 2.5

Kyusyu 29 14,474 13,964 1.6 1.5

47

(Statistics) Amount of shipment by therapeutic category of drugs and by classification according to use

Ranking of

amount of

shipment

Therapeutic category

Grand total Prescription drugs

Total Domestic Export Total Domestic Export

Amount of

shipment

Percent

distribution

Amount of

shipment

Percent

distribution

Amount of

shipment

Percent

distribution

Amount of

shipment

Percent

distribution

Amount of

shipment

Percent

distribution

Amount of

shipment

Percent

distribution

Mil. yen % Mil. yen % Mil. yen % Mil. Yen % Mil. yen % Mil. yen %

Total 10,478,472 100.0 10,324,960 100.0 153,512 100.0 9,603,864 100.0 9,464,993 100.0 138,871 100.0

1 Cardiovascular agents 1,323,678 12.6 1,317,729 12.8 5,949 3.9 1,313,665 13.7 1,308,462 13.8 5,204 3.7

2 Other agents affecting metabolism 1,204,474 11.5 1,189,805 11.5 14,669 9.6 1,160,559 12.1 1,145,945 12.1 14,613 10.5

3 Central nervous system agents 1,111,981 10.6 1,111,865 10.8 116 0.1 977,464 10.2 977,436 10.3 28 0.0

4 Antineoplastics 842,596 8.0 820,717 7.9 21,880 14.3 842,596 8.8 820,717 8.7 21,880 15.8

5 Chemotherapeutics 636,894 6.1 636,797 6.2 97 0.1 636,390 6.6 636,293 6.7 97 0.1

6 Digestive organ agents 627,913 6.0 620,477 6.0 7,436 4.8 540,020 5.6 535,416 5.7 4,604 3.3

7 Blood and body fluid agents 606,418 5.8 602,634 5.8 3,784 2.5 606,327 6.3 602,543 6.4 3,784 2.7

8 Dermatologic preparations 486,721 4.6 474,449 4.6 12,272 8.0 231,540 2.4 226,322 2.4 5,218 3.8

9 Biological preparations 481,483 4.6 480,774 4.7 709 0.5 481,483 5.0 480,774 5.1 709 0.5

10 Sensory organ agents 436,396 4.2 429,827 4.2 6,569 4.3 341,533 3.6 335,458 3.5 6,075 4.4

11 Hormones (including antihormones) 427,517 4.1 426,293 4.1 1,223 0.8 427,296 4.4 426,073 4.5 1,223 0.9

12 Extracorporeal diagnostic agents 345,252 3.3 301,635 2.9 43,617 28.4 334,230 3.5 290,613 3.1 43,617 31.4

13 Allergic agents 317,245 3.0 316,575 3.1 670 0.4 312,776 3.3 312,107 3.3 669 0.5

14 Antibiotics 280,544 2.7 267,853 2.6 12,691 8.3 280,544 2.9 267,853 2.8 12,691 9.1

15 Respiratory organ agents 244,284 2.3 243,844 2.4 439 0.3 219,265 2.3 218,996 2.3 269 0.2

16 Vitamins 210,818 2.0 204,600 2.0 6,218 4.1 131,106 1.4 127,307 1.3 3,799 2.7

17 Urogenital and anal organ agents 193,816 1.8 189,820 1.8 3,996 2.6 186,498 1.9 182,502 1.9 3,996 2.9

18 Traditional Chinese medicines 156,662 1.5 156,654 1.5 8 0.0 127,710 1.3 127,705 1.3 6 0.0

19 Nutrients, tonics 149,271 1.4 146,687 1.4 2,585 1.7 99,265 1.0 97,296 1.0 1,968 1.4


extracorporeal diagnostic agents) 92,683 0.9 92,559 0.9 124 0.1 92,683 1.0 92,559 1.0 124 0.1

21 Peripheral nervous system agents 59,068 0.6 51,584 0.5 7,484 4.9 58,459 0.6 50,975 0.5 7,484 5.4

22 Dialysis agents 48,984 0.5 48,984 0.5 - - 48,984 0.5 48,984 0.5 - -

23 Radioactive drugs 48,070 0.5 47,657 0.5 413 0.3 48,070 0.5 47,657 0.5 413 0.3

24 Other agents not mainly for therapeutic purpose 30,300 0.3 30,300 0.3 - - 26,864 0.3 26,864 0.3 - -

25 Non-alkaloidal narcotics 28,362 0.3 28,362 0.3 - - 28,362 0.3 28,362 0.3 - -

Others 87,042 0.8 86,478 0.8 565 0.4 50,174 0.5 49,774 0.5 400 0.3

(Note) The ranking in the main therapeutic category of drugs is based on the order of amounts of shipment (grand total) in 2015.

48

Amount of shipment by therapeutic category of drugs and by classification according to use

Ranking of

amount of

shipment

Therapeutic category

OTC drugs Drugs for household delivery

Total Domestic Export Total Domestic Export

Amount of

shipment

Percent

distribution

Amount of

shipment

Percent

distribution

Amount of

shipment

Percent

distribution

Amount of

shipment

Percent

distribution

Amount of

shipment

Percent

distribution

Amount of

shipment

Percent

distribution

Mil. yen % Mil. yen % Mil. yen % Mil. yen % Mil. yen % Mil. yen %

Total 854,679 100.0 840,579 100.0 14,101 100.0 19,929 100.0 19,388 100.0 541 100.0

1 Cardiovascular agents 9,222 1.1 8,476 1.0 745 5.3 791 4.0 791 4.1 - -

2 Other agents affecting metabolism 41,944 4.9 41,888 5.0 56 0.4 1,971 9.9 1,971 10.2 - -

3 Central nervous system agents 128,589 15.0 128,509 15.3 79 0.6 5,928 29.7 5,920 30.5 8 1.5

4 Antineoplastics - - - - - - - - - - - -

5 Digestive organ agents 504 0.1 504 0.1 - - - - - - - -

6 Blood and body fluid agents 84,953 9.9 82,526 9.8 2,426 17.2 2,941 14.8 2,535 13.1 406 75.0

7 Biological preparations 91 0.0 91 0.0 - - - - - - - -

8 Sensory organ agents 253,311 29.6 246,263 29.3 7,048 50.0 1,870 9.4 1,864 9.6 6 1.1

9 Dermatologic preparations - - - - - - - - - - - -

10 Hormones (including antihormones) 93,918 11.0 93,538 11.1 379 2.7 945 4.7 831 4.3 115 21.2

11 Extracorporeal diagnostic agents 221 0.0 221 0.0 - - - - - - - -

12 Chemotherapeutics 11,022 1.3 11,022 1.3 - - - - - - - -

13 Allergic agents 4,439 0.5 4,439 0.5 - - 29 0.1 29 0.1 - -

14 Antibiotics - - - - - - - - - - - -

15 Respiratory organ agents 24,529 2.9 24,359 2.9 170 1.2 489 2.5 489 2.5 - -

16 Vitamins 75,965 8.9 73,552 8.8 2,414 17.1 3,747 18.8 3,741 19.3 6 1.1

17 Urogenital and anal organ agents 7,317 0.9 7,317 0.9 - - 1 0.0 1 0.0 - -

18 Nutrients, tonics 28,055 3.3 28,053 3.3 2 0.0 897 4.5 897 4.6 - -

19 Traditional Chinese medicines 49,756 5.8 49,139 5.8 616 4.4 251 1.3 251 1.3 - -


extracorporeal diagnostic agents) - - - - - - - - - - - -

21 Peripheral nervous system agents 606 0.1 606 0.1 - - 3 0.0 3 0.0 - -

22 Dialysis agents - - - - - - - - - - - -

23 Other agents not mainly for therapeutic purpose - - - - - - - - - - - -

24 Radioactive drugs 3,436 0.4 3,436 0.4 - - - - - - - -

25 Non-alkaloidal narcotics - - - - - - - - - - - -

Others 36,803 4.3 36,639 4.4 164 1.2 65 0.3 65 0.3 - -

(Note) The ranking in the main therapeutic category of drugs is based on the order of amounts of shipment (grand total) in 2015.

49

Amount of shipment by main category of medical devices

Ranking

of

amounts

of

shipment

Main Category Total Percent

distribution Domestic

Percent

distribution Export

Percent

distribution 1

Mil. yen % Mil. yen % Mil. yen %

Total 3,339,928 100.0 2,717,345 100.0 622,584 100.0

1 Operating equipment and supplies 854,049 25.6 744,948 27.4 109,102 17.5

2 Artificial internal organ apparatus and

assist device 615,223 18.4 555,999 20.5 59,224 9.5

3 Diagnostic imaging system 415,623 12.4 267,859 9.9 147,764 23.7

4 Measuring and monitoring system for

biophenomena 282,770 8.5 211,824 7.8 70,946 11.4

5 Ophthalmic goods and related product 258,835 7.7 256,500 9.4 2,335 0.4

6 In vitro clinical test equipment 201,972 6.0 59,292 2.2 142,680 22.9

7 Dental material 173,785 5.2 164,561 6.1 9,223 1.5

8 Medical apparatus for home use 144,010 4.3 137,987 5.1 6,023 1.0

9 Therapeutic and surgical equipment 133,002 4.0 125,873 4.6 7,129 1.1

10 Dental equipment 73,496 2.2 52,376 1.9 21,120 3.4

11 Related device and tool for diagnostic

X-ray equipment 67,422 2.0 30,832 1.1 36,590 5.9

12 Steel product for medical use 48,266 1.4 42,028 1.5 6,238 1.0

13 Clinical equipment and supplies 40,902 1.2 36,693 1.4 4,209 0.7

14 Surgical dressing and hygienic

product 30,573 0.9 30,573 1.1 - -

(Note) The ranking in the main Category of medical devices is based on the order of amounts of shipment (total) in 2015.

Documents

Annual Report on Statistics of Production by ... · Annual Report on Statistics of Production by Pharmaceutical Industry in 2015 Health Policy Bureau, Ministry of Health, Labour and