Facts and Figures 2010 Medicines and Health Care The Association of the Pharmaceutical Industry in Norway (LMI)

Facts and Figures 2010Medicines and Health Care

The Association of the Pharmaceutical Industry in Norway (LMI)

Facts and Figures 2010 – Medicines and Health Care

1.01 The number of marketing authorisations, active ingredients and medicines in Norway


1.02 New and withdrawn active ingredients

Year New active ingrediants Withdrawn active ingrediants

2000 36 *

2001 45 *

2002 48 *

2003 24 *

2004 29 12

2005 25 13

2006 47 20

2007 51 16

2008 36 36

2009 54 27

Source: The Norwegian Medicines Agency* Number not available


1.03 Pharmaceutical sales in Norway in the last few years


1.04 Sales growth by value


1.05 Sales growth by volume (DDD)


1.06 The Norwegian pharmaceutical market by main therapeutic groups (ATC)

Sales PPP 2009,

NOK MillionGrowth

2008-2009Share of total

sales 2009

L Antineoplastic and immunomodulating agents

2 297 4,9 % 19,7%

N Central nervous system 2 135 2,8 % 18,3%

C Cardiovascular system 1 357 -0,6 % 11,7%

R Respiratory system 1 178 5,3 % 10.1%

A Alimentary and metabolism 1 158 2,8 % 9,9 %

J Systemic antiinfectives 1 023 22,5 % 8,8%

B Blood and bloodforming organs 783 6,1 % 6,7 %

G Urogenitals and sex hormones 605 1,2 % 5,2 %

M Musculo-skeletal system 329 1,0 % 2,8 %

H Systemic hormones excl. sex hormones

300 2,8 % 2,6 %

S Sensory organs 277 9,6 % 2,4 %

D Dermatologicals 237 2,5 % 2,0 %

V Various 133 8,3 % 1,1 %

P Antiparasitic products 30 -3,6 % 0,3 %

Source: LMI/Farmastat


1.07 The top 25 pharmaceutical companies on the Norwegian market

Rank 2009 (2008)

CompanySales 2009 PPP, NOK

Million

Sales growth

Market share

1 (1) Pfizer AS 1 320 -0,7 % 10,9 %

2 (2) Astrazeneca AS 912 10,4 % 7,6 %

3 (3) GlaxoSmithKline AS 839 5,3 % 6,9 %

4 (4) Novartis Norge AS 738 15,1 % 6,1 %

5 (5) Schering-Plough AS 608 -0,8 % 5,0 %

6 (6) sanofi-aventis 528 3,1 % 4,4 %

7 (10) Roche Norge A/S 526 46,1 % 4,4 %

8 (8) Nycomed Pharma AS 463 0,5 % 3,8 %

9 (9) MSD (Norge) AS 352 -14,7 % 2,9 %

10 (12) Abbott Norge AS 317 16,8 % 2,6 %

11 (-) Actavis Norway AS 297 1,8 % 2,5 %

12 (14) Weifa AS 295 3,3 % 2,4%

13 (11) Novo Nordisk Scandinavia AS 291 4,0 % 2,4 %

14 (15) Bayer Schering Pharma 250 1,3 % 2,1 %

15 (19) Boehringer Ingelheim Norway KS 203 6,9 % 1,7 %

16 (-) McNeil Consumer Healthcare 179 20,7 % 1,5%

17 (20) ratiopharm AS 177 3,8 % 1,5 %

18 (17) Eli Lilly Norge AS 177 -8,6 % 1,5 %

19 (22) Meda A/S 175 3,8 % 1,4 %

20 (21) H. Lundbeck A/S 172 5,9 % 1,4 %

21 (13) *Farmagon AS 168 -37,9 % 1,4 %

22 (16) Janssen-Cilag AS 165 3,4 % 1,4 %

23 (24) Amgen 147 6,5 % 1,2 %

24 (-) Baxter 139 28,9 % 1,2 %

25 (23) Merck Serono 128 -11,4 % 1,1 %

Aggregate sales all companies 12 080 4,7 % 100,0 %

*Parallell importers Source: LMI/Farmastat


1.08 The top 25 medicines on the Norwegian market in terms of sales value

Rank 2009 (2008) Medicines

Sales 2009 PPP NOK mill.

Sales growth

Share oftotal shares Area of application

1 (1) Enbrel 378 -1,7 % 3,2 % Rheumatoid arthritis

2 (2) Remicade 277 -1,1 % 2,3 % Rheumatoid arthritis

3 (3) Seretide 262 7,8 % 2,2 % Asthma

4 (4) Humira 242 30,4 % 2,0 % Rheumatoid arthritis

5 (6) Symbicort Turbuhaler 161 8,4 % 1,4 % Asthma

6 (5) Nexium 157 5,7 % 1,3 % Gastric ulcer

7 (-) Tamiflu 127 1,1 % Influenza

8 (7) Cipralex 125 3,1 % 1,1 % Depression

9 (8) Paracet 118 6,2 % 1,0 % Pain

10 (12) Atacand 111 20,0 % 0,9 % High blood pressure

11 (10) Lipitor 110 16,4 % 0,9 % High cholesterol

12 (11) Mabthera 108 15,2 % 0,9 %Cancer and Rheumatoid arthritis

13 (9) Ibux 99 4,0 % 0,8 % Pain

14 (13) Otrivin 96 5,1 % 0,8 % Nasal congestion

15 (14) Herceptin 88 6,2 % 0,7 % Cancer

16 (12) Atacand Plus 83 25,6 % 0,7 % High blood pressure

17 (17) Singulair 82 5,4 % 0,7 % Asthma

18 (15) Plavix 80 0,8 % 0,7 % Thrombosis

19 (18) Insulatard 77 1,4 % 0,7 % Diabetes

20 (-) Prevenar 76 0,6 % Pneumococcal vaccine

21 (16) Lamictal 75 -4,0 % 0,6 % Epilepsy

22 (-) Nicorette 71 27,9 % 0,6 % Smoking cessation

23 (20) Lyrica 71 -2,2 % 0,6 % Neuropathic pain

24 (-) Spiriva 70 48,0 % 0,6 % Copd

25 (-) Coaprovel 68 2,1 % 0,6 % High blood pressure

Aggregate sales all companies 12 080 4,7 %



1.09 The top 25 active ingredients as measured by defined daily doses (DDD)

Rank 2009 (2008) Active ingredient

Name of original medicine*

Sales DDD/1000 inhab./day

Growth 08-09 Area of application

1 (2) Acetylsalisylsyre Albyl-E 70 2,6 % Thrombosis

2 (1) Simvastatin Zocor 66 3,7 % High cholesterol

3 (3) Natriumfluorid Flux 52 -13,8 % Caries

4 (-) Levonorgestrel Mirena 37 1,4 % Contraception

5 (6) Cetirizin Zyrtec 34 9,5 % Allergy

6 (5) Zopiklon Imovane 32 0,5 % Insomnia

7 (8) Amlodipin Norvasc 31 0,3 % High blood pressure

8 (13) Paracetamol Paracet 31 6,2 % Pain

9 (7) Ascorbic acid Nycoplus C-vit. 31 -1,8 % Vitamin deficiency

10 (4) Atorvastatin Lipitor 30 22,0 % High cholesterol

11 (19) Xylometazolin Otrivin 29 0,5 % Nasal congestion

12 (9) Ramipril Triatec 27 5,2 % High blood pressure

13 (10) Metoprolol Selo-Zok 25 0,3 % High blood pressure

14 (11) Vitamin B complex 25 0,2 % Vitamin deficiency

15 (12) Levotyroksinnatrium Thyroksin 23 3,0 % Hypothyreosis

16 (15) Kandesartan Atacand 19 12,9 % High blood pressure

17 (14) Furosemid Lasix Retard 18 -3,6 % High blood pressure

18 (18) Ibuprofen Ibux 18 4,2 % Pain

19 (16) Escitalopram Cipralex 18 8,6 % Depression

20 (20) Esomeprazol Nexium 14 8,4 % Gastric ulcer

21 (17) Levonorgestrel and estrogen 14 -0,4 % Contraception

22 (21) Metformin 14 6,8 % Diabetes

23 (22) Losartan and diuretika Cozaar Comp 13 -0,8 % High blood pressure

24 (25) PrednisolonPrednisolon Nycomed

12 3,0 % Infections

25 (23) Codeine, combinations Paralgin Forte 12 -1,5 % Pain

Figures from 2009*Market leader given for some active ingredientsSource: LMI/Farmastat


1.10 Market share of generics (DDD)


1.11 Generics´ share of the generics interchangeable market


1.12 Market share of parallel imported medicines


1.13 Market share for wholesalers


1.14 Pharmacy chain market share


1.15 Pharmacy chain market share, excl. hospital pharmacies


1.16 Total number of users of prescription medicines in Norway


1.17 Number of inhabitants per pharmacy in Europe


1.18 Pharmaceutical consumption (DDD) in the Nordic countries


1.19 Distribution of the Nordic medicine market 2009


1.20 Nordic sales growth 2009


1.21 Medicine sales per inhabitant in the Nordic countries 2009


1.22 Leading pharmaceuticals on the global market

Medicine name,Rank 2008 (2007) Area of application Sales US$ Billion

1 (1) Lipitor High cholesterol 13,6

2 (2) Plavix Prevention of cardiovascular events 8,6

3 (3) Nexium Gastric ulcer and reflux 7,8

4 (4) Seretide (Advair) Asthma and COPD 7,7

5 (5) Enbrel Rheumatic diseases and skin diseases 5,7

6 (8) Seroquel Schizophrenia 5,4

7 (6) Zyprexa Schizophrenia 5,0

8 (-) Remicade Rheumatic diseases and skin diseases 4,9

9 (9) Singulair Asthma and COPD 4,7

10 (-) Lovenox (Klexane) Thrombosis 4,4

11 (-) Mabthera Cancer and rheumatic diseases 4,3

12 (-) Takepron (lansoprazole) Gastric ulcer and reflux 4,3

13 (-) Efexor Depression 4,3

14 (-) Humira Rheumatic diseases and skin diseases 4,1

15 (-) Avastin Cancer 4,0

Aggregate top 15 medicines 88,8

Source: IMS Health

Data from 2008Figures in ex-factory price


1.23 The Norwegian medicines market in relation to Europe

Country, Rank 2007 Sales million Euro, 2007 Share

1 France 25 501 19,9 %

2 Germany 25 241 19,7 %

3 Italy 16 734 13,1 %

4 United Kingdom 14 493 11,3 %

5 Spane 13 209 10,3 %

6 Greece 5 503 4,3 %

7 Netherlands 4 616 3,6 %

8 Belgium 3 932 3,1 %

9 Portugal 3 490 2,7 %

10 Sweden 3 052 2,4 %

11 Austria 2 737 2,1 %

12 Switzerland 2 726 2,1 %

13 Ireland 1 902 1,5 %

14 Denmark 1 860 1,5 %

15 Finland 1 848 1,4 %

16 Norway 1 360 1,1 %

Aggregate 128 204 100 %

Source: EFPIA Figures in ex-factory prices or Pharmacy Purchase Price


1.24 Leading pharmaceutical companies onthe global market

Company, rank 2008 Sales US$ billion Country

1 Pfizer 43 USA

2 GlaxoSmithKline 37 United Kingdom

3 Novartis 36 Switzerland

4 Sanofi-Aventis 36 France

5 AstraZeneca 33 United Kingdom

6 Roche Group 30 Switzerland

7 Johnson & Johnson 29 USA

8 Merck 26 USA

9 Abbott Laboratories 19 USA

10 Eli Lilly 19 USA

11 Amgen 16 USA

12 Wyeth 16 USA

13 Teva 15 Israel

14 Bayer 16 Germany

15 Takeda 14 Japan

Source: IMS Health


2.01 Changes in prices of medicines and general inflation


2.02 Public spending on reimbursable prescription medicines


2.03 Payment for pharmaceutical consumption


2.04 Public health expenditure per inhabitant


2.05 Public spending on health care and medicines

YearGDP

NOK mill

Public spendingon health care

Public spendingon medicines

% of public spending on healthcareNOK mill % of GDP NOK mill % of GDP

2002 1 532 307 120 146 7,8 % 9 643 0,6 % 8,0 %

2003 1 593 826 129 221 8,1 % 10 191 0,6 % 7,9 %

2004 1 743 041 134 138 7,7 % 11 063 0,6 % 8,2 %

2005 1 945 716 140 800 7,2 % 11 299 0,6 % 8,0 %

2006 2 159 573 148 693 6,9 % 11 597 0,5 % 7,8 %

2007 2 271 607 160 161 7,1 % 11 686 0,5 % 7,3 %

2008 2 543 189 171 664 7,1 % 11 783 0,5 % 6,9 %

Sources: Statistics Norway, NAV and LMI/Farmastat


2.06 Expenditure on medicines in the private and public sector


2.07 Daily costs for the 25 most commonly used medicines

# Active ingredient Area of application Daily dosePrice per day,

NOK

1 Acetylsalisylsyre Thrombosis 160 mg 1,0

2 Simvastatin High cholesterol 40 mg 2,3

3 Natriumfluorid Caries 0,5 mg 0,4

4 Levonorgestrel Contraception - -

5 Cetirizin Allergy 10 mg 0,7

6 Zopiklon Insomnia 5 mg 1,7

7 Amlodipin High blood pressure 10 mg 1,7

8 Paracetamol Pain 500 mg x 3 4,5

9 Askorbinsyre Vitamin deficiency 200 mg 0,9

10 Atorvastatin High cholesterol 40 mg 3,5

11 Xylometazolin Nasal congestion 0,64 ml 3,3

12 Ramipril High blood pressure 5 mg 1,3

13 Metoprolol High blood pressure 100 mg 1,2

14 Vitamin B kompleks Vitamin deficiency 1 tablett 0,5

15 Levotyroksinnatrium Hypothyriosis 0,1 mg 0,7

16 Kandesartan High blood pressure 8 mg 6,2

17 Furosemid High blood pressure 30 mg 1,0

18 Ibuprofen Pain 400 mg x 3 3,2

19 Escitalopram Depression 10 mg 5,4

20 Esomeprazol Gastric ulcer 20 mg 6,2

21 Levonorgestrel og østrogen Contraception 1 tablett 2,9

22 Metformin Diabetes 500 mg x 2 1,4

23 Losartan og diuretika High blood pressure 1 tablett 5,0

24 Prednisolon Infection 1 tablett 2,4

25 Codeine, combinations Pain 1 tablett x 4 6,4

Source: Farmastat/LMI, The Norwegian Medicine Agency


2.08 The consumer’s medicine expenses compared to other expenses


2.09 National Insurance expenditure


2.10 Health Care expenditure

2002 2003 2004 2005 2006 2007 2008Total health care expenditure, nominal values

150 160 168 177 188 203 217

Total public health care expenditure, nominal values

124 133 140 148 157 171 182

Publicly financed share of total health care expenditure

83 % 83 % 83 % 84 % 84 % 84 % 84 %

Total private expenditure, nominal values

26 27 29 29 31 33 35

Publicly financed share oftotal health care expenditure

17 % 17 % 17 % 16 % 16 % 16 % 16 %

Total expenditure medicines, nominal values

14 15 16 16 16 17 17

Medicines as share of total health care expenditure

9,5 % 9,1 % 9,3 % 9,1 % 8,7 % 8,3 % 7,9 %

Total health care expenditure, fixed 2007-currency

162 168 176 182 189 203 217

Annual growth in health care expenditure, fixed 2007-currency

9,5 % 3,8 % 5,0 % 3,6 % 3,7 % 7,6 % 2,9 %

Public health care expenditure as share of total public expenditure

18,6 % 18,4 % 18,9 % 19,2 % 19,1 % 19,6 % 21,3 %

NOK mill. or percentSources: Statistics Norway/LMI/Farmastat


2.11 International price index for medicines


2.12 VAT on medicines and other goods and services in Europe

Country Standard VAT %

VAT on medicines %

Prescription Non-prescription

Denmark 25,0 25,0 25,0

Norway 25,0 25,0 25,0

Germany 19,0 19,0 19,0

Italy 20,0 10,0 10,0

Finland 22,0 8,0 8,0

Greece 19,0 9,0 9,0

Belgium 21,0 6,0 6,0

Netherlands 19,0 6,0 6,0

Portugal 21,0 5,0 5,0

Spane 16,0 4,0 4,0

France (1) 19,6 2,1 - 5,5 2,1 - 5,5

Switzerland 7,6 2,4 2,4

Ireland (2) 21,0 0,0 - 21,0 0,0 - 21,0

Austria 20,0 10,0 10,0

Sweden 25,0 0,0 25,0

United Kingdom (3) 15,0 0,0 15,0

Source: EFPIA/EUData from 2009 (1) France: reimbursable medicines 2,1%, non reimbursable 5,5%

(2) Ireland: oral medication 0%, other medication 21%(3) United Kingdom: 15% VAT on medicines purchased by hospitals


2.13 Copayment for reimbursable medicines


2.14 Medicine costs as share of expenditure on health care in the OECD


2.15 Distribution of operating costs in specialized health care


3.01 Sales of non-prescription medicines


3.02 Non-prescription medicines, share of total market value (PRP) and DDD


3.03 The top 25 non-prescription medicines in terms of sales value

Rank 2009 (2008) Medicine

Sales PPP 2009 NOK million

Change in sales from 2008 Area of application

1 (2) Otrivin 96,0 5,1 % Nasal congestion

2 (1) Paracet 93,9 2,0 % Pain

3 (3) Ibux 86,1 2,2 % Pain

4 (4) Nicorette 61,4 10,1 % Smoking cessation

5 (5) Nicotinell 61,2 14,2 % Smoking cessation

6 (6) Pepcidduo 31,5 22,0 % Reflux

7 (-) Alli 26,2 Weight Loss

8 (7) Canesten 24,0 7,4 % Fungal infections

9 (8) Flux 22,0 15,0 % Caries prevention

10 (9) Livostin 17,0 22,7 % Allergy

11 (18) Bisolvon 12,2 30,4 % Respiratory diseases

12 (10) Nycoplus C-Vitamin 11,4 -1,1 % Vitamin supplement

13 (11) Duphalac 11,4 -0,1 % Constipation

14 (13) Noskapin 10,8 5,9 % Respiratory irritation

15 (24) Antix 10,0 27,7 % Herpes simplex

16 (16) Norlevo 9,9 4,5 % Emergency contraception

17 (14) Zyrtec 9,8 -3,4 % Allergy

18 (17) Microlax 9,6 2,0 % Constipation

19 (15) Solvipect 9,5 -2,3 % Respiratory irritation

20 (21) Phosphoral 9,0 1,4 % Intestine drain

21 (20) Pinex 8,8 -3,3 % Pain

22 (19) Kaleorid 8,4 -7,5 % Potassium supplement

23 (12) Rhinox 8,2 -20,7 % Nasal congestion

24 (-) Corsodyl 7,8 1,7 % Mouthwash

25 (-) Bacimysin 7,6 -1,3 % Wounds and skin infections

Figures from 2009Source: LMI/Farmastat


3.04 Non-prescription medicines sales by selected therapy groups (ATC)

2009 NOK million Growth 08-09

Analgesics 238,2 2,4 %

Gastrointestinals 152,1 1,5 %

Coughs and pneumonia 146,4 2,0 %

Smoking cessation 122,6 12,1 %

Dermatologicals 85,6 -12,5 %

Vitamins and minerals 43,1 -4,0 %

Allergy 27,5 4,4 %

Remedies for obesity 26,2 ny

Hormones 16,2 -1,7 %

Sum 867,8

Total sales OTC 1022 7,0 %

Figures (PPP) from 2009Source: LMI/Farmastat


3.05 The top 10 pharmaceutical companies in the non-prescription medicines market

Rank 2009 (2008) Company

Sales 2009, PPP, NOK mill. Sales growth Market share

1 (1) Weifa AS 198,8 2,0 % 19,5 %

2 (2) Novartis Norge AS 197,6 9,8 % 19,3 %

3 (4) McNeil 159,6 18,4 % 15,6 %

4 (3) Nycomed Pharma AS 104,8 0,2 % 10,3 %

5 (-) Actavis Norway AS 45,9 -9,9 % 4,5 %

6 (-) GlaxoSmithKline AS 44,5 142,3 % 4,4 %

7 (7) Bayer Schering Pharma 30,1 7,4 % 3,0 %

8 (10) Boehringer Ingelheim 22,5 19,7 % 2,2 %

9 (5) Antula Healthcare 20,8 15,7 % 2,0 %

10 (8) Solvay Pharma AS 20,5 -10,8 % 2,0 %

Aggregate sales top 10 companies 845,1 - 82,7 %

Aggregate sales all non-prescription medicines 1 022 7,2 % 100,0 %



3.06 Non-prescription medicines, market share in selected countries


3.07 Split by category of general sales outlets for non-prescription medicines except pharmacies


3.08 Segmentation of sales for non-prescription medicines


4.01 The top 10 veterinary medicines for aquaculture in terms of sales value

# Medicine Sales 2009 NOK Million Area of application

1 Norvax Compact 148,8 Fish vaccine

2 Alphaject MICR 6 82,5 Fish vaccine

3 Alpha Max 75,6 Treatment against sea lice

4 Alphaject 6-2 75,4 Fish vaccine

5 Pentium Forte 70,5 Fish vaccine

6 Norvax Minova 6 33,4 Fish vaccine

7 Pentium Forte 11,9 Fish vaccine

8 Betamax 9,7 Treatment against sea lice

9 Benzoak 8,9 Anesthesia

10 Alphaject 5-3 4,0 Fish vaccine

Figures measured in recommended retail prices to the costumerSource: LMI/Farmastat


4.02 The top 10 veterinary medicines for mammals in terms of sales value

# MedicineSales 2009, PPP

NOK million Area of application Animal segment

1 Metacam 12,2 Treatment of pain Both pets and animals for production

2 Nobivac DHPPI 9,3 Vaccine Pets

3 Panacur 9,1 Worm treatment Both pets and animals for production

4 Rimadyl 7,7 Treatment of pain Pets

5 Synulox 6,8 Bacterial infection Pets

6 Penovet 5,9 Bacterial infection Both pets and animals for production

7 Exspot pour on 5,7 Treatment against ectoparasites Pets

8 Frontline 5,5 Treatment against ectoparasites Pets

9 Scalibor 5,1 Treatment against ectoparasites Pets

10 Banminth 5,0 Worm treatment Pets



4.03 The top 5 companies within aquaculture

# Company Sales 2009, NOK Million

1 Pharmaq 244,8

2 Intervet/Schering-Plough Animal Health 196,7

3 Scan Vacc 72,8

4 Novartis 21,5

5 Europharma 8,7



4.04 The top 10 companies within veterinary medicines excluding aquaculture

# Company Sales 2009, NOK Million

1 Intervet/Schering-Plough Animal Health 54,1

2 Novartis 54

3 Orion Pharma 51,3

4 Boehringer Ingelheim 29,5

5 Bayer Schering 21,4

6 Merial 21,1

7 Scanvet 11,9

8 Vetpharma 2,2

9 Lifeline 1,4

10 Nordvacc 1,3



5.01 The investment of the pharmaceutical industry in research and development


5.02 Investments in research and development, percentage of sales


5.03 Submitted clinical trials


5.04 Ongoing clinical trials performed by the pharmaceutical industry

Phase of study Number of protocols Number of centres Number of patients

Fase I 9 10 56

Fase II 50 170 1 615

Fase III 129 739 9 188

Fase IV 30 164 1 253

Total 217 1 082 12 112

Source: LMIData from 2008


5.05 Industry initiated clinical trials


5.06 Norway's imports and exports of medicines


5.07 Number of employees in the pharmaceutical industry in Norway


5.08 Employees in companies with production facilities in Norway


5.09 Estimated total cost for bringing a new medicine to market


5.10 Investments in R&D by therapeutic groups

Documents

Facts and Figures 2010 Medicines and Health Care The Association of the Pharmaceutical Industry in Norway (LMI)