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TURKISH PHARMACEUTICAL INDUSTRY

TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

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Page 1: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

invest.gov.tr1

TURKISH PHARMACEUTICAL INDUSTRY

Page 2: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

invest.gov.tr2

AGENDA

invest.gov.tr

Opportunities in Turkish

Pharmaceutical Industry4

Growth Drivers

in Turkey3Executive Summary1

Turkish Pharmaceutical

Industry Outlook2

Page 3: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

invest.gov.tr3

STRONG INTERNATIONAL PRESENCE

FAVORABLE GROWTH

DRIVERS

OPPORTUNITIES

• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country• Turkish pharmaceutical market grew in value by 26.1% in 2018 and sales reached 30.9 billion TL,

with 11% CAGR during 2010-2018• Turkish pharma market is ranked 17th within the global market• The Turkish pharma market reached 33 billion Turkish Liras in the last 12 months as of March 2019 • Unit sales reached 2,3 billion units

• Turkey wants to reduce import dependency and increase local production• Turkey is emerging as an ideal location for clinical trials with potential treatment-naive

patients and a favorable regulatory environment aligned with international standards. • Turkey has a benign R&D ecosystem with its developed education institutions and incentives • Biopharmaceuticals have been rapidly increasing with double-digit growth rates • Strategic location with increasing export opportunities

• Global pharma giants have been present in Turkey, engaging in both manufacturing and R&D

• A well-developed direct and contract manufacturing by multinationals

TURKEY HAS A GROWING PHARMA INDUSTRY THAT

OFFERS OPPORTUNITIES IN VARIOUS AREAS...

EXECUTIVE SUMMARY

ROBUST GROWTH

IN THE SECTOR

• Strong macroeconomic growth with increasing income per capita• Increasing life expectancy and healthcare spending• Skilled labor force with cost advantage in manufacturing and R&D• Strong government support through incentives for manufacturing and R&D • Government policies to increase access to healthcare services; heavy investment

into healthcare infrastructure (building dozens of city hospitals across Turkey)

Page 4: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

invest.gov.tr4

AGENDA

invest.gov.tr

Opportunities in Turkish

Pharmaceutical Industry4

Growth Drivers

in Turkey3Executive Summary1

Turkish Pharmaceutical

Industry Outlook2

Page 5: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

invest.gov.tr5

Top 20 Pharmaceutical Markets (Index: US Market=100, based on constant US$)

Rank 2012 Index Rank 2017 Index Rank 2022 Index

1 USA 100 1 USA 100 1 USA 100

2 China 24 2 China 26 2 China 28

3 Japan 24 3 Japan 18 3 Japan 13

4 Germany 11 4 Germany 10 4 Germany 9

5 France 10 5 France 7 5 Brazil 8

6 Italy 7 6 Brazil 7 6 France 6

7 Brazil 6 7 Italy 6 7 Italy 6

8 UK 6 8 UK 6 8 UK 5

9 Spain 5 9 Spain 5 9 India 5

10 Canada 5 10 Canada 4 10 Spain 4

11 India 4 11 India 4 11 Canada 4

12 South Korea 3 12 Russia 3 12 Russia 4

13 Australia 3 13 South Korea 3 13 South Korea 3

14 Russia 3 14 Austrialia 3 14 Austrialia 2

15 Mexico 2 15 Mexico 2 15 Turkey 2

16 Argentina 2 16 Turkey 2 16 Mexico 2

17 Saudi Arabia 2 17 Poland 2 17 Argentina 2

18 Poland 2 18 Saudi Arabia 1 18 Poland 1

19 Switzerland 2 19 Argentina 1 19 Saudi Arabia 1

20 Belgium 2 20 Switzerland 1 20 Switzerland 1

AS A PHARMERGING MARKET WITH HIGH PHARMACEUTICAL

GROWTH, TURKEY OFFERS STRONG INVESTMENT OPPORTUNITIES

FOR MULTINATIONALS..

3

2

Change in ranking over prior five years

1

2

1

2

1

7

1

10

7

6

1

2

2

1

1

1

1

1

1

1

1

1

1

1

3

2

1

3

1

1

1

2

1

3 1

GLOBAL POSITION

Source: IQVIA Market Prognosis, Sep 2017; Rankings based on Constant US$. Index reflects comparison to the U.S. of spending in Constant US$. 5

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13,3 13,6 13,0 13,815,2

17,5

20,4

24,5

30,9

37,8

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019/9

CAGR

11.1%

TURKISH PHARMA MARKET TURKISH PHARMACEUTICAL MARKET HAS BEEN ROBUSTLY

GROWING OVER THE PAST DECADE..

TURKISH PHARMACEUTICAL SALES* (BILLION TRY)

• The Turkish pharmaceutical industry provides more than 12 thousand products produced at 81 facilities at international standards by

approximately 500 companies and 38 thousand employees…

1,6

1,8 1,9 1,9 1,92,1

2,22,2

2,3 2,3

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019/9

CAGR

4.5%

TURKISH PHARMACEUTICAL SALES (BILLIONS OF BOXES)

Source: Pharmaceutical Manufacturers Association of Turkey (IEIS) *ex-factory prices

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24,5

30,9

2017 2018

SOURCES OF GROWTH SHOW THE DYNAMIC STRUCTURE OF THE

TURKISH PHARMACEUTICAL MARKET THAT OFFERS

OPPORTUNITIES TO GROW..

TURKISH PHARMA MARKET

TURKISH PHARMACEUTICAL SALES (BILLION TRY)

SOURCES OF GROWTH (PERCENTAGE POINT-PP)

26%

Price14,9 pp

Volume2,9 pp

Sales Distribution

6,3 pp

New Products

2 pp

Source: IEIS

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WHILE ORIGINATOR DRUGS DOMINATE PHARMA SALES

IN TERMS OF VALUE WITH ABOUT 70%,

THEIR SHARE IN UNIT SALES IS ABOUT 40%...

TURKISH PHARMA MARKET

BREAKDOWN OF PHARMA SALES VALUE

(2018)

Source: IEIS

BREAKDOWN OF PHARMA SALES VALUE

(2018)

Generic32%

Originator68%

Generic59%

Originator41%

Page 9: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

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9,31 9,248,73

9,4610,44

12,17

13,89

16,69

21,02

25,16

4,08 4,36 4,19 4,28 4,65,38

6,53

7,85

9,92

12,62

0

5

10

15

20

25

30

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019/9

Bil

lio

nT

RY

Originator vs. Generic Products(Value)

Originator Generic

TURKISH PHARMA MARKET IN 2018, THE ORIGINATOR PRODUCTS MARKET GREW

BY 26% AND SALES REACHED 21 BILLION TL

Source: IEIS

Page 10: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

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TURKISH PHARMA MARKET DURING THE 2010-2018 PERIOD THE VOLUME OF THE GENERIC

PRODUCTS HAS INCREASED BY 57.7%

0,75

0,83 0,83 0,84 0,850,9 0,9 0,92 0,93 0,92

0,87

0,961

1,2

1,07

1,16

1,251,31

1,371,41

0,5

0,7

0,9

1,1

1,3

1,5

1,7

1,9

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019/9

Bil

lio

n B

ox

es

Originator vs. Generic Products(Volume)

Originator Generic

Source: IEIS

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46,40% 40,60% 39,30%

53,60% 59,40% 60,70%

0,00%

20,00%

40,00%

60,00%

80,00%

100,00%

120,00%

2010 2018 2019/9

Originator vs. GenericMarket Share

Unit

Originator Generic

69,50% 67,90% 66,60%

30,50% 32,10% 33,40%

0,00%

20,00%

40,00%

60,00%

80,00%

100,00%

120,00%

2010 2018 2019/9

Originator vs. GenericMarket Share

Value

Originator Generic

TURKISH PHARMA MARKET WHILE ORIGINATOR DRUGS DOMINATE PHARMA SALES

IN TERMS OF VALUE WITH ABOUT 70%,

THEIR SHARE IN UNIT SALES IS ABOUT 40%...

Source: IEIS

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TURKISH PHARMA MARKET ONCOLOGY REPRESENTED THE LARGEST PROPORTION BY VALUE…

ANTIBIOTICS AND ANTI-RHEUMATISM PRODUCTS

REPRESENTED THE LARGEST PROPORTION BY VOLUME…

Source: IEIS12

Therapeutical Class

(Value)

Page 13: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

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TURKISH PHARMA MARKET ONCOLOGY REPRESENTED THE LARGEST PROPORTION BY VALUE…

ANTIBIOTICS AND ANTI-RHEUMATISM PRODUCTS

REPRESENTED THE LARGEST PROPORTION BY VOLUME…

Source: IEIS13

Therapeutical Class

(Volume)

Page 14: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

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7,61 7,577,14

7,758,57

10,06

11,35

13,33

16,03

18,38

5,78 6,03 5,78 66,47

7,49

9,07

11,21

14,91

19,4

0

5

10

15

20

25

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019/9

Bil

lio

nT

RY

Imported vs. Local Products(Value)

Import Local

TURKISH PHARMA MARKET BETWEEN 2010-2018 LOCAL PRODUCTS ROSE

BY 157.9% IN VALUE…

Source: IEIS

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0,33 0,37 0,38 0,39 0,4 0,43 0,43 0,430,38

0,31

1,29

1,42 1,45 1,471,52

1,631,72

1,79

1,922,02

0

0,5

1

1,5

2

2,5

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019/9

Bil

lio

n B

ox

es

Imported vs. Local Products(Volume)

Import Local

TURKISH PHARMA MARKET BETWEEN 2010-2018 LOCAL PRODUCTS

GREW BY 49.4% IN UNIT TERMS..

Source: IEIS

Page 16: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

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20,40% 16,50% 13,30%

79,60% 83,50% 86,70%

0,00%

20,00%

40,00%

60,00%

80,00%

100,00%

120,00%

2010 2018 2019/9

Import vs. Local Market ShareVolume

Import Local

56,80% 51,80% 48,60%

43,20% 48,20% 51,40%

0,00%

20,00%

40,00%

60,00%

80,00%

100,00%

120,00%

2010 2018 2019/9

Import vs. Local Market ShareValue

Import Local

TURKISH PHARMA MARKET WHILE ORIGINATOR PRUDUCTS DOMINATE IMPORTS, LOCAL

PRODUCTION IS MAINLY IN GENERICS..

Source: IEIS

Page 17: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

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Imported Products, 2018

Originator97%

Generic 3%

92%

8%

Outer circle: Breakdown of Sales Value

Inner circle: Breakdown of Unit Sales

Originator36%

Generic 64%

30%

70%

TURKISH PHARMA MARKET WHILE ORIGINATOR PRUDUCTS DOMINATE IMPORTS,

LOCAL PRODUCTION IS MAINLY IN GENERICS..

Locally-produced Products, 2018

Source: IEIS

Page 18: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

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4.946 5.214

4.482 4.620 4.898 4.762 4.708

4.976 5.003 5.080

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019/9

Germany18%

USA 11%

Switzerland8%

S.Korea8%

Italy 7%

France 7%

Ireland 6%

UK 6%

606 615711

801 850925 865 897

1.173 1.218

Imports of Pharmaceutical Products(USD Million)

Exports of Pharmaceutical Products(USD Million)

93.7%

Main sources of imports

(2018)

Main exports destinations

(2018)

South Korea 30%

Iraq 5%

Switzerland

4%

Slovenia3%

Azerbaijan3%

TRNC 3%

Iran 2%

Libia 2%

FOREIGN TRADE WHILE EXPORTS HAVE BEEN INCREASING STEADILY,

TURKEY IS STILL DEPENDENT ON IMPORTED DRUGS..

Source: Turkstat,İEİS

Page 19: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

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MAJOR PLAYERS THERE ARE 70 COMPANIES ACTIVE IN PHARMA MANUFACTURING,

14 OF THEM ARE MULTINATIONAL COMPANIES..

70 Manufacturing Companies

31R&D Centers(2018)

14 Multinational Companies (Manufacturing)

11 Raw Material Producing Companies (3 multinational)

Source: IEIS, Ministry of Industry and Technology

Page 20: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

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92,1

194,2 191,5

210,3219,2

234,3219,5

314,1

0

50

100

150

200

250

300

350

2010 2011 2012 2013 2014 2015 2016 2017

R&D Expenditure of Turkish Pharma Sector

R&D BETWEEN 2010-2017 PHARMA R&D SPENDING GREW BY 241%…

Source: Turkstat,İEİS

Page 21: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

invest.gov.tr21

AGENDA

invest.gov.tr

Opportunities in Turkish

Pharmaceutical Industry4

Growth Drivers

in Turkey3Executive Summary1

Turkish Pharmaceutical

Industry Outlook2

Page 22: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

invest.gov.tr22

13TH LARGEST ECONOMY

IN THE WORLD

RANKING OF ECONOMIES BY GDP AT PPP

REAL GDP GROWTH (INDEX: 2002=100)

AVERAGE ANNUAL GDP

GROWTH (%), 2003-20185.6 2.14.0 3.9 2.8

TURKEY POLAND ROMANIA CZECHIA HUNGARY

100

120

140

160

180

200

220

240

260

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

TRACK RECORD GROWTH AND

BRIGHT FUTURE WITH PROVEN RESILIENCE

ROBUST ECONOMY

2003 2018

Source: TurkStat, OECD, World Bank, IMF, PPP: Purchasing Power Parity

1.

2.

3.

5.

4.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

1.

2.

3.

5.

4.

6.

7.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

8.

Page 23: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

invest.gov.tr23

71

31 30

-0.7

-32

Domestic

Consumption

Investment

Expenditures Stocks

Imports

Exports

236

784

2002 2018

ROBUST ECONOMY DRIVEN BY A DIVERSIFIED STRUCTURE, TURKISH ECONOMY

HAS MORE THAN TRIPLED OVER THE PAST 16 YEARS

Turkish economy has more than tripled over the past

15 years and is promising more growth in future

Driven by a robust domestic market and

entrepreneurial private sector which has spurred

investments and exports

Turkish Economy (GDP at current prices, $Billion)

Contribution to GDP Growth 2002-2018* (%)

Source: TurkStat, * current prices

Page 24: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

invest.gov.tr24

Universal

Coverage

Improving

Infrastructure

Increasing # of

Healthcare

Professionals

In 2006 Universal Health

Insurance introduced to

cover all citiziens

Number of Hospital increased

from 1156 in 2002 to

1534 in 2018 (bed capacity 165K to 232K)

Number of Doctors increased

from 92K in 2002 to 153K in

2018 (from 1.4 to 1.8 per 1000)

The government introduced the Health Transformation Program

in 2003 to provide universal healthcare services.

HEALTHCARE HAS BEEN A TOP PRIORITY FOR THE TURKISH

GOVERNMENT WHICH IS COMMITTED TO INCREASING

ACCESS TO HEALTHCARE SERVICES FOR ALL CITIZENS

HEALTHCARE POLICIES

Source: TurkStat, Ministry of Health

Page 25: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

invest.gov.tr25

61

70

80

86

9195

1996 2006 2016 2025 2035 2045

3,54,7

6,7

9,0

12,7

17,4

1996 2006 2016 2025 2035 2045

68,0

73,0

78,0

1996 2006 2017

295

702

1.088

1.274

1996 2006 2016 2017

Life Expectancy at Birth (years)

POPULATION TURKEY’S POPULATION DYNAMICS ARE

TRANSLATED INTO INCREASING HEALTHCARE SPENDING

Population over 65 (million)

Population (million)

Healthcare Spending per capita ($, PPP)

Source: Turkstat, UN, World Bank, OECD, Ministry of Health, ISPAT, Healthcare spending is total,

including public and private. PPP: Purchasing Power Parity

Page 26: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

invest.gov.tr26

6,926,41

6,02

5,35 5,13 5,02 4,88

Tu

rke

y

Po

lan

d

Ro

man

ia

Cze

ch

ia

Bu

lgari

a

Hu

ng

ary

Slo

va

kia

287

177

804

505

University Vocational & Technical HighSchool

2002 20175,85

5,10 4,96

3,87 3,873,38 3,17

Tu

rke

y

Po

lan

d

Cze

ch

ia

Ro

man

ia

Bu

lgari

a

Hu

ng

ary

Slo

va

kia

47,244,4

39,6

31,1

14,9 14,311,5 10,7

7,0 5,6 5,6G

erm

an

y

Fra

nc

e

US

A UK

Cze

ch

ia

Slo

va

kia

Hu

ng

ary

Po

lan

d

Ro

man

ia

Bu

lgari

a

Tu

rke

y

2018 2018

75,8%

24,2%

90%

10%

University High School & Below151

120 107

87

69 62

45 42 39 35 22

Ge

rma

ny

US

A

Fra

nc

e

UK

Slo

va

kia

Po

lan

d

Hu

ng

ary

Tu

rke

y

Cze

ch

ia

Ro

man

ia

Bu

lgari

a

$K, 2017$, 2018

Annual Number of Graduates

(thousands)

Labor Force by Education Level

TURKEY’S EDUCATION SYSTEM HAS BEEN UPGRADED TO SUPPORT A

SKILLED LABOR POOL THAT MEETS BUSINESS REQUIREMENTS..

SKILLED WORKORCE

WITH COST ADVANTAGE

Availability of Qualified Engineers

(10=Available; 0=Unavailable)

Labor Cost per hour

in Manufacturing

Availability of Competent Senior Managers

(10=Available; 0=Unavailable)

Remuneration of Management/Engineer Total base salary plus bonuses and long-term incentives

Source: Ministry of National Education, Council of Higher Education, Turkstat, IMD World Competitiveness Yearbook Executive Opinion Survey based on an index from 0 to 10; Eurostat, US BLS

Page 27: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

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Incentives Provided by the Ministry of Industry and Technology

INCENTIVES PLENTY OF INCENTIVE INSTRUMENTS TO BENEFIT FROM..

General

Investment

Incentives

Regional

Investment

Incentives

Region 6

Incentives

Customs Duty Exemption

VAT Exemption

Corporate Tax Reduction

Social Security PremiumSupport (Employer’s Share)

Land Allocation

Interest Rate Support

+

Customs Duty Exemption

VAT Exemption

Medium-High TechIncentives

Priority Incentives

Strategic

Investment

Incentives

Regional Incentives

Social Security Premium Support (Employee’s Share)

Income Tax Withholding Support

Customs Duty Exemption

VAT Exemption

Corporate Tax Reduction

Social Security PremiumSupport (Employer’s Share)

Land Allocation

Interest Rate Support

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INCENTIVES PLENTY OF INCENTIVE INSTRUMENTS TO BENEFIT FROM..

VAT Exemption:

Customs Duty Exemption:

Tax Reduction:

Social Security

Premium Support

(Employee’s Share):

Social Security Premium Support (Employer’s Share):

Income Tax Withholding Allowance:

Interest Rate Support:

Land Allocation:

VAT Refund:

VAT is exempt for imported and/or domestically delivered machinery and equipment within the scope of the investment incentive certificate.

Customs duty is exempt for imported machinery and equipment within the scope of the investment incentive certificate.

The income or corporate tax is calculated on basis of reduced rates until the total amount of reduced tax reaches the amount of contribution to the investment. The rate of contribution to investment refers to the rate of the total fixed investment amount that is subject to tax reduction.

For additional employment created by the investment, the employee’s share of the social security premium calculated on basis of the legal minimum wage will be covered by the government. The instrument is applicable only to investments made in Region 6 within the scope of the investment incentive certificate. There is no upper limit for Social Security Premium Support and it is applicable for 10 years.

For additional employment created by the investment, the employer’s share of the social security premium calculated on basis of the legal minimum wage will be covered by the government.

The income tax with regard to additional employment created by the investment, within the scope of the investment incentive certificate, will not be liable to withholding taxes. The instrument is applicable only to investments made in Region 6 within the scope of the investment incentive certificate. There is no upper limit for income tax withholding allowance and it is applicable for 10 years.

Interest rate support is a financial support instrument provided for investment loans with a term of at least one year obtained within the scope of an investment incentive certificate. A portion of the interest/profit share regarding the loan equivalent, at most 70 percent of the fixed investment amount registered in the investment incentive certificate, will be covered by the government for a maximum of the first five years.

Land may be allocated for investments, with an investment incentive certificate, in accordance with the rules and principles set by the Ministry of Finance, depending on the availability of such land.

VAT collected on construction expenses, made within the scope of strategic investments with a minimum fixed investment amount ofTRY 500 million, will be rebated.

Support Instruments

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AGENDA

invest.gov.tr

Opportunities in Turkish

Pharmaceutical Industry4

Growth Drivers

in Turkey3Executive Summary1

Turkish Pharmaceutical

Industry Outlook2

Page 30: TURKISH PHARMACEUTICAL INDUSTRY• Pharmaceutical industry is one of the most dynamic and strategic sectors of the country • Turkish pharmaceutical market grew in value by 26.1%

invest.gov.tr30

Number of Private Sector R&D Personnel in Pharma:

1.298 (2019)

Number of University Students Enrolled in Related Fields:

+205K (2017)

Number of Accredited Private R&D Centers in Pharma:

32 (May 2019)

Number of University Research Centersin Pharma Sector:

14 (2018)

Private Sector R&D Spending in Pharma:

₺314 Million (2017)

Field Associate Degree* Undergraduate Post-graduate Total

Medicine 20.498 93.648 6.576 101.820

Chemistry 54 14.278 6.277 47.737

Biology - 23.779 9.131 29.720

Pharmacy 3.569 13.943 481 13.910

Biochemistry 173 5.177 7.696 12.238

TOTAL 24.028 150.825 30.161 205.014

*vocational training school

R&D ECOSYSTEM TURKEY’S R&D ECOSYSTEM OFFERS

ADVANTAGEOUS OPPORTUNITIES FOR PHARMA COMPANIES..

Source: MSIT, Turkstat, Council of Higher Education, Ministry of Development

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R&D ECOSYSTEM TURKEY’S R&D ECOSYSTEM IS ALSO SUPPORTED

BY LUCRATIVE INCENTIVES EXCLUSIVE TO R&D …

100% deduction of R&D expenditure from the tax base

Income withholding tax exemption

50% social security premium exemption for employers

Stamp duty exemption

Customs duty exemption

Corporate tax exemption

Income withholding tax exemption

50% social security premium exemption for employers

Stamp duty exemption

Customs duty exemption

R&D and Innovation

Support

Technology Development

Zones

Incentives by Scientific & Technological

Research Council of Turkey

TECHNOINVESTMENT Program

Customized incentives according to project

1501 - Industrial R&D Projects Grant Programme;

Up to 60% of R&D projects could be financed through financial grant.

no budgetary limit

… and more grant programmes

Mass production of products developed out of R&D are incentivized through partial funding of;

machinery and equipment

rent and energy cost

labor cost

interests on loans for small & medium size companies.

Source: MSIT

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Source: Property Rights Alliance International Property Rights Index, 2017

0

1

2

3

4

5

6

7

8

Overall Protection ofIntellectual

Property Rights

PatentProtection

CopyrightPiracy

2007 2017

Turkey has been accepting patent applications since 1996, in

compliance with the WTO's Trade-Related Aspects of Intellectual

Property Rights (TRIPS) agreement.

R&D ECOSYSTEM TURKEY’S REGULATORY ENVIRONMENT

PROTECTS INTELLECTUAL PROPERTY RIGHTS..

The New Law on the Protection of

Industrial Property Rights (2017)

Simplifies proceedings, adopting tighter

regulations for the protection & enforcement of

IPR.

Aligns the Turkish patent regime with its

obligations as part of the European Patent

Convention

As a candidate country, Turkey has significantly aligned its technical and

IPR legislations with the European Union acquis communautaire

Specialized Courts on IPR

There are 9 criminal and 13 çivil specialized IP

courts functioning in Ankara, İstanbul and İzmir.

IPR protection in Turkey has significantly

improved over the past decade

Intellectual Property Right in Turkey(Score: 10=Best; 0=Worst)

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13,0

14,3

16,8

18,7

20,7

22,2

22,2

23,2

23,1

20,5

0,00,0

0,31,2

1,32,3

3,4 4,55,3 8,4

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019/9

Reference

Biosimilars

1404

1450

1613

1924

2360

2950

3296

3948 5143

5937

2.5 4,1 14,733,8

41,3

79,5123,6

190,0

281,6

528,3

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019/9

Reference

Biosimilars

• Biotechnological products constituted 17,5% of prescription products with 5,7 billion TL and 28,4 million units in the last 12 months as of March 2019.

• The reference biotechnological pharmaceutical market grew by 5,0% to total 5,4 billion TL. Biosimilar drugs market increased by 21,5%and reached 342 million TL.

BIOTECHNOLOGY BIOTECHNOLOGICAL PRODUCTS HAS BEEN

RAPIDLY GROWING IN TURKEY..

Biotechnological Products (Million TL)

18%

CAGR

Biotechnological Products (Million of Boxes)

10%

Source: IEIS

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Breakdown of Biotechnological ProductsBox (%) Value (%)

2010 2018 2010 2018

Bio

sim

ilar

Blood and hematopoietic organs 0 81.9 0 49.6

Antineoplastics and immunomodulatory agents 100 6.2 100 30.6

Digestive system and metabolism 0 10.1 0 13.6

Systematic hormonal preparations (excluding sex hormone and insulins) 0 1.6 0 5.9

Dermatological products 0 0.1 0 0.2

Ori

gin

ato

r

Antineoplastics and immunomodulatory agents 6.9 11.1 44.2 49.9

Digestive system and metabolism 51.1 59.4 23.8 22.9

Blood and hematopoietic organs 35.1 18.0 17.3 10.8

Ophthalmological 0.1 1.4 1.5 6.2

Systematic hormonal preparations (excluding sex hormone and insulins) 1.9 3.2 4.1 3.1

Respiratory system 0.1 1.1 0.4 2.7

Genital-urinary system and sex hormones 3.3 4.9 3.8 2.3

Systematic anti-infectives 1.5 0.4 5.0 1.1

Dermatological products 0 0.0 0 0.7

Musculoskeletal system 0 0.5 0 0.3

BIOTECHNOLOGY BIOTECHNOLOGICAL PRODUCTS HAS BEEN

RAPIDLY GROWING IN TURKEY..

Source: IEIS

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126

315

449

407

379

445

2000 2004 2008 2012 2016 2018

Phase I Phase II Phase III Phase IV PMS BA/BE Other

PMS: Postmarketing Studies; BA: Bioavailibility/BE: Bioequivalence

Source: Turkish Medicines and Medical Devices Agency Source: Pharm-Olam

WITH A LARGE NUMBER OF TREATMENT-NAÏVE PATIENTS, A PRACTICAL

REGULATORY ENVIRONMENT AND COMPETITIVE COST STRUCTURE, TURKEY

IS AN EMERGING IDEAL LOCATION FOR CLINICAL TRIALS IN THE WORLD..

CLINICAL TRIALS

Clinical Trials Ecosystem

A developing clinical research profile, supported by new regulations that are in accordance with international standards and European directives

A large and diverse patient population of almost 82 million, the majority of whom are treatment-naïve.

Consequently, Turkish people are highly motivated to participate in studies, and ready access to them makes for rapid enrolment

A high number of sites with the capacity to conduct clinical research: in university, private and government hospitals

Highly motivated research teams trained in GCP, capable of producing high-quality, reliable data

Comparatively low costs, relative to EU countries and the US

Number of Clinical Trials in Turkey

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Localization Track Record Regional Hub Enablers

CONTRACT MANUFACTURING TURKEY HAS A STRONG INDUSTRIAL BASE IN PHARMACEUTICALS

OFFERING OPPORTUNITIES FOR CONTRACT MANUFACTURING

AND LUCRATIVE PARTNERSHIPS...

Turkey’s dependency on import of pharmaceuticals is unsustainable, hence Turkey is prioritizing local production. Either direct or contact manufacturing will provide multinationals a competitive edge

Many multinational pharma companies have already cooperative agreements with the local manufacturers which have shown track record in delivering contracts

Geostrategic location offers drugmakersentry to European, MENA and Central Asian markets. Turkey has Custom Union with the EU and Free Trade Agreements with 29 countries

Skilled labor force

Low-cost manufacturing

Manufacturing incentives

R&D and Post-R&D grants

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What can Invest in

Turkey do for you?ASSIST YOU BEFORE, DURING AND AFTER YOUR ENTRY INTO TURKEY

A governmental agency

reporting to the President

Private sector approach with

public sector capabilities

Acting as your

solution partner

General & customized business information & Sectoral analysis & reports

Facilitating your investment at all stages

Site selection support to find appropriate location/land for your investment

Matchmaking with local partners & establishing business linkages

Arrangements of meetings with governmental bodies and other stakeholders

Project launch & Press release Services

AFTERSALES

Facilitating your visit to Turkey