ners inestent & tre market survey...the industrial production index data for the 2010-2018...

FLANDERS INVESTMENT & TRADE MARKET SURVEY

IN TURKEYLIFE SCIENCES SECTOR

Market Study

www.flandersinvestmentandtrade.com

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TURKEY LIFE SCIENCES SECTOR

OUTLOOK Istanbul / 26/12/2019

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Ezgi Çeri Fidan Inward Invest Deputy

Flanders Investment and Trade c/o Consulate General of Belgium in Istanbul

Siraselviler Caddesi 39 Taksim 34433

Turkey +90 212 293 99 17

[email protected]

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pagina 2 van 28 TURKEY LIFE SCIENCES SECTOR OUTLOOK 26.12.2019

TABLE OF CONTENTS

1. Foreword ............................................................................................................................................................................... 3 2. Turkey Economic Outlook .......................................................................................................................................... 4 3. Pharmaceutıcal Sector ın turkey ............................................................................................................................ 6

3.1 General Overvıew of Turkısh Market 6 3.1.1 Market Structure 7 3.1.2 Import 7 3.1.3 Production & Export 9 3.1.4 Employment 9 3.1.5 Price 9 3.1.6 Regulations 10 3.1.7 Major Players in Turkish Market 11 3.1.8 R&D in Pharmaceutical in Turkey 13 3.1.9 Conclusion & Evaluation 15

4. Bıotechnology Industry ın Turkey ...................................................................................................................... 16

4.1 Market Overview 16 4.2 Investment on Biopharmaceutical 19

5. Medical Technology in Turkey .............................................................................................................................. 20

5.1 Market Overview 20 5.2 Market Entry 22 5.3 Current Market Trends 22 5.4 Procurement & Tenders 23 5.5 Opportunities 23

6. Academic Life Science Research in Turkey ................................................................................................... 23 7. Key Organizations & Events in the Life Science sector in Turkey ................................................. 26

7.1 Key Organizations 26 7.2 Key Events 27

8. Sources ................................................................................................................................................................................. 28

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26.12.2019 TURKEY LIFE SCIENCES SECTOR OUTLOOK pagina 3 van 28

1. FOREWORD

As a result of aging populations, extended life spans, and socioeconomic changes around the world, health services are one of the most important topics of the 21st century. The pharmaceutical industry’s activities have significant socio-economic impacts on society in the form of investments in R&D and manufacturing. Of note, R&D is the “backbone” for success in any drug discovery program. In 2018, the expenditures for the pharmaceutical industry worldwide amounted to 1.2 trillion dollars. This figure is expected to increase by 5 percent to $ 1.3 trillion in 2019 and to $ 1.5 trillion in the next 5 years. The Turkish Government aims to make Turkey one of the world’s top ten economies in health services by 2023 by increasing R&D expenditures to 3% of GDP and by increasing exports to USD 500 billion. The aim of this report is to analyse the development of the Pharmaceutical industry in Turkey and its current situation, its strengths & weaknesses. Doing so, we hope to indicate to the companies from Flanders how they can find opportunities for business in this very big and growing sector in Turkey. In this report, we will focus on pharmaceutical, medical technology and biotechnology sectors in Turkey.

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2. TURKEY ECONOMIC OUTLOOK

Source: The World Bank


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3. PHARMACEUTICAL SECTOR IN TURKEY

Looking at the size of the world's pharmaceutical industry, North America has the largest share of 64.1 percent in the sales of newly produced drugs. This is followed by the European Union with 18.1 percent and Japan with 7.1 percent. In terms of spending by country, the US stands out first, followed by China and Japan. The top five countries in 2018 account for two thirds of the world’s pharmaceutical market, which reached $ 1.2 trillion. The US accounts for almost half of the world's pharmaceutical market. In 2018, the expenditure on pharmaceutical industry worldwide was 1 trillion 200 billion dollars and this figure is expected to increase by 5 percent in 2019 to 1.3 trillion dollars. A market of 1.5 trillion dollars is envisaged in the next five years. In the next five years, growth is expected to be led by advanced economies and new products, while in emerging economies (China, India and Brazil), the market is expected to grow more slowly than in the previous five years. On the other hand, it is estimated that the emerging markets such as Turkey, Egypt and Pakistan, will have a strong growth.1

3.1 GENERAL OVERVIEW OF TURKISH MARKET

The Turkish pharmaceutical industry is one of the most dynamic and strategic sectors of Turkey, In 2018, the value of the global pharmaceutical market reached USD 1.2 trillion, with Turkey ranking at the 17th spot. Some key facts and figures in the Turkish pharmaceuticals sector are as follows: ➢In 2018, the Turkish pharmaceuticals market grew in value by 26.1 percent, reaching TRY 30.94 billion. Unit sales rose by 3.6 percent to hit 2.3 billion in the same year. ➢Around 500 companies are operating in the industry. As of May 2019, there are 81 drug and 11 raw material production facilities that meet the highest international standards. ➢Among the 81 manufacturing facilities, 17 are owned by multinational companies. ➢Among the 11 raw material production facilities, 3 are owned by multinational companies. ➢The pharmaceutical industry employs approximately 40,000 staff and provides over 11,000 products. ➢The biosimilar drugs market grew by 54.2 percent to reach TRY 434.2 million. ➢Pharmaceutical exports, which stood at USD 606 million in 2010, surged by 93.7 percent to hit USD 1.17 billion in 2018.

1 KPMG, Pharmaceutical Report, 2019

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➢Turkish pharmaceutical manufacturers are exporting to more than 160 countries, including the EU, MENA, and CIS countries. ➢Regulations in the sector are in line with EU directives. ➢ The share of foreign capital companies is 69%.2

3.1.1 Market Structure

Turkish pharmaceutical industry is mainly located in the Marmara Region especially in provinces of Istanbul, Kocaeli and Tekirdağ. This is mainly due to the better infrastructure, ease of supply in packaging materials and technical personnel, telecommunication and transportation facilities and the existence of a high number of health institutions in the region. Most of the manufacturers and exporters have been organized under the roof of “The Pharmaceutical Manufacturers Association of Turkey” (İEİS) - http://ie²is.org.tr/

3.1.2 Import

Currently, drug production in Turkey is focused around low value-added products, with high value-added products being imported. These charts show both the value and volume of imported and locally produced drugs in the Turkish pharma market between 2010 and 2018. TL 16.03 billion (USD 2.7 billion) worth of imported drugs were sold in 2018 compared to TL 7,61 billion (USD 1,35 billion) in locally produced medicines. 3

2 Turkish Pharmaceutical Market 2018 by IEIS 3 Turkish Pharmaceutical Market 2018 by IEIS

http://ieis.org.tr/

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Source: IQVIA, İEİS Source: IQVIA, İEİS

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3.1.3 Production & Export

Turkey boasts a well-established pharmaceutical industry with advanced production technology and capacity. As of May 2019, there are 81 production and 11 raw material facilities meeting international standards. Between 2010 and 2018, local products rose by 157.9% in value. This expansion equates to a CAGR (compound annual growth rate) of 12.6%. Taking into account local producer prices, this marks a real increase of 8.9%. Local products grew by 49.4% in unit terms. The industrial production index data for the 2010-2018 period reveals 67.5%, 40.2%, and 102.4% production growth in the manufacturing industry, mid-technology chemical industry and pharmaceutical industry, respectively. Turkish exports have shown a steady increase in recent years, although in 2016, the total value of the pharmaceutical exports declined to US $ 874,3 million, in 2017 the total value of pharmaceutical exports increased to USD 909,8 million. Pharmaceutical exports, at USD 606 million in 2010, surged by 93.7% to hit USD 1.173 million in 2018. Turkey is now exporting various pharmaceutical products to 153 countries including developed countries like South Korea, Switzerland, Poland, Slovenia, Germany, the UK, the USA and Georgia.4

3.1.4 Employment

According to the data of the Ministry of Industry and Technology, as of 2015, approximately 31 thousand people were employed in the sector. According to TURKSTAT data, sector employment is estimated to reach 40 thousand by the end of 2018.

3.1.5 Price

From 2010 through 2018, average product price increased by 62.3% to 13.43 TL. That period indicates a 31% real shrinkage when the effect of inflation, which soared by 137%, is excluded. A comparison of the average drug prices between 2017-2018 demonstrates pharmaceutical market growth of 22%, with originators on 24%, generics on 20%, import products on 37% and local products on 24%.

4 Turkish Pharmaceutical Market 2018 by IEIS

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Distribution of Average Product Prices Change in Average Product Prices

In 2018, a total of 307 new products entered the market, all of them in prescription status. Oncology medicines were the most important group of drugs in terms of unit market share, while antibiotics followed.

3.1.6 Regulations

The healthcare system is governed principally by the Fundamental Law on Healthcare Services No. 3,359, which furnishes the Ministry of Health (MoH) with the authority to issue healthcare-related regulations and establish a healthcare system enabling each and every person living in Turkey to have equal, equitable access to the healthcare system. The regulatory authority is the MoH and its subsidiaries.

The MoH is responsible for establishing hospitals and public health institutions to provide healthcare services to the public. In addition to public hospitals and healthcare institutions, universities with medical faculties may also establish hospitals under the authority granted to universities by the Higher Education Law No. 2,547, and this system is also quite common in Turkey. Private hospitals and healthcare institutions are also common in places where the purchasing power of the population is high.

There has been a fundamental change in the structure of the MoH in 2011. The authorities of the General Directorate of Pharmaceuticals and Pharmacy of the MoH have been transferred to the Turkish Pharmaceuticals and Medical Devices Institution (the Institution), which was established by Decree Law No. 663. In line with the amendment, the institution undertakes the following duties in general:

• granting licences or authorisations, monitoring and imposing sanctions where necessary and setting forth the standards for licensing, pricing, manufacturing, storing, sales, import, export, marketing, distribution, promotion, monitoring, recall and usage-related activities regarding the products falling under the authority of the Institution (pharmaceuticals, medical devices,

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cosmetics, traditional herbal medicinal products, all other products marketed with a health claim);

• regulating, approving and controlling clinical trials with regard to the products falling under its authority; and taking the necessary precautions to maintain the accessibility of pharmaceuticals,

medical devices and other products that are of vital importance. 5

For specific requests, please contact FIT Istanbul office. We are always ready to help you and provide you with accurate and up to date information.

3.1.7 Major Players in Turkish Market

Turkey boasts a well-established pharmaceutical industry with advanced production technology and capacity. As of May 2019, there are 81 production and 11 raw material facilities meeting international standards. According to the 2018 Turkey's Top 500 Industrial Enterprises results, there are six pharmaceuticals companies in the list:

Company 2018 Rank 2018 Sales from

Production (Net) (TL)

2017 Sales from Production

(Net) (TL) Web Page

Abdi İbrahim Pharmaceutical 97 1.835.011.236 1.019.387.705 https://www.abdiibrahim.com.tr

Deva Holding A.Ş. 188 1.040.551.641 754.688.844 http://www.deva.com.tr/

Koçak Farma 200 1.005.950.067 721.658.976 http://www.kocakfarma.com/

Bayer Türk Kimya 230 882.104.800 776.176.554 https://www.bayer.com.tr/

Nobel Pharmaceutical 286 743.068.300 545.932.235 http://www.nobel.com.tr/

Santa Farma 461 457.189.300 363.340.042 https://www.santafarma.com.tr/

Source: ISO- Istanbul Chamber of Industry

Abdi İbrahim İlaç Sanayi ve Tic A.Ş. - https://www.abdiibrahim.com.tr Abdi İbrahim has the largest product portfolio in the sector, exceeding 180 brands and approximately 350 products by developing its own products as well as working with 30 licensors. Abdi İbrahim’s product range includes antianemic, antibacterial/antiviral, dermatology, endocrine, metabolism, gastrointestinal, cardiovascular, NSAI and myorelaxants, ophthalmology, central nervous system, respiratory and urogenital system products as well as food supplements, vitamins and minerals from 13 different therapeutic areas.

5 Gün + Partners Law Office, 2019

https://www.abdiibrahim.com.tr/

http://www.deva.com.tr/

http://www.kocakfarma.com/

https://www.bayer.com.tr/

http://www.nobel.com.tr/

https://www.santafarma.com.tr/

https://www.abdiibrahim.com.tr/

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Deva Holding A.Ş. - http://www.deva.com.tr/ DEVA, having one of the strongest product portfolios in the pharmaceutical industry, is working to locally manufacture and make products available on a global scale that address the needs in various therapeutic areas and differentiates itself from the others with its value-added products and original molecules. The product portfolio includes approximately 600 products spanning 13 therapeutic areas from oncology/hematology to cardiology, respiratory system and ophthalmology. Koçak Farma - http://www.kocakfarma.com/ Being established in 1971, Koçak Pharmaceuticals has become one of the most prominent companies of the Turkish pharma sector in the past 46 years. Today with almost 1200 employees, over 500 different types of products and both API and finished product production; Koçak has become an important contributor to Turkish medicine. Bayer Türk Kimya Sanayii Ltd. Şti. - https://www.bayer.com.tr/ Bayer's headquarters is in Istanbul, however it has many different regional offices and production facilities in Turkey. The products produced in Turkey are exported to over 40 countries. With its existing facilities and manpower in Turkey, Bayer is the largest subsidiary in the Middle East region. Nobel Pharmaceutical - http://www.nobel.com.tr/ Nobel is a long-standing, internationally active pharmaceutical company founded in 1964 with one hundred percent national capital. Being one of the 100 companies with the highest growth rate in recent years, Nobel is the only pharmaceutical company in Turkey that is not on a foreign trade deficit owing to its successful export activities to 50 countries in the pharmaceutical sector where there is high rate of imports. Santa Farma - https://www.santafarma.com.tr/ Operating in 11 distinct therapeutic categories including dermatology, digestive system and metabolism, gastroenterology and infection, and hematology with totally 63 products supplied to 45 different markets, Santa Farma has recently made investments in manufacturing, R&D and access network projects based on its vision to steer growth with export. Having opened a manufacturing plant on a land of 80 thousand sqm in Dilovası GEBKİM OIZ along with an R&D center, Santa Farma has begun to reap the fruits of its export-based growth strategy.

http://www.deva.com.tr/


https://www.bayer.com.tr/

http://www.nobel.com.tr/

https://www.santafarma.com.tr/

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For the other major players, please check the following link: http://www.ieis.org.tr/ieis/en/ieis/2/our-members

3.1.8 R&D in Pharmaceutical in Turkey

The pharmaceutical industry is a high-priority sector contributing to Turkey's industrial transformation with 34 accredited R&D centers and 1.298 R&D employees as of May 2019. Advances in R&D will make it possible to locally manufacture those products for which Turkey is currently dependent on imports. *As of May 2019 Source: Source: Ministry of Industry and Technology

The main actors of the innovation ecosystem are universities, research centers, public institutions, companies and entrepreneurs. Innovation is the result of the interaction of these actors with each other under appropriate environmental conditions. We will also examine university research centers under a separate heading.

Selected List of Pharmaceutical Companies with R & D Centers

Company Name City Web

1 Abdi İbrahim Pharmaceuticals Istanbul https://www.abdiibrahim.com.tr/en/

2 Ali Raif Pharmaceuticals Istanbul https://www.aliraif.com.tr/

3 Argis Pharmaceuticals Ankara http://argisilac.com.tr/

http://www.ieis.org.tr/ieis/en/ieis/2/our-members

http://www.ieis.org.tr/ieis/en/ieis/2/our-members

https://www.abdiibrahim.com.tr/en/

https://www.aliraif.com.tr/

http://argisilac.com.tr/

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4 Arion Pharmaceuticals Istanbul http://www.arionilac.com.tr/

5 Arven Pharmaceuticals Istanbul http://www.arvenilac.com.tr/

6 Atabay Kimya Sanayi Istanbul https://atabay.com/

7 Berko Pharmaceuticals Istanbul https://berkoilac.com.tr/

8 Bilim Pharmaceuticals Kocaeli http://www.bilimilac.com/en/

9 Biofarma Pharmaceuticals, Istanbul http://www.biofarma.com.tr/

10 Deva Holding A.Ş. Tekirdag http://www.deva.com.tr/en/devarge

11 Era Pharma Istanbul http://www.erapharma.com.tr/en/

12 Farmatek Pharmaceuticals Istanbul https://www.farma-tek.com/

13 Gen Pharmaceuticals Ankara https://www.genilac.com.tr/

14 İlko Pharmaceuticals Ankara http://www.ilko.com.tr/en/rd

15 Koçak Farma Tekirdag http://www.kocakfarma.com/

16 Kurtsan Pharmaceuticals Istanbul http://www.kurtsanilaclari.com/

17 Mustafa Nevzat Pharmaceuticals Istanbul https://www.mn.com.tr/

18 Nobel Pharmaceuticals Düzce http://www.nobel.com.tr/en/

19 Novagenix Bioanalytical Pharmaceuticals Ankara http://www.novagenix.com.tr/

20 Onko-Kocsel Pharmaceuticals Kocaeli https://www.onkokocsel.com/rd

21 Pharmactive Pharmaceuticals Tekirdag https://www.pharmactive.com.tr/

22 Polifarma Pharmaceuticals Tekirdag http://www.polifarma.com.tr/

23 Sanofi Pharmaceuticals Kırklareli https://www.sanofi.com.tr/

24 Sanovel Pharmaceuticals Istanbul http://www.sanovel.com/

25 Santa Farma Kocaeli https://www.santafarma.com.tr/en/

26 Teknovet Pharmaceuticals Istanbul http://www.teknovet.com.tr/

27 Tüm Ekip Pharmaceuticals Istanbul https://www.tumekip.com.tr/

28 Turgut Pharmaceuticals Istanbul http://www.turgutilac.com.tr/

29 Turktipsan A.Ş. Ankara https://turktipsan.com.tr/en/r-d/

30 Ulkar Kimya Tekirdag http://www.ulkarkimya.com/

31 Vefa Pharmaceuticals Istanbul https://vefailac.com.tr/

32 Vem Pharmaceuticals Tekirdag http://www.vemilac.com/uretim-tesisimiz

33 World Medicine Pharmaceuticals Istanbul http://worldmedicine.com.tr/en/

34 Zade Vital® Konya http://www.zadevital.com.tr/

Source: Source: Ministry of Industry and Technology

From 2010 to 2017, pharmaceutical R&D spending climbed from TL 92.1 million to TL 314.1 million on a 241% rise. This increase points to 92.3% real growth on a manufacturer price basis, and 19.1% CAGR. The following table is compiled from the survey of Turkey Exporters’ Union.

http://www.arionilac.com.tr/

http://www.arvenilac.com.tr/

https://atabay.com/

https://berkoilac.com.tr/

http://www.bilimilac.com/en/

http://www.biofarma.com.tr/

http://www.deva.com.tr/en/devarge

http://www.erapharma.com.tr/en/

https://www.farma-tek.com/

https://www.genilac.com.tr/

http://www.ilko.com.tr/en/rd


http://www.kurtsanilaclari.com/

https://www.mn.com.tr/

http://www.nobel.com.tr/en/

http://www.novagenix.com.tr/

https://www.onkokocsel.com/rd

https://www.pharmactive.com.tr/

http://www.polifarma.com.tr/

https://www.sanofi.com.tr/

http://www.sanovel.com/

https://www.santafarma.com.tr/en/

http://www.teknovet.com.tr/

https://www.tumekip.com.tr/

http://www.turgutilac.com.tr/

https://turktipsan.com.tr/en/r-d/

http://www.ulkarkimya.com/

https://vefailac.com.tr/

http://www.vemilac.com/uretim-tesisimiz

http://worldmedicine.com.tr/en/

http://www.zadevital.com.tr/

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While there were 5 pharmaceutical companies in the list in 2017, this number was 11 as of 2018. R&D 250, 2018

2018 Rank

Company

2018 R&D

Expenditure (TL)

R&D Share on

Revenue (%)

R & D Number of

Employees

Planned R & D Expenditure in

2019 (TL)

21 DEVA HOLDİNG A.Ş. 72.453.821,00 7 204 55.421.509,00

22 ABDİ İBRAHİM İLAÇ 70.116.470,94 2,75 161 79.563.360,00

40 SANOFİ İLAÇ 31.143.790,11 5,1 46 20.446.523,00

43 NOBEL İLAÇ 28.090.666,16 2,56 57 35.000.000,00

74 WORLD MEDICINE İLAÇ 15.000.000,00 6 73 20.000.000,00

84 İLKO İLAÇ 13.110.925,37 8 25 15.000.000,00

90 ARVEN İLAÇ 12.114.345,25 5,97 29 12.114.345,25

95 SANOVEL İLAÇ 11.905.817,60 1,84 56 15.000.000,00

131 PHARMACTİVE İLAÇ 7.614.529,17 1,7 32 20.646.439,13

138 ARGİS İLAÇ 7.056.312,00 38 70 15.000.000,00

139 ALİ RAİF İLAÇ 7.056.005,00 1,22 26 10.000.000,00

Source: Pharmaceutical R & D Leaders, R & D 250 List

3.1.9 Conclusion & Evaluation

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4. BIOTECHNOLOGY INDUSTRY IN TURKEY

4.1 MARKET OVERVIEW

There are basically two types of drugs in the pharmaceutical sector; Conventional drugs which are usually mainly chemical and biotechnological drugs. The worldwide use of biotechnological products has exceeded 20%, an uptrend that continues today. And Turkey is no exception to this trend. In the Turkish pharmaceutical market, there are 252 originator biotechnological products under 107 brands and 83 biosimilar products under 23 brands. The biotechnological drug market comprises 335 forms of drugs under a total of 130 brands. 29 types of biosimilars under 7 different brands are locally manufactured. Efforts are underway for the local production of two originator biotechnological, 39 biosimilar products and one bio better product by 2024. Local development and production of these products, for which Turkey is currently import-dependent, will ease patient access, while reducing the foreign trade deficit, therefore significantly contributing to the national economy. An analysis of the originator biotechnological products shows that the market grew by 30.3% in 2018 to TL 5.1 billion. For that year, the biosimilar pharmaceutical market exhibited a 48.2% increase to 282 million TL. On a unit scale, biotechnological products reached a volume of 28.5 million units on a 2.8% increase in 2018. The unit sales for originator biotechnological products decreased by 0.2% compared to the previous year, and that of biosimilar drugs increased by 18.5%. Biosimilar unit sales in 2018 were recorded at 5.3 million. In Turkey, biosimilars that contain abciximab, adalimumab, enoxaparin sodium, epoetin alpha, filgrastim, infliximab, insulin glargine, recombinant human epidermal growth factor, rituximab, somatropin and trastuzumab are licensed. Among them, those manufactured in Turkey contain the active ingredients of enoxaparin sodium, epoetin alfa, filgrastim, infliximab, and insulin glargine. The number of biosimilars is expected to increase over the coming term. Biotechnological drugs constitute 30% of the import products in Turkish pharmaceutical market.6 In 2010, the share of biosimilars among biotechnological products was 0.2% in value and 0.1% in unit terms, whereas in 2018, they had a respective 5.2% and 18.6% share in terms of value and units.

6 Turkish Pharmaceutical Market 2018 by IEIS

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Blood and hematopoietic biotechnological products have significantly expanded their market share within the biosimilars category. As for the originator biotechnological products market; antineoplastic, immunomodulatory agents, digestive system and metabolism products rank the highest in value terms

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Biotechnological Products

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4.2 INVESTMENT ON BIOPHARMACEUTICAL

Realizing the development in the sector, local and international companies are producing biotechnological drugs in Turkey. Major local players, including Abdi Ibrahim and Koçak Farma, have increasingly invested on biotechnological drugs. The top five firms in the sector have so far invested $250 million in this field. In addition, U.S. biotech giant Amgen has invested $40 million in a new biotechnological facility in Istanbul after it acquired Mustafa Nevzat for $700 million.

From Abdi İbrahim to CinnaGen, from Nobel to Koçak Farma, many companies have invested in this area. Growth in biotechnology is expected to continue with new investments.

Biopharmaceutical Investments by Companies Company Investment Amount

1 Abdi İbrahim 450 Million TL

2 Amgen 222,3 Million TL

3 Atabey 16,5 Million TL

4 Centurion 30 Million Euro

5 CinaGen 100 Million Dollar

6 Dem İlaç 80 Million Euro

7 İlko İlaç 32,4 Million Dolar

8 Koçak Farma 223 Million Dolar

9 Nobel İlaç 100 Million Dolar

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5. MEDICAL TECHNOLOGY IN TURKEY

5.1 MARKET OVERVIEW

Medicinal products that are within the portfolio of pharmaceutical companies, yet that are not classified as pharmaceutical products are as follows: biocidal products licensed by the Ministry of Health, certain medical devices in pharmaceutical form, medical infant formulas, cosmetic and derma-cosmetic products; vitamins authorized by the Ministry of Agriculture and Forestry, food supplements and infant formulas. These products scored 31.5% growth in 2018, printing at 2.4 billion TL. They posted a 9.8% rise in unit terms with sales of 178 million units. In the January-September period of 2018, the highest increase was seen in integral nutrition products, while food supplements took the second place. In the first nine months of 2018, the medical product market experienced an interesting period not only in terms of sales but also in terms of product variety. 161 new food supplements were entered to the market and 15 new enteral nutritional and medical foods were sold during the year. The medical devices market is imports-dominated, which makes up 85% of the market. This is expected to decrease to a 75%-80% range in the next ten years, as the government of Turkey plans to incentivize local medical devices manufacturing. Turkey has adjusted its medical devices regulations to match the European Union (EU) regulations, and it is required that devices obtain a CE mark when being imported into Turkey.7 According to The Ministry of Health (MoH) figures, there are 1,000 medical device manufactures, 2,300 importers, and 700 companies that do both. Manufacturers are typically small-scale manufacturers of products such as bandages, syringes, orthopaedic products, and surgical instruments. Some key facts and figures in the Turkish medical devices sector include: ➢The Turkish medical devices market surpassed USD 2.0 billion in 2018. ➢The market is expected to grow by 5.9 percent in TRY terms annually between 2016-2021. ➢The healthcare campus projects will cater to increasing demand in the sector over the next several years. ➢The growing medical tourism sector, in which the number of tourists rose to 554,000 in 2018, is expected to further stimulate demand for medical devices. The Ministry of Health expects this number to reach 1.5 million by 2023.

7 Healthcare Resource Guide: Turkey by The U.S. Department of Commerce’s International Trade Administration

https://www.export.gov/ITA

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➢Medical device regulations are in line with EU directives. The MoH is contracting the construction and management of a new group of hospitals, known as ‘city hospitals’ or ‘health campuses.’ The MoH has planned for 32 health campuses to be built. Nine are currently operational and 12 are under construction, with completion set for late 2021. The remaining hospitals are at various stages in the tendering process. These new hospitals will replace and renew about 50,000 beds in the current hospital bed stock. By 2023, the MoH seeks to increase the total number of beds under its operation to 169,000. The health campuses will be financed using the Public Private Partnership (PPP) model. The winning contractor of each project finances the construction and operates the campus for 25 years against guaranteed annual lease payments from MoH. Each campus has 500 to 4,000 beds and houses several general and specialized hospitals and labs with accompanying recreational areas. For further information on these PPP projects, please visit the official website of the Private-Public-Partnership Directorate under the MOH.

Medical Products Market

https://sygm.saglik.gov.tr/TR,33960/sehir-hastaneleri.html

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Whereas the average price of medical products was 7.8 TL in 2010, it reached 13.6 TL in 2018 on a rise of 75% over the past 9 years.

Average Price Breakdown of Medicinal Products

Source:İEİS

5.2 MARKET ENTRY

All medical devices must bear the CE marking and must be registered in the Turkish Ministry’s online database (TITUBB, Turkish Drug and Medical Device National Databank) in order to be marketed in Turkey. Manufacturers without local presence in Turkey must appoint a Local Authorized Representative.

5.3 CURRENT MARKET TRENDS

In general, it can be said that all major categories of medical equipment are present in the market, both in private and public hospitals. At this point, the market is open to state-of-the-art and innovative medical equipment and solutions. Turkey imports the following medical equipment and devices from abroad:

• Advanced pre-screening and diagnostics devices • Advanced point-of-care devices • Cancer treatment devices • Wound management devices • Surgical devices using robotics technologies • Dental equipment • Radiation oncology systems8



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5.4 PROCUREMENT & TENDERS

Procurement for public hospitals are mostly done through tenders which can be followed at Turkish Public Procurement Authority’s website (www.ekap.kik.gov.tr). However, most information posted is in Turkish, which shows the importance of having a local representative/distributor in the country. Private hospitals invite companies to bid when they procure medical devices.

5.5 OPPORTUNITIES

Total bed capacity in Turkish hospitals exceeds 200,000. Privatization and transformation of the healthcare system with the establishment of new healthcare facilities under the PPP model, and ongoing MoH hospital projects present opportunities for Flemish companies involved in medical technologies and services. As Turkey continues to expand the number of private and public hospitals, purchases of advanced medical equipment will continue. There are now some large hospital chains that operate not only in large cities but also in more remote parts of the country. These new hospitals are all state-of-the-art facilities that use advanced medical equipment.9

6. ACADEMIC LIFE SCIENCE RESEARCH IN TURKEY

The main actors of the innovation ecosystem are universities, research centers, public institutions, companies and entrepreneurs. Innovation is the result of the interaction of these actors with each other under appropriate environmental conditions. The environmental conditions that feed this ecosystem are composed of financial resources and incentive mechanisms, legal regulations, education & human resources and investment environment factors. The collaboration between universities and the pharmaceutical industry is not strong enough in Turkey. To increase R&D collaborations between universities and small-scale R&D companies is among Turkey's 2023 vision. Tubitak (The Scientific and Technological Research Council of Turkey) 1505 Program is a grant program that provides grants for entities that are located in Turkey and undertake product development activities to transfer knowledge and technology from research centers at universities and/or public research institutes to the private sector. The research entity must commit to implement the project results in Turkey. (https://www.gmka.gov.tr/1505---universite-sanayi-isbirligi-destek-programi)


http://www.ekap.kik.gov.tr/

https://www.gmka.gov.tr/1505---universite-sanayi-isbirligi-destek-programi


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Market Study


Selected Research Centers at Universities

Activity Area

City

Web Page

1 The Biotechnology Institute at Ankara University Health & agricultural bio-Tech Ankara https://biotek.ankara.edu.tr/en/

2 Bilkent University Genetics and Biotechnology Research Center -BilGen Cancer research Ankara http://infobil.bilkent.edu.tr/

3 Boğaziçi University Center for Life Sciences and Technologies Life Sciences Istanbul https://lifesci.boun.edu.tr/en

4 Research and Application Center of Drug Development and Pharmocokinetics at Ege University

Pharmaceutical Research Izmir https://argefar.ege.edu.tr/

5 Pharmaceutical Sciences Research Laboratory at Ege University Pharmaceutical Research Izmir http://fabal.ege.edu.tr/

6 Gazi University Life Sciences Research and Application Center Life Sciences Ankara http://yasam.gazi.edu.tr/

7 Hacettepe University Center for Genomics and Rare Diseases Health Ankara http://www.hugen.hacettepe.edu.tr/english/

8 Hacettepe University Technology, Research and Application Center for Pharmaceutical Sciences and Biopharmaceutics

Pharmaceutical Sciences and Biopharmaceutics

Ankara http://www.fatum.hacettepe.edu.tr/

9 Biomaterials Research and Characterization Laboratory at ITU Biomaterials Istanbul http://www.biomaterials.itu.edu.tr/

10 ITU Dr. Orhan Öcalgiray Molecular Biology-Biotechnology & Genetics Research Center Molecular Biology-Biotechnology and Genetics

Istanbul http://www.mobgam.itu.edu.tr/

11 Istanbul University Center for Research and Practice in Biotechnology and Genetic Engineering

Biotechnology and Genetic Engineering

Istanbul https://biyogem.istanbul.edu.tr/en/_

12 Kocaeli University (KOU) Stem Cell and Gene Therapies Research and Application Center (KÖGEM)

Stem Cell and Gene Kocaeli http://kogem.kocaeli.edu.tr/

13 METU - Middle East Technical University Central Laboratory Scientific Research Ankara http://merlab.metu.edu.tr/tr

14 Sabancı University Nanotechnology Research and Application Center Nanotechnology Istanbul https://sunum.sabanciuniv.edu/

15 Sabancı University EFSUN - Center of Excellence on Nano Diagnostics Nano Diagnostics Istanbul https://fens.sabanciuniv.edu/

16 Koç University Drug Research Center Drug Research Istanbul http://home.ku.edu.tr/~iam/About_Us.html

17 Karadeniz Technical University Drug and Pharmaceutical Technology Application and Research Center

Drug and Pharmaceutical Research

Trabzon http://www.ktu.edu.tr/dphar

18 Sabanci University Biotechnology Research Center Biotechnology Research Istanbul https://www.sabanciuniv.edu/en/labs

19 Boğaziçi University, and INOVITA Sciences and Technologies Istanbul Cooperation Platform / Center for Life Sciences and Technologies and Inovita

Life Sciences and Health Technologies

Istanbul http://www.inovita.org/

https://biotek.ankara.edu.tr/en/

http://infobil.bilkent.edu.tr/

https://lifesci.boun.edu.tr/en

https://argefar.ege.edu.tr/

http://fabal.ege.edu.tr/

http://yasam.gazi.edu.tr/

http://www.hugen.hacettepe.edu.tr/english/

http://www.fatum.hacettepe.edu.tr/

http://www.biomaterials.itu.edu.tr/

http://www.mobgam.itu.edu.tr/

https://biyogem.istanbul.edu.tr/en/_

http://kogem.kocaeli.edu.tr/

http://merlab.metu.edu.tr/tr

https://sunum.sabanciuniv.edu/

https://fens.sabanciuniv.edu/

http://home.ku.edu.tr/~iam/About_Us.html

http://www.ktu.edu.tr/dphar

https://www.sabanciuniv.edu/en/labs

http://www.inovita.org/

Market Study


7. KEY ORGANIZATIONS & EVENTS IN THE LIFE SCIENCE SECTOR IN TURKEY

7.1 KEY ORGANIZATIONS

Republic of Turkey Ministry of Health https://www.saglik.gov.tr/ Ministry of Industry and Technology https://www.sanayi.gov.tr/index.html?lang=en Association of Research-Based Pharmaceutical Companies (AİFD) www.aifd.org.tr/ Pharmaceutical Industry Association of Turkey (TISD) www.tisd.org.tr/ Pharmaceutical Manufacturers’ Association of Turkey (IEIS) www.ieis.org.tr

TUBITAK - The Scientific and Technological Research Council of Turkey https://www.tubitak.gov.tr/en

Federation of Medical Devices Manufacturers and Suppliers Association (TÜMDEF) www.tumdef.org

Manufacturers Association of Medical Devices www.tuder.org.tr

Titck - Turkish Medicines and Medical Devices Agency https://www.titck.gov.tr/ SURDER -Health Products Association https://surder.org.tr/

Health Industry Employers’ Association (SEIS) www.seis.org.tr

https://www.saglik.gov.tr/

https://www.sanayi.gov.tr/index.html?lang=en

http://www.aifd.org.tr/

http://www.tisd.org.tr/

http://www.ieis.org.tr/

https://www.tubitak.gov.tr/en

http://www.tumdef.org/

http://www.tuder.org.tr/

https://www.titck.gov.tr/

https://surder.org.tr/

http://www.seis.org.tr/

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7.2 KEY EVENTS

Exhibition Name Description Date

EKSPOMED 2020 International Istanbul Medical Analysis, Diagnosis,

Treatment, Rehabilitation Product, Device, System,

Technology, Equipment, and Hospitals Fair

March 19 - 21, 2020

EXPOMED EURASIA International Fair for Health Care, Hospital

Supplies, Medical and Laboratory Equipment and

Rehabilitation Aids

March 19 - 22, 2020

LABTECHMED EURASIA 2020 Istanbul International Laboratory Technology and

Equipment Fair

March 19 - 22, 2020

HEALTH EXPO ISTANBUL 2020 Medical Product, Hospital Equipment, Healthcare

Informatics and Technologies, Laboratory Systems,

Home Care Products and Medical Tourism

Exhibition

April 2020

IDEX ISTANBUL 2020 Istanbul Oral and Dental Health Apparatus and

Equipment Exhibition

April 2020

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8. SOURCES

• KPMG, Pharmaceutical Report, 2019

• Turkish Pharmaceutical Market 2018 by IEIS

• Investment Support and Promotion Agency of Turkey (ISPAT), Pharmaceutical sector in Turkey

• ISO- Istanbul Chamber of Industry

• Healthcare Resource Guide: Turkey by The U.S. Department of Commerce’s International Trade

Administration

• TOBB – General Overview of Health System of Turkey

• Turkish Statistical Institute (TurkStat)

• World Bank

• Pharmaceutical R & D Ecosystem Report by AIFD

• Turkish Health Sector 2018 by Garanti Securities

• Sectoral Outlook: Health Service, Medical Devices and Pharmaceuticals, 2018 by TSKB

• FuarPlus

The information in this publication is provided for background information that should enable you to get a picture of the subject treated in this document. It is collected with the greatest care based on all data and documentation available at the moment of publication. Thus this publication was never intended to be the perfect and correct answer to your specific situation. Consequently it can never be considered a legal, financial or other specialized advice. Flanders Investment & Trade (FIT) accepts no liability for any errors, omissions or incompleteness, and no warranty is given or responsibility accepted as to the standing of any individual, firm, company or other organization mentioned. Date of publication: 01/2020



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