The production of local biotechnological medicine
The production of local biotechnological medicine
Business Model Description
Investments in the R&D and production of biotechnology medicine
Expected Impact
Investments in biotechnology medicine production will increase the value added from medicine and make essential pharmaceuticals more readily accessible for Turkish patients.
How is this information gathered?
Investment opportunities with potential to contribute to sustainable development are based on country-level SDG Investor Maps.
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Country & Regions
- Turkey: Black Sea Region
- Turkey: Central Anatolia Region
- Turkey: Marmara Region
- Turkey: Mediterranean Region
Sector Classification
Health Care
Development need
According to the Sustainable Development Report Dashboard of 2020, significant challenges remain in Turkey's performance on SDG 3 (Good Health and Well-being). This situation is exacerbated by COVID-19
Policy priority
Pharmaceuticals and medical devices are listed as priority investment areas (11th Development Plan and the 2020 Presidential Program). The Ministry of Health 2019-2023 Strategic Plan highlights constraints such as the the inefficient use of information technologies, the limited scale of R&D, inequalities in regional health services and the underemployment of health personnel
Gender inequalities and marginalization issues
60% of healthcare workers in Turkey are women. (15) There is no official data providing a gender-based breakdown of the job categories in the healthcare sector. There are 1.83 doctors per 1000 people in Turkey (16), this is below the OECD average of 3.4.(17) There are currently 19.05 hospital beds per one million people in the country. (16) Although the regional breakdown of these indicators are not provided, rural and remote areas have an unequal access to health facilities and personnel.
Investment opportunities
Wide-scale reforms and significant sectoral growth drive investments towards healthcare.The production of high-value added pharmaceuticals and medical devices are marked as priority investment areas by the country. Moreover, the presence of many clinics and hospitals under the internationally accredited Joint Commission International supports prospects for health tourism
Key bottlenecks
The lack of collaboration among scientists and industry & the shortage of opportunities to encourage the private sector to invest in basic research limit scale. Overall, health research and R&D infrastructure development is necessary
Biotechnology and Pharmaceuticals
"Development need
The coronavirus pandemic has demonstrated the importance of medical biotechnology in the efforts to produce a vaccine. Turkey's yearly investments in innovative drug R&D is significantly lower than the world average (global investments in innovative drug R&D is USD 120 bl/y, Turkey’s share is only USD 60 mil/y representing only 0.039% of global R&D). (8)
"
Policy priority
Medicine and Medical Devices are among the priority sectors highlighted by the 11th Development Plan. The 2020 Presidential Program highlights biotechnological drugs as a priority area in healthcare.The 2019-2023 Strategic Plan of the Ministry of Health stresses the importance of domestic medicine production and R&D efforts.
Gender inequalities and marginalization issues
60% of healthcare workers in Turkey are women. (15) There is no official data providing a gender-based breakdown of the job categories in the healthcare sector. There are 1.83 doctors per 1000 people in Turkey (16), this is below the OECD average of 3.4.(17) There are currently 19.05 hospital beds per one million people in the country. (16) Although the regional breakdown of these indicators are not provided, rural and remote areas have an unequal access to health facilities and personnel.
"Investment opportunities
Existing biotechnology clusters in Izmir under the Izmir Biotech Cluster Initiative: they offer a biotech startup end-to-end
product development as well as testing
and certification (6)(7). Moreover, biotechnology drug production is a priority investment area for the country, and therefore is eligible for multiple government investment incentive programs. "
"Key bottlenecks
Entry barriers include the few API manufacturers in operation, high costs of initial investment, the ambiguity in the regulatory approval processes of locally produced biosimilars and the difficulty of finding trained scientists for
biosimilar/biotech production (6)"
Biotechnology and Pharmaceuticals
Pipeline Opportunity
The production of local biotechnological medicine
Investments in the R&D and production of biotechnology medicine
Business Case
Market Size and Environment
> USD 1 billion
Per kilogram value
Since August 2018, The Turkish biotechnologiy medicine market is valued above 5 billion TL. Biotechnology medicines constitute 20% of the Turkish pharmaceutical market. (9)
The world pharmaceutical market is worth around 1.2 trillion dollars, biotechnology medicines constitute approximately 260 billion dollars of this total value. (9)
On average, the per kilogram value of biotechnological drugs is one million dollars (9)
Indicative Return
> 25%
Interviewed local investors interested in medical technology models target an IRR of 20-40% from these investments.
Investment Timeframe
Long Term (10+ years)
On average, the production of a new medicine takes around 12-15 years, and requires a significant amount of initial investments.
The licensing process in Turkey is composed of many stages such as 1) R&D efforts 2) Pre-Clinical Trials 3) Clinical Trials 4) License Application and Review Process 5) Sales Approval.
Ticket Size
> USD 10 million
Market Risks & Scale Obstacles
Market - High Level of Competition
Impact Case
Sustainable Development Need
Access to essential medicine and its affordability constitute a global policy concern in terms of SDG 3.The coronavirus pandemic has demonstrated the importance of medical biotechnology in the efforts to produce a vaccine
Turkey's yearly investments in innovative drug R&D is significantly lower than the world average.
Currently, drug production in Turkey is oriented towards low value-added products, while high value-added products are imported. (10)
Gender & Marginalisation
There are rural-urban disparities in the access to health services and personnel in Turkey
Expected Development Outcome
Increase the value added from medicine and possibly make essential pharmaceuticals more readily accessible for Turkish patients
Enhance scientific research and the R&D capacity of Turkey
Increase R&D expenditure as a proportion of the GDP
Gender & Marginalisation
Increase access to essential medicines for female, inmigrants or rural ppopulation
Primary SDGs addressed
3.b.1 Proportion of the target population covered by all vaccines included in their national programme
3.b.2 Total net official development assistance to medical research and basic health sectors
86.47% (12)
2.16 billion US$ (12)
100%
9.5.1 Research and development expenditure as a proportion of GDP
9.5.2 Researchers (in full-time equivalent) per million inhabitants
9.b.1 Proportion of medium and high-tech industry value added in total value added
0.96% (1)
1,156.51 per million people (2015) (12)
31.45% (12)
3.7% (1)
15 per thousand (1)
Secondary SDGs addressed
Directly impacted stakeholders
People
Corporates
Public sector
Indirectly impacted stakeholders
People
Gender inequality and/or marginalization
Corporates
Outcome Risks
Without an effective and transparent regulatory system which monitors the production processes and quality standards closely, new drugs might pose health risks to users
Impact Risks
Execution Risk
Unexpected Impact Risk
Impact Classification
What
Important, positive outcome: increased wellbeing and competitives in biotechnological medicine.
Risk
Low Risk (The potential risks for this model include problems related to quality and safety procedures (litigation and quality assurance)
Impact Thesis
Investments in biotechnology medicine production will increase the value added from medicine and make essential pharmaceuticals more readily accessible for Turkish patients.
Enabling Environment
Policy Environment
(11th Development Plan): Medicine and Medical Devices are among the priority sectors highlighted by the 11th Development Plan.
(2020 Presidential Program): The 2020 Presidential Program highlights biotechnological drugs as a priority area in healthcare
(2019-2023 Strategic Plan of the Ministry of Health): The 2019-2023 Strategic Plan of the Ministry of Health highlights the importance of domestic medicine production and R&D efforts.
Financial Environment
Financial incentives: The Ministry of Industry and Technology offers project-based incentives for R&D projects. The Central Bank of Turkey provides grant support to innovative drug production and R&D activities. (13). TÜBİTAK provides financial support to eligible R&D and innovation projects.
Fiscal incentives: Biotechnology drug production benefits from Region 5 Incentives: tax reductions, VAT exemption, credit and insurance support. Pharmaceutical production is also included in the Large Scale Investment Incentive Program if they have a minimum investment of 50 million TL
Other incentives: Companies geographically active or established in the Technology Development Zone will benefit from Institutions Tax Exemption (Kurumlar Vergisi İstisnası), Income Tax Exemption, Insurance Prime Support and VAT exemptions.
Regulatory Environment
Law 6550 on Supporting Research Infrastructure; qualified research centers are entitled to acquire legal personality as thematic research infrastructure.
The Social Security Institution, Medicine Refund Regulation and the Alternative Refund Regulation lays out the conditions for social security refunds/coverage of treatments and medicine in the Turkish health system
The Ministry of Health Human Medical Products Licensing Regulation (Beşeri Tıbbi Ürünleri Ruhsatlandırma Yönetmeliği) sets out the procedure and the principles for the licensing of human medical products
The Turkish Medicine and Medical Devices Institution sets the standards and regulations for the production of medicine and medical devices
Official Gazete # 30217 (21 October 2017) Human Medicine Manufecturers Regulation delineates the principles and procedures of manufacturing medicinal products for human use in compliance with Good Manufacturing Practices and nationally and internationally accepted standards
Marketplace Participants
Private Sector
Banks like İş Bankası with R&D credit lines, companies like Eczacıbaşı, VSY Biotechnology, EPİGENETİKS Genetik Biyoinformatik Yazılım A.Ş, ARVEN İlaç, Inovita etc.
Government
Industrial Development Bank of Turkey, The Social Security Institution, The Directorate of Health Industry of Turkey, the Ministry of Health, the Medicine and Medical Devices Agency. Dokuz Eylul Uni. International Biomedicine and Genom Institute, Ege Uni. Research and Application Center of Drug Development, Investigative Pharmaceutical Firms Foundation, Black Sea Technical Uni. Pharmaceutical Technology Research and Application Center, Trabzon's Innovation and Biotechnology Center The Medicine and Medical Devices Institution of Turkey.
Multilaterals
International Finance Corporation, WHO
Public-Private Partnership
Türkiye Teknoloji Geliştirme Vakfı'nın (TTGV), Turkish Chamber of Pharmacies, The Pharmaceutical Manufacturers Association
Target Locations
Turkey: Black Sea Region
Turkey: Central Anatolia Region
Turkey: Marmara Region
Turkey: Mediterranean Region
References
- (1) SDG Index & Dashboard, 2020, https://dashboards.sdgindex.org/profiles/TUR/indicators "2) 11th Development Plan http://www.sbb.gov.tr/wp-content/uploads/2020/03/On_BirinciPLan_ingilizce_SonBaski.pdf " "3) 2020 Annual Presidential Program, http://www.sbb.gov.tr/wp-content/uploads/2019/11/2020_Yili_Cumhurbaskanligi_Yillik_Programi.pdf "
- (4) 2019-2023 Strategic Plan of the Ministry of Health, http://www.sp.gov.tr/upload/xSPStratejikPlan/files/Anobg+StratejikPlan2019-2023.pdf "5) Sustainable Development Goals Evaluation Report http://www.surdurulebilirkalkinma.gov.tr/wp-content/uploads/2020/03/Surdurulebilir-Kalkinma-Amaclari-Degerlendirme-Raporu_13_12_2019-WEB.pdf "
- (6) Swiss Chamber of Commerce, 2015, https://www.tr-ch.org/wp-content/uploads/2015/06/Turkey-Pharmaceuticals2015DT.pdf
- (7) Bioizmir, http://bioizmir.deu.edu.tr/en/
- (8) PwC, "İlaç Sektörü Vizyon 2023 Raporu, https://www.pwc.com.tr/en/publications/industrial/pharma/pdf/ilac-sektoru-vizyon-2023-raporu-eng.pdf
- (9) Cumhuriyet Daily, "Türkiye'nin İlk Yerli Kanser İlaci Üretildi", http://www.cumhuriyet.com.tr/haber/turkiyenin-ilk-yerli-kanser-ilaci-uretildi-1144366
- (10) PwC, "İlaç Sektörü Vizyon 2023 Raporu, https://www.pwc.com.tr/en/publications/industrial/pharma/pdf/ilac-sektoru-vizyon-2023-raporu-eng.pdf
- (11) Gün + Partners Avukatlık Bürosı, Turkey a Rising Star in the Pharmaceutical Industry, https://gun.av.tr/insights/articles/turkey-a-rising-star-in-the-pharmaceutical-industry
- (12) SDG Tracker, 2020, https://sdg-tracker.org/
- (13) The Central Bank of Turkey, "Yatırım Taahütlü Avans Kredisi Uygulama Talimatı", https://www.tcmb.gov.tr/wps/wcm/connect/4f7dcdda-a5f9-4b34-a4e5-fbde33496d6a/Yat%C4%B1r%C4%B1m+Taahh%C3%BCtl%C3%BC+Avans+Kredisi+Uygulama+Talimat%C4%B1+Temmuz+2020.pdf?MOD=AJPERES
- (14) WHO, Local Production for Access to Medical Products: Developing a Framework to Improve Public Health, https://www.who.int/phi/publications/Local_Production_Policy_Framework.pdf
- (15) Anatolian Agency, 2020. https://www.aa.com.tr/tr/sirkethaberleri/saglik/saglik-sektorunde-kadin-paneli/656192
- (16) Trading Economics: OECD Health Data, 2018. https://tradingeconomics.com/turkey/medical-doctors
- (17) OECD, 2017. https://www.oecd-ilibrary.org/docserver/health_glance-2017-52-en.pdf?expires=1615450933&id=id&accname=guest&checksum=75ABA90B65E377ACA91EBA3E9CEBA6B2