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Turkish Pharma Market

Turkish Pharma Market : 작성자, 작성일, 조회수, 원문,출처,대표이미지 정보 제공
작성자 관리자
작성일 2018-06-27 조회수 140
원문
출처 한국보건산업진흥원
kemal hatip.png

Turkish Pharma Market

전문가
Kemal Hatip
(케말 하팁)
KHIDI 해외제약전문가
▶ 컨설팅 분야  
  · 인허가, 기술마케팅
    - 중동지역(GCC) 의약품 해외수출 전략 및 시장개척
    - 기술사업화 및 제품 공공개발과 제휴 관리
    * 의약품(제네릭, 바이오포함), 바이오시밀러, 진단 및 의료기기

▶ 주요 약력 
  · 2009~현재 온코파마 중동아시아 디렉터
  · 2002~2009 Al Razi Pharmacy Co. & IBN Khaldoon Drug Store
  · 1997~2002 Novatis Pharma Service
  · 1980~1996 Ciba Geigy Ltd
  · 1979 이집트 AL MANSOURA University, Pharmaceutical Science 터키 약사
  · 임상시험 모니터링, 코즈메틱 분야



Turkey is the 29th largest pharmaceutical market in the world with the second largest in Central/Eastern Europe,   healthcare is projected to reach 50.9 billion US$ by 2020. The Turkish Pharmaceutical Industry is proud to be contributing significantly to the Turkish economy with approximately 500 institutions, 69 facilities meeting the highest international stranded. And 24 accredited R&D centers.

This industry which provide more than 11,000 products to the service of the Turkish people, is also proud to promote the economy through the exports to over 150 countries mainly in the EU, common wealth of independent states (CIS), North Africa & Middle East.

Although Public spending will continue to dominate the market, growing demand for higher quality care and market liberalization is spurring private healthcare spending, which is expected to rise from 9 billion US$ to 11.9 US$ billion by 2020.

In 2010 the Turkish pharma market was 13.33 billion TL (3.8 billion US$) & in 2017 grow to a total value of 22.24 billion TL (6.35 billion US$), which indicate that the Pharma market grow by over 65% with a compound annual growth rate (CAGR) of 7.6% which is an indication of market dynamism & potential for pharma business.

An analysis of the pharma market from the prospective of therapeutic groups indicate the following in 2016:

                Products                              Market Share %

  1. Oncology                                          11.3%

  2. Antibiotics                                         9.5%

  3. CVS                                                 7.2%

  4. Blood Products                                   6.7%

  5. CNS                                                 6.4%

  6. Anti-Rheumatics                                 5.9%

 

Exports and imports of Pharmaceutical products in billions US$


 



EXPORT



IMPORTS



EXPORT/IMPORT



2017



863



4,521



19.1%


 

This indicate that the gap is very big between the exports & imports of pharmaceutical products & the opportunity to improve the export to decrease the gap in favor of the country better economic situation.


Challenges & opportunities in Turkey for pharma business:

For life science companies there is always opportunity & barriers

The advantage of bringing a product to market in Turkey include its ongoing   efforts to harmonies with EU, it is now requiring eCTD & has standardized in line with the EU procedures, while keeping the file name in Turkish language. This simplifies the submission process for companies familiar with EU procedures.

A second opportunity for Turkish Market is the country`s adoption of the early access procedure and pre-licensing access to Orphan Drug products and also to national reimbursement scheme covering these products regardless of their market authorization status .

However, there are a number of areas where companies have faced obstacles like pricing and reimbursement scheme for generics and in particular with regard to Good Manufacturing Practices (GMP) Certification. Since 2009 Turkey has required companies bringing products in to the country to have GMP certification issued by Turkish Drug and Medical Device Agency (TITEK). In the intervening years the requirements has undergone many updates in terms of dossier requirements & definition of products priority status which determines parallel marketing authorization dossier evaluation. As a result, many companies are struggling to obtain marketing authorization.     

To deal with GMP requirement, companies must work closely with a local affiliate. It`s not only a requirement to have a local affiliate as the marketing authorization holder, but the affiliate also needs to have the expertise to guide life science companies through a number of complexities. For example: all documents are in Turkish with limited English translations. Furthermore, regulations & requirements change frequently, which underscores the need for on-the-ground knowledge of the market.

Another way to manage the GMP clarification requirements barriers is to manufacture products in Turkey or to shift the manufacturing to a third-party manufacturing in the country. Such a products won`t be subject to the same difficult and time consuming GMP certification requirements, since the local manufacturing site are inspected by Turkish authorities periodically.

Those companies that have chosen not to manufacture in Turkey will need to request the Turkish Drug & Medical Devise Agency to determine the priority status of their products by justifying why their product is important to the Turkish market. Again, local expertise will be essential since this will require knowledge of the Turkish market, not only with regard to regulatory requirements, but on certain criteria: for example, if the product is the first generation one or biotech, then, they will be considered high priority. Even for those higher priority, the time to market including dealing with the GMP certification in parallel with the submit ion evaluation process is max. Two years, and that actually a significant improvement since before it used to take 4 to 5 years to obtain a marketing authorization of imported products which needs a GMP inspection of GMP audits   

 Although Turkish laws provide for six years of regulatory Data Protection (RDP) in practice this protection is greatly limited. This is because the RDP is tied to the patent term so that data exclusively ends when the patent expires. Turkey does not recognize RDP for combination products or biologics.

Patent protection for pharmaceuticals is relatively new concept in Turkey, which first started granting it in 1999  

In the long-term, Turkey provides considerable commercial opportunity for pharma business companies for investments, due to the large population size and low per-capita pharmaceutical spending  suggest enormous growth potential, including health insurance coverage for the Turks coupled with private healthcare spending expansion will make it increasingly attractive to innovative drug companies  investments.

Turkey, a rising star in the region & the world has ambitious social & economic goals for 2023 – the 100th anniversary of the Republic. The vision for 2023 is making the country Global Center for pharmaceutical & R&D & Production.

The Pharmaceutical industry creates value through innovation. By tapping its potential, the innovative pharmaceutical industry can lead the way in helping the country achieve it 2023 goals & this is part of the vision for the 100thanniversary of the republic in 2023.



Prepared by Mr. Kemal Hatip / Executive Consultant
Korea Health Industry Development Institute (KHIDI)
Pharma Support Team
For more information, please call 010 3403 0032
Or e mail to kehatip@khidi.co.kr



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