Araştırma Makalesi
BibTex RIS Kaynak Göster

Drug Research And Development Process In Turkey

Yıl 2025, Cilt: 2 Sayı: 50, 176 - 199, 04.01.2026
https://doi.org/10.35343/kosbed.1619884

Öz

Medicine is a strategic product that directly affects human health, and R&D processes are notably long, costly, and technology-intensive. Globally, 27% of pharmaceutical R&D expenditures are allocated to clinical trials, with the entire process taking 12-15 years and costing $2.6-4.5 billion. Innovative approaches such as artificial intelligence, biotechnology, and OMICS technologies are driving the sector's development. The United States leads with $103 billion in annual R&D spending.Turkey, on the other hand, allocates $452 million to pharmaceutical R&D, ranking among the lowest OECD countries and dedicating only 1.8% of its total R&D expenditures to this field. Nevertheless, the efforts of the Turkish Medicines and Medical Devices Agency to comply with international standards highlight the potential for capacity growth in the sector. To strengthen its competitiveness and reduce dependency, Turkey must prioritize investments in funding, skilled human resources, innovation, and technological infrastructure.

Kaynakça

  • Austin, D. H. (2006). Research and development in the pharmaceutical industry.
  • Becker, M. C., & Lillemark, M. (2006). Marketing/R&D integration in the pharmaceutical industry. Research Policy, 35(1), 105-120.
  • Bennani, Y. L. (2012). Drug discovery in the next decade: Innovation needed ASAP. Drug Discovery Today, 17, S31-S44. https://doi.org/10.1016/j.drudis.2011.12.007
  • Blau, G. E., Pekny, J. F., Varma, V. A., & Bunch, P. R. (2004). Managing a Portfolio of Interdependent New Product Candidates in the Pharmaceutical Industry. Journal of Product Innovation Management, 21(4), 227-245. https://doi.org/10.1111/j.0737-6782.2004.00075.x
  • Blau, G., Mehta, B., Bose, S., Pekny, J., Sinclair, G., Keunker, K., & Bunch, P. (2000). Risk management in the development of new products in highly regulated industries. Computers & Chemical Engineering, 24(2-7), 659-664. https://doi.org/10.1016/S0098-1354(00)00388-4
  • Buntz, B. (2024). Pharma50-2024-vs2-2-original.original.pdf. drug Discovery Pharma 50. https://www.drugdiscoverytrends.com/pharma50/
  • Cummings, J. L., Morstorf, T., & Zhong, K. (2014). Alzheimer’s disease drug-development pipeline: Few candidates, frequent failures. Alzheimer’s Research & Therapy, 6(4), 37. https://doi.org/10.1186/alzrt269
  • Deloitte. (2024). Deloite-report-14th-edition-2024.pdf [Araştırma]. https://www.deloitte.com/content/dam/assets-zone2/ch/en/docs/about/2024/ch-lshc-randd-roi-report-14th-edition-2024.pdf
  • DiMasi, J. A., Feldman, L., Seckler, A., & Wilson, A. (2010). Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs. Clinical Pharmacology & Therapeutics, 87(3), 272-277. https://doi.org/10.1038/clpt.2009.295
  • DiMasi, J. A., Grabowski, H. G., & Vernon, J. (1995). R&D costs, innovative output and firm size in the pharmaceutical industry. International Journal of the Economics of Business, 2(2), 201-219.
  • DiMasi, J. A., Hansen, R. W., & Grabowski, H. G. (2003). The price of innovation: New estimates of drug development costs. Journal of Health Economics, 22(2), 151-185. https://doi.org/10.1016/S0167-6296(02)00126-1
  • Drews, J. (2000). Drug Discovery: A Historical Perspective. Science, 287(5460), 1960-1964. https://doi.org/10.1126/science.287.5460.1960
  • EFPIA. (2024). EFPIA the-pharmaceutical-industry-in-figures-2024.pdf. EFPIA.
  • Hefti, F. F. (2008). Requirements for a lead compound to become a clinical candidate. BMC Neuroscience, 9(S3), S7. https://doi.org/10.1186/1471-2202-9-S3-S7
  • Hopkins, A. L., & Groom, C. R. (2002). The druggable genome. Nature reviews Drug discovery, 1(9), 727-730.
  • Hughes, J., Rees, S., Kalindjian, S., & Philpott, K. (2011). Principles of early drug discovery. British Journal of Pharmacology, 162(6), 1239-1249. https://doi.org/10.1111/j.1476-5381.2010.01127.x
  • IFPMA. (2021). THE PHARMACEUTICAL INDUSTRY AND GLOBAL HEALTH. INTERNATIONAL FEDERATION OF PHARMACEUTICAL MANUFACTURERS & ASSOCIATIONS. https://www.ifpma.org/wp-content/uploads/2021/04/IFPMA-Facts-And-Figures-2021.pdf
  • IQVIA. (2020). Türkiye için klinik araştırma stratejisinin faydaları.
  • IQVIA. (2023). TÜRKİYE İLAÇ SEKTÖRÜ RAPORU [Araştırma]. IQVIA (AIFD), (EFPIA).
  • IQVIA. (2024). TÜRKİYE İLAÇ SEKTÖRÜ RAPORU [Araştırma]. IQVIA.
  • Jibu, M., & Osabe, Y. (2014). Refined R&D Indicators for Pharmaceutical Industry. 549-554.
  • Jorge Mestre-Ferrandiz, Sussex, J., & Towse, A. (2012). The R and D cost of a new medicine. Office of Health Economics.
  • Kandi, V., & Vadakedath, S. (2023). Clinical Trials and Clinical Research: A Comprehensive Review. Cureus. https://doi.org/10.7759/cureus.35077
  • Khazabi, M., & Quyen, N. V. (2017). The search for new drugs: A theory of R&D in the pharmaceutical industry. Journal of Economic Studies, 44(5), 690-726.
  • Liu, Y., Zhang, S., Liu, K., Hu, X., & Gu, X. (2024). Advances in drug discovery based on network pharmacology and omics technology. Current Pharmaceutical Analysis, 21(1), 33-43. https://doi.org/10.1016/j.cpan.2024.12.002
  • Mohs, R. C., & Greig, N. H. (2017). Drug discovery and development: Role of basic biological research. Alzheimer’s & Dementia: Translational Research & Clinical Interventions, 3(4), 651-657. https://doi.org/10.1016/j.trci.2017.10.005
  • Paul, S. M., Mytelka, D. S., Dunwiddie, C. T., Persinger, C. C., Munos, B. H., Lindborg, S. R., & Schacht, A. L. (2010). How to improve R&D productivity: The pharmaceutical industry’s grand challenge. Nature Reviews Drug Discovery, 9(3), 203-214. https://doi.org/10.1038/nrd3078
  • Pennings, E., & Sereno, L. (2011). Evaluating pharmaceutical R&D under technical and economic uncertainty. European Journal of Operational Research, 212(2), 374-385.
  • PhRMA. (2021). PhRMA_membership survey_2021.
  • Pina, A. S., Hussain, A., & Roque, A. C. A. (2010). An Historical Overview of Drug Discovery. Içinde A. C. A. Roque (Ed.), Ligand-Macromolecular Interactions in Drug Discovery (C. 572, ss. 3-12). Humana Press. https://doi.org/10.1007/978-1-60761-244-5_1
  • Pognan, F., Beilmann, M., Boonen, H. C. M., Czich, A., Dear, G., Hewitt, P., Mow, T., Oinonen, T., Roth, A., Steger-Hartmann, T., Valentin, J.-P., Van Goethem, F., Weaver, R. J., & Newham, P. (2023). The evolving role of investigative toxicology in the pharmaceutical industry. Nature Reviews Drug Discovery, 22(4), 317-335. https://doi.org/10.1038/s41573-022-00633-x
  • Romasanta, A. K. S., van der Sijde, P., & van Muijlwijk-Koezen, J. (2020). Innovation in pharmaceutical R&D: mapping the research landscape. Scientometrics, 125, 1801-1832.
  • Rubin, A. E., Tummala, S., Both, D. A., Wang, C., & Delaney, E. J. (2006). Emerging technologies supporting chemical process R&D and their increasing impact on productivity in the pharmaceutical industry. Chemical reviews, 106(7), 2794-2810.
  • Schlander, M., Hernandez-Villafuerte, K., Cheng, C.-Y., Mestre-Ferrandiz, J., & Baumann, M. (2021). How Much Does It Cost to Research and Develop a New Drug? A Systematic Review and Assessment. PharmacoEconomics, 39(11), 1243-1269. https://doi.org/10.1007/s40273-021-01065-y
  • Schuhmacher, A., Gassmann, O., & Hinder, M. (2016). A review of the pharmaceutical R&D efficiency: Costs, timelines, and probabilities. Value creation in the pharmaceutical industry: the critical path to innovation, 60-79.
  • Singh, N., Vayer, P., Tanwar, S., Poyet, J.-L., Tsaioun, K., & Villoutreix, B. O. (2023). Drug discovery and development: Introduction to the general public and patient groups. Frontiers in Drug Discovery, 3, 1201419. https://doi.org/10.3389/fddsv.2023.1201419
  • STB. (2021). IlacSektorRaporu(2021) sanayi ve teknoloji bakanlığı.pdf. sanayi ve teknoloji bakanlığı.
  • TCC-SBB. (2019). On Birinci Kalkınma Planı 2019-2023.
  • TCTB. (2023). İlaç ve Eczacılık 2023 Ticaret Bakanlığı raporu.pdf.
  • TİSD. (2025). İlaç Sektörü Akredite Ar-Ge Merkezi Sayısı. https://www.tisd.org.tr/digerSektorDetay.aspx?set_id=2
  • Turkishtime. (2023). Arge250-2023.pdf. TURKISHIME EKONOMI VE IŞ DÜNYASI PORTALI. https://turkishtimedergi.com/arge250/index.html

Türkiye’de İlaç Araştirma Ve Geliştirme Süreci

Yıl 2025, Cilt: 2 Sayı: 50, 176 - 199, 04.01.2026
https://doi.org/10.35343/kosbed.1619884

Öz

İlaç, insan sağlığını doğrudan etkileyen stratejik bir üründür ve Ar-Ge süreçleri oldukça uzun, maliyetli ve teknoloji yoğun bir yapıya sahiptir. Dünyada ilaç Ar-Ge harcamalarının %27’si klinik araştırmalarda gerçekleşirken, toplam süreç 12-15 yıl sürmekte ve maliyeti 2,6-4,5 milyar dolara ulaşmaktadır. Yapay zeka, biyoteknoloji ve OMICS teknolojileri gibi yenilikçi yaklaşımlar sektörün gelişimine yön vermektedir. ABD, yıllık 103 milyar dolarlık Ar-Ge harcamasıyla liderdir. Türkiye ise 452 milyon dolarlık ilaç Ar-Ge harcamasıyla OECD ülkeleri arasında son sıralarda yer almakta, toplam Ar-Ge harcamalarının %1,8’ini bu alana ayırmaktadır. Buna rağmen, Türkiye İlaç ve Tıbbi Cihaz Kurumu’nun uluslararası standartlara uyum çabaları, sektörde kapasite artışı potansiyelini ortaya koymaktadır. Türkiye’nin ilaç sektöründe rekabet gücünü artırması için finansman, insan kaynağı, inovasyon ve teknolojik altyapı alanlarında yatırımlar kritik önem taşımaktadır.

Etik Beyan

Çalışma etik kurul izni gerektirmemektedir.

Destekleyen Kurum

Bu çalışma mali olarak desteklenmemiştir.

Kaynakça

  • Austin, D. H. (2006). Research and development in the pharmaceutical industry.
  • Becker, M. C., & Lillemark, M. (2006). Marketing/R&D integration in the pharmaceutical industry. Research Policy, 35(1), 105-120.
  • Bennani, Y. L. (2012). Drug discovery in the next decade: Innovation needed ASAP. Drug Discovery Today, 17, S31-S44. https://doi.org/10.1016/j.drudis.2011.12.007
  • Blau, G. E., Pekny, J. F., Varma, V. A., & Bunch, P. R. (2004). Managing a Portfolio of Interdependent New Product Candidates in the Pharmaceutical Industry. Journal of Product Innovation Management, 21(4), 227-245. https://doi.org/10.1111/j.0737-6782.2004.00075.x
  • Blau, G., Mehta, B., Bose, S., Pekny, J., Sinclair, G., Keunker, K., & Bunch, P. (2000). Risk management in the development of new products in highly regulated industries. Computers & Chemical Engineering, 24(2-7), 659-664. https://doi.org/10.1016/S0098-1354(00)00388-4
  • Buntz, B. (2024). Pharma50-2024-vs2-2-original.original.pdf. drug Discovery Pharma 50. https://www.drugdiscoverytrends.com/pharma50/
  • Cummings, J. L., Morstorf, T., & Zhong, K. (2014). Alzheimer’s disease drug-development pipeline: Few candidates, frequent failures. Alzheimer’s Research & Therapy, 6(4), 37. https://doi.org/10.1186/alzrt269
  • Deloitte. (2024). Deloite-report-14th-edition-2024.pdf [Araştırma]. https://www.deloitte.com/content/dam/assets-zone2/ch/en/docs/about/2024/ch-lshc-randd-roi-report-14th-edition-2024.pdf
  • DiMasi, J. A., Feldman, L., Seckler, A., & Wilson, A. (2010). Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs. Clinical Pharmacology & Therapeutics, 87(3), 272-277. https://doi.org/10.1038/clpt.2009.295
  • DiMasi, J. A., Grabowski, H. G., & Vernon, J. (1995). R&D costs, innovative output and firm size in the pharmaceutical industry. International Journal of the Economics of Business, 2(2), 201-219.
  • DiMasi, J. A., Hansen, R. W., & Grabowski, H. G. (2003). The price of innovation: New estimates of drug development costs. Journal of Health Economics, 22(2), 151-185. https://doi.org/10.1016/S0167-6296(02)00126-1
  • Drews, J. (2000). Drug Discovery: A Historical Perspective. Science, 287(5460), 1960-1964. https://doi.org/10.1126/science.287.5460.1960
  • EFPIA. (2024). EFPIA the-pharmaceutical-industry-in-figures-2024.pdf. EFPIA.
  • Hefti, F. F. (2008). Requirements for a lead compound to become a clinical candidate. BMC Neuroscience, 9(S3), S7. https://doi.org/10.1186/1471-2202-9-S3-S7
  • Hopkins, A. L., & Groom, C. R. (2002). The druggable genome. Nature reviews Drug discovery, 1(9), 727-730.
  • Hughes, J., Rees, S., Kalindjian, S., & Philpott, K. (2011). Principles of early drug discovery. British Journal of Pharmacology, 162(6), 1239-1249. https://doi.org/10.1111/j.1476-5381.2010.01127.x
  • IFPMA. (2021). THE PHARMACEUTICAL INDUSTRY AND GLOBAL HEALTH. INTERNATIONAL FEDERATION OF PHARMACEUTICAL MANUFACTURERS & ASSOCIATIONS. https://www.ifpma.org/wp-content/uploads/2021/04/IFPMA-Facts-And-Figures-2021.pdf
  • IQVIA. (2020). Türkiye için klinik araştırma stratejisinin faydaları.
  • IQVIA. (2023). TÜRKİYE İLAÇ SEKTÖRÜ RAPORU [Araştırma]. IQVIA (AIFD), (EFPIA).
  • IQVIA. (2024). TÜRKİYE İLAÇ SEKTÖRÜ RAPORU [Araştırma]. IQVIA.
  • Jibu, M., & Osabe, Y. (2014). Refined R&D Indicators for Pharmaceutical Industry. 549-554.
  • Jorge Mestre-Ferrandiz, Sussex, J., & Towse, A. (2012). The R and D cost of a new medicine. Office of Health Economics.
  • Kandi, V., & Vadakedath, S. (2023). Clinical Trials and Clinical Research: A Comprehensive Review. Cureus. https://doi.org/10.7759/cureus.35077
  • Khazabi, M., & Quyen, N. V. (2017). The search for new drugs: A theory of R&D in the pharmaceutical industry. Journal of Economic Studies, 44(5), 690-726.
  • Liu, Y., Zhang, S., Liu, K., Hu, X., & Gu, X. (2024). Advances in drug discovery based on network pharmacology and omics technology. Current Pharmaceutical Analysis, 21(1), 33-43. https://doi.org/10.1016/j.cpan.2024.12.002
  • Mohs, R. C., & Greig, N. H. (2017). Drug discovery and development: Role of basic biological research. Alzheimer’s & Dementia: Translational Research & Clinical Interventions, 3(4), 651-657. https://doi.org/10.1016/j.trci.2017.10.005
  • Paul, S. M., Mytelka, D. S., Dunwiddie, C. T., Persinger, C. C., Munos, B. H., Lindborg, S. R., & Schacht, A. L. (2010). How to improve R&D productivity: The pharmaceutical industry’s grand challenge. Nature Reviews Drug Discovery, 9(3), 203-214. https://doi.org/10.1038/nrd3078
  • Pennings, E., & Sereno, L. (2011). Evaluating pharmaceutical R&D under technical and economic uncertainty. European Journal of Operational Research, 212(2), 374-385.
  • PhRMA. (2021). PhRMA_membership survey_2021.
  • Pina, A. S., Hussain, A., & Roque, A. C. A. (2010). An Historical Overview of Drug Discovery. Içinde A. C. A. Roque (Ed.), Ligand-Macromolecular Interactions in Drug Discovery (C. 572, ss. 3-12). Humana Press. https://doi.org/10.1007/978-1-60761-244-5_1
  • Pognan, F., Beilmann, M., Boonen, H. C. M., Czich, A., Dear, G., Hewitt, P., Mow, T., Oinonen, T., Roth, A., Steger-Hartmann, T., Valentin, J.-P., Van Goethem, F., Weaver, R. J., & Newham, P. (2023). The evolving role of investigative toxicology in the pharmaceutical industry. Nature Reviews Drug Discovery, 22(4), 317-335. https://doi.org/10.1038/s41573-022-00633-x
  • Romasanta, A. K. S., van der Sijde, P., & van Muijlwijk-Koezen, J. (2020). Innovation in pharmaceutical R&D: mapping the research landscape. Scientometrics, 125, 1801-1832.
  • Rubin, A. E., Tummala, S., Both, D. A., Wang, C., & Delaney, E. J. (2006). Emerging technologies supporting chemical process R&D and their increasing impact on productivity in the pharmaceutical industry. Chemical reviews, 106(7), 2794-2810.
  • Schlander, M., Hernandez-Villafuerte, K., Cheng, C.-Y., Mestre-Ferrandiz, J., & Baumann, M. (2021). How Much Does It Cost to Research and Develop a New Drug? A Systematic Review and Assessment. PharmacoEconomics, 39(11), 1243-1269. https://doi.org/10.1007/s40273-021-01065-y
  • Schuhmacher, A., Gassmann, O., & Hinder, M. (2016). A review of the pharmaceutical R&D efficiency: Costs, timelines, and probabilities. Value creation in the pharmaceutical industry: the critical path to innovation, 60-79.
  • Singh, N., Vayer, P., Tanwar, S., Poyet, J.-L., Tsaioun, K., & Villoutreix, B. O. (2023). Drug discovery and development: Introduction to the general public and patient groups. Frontiers in Drug Discovery, 3, 1201419. https://doi.org/10.3389/fddsv.2023.1201419
  • STB. (2021). IlacSektorRaporu(2021) sanayi ve teknoloji bakanlığı.pdf. sanayi ve teknoloji bakanlığı.
  • TCC-SBB. (2019). On Birinci Kalkınma Planı 2019-2023.
  • TCTB. (2023). İlaç ve Eczacılık 2023 Ticaret Bakanlığı raporu.pdf.
  • TİSD. (2025). İlaç Sektörü Akredite Ar-Ge Merkezi Sayısı. https://www.tisd.org.tr/digerSektorDetay.aspx?set_id=2
  • Turkishtime. (2023). Arge250-2023.pdf. TURKISHIME EKONOMI VE IŞ DÜNYASI PORTALI. https://turkishtimedergi.com/arge250/index.html
Toplam 41 adet kaynakça vardır.

Ayrıntılar

Birincil Dil Türkçe
Konular Mikro İktisat (Diğer)
Bölüm Araştırma Makalesi
Yazarlar

İbrahim Aki 0009-0000-3776-1418

İdris Sarısoy 0000-0002-6682-1958

Gönderilme Tarihi 14 Ocak 2025
Kabul Tarihi 9 Aralık 2025
Yayımlanma Tarihi 4 Ocak 2026
Yayımlandığı Sayı Yıl 2025 Cilt: 2 Sayı: 50

Kaynak Göster

APA Aki, İ., & Sarısoy, İ. (2026). Türkiye’de İlaç Araştirma Ve Geliştirme Süreci. Kocaeli Üniversitesi Sosyal Bilimler Dergisi, 2(50), 176-199. https://doi.org/10.35343/kosbed.1619884

**