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Pharmaceutical industry in Taiwan

From Wikipedia, the free encyclopedia

Thepharmaceutical industry in Taiwan is a key segment of the nation’s broader biomedical sector, which includespharmaceuticals,medical devices,biotechnology, andhealthcare services. In 2021,Taiwan’s biomedical industry generated roughly US $23.8 billion in revenue—of which pharmaceuticals, medical devices, and healthcare contributed about 14.8%, 35.4%, and 31.9%, respectively.[1] The pharmaceutical sub‑sector alone produced revenues of approximately NT $67.05 billion (roughly US $2.2 billion) in 2011, and total pharmaceutical exports reached approximately US $815 million in 2021.[2][3]

History

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The origins of Taiwan’s pharmaceutical sector date back to the 1960s, when government initiatives encouraged domestic medicine production to reduce dependency on imports and Taiwan shifted from repackaging to manufacturing domestically produced antibiotics, formalin, and other chemical products. The Taiwanese government's 1968 Resolution promoted national pharmaceutical self-sufficiency, leading to the establishment of local drug manufacturers. During the economic surge of theTaiwan Miracle in the 1960s and 1970s, the government supported the pharmaceutical sector through industrial planning and infrastructure investments such as theTen Major Construction Projects. The establishment of the Pharmaceutical Affairs Law in 1970 and its updates throughout the 1990s and 2000s laid the legal foundation for safety standards and regulatory control over drug manufacturing, importation, and marketing.[4] By 2000, the industry had grown with approximately 280 Western medicine producers and 250traditional Chinese medicine firms.

Research and development

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As of 2023, Taiwan hosted around 59 pharma manufacturing sites, including 44 with U.S. FDA orEuropean Medicines Agency approval and 7 approved for the Chinese market. According to Global Data Healthcare, Taiwan has comparatively more high-valueActive ingredient biologics and injectables capacity for its size compared toChina, despite the fact that the two countries' workforces speak the same language.[5] These facilities are concentrated near Taipei, Taoyuan, and Tainan, with Taoyuan alone accounting for 30% of all domestic sites.[6]

The sector features a mix of domestic and foreign-owned companies. While most facilities are Taiwanese-owned, international companies also operate in Taiwan. Companies specialize in APIs, commercial dose injectables, biologics, andContract manufacturing organization services. Emerging biotech firms such as TailMed Biologics,Taimed Biologics,[7] and Taiwan Bio-Manufacturing Corporation (TBMC)[8] focus primarily on advanced therapies, monoclonal antibodies, gene therapies, and vaccines.

Taiwan’s R&D intensity ranks among the highest globally, with total R&D expenditure reaching NT $898 billion (US $27.8 billion) in 2022—nearly 4% of GDP, the highest proportion in its history.[9] In the biomedical space, the government’s "5+2 Innovative Industries Plan" has prioritized biomedicine since 2017, aiming for annual output of NT $1 trillion (~US $32 billion) by 2025.[10] Government-backed initiatives include research subsidies, infrastructure development, and legislation such as the Act for the Development of Biotech and New Pharmaceuticals Industry (2007). R&D funding—covering tax incentives, grants, and collaboration with public science parks—has spurred innovation, particularly in generic drug development.[11] As of 2011, six local firms receivedNT$220 million in government subsidies (~US $7.7 million) to bolster R&D for generics.[12]

Regulation

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TheTaiwan Food and Drug Administration (TFDA) was established in 2010, integrating multiple agencies to oversee pharmaceuticals, food safety, and medical devices. Taiwan’s API standards have been recognized by theEuropean Commission as equivalent to EU requirements, and as of 2017, over 115 locally developed drugs heldInvestigational New Drug approval from the United StatesFood and Drug Administration.[13] These modern regulations enable Taiwan's pharmaceutical companies to seamlessly transition from Phase II to Phase III trials in Western markets. Taiwan continues working with international regulators to promote collaborative drug development and global market integration.[14]

Challenges

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Taiwan’s pharmaceutical industry faces persistent price pressures stemming from itsNational Health Insurance (NHI) system. In efforts to control medical expenditures—where drugs account for about 25% of total medical costs, notably above theOECD average of 16%—the government enforces frequent price‑volume reviews and periodic across‑the‑board price cuts. While patented drugs constitute approximately 70% of prescription spending, patent expirations trigger mandatory price reductions under Article 46 of the National Health Insurance Act, which frequently compress new drug profits and discourages innovation.[15] These chronic price reductions have raised concerns about future drug availability and supply stability. Industry stakeholders have warned of potential shortages, particularly for older off‑patent drugs, as manufacturers find continued production unprofitable. hospital bargaining power combined with steep reimbursement cuts has led to diminished profitability and reduced incentives for R&D investment. In April 2024, the NHIA implemented new drug price adjustments—totaling NT$55.3 billion—but assured that essential drugs would be exempt; nevertheless, concerns linger over the six‑month lag before possible shortages emerge.[16]

Another pressing challenge is supply chain vulnerability, largely due to Taiwan’s heavy dependence on importedactive pharmaceutical ingredients, with over 90% sourced internationally—nearly half from China. This reliance has led to recent supply disruptions, particularly impacting smaller clinics and pharmacies, prompting calls for a designated drug‑shortage response office.[17]

Additionally, regulatory barriers affect biopharmaceutical innovation. While programmes like the 2007 Biotech and New Pharmaceuticals Development Act aim to boost R&D, many companies still struggle with limited funding, talent shortages, and difficulties navigating international regulatory frameworks.[18] A lack of compulsory patent linkage further deters foreign investment and complicates generic drug approvals.[19] This creates a fragmented ecosystem where ambitious biotech goals are hampered by weak infrastructure and insufficient global integration

See also

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References

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  1. ^Siddiqui, Ayesha (August 2, 2023)."Taiwan BioMed Industry Eyes $32B".BioSpectrum. RetrievedJune 4, 2025.
  2. ^"R&D spending ratio hits record: science council".Taipei Times. November 5, 2023. RetrievedJune 4, 2025.
  3. ^Lin, Chia-nan (December 31, 2021)."Technology R&D spending makes up 3.63% of GDP".Taipei Times. RetrievedJune 4, 2025.
  4. ^"Pharmaceutical Affairs Act".Ministry of Health and Welfare (Taiwan). RetrievedJune 4, 2025.
  5. ^"Taiwan offers advanced pharma manufacturing potential". Pharmaceutical Technology. September 24, 2021. RetrievedJune 4, 2025.
  6. ^Bhaskar, Hithaishi (August 31, 2023)."BIO Asia-Taiwan 2023: Embracing Asian Dynamics around precision health and CDMO".BioSpectrum. RetrievedJune 4, 2025.
  7. ^"TaiMed Biologics: Pioneering innovation in HIV therapy and CDMO services".The Japan Times. May 20, 2024. RetrievedJune 4, 2025.
  8. ^"Taiwan biomanufacturer aims to be 'biotech TSMC'".Taipei Times. February 5, 2024. RetrievedJune 4, 2025.
  9. ^"Taiwan 2019 Budget: Support For Biomedical Innovation A Positive For The Pharmaceutical Market".Fitch Solutions. 23 October 2018. RetrievedJune 4, 2025.
  10. ^"5+2 innovative industries plan-Introduction".Executive Yuan. RetrievedJune 4, 2025.
  11. ^Chung, Ching-Hu (February 2023)."Trends in pharmaceutical expenditure in the Taiwan National Health Insurance database at different hospital levels".Journal of Comparative Effectiveness Research.12.doi:10.2217/cer-2022-0162.PMC 10286779.
  12. ^"The Taiwanese medtech transforming healthcare".BBC. RetrievedJune 4, 2025.
  13. ^"Taiwan has successfully been included in the list of third countries for APIs, indicative of the regulatory system recognized by the European Union".Ministry of Health and Welfare (Taiwan). 2023-11-29. RetrievedJune 4, 2025.
  14. ^Chang, Tom (September 13, 2024)."The benefits of outsourcing pharma manufacturing to Taiwan".www.pharmamanufacturing.com. RetrievedJune 4, 2025.
  15. ^Fulco, Matthew (2016-06-30)."Boosting Taiwan's Biopharma Sector".The News Lens. RetrievedJune 4, 2025.
  16. ^Ho, Huang-Chi (2024-06-24)."Drug shortage hits Taiwan, small clinics most affected".TVBS. RetrievedJune 4, 2025.
  17. ^Strong, Matthew (June 9, 2021)."Chinese firms control 30% of pharmaceutical distribution rights in Taiwan".Taiwan News. RetrievedJune 4, 2025.
  18. ^"Taiwan Planed Major Promoting Program for Biotechnology and Pharmaceutical Industry".stli.iii.org.tw. RetrievedJune 4, 2025.
  19. ^Lee, Shen-yi (October 9, 2021)."Challenges facing the biotech industry".Taipei Times. RetrievedJune 4, 2025.
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