Taiwan Cell and Gene Therapy

Taiwan’s rapidly advancing cell and gene therapy (CGT) ecosystem offers U.S. companies strong opportunities to license technology, form clinical and commercial partnerships, and provide expertise in reimbursement, outcomes analytics, and advanced manufacturing. Taiwan is positioning itself as a strategic partner for U.S. exporters seeking to enter or expand in the Asia-Pacific CGT market.

Taiwan’s CGT ecosystem is rapidly maturing with growing clinical activity, government support, and early reimbursement pathways for high-cost therapies such as Chimeric Antigen Receptor T-cell therapy (CAR-T). Furthermore, Taiwan’s broader biotech sector is expanding and showing strong investment and R&D momentum. With the Asia-Pacific cell-therapy market projected to grow rapidly, Taiwan is becoming an attractive hub for regional collaboration.

Several major Taiwanese medical centers are running CAR-T and other cell therapy programs. The country’s well-established clinical trial infrastructure and cancer registries enable rapid patient enrollment in oncology studies, further accelerating development timelines.

Key Opportunities for U.S. Exporters

1. Technology Licensing: Taiwanese companies are actively seeking to license advanced U.S. technologies in areas such as gene editing, cell processing, and automated manufacturing, providing an opportunity for U.S. companies in Taiwan.
2. Clinical partnerships: partnering with academic hospitals and local CDMOs for research and development.
3. Reimbursement & outcomes analytics: support for real-world evidence, health-economic models, and outcome-based contracting expertise to fit Taiwan’s pay-for-outcomes approaches.

Regulatory & Reimbursement Environment

• Taiwan’s Food and Drug Administration, under the Ministry of Health & Welfare, regulates CGT and has been modernizing its frameworks for regenerative medicine. Many cell therapy products (CTP), investigational new drugs (IND), and clinical studies are ongoing, with academic-led CTP development a major part of current activities.
• Taiwan’s National Health Insurance has begun limited coverage of CAR-T therapies in 2023 through temporary/outcomes-linked arrangements. This shows a willingness by payers to fund selected high-value CGTs under controlled schemes. 

How U.S. Companies Can Get Started

• Find a local partner: The most effective strategy is to find a local partner with expertise in the CGT area.
• Attend trade events: The BIO Asia–Taiwan Conference and Exhibition is a premier networking platform to meet potential partners and stakeholders.

For additional information, please contact the American Institute in Taiwan (AIT), Grace Tao at Grace.Tao@trade.gov.