The dominant trends in the biotechnology industry remain unchanged in 2025, with the sector benefiting from policy support in both Taiwan and the U.S. The three hottest areas—domestic U.S. manufacturing, AI-driven digital healthcare, and cell therapy—are gaining momentum. Bora Pharmaceuticals and Lotus Pharmaceutical are expected to surpass NT$20 billion in revenue, while PharmaEssentia is set to exceed NT$10 billion. Meanwhile, StemCyte, Taiwan Bio Therapeutics, and Ever Supreme are making significant inroads into the U.S. market, marking them as key players to watch.
With continuous positive developments in the biotechnology sector, the "America First" policy introduced by former President Donald Trump is further boosting the industry. This policy encourages pharmaceutical and biotech companies to conduct research and manufacturing within the U.S. by offering tax incentives to lower domestic drug prices. As a result, companies with established U.S. production facilities—such as Bora Pharmaceuticals, EASYWELL BIOMEDICALS, Tanvex BioPharma, and Yung Shin Pharmaceutical—are well-positioned to emerge as major beneficiaries.
Furthermore, Trump’s stance on drug pricing, which leans toward affordability, favors the development of generic drug manufacturers. API producers such as Formosa Laboratories, SYN-TECH, ScinoPharm Taiwan, SCI Pharmtech, YUNGZIP, and Chunghwa Chemical Synthesis & Biotech are expected to benefit from this policy shift.
Trump’s anti-opioid agenda is also influencing market dynamics. Lotus Pharmaceutical’s addiction treatment drugs, along with Alar Pharmaceuticals’ long-acting addiction treatment drug ALA-1000 (licensed out to Indivior), are expected to see accelerated development. Additionally, TAHO Pharmaceuticals’ new formulation for addiction treatment is gaining momentum.
In the field of cell therapy, strong support from U.S. Health Secretary Robert F. Kennedy Jr., combined with the recent passage of Taiwan’s regenerative medicine legislation, has propelled the sector into the spotlight. Ever Supreme, Taiwan Bio Therapeutics, and Acepodia, which have secured partnerships in the U.S., are garnering attention. StemCyte, with its fully operational base and commercial-scale GMP facility in California, has achieved a major milestone by obtaining FDA approval for its new drug RegeneCyte. This makes it the world’s first biotech company to secure U.S. regulatory approval for a cord blood stem cell therapy.
Taiwan Bio Therapeutics, which generates over half of its revenue from overseas markets, is advancing its osteoarthritis drug Chondrochymal, having submitted a Phase III clinical trial application to Taiwan’s TFDA. Additionally, its regulatory T cell therapy TRK-001, developed in collaboration with U.S.-based TRACT, has already received FDA approval for a Phase II clinical trial in the U.S. and is now seeking approval in Taiwan for the treatment of kidney transplant rejection. If approved, it will be Taiwan’s first regulatory T cell therapy to initiate a global multi-center clinical trial simultaneously in both the U.S. and Taiwan.
Ever Supreme is another leader in the cell therapy sector, holding the highest number of regulatory approvals, product categories, hospital collaborations, and enrolled patients in Taiwan. It is also the first profitable cell therapy company in the country. Its allogeneic immune cell therapy CAR001 has received Phase I/IIa clinical trial approvals from both the U.S. FDA and Taiwan’s TFDA.
In the AI-driven digital healthcare sector, aetherAI, Medimaging Integrated Solution, EVER FORTUNE AI TECHNOLOGY, and BONRAYBIO are leading the charge. aetherAI specializes in digital pathology and AI-driven medical solutions, with its flagship product, the "AI-assisted bone marrow smear classification and counting system," having received approvals from both Taiwan’s Ministry of Health and Welfare and the European CE certification, making it the world’s first AI medical device in this field to achieve dual regulatory approval. The company is now seeking health insurance reimbursement in Taiwan for its bone marrow smear analysis system.
EVER FORTUNE AI TECHNOLOGY has secured over 40 regulatory approvals worldwide. Its flagship products, the AI-assisted radiotherapy organ contouring system and the AI-driven intracranial hemorrhage detection system (ICH), are particularly noteworthy. The latter, which uses deep learning algorithms to automatically analyze non-contrast head CT scans and identify acute intracranial hemorrhages, integrates with PACS/RIS workstations to issue alerts, positioning it as a key future revenue driver.
Resource: 生技政策加持 三族群當紅
