In recent years, Taiwan’s policymakers have been aggressively deploying a multi-layered industrial strategy – and doing so with the benefit of watching earlier regional movers stumble – in an effort to transform the island into a premier global hub for Cell and Gene Therapy (C>) manufacturing and development. This state-driven momentum has perhaps been most evident in the introduction of a bespoke, forward-looking regulatory regime designed to nurture and accelerate the budding sector.
“To date, Taiwan enjoys the distinction of being one of only two jurisdictions – the other being Japan – to have enacted a dedicated cell and gene therapy framework, providing a clear, evidence-based pathway for advanced therapies,” observes Wallace Lin, secretary-general of Taiwan Bio Industry Organisation (Taiwan BIO), the island’s primary life sciences association, who notes that biotechnology remains the sole sector governed by its own statute. “Such a degree of regulatory foresight and sophistication is frankly uncommon and constitutes a genuine point of differentiation and competitive advantage,” he believes.
Indeed, in June 2024, Taiwan’s Legislative Yuan achieved a historic milestone with the passing of two complementary landmark laws: namely the Regenerative Medicine Act and the Regenerative Medicinal Products Act. The first of which governs clinical practice, while the second, administered by Taiwanese Food & Drug Administration (TFDA), regulates the development, manufacturing, and commercialisation of regenerative medicinal products, including cell and gene therapies. Together, they established a dual-track system for clinical and industrial advancement.
Bespoke Regulatory Architecture
“This intelligently-designed legal architecture deliberately separates ‘medical practice,’ – meaning hospital-led, custom cell therapies – from mass-manufactured pharmaceutical cell products, and thus provides a highly flexible environment for early clinical operations,” explains Chih-Kang Chiang, director-general of the TFDA.
“Significantly that allows CGT developers to gain conditional market approval to treat patients with life-threatening or unmet clinical needs before completing Phase III clinical trials, provided that Phase II data demonstrates safety and efficacy,” Chiang continues, noting that such approvals, valid for up to five years, can be converted to full authorisation so long as the accumulated evidence confirms benefit.
In the eyes of Sean Chang, CEO of Locus Cell, a Taipei-based CDMO for advanced cell therapies, this “strikes the optimal balance between accelerating the entry of innovative therapeutic approaches while simultaneously upholding rigorous safety and quality standards in a niche industry segment that is still in its formative phase and needs to demonstrate credibility on the wider international stage.”
The TFDA’s Chiang strongly agrees. “We have established robust post-marketing pharmacovigilance and traceability systems specifically tailored for regenerative and cell-based therapies to monitor long-term safety and efficacy,” he reassures, while pointing out that the regulator is also in the process of launching a Regenerative Medicine Support Office to guide developers from early research through clinical application, ensuring full compliance with international standards.” The ultimate goal, he confirms, is to “anchor Taiwan as a globally trusted leader in next-generation biomedical innovation, built on a foundation of quality, safety, and scientific excellence.”
Such regulatory enhancements have already triggered a far-reaching impact. According to Lee-Cheng Liu, CEO of EirGenix – Taiwan’s largest domestic biopharmaceutical CDMO – the new frameworks have enabled an unprecedented number of C> university spinouts to advance toward commercialisation, while also placing the island squarely on the map as one of the few markets in Asia, Japan excepted, where patients can systematically access advanced cell therapies beyond early clinical stages.
Yet regulatory sophistication alone is no guarantee of success — a lesson Asia has already learned at some cost. Japan moved first, enshrining a conditional approval pathway for regenerative medicine through its Act on the Safety of Regenerative Medicine in 2014, a framework that generated considerable optimism at the time. The commercial reality proved sobering: approvals multiplied, but clinical integration lagged, products struggled to find reimbursement pathways, and international uptake remained minimal. South Korea followed a similarly ambitious trajectory, building regulatory infrastructure with notable speed, only to see bureaucratic complexity and a fragmented hospital ecosystem blunt the clinical translation of its early promise.
Taiwan’s policymakers have studied these stumbles deliberately. The 2024 dual-track legislation reflects a conscious attempt to learn from both models — retaining the speed-to-patient ambition of the Japanese conditional pathway while embedding the clinical-commercial integration and post-marketing surveillance mechanisms that were absent or underbuilt in the region’s first movers. Whether that recalibration is sufficient to avoid the same fate remains the central question.
Deep Knowledge Base
In terms of capability engineering, the helping hand of the state has also been conspicuously present. In an effort to offset the high financial risks of cell and gene therapy R&D, the government has resorted to direct capital injections and tax incentives. For instance, biotech companies building local cell banks now find themselves eligible for expedited government grants and licensing fee waivers.
Moreover, to fortify the manufacturing component, the government has been ensuring that cell processing centres’ abilities to adhere to PIC/S GMP and Good Tissue Practice (GTP) standards by providing matching capital grants to hospitals and commercial entities to construct automated, cleanroom biomanufacturing infrastructure.
However, it is in helping to cultivate the requisite expert knowledge base able to support such a sector that successive government administrations have perhaps been most instrumental. “Our island nowadays possesses a deep pool of life science talent developed over the past two decades as a direct result of the government’s decision to invest in biosciences as a national pillar,” explains Steve Kuo, chairman of the Taiwan Research-based Biopharmaceutical Manufacturers Association (TRPMA).
“That generation of researchers is now mid-career, technically sophisticated, and intimately familiar with the disciplines – cell culture, quality systems, manufacturing process development – that cell therapy demands,” he affirms.
Cyrus Yang, CEO of Taiwan Bio Therapeutics echoes this sentiment. “In the mid-2000s, the Taiwanese government launched an initiative to make biotechnology the second trillion-dollar industry after semiconductors, and this spurred a wave of students into life sciences, who have lately been applying their knowledge to the discipline of regenerative medicine to the extent that we now boast a talent surplus,” he recalls.
“This steady emergence of a specialised talent base may have been somewhat overshadowed in Taiwan’s national narrative by the semiconductor industry’s dominance,” agrees Kuo, but their capabilities are very real and their relevance to this field is direct. After all, cell therapy is a life science discipline at its core, not a chemical engineering one, and Taiwan’s scientists have come to be genuinely well-suited to it.”
Uniquely Positioned
In fact, a growing number of industry insiders believe that Taiwan, by leveraging its world-class ICT capabilities, engineering talent, and newly cultivated biomedical expertise, is uniquely primed to solve many of the commercial viability issues that have so far blighted Western pharmaceutical giants’ activities in the C> space.
“While advancements in medical science have undoubtedly delivered potentially curative cell and gene therapies, the business perspective has never really functioned properly and most Western contract manufacturers have singularly failed to make these breakthrough treatments commercially viable,” contends Cyrus Yang. “These therapies are autologous – bespoke – eliminating any economy of scale. Supply chains are completely different: circular manufacturing cycles requiring material extraction from patients and return to patients, contrasting sharply with the familiar unidirectional supply‑chain model so are categorically ill-suited to conventional manufacturing styles,” he explains.
Locus Cell’s Sean Chang agrees with this assessment pointing out that, “a clear bottleneck around the cost and complexity of manufacturing has emerged between the innovation at the hospital and academic level and the viable translation of those discoveries into commercial products” and this has created an “extraordinary opening for Taiwanese CDMOs to step in leveraging their unique experiences and learnings from other sectors such as semiconductor manufacturing to offer a more appropriate solution.”
“One could even say that the Western world is in retreat when it comes to C>,” opines David Chang, CEO of the Taiwan Bio-Manufacturing Corporation (TBMC). “I first entered the segment with Celgene Juno during the gold rush when investors committed one hundred million USD to establish contract manufacturers. When the first CAR-T products launched and economics proved less attractive than anticipated, investors withdrew,” he recalls pointing out that recent casualties even include Catalent’s MaSTherCell, once Belgium’s crown jewel.
The crux of the issue is that conventional Western contract manufacturers often focus on scale-up as the primary route to cost reduction, a strategy that fails for cell therapies. Even allogeneic products face scale limitations, while autologous or on-demand formulations require batch-specific quality control. Consequently, most Western CMOs have resorted to distributed manufacturing as an eventual solution, yet they have run into severe financial difficulties; building multiple high-quality facilities prematurely is prohibitively expensive.
“What fails in Belgium or the United States can nonetheless become viable in Taiwan,” confidently predicts David Chang. “Compared to the US or Europe, our cost base is decidedly lower. What’s more, Taiwanese industry has proven over the past 30 years that it is exceptionally strong in manufacturing execution. Based on that track record of following standard operating procedures rigorously and consistently, we believe we will perform extremely well in regenerative medicine.”
Numerous practical examples validate this claim. “Taiwan Bio Therapeutics is currently involved in a Phase II clinical trial of autologous regulatory T cells for kidney transplantation, a therapy designed to reduce or replace long-term immunosuppressive medication,” points out the TRPMA’s Steve Kuo. “In that programme, patient cells are collected in the United States, transferred to Taiwan for processing and manufacturing, and then returned to the US for infusion. This arrangement exists not for convenience, but because Taiwan can produce cells of higher quality at a lower cost than equivalent processes in the US.”
Even from a cultural perspective, Taiwan is uniquely positioned to take on this mantle. Local investors value tangible manufacturing and supply chain capabilities, making the asset-heavy infrastructure of cell and gene therapy a perfect match for the regional investment landscape. “Our nation excels in manufacturing and supply chain capability, with investors prioritising tangible capabilities over abstract intellectual property,” argues Cyrus Yang. “Cell and gene therapy aligns perfectly: its science is proven and tangible, while the remaining challenges – manufacturing, supply chains, and ecosystem design – fit Taiwanese investors’ sweet spot.”
Therapeutic Design in Manufacturing
The fundamental error of most classic contract manufacturers has been to fail to integrate with the full clinical process, focusing solely on production and technology transfer, often resulting in delays or misalignment with patient scheduling. The needle-to-needle process – from patient apheresis to infusion – can be highly inefficient if medical centres, suppliers, and manufacturing facilities are not fully synchronised,” reasons Cyrus Yang.
To circumvent these issues, Taiwanese manufacturers like Taiwan Bio Therapeutics have thus been leveraging a methodology called Therapeutic Design in Manufacturing (TDM) which integrates medical centres into product design from day one. Digitalisation ensures seamless communication across all stakeholders, minimising waste from misaligned schedules, expired reagents, or delayed shipments. This ecosystem approach reduces hidden costs that traditional manufacturing models overlook. –
“We design manufacturing and clinical processes in tandem with medical centres, mapping the entire needle-to-needle workflow: patient identification, apheresis, shipping, manufacturing, infusion, and post-infusion care. This holistic integration reduces inefficiencies, shortens timelines, and ensures robust, repeatable operations,” explains Yang.
By establishing Centres of Excellence that function as local hubs, he and other stakeholders are creating scalable treatment ecosystems that gradually expand access to cell and gene therapies, much like building the charging infrastructure needed for early electric vehicles. “In short, our differentiation lies in building an open, agile, and operationally integrated ecosystem, rather than a closed infrastructure or purely scaled manufacturing operation,” he concludes.
Repurposing the Semiconductor Model
Much of this borrows from the island’s highly successful experience in mastering semiconductor manufacturing. “The semiconductor parallel is most pertinent,” opines Steve Kuo. “Taiwan did not originate semiconductor technology. Instead, over decades of disciplined investment and accumulated expertise, it built an ecosystem of manufacturing precision, process efficiency, and consistent quality that ultimately outperformed every other producer on commercial metrics. That same logic applies to cell therapy, and we already see tangible evidence of it taking hold.”
Locus Cell’s Sean Chang reiterates this conviction. “Taiwan already excels in automation and digital technology through its semiconductor and electronics industries. We aim to transfer these capabilities to regenerative medicine CDMOs, positioning ourselves as the ‘TSMC’ of cell therapy. Our vision is to serve as a foundational engine for cell and gene therapy manufacturing across Asia, particularly Southeast Asia. We do not develop proprietary products; our focus is entirely on CDMO services, much like TSMC’s foundry model. Our role is straightforward yet essential: to enable innovators and researchers to make their therapies manufacturable, scalable, and commercially viable.”
However, fully realising this vision requires a complete ecosystem encompassing raw material suppliers alongside upstream and downstream partners. “Only by constructing this ecosystem can we achieve cost competitiveness, following TSMC’s example,” Chang explains. “At present, many large pharmaceutical companies rely on proprietary media, beads, and cytokines, which are extremely costly. Even simple items like imported tubing from Europe or the US carry a high premium. To compete effectively with global giants like Lonza, Catalent, and WuXi Pharma, we must develop a localised ecosystem. Establishing our own domestic supply chain is essential to achieving that competitive edge.”
This is precisely why many of Taiwan’s cell and gene speciality CDMOs welcome government-sponsored outfits like the Taiwan Bio-Manufacturing Corporation (TBMC). “Rounding out the ecosystem is incredibly important, and we view the state’s efforts as complementary rather than a source of direct competition,” explains EirGenix’s Lee-Cheng Liu. “The TBMC can strengthen the overall infrastructure without necessarily duplicating the large-scale commercial capacities that we focus on.”
Trailblazing the Next Generation of CGT
Armed with these unique attributes, many commentators believe Taiwan can lead in shaping manufacturing processes for next-generation cell and gene therapies. “Many therapeutic cell types, such as Tregs or CAR-T cells, expand naturally in vivo,” notes Cyrus Yang. “By shifting some expansion from ex vivo manufacturing into the patient’s body, we can drastically reduce production times and costs. For example, compressing a twenty-day manufacturing timeline down to two days significantly lowers cytokine and media usage. This cuts multiple supplementation cycles down to one, translating into substantial cost savings while accelerating therapy delivery to improve patient access.”
Meanwhile, other Taiwanese outfits like TLC Biosciences are positioning themselves at the forefront of next-generation modalities. They deploy mRNA and in vivo CAR-T to transform labour-intensive processes into stable, off-the-shelf products. “We are now moving into the third generation: in vivo CAR-T,” explains George Yeh, the company’s CEO. “This involves encapsulating mRNA to achieve delivery at the cellular level. By shifting from small molecules to peptides and antibodies – such as our once-monthly GLP-1 formulation – we tackle the rebound effect and the burden of frequent injections. Our goal is to transform cell therapy from a labour-intensive process into a stable, off-the-shelf product within the next decade.”
A critical strategic logic underpins this next-generation pivot. Of the six to seven cell therapy products currently holding FDA approval, virtually all target liquid tumours — haematological malignancies that represent merely ten percent of the oncology market. “Solid tumours constitute 90 percent of cancer cases, representing a vastly larger commercial opportunity,” notes Wen-Liang Huang, general manager of Ever Supreme Biotechnology, a cell therapy company founded as a spinout of China Medical University Hospital and one of the few Taiwanese firms to hold US FDA IND approval for a regenerative medicine therapy. Ever Supreme has developed a novel CAR-T construct targeting HLA-G with integrated PD-1 checkpoint inhibition, designed specifically to overcome the immunosuppressive tumour microenvironment that has caused most solid tumour CAR-T programmes globally to fail. Early Phase I data — including a 72 percent reduction in HLA-G expression in one colorectal cancer patient and approximately 37 percent tumour burden reduction in a glioblastoma case — suggest the approach may be gaining traction where Western programmes have not.
Sean Chang, for his part, forecasts immense potential for Taiwanese CDMOs in unlocking the emerging discipline of induced pluripotent stem cell (iPSC) therapies. “Within regenerative medicine, the CAR-T field is already relatively mature,” Chang predicts. “Several companies, including Novartis, BMS, Gilead, and Miltenyi, have products in production or on the market. By contrast, iPSC therapies are still at an early stage, with only a handful of clinical trials and no market-ready products. Nevertheless, I am highly optimistic. In the coming years, iPSCs will enter a rapid growth phase. At that point, Taiwanese CDMOs like Locus Cell are set to play a pivotal role, as manufacturing complexity will surpass what individual innovators can manage independently.”
Ultimately, Taiwan’s edge lies in agility over sheer scale. “Taiwan will compete best where success depends on technology and innovation rather than capital intensity,” outlines TBMC’s David Chang. “Companies like Samsung and Fujifilm have built gigantic capacity targeting high-volume therapeutics, competing through massive capital investment. Taiwanese firms, by contrast, will come into their own by finding viable pathways for emerging modalities. These complex areas represent the true future of therapeutics.”
