Cell and Gene Therapy Manufacturing in Singapore

Singapore has positioned itself as the most credible base for cell and gene therapy manufacturing in Southeast Asia. It combines internationally aligned standards, a transparent regulatory framework, modern facilities, and a logistics platform built for living products. For investors deciding where to place capital, this combination reduces execution risk and accelerates commercialization, turning a small domestic market into a strategic hub for the region.

Regulatory and manufacturing standards

The Health Sciences Authority (HSA) regulates Cell, Tissue, and Gene Therapy Products (CTGTP) under the Health Products Act and specific regulations introduced in 2021.

The framework is risk-based, with Class 1 products — minimally manipulated and used for homologous purposes — subject to notification and acceptance, while Class 2 products require full registration. Manufacturers, importers, and wholesalers handling Class 2 therapies must be licensed, and distribution is tied to Good Distribution Practice (GDP) audits. This clarity informs investors precisely which category their products fall into and what obligations they incur.

Singapore is also a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), meaning its GMP inspections are recognized internationally. From October 2024, HSA began requiring GMP compliance evidence for drug-substance manufacturers in new applications, making clear that enforcement is active and non-negotiable.

Distribution is equally controlled: GDP guidance requires importers and wholesalers to maintain quality systems covering storage, transport, and record-keeping, with audits before licensing. For businesses, this assures that every stage of the chain meets international expectations.

Infrastructure and facilities

Standards are reinforced by infrastructure. The Advanced Cell Therapy and Research Institute, Singapore (ACTRIS), opened in August 2023 with fourteen GMP-compatible clean suites, four translational labs, and a QC laboratory. It was designed to give hospitals, universities, and start-ups a platform to scale therapies without years of capital-intensive facility construction.

Beyond ACTRIS, Tuas Biomedical Park and Biopolis anchor Singapore’s industrial and research ecosystems with integrated utilities, cleanroom layouts, and co-located R&D facilities that align with global norms.

The presence of this ecosystem has catalyzed private investment. WuXi Biologics is committing S$2 billion to a new CRDMO campus at Tuas, adding 120,000 liters of bioreactor capacity and employing around 1,500 staff.

Multinationals such as Novartis, GSK, and Sanofi have also established operations, using Singapore as both a production base and a regional distribution hub.

Together, these public and private commitments demonstrate that the system functions at a global scale, not only at a pilot scale.

Case example: First-in-region approval

In March 2021, HSA approved Novartis’ Kymriah, making it the first commercial CAR-T therapy authorized in Southeast Asia. This approval demonstrated that Singapore’s CTGTP framework can handle advanced therapy dossiers and bring products to patients under international scrutiny. For investors, this provides tangible proof that the regulatory system functions in practice, not only on paper.

Logistics and export readiness

Export capacity is critical for cell and gene therapies. Changi Airport operates Asia-Pacific’s first IATA CEIV Pharma-certified community, with temperature-controlled warehouses, 24/7 monitoring, and end-to-end audited handling. This means therapies can move from cleanroom release to outbound flight under continuous conditions recognized by regulators abroad. For living products where a break in the cold chain can destroy an entire batch, this infrastructure reduces one of the biggest operational risks.

Incentives and operating economics

Singapore’s 17 percent corporate tax rate is made more attractive through targeted incentives. The Development and Expansion Incentive and the Pioneer Certificate Incentive can reduce effective rates to 5–10 percent for qualifying activities.

The Enterprise Innovation Scheme, introduced in 2024, provides a 400 percent tax deduction on up to S$400,000 of annual R&D and training expenses, with an option to convert part of the deduction into a cash payout. Multinationals subject to the OECD’s 15 percent global minimum tax can structure these incentives compliantly through Singapore’s domestic top-up tax regime.

For investors, this means early cash savings and predictable compliance with international tax rules.

Market trends and outlook

Singapore’s biomedical exports totaled S$38 billion (US$29.4 billion) in 2022, with advanced therapies representing a small but fast-growing share. ASEAN’s healthcare expenditure is on track to reach US$740 billion by 2025, and most countries lack the infrastructure to support advanced therapy production domestically. Singapore’s combination of standards, logistics, and incentives positions it as the natural hub to fill this gap.

Subsector opportunities within cell and gene therapy manufacturing

Cell therapies: CAR-T and stem cell applications

Cell therapies are among the most commercially advanced areas of the industry. Global cell therapy revenue reached US$18.25 billion in 2024 and is projected to rise to US$50.5 billion by 2037.

In the Asia-Pacific region, the CAR-T market alone is expected to grow from US$620 million in 2024 to US$2.07 billion by 2033. Singapore’s ACTRIS is already supporting CAR-T clinical trials, giving investors immediate entry into this fast-growing market with access to compliant facilities and established hospital networks.

Gene therapies and viral vector manufacturing

Gene therapy depends heavily on viral vectors, which remain a global supply bottleneck. The Asia-Pacific viral vector market is projected to expand from US$174 million in 2024 to US$1.16 billion by 2033, growing at more than 23 percent annually, while globally the segment could reach US$7.66 billion by 2030.

Singapore is outfitting its facilities for scalable vector production, opening the door for investors with expertise in adeno-associated and lentiviral vectors, purification, and automation to address unmet demand both regionally and internationally.

Delivery platforms: Ex vivo and in vivo therapies

Ex vivo therapies, where cells are modified outside the body, currently represent about US$3.24 billion globally and are well supported by Singapore’s cleanroom infrastructure. In vivo therapies, valued at US$16.89 billion worldwide, are less mature but are advancing quickly, representing the next frontier of investment. Singapore’s translational research base is well-positioned to support in vivo breakthroughs, allowing investors to pursue near-term revenues from ex vivo therapies while preparing for longer-term in vivo opportunities.

CDMO services

Contract development and manufacturing organizations already form part of Singapore’s value chain. WuXi Biologics’ S$2 billion project at Tuas demonstrates that the city-state is trusted to host large-scale outsourcing facilities. For smaller biotechs, CDMOs offer speed and compliance without the need for massive upfront investment. Investors also have the chance to support niche CDMOs focused on vectors, quality testing, or patient-specific processes.

Ancillary services and supply chain enablers

Supporting services such as quality control, cryopreservation, and cold-chain technology are expanding quickly. The Asia-Pacific quality control market for cell and gene therapies is expected to grow from US$246 million in 2023 to US$1.32 billion by 2033.

Although Singapore already has GDP-certified logistics through Changi Airport, there remains unmet demand for specialized storage, tracking systems, and advanced packaging solutions. Companies that address these needs can build profitable positions adjacent to the core manufacturing sector.

Clinical trial and research support services

Clinical trial support is another area of growth. Singapore is rated as an “advancing” market for CAR-T readiness by IQVIA, reflecting its clear ethics frameworks and robust trial infrastructure. Investors can contribute through reagents, trial management platforms, or bioinformatics tools that integrate hospitals, regulators, and manufacturers.

As the pipeline of therapies expands, demand for trial support will scale in parallel.

Decision pathways for investors

Investors evaluating Singapore as a base for cell and gene therapy manufacturing typically choose among three routes: direct facility investment, joint ventures with local or regional players, or outsourcing to contract development and manufacturing organizations. Each option balances control, cost, and timing differently and will shape both regulatory strategy and financial outcomes.

At one end of the spectrum, companies that pursue direct facility investment gain maximum control over processes, intellectual property, and long-term margins. A greenfield plant at Tuas Biomedical Park or Biopolis can span from cell and gene therapy–scale builds in the US$80–155 million range to large biologics expansions around S$300 million, and for complex modalities can reach US$1.5 billion. Traditional greenfields typically take three to five years from concept to qualified operations, while modular or retrofit projects can compress timelines to ~12–18 months. The payoff is ownership of quality systems and the ability to qualify facilities for FDA or EMA oversight, which suits multinationals or well-capitalized biotechs planning multiple therapies with sustained demand.

For businesses not ready to commit that level of capital, joint ventures offer a more measured path. Partnering with institutions such as ACTRIS or regional hospital networks allows investors to tap existing infrastructure while sharing compliance and financial risk. This provides faster market entry with lower upfront cost, though at the expense of shared decision-making and the need to structure agreements carefully to protect proprietary technology. Singapore’s strong IP protections and contract law help mitigate these risks, but executives must still decide how much influence they are willing to concede.

Outsourcing to CDMOs is the fastest and least capital-intensive option. A company can initiate production in Singapore within months by contracting with an established operator, paying primarily variable costs tied to volumes. These costs can be offset by the Enterprise Innovation Scheme, which grants 400% tax deductions on the first S$400,000 of qualifying R&D or training per year of assessment and allows an optional cash payout on up to S$100,000 of qualifying spend. This model is well suited to firms with a narrow pipeline or limited initial demand, though dependence on CDMOs can constrain flexibility if capacity tightens, and margins are naturally thinner than in direct ownership models.

Whichever route is chosen, regulatory timing is pivotal. Class 1 cell, tissue, and gene therapy products (CTGTPs) proceed by notification, with outcomes typically issued in ~14 working days. Class 2 products require full registration, scheduled as 50 working days for screening plus 180 (abridged) or 270 (full) working days for evaluation, excluding applicant stop-clocks. In practice, this means a process of roughly 9–15 months for an unpaused review. Early engagement with the Health Sciences Authority to confirm classification and evaluation route is therefore essential.

Incentive alignment should also be considered carefully. Large-scale facilities are best matched to the Development and Expansion Incentive or the Pioneer Certificate Incentive, which can reduce corporate tax on qualifying income to 5–15 percent for an initial period of up to 10 years. Pilot-scale or outsourced models, by contrast, derive greater value from the Enterprise Innovation Scheme’s enhanced deductions and cash-conversion features. Aligning the right incentive framework with the chosen pathway improves returns and strengthens internal investment cases.

Ultimately, the decision depends on strategic intent. Investors seeking a durable Asian manufacturing base will find direct investment offers the greatest control, while those testing markets may prefer the speed and flexibility of a joint venture or CDMO outsourcing. The critical point is that Singapore makes all three pathways viable within one jurisdiction, allowing companies to calibrate their commitment in line with commercial traction.

ASEAN gateway advantage

Singapore’s domestic market may be small, but its role as a springboard into ASEAN gives it disproportionate importance. With ASEAN’s population of 740 million and projected healthcare spend of USD 740 billion by 2025, investors manufacturing in Singapore can serve Indonesia, Thailand, Vietnam, and the Philippines without encountering their regulatory fragmentation or infrastructure gaps. Products made in Singapore benefit from HSA’s international recognition, and Changi’s cold-chain logistics provide secure export pathways. Combined with robust IP protections and predictable contract enforcement, this makes Singapore the safest and most reliable hub for advanced therapies in Southeast Asia.

Building the first-year plan

Investors entering Singapore should approach the first year as a staged process that aligns regulatory milestones with operational build-out. The initial step is engagement with the Health Sciences Authority to confirm whether the therapy falls into Class 1 or Class 2 and to map the corresponding licensing path. While this review is underway, interim compliant capacity can be secured through ACTRIS suites or established CDMOs, ensuring that product development and early trials are not delayed.

Parallel preparation should focus on activating incentives. The Enterprise Innovation Scheme supports early-stage hiring, training, and R&D costs, providing both tax offsets and cash conversion options that ease the initial cash flow burden. For companies planning larger facilities, applications for the Development and Expansion Incentive or the Pioneer Certificate Incentive can be timed to coincide with construction and technology transfer. By sequencing these steps, boards can achieve regulatory progress, early market presence, and fiscal efficiency within the same twelve-month window.