The Cell and Gene Therapy Manufacturing Market is set to witness rapid expansion on account of several factors during the period of 2025 to 2035 including clinical demand for personalized medicine, faster approvals from regulatory bodies and increasing investments directed towards contemporary bio manufacturing infrastructure.
Cell and gene therapies are transforming the treatment paradigms for genetic diseases, cancers, and rare diseases and as of 2024, over 2,000 clinical trials are been run globally.
The complexity, cost, and regulatory requirements of these therapies have made manufacturing capacity a significant bottleneck to scaling CGT access. The market for contract development and manufacturing organizations (CDMOs), modular cleanroom solutions, and actuation tools is therefore expanding.
The global market for CGT manufacturing is forecast to grow from USD 32,117.1 Million in 2025 to USD 403,548.1 Million by 2035, at a compound annual growth rate (CAGR) of 28.8% during that period.
Key Market Metrics
| Metric | Value |
|---|---|
| Market Size in 2025 | USD 32,117.1 Million |
| Projected Market Size in 2035 | USD 403,548.1 Million |
| CAGR (2025 to 2035) | 28.8% |
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CGT Manufacturing Market is Dominated by North America with Robust R&D Pipeline, Regulatory Backing, and Biopharma Funding. The USA FDA regenerative medicine advanced therapy (RMAT) designation has expedited novel therapy approval.
The USA CDMOs are ramping up viral vector production, autologous and allogeneic cell processing, and cryogenic logistics. The decentralized manufacturing and AI-grade quality control regional context questioning is already investing heavy resources.
Intense development of CGT implementation in Europe is achieved through solid partnerships with the private sector as well as substantial government funding. Germany, the UK, and the Netherlands have invested in advanced therapy medicinal product (ATMP) hubs.
CGT Scalability Through Regional Innovation Ecosystems Supported by the EU’s Horizon Europe Program Cross-border cooperation is also being assisted through a focus on GMP compliance, vector manufacturing, and training programs.
Asia-Pacific is the fastest-growing region, through increased clinical trial activity, favorable regulatory transformation and investments from biotech companies in China, Japan and South Korea. Japan’s fast-track approval pathway for regenerative medicine has speeded rate commercialization. And there are even state-backed innovation parks in China that offer incentives to CGT startups and CDMOs. Infrastructure expansion to support regional cell processing and vector capacity also exists across India and Singapore.
Manufacturing scalability, cost intensity, and regulatory heterogeneity slow market efficiency.
CGT sector bottlenecks are systemic, particularly in the autologous cell therapy manufacturing, where personal batch processing and rapid turnaround limits productivity. The cost of manufacturing often exceeds USD 100,000 per patient and can be prohibitively expensive in high-income countries. Distribution is challenged further by relatively short shelf life and complex cold-chain logistics.
Global trial design, manufacturing site approval, and market access are further complicated by the inconsistent regulations between the USA, EU, and APAC. The absence of harmonized standards for viral vector production, raw material traceability, and product release testing prolongs development cycles and adds expense, especially for early-stage developers and startups.
Modular platforms, automation, and decentralized manufacturing unlock long-term growth.
There are huge opportunities for growth by moving from manual, labor-intensive workflows to closed, automated manufacturing systems.Examples include scalable, GMP-compliant operations (enabled through modular cleanrooms, single-use bioreactors, and automated cell expansion tools). AI and machine learning will also enhance process monitoring, predictive quality assurance, and supply chain forecasting.
Decentralized manufacturing models like point-of-care (PoC) manufacturing for hospitals and local GMP suites are being proposed as a means to increased turnaround times and greater therapy accessibility. Emerging Allogeneic (off-the-shelf) therapies with batch manufacturing capabilities have the potential to overshadow autologous solutions in the future pipelines, in terms of cost, quality, and high consistency across batches of drug products.
Between 2020 and 2024, record levels of investment poured into the CGT sector, with 20 or more cell and gene therapies receiving market authorization in the major markets. Yet, restricted vector generation capacity, labor-intensive cell enlargement workflows, and a shortage of workforce restricted the scale of operations. The COVID-19 pandemic also caused challenges to global supply chains, which led to vector manufacturing being moved to the regions of demand and supply.
From 2025 to 2035, the years mark the transition from traditional, factory style manufacturing to a platform based manufacturing empowered with digital twins, smart sensors, AI-enabled analytics. Standardization between viral vector types, enhanced engineering of cell lines, and unified regulatory frameworks will all contribute to the decrease of the cost of goods sold (COGS). Cell and gene therapies will broaden their reach beyond the oncology and rare disease windows into cardiology, ophthalmology and autoimmune indications.
Market Shifts: A Comparative Analysis 2020 to 2024 vs. 2025 to 2035
| Market Shift | 2020 to 2024 Trends |
|---|---|
| Regulatory Landscape | Region-specific approval pathways |
| Consumer Trends | Focus on life-saving rare disease therapies |
| Industry Adoption | Dominated by oncology and CAR-T manufacturing |
| Supply Chain and Sourcing | Shortages of GMP vectors, cell lines, and reagents |
| Market Competition | Led by early movers and CDMO giants |
| Market Growth Drivers | Venture capital, first approvals, and public interest |
| Sustainability and Impact | High waste from single-use systems |
| Smart Technology Integration | Manual QA/QC and operator-led decisions |
| Sensorial Innovation | Basic monitoring and offline testing |
| Market Shift | 2025 to 2035 Projections |
|---|---|
| Regulatory Landscape | Global harmonization of GMP and release standards |
| Consumer Trends | Demand for scalable, cost-effective mainstream therapies |
| Industry Adoption | Expanding into cardiovascular, metabolic, and ophthalmic indications |
| Supply Chain and Sourcing | Vertically integrated vector and raw material manufacturing hubs |
| Market Competition | Entry of decentralized, hospital-based manufacturers and digital platforms |
| Market Growth Drivers | Process innovation, allogeneic therapies, and regulatory alignment |
| Sustainability and Impact | Emergence of reusable modular components and energy-efficient cleanrooms |
| Smart Technology Integration | AI-powered batch release, robotics, and real-time analytics |
| Sensorial Innovation | Multi-sensor feedback, digital twins, and predictive contamination alerts |
The United States leads the world in the cell and gene therapy manufacturing market, bolstered by world-class biotech infrastructure, favorable regulatory pathways, and an aggressive push into personalized medicine and gene editing. Several cell and gene therapeutics have been approved by the USA Food and Drug Administration (FDA), including those based on CAR-T and AAV approaches, creating a demand for scalable manufacturing platforms.
GMP-compliant cleanroom facilities, automated bioreactors, and viral vector production systems in biotech clusters of Massachusetts and California are investing in these technologies. NIH continues to fund translational research that speeds progress from lab (process development) to clinic (tech transfer).
| Country | CAGR (2025 to 2035) |
|---|---|
| United States | 29.3% |
Supported strategically and embraced industrially, the cell and gene therapy manufacturing market is booming in the U.K. In London, the Cell and Gene Therapy Catapult serves as a national innovation hub that provides end-to-end clinical trial and commercial-scale manufacture support.
In autologous cell therapy platforms, post-Brexit regulatory flexibility is internationalizing market opportunities. Demand for viral vectors and engineered T-cell therapies is another growth driver. Building out modular cleanroom and cryogenic storage infrastructure at regional bio manufacturing centers to enable new therapies launches
| Country | CAGR (2025 to 2035) |
|---|---|
| United Kingdom | 28.1% |
The EU market is also growing because of harmonized clinical trial frameworks, high investment in biotech hubs, and EU-funded infrastructure supporting advanced therapy medicinal products (ATMPs). Germany, Belgium, and the Netherlands top the list for constructing cell therapy manufacturing units, especially for allogeneic products.
This should rightly be facilitated by all EU Horizon research programs, whether on vector engineering, closed-system processing, cell expansion or any other, to support clinical innovation as it necessarily will be in this segment. The European Medicines Agency (EMA) is streamlining regulatory cooperation to expedite approvals for rare disease gene therapies and oncology.
| Country | CAGR (2025 to 2035) |
|---|---|
| European Union | 28.8% |
Expedited regulatory frameworks such as PMDA’s Sakigake designation that accelerates review for breakthrough therapies in Japan’s cell and gene therapy manufacturing sector also help to boost manufacturers.
The government takes an active role in supporting regenerative medicine through an Act on the Safety of Regenerative Medicine. Japanese manufacturers are working on iPSC-derived therapies, autologous stem cell therapies and vector production for ocular and neuromuscular diseases. Most of the growth is occurring in Tokyo and Kobe, with biopharma companies creating modular GMP facilities designed to cater to local and international markets.
| Country | CAGR (2025 to 2035) |
|---|---|
| Japan | 27.6% |
With the Bioeconomy 2030 Strategy among others, South Korea is emerging as a global leader in cell and gene therapy manufacturing. Korea has created biopharmaceutical clusters in Songdo and Osong, where local companies are allocating resources for viral vector and cell expansion systems.
Novel regulations enable conditional endorsement of regenerative medicines, expediting market access. And now, Korean CDMOs (contract development manufacturing organizations) are pursuing their global clients for their cells and gene therapy production for cost-effective GMP-compliant operations.
| Country | CAGR (2025 to 2035) |
|---|---|
| South Korea | 29.0% |
The cell and gene therapy manufacturing market continues to accelerate with increasing global investment in next-generation biopharmaceuticals. Both of these therapies which encompass genetic disorders, rare diseases and oncology demand highly complex, high-precision production systems in order to secure clinical safety, scalability and quality control.
Gene therapy manufacturing and commercial-scale facilities capture Global Market Share owing to the increasing number of FDA and EMA-approved gene therapies, expanding clinical pipelines, and need for full-scale GMP-compliant daughter production across all parts of the world. These sections facilitate industrialized therapeutic delivery, global regulatory harmonization, and commercial market access for novel gene-based therapies.
With healthcare systems moving toward personalized therapies and treating many rare diseases with access to public and private funding, gene therapy manufacturing infrastructure and global commercial readiness are vital to achieving long-term market success.
| Therapy Type | Market Share (2025) |
|---|---|
| Gene Therapy Manufacturing | 63.9% |
The gene therapy manufacturing has retained its lead in this segment as the number of approved products and the number of ongoing clinical trials in many of the rare and chronic disease settings are on the rise. Production of viral vectors (e.g., AAV, lentivirus) and non-viral delivery systems for inserting or modifying genes at the molecular level.
Gain insight into why pharmaceutical and biotechnology companies are increasingly outsourcing and co-developing manufacturing with gene therapy expert CDMOs (Contract Development and Manufacturing Organizations), requiring stringent contamination control, biosafety level facilities, as well as extensive analytical validation.
Gene therapies that address previously untreatable diseases such as spinal muscular atrophy and some cancers have fast track approval programs under regulatory bodies such as the FDA and EMA. Both of these factors have led companies to make massive investments in proprietary vector platforms and upstream/downstream bioprocessing technologies in their bid for competitive edge.
Stem cells and non-stem cells therapies continue to be crucial in the regenerative medicine and immunotherapy pipelines, but gene therapy manufacturing dominates overall due to its commercial maturity, rare disease orientation, and depth of innovation.
| Scale | Market Share (2025) |
|---|---|
| Commercial Scale Manufacturing | 67.5% |
As more cell and gene therapies become market authorized and move from pilot to commercial volume production, making the most of that opportunity will be critical, and commercial-scale manufacturing will lead the market.
All such facilities comply with GMP and are built to enable product launches, multi-country distribution, and post-approval scale-up.To meet stringent commercially oriented requirements, manufacturers harness integrated modular cleanroom infrastructure, digital batch control and closed-system bioreactors. Vector yield optimizations, high-throughput automated cell processing, and real-time release testing capabilities are tackled as critical priorities for reproducibility and regulatory compliance.
Pharma and biotech companies look to niche CMOs and technology providers to help ensure capacity to meet expected global demand in North America, Europe and Asia. Facilities are also structured for flexibility so they can support multiple therapeutic platforms.While pre-commercial and R&D manufacturing is crucial for innovation and early-stage trials, commercial-scale manufacturing vastly outweighs them in value and infrastructure investment, as the market evolves from development to delivery.
The cell and gene therapy (CGT) manufacturing market is experiencing tremendous growth, largely as the result of greater approvals for personalized and regenerative therapeutics aimed at treating cancer, rare diseases, and genetic disorders. Industrial scaling is driven by advances in viral vector production and cell processing technologies, as well as regulatory support for accelerated therapies.
To combat these challenges of scalability, reproducibility, cost (to name just a few), major players are investing in flexible cGMP manufacturing, automated closed systems and AI-enabled analytics. These reasons collectively set the stage and grow the trend of outsourcing, especially with the growing demand for CDMO partners which are taking pivotal roles in the efficient delivery of clinical and commercial CGT products.
Market Share Analysis by Key Players & CGT Manufacturing Providers
| Company Name | Estimated Market Share (%) |
|---|---|
| Lonza Group | 14-17% |
| Thermo Fisher Scientific | 11-14% |
| Catalent Inc. | 9-12% |
| WuXi Advanced Therapies | 7-10% |
| Fujifilm Diosynth Biotechnologies | 6-9% |
| Other Providers | 38-45% |
| Company Name | Key Offerings/Activities |
|---|---|
| Lonza Group | In 2024 , opened a new viral vector facility in the USA; in 2025 , expanded automated allogeneic cell therapy suites for commercial-scale delivery. |
| Thermo Fisher Scientific | In 2024 , launched Gibco CTS DynaCellect for automated T-cell selection; in 2025 , introduced closed modular platforms for lentiviral production. |
| Catalent Inc. | In 2024 , enhanced its gene therapy site in Maryland with plasmid DNA capabilities; in 2025 , launched turnkey viral vector services for rare disease therapies. |
| WuXi Advanced Therapies | In 2024 , scaled AAV and lentiviral capabilities for ex vivo gene-modified cell therapies; in 2025 , deployed digital twin platforms for real-time process optimization. |
| Fujifilm Diosynth Biotechnologies | In 2024 , opened UK-based cell therapy plant with cryopreservation facilities; in 2025 , introduced single-use bioreactor suites for flexible CGT manufacturing. |
Key Market Insights
Lonza Group (14-17%)
Lonza leads the global CGT manufacturing landscape with robust infrastructure and process development capabilities. In 2024, the company opened a viral vector facility in Massachusetts, focused on supporting late-stage gene therapy trials. In 2025, it expanded commercial production of allogeneic cell therapies using closed-system automation, enabling cost-effective and scalable delivery. Lonza’s end-to-end CGT support, from preclinical development to commercial supply, aligns with global efforts to expand access to advanced therapies.
Thermo Fisher Scientific (11-14%)
Thermo Fisher continues to integrate manufacturing equipment with cell therapy solutions. In 2024, it introduced the Gibco CTS DynaCellect System, enabling high-yield, high-purity T-cell separation with reduced manual handling. In 2025, it launched modular, closed systems for lentiviral production, reducing contamination risk and increasing output reliability. Thermo Fisher’s approach supports global regulatory trends emphasizing traceability, automation, and data integrity in CGT manufacturing.
Catalent Inc. (9-12%)
Catalent has expanded rapidly into viral vector and cell therapy services, serving biopharma partners worldwide. In 2024, its Maryland facility was upgraded with GMP-grade plasmid DNA production lines to support gene therapy pipelines.
In 2025, Catalent launched turnkey manufacturing services tailored for rare disease treatments, offering compressed timelines from development to market. The company’s expertise in fill-finish and aseptic manufacturing supports CGT developers with streamlined regulatory and logistical pathways.
WuXi Advanced Therapies (7-10%)
WuXi is strengthening its global presence with integrated CGT manufacturing and testing services. In 2024, the company expanded its lentiviral and AAV vector capacities for gene-modified cell therapy clients. In 2025, WuXi deployed AI-driven digital twin systems to simulate and optimize cell culture and viral production processes in real time. This reduces cost and variability while meeting global demand for scalable, reliable CGT supply.
Fujifilm Diosynth Biotechnologies (6-9%)
Fujifilm is focused on flexible and modular CGT manufacturing infrastructure. In 2024, it launched a dedicated UK-based facility equipped with cryopreservation for autologous cell therapies. In 2025, it implemented single-use bioreactor suites supporting scale-up of both viral vectors and cell expansion protocols. Fujifilm’s rapid batch changeover capabilities and patient-centric manufacturing solutions make it a strategic partner in both clinical and commercial markets.
Other Key Players (38-45% Combined)
A dynamic range of CDMOs, biotech innovators, and academic manufacturing centers are contributing to CGT manufacturing innovations. These include:
The overall market size for the cell and gene therapy manufacturing market was USD 32,117.1 Million in 2025.
The cell and gene therapy manufacturing market is expected to reach USD 403,548.1 Million in 2035.
The demand for cell and gene therapy manufacturing is rising due to rapid advancements in regenerative medicine, increasing regulatory approvals, and the expansion of personalized therapies. Growth in commercial-scale operations and specialized gene therapy manufacturing platforms is further accelerating market expansion.
The top 5 countries driving the development of the cell and gene therapy manufacturing market are the USA, Germany, Japan, China, and the UK.
Gene therapy manufacturing and commercial-scale operations are expected to command a significant share over the assessment period.
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Cell and Gene Therapy Manufacturing Market
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