Cell and Gene Therapy Manufacturing Market Trends, Growth Forecast & Analysis 2025-2035

Market Overview

The global Cell and Gene Therapy Manufacturing Market is valued at USD 12.58 Billion in 2024 and is projected to reach a value of USD 168.6 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 26.62% between 2025 and 2035.

The Cell and Gene Therapy Manufacturing Market is undergoing a transformative expansion driven by breakthroughs in regenerative medicine, rising demand for personalized treatments, and increasing approvals of advanced therapies by global regulatory agencies. This market focuses on the production, scaling, and quality control of therapeutic products based on cellular and genetic modification, making it a crucial enabler in the development of innovative treatments for cancer, rare diseases, and genetic disorders. Demand is growing rapidly as pharmaceutical companies and biotech firms race to bring novel therapies to market. Key driving factors include technological advancements in cell manipulation, growing investments in R&D, and strategic partnerships between research institutions and contract manufacturing organizations (CMOs). Furthermore, the increasing number of clinical trials and regulatory support for faster approvals of life-saving therapies continue to bolster this high-growth sector.

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Market Segmentation & Market Key Companies

Segment Covered

By Type

• Cell Therapy (60.2%)
• Allogeneic
• Autologous
• Viral Vector
• Gene Therapy (39.8%)
• Non-viral Vectors
• Viral Vectors

By Indication

• Oncology Diseases
• Inherited Disorders
• Cardiovascular Diseases
• Musculoskeletal Disorders
• Neurological Diseases
• Other Indications

By Application

• Clinical Manufacturing
• Commercial Manufacturing

By End User

• Pharmaceutical & Biotechnology Companies
• Contract Manufacturing Organizations (CMOs)
• Research Institutes & Academic Centers
• Regulatory Agencies
• Other End Users

By Region

• North America (U.S., Canada, Mexico)
• Europe (Germany, France, U.K., Italy, Spain, Nordic Countries, Benelux Union, Rest of Europe)
• Asia Pacific (China, Japan, India, New Zealand, Australia, South Korea, South-East Asia, Rest of Asia Pacific)
• Latin America (Brazil, Argentina, Rest of Latin America)
• Middle East & Africa

Companies Covered  

• Lonza (Switzerland)
• Bluebird Bio (U.S.)
• Catalent Inc. (U.S.)
• F. Hoffmann-La Roche Ltd. (Switzerland)
• Samsung Biologics (South Korea)
• Boehringer Ingelheim (Germany)
• Cellular Therapeutics (China)
• Hitachi Chemical Co. Ltd. (Japan)
• Takara Bio Inc. (Japan)
• Miltenyi Biotec (U.S.)
• Thermo Fisher Scientific (U.S.)
• Novartis International AG (Switzerland)
• Merck KGaA (Germany)
• Wuxi Advanced Therapies (U.S.)
• Fujifilm Holdings Corp. (Japan)
• Charles River Laboratories International Inc. (U.S.)
• GE Healthcare Life Sciences (U.S.)
• CGT Catapult (UK)
• CoJourney Inc. (China)
• ElevateBio LLC (U.S.)
• Pfizer Inc. (U.S.)
• Incyte Corp. (U.S.)
• AllogeneTherapeutics Inc. (U.S.)

Market Dynamics 

The cell and gene therapy manufacturing market is defined by a complex but highly dynamic ecosystem comprising biotech firms, academia, CDMOs (Contract Development and Manufacturing Organizations), and regulatory agencies. One of the primary market drivers is the accelerating pipeline of cell and gene therapies globally, with over 2,000 clinical trials ongoing and several cell-based therapies already receiving FDA and EMA approvals. The demand for personalized, targeted, and regenerative therapies—especially for conditions like cancer, spinal muscular atrophy, and inherited retinal diseases—has significantly shifted industry focus toward sophisticated manufacturing technologies capable of handling intricate biological processes.

Recent market dynamics reveal a surge in demand for Good Manufacturing Practice (GMP) compliant facilities, automation in bioprocessing, and closed system technologies to ensure scalability and reduce the contamination risks associated with manual operations. Partnerships and collaborations between pharmaceutical companies and specialized CDMOs have been instrumental in optimizing production capabilities, cost efficiency, and compliance with regulatory frameworks. Additionally, governments and funding bodies are providing financial incentives for infrastructure development, which accelerates market readiness. However, fluctuating raw material costs, the requirement for a highly skilled workforce, and challenges in managing patient-specific products remain complex obstacles. Nevertheless, the growing prevalence of chronic and rare illnesses across global economies continues to maintain a robust demand curve for cell and gene manufacturing services.

Top Trends in the Market 

One of the most prominent trends reshaping the landscape of the cell and gene therapy manufacturing market is the transition toward automation and digitization of the manufacturing process. With cell and gene therapies requiring high precision and consistency, manufacturers are increasingly adopting closed-loop systems, robotic automation, and digital bioprocessing equipment to improve yields, reduce errors, and enable real-time data analytics for quality control. Another important trend is the rise of decentralized manufacturing models, such as point-of-care (POC) manufacturing. These models allow therapies to be produced near or within hospitals and research institutions, reducing transportation time, preserving cell integrity, and improving turnaround speed.

Moreover, modular facility designs are gaining traction as companies aim to scale operations rapidly to meet growing market demand. These modular GMP suites allow for faster deployment at lower costs, helping companies respond more agilely to regulatory changes and market shifts. Increasing reliance on contract manufacturers (CDMOs) is another key trend, offering emerging biotech startups access to high-end technologies and production infrastructure without deep capital investment. Additionally, artificial intelligence (AI) and machine learning (ML) are being integrated into process development to accelerate optimization, reduce trial-and-error cycles, and improve reproducibility. There is also an uptick in the development of next-generation gene editing technologies, including CRISPR Cas9 and base editing, which require bespoke manufacturing techniques and highly customized production processes. With regulatory agencies like the FDA establishing clear guidelines and expedited approval pathways, the market continues to evolve toward a more standardized, scalable, and commercially viable future.

Recent Market Developments

• July 13, 2023: The $30 M Series A financing for CoJourney Inc., a leading manufacturer and developer of cell and gene therapies, has been completed. The company is also expanding its US organization and commercial manufacturing capabilities. Legend Star Investment Management, Lake Bleu Capital, GL Ventures, and Legend Capital all contributed to this funding round. To support end-to-end custom development and manufacturing for genetic medicines, including plasmids, viral vectors, and mRNA, CoJourney has created high-efficiency processes.
• June 7, 2023:The Cell and Gene Therapy Catapult (CGT Catapult) opened new labs at the University of Edinburghs Institute of Regeneration and Repair, its first location in Scotland. The labs are located in the Edinburgh BioQuarter. CGT Catapult hopes to offer knowledge, resources, and technology to assist cell therapy developers in improving their manufacturing processes and navigating the intricate regulatory requirements associated with bringing these therapies to market with its new 350m2 high-specification laboratory space.
• May 25, 2023: To develop its technological platforms and accelerate the creation, manufacturing, and development of cell and gene therapies, ElevateBio has raised $401 million in a Series D financing round.

Top Report Findings

• The global cell and gene therapy manufacturing market is projected to exceed USD 168.6 billion by 2035, growing at a CAGR of over 26.62%. 
• Biopharmaceutical companies dominate the demand, followed by academic research institutions and contract manufacturers. 
• CAR T therapies and gene editing solutions are the fastest-growing segments due to their success in oncology and rare disease treatment. 
• North America leads the global market due to extensive R&D activity, strong regulatory support, and infrastructure readiness. 
• Closed system bioprocessing and automation technologies are revolutionizing production efficiency and reducing contamination risks. 
• A significant portion of market revenue is attributed to viral vector manufacturing, which remains a critical bottleneck for gene therapies. 
• Strategic partnerships and M&A activities are frequent, aimed at acquiring technological know-how and expanding production capabilities. 
• Personnel shortages and high operational costs continue to be constraints for new manufacturing entrants.

Challenges in the Market 

The cell and gene therapy manufacturing market, while promising, remains fraught with several significant challenges that hamper its scalability and accessibility. One of the most notable issues is the lack of standardized manufacturing protocols, which creates considerable variability between batches and thwarts the consistency essential for regulatory approvals. Developing a universal process for therapies tailored to individual patients (especially autologous therapies) is exceptionally complex and resource-intensive.

Additionally, the high cost of production—driven by expensive raw materials, specialized labor, and the need for stringent quality controls—poses a considerable barrier for emerging companies.

Skilled labor shortages in bioengineering and regulatory talent further exacerbate timelines and increase dependency on external consultants, especially during clinical trial manufacturing. The complexity of viral vector production, particularly for gene editing and delivery systems, creates a bottleneck that can result in delays and escalated costs.

Moreover, global disparities in regulatory environments, combined with lengthy approval processes, complicate cross-border clinical trials and commercialization. These challenges must be effectively addressed to prevent stagnation in a market that holds immense therapeutic potential across a wide range of diseases.

Opportunities in the Market 

Despite facing several operational and regulatory headwinds, the cell and gene therapy manufacturing market presents vast growth opportunities across the healthcare spectrum. With only a fraction of the potential therapies currently commercialized, there's enormous untapped potential in rare and orphan diseases, many of which are prime candidates for gene and cell-based interventions. As awareness grows among clinicians, patients, and policymakers, the demand is likely to increase dramatically, driving innovation and uptake.

Additionally, the advancement in process development tools, such as automation, single-use systems, and real-time analytics, opens new avenues for reducing costs and improving scalability. Collaborations between CDMOs and pharmaceutical companies are increasingly focused on expanding capacity, optimizing viral vector production, and meeting commercial-scale demand. The emergence of allogeneic therapies, which are developed from donor cells and can serve multiple patients, also offers a more scalable and cost-efficient model compared to patient-specific (autologous) therapies.

Moreover, increasing investment from venture capitalists, private equity, and government grants into manufacturing infrastructure development is creating fertile ground for innovation. The convergence of bioinformatics, AI, and synthetic biology further streamlines R&D and accelerates time to market. These opportunities, if harnessed correctly, could revolutionize the way medicine is produced and delivered globally.

Key Questions Answered in the Market Report 

1. What are cell and gene therapies, and how do their manufacturing processes differ from conventional biologics? 
2. What factors are driving the growth of the cell and gene therapy manufacturing market globally? 
3. Which therapeutic areas are witnessing the fastest adoption of cell and gene therapies? 
4. What are the main challenges associated with scaling up manufacturing processes for advanced therapies? 
5. How are CDMOs contributing to the expansion of the cell and gene manufacturing market? 
6. What technological advancements are reshaping the future of therapy production? 
7. What role do regulatory agencies play in shaping the manufacturing landscape for cell and gene therapies? 
8. Which companies are leading in terms of infrastructure, innovation, and product development within the market?

Regional Analysis: Focus on North America

North America remains the largest and most established regional market for cell and gene therapy manufacturing, primarily led by the United States. The region's dominance is underpinned by a strong foundation in biopharmaceutical R&D, a mature regulatory framework, high healthcare expenditure, and a collaborative ecosystem involving academia, biotech companies, and healthcare institutions. The U.S. Food and Drug Administration (FDA) plays a proactive role by offering fast-track designations and establishing clear regulatory pathways through initiatives like the Regenerative Medicine Advanced Therapy (RMAT) designation, which further accelerates product development and approval.

Manufacturing infrastructure in North America has expanded rapidly due to substantial investments from both the public and private sectors. Companies like Thermo Fisher Scientific, Catalent, Lonza, and WuXi Advanced Therapies have significantly increased their production capabilities through facility expansion, acquisitions, and joint ventures. Additionally, the increasing number of cell and gene therapy clinical trials conducted in U.S.-based facilities fuels the need for state-of-the-art production capabilities.

The presence of leading academic institutions, research organizations, and funding from the National Institutes of Health (NIH) contributes to continued innovation in advanced therapy manufacturing. Government-backed initiatives aimed at bolstering domestic biomanufacturing further solidify North America's role as the global leader. As the therapies gain FDA approvals and move from bench to bedside, North America is expected to maintain its leadership in both innovation and commercialization.

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Conclusion 

The Cell and Gene Therapy Manufacturing Market sits at the heart of the next medical revolution. Fuelled by scientific breakthroughs, rising demand for personalized medicine, and regulatory support, this market is poised for exponential growth. Despite facing significant challenges like scalability, skilled labor shortages, and regulatory complexity, rapid advancements in biotechnology, automation, and process development are streamlining production and expanding accessibility. Companies investing in infrastructure, innovation, and strategic partnerships will be best positioned to define the future of medical treatment. North America continues to lead the global market, offering an ideal ecosystem for the development, clinical testing, and commercialization of advanced therapies. As research deepens and new therapies receive approval, the need for efficient, compliant, and scalable manufacturing will become more critical than ever. The path ahead is promising, and with the right investments and collaborations, the cell and gene therapy manufacturing industry has the potential to transform global healthcare and the lives of millions of patients.