Advanced Therapy Medicinal Products CDMO Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Gene Therapy, Cell Therapy, Tissue Engineered, Others), By Phase (Phase I, Phase II, Phase III, Phase IV), By Indication (Oncology, Cardiology, Central Nervous System, Musculoskeletal, Infectious disease, Immunology & inflammation, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 5.23 Billion
CAGR (2026-2031)	9.59%
Fastest Growing Segment	Oncology
Largest Market	North America
Market Size (2031)	USD 9.06 Billion

Market Overview

The Global Advanced Therapy Medicinal Products CDMO Market will grow from USD 5.23 Billion in 2025 to USD 9.06 Billion by 2031 at a 9.59% CAGR. Advanced Therapy Medicinal Products Contract Development and Manufacturing Organizations provide specialized outsourcing services for the development and production of gene therapies, somatic cell therapies, and tissue engineered products. The market is primarily supported by the increasing necessity for biopharmaceutical companies to access specialized technical expertise and avoid the substantial capital investment required for internal manufacturing facilities. Additionally, the growing intricacy of these therapeutic modalities compels innovators to leverage the regulatory experience and established infrastructure of external partners to accelerate clinical timelines and commercialization.

However, the sector encounters a significant challenge regarding the scarcity of available manufacturing slot capacity and a shortage of highly skilled personnel. This limitation restricts the ability of service providers to accommodate the surging volume of projects effectively. According to the Alliance for Regenerative Medicine, in 2025, the sector demonstrated robust activity with a 6 percent increase in the global number of developers and a 3 percent rise in clinical trials. This expansion in the development pipeline exacerbates the existing pressure on manufacturing resources and highlights the critical need for capacity expansion.

Key Market Drivers

The surge in cell and gene therapy clinical development pipelines acts as a primary catalyst for the Global Advanced Therapy Medicinal Products CDMO Market. As developers aggressively expand research efforts, the sheer volume of therapeutic candidates entering pre-clinical and clinical stages necessitates external manufacturing support to manage throughput. This demand is significantly amplified by robust sector financing, which fuels the progression of these candidates through costly development phases. According to the Alliance for Regenerative Medicine, October 2024, at the 'Cell & Gene Meeting on the Mesa', the sector attracted USD 10.9 billion in investment during the first half of the year. Consequently, the industry relies heavily on contract partners to handle the increasing project density. According to Citeline and the American Society of Gene & Cell Therapy, April 2024, in the 'Gene, Cell, + RNA Therapy Landscape Q1 2024 Report', there were more than 4,000 gene, cell, and RNA therapies in development globally, creating a sustained demand for specialized services.

Concurrently, the complexity of advanced therapy manufacturing processes drives a strategic shift toward end-to-end integrated outsourcing models. Innovators face significant technical hurdles in scaling viral vector production and autologous cell processing, prompting them to seek partners who can provide a single-source solution from early-phase development through commercialization. This "one-stop-shop" approach significantly reduces the logistical and regulatory risks associated with tech transfers between multiple vendors. To align with this trend, leading service providers are making massive capital outlays to construct integrated facilities. According to Fujifilm Diosynth Biotechnologies, April 2024, the company committed an additional USD 1.2 billion investment to expand its large-scale cell culture manufacturing facility, explicitly aiming to establish one of the largest end-to-end biopharmaceutical manufacturing sites in North America. This strategy reflects the critical market requirement for streamlined, comprehensive capabilities.

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Key Market Challenges

The scarcity of available manufacturing slot capacity combined with a shortage of highly skilled personnel functions as a substantial hindrance to the expansion of the Advanced Therapy Medicinal Products CDMO market. These constraints limit the operational throughput of service providers, preventing them from absorbing the full scope of demand from biopharmaceutical innovators. Because these therapies require precise handling by experienced staff, Contract Development and Manufacturing Organizations cannot rapidly scale operations to meet client needs, resulting in project backlogs and extended lead times for clinical and commercial production.

This operational bottleneck directly impacts market revenue growth by delaying project initiation and milestone completion. The disparity between the high demand for development services and the restricted supply of technical resources creates a ceiling on market performance. According to the Alliance for Regenerative Medicine, in 2024, there were more than 1,900 active clinical trials globally in the regenerative medicine sector. This robust pipeline volume intensifies the competition for limited manufacturing slots, ensuring that capacity limitations remain a primary factor slowing the overall trajectory of the outsourcing sector.

Key Market Trends

The Expansion of CDMO Operations into Asia-Pacific Hubs is reshaping the global supply chain as service providers establish large-scale manufacturing clusters in the region to leverage skilled labor and government incentives. This geographical diversification addresses the industry's need for redundant capacity and reduces reliance on Western-centric production, particularly for commercial-scale biologic and advanced therapy manufacturing. Companies are aggressively constructing mega-plants in locations like Singapore and South Korea to serve global clients with competitive timelines and cost structures. According to WuXi Biologics, July 2025, in a press release announcing the 'Construction of New Modular Drug Product Facility in Singapore', the company commenced the development of a 30,000-square-meter site at Tuas Biomedical Park, which is designed to enhance its global manufacturing network with advanced modular production lines.

Concurrently, the market is undergoing a Transition from Transactional to Strategic Long-Term Partnerships, driven by the biopharmaceutical industry's requirement for guaranteed slot availability and supply chain security. Unlike traditional project-by-project outsourcing, these extended collaborations involve multi-year capacity reservations and dedicated production lines, effectively treating the CDMO as an extension of the client's internal network. This model provides financial stability for manufacturers while ensuring innovators have immediate access to resources during critical clinical and commercial phases. According to Oxford Biomedica, September 2025, in the 'Interim Results for the Six Months Ended 30 June 2025', the company reported a contracted value of client orders totaling £149 million signed during the first half of the year, representing a 166 percent increase compared to the same period in 2024.

Segmental Insights

The oncology segment represents the fastest growing category within the Global Advanced Therapy Medicinal Products CDMO market. This expansion is driven by the substantial volume of ongoing clinical trials targeting various cancer indications, particularly involving CAR-T cell therapies. As pharmaceutical developers prioritize these treatments, the need for specialized manufacturing capabilities has increased significantly to meet market demand. Consequently, companies frequently partner with CDMOs to navigate complex production requirements and ensure compliance with stringent safety protocols established by regulatory entities such as the US FDA and EMA.

Regional Insights

North America maintains a leading position in the global Advanced Therapy Medicinal Products CDMO market, driven by a dense network of biotechnology and pharmaceutical companies. The region possesses an established infrastructure for clinical research and significant funding for cell and gene therapy programs. Additionally, clear regulatory pathways provided by the U.S. Food and Drug Administration facilitate faster product development, thereby increasing the reliance on contract manufacturing partners. This strong demand for scalable production and technical expertise supports the continued expansion of the contract development and manufacturing sector within the region.

Recent Developments

• In November 2024, Fujifilm Diosynth Biotechnologies completed the expansion of its cell therapy manufacturing facility in Thousand Oaks, California. This project added two new independent production suites and upgraded development laboratories to significantly increase cleanroom capacity for both clinical and commercial programs. The site was designed to support autologous and allogeneic cell therapy manufacturing with flexibility for new modalities. This milestone aligned with the company’s broader strategy to enhance its manufacturing network for advanced therapies, ensuring it could meet growing client demand and evolving regulatory standards in the "Global Advanced Therapy Medicinal Products CDMO Market".
• In September 2024, Lonza entered into a long-term commercial supply agreement with Vertex Pharmaceuticals to manufacture Casgevy, a CRISPR/Cas9 gene-edited therapy indicated for the treatment of sickle cell disease and beta-thalassemia. Under this collaboration, the company committed to producing the therapy at its cell therapy manufacturing centers in Geleen, Netherlands. This partnership highlighted the company's capabilities in supporting the commercialization of complex cell and gene therapies. The agreement further solidified the company’s position as a key partner in the "Global Advanced Therapy Medicinal Products CDMO Market" by facilitating patient access to transformative treatments through its established global manufacturing network.
• In June 2024, Charles River Laboratories International, Inc. signed a contract development and manufacturing organization agreement with the Gates Institute at the University of Colorado Anschutz Medical Campus. Through this collaboration, the company agreed to provide its expertise in cell and gene therapy manufacturing to develop lentiviral vectors for use in chimeric antigen receptor T-cell therapies targeting hematological cancers. The partnership granted the institute access to the company's specialized platforms and viral vector center of excellence. This strategic alliance underscored the company's commitment to accelerating the development of advanced treatments within the "Global Advanced Therapy Medicinal Products CDMO Market".
• In May 2024, Catalent entered into a strategic partnership with Siren Biotechnology to support the development and manufacturing of AAV immuno-gene therapies for cancer. Under the agreement, the company agreed to provide process development and cGMP manufacturing services for the client’s adeno-associated viral vector-based therapeutic candidates. The collaboration leveraged the company’s specialized capabilities in viral vector development to advance the client's pipeline toward clinical trials. This partnership reinforced the company's role in the "Global Advanced Therapy Medicinal Products CDMO Market" by delivering integrated solutions for the production of next-generation gene therapies.

Key Market Players

• Celonic AG
• Rentschler Biopharma SE
• Catalent, Inc.
• Lonza Group AG
• WuXi Advanced Therapies
• Minaris Regenerative Medicine, LLC
• Pluri Biotech Ltd.
• REPROCELL USA Inc.
• BioPhorum Operations Group
• Cellares Corporation

By Product	By Phase	By Indication	By Region
Gene Therapy Cell Therapy Tissue Engineered Others	Phase I Phase II Phase III Phase IV	Oncology Cardiology Central Nervous System Musculoskeletal Infectious disease Immunology & inflammation Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Advanced Therapy Medicinal Products CDMO Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Advanced Therapy Medicinal Products CDMO Market, By Product:

• Gene Therapy
• Cell Therapy
• Tissue Engineered
• Others

• Advanced Therapy Medicinal Products CDMO Market, By Phase:

• Phase I
• Phase II
• Phase III
• Phase IV

• Advanced Therapy Medicinal Products CDMO Market, By Indication:

• Oncology
• Cardiology
• Central Nervous System
• Musculoskeletal
• Infectious disease
• Immunology & inflammation
• Others

• Advanced Therapy Medicinal Products CDMO Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE