Advanced Therapy Medicinal Products (ATMP) CDMO Market Report Scope & Overview

The Advanced Therapy Medicinal Products (ATMP) CDMO Market was valued at USD 7.75 Billion in 2025 and is expected to reach USD 54.89 Billion by 2035, growing at a CAGR of 21.65% from 2026 to 2035.

The Advanced Therapy Medicinal Products (ATMP) CDMO market is growing owing to the rise in cell and gene therapy pipeline, increasing clinical trial, and increasing demand for customized manufacturing services. Outsourcing of processes such as development process, production of viral vectors, analysis, and commercial production to CDMO is seen to be done by biopharmaceutical firms in order to decrease expenses and bring forward time to market. Increasing regulatory approvals, increased investment in regenerative medicine, and increased prevalence of rare genetic disorder and cancer also increase demand for the product.

Lonza to increase advanced cell and gene therapy manufacturing capacity to meet growing commercial demand March 2026. In July 2025, Catalent increased its capacity to manufacture viral vectors for next-generation gene therapy development and activities around the world.

Market Size and Forecast

• Market Size in 2026E: USD 9.40 Billion

• Market Size by 2035: USD 54.89 Billion

• CAGR: 21.65% from 2026 to 2035

• Fastest Growing Region: Asia Pacific

• Largest Region: North America

Market Trends

• Growing outsourcing of cell and gene therapy manufacturing activities.

• Rising demand for viral vector and plasmid DNA production services.

• Increasing investments in commercial-scale ATMP manufacturing facilities.

• Expanding clinical pipeline for cell and gene therapies worldwide.

• Growing adoption of integrated end-to-end CDMO service models.

 U.S. Advanced Therapy Medicinal Products (ATMP) CDMO Market Outlook

The U.S. Advanced Therapy Medicinal Products (ATMP) CDMO Market was valued at USD 2.10 Billion in 2025 and is expected to reach USD 13.18 Billion by 2035, growing at a CAGR of 20.18% from 2026 to 2035.

The Advanced Therapy Medicinal Products (ATMP) CDMO market is growing fueled by an increasing development of cell and gene therapies, increasing FDA approvals for advanced therapeutic products, and increasing investments in biopharmaceutical innovation. Biotech companies are increasingly leveraging CDMO partners’ expertise and resources in specialized manufacturing, regulatory support, and commercial-scale manufacturing. “Continued expansion of clinical development programmers and increased demand for flexible manufacturing solutions continue to drive long-term market expansion across the United States.

Thermo Fisher Scientific expanded its cell therapy manufacturing capabilities in January 2026 to support the production of commercial ATMPs. In September 2025 Charles River Laboratories enhanced advanced therapy development services to support global cell and gene therapy programmers.

Advanced Therapy Medicinal Products (ATMP) CDMO Market Segment Analysis

• By Therapy Type, Cell Therapy dominated the ATMP CDMO Market with 44.20% share in 2025, while Gene Therapy is the fastest growing therapy segment from 2026 to 2035.

• By Service Type, Manufacturing Services dominated the ATMP CDMO Market with 48.60% share in 2025, while Analytical & Quality Control Services are the fastest growing service segment from 2026 to 2035.

• By Indication, Oncology dominated the ATMP CDMO Market with 41.30% share in 2025, while Rare Genetic Disorders are the fastest growing indication segment from 2026 to 2035.

• By End User, Biopharmaceutical Companies dominated the ATMP CDMO Market with 57.50% share in 2025, while Emerging Biotechnology Companies are the fastest growing end-user segment from 2026 to 2035.

By Therapy Type, Cell Therapy dominates, Gene Therapy grows fastest

Cell Therapy dominated the Advanced Therapy Medicinal Products (ATMP) CDMO Market in 2025 and held approximately 44.20% revenue share. The growing commercialization of CAR-T therapies, stem cell therapies and regenerative medicine products continues to fuel demand for specialized manufacturing capabilities. Biopharmaceutical companies are increasingly partnering with CDMOs to access advanced production technologies, regulatory expertise and scalable manufacturing infrastructure to support the development of complex cell therapies worldwide.

Gene Therapy is estimated to grow at the fastest CAGR during the forecast period due to increasing clinical pipeline activities and approvals of gene-based therapeutics across the globe. Continued investment in viral vector production, plasmid manufacturing and next-generation gene editing technologies is also driving opportunities across the global gene therapy manufacturing ecosystems.

By Service Type, Manufacturing Services dominate, Analytical & Quality Control Services grow fastest

Manufacturing Services dominated the Advanced Therapy Medicinal Products (ATMP) CDMO Market in 2025 and accounted for approximately 48.60% revenue share. To lower costs and speed product, biopharmaceutical companies increasingly outsourced commercial production and process development activities to specialized CDMOs. Further strengthening market leadership across manufacturing service providers globally was the growing demand for scalable manufacturing capacity and regulatory-compliant production environments.

Analytical & Quality Control Services are projected to have the fastest CAGR due to rising regulatory scrutiny and the increasing complexity of advanced therapy products. Developers need full characterization, potency testing and quality assurance services to support product approvals. Growing demand for specialized analytical expertise continues to fuel growth opportunities across quality control service ecosystems.

By Indication, Oncology dominates, Rare Genetic Disorders grow fastest

Oncology dominated the Advanced Therapy Medicinal Products (ATMP) CDMO Market in 2025 and held approximately 41.30% revenue share.  Manufacturing demand around the world continues to be driven by the increasing development of CAR-T therapies and other cell-based cancer therapies. Rising investments in immuno-oncology and personalized cancer therapies also created opportunities across the advanced therapy manufacturing ecosystems that support product development activities in oncology.

The Rare Genetic Disorders are projected to witness the fastest CAGR during the forecast period owing to increasing development of gene therapies targeting previously untreatable conditions. Increased regulatory support, orphan drug incentives and advances in gene-editing technologies are further accelerating the opportunities for advanced therapy developers targeting rare disease markets across the world.

By End User, Biopharmaceutical Companies dominate, Emerging Biotechnology Companies grow fastest

Biopharmaceutical Companies dominated the Advanced Therapy Medicinal Products (ATMP) CDMO Market in 2025 and accounted for approximately 57.50% revenue share. Increasingly, large pharmaceutical and biotechnology organizations outsourced manufacturing and development activities to specialized CDMOs to improve flexibility and accelerate the commercialization of products. Rising investments in advanced therapeutic platforms continue to drive strong demand for outsourced manufacturing services globally.

Emerging Biotechnology Companies are anticipated to be the fastest growing end-user segment as innovation in the development of cell and gene therapies is growing. CDMO partnerships provide many emerging firms with the manufacturing infrastructure, technical expertise and regulatory support they need without having to make significant capital investments. This segment continues to experience growth in demand, driven by continued venture funding.

Regional Analysis

North America Advanced Therapy Medicinal Products (ATMP) CDMO Market Insights

North America led the global ATMP CDMO Market in 2025, accounting for approximately 31.84% of global revenues. The region has a well-developed biotech ecosystem, significant clinical trial activity. CDMOs continue to expand their manufacturing capacity, viral vector manufacturing, and integrated development services to meet the growing need for advanced therapies. Strong collaboration between biotechnology firms, research institutions and manufacturing partners further supports the regional market.

The North America market growth is further supported by the rising investments in automation, process optimization, and advanced analytical technologies. The region’s strength is buoyed by increasing outsourcing of development and manufacturing activities from therapy developers seeking specialized expertise and scalable production capabilities. As the regional biotechnology ecosystem continues to innovate in regenerative medicine, personalized healthcare, and the adoption of next-generation cell and gene therapies, long-term demand for ATMP CDMO services is anticipated.

Europe Advanced Therapy Medicinal Products (ATMP) CDMO Market Insights

The European market for ATMP CDMO services remains significant, driven by increasing advanced therapy development efforts, favorable regulatory environments, and growing biotechnology research capabilities. Contract manufacturers are expanding process development, analytical testing and commercial production capabilities to meet growing demand from therapy developers. Growing collaboration between biotechnology companies, academic research organizations and manufacturing providers continues to drive clinical development and activities across the region.

The region is seeing growing investment in specialized manufacturing infrastructure to support cell therapy, gene therapy and regenerative medicine products. The increasing demand for outsourced manufacturing services and the rise in the adoption of innovative therapeutic technologies continue to create opportunities for CDMO providers. Growing clinical pipelines and increased focus on advanced biopharmaceutical innovation are expected to further strengthen Europe’s position in the global ATMP manufacturing and development ecosystem.

Asia Pacific Advanced Therapy Medicinal Products (ATMP) CDMO Market Insights

Asia Pacific is expected to register the fastest growth throughout the forecast period owing to rapidly expanding biotechnology investments, increasing healthcare modernization initiatives, and growing participation in global advanced therapy development programs. Governments and private organizations continue investing in research infrastructure, manufacturing facilities, and biotechnology innovation initiatives. CDMOs are increasingly expanding capabilities in cell therapy production, viral vector manufacturing, and process development services to address rising industry demand.

Growing outsourcing activities by global biotechnology companies continue supporting regional market expansion. The region is emerging as an important destination for advanced therapy manufacturing due to expanding technical expertise, improving infrastructure, and increasing participation in international clinical development programs. Rising investment in regenerative medicine and next-generation therapeutic technologies is expected to accelerate opportunities and strengthen the overall ATMP CDMO ecosystem across Asia Pacific.

Middle East & Africa & Latin America Advanced Therapy Medicinal Products (ATMP) CDMO Market Insights

The Middle East and Latin America are slowly developing as promising markets for ATMP CDMO services, with increasing healthcare investments, growing awareness of biotechnology and expanding research capabilities. Regional healthcare organizations are increasing their collaborations with international biotech companies and manufacturing providers to improve access to advanced therapeutic technologies. Both regions also continue to promote investment in biotechnology infrastructure and advanced therapy development capabilities as part of healthcare modernization initiatives.

Regions are seeing increased interest in cell and gene therapies as healthcare systems are focusing on innovation and long-term treatment solutions. The increasing collaboration with global industry participants, improving healthcare infrastructure, and expanding clinical research activities continue to create opportunities for contract development and manufacturing providers. Further development of the biotechnology ecosystem is expected to support gradual expansion of ATMP CDMO services throughout the Middle East and Latin America.

Market Dynamics

Growth Driver: Expanding Cell and Gene Therapy Pipeline

The growing development activities in cell and gene therapy are generating significant demand for specialized CDMO services. Biopharmaceutical companies need more advanced manufacturing expertise, scalable production capabilities, and regulatory support to accelerate therapy. Growing clinical trial activity, and increased approvals, continue to strengthen global outsourcing demand.

Increasing investment in regenerative medicine and personalized therapeutics further boosts the growth of the market. CDMOs provide the infrastructure and technical expertise that allow developers to lower costs and accelerate development timelines while meeting complex manufacturing requirements.

Restraint: High Manufacturing Complexity and Costs

ATMP manufacturing involves complex production processes, stringent quality requirements, and specialized facilities, creating substantial operational challenges. Developers and manufacturing partners face high capital requirements and technical barriers associated with advanced therapy production and commercialization activities.

Regulatory compliance requirements and process variability further increase manufacturing complexity. These factors can delay commercialization timelines and increase operational costs, limiting broader adoption of advanced therapy manufacturing programs.

Opportunity: Commercial-Scale Manufacturing Expansion

The growth of approved advanced therapies is opening up significant opportunities for CDMO expansion globally. Developers increasingly need large-scale production capabilities to support global product launches and growing patient demand.

Investments in next generation manufacturing technologies, automation platforms and integrated service offerings continue to generate new revenue opportunities. The growing need for end-to-end development and manufacturing solutions is expected to help long-term market growth.

Recent Developments

• 2026: Lonza expanded advanced cell and gene therapy manufacturing capabilities supporting commercial-scale ATMP production globally.

• 2026: Thermo Fisher Scientific strengthened viral vector manufacturing infrastructure to support increasing gene therapy development and activities.

• 2025: Catalent expanded cell therapy manufacturing services and commercial production capacity supporting advanced therapeutic product developers worldwide.

• 2025: Charles River Laboratories enhanced integrated ATMP development and manufacturing solutions supporting global cell and gene therapy programs.

Key Players

• Lonza Group AG

• Catalent, Inc.

• Thermo Fisher Scientific Inc.

• Charles River Laboratories International, Inc.

• WuXi Advanced Therapies

• Fujifilm Diosynth Biotechnologies

• Samsung Biologics Co., Ltd.

• AGC Biologics

• Cytiva

• Recipharm AB

• Oxford Biomedica plc

• Viralgen Vector Core

• Cell and Gene Therapy Catapult

• RoslinCT

• Miltenyi Biotec

• Minaris Regenerative Medicine

• Rentschler Biopharma SE

• Yposkesi

• Takara Bio Inc.

• Genezen Laboratories

Advanced Therapy Medicinal Products (ATMP) CDMO Market Report Scope: