Advanced Therapy Medicinal Products CDMO Market Size Report, 2024-2033
The global advanced therapy medicinal products CDMO market size was estimated at USD 6.10 billion in 2023 and is projected to hit around USD 34.53 billion by 2033, growing at a CAGR of 18.93% during the forecast period from 2024 to 2033.
The Advanced Therapy Medicinal Products (ATMP) Contract Development and Manufacturing Organization (CDMO) Market represents a dynamic and rapidly growing sector in the life sciences industry. ATMPs are next-generation therapeutic products based on genes, tissues, or cells, including gene therapies, somatic cell therapies, and tissue-engineered products. These novel therapeutics offer the potential to cure genetic disorders, regenerate damaged tissues, and transform cancer care, marking a revolutionary shift in personalized medicine.
The rise of ATMPs has outpaced the internal capacity of many biopharmaceutical developers. Given the complex manufacturing processes, regulatory challenges, and specialized infrastructure required, outsourcing to CDMOs has become a strategic necessity. CDMOs dedicated to ATMPs offer integrated services, from early-stage development and process optimization to GMP manufacturing and regulatory support, enabling biotech companies to focus on innovation and clinical development.
The market has gained considerable momentum with a growing number of FDA and EMA approvals, such as Novartis’s Zolgensma (gene therapy for SMA), Gilead’s Yescarta (CAR-T cell therapy for lymphoma), and Holoclar, the first tissue-engineered product approved in the EU. With hundreds of ATMPs in the clinical pipeline and a limited number of facilities globally equipped to handle their production, CDMOs have emerged as critical partners in scaling and commercializing these therapies.
ATMPs are inherently more complex than traditional biologics or small molecules. They often require specialized environments, cold chain logistics, viral vector manufacturing, and personalized (often autologous) batch production. This has led to significant investments in specialized CDMO infrastructure, including modular cleanrooms, closed-system bioreactors, and single-use technologies. The market is evolving rapidly, driven by technological innovation, regulatory flexibility, and a strong pipeline of therapies targeting unmet medical needs.
Growth in Viral Vector Manufacturing Capacity: Gene therapies often rely on viral vectors such as AAV or lentivirus, creating a surge in demand for viral vector CDMOs.
Shift Toward Modular and Closed-System Manufacturing: Modular cleanrooms and closed automated systems are becoming standard to support flexibility and scalability in ATMP production.
Expansion of Allogeneic Therapies: While autologous products dominate today, allogeneic (off-the-shelf) therapies are gaining traction for scalability and cost-effectiveness.
Increased Investment in Digital Manufacturing and Analytics: CDMOs are incorporating AI, real-time analytics, and digital twins to optimize yield, batch quality, and speed.
Regional Diversification of CDMO Facilities: To meet regulatory requirements and reduce supply chain risks, CDMOs are establishing facilities across North America, Europe, and Asia-Pacific.
Strategic Partnerships and Acquisitions: Pharma and biotech companies are partnering with or acquiring CDMOs to ensure long-term capacity and regulatory alignment.
Regulatory Streamlining by FDA and EMA: Regulatory bodies are creating pathways like RMAT (FDA) and PRIME (EMA) to accelerate the development and approval of ATMPs, encouraging CDMO involvement early in the lifecycle.
| Report Attribute | Details |
| Market Size in 2024 | USD 7.25 Billion |
| Market Size by 2033 | USD 34.53 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 18.93% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Product, phase, indication, region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | Celonic; Bio Elpida; CGT Catapult; Rentschler Biopharma SE; AGC Biologics; Catalent; Lonza; WuXi Advanced Therapies; BlueReg; Minaris Regenerative Medicine; Patheon |
A primary driver of the ATMP CDMO market is the explosive growth in the global pipeline of advanced therapy products. As of 2025, over 2,000 ATMPs are in various clinical phases, with a notable surge in gene therapies and CAR-T cell therapies targeting rare diseases and cancer. This rapid expansion has created a capacity bottleneck, as the in-house manufacturing capabilities of most companies especially startups are insufficient to meet development timelines or regulatory compliance.
CDMOs offer an efficient and scalable alternative, particularly during transitions from preclinical to GMP-grade manufacturing. With regulatory agencies increasingly requiring consistency, quality, and traceability, experienced CDMOs bring valuable expertise in GMP validation, tech transfer, batch documentation, and comparability studies. As more ATMPs progress to late-stage trials and commercialization, demand for experienced CDMOs capable of large-scale vector production, aseptic fill-finish, and analytical testing will continue to surge.
The biggest challenge facing the ATMP CDMO market is the extraordinary complexity and cost of manufacturing ATMPs. Unlike traditional biologics, ATMPs often involve living cells or viral vectors, requiring highly controlled environments and specialized skillsets. Each therapy may need unique workflows custom protocols for cell sourcing, expansion, gene editing, and cryopreservation adding logistical and operational complexity.
Infrastructure requirements for ATMP manufacturing are significant. Facilities must meet high biosafety standards, and equipment must support single-use processing to minimize contamination risk. Moreover, autologous therapies (using a patient’s own cells) require individualized batch management, which limits scalability and throughput. The cost of producing a single patient dose for some CAR-T therapies can exceed $200,000, which is unsustainable without advances in automation and process innovation.
For CDMOs, this translates into high upfront capital investments and a steep learning curve, especially when adapting to novel client technologies. Not all CDMOs are equipped to manage such complexity, and even those that are often face capacity constraints.
An exciting opportunity lies in the increased demand for integrated, end-to-end CDMO services that span discovery support, process development, GMP manufacturing, and regulatory documentation. ATMP developers, particularly smaller biotech firms and academic spinouts, often lack internal infrastructure and regulatory expertise. These companies are increasingly seeking CDMOs that offer a single, streamlined solution from lab bench to commercial-scale production.
This trend benefits CDMOs that invest in vertically integrated service models, capable of guiding a therapy from early cell line development to clinical trial material production and even post-approval manufacturing. Furthermore, CDMOs that incorporate regulatory consulting, analytical development, cold chain logistics, and quality assurance gain a competitive edge.
CDMOs that specialize in tech transfer from R&D to GMP and offer scalability across platforms (e.g., transitioning autologous to allogeneic workflows) are particularly well-positioned to capture long-term contracts and build strategic partnerships with major biopharma players.
Gene Therapy CDMO services dominated the product segment. Gene therapy, particularly those using viral vectors (AAV, lentivirus), has seen a dramatic rise in demand for specialized CDMO support. These therapies require stringent production protocols for vector purification, plasmid preparation, and contamination control. High-profile products like Zolgensma and Luxturna highlight the therapeutic potential and commercial viability of gene therapy, increasing the number of companies outsourcing their vector manufacturing. CDMOs offering viral vector design, scale-up, and fill-finish are currently the most sought-after partners.
Cell Therapy is the fastest-growing segment, driven by the success of CAR-T therapies like Kymriah and Yescarta. These autologous therapies require individualized manufacturing workflows, cryopreservation, and close coordination with clinical sites. As new cell therapies enter clinical trials for oncology, autoimmune diseases, and regenerative applications, CDMOs are scaling up capabilities in T-cell processing, ex vivo expansion, gene editing (e.g., CRISPR), and cell banking. The shift toward allogeneic therapies is also driving demand for process optimization and bioreactor scalability, accelerating growth in this segment.
Phase II services dominate the CDMO demand landscape. The transition from proof-of-concept to efficacy studies often marks the point where developers engage CDMOs for scale-up, process refinement, and GMP-grade production. CDMOs offer invaluable support during this phase by establishing clinical supply chains, supporting IND submissions, and managing pilot-scale manufacturing. The high attrition rate in Phase II necessitates flexibility and modular production approaches, a hallmark of leading ATMP CDMOs.
Phase III is the fastest-growing phase segment, as more ATMPs advance into pivotal trials and prepare for commercialization. CDMOs are increasingly investing in large-scale viral vector production lines, modular cleanrooms for simultaneous batches, and high-throughput analytical platforms. As regulatory agencies scrutinize comparability and reproducibility, Phase III CDMO services must ensure validated processes, quality assurance, and risk mitigation strategies for product approval.
Oncology dominates the ATMP CDMO market by indication. A significant portion of ATMPs, especially CAR-T and oncolytic virus therapies, target hematologic and solid tumors. These therapies offer unique benefits in relapsed/refractory cancers and have demonstrated unprecedented remission rates in clinical trials. Given the urgent need for innovation in cancer treatment, oncology-focused ATMPs attract substantial investment, clinical activity, and outsourcing demand. CDMOs that specialize in immunotherapy-related platforms, such as TILs, NK cells, and engineered T cells, are leading service providers in this space.
Neurological and genetic disorders (endocrine/metabolic/genetic) represent the fastest-growing indications. Gene therapies for rare genetic diseases—such as spinal muscular atrophy (SMA), Leber congenital amaurosis (LCA), and Duchenne muscular dystrophy (DMD)—are gaining regulatory traction. These conditions require highly targeted delivery vectors, long-term efficacy, and ultra-precise safety profiles. CDMOs capable of custom vector design, capsid optimization, and scalable purification are in high demand for such indications, driving rapid growth in non-oncology therapeutic areas.
North America, particularly the United States, is home to the most advanced ecosystem for ATMP development and manufacturing. The U.S. FDA has established fast-track regulatory pathways, including RMAT and Breakthrough Designation, to support ATMP development. The region hosts a concentration of leading CDMOs (e.g., Catalent, Thermo Fisher, Brammer Bio), biotech startups, and academic institutions involved in cutting-edge ATMP innovation.
Furthermore, strategic partnerships between biotech firms and CDMOs in the U.S. are flourishing. Companies are investing in U.S.-based GMP manufacturing to reduce reliance on international supply chains and gain faster regulatory approval. The government’s focus on reshoring critical biomanufacturing capabilities further strengthens North America’s leadership.
Asia-Pacific is the fastest-growing region.
Asia-Pacific is rapidly emerging as a critical hub for ATMP development and CDMO expansion. Countries like China, Japan, South Korea, and Singapore are investing heavily in regenerative medicine and advanced therapy research. Regulatory reforms in China have significantly reduced review timelines, encouraging local and foreign developers to enter the market. Japan’s PMDA has also streamlined approvals under its fast-track for regenerative therapies.
In addition, APAC-based CDMOs are scaling up capabilities in cell processing, viral vector production, and GMP manufacturing. Regional governments are offering tax incentives, infrastructure grants, and clinical trial networks to support advanced therapy growth. The cost-effective manufacturing environment, combined with a rising number of biotech startups, makes Asia-Pacific a key future growth engine.
March 2025: Catalent announced a $500 million investment to expand its gene therapy manufacturing capacity in Maryland, including new plasmid and viral vector suites with fully automated capabilities.
February 2025: Lonza signed a multi-year agreement with a U.S.-based gene therapy startup to provide end-to-end development and commercial manufacturing services for a rare pediatric indication.
January 2025: WuXi Advanced Therapies launched a digital analytics platform to integrate real-time process monitoring and AI-based yield prediction for its viral vector clients.
December 2024: Thermo Fisher Scientific completed the expansion of its viral vector CDMO facility in Lexington, MA, doubling its capacity to meet growing demand from gene therapy developers.
November 2024: AGC Biologics opened a new GMP facility in Yokohama, Japan, dedicated to allogeneic cell therapy manufacturing and cryopreservation, strengthening its Asia-Pacific footprint.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Advanced Therapy Medicinal Products CDMO market.
By Product
By Phase
By Indication
By Region
Cross-segment Market Size and Analysis for Mentioned Segments
Additional Company Profiles
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Additional Countries (Apart
From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers