The global advanced therapy medicinal products CDMO market size was estimated at USD 7.45 billion in 2024 and is projected to hit around USD 42.25 billion by 2034, growing at a CAGR of 18.95% during the forecast period from 2025 to 2034.

The advanced therapy medicinal products CDMO Market is a dynamic sector within the broader biopharmaceutical landscape. ATMPs, which include gene therapies, tissue-engineered products, and somatic cell therapies are gaining traction due to their potential to treat complex and previously untreatable diseases.
Recent trends in the ATMP CDMO market include the adoption of innovative technologies such as artificial intelligence and machine learning in order to improve efficiency and precision in manufacturing processes. The market is also witnessing a shift towards integrated CDMO services, where providers are able to offer a comprehensive range of services from early-stage development to commercial manufacturing. Moreover, there is also a growing focus on patient-centricity, with CDMOs prioritizing the delivery of high-quality, personalized therapies.
The integration of AI and ML within the ATMP CDMO Market has led to revolutionary changes, marking a significant advancement in maintaining product quality and consistency. AI algorithms have proven to be vital in real-time tracking and oversight, enabling the early detection of deviations and ensuring that each batch meets the stringent quality standards required. These types of systems integrate sensor data streams and employ multivariate models in order to analyze relationships between various parameters and product attributes. This real time analysis surpasses is better than periodic manual sampling as it allows for a more dynamic and responsive process control.
Advanced technologies like process analytical technology (PAT), continuous manufacturing, and AI present multiple opportunities to enhance hospital capabilities within ever-present constraints. Such technology and tools employ in-line monitoring and automated feedback control, thus optimizing manufacturing. By tracking parameters like pH, nutrients, metabolites and cell growth in real- time, bioreactors can be automatically controlled, reducing manual operations while ensuring consistency between batches.
This gives rise to continuous manufacturing in an uninterrupted flow, rather than individual batches, which simultaneously increases productivity. Altogether, we can see how the adoption of these technologies allows hospitals to boost productivity and quality within limited space, time, cost as well as staffing.
| Report Attribute | Details |
| Market Size in 2025 | USD 8.86 Billion |
| Market Size by 2034 | USD 42.25 Billion |
| Growth Rate From 2025 to 2034 | CAGR of 18.95% |
| Base Year | 2024 |
| Forecast Period | 2025 to 2034 |
| 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 |
Rising Focus on Cell and Gene Therapies and Regulatory Support
The Global Advanced Therapy Medicinal Products CDMO Market is significantly influenced by the growing focus on cell and gene therapies. These innovative treatment modalities serve as key market drivers and offer potential cures for previously untreatable conditions, driving demand for specialized manufacturing capabilities. CDMOs are increasingly adapting and modifying their facilities and processes in order to accommodate the unique requirements of these therapies, which often involve complex production techniques.
Regulatory bodies worldwide are also driving the market forward by increasing the support of advanced therapies. Initiatives aimed at expediting the approval process for innovative treatments encourage investments in research and development and foster partnerships with various companies and institutions. This robust regulatory environment fosters collaboration and makes navigating complex compliance landscapes easy.
High Costs
One of the biggest challenges faced by the ATMP CDMO market is the 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 needs unique workflow protocols for cell sourcing, expansion, gene editing and cryopreservation, which adds to logistical and operational complexity. Facilities are mandated to meet high biosafety standards, and equipment must support single-use processing to minimize contamination risk. This complex landscape makes it difficult for small scale and medium scale companies to keep up, thus slowing down market entry and growth.
Rise in Personalized Medicine and Technological Advancements
The Global Advanced Therapy Medicinal Products CDMO Market is experiencing a surge in demand for personalized medicine, driven by advancements in genomics and biotechnology. This has opened up new areas for opportunity. As healthcare shifts towards tailored or personalized therapies, CDMOs are increasingly pushed for developing and manufacturing apt treatments. The ability to produce individualized therapies not only enhances patient outcomes but also aligns with regulatory frameworks that favor innovative treatment modalities, thus pushing the ATMP CDMO market forward.
Technological innovations in manufacturing processes are another such opportunity propelling the market. Aspects like automation, artificial intelligence and advanced bioprocessing techniques are streamlining production, enhancing efficiency and reducing costs. These advancements enable CDMOs to scale up production while also maintaining compliance with stringent regulatory standards. The integration of cutting-edge technologies not only improves operational capabilities but also fosters collaboration between CDMOs and biopharmaceutical companies, leading to rapid development of the market.
Which product dominated the market in 2024?
Gene Therapy CDMO services dominated the product segment in 2024. These therapies require stringent production protocols for vector purification, plasmid preparation and contamination control. High-profile highlight the therapeutic potential and commercial viability of gene therapy, increasing the number of companies outsourcing their vector manufacturing.
Cell Therapy is the fastest-growing segment as of this year, driven by the success of CAR-T therapies. These 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 seen scaling up capabilities in T-cell processing, ex vivo expansion, gene editing and cell banking. The shift toward allogeneic therapies is also driving demand for this segment.
Advanced Therapy Medicinal Products CDMO Market By Product, 2024-2034 (USD Billion)
| Year | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | 2034 |
| Gene Therapy | 3.35 | 3.97 | 4.67 | 5.53 | 6.52 | 7.71 | 9.11 | 10.76 | 12.73 | 15.02 | 17.75 |
| Cell Therapy | 2.98 | 3.55 | 4.24 | 5.05 | 6.03 | 7.19 | 8.57 | 10.22 | 12.18 | 14.53 | 17.32 |
| Tissue Engineered | 0.75 | 0.9 | 1.1 | 1.33 | 1.61 | 1.95 | 2.36 | 2.86 | 3.46 | 4.19 | 5.07 |
| Others | 0.37 | 0.44 | 0.53 | 0.63 | 0.75 | 0.89 | 1.06 | 1.26 | 1.49 | 1.78 | 2.11 |
Which phase segment led the market in 2024?
Phase II services led the market as of this year in 2024. This is due to the transition from proof-of-concept to efficacy studies, which 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 advantage of this segment lies in its flexibility and modular production approach, helping it maintain its market position.
Phase III is seen to be the fastest-growing phase segment, this is because 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. Phase III CDMO services always ensure validated processes, quality assurance and risk mitigation strategies for product approval.
Advanced Therapy Medicinal Products CDMO Market By Phase, 2024-2034 (USD Billion)
| Year | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | 2034 |
| Phase I | 1.64 | 1.89 | 2.17 | 2.5 | 2.86 | 3.28 | 3.76 | 4.29 | 4.9 | 5.58 | 6.34 |
| Phase II | 2.82 | 3.32 | 3.9 | 4.57 | 5.37 | 6.29 | 7.38 | 8.66 | 10.15 | 11.9 | 13.94 |
| Phase III | 2.24 | 2.7 | 3.27 | 3.95 | 4.77 | 5.77 | 6.96 | 8.41 | 10.15 | 12.25 | 14.79 |
| Phase IV | 0.75 | 0.95 | 1.2 | 1.52 | 1.91 | 2.4 | 3 | 3.74 | 4.66 | 5.79 | 7.18 |
Which Indication segment dominated the market this year?
Oncology segment held the largest market share in 2024. These therapies offer unique benefits in relapsed cancers and have demonstrated unprecedented remission rates in clinical trials. Given the urgent need for innovation in complex 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 segment.
Neurological and genetic disorders are expected to be the fastest-growing throughout the forecast period. Gene therapies for rare genetic diseases such as spinal muscular atrophy (SMA), Leber congenital amaurosis (LCA) and Duchenne muscular dystrophy (DMD) are gaining traction in today’s market. These conditions require highly targeted delivery vectors, long-term efficacy, and ultra-precise safety profiles, and CDMOs capable of custom vector design, capsid optimization and scalable purification, thus driving demand.
Advanced Therapy Medicinal Products CDMO Market By Indication, 2024-2034 (USD Billion)
| Year | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | 2034 |
| Oncology | 2.61 | 3.08 | 3.63 | 4.28 | 5.05 | 5.95 | 7 | 8.25 | 9.74 | 11.45 | 13.53 |
| Cardiology | 0.52 | 0.62 | 0.74 | 0.88 | 1.04 | 1.24 | 1.48 | 1.76 | 2.09 | 2.49 | 2.96 |
| Central nervous system | 0.67 | 0.8 | 0.95 | 1.13 | 1.34 | 1.6 | 1.9 | 2.26 | 2.69 | 3.2 | 3.8 |
| Musculoskeletal | 0.45 | 0.53 | 0.63 | 0.75 | 0.89 | 1.06 | 1.27 | 1.51 | 1.79 | 2.13 | 2.53 |
| Infectious disease | 0.6 | 0.7 | 0.82 | 0.97 | 1.13 | 1.33 | 1.56 | 1.83 | 2.15 | 2.52 | 2.96 |
| Dermatology | 0.3 | 0.35 | 0.42 | 0.5 | 0.6 | 0.71 | 0.84 | 1 | 1.19 | 1.42 | 1.69 |
| Endocrine, metabolic, genetic | 0.52 | 0.64 | 0.78 | 0.95 | 1.16 | 1.42 | 1.73 | 2.11 | 2.57 | 3.13 | 3.8 |
| Immunology & inflammation | 0.52 | 0.64 | 0.78 | 0.95 | 1.16 | 1.42 | 1.73 | 2.11 | 2.57 | 3.13 | 3.8 |
| Ophthalmology | 0.45 | 0.54 | 0.65 | 0.79 | 0.95 | 1.15 | 1.39 | 1.68 | 2.03 | 2.45 | 2.96 |
| Hematology | 0.37 | 0.44 | 0.53 | 0.63 | 0.75 | 0.89 | 1.06 | 1.26 | 1.49 | 1.78 | 2.11 |
| Gastroenterology | 0.22 | 0.27 | 0.34 | 0.41 | 0.51 | 0.62 | 0.76 | 0.93 | 1.13 | 1.39 | 1.69 |
| Others | 0.22 | 0.25 | 0.27 | 0.3 | 0.33 | 0.35 | 0.38 | 0.4 | 0.42 | 0.43 | 0.42 |
Why did North America Dominate the Market in 2024?
North America dominated the Advanced therapy medicinal products CDMO market in 2024. This dominance can be attributed to increasing outsourcing activities and rising awareness about advanced therapy. The region has consistently been a leader in research and development for advanced treatments, and will most likely keep this position in the upcoming years. Recent approvals of products such as Kymriah and Yescarta have also propelled investments in the regional market.
United States Advanced Therapy Medicinal Products CDMO Market Analysis:
The United States is emerging as the epicenter of growth in the Advanced Therapy Medicinal Products (ATMP) CDMO market, driven by a powerful convergence of scientific innovation, robust investment, and supportive regulatory frameworks. The country hosts a dense concentration of biotechnology firms, research institutions, and CDMOs specializing in cell and gene therapy development, positioning it at the forefront of the global ATMP ecosystem.
Favorable FDA initiatives, such as accelerated approval pathways for breakthrough and orphan therapies, have encouraged rapid clinical translation and commercialization. Additionally, the expanding pipeline of CAR-T, gene editing, and regenerative medicine programs has created a surge in demand for advanced manufacturing infrastructure and specialized CDMO partnerships.
What are the Advancements in Asia-Pacific?
Asia Pacific is expected to grow at the fastest rate over the forecast period. This growth is due to the increasing demand for novel ATMPs and rising research and development activities which helps to develop novel therapies. Moreover, the region’s market growth is driven by continuously expanding CDMO Cell Therapy. This is because a number of domestic players are increasingly collaborating with biotech companies from other countries involved in mesenchymal stem cell research and therapy development.
Advanced Therapy Medicinal Products CDMO Market By Region, 2024-2034 (USD Billion)
| Year | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | 2034 |
| North America | 2.84 | 3.33 | 3.91 | 4.61 | 5.42 | 6.39 | 7.51 | 8.83 | 10.39 | 12.21 | 14.37 |
| Europe | 2.38 | 2.81 | 3.31 | 3.9 | 4.59 | 5.41 | 6.37 | 7.51 | 8.84 | 10.41 | 12.25 |
| Asia-Pacific | 1.64 | 2.02 | 2.49 | 3.06 | 3.76 | 4.61 | 5.66 | 6.93 | 8.48 | 10.37 | 12.67 |
| Latin America | 0.37 | 0.43 | 0.51 | 0.59 | 0.69 | 0.8 | 0.93 | 1.08 | 1.25 | 1.46 | 1.69 |
| Middle East & Africa (MEA) | 0.22 | 0.27 | 0.32 | 0.38 | 0.45 | 0.53 | 0.63 | 0.75 | 0.9 | 1.07 | 1.27 |
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 2034. For this study, Nova one advisor, Inc. has segmented the Advanced Therapy Medicinal Products CDMO market.
By Product
By Phase
By Indication
By Region
List of Tables
List of Figures