The global cell and gene therapy CDMO (Contract Development and Manufacturing Organization) market is seeing rapid growth. Valued at around USD 6.41 billion in 2024, it is expected to rise to USD 8.2 billion in 2025 and is projected to soar to approximately USD 75.32 billion by 2034. This reflects a strong compound annual growth rate (CAGR) of 27.94% over the forecast period from 2025 to 2034.
Factors contributing to the growth of the cell and gene therapy CDMO market are rising cases of chronic disease, such as cancer, genetic conditions, and autoimmune diseases, which are fueling demand for novel and customized cell and gene therapies. As well as advancements in gene editing technologies like CRISPR-Cas9, TALEN, and others, and increasing demand for outsourced manufacturing services are driving the expansion market.
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Cell and Gene Therapy CDMO Market Highlights
• North America dominated the cell and gene therapy CDMO market share by 41% in 2024.
• Asia Pacific is expected to grow at the fastest CAGR during 2025-2034.
• By indication, the oncology segment led the cell and gene therapy CDMO market in 2024.
• By indication, the rare diseases segment is expected to grow significantly in the coming years.
• By phase, the pre-clinical segment was dominant in the market in 2024.
• By phase, the clinical segment is expected to grow at a notable CAGR in the projected period.
• By product type, the cell therapy segment dominated in the cell and gene therapy CDMO market in 2024.
• By product type, the gene-modified cell therapy segment is expected to expand significantly during 2025-2034.
Market Overview
The cell and gene therapy CDMO market works on partnerships with companies developing cell and gene therapies. Normally, these CDMOs allow skilled professionals and infrastructure for different stages of development, from process development and improvement in production and analytical testing, to assist in bringing these innovative therapies to patients. Additionally, growing investments in biopharmaceutical R&D, the expansion of full-service CDMOs, and the accelerating demand for outsourced manufacturing services are propelling the market growth.
Emergence of Therapies in Diverse Conditions: Major Potential
Nowadays, highly growing cases of cancer, genetic, and autoimmune disorders are boosting demand for innovative and personalized cell & gene therapies based on individual patient genetic information. These approaches usually alter a patient’s cells or incorporate new genetic material to resolve defects, boost immune responses, or remove damaged cells. In the cell and gene therapy CDMO market, particularly, CAR T-cell therapy is a cancer cell marker widely used to target specific cancers. As well as oncolytic viruses are also used by being altered to selectively infect and kill cancer cells with an enhanced immune response.
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The Cell and Gene Therapy CDMO Market: Regional Analysis
North America led the market by capturing a 41% major revenue share of the market in 2024. The region is impacted by an increasing clinical pipeline for cell and gene therapies, fueling demand for well-established manufacturing services, for which companies rely on pharmaceutical CDMOs to manage the complex production processes. Along with this, public and private organizations in North America investing in R&D for these therapies are developing opportunities for CDMOs.
The US in North America is showing major expansion in the cell and gene therapy CDMO market, due to increased demand for outsourcing from numerous biotech and pharmaceutical companies in production services for cell and gene therapies. Also, they are highly adopting the broad application of novel and innovative technologies in these therapies are creating a need for CDMOs.
For this market,
• In February 2025, PHC corporation and CCRM partnered to develop T-cell expansion culture processes and advance cell & gene therapy manufacturing.
The rising planned partnerships between biopharmaceutical companies and CDMOs are widely adopted in Canada is enabling the development and production of cell and gene therapies. Furthermore, innovations in automation, high-throughput screening, and digital manufacturing platforms are accelerating CDMOs with fueled efficiency and scalability in the market.
For instance,
• In October 2024, OmniaBio Inc., a technology-focused, global cell and gene therapy CDMO, introduced a new North American cell and gene therapy (CGT) manufacturing and artificial intelligence (AI) centre of excellence.
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The Asia Pacific is Predicted to be the Fastest-Growing Region During 2025-2034
In the cell and gene therapy CDMO market, Asia Pacific is estimated to grow at the fastest CAGR in the upcoming years. ASAP is influenced by accelerated investments in pharmaceutical and biotech R&D activities, resulting in a higher requirement for specialized CDMO services for cell and gene therapy development and manufacturing. Besides this, enhanced demand for biologics in growing cancer, genetic conditions, and autoimmune disorders is fueling demand for CDMOs in these complex sectors.
For this market,
• In October 2024, Teijin Limited and Hilleman Laboratories, a biotechnology company based in Singapore, to expand their business in ASAP through a planned collaboration to accelerate CDMO services in cell and gene therapy.
In China, the government is actively supporting cell and gene therapy (CGT) trials and innovation, along with attracting investments in CGT areas are fostering the market growth. As well as enhanced M&A activity in the CGT space, is further driving the growth of the cell and gene therapy CDMO market.
India encompasses specialized scientists and researchers, and a robust regulatory framework supporting to CDMO hub for CGT manufacturing. Besides this, the expansion of cell therapy and gene therapies, with the development of off-the-shelf therapies, is propelling demand for sophisticated manufacturing services provided by CDMOs.
For instance,
• In June 2025, Vector BioMed, a purpose-driven contract vector development and manufacturing organization (CVDMO), partnered with Muni Seva Ashram's Kailash Cancer Hospital and Research Center (KCHRC) in Gujarat, India, to bring CAR T-Cell therapy to rural India.
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Cell and Gene Therapy CDMO Market: Segmentation Analysis
By indication analysis
The oncology segment held a major revenue share of the market in 2024. The segment is fueled by growing cases of diverse cancers with demand for targeted therapies, increasing demand for novel, tailored therapies, and enhanced investments in oncology R&D areas. Moreover, rising outsourcing is propelling pharmaceutical companies to depend on CDMOs for targeted therapies in cancer is boosting segment development.
Whereas, the rare diseases segment is predicted to expand at a rapid CAGR during the forecast period. For increased rare disease cases, several biopharmaceutical industries employ specialized knowledge in difficult bioprocessing, viral vector production, and regulatory compliance by CDMOs, which are necessary for the development of these therapies.
By phase analysis
The pre-clinical segment led the cell and gene therapy CDMO market in 2024. The segment is driven by increased ongoing research and development in cell and gene therapies, along with accelerated investment in the same areas, resulting in a higher demand for CDMO services in the pre-clinical stage.
However, the clinical segment is anticipated to expand at a significant CAGR in the predicted timeframes. The particular rise of cell and gene therapy trials in Phase 1 and Phase 2 is fueling the segment's growth. As well as increase in early-stage clinical trials, especially for rare diseases, necessitates specialized production and analytical capabilities, propelling demand for CDMOs with expertise in these areas.
By product type analysis
The cell therapy segment led the cell and gene therapy CDMO market in 2024. The accelerated need for customized medicine and regenerative medicine approaches is impacting demand for cell therapies personalized to individual needs. Besides this, novel creations in domains such as gene editing, delivery technologies, and AI are boosting the adoption of cell therapies.
By product type, the gene-modified cell therapy segment is estimated to grow notably during 2025-2034. Benefits of CAR T-cell therapy in hematological malignancies show a surge in investment and development, leading to increased adoption of CDMO services. Additionally, viral and non-viral methods are boosting the possibilities for gene-modified cell therapies.
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Top Companies and Their Contributions to the Cell and Gene Therapy CDMO Market
|
Company |
Key Contributions & Offerings |
|
Lonza |
Over 25 years of GMP, >250 process development projects, support for 15+ Phase III/commercial programs. Modalities: autologous/allogeneic cells (CAR‑T/TCR/NK/iPSC), viral vectors (AAV, LVV, adenovirus), exosomes. Proprietary platforms like Cocoon®, Nucleofector®, and TheraPEAK®, plus ADC bioconjugation (new large-scale suites in Visp). |
|
Catalent, Inc |
Global manufacturing across biologics, gene & cell therapies, drug delivery, fill/finish. Supports half of FDA approvals in the last decade, 70 bn doses/year, 50+ facilities. Acquired Paragon, MaSTherCell, and Rheincell to boost gene/CAR‑T capabilities. Works with Moderna, Sarepta, and Pfizer. |
|
Samsung Biologics |
4 plants (600k L), 5th coming online; offers discovery-through-commercial biologics, mRNA vaccines, ADCs, bispecifics. Proprietary platforms: S‑CHOice, S‑DUAL, DEVELOPICK. Partners include Pfizer, GSK, Lilly, AstraZeneca, and Moderna. |
|
Novartis AG |
As a CDMO, its Global Biotech Cooperations offers mammalian (up to 15k L), microbial, viral vector, RNA (mRNA, pDNA, LNP), fill/finish, and analytical services. Manufactures CAR‑T (e.g., Kymriah), CAR‑Macs (for Carisma), and Zolgensma via AveXis heritage. |
|
WuXi AppTec |
Built extensive biologics/CDMO capabilities since 2011: antibody discovery, biosafety testing, GMP biologics drug substance. Facilities across Shanghai, Wuxi, and Wuhan, large-scale single-use bioreactors (up to 60,000 L). |
|
AGC Biologics |
Offers cell & gene services across modalities, including exosome-based therapies. Recent tech‑transfer collaboration on exosome IPF treatment with Jikei University in Milan. |
|
OmniaBio |
Canada’s largest dedicated CGT CDMO (120k ft² Hamilton facility) with AI-enabled, closed/automated platforms. Offers process and analytical development, as well as GMP manufacturing, for CAR-T/NK/iPSC and viral vectors. First client Medipost’s allogeneic MSC product, plus iPSC-based DMD therapy support. |
|
Rentschler Biopharma SE |
Purified mRNA for BioNTech’s Comirnaty (1B+ doses), founded ATMP CDMO in the UK, offers end-to-end gene/cell manufacturing. |
Cell and Gene Therapy CDMO Market
Companies • Lonza • Catalent, Inc • Cytiva • Samsung Biologics • Thermo Fisher Scientific Inc. • Novartis AG • WuXi AppTec • AGC Biologic • OmniaBio • Rentschler Biopharma SE • Charles River Laboratories Top Companies Latest Updates Company Latest Updates Cytiva (January 2025) Partnered with Cellular Origins to integrate its manufacturing
with a robotics platform for CGTs AGC Biologics (January 2025) Allied with Genenta to introduce an exclusive GMP suite at the AGC
Biologics Cell and Gene Center of Excellence in Milan. Samsung Biologics (October 2024) Signed $1.24B manufacturing deal with Asia-based pharma company Cytiva (June 2024) Unveiled next-gen cell therapy manufacturing platform AGC Biologics (September 2024) Signed an agreement for the cell therapy CDMO business with
Medinet WuXi (February 2024) Received FDA approval to manufacture Iovance's AMTAGVI™
(lifileucel) for advanced melanoma OmniaBio (September 2024) Made a collaboration with Somite Therapeutics to expand Somite's
cell therapy flagship program
What is Happening Across the World? • In June 2025, 64x Bio, a biotechnology
company, launched AAV Apex Suite to address gene therapy manufacturing
bottlenecks. • In May 2025, Matica Biotechnology, a specialized
contract development and manufacturing organization (CDMO) for cell and gene
therapies (CGT), collaborated with the National Center for Therapeutics
Manufacturing (NCTM) to deliver end-to-end support for cell and gene therapy
innovators. • In March 2025, Porton Advanced, a
leading contract development and manufacturing organization (CDMO), allied with
Eureka Therapeutics, Inc., a clinical-stage biotechnology company for
developing novel T‑cell therapies for both solid tumors and hematologic malignancies. Browse More Insights of Towards
Healthcare: The CDMO
services market for pharma and biotech is expanding as more companies
outsource their operations and focus on new cancer treatments. North America is
leading the market thanks to its strong industrial infrastructure. The CDMO
aseptic filling solutions market is also growing. This is due to strict
government regulations aimed at improving patient safety. North America
dominates this space because of the rising demand for biologics and advanced
biopharmaceutical research. The active
pharmaceutical ingredients (API) CDMO market was valued at USD 127.45
billion in 2024, increased to USD 136.92 billion in 2025, and is expected to reach
USD 260.98 billion by 2034, growing at a CAGR of 7.43%. The global oligonucleotide
CDMO market is on the rise as well starting at USD 2.55 billion in
2024, increasing to USD 3.11 billion in 2025, and projected to hit USD 18.37
billion by 2034. It’s growing rapidly at a CAGR of 21.83%. The small
molecule CDMO market is growing steadily, from USD 72.81 billion in
2024 to USD 78.01 billion in 2025, and is expected to reach USD 145.12 billion
by 2034, at a CAGR of 7.14%. The topical
drugs CDMO market is expanding too. It was valued at USD 46.32 billion
in 2024, grew to USD 51.62 billion in 2025, and is expected to reach USD 136.71
billion by 2034, growing at a CAGR of 11.43%. The biologics
CDMO market is also seeing strong growth. It stood at USD 22 billion in
2024, rose to USD 25.41 billion in 2025, and is forecasted to reach USD 92.79
billion by 2034, with a CAGR of 15.48%. The European
pharmaceutical CDMO market was worth USD 35.48 billion in 2024, grew to
USD 37.98 billion in 2025, and is set to reach USD 70.05 billion by 2034, at a
CAGR of 7.04%. In the U.S.
pharmaceutical CDMO market was valued at USD 36.77 billion in 2024,
increased to USD 39.14 billion in 2025, and is projected to hit USD 68.57
billion by 2034, growing at a CAGR of 6.43%. The global third-party
logistics market for cell and gene therapy is growing as well. It was
valued at USD 10.75 billion in 2024, increased to USD 11.94 billion in 2025,
and is expected to reach USD 30.67 billion by 2034, with a CAGR of 11.09%. The exosome
cell and gene therapy market is booming, driven by its ability to treat
cancer, rare conditions, and genetic diseases. Technologies like AI and
automation are helping personalize therapies and improve patient care. North
America is leading this market, while Asia Pacific is growing quickly and
Europe is seeing steady progress. Cell and Gene Therapy CDMO Market
Segmentation By Phase • Pre-clinical • Clinical By Product • Gene Therapy • Ex-vivo • In-vivo • Gene-Modified Cell Therapy • CAR T-cell
Therapies • CAR-NK Cell
Therapy • TCR-T Cell
Therapy • Other • Cell Therapy By Indication • Oncology • Infectious Diseases • Neurological Disorders • Rare Diseases • Others By Region • North America • U.S. • Canada • Asia Pacific • China • Japan • India • South Korea • Thailand • Europe • Germany • UK • France • Italy • Spain • Sweden • Denmark • Norway • Latin America • Brazil • Mexico • Argentina • Middle East and Africa (MEA) • South Africa • UAE • Saudi Arabia • Kuwait Access the complete strategic analysis
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