Cell & Gene Therapy Contract Research Organizations Market Size Worth USD 12.29 Billion by 2034 | CAGR: 9.84%

The cell & gene therapy contract research organizations market size is expected to reach USD 12.29 Billion by 2034, according to a new study by Polaris Market Research. The report “Cell & Gene Therapy Contract Research Organizations Market Size, Share, Trends, Industry Analysis Report By Type of Therapy (Gene Therapy, Cell Therapy), By Type of Manufacturing Service, By Cell and Gene Therapy Modality, By Therapeutic Area, and By End-User, By Region – Market Forecast, 2025–2034” gives a detailed insight into current market dynamics and provides analysis on future market growth.

The global cell & gene therapy contract research organizations market is significantly growing driven by the accelerating development of advanced therapies and the increasing need for specialized expertise in navigating complex clinical, regulatory, and manufacturing processes. Cell & gene therapy CROs are crucial in supporting biopharmaceutical companies by managing end-to-end development activities, from early-stage research and clinical trial design to regulatory submissions and post-approval monitoring.

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The market is further supported by the rapid expansion of cell and gene therapy pipelines, growing investment from pharmaceutical and biotechnology companies, and favorable regulatory pathways that accelerate product approvals. Service providers are increasingly adopting advanced analytical tools, scalable manufacturing platforms, and integrated service models to deliver faster timelines, improved quality, and cost-efficient solutions for sponsors worldwide.

Cell & Gene Therapy Contract Research Organizations Market Report Highlights

• Based on type of therapy, the cell therapy segment dominated the market in 2024, driven by the rising number of commercialized products, a steadily expanding clinical pipeline, and the growing adoption of autologous and allogeneic therapeutic approaches.
• In terms of type of manufacturing service, the production services segment accounted for the largest market share in 2024, owing to the intricate processes and specialized infrastructure required for the large-scale production of viral vectors, engineered cells, and other advanced therapeutic materials.
• Based on cell and gene therapy modality, the viral vectors segment led the market in 2024, attributed to their well-established role as delivery systems for both gene therapies and genetically modified cell therapies.
• By therapeutic area, the oncology segment dominated the market in 2024, supported by the high prevalence of hematologic malignancies and the ongoing expansion of therapies into solid tumor indications.
• Based on end user, the biopharmaceutical segment held the largest share in 2024, due to the increasing number of clinical trials progressing to late-stage development.
• North America accounted for the majority share of the global market in 2024, attributed to robust regulatory frameworks and expedited approval pathways from agencies such as the US Food and Drug Administration (FDA) and Health Canada for innovative therapies.
• Asia Pacific emerged as the fastest-growing regional market in 2024, driven by the expanding biotech ecosystems in countries such as China, Japan, South Korea, and Australia.
• A few global key market players include Allucent, CMED, CMIC Group, Linical Accelovance, Novotech CRO, Pharmalex GmbH, PPD (Thermo Fisher Scientific, Inc.), Precision for Medicine Group LLC, QPS Holdings, LLC, and Syngene International Limited.

Polaris Market Research has segmented the market report on the basis of type of therapy, type of manufacturing service, cell and gene therapy modality, therapeutic area, and end-user, and region:

By Type of Therapy Outlook (Revenue, USD Billion, 2020–2034)

• Gene Therapy
• Cell Therapy
• Stem Cell Therapy
• CAR-T Therapy
• Other Cell Therapies

By Type of Manufacturing Service Outlook (Revenue, USD Billion, 2020–2034)

• Development Services
• Production Services
• Other Services

By Cell and Gene Therapy Modality Outlook (Revenue, USD Billion, 2020–2034)

• Viral Vectors
  • Adeno-associated Virus (AAV)
  • Lentivirus
  • Adenovirus
  • Retrovirus
  • Other Viral Vectors
• Non-Viral Vectors
  • Plasmid DNA
  • mRNA-based Therapies
• CRISPR/Cas9 and Other Gene Editing Tools

By Therapeutic Area Outlook (Revenue, USD Billion, 2020–2034)

• Oncology
• Neurology
• Cardiovascular
• Metabolic Disorders
• Other Therapeutic Areas

By End-User Outlook (Revenue, USD Billion, 2020–2034)

• Biopharmaceutical Companies
• Academic and Research Institutions
• Contract Development & Manufacturing Organizations (CDMOs)

By Regional Outlook (Revenue, USD Billion, 2020–2034)

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Netherlands
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Malaysia
  • South Korea
  • Indonesia
  • Australia
  • Vietnam
  • Rest of Asia Pacific
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Israel
  • South Africa
  • Rest of Middle East & Africa
• Latin America
  • Mexico
  • Brazil
  • Argentina
  • Rest of Latin America