Cell and Gene Therapy CDMO Market size is approximated to develop at a rate of USD 75.0 Billion by 2035; Increasing Demand for Outsourced Services is expected to pitch the Market Expansion

Published Date: April 2025

Cell and gene therapy CDMOs are a growing market due to the increasing demand for innovative therapies, outsourced services, clinical trials, rare diseases, research, and investments. The increasing prevalence of chronic diseases and improving healthcare infrastructures in emerging countries create new opportunities. Innovations in manufacturing techniques, data analytics, artificial intelligence, and advanced gene editing technologies drive growth in the cell and gene therapy CDMO market.

Segmentation Analysis:

By Product Type

Gene Therapy and Cell Therapy

By Services

Contract Development, and Contract Manufacturing

By Phase

Pre-Clinical and Clinical

By Application

Oncology, Immunology, Neurology, Cardiovascular, and Others

By End User

Biopharmaceutical Companies, Academic Institutions, Hospitals, and Others

Report Highlights:

  • Cell and Gene Therapy CDMO Market size is valuated at USD 7.9 Billion in 2025.
  • Target Market size is estimated to grow at a rate of USD 75.0 Billion by 2035 and at a registered CAGR of 28.0%.
  • By product type, the cell therapy sector is attributed to rule over the cell and gene therapy CDMO market share.
  • Appertaining from services, the contract manufacturing segment is expected to govern the cell and gene therapy CDMO market.
  • On the basis of phase, the pre-clinical phase is anticipated to influence the target market.
  • Stemming from application, the oncology segment is holding the superior position in the cell and gene therapy CDMO market.
  • Based on end user, the biopharmaceutical companies is the end user which is dominating the cell and gene therapy CDMO market.
  • Under region North America is the region which is attributed to lead the cell and gene therapy CDMO market share.
  • Europe is the region which has the cell and gene therapy CDMO market, growing with the highest CAGR, during the forecast period.

Market Dynamics:

Growing Factor

Challenge Factor

Market Trend

Increasing Focus On Rare Diseases

High Costs Of Cell And Gene Therapy CDMO

Integrating Advanced Technologies With Cell And Gene Therapy CDMO

Key Highlights:

  • In April 2025, AGC Biologics had unveiled a new Cell and Gene Technologies Division, hubbed at the CDMO’s Milan Cell and Gene Center of Excellence. The Milan site offered 30 years of experience in cell and gene therapy, with nine commercial approvals and hundreds of GMP batches produced successfully. The site was tasked with the commercial manufacturing of the lentiviral vectors for Autolus Therapeutics' Aucatzyl and the lentiviral vector and genetically modified cell drug product for Orchard Therapeutics’ Lenmeldy.

Report Analysis:

Future Role of CDMOs in Cell Therapy:

  • Automated, closed systems: Greater automation and use of closed-system manufacturing to transition away from manual equipment and single unit operations, overall reducing labor costs and training required for on-site personnel.
  • Novel non-viral gene delivery and gene-editing technology: Use of non-viral technology (e.g., electroporation and lipid nanoparticles) and gene-editing tools (e.g., CRISPR) to push beyond viral-based cell therapy methods, broaden the toolbox of cell engineering approaches and enable multiple, precise edits for next-generation cell therapies.
  • AI/machine learning (ML) process optimization: AI/ML approaches for process optimization and workflow standardization incorporating multimodal datasets.
  • Allogeneic cell therapy development: Allogeneic cell therapy programs to replace the fit for-purpose tools that were developed for the autologous space and expand use in broader treatment settings and larger addressable populations.

Browse ∼40 market data tables and ∼45 figures through ∼180 slides and in-depth TOC on “Cell and Gene Therapy CDMO Market, By Product Type (Gene Therapy and Cell Therapy), Services (Contract Development, and Contract Manufacturing), Phase (Pre-Clinical and Clinical), Application (Oncology, Immunology, Neurology, Cardiovascular, and Others), End User (Biopharmaceutical Companies, Academic Institutions, Hospitals, and Others), and By Region - Trends, Analysis, and Forecast till 2035”

Segmentation:

By Product Type:

  • Gene Therapy
    • Ex-vivo
    • In-vivo
  • Cell Therapy
    • CAR T-cell Therapy
    • CAR-NK Cell Therapy
    • TCR-T Cell Therapy
    • Others

By Services:

  • Contract Development
  • Contract Manufacturing

By Phase:

  • Pre-Clinical
  • Clinical

By Application:

  • Oncology
  • Immunology
  • Neurology
  • Cardiovascular
  • Others

By End User:

  • Biopharmaceutical Companies
  • Academic Institutions
  • Hospitals
  • Others

By Region:

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

For more insights into the Cell and Gene Therapy CDMO Market and its future trends, visit link below: https://www.prophecymarketinsights.com/market_insight/Cell-and-Gene-Therapy-CDMO-Market-5065

Competitive Landscape of Cell and Gene Therapy CDMO Market:

The companies operating in the market are FUJIFILM Diosynth Biotechnologies, WuXi AppTec, Lonza, Thermo Fisher Scientific Inc., Charles River Laboratories, Novartis AG, AGC Biologics, OmniaBio, Catalent, Inc, Evotec, Cytiva, Rentschler Biopharma SE, and SK pharmteco Inc.

Company Name

Novartis AG

Headquarter

Basel, Switzerland

CEO

Mr. Vasant Narasimhan

Employee Count (2024)

75,833 Employees

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