Global Cell and Gene Therapy Manufacturing Services Market 2025-2035

Description

List of Tables

Global Cell and Gene Therapy Manufacturing Services Market Size, Share & Trends Analysis by Therapy (Cell Therapy, and Gene Therapy ), by Scale (Pre-commercial/ R&D Scale Manufacturing, and Commercial Scale Manufacturing) by Indication (Oncology, Cardiovascular Diseases, Orthopedic Diseases, Infectious Diseases, Ophthalmology Diseases, and Others) and by End User (Pharmaceutical and Biotechnology Companies, and Academic and Research Institutes) Forecast Period (2025-2035)

Industry Overview

Cell and gene therapy manufacturing services market was valued at $7.74 billion in 2024 and is projected to reach $76.20 billion by 2035, growing at a CAGR of 23.1% during the forecast period (2025-2035). The market is growing due to factors like the rising prevalence of chronic diseases, advances in gene editing, and increasing investment. Key drivers also include the growing demand for personalized medicine, the supportive regulatory environment for new therapies, and the expansion of contract manufacturing organizations (CMOs) to handle complex production.

Market Dynamics

Surge in Biotechnology Investments and Strategic Partnerships

The increasing demand for advanced therapies targeting cancer, genetic disorders, and rare diseases has led to a significant rise in investments and strategic collaborations. For instance, AstraZeneca's acquisition of EsoBiotec for up to $1 billion underscores the industry's commitment to expanding cell therapy capabilities. Such partnerships facilitate the development and commercialization of innovative CGT products, thereby accelerating market growth.

Advancements in Manufacturing Technologies and Infrastructure

Technological innovations and the establishment of state-of-the-art manufacturing facilities are enhancing the scalability and efficiency of CGT production. Companies like Bayer are investing heavily in infrastructure, exemplified by their $250 million investment in a California-based cell therapy facility. These advancements ensure consistent product quality and meet the growing demand for CGT products.

Supportive Regulatory Environment and Accelerated Approvals

Regulatory agencies, particularly in regions like North America, are implementing favorable policies to expedite the approval of CGT products. The US FDA's Regenerative Medicine Advanced Therapy (RMAT) designation has accelerated the development of therapies such as Zolgensma for spinal muscular atrophy. This supportive regulatory framework encourages investment and innovation in the CGT sector, contributing to market expansion.

Market Segmentation

Based on therapy, the market is segmented into cell therapy and gene therapy.
Based on the Scale, the market is segmented into Pre-commercial/ R&D Scale Manufacturing and Commercial Scale Manufacturing.
Based on the indication, the market is segmented into oncology, cardiovascular diseases, orthopedic diseases, infectious diseases, ophthalmology diseases, and others.
Based on the End User, the market is segmented into pharmaceutical and biotechnology companies and academic and research institutes.

Cell Therapy Segment to Grow at a Considerable Market Share

Among all segments in the global cell and gene therapy (CGT) manufacturing services market, the cell therapy segment is expected to lead with the largest share. Cell therapy involves administering live cells to patients to repair or replace damaged tissues, offering transformative solutions for conditions like cancer, autoimmune disorders, and degenerative diseases. Its dominance is driven primarily by the success of CAR-T therapies in oncology, which have demonstrated remarkable clinical outcomes for blood cancers and continue to expand into other therapeutic areas. Pre-commercial and R&D scale manufacturing within cell therapy remains significant, as companies focus on optimizing production processes and conducting clinical trials.

Additionally, pharmaceutical and biotechnology companies, which form the primary end users of CGT manufacturing services, are increasingly investing in cell therapy development and strategic collaborations to accelerate commercialization. Oncology indications, in particular, account for a substantial portion of demand due to the high prevalence of cancers and growing investment in advanced therapies. The increasing number of clinical trials, regulatory approvals, and government incentives for regenerative medicine further bolsters the segment's market dominance.

Pre-commercial/ R&D Scale Manufacturing: A Key Segment in Market Growth

The pre-commercial/R&D scale manufacturing segment is the key driver of market growth within CGT manufacturing services. This segment is crucial as it forms the foundation for developing innovative therapies, ensuring quality control, and scaling up production for clinical trials. Companies are heavily investing in state-of-the-art R&D facilities and automated manufacturing platforms to improve process efficiency, reduce costs, and meet regulatory compliance requirements. The growth of this segment is fueled by the rising number of cell and gene therapy candidates entering early-phase clinical trials, particularly in oncology, infectious diseases, and rare genetic disorders.

Moreover, strategic partnerships between pharmaceutical companies, contract manufacturing organizations (CMOs), and academic institutions are expanding production capacity and expertise, enabling faster development timelines. Regulatory frameworks like the U.S. FDA's RMAT designation and Europe's Advanced Therapy Medicinal Products (ATMP) guidelines are also supporting accelerated development and market entry.

Regional Outlook

The global cell and gene therapy manufacturing services market is further divided by geography, including North America (the US and Canada), Asia-Pacific (India, China, Japan, South Korea, Australia and New Zealand, ASEAN Countries, and the Rest of Asia-Pacific), Europe (the UK, Germany, France, Italy, Spain, Russia, and the Rest of Europe), and the Rest of the World (the Middle East & Africa, and Latin America).

Market Players Outlook

The major companies operating in the global cell and gene therapy manufacturing services market include Catalent, Inc., Charles River Laboratories, FUJIFILM Diosynth Biotechnologies, Lonza Group AG, Thermo Fisher Scientific, among others. Market players are leveraging partnerships, collaborations, mergers, and acquisition strategies for business expansion and innovative product development to maintain their market positioning.

Recent Development

In October 2025, AGC Biologics partnered with Rarity PBC to develop and manufacture Rarity's gene therapy, RDP-101, for Adenosine Deaminase Severe Combined Immunodeficiency Disorder (ADA-SCID). If approved by the FDA, RDP-101 would be the first gene therapy available for commercial use to reverse ADA-SCID in US patients. ADA-SCID is a rare, life-threatening inherited condition that severely compromises the immune system, leaving infants vulnerable to infections.
In August 2025, Minaris Advanced Therapies opened a new GMP manufacturing facility in Munich, Germany, to support global cell and gene therapy growth. The facility, located in Taufkirchen, consolidates process and analytical development operations onto a single site, offering a strategic logistical advantage for clients across Europe and beyond. The facility includes six Grade B/A cleanrooms, one Grade C cleanroom, customizable cleanroom configurations, independently controlled HVAC systems, dedicated process development and quality control laboratories, and enhanced alarming and safety systems.
In April 2025, AGC Biologics launched a new Dedicated Cell and Gene Business Division, focusing on enhancing its capabilities and supporting developers in need of capacity, scientific capabilities, and technically qualified cell and gene CDMO operators. The division will be based at the AGC Biologics Milan Cell and Gene Center of Excellence, which has 30 years of experience in cell and gene therapy and has nine commercial approvals. The division will also utilize AGC Biologics' proprietary cell therapy and viral vector platforms, including ProntoLVV and BravoAAV, to increase speed to GMP phases while controlling costs.

The Report Covers:

Market value data analysis for 2024 and forecast to 2035.
Annualized market revenues ($ million) for each market segment.
Country-wise analysis of major geographical regions.
Key companies operating in the global cell and gene therapy manufacturing services market. Based on the availability of data, information related to new products and relevant news is also available in the report.
Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
Analysis of market-entry and market expansion strategies.
Competitive strategies by identifying 'who-stands-where' in the market.

Product Code: OMR2024042

1. Report Summary

Current Industry Analysis and Growth Potential Outlook
Global Cell and Gene Therapy Manufacturing Services Market Sales Analysis - Therapy | Scale| Indication ($ Million)
Cell and Gene Therapy Manufacturing Services Market Sales Performance of Top Countries
1.1. Research Methodology
Primary Research Approach
Secondary Research Approach
1.2. Market Snapshot

2. Market Overview and Insights

2.1. Scope of the Study
2.2. Analyst Insight & Current Market Trends
- 2.2.1. Key Cell and Gene Therapy Manufacturing Services Market Trends
- 2.2.2. Market Recommendations
2.3. Porter's Five Forces Analysis for the Cell and Gene Therapy Manufacturing Services Market
- 2.3.1. Competitive Rivalry
- 2.3.2. Threat of New Entrants
- 2.3.3. Bargaining Power of Suppliers
- 2.3.4. Bargaining Power of Buyers
- 2.3.5. Threat of Substitutes

3. Market Determinants

3.1. Market Drivers
- 3.1.1. Drivers For Global Cell and Gene Therapy Manufacturing Services Market: Impact Analysis
3.2. Market Pain Points and Challenges
- 3.2.1. Restraints For Global Cell and Gene Therapy Manufacturing Services Market: Impact Analysis
3.3. Market Opportunities
- 3.3.1. Opportunities For Global Cell and Gene Therapy Manufacturing Services Market: Impact Analysis

4. Competitive Landscape

4.1. Competitive Dashboard - Cell and Gene Therapy Manufacturing Services Market Revenue and Share by Manufacturers
Cell and Gene Therapy Manufacturing Services Comparison Analysis
Top Market Player Ranking Matrix
4.2. Key Company Analysis
- 4.2.1. Catalent, Inc.
  - 4.2.1.1. Overview
  - 4.2.1.2. Product Portfolio
  - 4.2.1.3. Financial Analysis
  - 4.2.1.4. SWOT Analysis
  - 4.2.1.5. Business Strategy
- 4.2.2. Charles River Laboratories
  - 4.2.2.1. Overview
  - 4.2.2.2. Product Portfolio
  - 4.2.2.3. Financial Analysis
  - 4.2.2.4. SWOT Analysis
  - 4.2.2.5. Business Strategy
- 4.2.3. FUJIFILM Diosynth Biotechnologies
  - 4.2.3.1. Overview
  - 4.2.3.2. Product Portfolio
  - 4.2.3.3. Financial Analysis
  - 4.2.3.4. SWOT Analysis
  - 4.2.3.5. Business Strategy
- 4.2.4. Lonza Group AG
  - 4.2.4.1. Overview
  - 4.2.4.2. Product Portfolio
  - 4.2.4.3. Financial Analysis
  - 4.2.4.4. SWOT Analysis
  - 4.2.4.5. Business Strategy
- 4.2.5. Thermo Fisher Scientific
  - 4.2.5.1. Overview
  - 4.2.5.2. Product Portfolio
  - 4.2.5.3. Financial Analysis
  - 4.2.5.4. SWOT Analysis
  - 4.2.5.5. Business Strategy
4.3. Top Winning Strategies by Market Players
- 4.3.1. Merger and Acquisition
- 4.3.2. Product Launch
- 4.3.3. Partnership And Collaboration

5. Global Cell and Gene Therapy Manufacturing Services Market Sales Analysis by Therapy ($ Million)

5.1. Cell Therapy
5.2. Gene Therapy

6. Global Cell and Gene Therapy Manufacturing Services Market Sales Analysis by Scale ($ Million)

6.1. Pre-commercial/ R&D Scale Manufacturing
6.2. Commercial Scale Manufacturing

7. Global Cell and Gene Therapy Manufacturing Services Market Sales Analysis by Indication($ Million)

7.1. Oncology
7.2. Cardiovascular Diseases
7.3. Orthopedic Diseases
7.4. Infectious Diseases
7.5. Ophthalmology Diseases
7.6. Others

8. Global Cell and Gene Therapy Manufacturing Services Market Sales Analysis by End User Million)

8.1. Pharmaceutical and Biotechnology Companies
8.2. Academic and Research Institutes

9. Regional Analysis

9.1. North American Cell and Gene Therapy Manufacturing Services Market Sales Analysis - Therapy | Scale | Indication | End User ($ Million)
Macroeconomic Factors for North America
- 9.1.1. United States
- 9.1.2. Canada
9.2. European Cell and Gene Therapy Manufacturing Services Market Sales Analysis - Therapy | Scale | Indication | End User ($ Million)
Macroeconomic Factors for Europe
- 9.2.1. UK
- 9.2.2. Germany
- 9.2.3. Italy
- 9.2.4. Spain
- 9.2.5. France
- 9.2.6. Russia
- 9.2.7. Rest of Europe
9.3. Asia-Pacific Cell and Gene Therapy Manufacturing Services Market Sales Analysis - Therapy | Scale | Indication | End User ($ Million)
Macroeconomic Factors for Asia-Pacific
- 9.3.1. China
- 9.3.2. Japan
- 9.3.3. South Korea
- 9.3.4. India
- 9.3.5. Australia & New Zealand
- 9.3.6. ASEAN Countries (Thailand, Indonesia, Vietnam, Singapore, And Other)
- 9.3.7. Rest of Asia-Pacific
9.4. Rest of the World Cell and Gene Therapy Manufacturing Services Market Sales Analysis - Therapy | Scale | Indication | End User ($ Million)
Macroeconomic Factors for the Rest of the World
- 9.4.1. Latin America
- 9.4.2. Middle East and Africa

10. Company Profiles

10.1. Catalent, Inc.
- 10.1.1. Quick Facts
- 10.1.2. Company Overview
- 10.1.3. Product Portfolio
- 10.1.4. Business Strategies
10.2. Charles River Laboratories
- 10.2.1. Quick Facts
- 10.2.2. Company Overview
- 10.2.3. Product Portfolio
- 10.2.4. Business Strategies
10.3. FUJIFILM Diosynth Biotechnologies
- 10.3.1. Quick Facts
- 10.3.2. Company Overview
- 10.3.3. Product Portfolio
- 10.3.4. Business Strategies
10.4. Lonza Group
- 10.4.1. Quick Facts
- 10.4.2. Company Overview
- 10.4.3. Product Portfolio
- 10.4.4. Business Strategies
10.5. Merck KGaA
- 10.5.1. Quick Facts
- 10.5.2. Company Overview
- 10.5.3. Product Portfolio
- 10.5.4. Business Strategies
10.6. Oxford Biomedica plc
- 10.6.1. Quick Facts
- 10.6.2. Company Overview
- 10.6.3. Product Portfolio
- 10.6.4. Business Strategies
10.7. Samsung Biologics
- 10.7.1. Quick Facts
- 10.7.2. Company Overview
- 10.7.3. Product Portfolio
- 10.7.4. Business Strategies
10.8. SGS SA
- 10.8.1. Quick Facts
- 10.8.2. Company Overview
- 10.8.3. Product Portfolio
- 10.8.4. Business Strategies
10.9. Takara Bio Inc.
- 10.9.1. Quick Facts
- 10.9.2. Company Overview
- 10.9.3. Product Portfolio
- 10.9.4. Business Strategies
10.10. Thermo Fisher Scientific
- 10.10.1. Quick Facts
- 10.10.2. Company Overview
- 10.10.3. Product Portfolio
- 10.10.4. Business Strategies
10.11. WuXi AppTec
- 10.11.1. Quick Facts
- 10.11.2. Company Overview
- 10.11.3. Product Portfolio
- 10.11.4. Business Strategies