Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Size and Forecast (2021

Description

List of Tables

The Europe Cell and Gene Therapy Contract Development and Manufacturing Organization (CDMO) market is projected to experience significant growth, with an expected market size of approximately US$ 7,129.1 million by 2031, up from US$ 1,414.4 million in 2024. This growth translates to a remarkable compound annual growth rate (CAGR) of 26.2% from 2025 to 2031.

Executive Summary and Market Analysis

The European market for cell and gene therapy CDMOs is divided into several key regions, including Germany, the UK, France, Italy, Spain, and the Rest of Europe. A primary driver of this market expansion is the rising demand for advanced therapies aimed at treating previously untreatable or poorly managed conditions, such as rare genetic disorders and specific cancer types. The manufacturing of cell and gene therapies is complex and requires specialized capabilities that many biotech startups and even larger pharmaceutical companies may not possess. CDMOs provide the essential infrastructure, expertise, and scalability needed to meet these demands, thereby reducing the time required to bring products to market and ensuring compliance with regulatory standards.

The European biotech industry is notably fragmented, characterized by a high number of small and mid-sized enterprises. This fragmentation makes outsourcing an appealing option for these companies, as partnering with CDMOs allows them to leverage cutting-edge technologies and capabilities without incurring substantial capital expenditures. Additionally, CDMOs are expanding their service offerings in response to the growing demand, providing integrated solutions that cover the entire product lifecycle, from early-stage development to commercial manufacturing.

Strategic Insights

Market Segmentation Analysis

The Europe Cell and Gene Therapy CDMO market can be segmented by service type, product type, and end user:

By Service Type: The market is divided into Drug Development and Manufacturing, Testing and Regulatory Services, and Others. In 2024, Drug Development and Manufacturing held the largest market share.
By Product Type: The market is categorized into Gene Therapy and Cell Therapy, with Gene Therapy commanding the largest share in 2024.
By End User: The end users include Pharmaceutical Companies, Biopharmaceutical Companies, and Others, with Biopharmaceutical Companies holding the largest share in 2024.

Market Outlook

In recent years, regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have streamlined their approval processes for cell and gene therapies. This expedited process facilitates faster market entry for innovative therapies, thereby increasing the demand for specialized manufacturing services provided by CDMOs. The recognition of cell and gene therapies as viable treatments for previously untreatable diseases has been a significant factor in this regulatory shift. For example, the FDA has introduced designations such as the Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy Designation, which accelerate the development and review of promising therapies.

A notable case is Zolgensma, a gene therapy for spinal muscular atrophy (SMA), which received its first FDA approval in 2019 and was subsequently approved in 51 other countries by 2024. This rapid approval process highlights the regulatory push to bring transformative therapies to market. According to the Alliance for Regenerative Medicine (ARM), over 24 gene therapies have received global regulatory approval since 2020, with many more in development. As of 2024, there are more than 1,900 ongoing clinical trials for gene therapies worldwide, reflecting the expanding therapeutic potential and increasing regulatory support.

The surge in FDA approvals and the swift commercialization of gene therapies have led to a significant increase in outsourcing to CDMOs. Major pharmaceutical companies, including Novartis, Gilead, and Bristol-Myers Squibb, have partnered with CDMOs to rapidly scale production and meet regulatory requirements. For instance, in April 2025, the FDA approved prademagene zamikeracel (pz-cel), the first autologous, cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB), marking a significant advancement for patients with this severe skin condition. As the demand for such therapies continues to rise, CDMOs play a crucial role in providing the necessary infrastructure, regulatory expertise, and production scalability required for the successful commercialization of cell and gene therapies, thus driving market growth.

Country Insights

The market is also analyzed by country, with Germany, the United Kingdom, France, Spain, Italy, and the Rest of Europe being key regions. Germany is expected to hold the largest market share in 2024, bolstered by its robust pharmaceutical industry and strong focus on research and development. The country is home to approximately 660 biotechnology companies dedicated to advancing cell and gene therapies. Germany's active involvement in clinical trials and research initiatives underscores its commitment to therapeutic innovation. For instance, over 29 active clinical trials evaluating CAR-modified immune cells were ongoing in 2021, primarily focusing on CAR-T cells, alongside more than 50 clinical studies in gene therapy.

As more companies initiate clinical trials, particularly in innovative fields such as oncology and rare diseases, they increasingly rely on CDMOs for Good Manufacturing Practice (GMP)-compliant manufacturing, process development, and logistical support.

Company Profiles

Key players in the Europe Cell and Gene Therapy CDMO market include Charles River Laboratories International Inc, Catalent Inc, Lonza Group AG, WuXi Biologics Inc, Pluri Inc, Aenova Holding GmbH, Takara Bio Inc, FUJIFILM Holdings Corp, AGC Biologics AS, Thermo Fisher Scientific Inc., Minaris Advanced Therapies, and SK pharmteco Inc. These companies are employing various strategies, including expansion, product innovation, and mergers and acquisitions, to enhance their market presence and offer innovative solutions to their clients.

Product Code: TIPRE00043118

1. Introduction

1.1 Report Guidance
1.2 Market Segmentation

2. Executive Summary

2.1 Key Insights
2.2 Market Attractiveness

3. Research Methodology

3.1 Secondary Research
3.2 Primary Research
- 3.2.1 Hypothesis formulation:
- 3.2.2 Macroeconomic factor analysis:
- 3.2.3 Developing base number:
- 3.2.4 Data Triangulation:
- 3.2.5 Country-level data:

4. Cell and Gene Therapy Contract Development and Manufacturing Organization Market Landscape

4.1 PEST Analysis

5. Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Key Market Dynamics

5.1 Market Drivers
5.2 Market Restraints
5.3 Market Opportunities
5.4 Future Trends
5.5 Impact of Drivers and Restraints:

6. Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Europe Market Analysis

6.1 Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Revenue (US$ Million), 2024 - 2031
6.2 Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Forecast and Analysis

7. Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Revenue Analysis - by Service Type

7.1 Drug Development and Manufacturing
- 7.1.1 Overview
- 7.1.2 Drug Development and Manufacturing: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
7.2 Testing and Regulatory Services
- 7.2.1 Overview
- 7.2.2 Testing and Regulatory Services: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
7.3 Others
- 7.3.1 Overview
- 7.3.2 Others: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)

8. Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Revenue Analysis - by Product Type

8.1 Gene Therapy
- 8.1.1 Overview
- 8.1.2 Gene Therapy: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
8.2 Cell Therapy
- 8.2.1 Overview
- 8.2.2 Cell Therapy: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)

9. Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Revenue Analysis - by End User

9.1 Pharmaceutical Companies
- 9.1.1 Overview
- 9.1.2 Pharmaceutical Companies: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
9.2 Biopharmaceutical Companies
- 9.2.1 Overview
- 9.2.2 Biopharmaceutical Companies: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
9.3 Others
- 9.3.1 Overview
- 9.3.2 Others: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)

10. Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Country Analysis

10.1 Europe
- 10.1.1 Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Revenue and Forecast and Analysis - by Country
  - 10.1.1.1 Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Revenue and Forecast and Analysis - by Country
  - 10.1.2.2 Germany: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
    - 10.1.2.2.1 Germany: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by Service Type
    - 10.1.2.2.2 Germany: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by Product Type
    - 10.1.2.2.3 Germany: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by End User
  - 10.2.3.3 United Kingdom: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
    - 10.2.3.3.1 United Kingdom: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by Service Type
    - 10.2.3.3.2 United Kingdom: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by Product Type
    - 10.2.3.3.3 United Kingdom: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by End User
  - 10.3.4.4 France: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
    - 10.3.4.4.1 France: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by Service Type
    - 10.3.4.4.2 France: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by Product Type
    - 10.3.4.4.3 France: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by End User
  - 10.4.5.5 Spain: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
    - 10.4.5.5.1 Spain: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by Service Type
    - 10.4.5.5.2 Spain: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by Product Type
    - 10.4.5.5.3 Spain: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by End User
  - 10.5.6.6 Italy: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
    - 10.5.6.6.1 Italy: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by Service Type
    - 10.5.6.6.2 Italy: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by Product Type
    - 10.5.6.6.3 Italy: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by End User
  - 10.6.7.7 Rest of Europe: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
    - 10.6.7.7.1 Rest of Europe: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by Service Type
    - 10.6.7.7.2 Rest of Europe: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by Product Type
    - 10.6.7.7.3 Rest of Europe: Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Share - by End User

11 Competitive Landscape

11.1 Global Company Market Share Analysis, 2024

12 Industry Landscape

12.1 Overview
12.2 New Product Development
12.3 Merger and Acquisition
12.4 Other Strategic Developments

13 COMPANY PROFILES

13.1 Charles River Laboratories International Inc
- 13.1.1 Key Facts
- 13.1.2 Business Description
- 13.1.3 Products and Services
- 13.1.4 Financial Overview
- 13.1.5 SWOT Analysis
- 13.1.6 Key Developments
13.2 Catalent Inc
- 13.2.1 Key Facts
- 13.2.2 Business Description
- 13.2.3 Products and Services
- 13.2.4 Financial Overview
- 13.2.5 SWOT Analysis
- 13.2.6 Key Developments
13.3 Lonza Group AG
- 13.3.1 Key Facts
- 13.3.2 Business Description
- 13.3.3 Products and Services
- 13.3.4 Financial Overview
- 13.3.5 SWOT Analysis
- 13.3.6 Key Developments
13.4 WuXi Biologics Inc
- 13.4.1 Key Facts
- 13.4.2 Business Description
- 13.4.3 Products and Services
- 13.4.4 Financial Overview
- 13.4.5 SWOT Analysis
- 13.4.6 Key Developments
13.5 Pluri Inc
- 13.5.1 Key Facts
- 13.5.2 Business Description
- 13.5.3 Products and Services
- 13.5.4 Financial Overview
- 13.5.5 SWOT Analysis
- 13.5.6 Key Developments
13.6 Aenova Holding GmbH
- 13.6.1 Key Facts
- 13.6.2 Business Description
- 13.6.3 Products and Services
- 13.6.4 Financial Overview
- 13.6.5 SWOT Analysis
- 13.6.6 Key Developments
13.7 Takara Bio Inc
- 13.7.1 Key Facts
- 13.7.2 Business Description
- 13.7.3 Products and Services
- 13.7.4 Financial Overview
- 13.7.5 SWOT Analysis
- 13.7.6 Key Developments
13.8 FUJIFILM Holdings Corp
- 13.8.1 Key Facts
- 13.8.2 Business Description
- 13.8.3 Products and Services
- 13.8.4 Financial Overview
- 13.8.5 SWOT Analysis
- 13.8.6 Key Developments
13.9 AGC Biologics AS
- 13.9.1 Key Facts
- 13.9.2 Business Description
- 13.9.3 Products and Services
- 13.9.4 Financial Overview
- 13.9.5 SWOT Analysis
- 13.9.6 Key Developments
13.10 Thermo Fisher Scientific Inc.
- 13.10.1 Key Facts
- 13.10.2 Business Description
- 13.10.3 Products and Services
- 13.10.4 Financial Overview
- 13.10.5 SWOT Analysis
- 13.10.6 Key Developments
13.11 Minaris Advanced Therapies
- 13.11.1 Key Facts
- 13.11.2 Business Description
- 13.11.3 Products and Services
- 13.11.4 Financial Overview
- 13.11.5 SWOT Analysis
- 13.11.6 Key Developments
13.12 SK pharmteco Inc
- 13.12.1 Key Facts
- 13.12.2 Business Description
- 13.12.3 Products and Services
- 13.12.4 Financial Overview
- 13.12.5 SWOT Analysis
- 13.12.6 Key Developments

14. Appendix

14.1 About The Insight Partners