Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Analysis and Forecast by Size, Share, Growth, Trends 2031

The Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market size is expected to reach US$ 7,129.1 Million by 2031 from US$ 1,414.4 Million in 2024. The market is estimated to record a CAGR of 26.2% from 2025 to 2031.

Executive Summary and Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Analysis:

Europe cell and gene therapy contract development and manufacturing organization market is segmented into Germany, the UK, France, Italy, Spain, and the Rest of Europe. One of the reasons for the market's growth is the increasing demand for advanced therapies targeting previously untreatable or poorly managed diseases, including rare genetic disorders and certain types of cancers. Cell and gene therapies require complex and highly specialized manufacturing capabilities, which many biotech startups and even large pharmaceutical companies may lack. CDMOs offer the necessary infrastructure, expertise, and scalability to meet these demands, reducing time-to-market and ensuring regulatory compliance.

Moreover, the fragmented nature of the European biotech industry, characterized by a high number of small and mid-sized enterprises, has made outsourcing an attractive option. Partnering with CDMOs allows these companies to access cutting-edge technologies and capabilities without the need for heavy capital investment. Furthermore, CDMOs are expanding their capabilities in response to increasing demand, offering integrated services that span from early-stage development to commercial manufacturing, thereby supporting clients across the full product lifecycle.

Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market: Strategic Insights

Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Segmentation Analysis:

• By Service Type, the Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market is segmented into Drug Development and Manufacturing, Testing and Regulatory Services, and Others. Drug Development and Manufacturing held the largest share of the market in 2024.
• By Product Type, the Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market is segmented into Gene Therapy and Cell Therapy. Gene Therapy held the largest share of the market in 2024.
• By End User, the Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market is segmented into Pharmaceutical Companies, Biopharmaceutical Companies, and Others. Biopharmaceutical Companies held the largest share of the market in 2024.

Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Players Density: Understanding Its Impact on Business Dynamics

The Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Outlook

Over the past few 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. The expedited process enables faster market entry for innovative therapies and increases the demand for specialized manufacturing services provided by CDMOs. One of the primary reasons for this change is the recognition of cell and gene therapies in the treatment of diseases that were previously untreatable. The FDA has introduced the Regenerative Medicine Advanced Therapy (RMAT) designation and the Breakthrough Therapy Designation, which expedite the development and review of promising therapies. These designations are helpful in the faster approval of cell and gene therapies. For instance, Zolgensma, a gene therapy for spinal muscular atrophy (SMA), received first FDA approval in 2019 and by 2024 it is approved in 51 other countries in just four years, a process that would typically take much longer. This rapid approval represents the regulatory push to bring life-changing therapies to market. According to the Alliance for Regenerative Medicine (ARM), over 24 gene therapies have received regulatory approval globally since 2020, with many more in the pipeline. As of 2024, more than 1,900 clinical trials for gene therapies are ongoing worldwide, reflecting the expanding therapeutic potential and increasing regulatory support. The FDA has granted breakthrough status to several gene therapies, signaling its commitment to speeding up access to the treatments. This process has created a huge impact on the CDMOs, as companies need specialized contract manufacturers to handle the production demand for these therapies, especially during clinical trial phases.

The increasing number of FDA approvals and the rapid commercialization of gene therapies have led to significant outsourcing to CDMOs. Companies such as Novartis, Gilead, and Bristol-Myers Squibb have partnered with CDMOs to scale production quickly and meet regulatory standards. For instance, in April 2025, the FDA approved prademagene zamikeracel (pz-cel), also known as Zevaskyn. It is the first autologous, cell-based gene therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). This approval represents a significant breakthrough for patients suffering from this devastating skin disorder. As the demand for such therapies grows, the CDMOs are essential in providing the infrastructure, regulatory expertise, and production scalability required for the commercialization of cell and gene therapy, thus driving the market growth.

Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Country Insights

By country, the Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market is segmented into Germany, the United Kingdom, France, Spain, Italy, and the Rest of Europe. Germany held the largest share in 2024.

Germany has a strong pharmaceutical industry with a notable focus on RandD. The country is at the forefront of therapeutic innovation and has 660 biotechnology companies that are focused on the development of cell and gene therapies. Germany's active participation in clinical trials and research initiatives underscores its commitment to advancing cell and gene therapies. As per the NecstGen report, more than 29 active clinical trials evaluating CAR-modified immune cells were ongoing in 2021, and the majority of the production involved CAR-T cells. Also, over 50 clinical studies have been conducted in gene therapy in Germany so far. As more companies initiate clinical trials-especially in innovative areas such as oncology, rare diseases, and cell and gene therapies-they increasingly rely on CDMOs to provide GMP-compliant manufacturing, process development, and logistical support.

Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Company Profiles

Some of the key players operating in the 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 players are adopting various strategies such as expansion, product innovation, and mergers and acquisitions to provide innovative products to their consumers and increase their market share.

Europe Cell and Gene Therapy Contract Development and Manufacturing Organization Market Research Methodology

The following methodology has been followed for the collection and analysis of data presented in this report:

Secondary Research

The research process begins with comprehensive secondary research, utilizing internal and external sources to gather qualitative and quantitative data for each market. Commonly referenced secondary research sources include, but are not limited to:

• Company websites, annual reports, financial statements, broker analyses, and investor presentations
• Industry trade journals and other relevant publications
• Government documents, statistical databases, and market reports
• News articles, press releases, and webcasts specific to companies operating in the market

Note: All financial data included in the Company Profiles section has been standardized to US$. For companies reporting in other currencies, figures have been converted to US$ using the relevant exchange rates for the corresponding year.

Primary Research

The Insight Partners conducts a significant number of primary interviews each year with industry stakeholders and experts to validate its data analysis and gain valuable insights. These research interviews are designed to:

• Validate and refine findings from secondary research
• Enhance the expertise and market understanding of the analysis team
• Gain insights into market size, trends, growth patterns, competitive dynamics, and future prospects

Primary research is conducted via email interactions and telephone interviews, encompassing various markets, categories, segments, and sub-segments across different regions. Participants typically include:

• Industry stakeholders: Vice Presidents, Business Development Managers, Market Intelligence Managers, and National Sales Managers
• External experts: Valuation specialists, research analysts, and key opinion leaders with industry-specific expertise