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

The North America Cell and Gene Therapy Contract Development and Manufacturing Organization Market size is expected to reach US$ 15,571.7 Million by 2031 from US$ 3,012.9 Million in 2024. The market is estimated to record a CAGR of 26.6% from 2025 to 2031.

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

The North America cell and gene therapy contract development and manufacturing organization market is divided into the US, Canada, and Mexico. North America is likely to capture a significant share of the global market. The cell and gene therapy contract development and manufacturing organization market is experiencing robust growth, driven by increasing prevalence of genetic diseases, advancements in biotechnology, and a surge in demand for specialized manufacturing services.

Technological advancements also play a crucial role. The integration of artificial intelligence and automation in manufacturing processes enhances efficiency, scalability, and cost-effectiveness. For instance, companies like OmniaBio are leveraging AI to optimize production workflows, improving both speed and quality. Additionally, the consolidation of CDMOs through mergers and acquisitions enables companies to expand their capabilities and geographic reach, enhancing service offerings and operational efficiency.

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

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

• By Service Type, the North America 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 North America 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 North America 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.

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

The North America 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.

North America Cell and Gene Therapy Contract Development and Manufacturing Organization Market Outlook

Cell and gene therapies require highly specialized manufacturing processes, including the production of viral vectors, transduced cells, and other specialized biological materials. These therapies often target rare or complex diseases, such as genetic disorders, cancer, and autoimmune diseases. As of 2024, there were approximately 1,975 ongoing clinical trials for cell and gene therapies (CGTs), marking a pivotal year for approvals, with hundreds more in the pipeline, creating the demand for contract development and manufacturing organizations (CDMOs).

The increasing number of biotech startups and biopharmaceutical companies entering the gene and cell therapy field has propelled the demand for CDMOs. Biopharmaceutical companies, especially small and medium-sized enterprises, lack the infrastructure and expertise required for manufacturing these highly specialized therapies. Consequently, they turn to CDMOs for their comprehensive expertise in managing clinical trial production, ensuring regulatory compliance, and scaling up manufacturing processes. The Autologus Therapeutics and AGC Biologics Milan Partnership started in 2020 when the company was involved in the development, manufacturing, and supply of viral vectors for Autolus' obe-cel CAR-T product candidate, AUCATZYL. The collaboration between the two parties was instrumental in bringing the therapy to market in a timely manner. Technological advancements such as artificial intelligence (AI) optimize manufacturing processes for clinical trials. These innovations enable more efficient and cost-effective production methods, which are critical based on the complexities involved. Therefore, increasing clinical trials for innovative therapies, along with increasing demand for CDMOs for increasing research, development, and commercialization, drive the growth of the cell and gene therapy contract development and manufacturing organization market.

North America Cell and Gene Therapy Contract Development and Manufacturing Organization Market Country Insights

By country, the North America Cell and Gene Therapy Contract Development and Manufacturing Organization Market is segmented into the United States, Canada, and Mexico. The United States held the largest share in 2024.

The US is observing growing advancements in biotechnology, an increasing prevalence of genetic diseases, and surging demand for specialized manufacturing services. As per the estimates of the US Government Accountability Office published in October 2021, ~25 to 30 million people suffer from rare diseases in the country. As per the Food and Drug Administration (FDA), more than 7,000 rare diseases affect over 30 million people in the country. The growing understanding of these diseases has led to a surge in gene therapy development. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in this space by providing specialized services for the development and manufacturing of gene therapies targeting rare genetic disorders.

The increasing approval of advanced therapies is one of the primary drivers. In 2023, the US FDA approved numerous cell and gene therapies, including gene-editing treatments targeting rare diseases. Therapies such as exagamglogene autotemcel (Casgevy) and lovotibeglogene autotemcel for sickle cell disease, as well as valoctocogene roxaparvovec for severe hemophilia A, have received FDA approval, highlighting the potential of gene therapies in addressing rare disease challenges. The accelerated regulatory pathways, such as the Regenerative Medicine Advanced Therapy (RMAT) designation, have spurred biotechnology companies to partner with CDMOs for scaling production.

North America 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.

North America 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:

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