Cell And Gene Therapy CDMO Market Size & Share, By Phase (Pre-clinical, Clinical), Product Type (Gene Therapy, Gene-Modified Cell Therapy, Cell Therapy), Indication (Oncology, Infectious Diseases) - Growth Trends, Regional Insights (U.S., Japan, South Korea, UK, Germany), Competitive Positioning, Global Forecast Report 2025-2034

Perspectiva del mercado:

Cell And Gene Therapy CDMO Market size is predicted to reach USD 69.74 billion by 2034, up from USD 6.24 billion in 2024, reflecting a CAGR of over 27.3% during the forecast period from 2025 to 2034. The industry revenue for 2025 is projected to be USD 7.81 billion.

• Base Year Value (2024): USD 6.24 billion
• CAGR (2025-2034): 27.3%
• Forecast Year Value (2034): USD 69.74 billion
• Historical Data Period: 2021-2034
• Largest Region: North America
• Forecast Period: 2025-2034

Dinámica del mercado:

Growth Drivers & Opportunities

The Cell and Gene Therapy CDMO market is experiencing significant growth, driven primarily by advancements in biomanufacturing technologies. Innovations in process development and production techniques enable more efficient and scalable manufacturing of cell and gene therapies. This advancement not only reduces costs but also shortens the time to market, making it an attractive option for biopharmaceutical companies. Increased investment in research and development by both established companies and startups is bolstering the demand for Contract Development and Manufacturing Organizations (CDMOs). As organizations seek to expedite their product development processes, the reliance on specialized CDMOs that can navigate the complexities of cell and gene therapies is growing.

Another critical driver in the market is the rising incidence of genetic disorders and chronic diseases, which are prompting the demand for effective therapeutic solutions. As awareness of gene therapies increases, regulatory bodies are becoming more supportive through streamlined approval processes. This supportive environment encourages the development of innovative treatments, creating opportunities for CDMOs to collaborate with biotech firms to develop and manufacture these therapies. Additionally, partnerships between academic institutions and CDMOs are becoming more common, leading to the development of cutting-edge therapies, particularly in areas like personalized medicine.

The globalization of biopharmaceutical production presents another opportunity for CDMOs in the cell and gene therapy market. Companies are seeking to leverage cost-effective manufacturing locations and are looking for CDMOs with global reach who can cater to diverse regulatory requirements. This demand for global partnerships opens new markets for CDMOs and fosters innovation through different regional expertise. Moreover, the COVID-19 pandemic has highlighted the need for agile and responsive supply chains in healthcare, further emphasizing the role of CDMOs in ensuring product availability and adaptability.

Industry Restraints

Despite the positive outlook for the Cell and Gene Therapy CDMO market, several industry restraints could impede growth. One of the primary challenges is the complex regulatory environment surrounding cell and gene therapies. These therapies are subject to rigorous scrutiny from regulatory bodies, which can prolong the approval process and increase development costs. Such uncertainty can deter investment or lead to delays in bringing therapies to market, putting pressure on CDMOs to not only meet compliance but also navigate changing regulations effectively.

Another significant restraint is the high cost associated with the manufacturing of cell and gene therapies. The sophisticated technology and specialized expertise required for production can result in substantial operational costs for CDMOs. These expenses often get passed on to clients, potentially making therapies less accessible. Furthermore, the emerging nature of the technology means many CDMOs may face challenges in maintaining the necessary skilled workforce to meet demand, leading to supply chain bottlenecks.

Intellectual property issues also pose a challenge within this evolving landscape. As companies race to develop novel therapies, disputes over patents and proprietary technology may arise, complicating collaborations between CDMOs and pharmaceutical companies. This uncertainty can deter entities from engaging in necessary partnerships or sharing critical innovations, thereby stifling overall growth in the sector. Lastly, the competitive landscape is intensifying, with new entrants and established companies vying for market share, which may pressure pricing strategies and profitability among CDMOs.

Pronóstico Regional:

North America

The North American cell and gene therapy CDMO market is led by the United States, which is at the forefront of biopharmaceutical innovation and regulatory advancements. The U.S. benefits from a robust healthcare infrastructure, a high prevalence of chronic diseases, and significant investment in research and development. Furthermore, major biotech companies and academic institutions in the U.S. drive demand for contract manufacturing services, leading to increased production capacities. Canada is also emerging as a notable player in this market, with increasing government support for biotechnology innovations and an expanding network of research facilities contributing to growth. The combination of these factors positions North America as a dominant market in terms of both size and growth potential.

Asia Pacific

The Asia Pacific region is witnessing rapid growth in the cell and gene therapy CDMO market, particularly in China and Japan. China stands out due to its large patient population, accelerating regulatory approvals, and government initiatives aimed at advancing its biotech sector. The country's increasing investments in healthcare and biotechnology, coupled with a shift toward personalized medicine, are driving the demand for CDMO services. Japan, on the other hand, is recognized for its advanced technological capabilities and a strong emphasis on research and development, contributing to a thriving environment for cell and gene therapies. South Korea is also noteworthy within this region, showing promise through its innovative biopharmaceutical landscape and strategic collaborations between local firms and global players.

Europe

In Europe, the cell and gene therapy CDMO market is characterized by significant activity in the United Kingdom, Germany, and France. The UK benefits from a well-established ecosystem that supports biotechnology growth, fueled by favorable regulations and strong academic institutions engaged in groundbreaking research. Germany showcases a powerful manufacturing base and a focus on technological advancements, resulting in a competitive environment for CDMO services. France is also making strides with governmental policies that support innovation and attract investments in cell and gene therapy. These countries collectively contribute to a dynamic European market, with the potential for remarkable growth driven by increasing clinical trials and the commercialization of novel therapies.

Análisis de segmentación:

In terms of segmentation, the global Cell And Gene Therapy CDMO market is analyzed on the basis of Phase, Product Type, Indication.

Phase

The Cell and Gene Therapy Contract Development and Manufacturing Organization (CDMO) market can be segmented by phase, primarily dividing it into preclinical, clinical, and commercial phases. The commercial phase is expected to exhibit the largest market size, driven by an increasing number of therapies receiving regulatory approvals and entering the market. This segment is characterized by its demand for scalable manufacturing capabilities, which CDMOs are uniquely positioned to provide. Meanwhile, the clinical phase is anticipated to experience the fastest growth, as a growing number of clinical trials for cell and gene therapies are underway, requiring specialized manufacturing services that adhere to stringent regulatory standards. The preclinical phase, while smaller in market size, remains vital for innovation and development, representing a crucial entry point into the therapy lifecycle.

Product Type

In terms of product type, the Cell and Gene Therapy CDMO market can be categorized into cell therapy and gene therapy. Cell therapy includes sub-segments such as hematopoietic stem cells, CAR T-cell therapies, and stem cell-based therapies, which are witnessing remarkable growth due to advancements in research and the success of ongoing clinical trials. Among these, CAR T-cell therapies stand out as a segment expected to generate substantial market size owing to their established effectiveness in treating certain cancers. Gene therapy, on the other hand, encompasses viral vectors, plasmid DNA, and RNA-based therapies. Viral vectors, particularly adeno-associated viruses (AAV), are poised for accelerated growth, driven by their critical role in facilitating effective gene delivery and the increasing number of gene therapies in development.

Indication

The indication segment of the Cell and Gene Therapy CDMO market is primarily classified into oncology, genetic disorders, and autoimmune diseases among others. The oncology segment is anticipated to capture the largest market share, largely due to the substantial funding for cancer research and development, alongside a growing number of approved therapies targeting hematological malignancies and solid tumors. This segment's growth is further fueled by the increasing prevalence of cancer and the demand for innovative therapeutic options. Conversely, the genetic disorders segment is projected to exhibit the fastest growth, reflecting a rising awareness and focus on rare genetic conditions as well as advancements in gene-editing technologies. As the therapeutic landscape evolves, autoimmune diseases are also becoming a focal point, though they currently represent a smaller share of the market compared to oncology and genetic disorders.

Panorama competitivo:

The competitive landscape in the Cell and Gene Therapy CDMO market is characterized by rapid advancements in technology, increasing partnerships between biopharmaceutical companies and contract development and manufacturing organizations, and a focus on regulatory compliance and quality assurance. Major players in this space are investing heavily in capacity expansion, infrastructure development, and innovation to meet growing demand for personalized medicine and advanced therapies. The market is witnessing an influx of new entrants, as well as established firms expanding their service offerings to include proprietary platforms, supply chain solutions, and flexible manufacturing capabilities, further intensifying competition. Companies are also focusing on strategic collaborations to enhance their development pipelines, optimize production processes, and gain a competitive edge in a rapidly evolving market.

Top Market Players

1. Lonza Group

2. Catalent, Inc.

3. WuXi AppTec

4. Thermo Fisher Scientific

5. Ginkgo Bioworks

6. Holding Company for the Development of Biolife Sciences

7. Samsung Biologics

8. Synlogic

9. ATUM

10. Charles River Laboratories