Cell & Gene Therapy Manufacturing Services Market - By Type [Cell (Allogenic, Autogenic), Gene], Mode (Contract, In-house), Indication (Oncology, Cardiovascular), End-user (Biopharmaceutical, Academic & Research Institute), Global Forecast 2024 – 2032

Cell & Gene Therapy Manufacturing Services Market - By Type [Cell (Allogenic, Autogenic), Gene], Mode (Contract, In-house), Indication (Oncology, Cardiovascular), End-user (Biopharmaceutical, Academic & Research Institute), Global Forecast 2024 – 2032

Cell & Gene Therapy Manufacturing Services Market Size

Cell & Gene Therapy Manufacturing Services Market size was valued at USD 5.9 billion in 2023 and is projected to grow at a CAGR of 18.9% between 2024 and 2032. The substantial growth in the market can be attributed to biotechnological advancements facilitating the development of cutting-edge cell and gene therapies, which hold promise in treating various diseases such as genetic disorders and cancers.

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With rising number of therapies transitioning from preclinical stages to clinical trials and commercialization, the need for specialized manufacturing services is surging to facilitate their production bolstering market demand. Moreover, regulatory agencies are streamlining approval processes, enhancing investor trust, and stimulating investments in manufacturing infrastructure and technology has further explored opportunities in the market.
 

The market refers to the types provided by contract manufacturing organization (CMOs) and contract development and manufacturing organizations (CDMOs) to support the development of manufacturing commercialization of gene and cell therapies. These types include process development, cell line development, analytical testing, clinical and commercial manufacturing, and regulatory support.
 

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Cell & Gene Therapy Manufacturing Services Market Trends

• Rising investments in research and development (R&D) activities have had a profound impact on the growth of the cell and gene therapy manufacturing services market. These investments, driven by increasing private equity and capital infusion in the life sciences sector over the past decade, have been instrumental in fueling the expansion of the market.
   
• For instance, according to the dealforma data, the cash flow into cell and gene therapies remained strong, with a total influx of USD 24 billion in 2021. This includes USD 1.6 billion in upfront cash and equity for partnerships and USD 6.7 billion in venture capital. This surge in investment aimed to support the research, with a notable shift towards innovative and personalized treatment approaches are fueling the market growth.
   
• In addition, strategic partnerships and agreements between pharmaceutical companies and CDMOs, and supportive government initiatives and funding for R&D in cell and gene therapies have played a crucial role in propelling the growth of the market.

Cell & Gene Therapy Manufacturing Services Market Analysis

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Based on type, the market is segmented into cell therapy and gene therapy. The cell therapy segment is further bifurcated into allogenic and autologous. The cell therapy segment dominated the market in 2023 with a market share of 60.6% anticipating its dominance with a CAGR of 18.6% during the forecast period.

• The cell therapy prominence can be attributed to its versatile applications in treating a wide range of conditions such as cancers, autoimmune diseases, urinary problems, infectious diseases, and other applications.
   
• The increased number of products entering the market and the large number of ongoing clinical studies are attributable to the larger market share.
   
• For instance, according to Pharma Intelligence UK Limited., there are over 2,000 clinical trials concentrating on cell-based therapies are being conducted to determine their potential for treating various disease indications.
   
• As a result, the need for advanced therapeutic manufacturing services is likely to rise over the forecast period, hence will further accelerate the segment growth.

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Based on mode, the cell & gene therapy manufacturing services market is segmented into contract manufacturing and in-house manufacturing. The contract manufacturing segment accounted for significant market share in 2023 and is poised to capture the market size of USD 21.3 billion by 2032.

• Contract manufacturing organizations (CMOs) specialize in providing manufacturing services to biotechnology and pharmaceutical companies, offering expertise in cell culture, viral vector production, process development, and manufacturing scale-up.
   
• This segment is witnessing rapid growth due to the increasing outsourcing of manufacturing activities by biotech and pharma companies to leverage specialized expertise and infrastructure, streamline production processes, and accelerate time-to-market for their therapies.
   
• Additionally, the dynamic regulatory landscape and the need for flexibility in manufacturing capacity further drive demand for contract manufacturing services, solidifying the segment's dominance in the market.

Based on indication, the cell & gene therapy manufacturing services market is segmented into oncology diseases, cardiovascular diseases, orthopedic diseases, infectious diseases, and ophthalmology diseases. The oncology disease segment accounted for the revenue of USD 3 billion in 2023.

• Cell and gene therapies offers a promising new approach in cancer treatment, targeting precise molecular pathways, bolstering the immune system's response to tumors, or directly eradicating cancer cells.
   
• The pressing need to address oncology's unmet requirements drives a robust demand for cell and gene therapies facilitating the development and assessment of groundbreaking cell and gene therapy interventions and surging the manufacturing services demand.
   
• Additionally, the success of cell and gene therapies in treating certain types of cancer has spurred further exploration and investment in this area, solidifying oncology's dominance in driving the growth and development of the cell and gene therapy manufacturing services market.

Based on end user, the cell & gene therapy manufacturing services market is segmented into biopharmaceutical companies, academic research institutes, and hospitals. In 2023, the biopharmaceutical companies are anticipated to maintain the highest share of 69.4% in the cell and gene therapy manufacturing services market.

• This dominance can be attributed to their significant investments in research and development, as well as their extensive expertise in drug discovery and development.
   
• These companies often spearhead the development of cell and gene therapies, leveraging their resources to advance promising candidates from preclinical stages through clinical trials and eventual commercialization.
   
• Additionally, biotechnology companies frequently collaborate with CDMOs to scale up production and ensure the efficient manufacturing of therapies.
   
• Thus, as the demand for innovative treatments continues to rise, pharmaceutical and biotechnology companies are poised to remain at the forefront of the cell and gene therapy manufacturing services market.

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North America dominated the global cell & gene therapy manufacturing services market in 2023 with a market share of 41% and is anticipated to grow at a CAGR of 18.1% over the analysis period.

• This dominance can be attributed to the region's growing participation in gene and cell therapy research and product development, rising cancer cases, as well as a large number of contract development manufacturing organizations.
   
• Furthermore, domestic companies in the region are increasing their production operations in the region. Additionally, favourable regulatory environment is anticipated to boost the region’s growth.
   
• Moreover, North America's favorable regulatory environment, exemplified by the U.S. FDA's clear framework and expedited approval pathways for cell and gene therapies, accelerated the market growth by facilitating efficient development and commercialization of advanced treatments.
   
• Additionally, a strong network of contract development and manufacturing organizations (CDMOs) in North America provides essential services to biotech and pharmaceutical companies, enabling efficient and scalable production of cell and gene therapies.

The U.S. cell & gene therapy manufacturing services market is anticipated to grow at a CAGR of 18% between 2024 and 2032.

• The U.S. holds a dominant position in the global cell and gene therapy manufacturing services market, driven by a combination of robust technological infrastructure, significant investment in biotechnology, and a highly skilled workforce.
   
• This market leadership is further bolstered by the presence of numerous leading biotech firms and specialized contract manufacturing organizations (CMOs) that offer advanced and scalable production capabilities.
   
• Additionally, supportive regulatory frameworks and substantial funding from both private and public sectors have accelerated research and development activities, leading to a surge in clinical trials and approvals of innovative therapies.

Asia Pacific region is anticipated to witness high growth in cell & gene therapy manufacturing services market, growing at a CAGR of 20.2% over the analysis years.

• Many countries in the Asia-Pacific region, such as China, India, and South Korea, are rapidly developing their healthcare infrastructure. This includes building state-of-the-art research facilities, manufacturing plants, and investing in skilled workforce development.
   
• Asia-Pacific region is increasingly recognizing the potential of the life sciences sector, including cell and gene therapy. This has led to significant investments in research and development, as well as manufacturing capabilities.
   
• Additionally, this region is home to a large and diverse population, including a significant number of patients with diseases that could potentially be treated with cell and gene therapies. This presents a substantial market opportunity for companies offering manufacturing services in this area, further fueling market growth.

Cell & Gene Therapy Manufacturing Services Market Share

The global market is characterized by a diverse array of companies offering a range of manufacturing services and technologies. Promising players including Thermo Fisher Scientific Inc., Boehringer Ingelheim International GmbH, Merck KGaA, WuXi AppTec, Catalent, Inc., Charles River Laboratories International, Inc., and Samsung Biologics dominate the market with their comprehensive service portfolios, advanced technologies, and global presence. These companies offer a comprehensive suite of services, including process development, GMP manufacturing, analytical testing, and regulatory support, catering to the needs of cell and gene therapy developers across the globe. Factors such as technological advancements, regulatory landscape, and strategic alliances continue to shape the competitive dynamics of the market.

Cell & Gene Therapy Manufacturing Services Market Companies

Prominent players operating in the cell & gene therapy manufacturing services industry include

• Boehringer Ingelheim International GmbH
• Bluebird Bio, Inc.
• Catalent, Inc.
• Charles River Laboratories International, Inc.
• Merck KGaA
• Miltenyi Bioindustry (Miltenyi Biotec)
• Samsung Biologics
• Takara Bio Inc.
• Thermo Fisher Scientific Inc
• WuXi AppTec Co., Ltd.

Cell & Gene Therapy Manufacturing Services Industry News

• In January 2023, Catalent launched new service for end-to-end supply chain case management of cell and gene therapies. The launch of its new service has helped the company to broaden its service offerings and boost revenue.
   
• In March 2019, Bluebird Bio announced the opening of its first wholly owned manufacturing facility in Durham, N.C., that will produce lentiviral vector for the company’s investigational gene and cell therapies. This strategic initiative helped the company to enhance their manufacturing capabilities and generate revenue.

The cell & gene therapy manufacturing services market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 – 2032 for the following segments

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Market, By Type

• Cell therapy
  • Allogenic
    • Mesenchymal stem cells
    • T-cells
    • Natural killer cells
    • Hematopoietic stem cells
    • Other allogeneic cells
  • Autologous
    • Mesenchymal stem cells
    • T-cells
    • Natural killer cells
    • Hematopoietic stem cells
    • Other allogeneic cells 
• Gene therapy
  • Viral vectors
  • Non-viral vectors

Market, By Mode

• Contract manufacturing
• In-house manufacturing

Market, By Indication

• Oncology diseases
• Cardiovascular diseases
• Orthopedic diseases
• Infectious diseases
• Ophthalmology diseases
• Other indications

Market, By End-user

• Biopharmaceutical companies
• Academic research institutes
• Hospitals

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada 
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • Rest of Middle East and Africa