Cell & Gene Therapy Manufacturing Services Market - By Type [Cell (Allogenic), Gene], Mode (Contract, In-house), Indication (Oncology, Cardiovascular, Orthopedic), End-user (Pharma, Biotech, Academic Research Institute), Global Forecast, 2023–2032

Cell & Gene Therapy Manufacturing Services Market Size

Cell & Gene Therapy Manufacturing Services Market size valued at USD 4.85 billion in 2022 and is predicted to record more than 19.9% CAGR from 2023 and 2032. Factors such as advancements in cell and gene therapy manufacturing technology, regulatory support, and increase in investment and funding, are influencing the market development.
 

The rising prevalence of chronic and genetic diseases such as cancer, rare genetic disorders, and autoimmune diseases, is increase the demand for cell and gene therapies. These therapies have the potential to offer curative or long-term treatment options for these conditions which are often difficult to treat using traditional therapies. These factors are fuelling the expansion of the cell & gene therapy manufacturing services industry.
 

The development of advanced therapeutics has been crucial in altering the treatment paradigm for a wide range of life-threatening and rare diseases, as well as in reshaping the biopharmaceutical market. Increasing advance technology, such as gene editing tools and next-generation sequencing, are propelling innovation in the research and manufacture of cell and gene treatments. These technologies have the potential to increase the therapeutics' safety, effectiveness, and scalability. The rapid development of the advanced therapeutic landscape is a key driver of the cell & gene therapy manufacturing services market growth.
 

COVID-19 Impact

The COVID-19 pandemic also acted as a catalyst for commercial expansion. Several firms developed their vector manufacturing capacity and launched diverse approaches to develop experimental medicines. In April 2022, BioCardia Inc. announced that the FDA has cleared the company's IND applications for COVID-19 stem cell therapy for the treatment of patients suffering from Acute Respiratory Distress caused by SARS-CoV-2. The COVID-19 pandemic has had both positive and negative impacts on the cell & gene therapy manufacturing services industry. While the pandemic has caused disruptions and delays, it should advocate the development of new therapies and highlighted the importance of cell and gene therapies in treating diseases.
 

Cell & Gene Therapy Manufacturing Services Market Trends

Increasing investments in cell and gene therapy, adoption of automation and digitalization to meet the growing demand for cell and gene therapy manufacturing services, and expansion of manufacturing capacity is beneficial for the market growth. There is a growing demand for cell and gene therapies, and this has led to an expansion of manufacturing capacity. Biopharmaceutical companies are investing in new manufacturing facilities, expanding existing facilities, and partnering with contract manufacturing organisations (CMOs) to meet the increasing demand for these therapies.
 

Cell & Gene Therapy Manufacturing Services Market Analysis

Based on type, the cell & gene therapy manufacturing services market is segmented as cell therapy and gene therapy. The cell therapy segment dominates the largest revenue share. The increased number of products entering the market and the large number of ongoing clinical studies are attributable to the larger market share. 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 will further accelerate the segmental growth.
 

Based on cell therapy, the market is segmented as allogeneic cell therapy and autologous cell therapy. The allogeneic cell therapy segment held the largest revenue share. Allogenic cell and gene therapies are more cost-effective and scalable than autologous therapies, which rely on cells from the patient themselves. This can make these therapies more accessible to a larger patient population, particularly for rare diseases where it may be difficult to collect enough cells from a single patient for an autologous therapy.
 

Based on mode segment, the cell & gene therapy manufacturing services market is segmented as contract manufacturing and in-house manufacturing. The contract manufacturing segment captured 67.7% of the market share in 2022. With rising demand for cell and gene treatments, a lack of manufacturing capacity is opening new prospects for contract manufacturing service providers. Due to the non-standardized and frequently changing nature of the cell and gene therapy industry, outsourcing to a contract manufacturing service provider is likely to give a competitive advantage in terms of experience and competence.
 

According to a March 2020 article, around 35% of the process for standard biologics is outsourced, while more than 65% of the process for cell and gene treatments is outsourced. This is due to the fact that small businesses account for around two-thirds of all innovation in this field.
 

Based on indication, the market is segmented as oncology diseases, cardiovascular diseases, orthopedic diseases, infectious diseases, ophthalmology diseases, and other indications. The set to attain approximately 20.9% CAGR up to 2032. Oncology is a major focus of cell & gene therapy manufacturing services market owing to personalised medicine, advances in genetic engineering, and high unmet medical need. There is a high unmet medical need for effective treatments for oncology diseases, as traditional treatments such as chemotherapy and radiation therapy often have significant side effects and limited efficacy. Cell and gene therapies offer a potential cure or long-term treatment option for oncology diseases, which has led to significant investments and development in this area.
 

Based on end-user, the market is segmented as pharmaceutical and biotechnology companies, academic and research institutes, and other end-users. The pharmaceutical and biotechnology sector is forecast to observe around 48% growth rate through 2032. Pharmaceuticals and biotechnology companies are major players in the cell & gene therapy manufacturing services market, both as developers of therapies and as customers for manufacturing services. Some factors that drive the segment growth includes, potential for new revenue streams, and access to advance manufacturing technologies.
 

Many pharmaceutical and biotechnology companies do not have the expertise or capacity to manufacture cell and gene therapies in-house. Partnering with third-party manufacturers can provide access to advanced manufacturing technologies and expertise, without the need of significant capital investment.
 

North America will acquire 46.3% of the cell & gene therapy manufacturing services market share in 2022. This can be attributed to the region's growing participation in gene and cell therapy research and product development, as well as a large number of contract development organizations.
 

Additionally, favorable regulatory environment is anticipated to boost the region’s growth. The US FDA (Food and Drug Administration) has established a clear regulatory framework for the development and approval of cell and gene therapies, has helped to accelerate the growth of the market in North America. The FDA has also established expedited approval pathways for cell and gene therapies, which has helped to speed up the approval process and bring new therapies to market more quickly.
 

Cell & Gene Therapy Manufacturing Services Market Share

Some of the major market players operating in the cell & gene therapy manufacturing services market are:

• Merck KGaA
• F. Hoffmann-La Roche Ltd
• Boehringer Ingelheim
• Cellular Therapeutics
• Hitachi Chemical Co Ltd
• Bluebird Bio Inc
• Takara Bio Inc
• Miltenyi Biotec,
• Thermo Fisher Scientific, Inc
• Samsung Biologics,
   

These players focus on strategic partnerships, new product launch & commercialization for market expansion. Furthermore, these players are heavily investing in research that allows them to introduce innovative products and garner maximum revenue in the market.
 

Cell & Gene Therapy Manufacturing Services Industry News:

• In January 2022, Allogen Therapeutics Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T products for cancer, and Antion Biosciences Inc. have formed an exclusive collaboration and global licence agreement for Antion's miRNA technology (miCAR) to advance multiplex gene silencing as an additional tool in the development of next-generation allogeneic CAR T products.
   
• In May 2021, Charles River Laboratories purchased Vigene Biosciences Inc., a cell and gene therapy Contract Development and Manufacturing Organisation (CDMO), to enhance its cell and gene therapy manufacturing capabilities.
   

This 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 from 2018 to 2032, for the following segments:

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By type

• Cell Therapy                  
• Allogeneic       
  • 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 autologous cells

• Gene Therapy               
• Viral vectors    
• Non-viral vectors         

By Mode

• Contract manufacturing
• In-house manufacturing

By Indication

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

By End-user

• Pharmaceutical and biotechnology companies
• Academic and research institutes
• Other end-users

The above information is provided for the following regions and countries:

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