Cell & Gene Therapy Manufacturing Services Market Analysis

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.