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Cell and Gene Therapy Manufacturing Services Market Analysis

The cell and gene therapy manufacturing services market is projected to register a CAGR of 12.5% during the forecast period.

During the COVID-19 pandemic, the cell and gene therapy manufacturing services market was significantly affected. There were two primary reasons for that, the limited running capacity protocols introduced by the governments and the disruption of supply chain and logistics processes. However, new cell and gene therapy products were also launched during the pandemic for the treatment of COVID-19, which also impacted the market growth. For instance, in April 2022, the United States Food and Drug Administration (FDA) granted clearance to BioCardia's Investigational New Drug (IND) application to commence a Phase I/II clinical trial of COVID-19 stem cell therapy, BCDA-04, in adults recovering from COVID-19-linked acute respiratory distress syndrome (ARDS). These new IND applications in the treatment of COVID-19 helped to increase contract manufacturing services among companies. However, as the pandemic has subsided, the market is expected to have pre-pandemic growth levels during the study's forecast period.

Factors driving the market growth include the high prevalence of cancer and other target diseases and increasing R&D investments in pharmaceutical companies. For instance, according to an article published by the Chinese Medical Journal in February 2022, it was estimated that 2022 there were approximately 4,820,000 and 2,370,000 new cancer cases in China and the United States. The most common cancers were lung cancer in China and breast cancer in the United States. As the number of cancer cases increases, the reliance on gene therapy will also increase, thus, boosting the market's growth.

Furthermore, according to the data published by the National Cancer Center of Japan in June 2022, an estimated 158,200 new cancer cases were expected in Japan in the current year, out of which 89,500 were estimated to be in males and 68,700 in females. Such an increasing incidence of colorectal cancer is expected to drive the demand for gene and cell therapy products, fueling segment growth over the forecast period.

Moreover, as per the report published by the Journal of Orthopedic Surgery and Research in October 2021, the pooled prevalence of osteoporosis worldwide was reported to be 18.3%. Stem cell therapy for osteoporosis could potentially reduce the susceptibility to fractures. Thus, with the rising burden of orthopedic disorders, the demand for cell and gene therapy manufacturing services is also expected to grow.

Furthermore, the rising development of cell therapy facilities is also expected to boost the market growth. For instance, in June 2022, OrganaBio, LLC initiated Good Manufacturing Practice (GMP) manufacturing operations at its new cell therapy manufacturing facility in the United States. The new facility offered contract and development manufacturing for custom solutions for therapeutics developers.

Thus the above-mentioned factors such as the rising prevalence of various diseases such as cancer and osteoporosis, among others are expected to drive the growth of the studied market during the forecast period. However, high operational costs associated with the cell and gene therapy manufacturing are expected to restrain the market growth.

Cell and Gene Therapy Manufacturing Services Market Trends

Allogeneic Segment is Expected to Have a Significant Market Share During the Forecast Period

Cell and Gene Therapy Manufacturing Services Industry Segmentation

As per the scope of the report, cell therapy aims to treat disorders and diseases by restoring or changing certain groups of cells or by providing cells to carry therapy through the body. With cell therapy, cells are formed or modified outside the body before being introduced into the patient. The cells may derive from the patient (autologous cells) or a donor (allogeneic cells). Gene therapy aims to treat disorders by replacing or introducing genes into cells- either inside the body (in vivo) or outside of the body (ex vivo). The cell and gene therapy manufacturing services market is segmented by type (cell therapy (allogeneic, autologous, and viral vector) and gene therapy (non-viral vectors and viral vectors)), application (clinical manufacturing and commercial manufacturing), indication (oncology diseases, cardiovascular diseases, orthopaedic diseases, ophthalmology diseases, central nervous system disorders, infectious diseases, and other indications), end user (pharmaceutical and biotechnology companies, academic and research institutes, and other end users), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD) for the above segments.