Cell and Gene Therapy Manufacturing Services Market Size, Share, Industry, Forecast and outlook (2024-2031)

Cell and Gene Therapy Manufacturing Services Market is segmented By Type (Cell Therapy (Allogeneic, Autologous, Viral Vector), Gene Therapy (Non-viral Vectors, Viral Vectors), By Indication (Oncology Diseases, Cardiovascular Diseases, Orthopedic Diseases, Ophthalmology Diseases, Central Nervous System Disorders, Infectious Diseases, Others), By Application (Clinical Manufacturing, Commercial Manufacturing), By End-user (Pharmaceutical and Biotechnology Companies, Academic and Research Institutes, Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031.

Cell and Gene Therapy Manufacturing Services Market Overview

Cell & Gene Therapy Manufacturing Services Market is estimated to reach a CAGR 12.9% during the forecast period (2024-2031).

Cell and gene therapies are intended to stop or reverse disease progression. They are frequently one-time treatments that can cure specific ailments by alleviating the underlying cause of disease. Cell and gene therapies are a niche product area. They have been a recent active area of investment by both pharmaceutical companies to add products to the pipeline and manufacturing capabilities and by certain contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) to add cell-therapy manufacturing capabilities to their toolbox.

Cell and Gene Therapy Manufacturing Services Market Scope

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Cell and Gene Therapy Manufacturing Services Market Dynamics

Increasing research and development of cell and gene therapy products in pharmaceutical and biotechnology companies is expected to drive market growth.

ElevateBio shares some parallels with The Discovery Labs, another innovative service firm. BioCentriq, a university-based services organization already operating in New Jersey, would better compare the Philadelphia-area venture. These three firms and others like them are targeting the booming cell and gene therapy market with their services. They are assisting in creating a completely new branch of the pharmaceutical CDMO world in the process. Moreover, Only seven cell and gene therapy medications have been licensed by the US Food and Drug Administration. Still, more than 1,200 investigational therapies are in the pipeline, with more than half in Phase 2 clinical trials. Annual sales growth is expected to be over 15% for cell therapies and approximately 30% for gene therapies. And the number of companies developing cell and gene therapies is fast increasing; the Alliance for Regenerative Medicine predicts 1,100 such companies in 2020, up 10% from 2019. Thus, the market is expected to drive in the forecast period from the above statements.

Restraint:

Cell and gene therapy production has substantial operating costs. For instance, The cost of goods/manufacturing alone for a gene treatment can range from $500,000 to $1 million. It doesn't include R&D, clinical trial costs, or the price of establishing the commercial infrastructure needed to enable access to patients. Therefore, the market is expected to hamper market growth.

Industry Analysis

Porter’s Five Forces:

COVID-19 Impact Analysis

The COVID-19 pandemic has moderately impacted healthcare systems and the market. The pandemic resulted in control measures that impacted life science operations, including production and research. The CEO of Flagship Pioneering (US) indicated in an article published by Nature Biotechnology that lab productivity at many of its research-based settings was just 30–50 percent. Maintaining that rate was a difficulty. Moreover, hundreds of relevant clinical trials are currently underway worldwide. Numerous research facilities implemented protocols limiting the number of lab employees allowed on-site to reduce the risk of virus transmission, putting many investigations on hold. For instance, The stoppage of patient enrolment caused about 61 percent of clinical studies to be halted. Thus, the market will undergo impetus growth during the forecast period.

Cell and Gene Therapy Manufacturing Services Market Segment Analysis

Cell Therapy segment is expected to hold the largest market share in cell & gene therapy manufacturing services market

The cell therapy segment is expected to dominate in 2020. Raising cell therapy awareness, increasing demand for cell therapy, increasing financing for new cell lines, expanding collaborations and acquisitions, and developing improved genomics tools for cell analysis are factors that the market is expected to boost in the forecast period. For instance, Cell therapies that are allogeneic or universal rely on a single source of cells to treat many patients. To construct a master cell bank, cells are taken from a donor sample (MCB). The MCB is then utilized as a source to generate cell populations treated according to the therapy's requirements. Moreover, Most CAR cell therapies, including the FDA-approved products, are generated using autologous T cells. It has several important advantages, including infusion of CAR-engineered cell products without immunologic mismatch between donor and recipient.

Additionally, Allogene Therapeutics, a clinical-stage biotechnology firm based in South San Francisco, California that develops allogeneic CAR T therapies for cancer, signed a lease deal in February 2019 to establish a 118,000-square-foot cell-therapy production facility in Newark, California. The facility is used to produce allogeneic CAR T treatments, which are patented. Thus, the market segment is expected to hold the largest market share in the forecast period. 

Cell and Gene Therapy Manufacturing Services Market Geographical Share

North America region holds the largest market share in the global cell & gene therapy manufacturing services market

In 2020, North America accounted for the highest revenue share. The increasing prevalence of cancer and clinical trials carried out by the market players and well-established healthcare facilities in the region are a few factors the market is expected to boost in the forecast period. For instance, according to the American Cancer Society, In 2021, 1,898,160 new cancer cases and 608,570 cancer deaths are projected to occur in the United States. In contrast, In 2020, an estimated 1,806,590 new cancer cases were diagnosed in the United States, and 606,520 people died from the disease. The three most common cancers for women are breast, lung, and colorectal, and they will account for an estimated 50% of all new cancer diagnoses in 2020.

Moreover, considerable part is by an increase in research and development activities and the availability of favorable healthcare infrastructure. For instance, According to a research titled Profitability of Large Pharmaceutical Companies Compared With Other Large Companies," published in March 2020, biotech companies earned USD 15.9 billion in the first three quarters of 2020, compared to USD 13.5 billion in the same period of 2018. Thus, the North American region is expected to hold the largest market share in the forecast period from the above statements.   

Cell and Gene Therapy Manufacturing Services Market Companies

Major key players in the cell & gene therapy manufacturing services market are Charles River Laboratories, Thermo Fisher Scientific Inc., Lonza, Merck KGaA, Catalent, Inc., Takara Bio Inc., FUJIFILM Irvine Scientific, F. Hoffmann-La Roche Ltd., Oxford Biomedica plc. and BioCentriq      

BioCentriq:

Overview:

BioCentriq was founded in 2018 and is a full-service CDMO for cell and gene therapy process development and clinical manufacturing. An ISO-7 certified GMP clinical manufacturing facility is in Newark, NJ. The company manufactures autologous and allogeneic cell therapies gene therapies at this facility and provides analytical and quality services across several cell types. Moreover, it also offers viral vector production, cell and viral banking and upstream and downstream processing. Additionally, it can manufacture immunotherapies, including monoclonal antibodies and proteins and vaccines. The facilities provide full customer access to hybrid teams from tech transfer through GMP clinical production. BioCentriq has a BSL-2 certified process development facility in South Brunswick, NJ, to accelerate scale-up and translation activities.

­Product Portfolio:

The company offers cell and gene therapy development and optimization, a dedicated scientific team with significant experience in the field, suspension and adherent cell culture capability, optimization: cell growth, vector selection, yield and R&D process replication with open to closed system transformation and optimization.