At 17.1% CAGR, the North America Cell and Gene Therapy Manufacturing Services Market is Projected to be worth US$ 14,711.72 million by 2030, says Business Market Insights

According to Business Market Insights research, the North America cell and gene therapy manufacturing services market was valued at US$ 4,153.27 million in 2022 and is expected to reach US$ 14,711.72 million by 2030, registering a CAGR of 17.1% from 2022 to 2030. Increase in number of approvals of cell and gene therapies and increasing popularity of outsourcing cell and gene therapy manufacturing are among the critical factors attributed to the North America cell and gene therapy manufacturing services market expansion.               

The advancements in biotechnology have led to the adoption of personalized treatments for a wide range of indications. Stem cell therapies are being used to treat chronic diseases, such as cancer, neurological disorders, and genetic disorders. Further, the advantages of cell therapy, such as targeted treatment, faster and efficient recovery, and reduced side effects, promote the adoption of various products. Globally, cell therapies are widely adopted owing to the availability of Food and Drug Administration (FDA) approved products. Following is the list of cell and gene therapy products approved by FDA in recent years:

• In April 2020, the FDA awarded regenerative medicine advanced therapy designation to Novartis' Kymriah to treat refractory (r/r) follicular lymphoma (FL) in adults.

• In July 2020, the FDA approved a CAR T-cell therapy brexucabtagene autoleucel (Tecartus) for patients with mantle cell lymphoma. It is the first FDA-approved CAR T-cell therapy for mantle cell lymphoma, and it was approved under the Accelerated Approval pathway. Tecartus also received Orphan Drug designation, which encourages the development of drugs for rare diseases. The other approved CAR-T cell therapies for cancer are Kymriah for acute lymphoblastic leukemia and Yescarta for diffuse large B-cell lymphoma.

• In 2022, ADSTILADRIN, an adenovirus manufactured by Ferring Pharmaceuticals A/S, was approved by FDA. This recombinant adenovirus (rAd-IFNa/Syn3) delivers human interferon alfa-2b cDNA into the bladder epithelium to treat patients with certain types of bladder cancer.

• In 2022, CARVYKTI, manufactured by Janssen Biotech, Inc.—an autologous CAR-T cell engineered with lentivirus to attack BCMA-expressing tumor cells for treatment of certain kinds of relapsed or refractory multiple myeloma—was also approved by FDA.

• In 2022, FDA approved HEMGENIX, manufactured by CSL Behring LLC, which is a recombinant AAV5 delivers F9 to treat patients with certain kinds of Hemophilia B.

• In 2022, FDA approved VYJUVEK, manufactured by Krystal Biotech, Inc., for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

Therefore, the increasing approval of cell and gene therapies is fueling the growth of North America cell and gene therapy manufacturing services market.  

On the contrary, high cost of cell and gene therapy manufacturing hurdles the growth of North America cell and gene therapy manufacturing services market.

Based on type, the North America cell and gene therapy manufacturing services market is bifurcated into cell therapy and gene therapy. The cell therapy segment held 67.7% share of North America cell and gene therapy manufacturing services market in 2022, amassing US$ 2,810.13 million. It is projected to garner US$ 10,084.57 million by 2030 to expand at 17.3% CAGR during 2022–2030. The cell therapy segment is further segmented into autologous and allogenic. The gene therapy segment is further segmented into viral and non-viral vector.

Based on indication, the North America cell and gene therapy manufacturing services market is segmented into cancer, orthopedics, and others. The cancer segment held 55.9% share of North America cell and gene therapy manufacturing services market in 2022, amassing US$ 2,320.41 million. It is projected to garner US$ 8,766.41 million by 2030 to expand at 18.1% CAGR during 2022–2030.

Based on application, the North America cell and gene therapy manufacturing services market is bifurcated into clinical manufacturing and commercial manufacturing. The commercial manufacturing segment held 62.8% share of North America cell and gene therapy manufacturing services market in 2022, amassing US$ 2,609.36 million. It is projected to garner US$ 9,734.30 million by 2030 to expand at 17.9% CAGR during 2022–2030.  

Based on end user, the North America cell and gene therapy manufacturing services market is bifurcated into pharmaceutical and biotechnology companies and contract research organization (CROs). The pharmaceutical and biotechnology companies segment held 79.0% share of North America cell and gene therapy manufacturing services market in 2022, amassing US$ 3,280.09 million. It is projected to garner US$ 11,705.28 million by 2030 to expand at 17.2% CAGR during 2022–2030.

Based on country, the North America cell and gene therapy manufacturing services market is segmented into the US, Canada, Mexico. Our regional analysis states that the US captured 80.3% share of North America cell and gene therapy manufacturing services market in 2022. It was assessed at US$ 3,334.61 million in 2022 and is likely to hit US$ 11,822.40 million by 2030, exhibiting a CAGR of 17.1% during 2022–2030.  

Key players operating in the North America cell and gene therapy manufacturing services market are Catalent Inc, Charles River Laboratories International Inc, FUJIFILM Holdings Corp, Lonza Group AG, Merck KgaA, National Resilience Inc, Nikon Corp, Oxford BioMedica Plc, Takara Bio Inc, Thermo Fisher Scientific Inc, and WuXi AppTec Co LtdĀ, among others.

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