U.S. Cell & Gene Therapy Market - Focused Insights 2023-2028

U.S. CELL AND GENE THERAPY MARKET OVERVIEW

The U.S. cell and gene therapy market was valued at USD 3.22 billion in 2022 and is projected to surpass USD 25.58 billion by 2028, growing with a CAGR of 41.25% during the forecast period. 

By 2028, the U.S. cell and gene therapy market is predicted to grow nearly seven times its current market value. The growth can be attributed to the rising target patient population, regulatory body support, moderate reimbursement coverage, and other factors. The growing focus of vendors in R&D to develop novel cell and gene therapies is projected to impact the market growth significantly. 

The report covers commercial cell and gene therapy products, such as conventional cell therapies, CAR-T cell therapies, gene therapies, cell-based immunotherapies, and oncolytic virus therapies. Cell therapies sourced from mesenchymal stem cells, cell-based immune modulation therapies, and cell/tissue-based products derived from patients' blood are also covered in the report. Tissue-engineered products and tissue grafts/scaffolds with synthetic mechanical structures are excluded from the report's scope. This report provides a comprehensive and current market scenario of the U.S. cell and gene therapy market, including the U.S. cell and gene therapy market size, anticipated market forecast, relevant market segmentations, and industry trends.   

MARKET DRIVERS 

Increasing  Targeting Patient Population: With the increasing prevalence of various chronic diseases and conditions, cell and gene therapy demand has grown in recent years. Conventional medications are not providing a satisfying cure for multiple diseases, thereby paving the way for cell and gene therapy products that fill the unmet needs in the market. 

Increase in CMOs to Manufacture Cell and Gene Therapies: In anticipation of high future demand, the largest CMO invested in the manufacturing capacity of advanced therapy medicinal products. The major factors driving the demand for contract manufacturers include continuous cost-cutting efforts, decreased time to market, a growing number of specialty firms that lack in-house manufacturing facilities, and an increase in outsourcing activities. 

US CELL AND GENE THERAPY MARKET INSIGHTS 

• The gene therapy segment is growing significantly, with the highest CAGR of 46.22% during the forecast period. The growth of the gene therapy market can be attributed to the rising target patient population, regulatory body support, and higher access to healthcare due to well-established healthcare infrastructure. 
• In the end-user segment, hospitals are dominating with the largest market size in 2022 of the U.S. cell and gene therapy market. Hospitals being the first point of care for any disease condition, and cell and gene therapies demanding advanced equipment and skilled professionals available in hospitals prompts most patients to prefer hospitals to other clinics or centers. 
• The U.S. cell and gene therapy industry by application type is classified into oncology, genetic disorders, and others. In 2022, the oncology segment dominated the segmental share of the U.S. industry. 
• Among all commercial cell and gene therapies, Zolgensma is the first and only product to achieve the blockbuster drug tag. Zolgensma generated a revenue of USD 1.37 billion in 2022 and could reach around USD 5.00 billion by 2026. 
• Drug developers are prioritizing developing and commercializing CAR-T cell-based gene therapies. Globally, more than 1,000 clinical trials are being conducted on CAR T-cell therapies, of which at least 500 clinical trials are for cancer alone. Kymriah (Novartis), Yescarta (Gilead Sciences), Tecartus (Gilead Sciences), Breyanzi (Bristol Myers Squibb), Abecma (Bristol Myers Squibb), and Carvykti (Janssen Biotech / Legend Biotech) are the commercial CAR-T therapies available in the market. 
• The Food and Drug Administration (FDA) has approved over twenty cell and gene therapy drugs. Still, the new product pipeline has approximately 365 investigational therapies, with more than half of these in Phase 2 clinical trials. Oncology and rare diseases remain the top areas targeted by gene therapies from preclinical through pre-registration. 
• Approximately 1,604 clinical trials are under investigation for various cell and gene therapies in the U.S. This increase could be because of increased funding for cell and gene therapy. The industry-sponsored trials continue to dominate with a share of 51.81%. 

VENDOR LANDSCAPE  

Novartis, Gilead Sciences, Spark Therapeutics, Amgen, Orchard Therapeutics, Bristol-Myers Squibb, BioMarin, PTC Therapeutics, and Organogenesis are key players in the U.S. cell and gene therapy market. The market offers tremendous growth opportunities for existing and future/emerging players because of a large pool of target patient populations with chronic diseases such as cancer, genetic and rare diseases, and other complex disorders.