US Cell & Gene Therapy Market - Focused Insights 2023-2028

REPORT OVERVIEW

• This report offers market size & forecast data for the cell & gene therapy market in the US. The report covers commercial cell & 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 US cell & gene therapy market, including the US cell & gene therapy market size, anticipated market forecast, relevant market segmentations, and industry trends.
• The study considers a detailed scenario of the present cell and gene therapy market and its market dynamics for 2023-2028 in the US. It covers a detailed overview of several market growth enablers, restraints, and trends. The report offers both the demand and supply aspects of the market. It profiles and examines leading companies and other prominent players operating in the market.

MARKET DEFINITION

Cell and gene therapies are part of advanced therapy medicinal products (ATMPs) developed based on genes, tissues, and cells. The introduction of many novel ATMPs in recent years, especially cell and gene therapies, changed the treatment dynamics of many complex and challenging diseases like cancer and genetic disorders. In recent years, growth in the cell and gene therapy market has fueled some high-profile mergers and acquisitions, including bluebird bio/BioMarin, Bristol-Myers Squibb/Celgene/Juno Therapeutics, Gilead Sciences/Kite, Novartis/AveXis and the CDMO CELLforCURE, Roche/Spark Therapeutics, and Smith & Nephew/Osiris Therapeutics. Over 20 cell therapy launches and as many as 31 gene therapies launches - including more than 29 Adeno-associated viruses (AAV) therapies - are projected to be approved by 2024.

KEY HIGHLIGHTS

• The US cell and gene therapy market was valued at $3.22 billion in 2022 and is projected to reach $25.58 billion in 2028, with a compound annual growth rate (CAGR) of 41.25%, during the study period.
• Among all commercial cell & gene therapies, Zolgensma is the first and only product to achieve the blockbuster drug tag. Zolgensma generated a revenue of $1.37 billion in 2022 and could reach around $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.
• In 2022, the US was the fastest-growing market with a high market share in North America. The market is driven by an increased target patient population, regulatory body support, and higher access to healthcare due to well-established healthcare infrastructure.
• 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 US. This increase could be because of increased funding for cell and gene therapy. The industry-sponsored trials are continued to dominate with a share of 51.81%.
• Novartis, Gilead Sciences, Spark Therapeutics, Amgen, Orchard Therapeutics, Bristol-Myers Squibb, BioMarin, PTC Therapeutics, and Organogenesis are the leading players in the US 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.

VENDOR ANALYSIS

• Novartis
• Gilead Sciences
• Amgen
• Roche
• bluebird bio
• Legend Biotech
• Bristol-Myers Squibb
• UniQure
• Ferring Pharmaceuticals
• Organogenesis
• Vericel Corp
• Dendreon
• Mallinckrodt
• Enzyvant
• Avita Medical
• Fibrocell
• 4DMT
• Abeona Therapeutics
• Autolus Therapeutics
• Candel Therapeutics
• Castel Creek Biosciences
• Cellectis
• Evox Therapeutics
• Freeline Therapeutics
• Generation Bio
• Gensight Biologics
• Krystal Biotech
• MeiraGTx
• Pfizer
• Gamida Cell
• Iovance Biotherapeutics
• Sarepta Therapeutics
• PTC Therapeutics
• Atara Bio
• Adaptimmune
• CRISPR Therapeutics
• Carsgen Therapeutics
• Orchard Therapeutics
• Biomarin
• StemCyte
• Helixmith

REPORT HIGHLIGHTS

PRODUCT SEGMENTATION & FORECAST

• Product type
• Cell therapy
• Gene therapy
• Application type
• Oncology
• Genetic Disorders
• Dermatology
• Musculoskeletal
• Others
• End-user type
• Hospitals
• Cancer Care Centers
• Others

MARKET STRUCTURE

• Approved Cell & Gene Therapies
• Pipeline Analysis
• Clinical Trial Analysis
• Market Dynamics
• Competitive Landscape of Cell & Gene Therapies
• Key Vendors
• Other Prominent Vendors

PRICING & REIMBURSEMENT SCENARIO

• Pricing, Reimbursement, and Market Access
• Contract Manufacturing Organizations

APPENDIX

• Research Methodology
• Abbreviations