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Market Overview

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The US cell and gene therapy market had a value of $3.22 billion in 2022, and it is projected to reach $25.58 billion by 2028, with a compound annual growth rate (CAGR) of 41.25% during the study period.

Cell and gene therapies are advanced therapy medicinal products (ATMPs) that are developed based on genes, tissues, and cells. The introduction of many new ATMPs in recent years, particularly cell and gene therapies, has significantly changed the treatment landscape for complex and challenging diseases such as cancer and genetic disorders. This growth in the cell and gene therapy market has led to several high-profile mergers and acquisitions, including bluebird bio/BioMarin, Bristol-Myers Squibb/Celgene/Juno Therapeutics, Gilead Sciences/Kite, Novartis/AveXis, CDMO CELLforCURE, Roche/Spark Therapeutics, and Smith & Nephew/Osiris Therapeutics. It is projected that over 20 cell therapy launches and up to 31 gene therapy launches, including more than 29 Adeno-associated viruses (AAV) therapies, will be approved by 2024.

Among all the commercial cell and gene therapies, Zolgensma is the first and only product to achieve blockbuster status. Zolgensma generated $1.37 billion in revenue in 2022 and is expected to reach approximately $5.00 billion by 2026.

Drug developers are focusing on the development and commercialization of CAR-T cell-based gene therapies. Globally, there are over 1,000 clinical trials underway for CAR T-cell therapies, with at least 500 trials focused on cancer alone. Currently available commercial CAR-T therapies in the market include Kymriah (Novartis), Yescarta (Gilead Sciences), Tecartus (Gilead Sciences), Breyanzi (Bristol Myers Squibb), Abecma (Bristol Myers Squibb), and Carvykti (Janssen Biotech / Legend Biotech).

In 2022, the US had the fastest-growing market share in North America. The growth of the market is driven by an increasing target patient population, support from regulatory bodies, and improved access to healthcare due to a well-established healthcare infrastructure.

The Food and Drug Administration (FDA) has approved over twenty cell and gene therapy drugs. However, there is a pipeline of approximately 365 investigational therapies, with more than half of them in Phase 2 clinical trials. Gene therapies targeting oncology and rare diseases continue to be the top areas of focus from preclinical stages through pre-registration.

There are around 1,604 clinical trials investigating various cell and gene therapies in the US. This increase can be attributed to the rise in funding for cell and gene therapy. Industry-sponsored trials continue to dominate, accounting for 51.81% of the total.

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Market Segmentation

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The market is segmented based on various factors, including product, application, and end-user.

Segmentation by Product
Cell Therapy
Gene Therapy

Segmentation by Application
Oncology
Genetic Disorders
Dermatology
Musculoskeletal
Others

Segmentation by End-user
Hospitals
Cancer Care Centers
Others

In the United States, the gene therapy segment was valued at $2.48 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 46.22% between 2022 and 2028. During the forecast period, the gene therapy segment is expected to witness faster growth compared to the cell therapy segment among the product segmentation. Cell and gene therapy has emerged as a revolutionary form of medicine, showing promising results in the treatment of various cancers and rare genetic disorders. The market already boasts more than five major commercialized cell therapies. Furthermore, the recent approval by the FDA of Tecartus for patients with mantle cell lymphoma (MCL), a rare cancer of white blood cells, further contributes to the advancements in this field.

In the United States, the hospital segment was valued at $1.61 billion in 2022 and is projected to grow at a CAGR of 42.96% between 2022 and 2028. Among the end-user segmentation, hospitals are expected to dominate the market. However, cancer care centers are anticipated to be the fastest-growing segment during the forecast period. Given that hospitals are typically the first point of care for any medical condition, and considering the advanced equipment and skilled professionals required for cell and gene therapies, most patients prefer hospitals over other clinics or centers for these treatments.

In terms of application segmentation, the oncology segment was valued at $1.30 billion in 2022 and is projected to grow at a CAGR of 46.39% from 2022 to 2028. During the study period, oncology is expected to dominate the market. Vendors have introduced multiple cell and gene therapies for the treatment of cancer, including Kymriah, Yescarta, and Tecartus, which have played significant roles in the US market. The approval of these therapies has made a substantial impact on oncology treatments, leading patients to shift from traditional chemotherapy to more personalized targeted treatments in the country.

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Competitive Landscape

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The competition in the cell and gene therapies market in the United States is currently becoming more intense, as global players offer a wide range of products for the treatment of various diseases. In terms of market share, several major players currently dominate the market. These include Novartis, Gilead Sciences, Bluebird bio, Amgen, and Spark Therapeutics (Roche). Due to the presence of a large pool of target patient populations with chronic diseases such as cancer and diabetic foot ulcers, the market presents significant growth opportunities for both existing and future/emerging players.

Key companies profiled in this report include 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.

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Key Questions Answered

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What is the market size of the cell and gene therapy market in the United States?
What are the latest trends observed in the cell and gene therapy market?
Who are the key players in the cell and gene therapy market?
What are the key areas where cell and gene therapy manufacturing companies in the United States should invest to sustain their presence in the market?
Which cell and gene therapy products have recently been approved in the United States? How many companies are currently developing cell and gene therapies in the United States?
How many clinical trials are currently investigating cell and gene therapy in the United States?
Which application segmentation holds a larger market share in the cell and gene therapy market in the United States?
Which end-user segment offers greater business opportunities in the cell and gene therapy market in the United States?
Which product type segment is expected to have a significant influence on the future of the cell and gene therapy market in the United States?