U.S. Cell and Gene Therapy Market - Databook 2025 to 2034

The U.S. cell and gene therapy market size surpassed USD 5.5 billion in 2024 and is predicted to reach around USD 26.99 billion by 2034, registering a CAGR of 17.24% from 2025 to 2034.

Highlights of the U.S. Cell and Gene Therapy Market

• By therapy type, the cell therapy segment held a dominant presence in the market in 2024.
• By therapy type, the gene therapy segment is expected to grow at the fastest rate in the market during the forecast period of 2025 to 2034.
• By therapeutic class, the infectious disease segment accounted for a considerable share of the market in 2024.
• By therapeutic class, the genetic disorders segment is projected to experience the highest growth rate in the market between 2025 and 2034.
• By delivery method, the in vivo segment led the market and is also the fastest-growing segment in the market.
• By end-users, the cancer care centers segment registered its dominance over the market in 2024.
• By end-users, the hospitals segment is anticipated to grow with the highest CAGR in the market during the studied years.

Industry Valuation and Growth Rate Projection

The U.S. cell and gene therapy market is growing rapidly and redefining how we treat serious diseases. The market uses science to repair or replace damaged cells and genes in the body, helping to treat cancer and rare genetic disorders, as well as other chronic health conditions. There are multiple companies and research centers in the U.S. that are developing new and better treatments.

There is a good amount of governmental and FDA support, which is assisting in growing this market. The idea and options of these therapies are now reaching more people, and with that, more patients are beginning to use them. The new technologies and influx of investment in cell and gene therapy are leading to further growth of the U.S. cell and gene therapies market over the next several years.

What Are the Market Trends in the U.S. Cell and Gene Therapy Market?

The market trends in the U.S. cell and gene therapy market indicate the increase in cancer diagnoses, strict FDA approvals, adoption of personalized medicine, and partnerships amongst the pharmaceutical companies and hospitals.

• Gene therapy for cancer: The increase in cancer diagnoses has shown an increasing demand for complex cell and gene therapies, especially CAR-T therapy as potential treatments for blood cancers.
• FDA approvals are happening, and new therapies are being made available to patients more quickly across the U.S.
• Advances in personalized medicine allow for treatments that are best for that type of patient.
• Therapies are more available as partnerships develop, and pharmaceutical companies and hospitals begin to team up.

What Are the Restraints in the U.S. Cell and Gene Therapy Market?

Restraints in the U.S. cell and gene therapy market include high treatment costs, complex supply chains and strict regulations, delays in offering therapies due to FDA review times, and limited supply of skilled workers in the U.S. market.

• As a result of high treatment costs, therapies are simply too expensive for many patients and insurance plans in the U.S.
• Complex supply chains and handling regulations mean longer delivery and storage times.
• FDA review times for some newly approved therapies create additional delays in offering therapies from the time of initiation to market.
• A limited supply of skilled workers in biotechnology labs creates difficulties for labs to keep up with demand.

What Are the Opportunities in the U.S. Cell and Gene Therapy Market?

Growth opportunities in the U.S. cell and gene therapy market are linked to the government funding and support, an increase in centers for cancer treatment, insurance reform in the country, and new and advanced scientific tools for treatment.

• Government funding and tax support can assist companies in developing lower-cost, faster therapies.
• Increasing cancer treatment center availability across the U.S. increases therapy availability.
• New tools for U.S. scientists, such as CRISPR, can be used to develop new treatments.
• Insurance reform efforts may lead to improved coverage for expensive cell and gene therapies.

Recent Developments in the U.S. Cell and Gene Therapy Market:

• In June 2025, in an unexpected leadership shake-up, the U.S. FDA removed its most senior cell and gene therapy regulators, Peter Marks and Celia Witten. There are concerns about regulatory stability and whether the USA will continue to approve advanced therapies.
• In June 2025, there was a recent summit of leading experts in cell and gene therapy, who have written to the FDA to ask to expedite American solutions, while asking the FDA to shorten regulatory timelines. They stressed faster approvals and creating more innovative manufacturers, in order to keep the USA competitive in the advanced biotechnology sector.
• In May 2025, the NIH previously successfully treated an infant with a rare and currently incurable genetic disease with personalized gene therapy. The treatment was also unique in the fact that it was the first fully customized treatment of its kind created and administered in the USA, showing plausible outcomes for treatments in the future.
• In April 2025, Obsidian Therapeutics reported preclinical data regarding their cytoDRiVE platform at a meeting of the American Society of Gene and Cell Therapy. The research reported results in precision-controlled cell therapies that could lead to new treatment strategies targeting cancer.