U.S. Cell Therapy Market Size to Hit USD 19.67 Billion by 2034

The U.S. cell therapy market size was estimated at USD 2.88 billion in 2023 and is projected to hit around USD 19.67 billion by 2033, growing at a CAGR of 21.18% during the forecast period from 2024 to 2033. The U.S. cell therapy market growth is attributed to substantial expansion, fueled by progress in regenerative medicine a rise in clinical trials and technological advancements.

Key Takeaways:

·         Autologous therapies segment dominated the market with a share of 91.9% in 2023.

·         Allogenic therapies segment is projected to witness growth at the largest CAGR from 2024 to 2033

·         The oncology segment held the market with a share of 92.5% in 2023.

·         The dermatology segment is anticipated to grow at a significant CAGR from 2024 to 2033

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U.S. Cell Therapy Market Report Scope

The U.S. cell therapy market is concentrated on the development, research and commercialization of therapies based on live cells for repairing or regenerating damaged organs and tissues. It comprises autologous and allogeneic therapies aimed at treating cancer, cardiovascular disease, autoimmune disorders and neurological conditions. Major drivers are growth in stem cell research, gene editing and increasing demand for personalized medicine. This category also covers bone marrow transplant, stem cell treatments and CAR T-cell treatments, each offering therapeutic measures for a host of medical issues.

The U.S. cell therapy market holds key opportunities especially in cancer immunotherapy and the increased need for CAR-T cell treatments, which have revolutionized the treatment of haematological cancers. The therapies work effectively to leverage the immune system to kill cancer cells, a great leap in personalized medicine. Moreover, the incorporation of CRISPR-Cas9 gene editing technology provides improved efficacy in cell therapy enabling precise editing for treating inherited diseases and cancers. The CRISPR-Cas9 market is expected to reach driving solid growth.

The U.S. government has initiated several programs to enhance access to cell and gene therapies especially for sickle cell disease. The Cell and Gene Therapy Access Model initiated in January 2025, is intended to enhance outcomes-based agreements. The regulatory guidance agenda of FDA is intended to provide clarity on development pathways. The FDA and NIH will also organize a Rare Disease Day Event on February 2025, with a focus on patient voices and scientific progress in rare diseases.

Artificial Intelligence is transforming the cell therapy industry by streamlining processes such as drug discovery, patient stratification and production efficiency. AI algorithms are capable of processing advanced data sets to predict therapeutic targets along with forecast patient reactions and improve clinical trial design. AI automated process also minimizes variability and scalability in cell therapy production, creating more consistent and compliant products with regulatory requirements. In 2024, Novartis collaborated with Owkin to leverage AI and machine learning for the improvement of CAR-T cell treatments through the identification of biomarkers indicative of therapy success allowing for personalized cancer immunotherapy.

Market Trends

·         Expanding Use of Regenerative Health Care

Regenerative medicine is an emerging area that incorporates cell therapies to meet unmet clinical needs in diseases such as spinal cord injury, diabetes and osteoarthritis. Stem cell therapies propel progress in organ regeneration and tissue repair, providing groundbreaking solutions to degenerative and chronic diseases in US.

·         Integration of Technology

The incorporation of technologies such as CRISPR gene editing, 3D bioprinting and automation in the production of cell therapies is transforming the industry improving productivity efficiency and facilitating access to innovative therapies. Technologies such as CRISPR-Cas9 are also fueling industry growth improving production and outcomes.

·         Growing Use of CAR-T Cell Treatments

CAR-T therapies, particularly for haematological cancers like leukaemia and lymphoma are gaining popularity due to their high efficacy and sustained remission rates. FDA approvals and ongoing clinical trials further enhance their market potential in solid tumors.

·         Partnerships and Funding

Cooperative ventures between biotechnology companies, pharma firms, and research institutes drive innovation by sharing resources and knowledge. Partnerships augment the development of cell therapy, enrich clinical trials and hasten the market release of new drugs with massive amounts of funding available.

Segment Insights

By Therapy Type Insights

Autologous therapies segment dominated the market with a share of 91.9% in 2023. due to its personalized nature that utilizes own cells of patient, lowering immune rejection threats and improving treatment effectiveness. Such therapies are highly effective on difficult to treat conditions like cancer, cardiovascular disease, neurodegenerative diseases and orthopedic trauma. The increased focus on precision medicine and improvements in cell processing technologies further reinforce leadership of the region. Key ones are CardiAMP Cell Therapy of BIOCARDIA, autologous bone marrow cells-based treatment for ischemic heart failure and Yescarta of Kite Pharma, a licensed CAR-T product for large B-cell lymphoma.

The allogeneic therapies market is expected to register the highest CAGR between 2025 and 2035 based on their benefits over autologous therapies, including ease of availability, scalability and affordability. Donor cells are employed in these therapies enabling standardized manufacturing and wider patient access. Growth is being promoted due to the emphasis on off the shelf therapies as well as process improvements. AlloCAR T therapy of Allogene Therapeutics, intended for multiple cancers is a prime example of the scalability and affordability of allogeneic solutions. Firms such as Kite owned by Gilead are working on allogenic CAR T-cell therapies, providing a more scalable and cost-effective option.

By Therapeutic Area Insights

The oncology segment held the market with a share of 92.5% in 2023. with highest of the market share because it has a wider range of applications in cancer therapies. Therapies such as CAR T-cell therapy TCR-based therapy and allogeneic cord blood therapy have been demonstrated to be exceptionally effective in cancer treatment of blood cancers, melanoma and multiple myeloma. This development is fueled by growing investment and advancements in cancer specific cell therapies as well as FDA approvals that increase their availability. Cases in point include Yescarta from Kite Pharma, a CAR T-cell therapy for relapsed large B-cell lymphoma and Abecma from Bristol Myers Squibb approved for multiple myeloma. These show the strong role of cell therapies in transforming the treatment of oncology.

The U.S. cell therapy market dermatology segment is expected to experience strong growth between 2025 and 2035 based on the increased application of cell therapies in skin disease treatment. More companies are developing dermatological therapeutics via cell therapy and this will help drive the growth of the segment. For example, SkinCure Oncology announced a novel non-invasive skin cancer therapy technology in March 2024 providing a targeted and effective solution for non-melanoma skin cancer. This technology is a good example of the evolution of cell therapies for dermatological diseases, supporting the high growth rate of segment.

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Related Report

·         Cell Therapy Manufacturing Market - https://www.precedenceresearch.com/cell-therapy-manufacturing-market

·         CAR T-Cell Therapy Market - https://www.precedenceresearch.com/car-t-cell-therapy-market

·         Automated And Closed Cell Therapy Processing System Market - https://www.precedenceresearch.com/automated-and-closed-cell-therapy-processing-system-market

·         Automated And Closed Cell Therapy Market - https://www.precedenceresearch.com/automated-and-closed-cell-therapy-market

·         Autologous Cell Therapy Market- https://www.precedenceresearch.com/autologous-cell-therapy-market

U.S. Cell therapy Market Top Companies

·         Gilead Sciences, Inc.

·         Selecta Bioscience

·         Bristol-Myers Squibb Company

·         CARGO Therapeutics, Inc.

·         Johnson & Johnson

·         Atara Biotherapeutics, Inc

·         Nkarta, Inc

·         Cellular Biomedicine Group, Inc

·         Vertex Pharmaceuticals Incorporated

·         Aurion Biotech

U.S. Cell therapy Market Recent Developments

·         In September 2024, Cellares a biotechnology startup company has launched the Cell Shuttle, an automated device intended to revolutionize the production of cell therapy by minimizing the need for human labor and area thus driving efficiency and scalability for individualized cell therapies.

·         In December 2024, Remestemcel-L branded as Ryoncil has been approved by the FDA for the treatment of steroid refractory acute graft versus host disease in children, the first mesenchymal stromal cell therapy approved in the U.S. providing an additional therapeutic option.

·         In March 2024, Breyanzi of Bristol-Myers Squibb, CD19 directed CAR T cell treatment has obtained FDA approval to treat relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treatment.

·         In November 2024, Roche is set to buy US cell therapy company Poseida Therapeutics, which develops cell therapies for blood cancer, solid tumours and autoimmune diseases in a deal worth as much as USD 1.5 billion to reinforce its cell therapy pipeline and enlarge its oncology footprint.

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Cell Therapy market.

By Therapy Type

·         Allogeneic Therapies

o   Stem Cell Therapies

§  Hematopoietic Stem Cell Therapies

§  Mesenchymal Stem Cell Therapies

o   Non-Stem Cell Therapies

§  Keratinocytes & Fibroblast-based Therapies

§  Others

·         Autologous Therapies

o   T-Cell Therapies

§  CAR T Cell Therapy

§  T Cell Receptor (TCR)-based

o   Others

By Therapeutic Area

·         Oncology

·         Dermatology

·         Others

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