U.S. Cell Therapy Market Flourishes with Increased FDA Approvals for New Therapies

The U.S. Cell therapy market size was valued at USD 2.66 billion in 2023 and is anticipated to grow at a CAGR of 21.18% from 2024 to 2030. Major factors contributing to this growth include the growing adoption of regenerative medicine, the rising number of clinical trials on cell therapies due to positive therapeutic outcomes, and the introduction of technological advancements in the market.

The U.S. cell therapy market accounted for a 56% share of the global cell therapy market in 2023. The increasing number of clinical studies on cellular therapies showcases a growing recognition of their potential across various medical conditions. Pharmaceutical companies are increasingly focusing on exploring and utilizing the therapeutic benefits of cells. Over 2,000 clinical trials were ongoing in the cell and gene therapy field as of January 2023, driven by positive outcomes in early-phase trials. These studies target conditions like cancer, autoimmune disorders, and degenerative diseases, aiming to maximize the therapeutic potential of different cell types, including stem cells and immune cells. Moreover, the advancement of genetic editing technologies like CRISPR-Cas9 enables precise modifications to cells’ genetic material thereby driving market growth.

In addition, the growing investments and funding for cell therapies are anticipated to enhance competition in the market. Academic and medical institutions are contributing to improving access to cell therapies. For instance, in October 2022, Cedars-Sinai received a 5-year, USD 8 million grant from California’s stem cell agency to establish a new clinic aimed at enhancing access to stem cell and gene therapies. This escalating investment and funding for cell therapies is projected to intensify competition within the market.

Gather more insights about the market drivers, restrains and growth of the U.S. Cell Therapy Market

The fragmented landscape of the U.S. cell therapy market is influenced by the presence of numerous companies operating within it. Moreover, companies are investing heavily in clinical trials for these products, and growing research funding from government entities in this sector, is anticipated to expand the industry in the coming years.

The research institutions are introducing cutting-edge cell therapies to significantly improve patient outcomes and escalate customer base. The use of cell therapy in developing advanced treatments provides a promising opportunity to address changing patient needs and advance personalized medicine. For instance, in July 2023, the University of Maryland School of Medicine (UMSOM) researchers developed a novel CAR T-cell therapy that, in preclinical investigations, targeted cancer cells specifically while preserving healthy cells.

Companies in the U.S. cell therapy industry leverage partnership and collaboration strategies to enhance their manufacturing capabilities and expand the geographic reach of their product offerings. Collaborative efforts with various entities, enable companies to access new markets, resources, and opportunities, ultimately strengthening their market presence and competitiveness. for instance, in October 2023, Lupus Therapeutics announced a partnership agreement with Nkarta, Inc. to support the evaluation of Natural Killer (NK) cell therapy in Lupus Nephritis.

The U.S. cell therapy industry is supported by the M&A activities undertaken by various companies. These crucial aspects of strategic management facilitate growth, restructuring, and enhancing competitive positions within the industry. For instance, in November 2023, Selecta Biosciences, Inc. announced a merger with Cartesian Therapeutics, Inc. This merger was accompanied by a $60.25 million private financing. This would result in the introduction of cutting-edge treatments for autoimmune conditions.

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) are increasingly supporting advanced therapies, simplifying approval procedures, enabling allogeneic stem cell therapies for a range of diseases, and nurturing favorable research. The rise in regulatory authorizations within this sector attracted new entrants in the biotechnology sector. For instance, in June 2022, the U.S. FDA granted approval to Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi for treating relapsed or refractory Large B-cell Lymphoma.

The rising emphasis on regional expansion by major manufacturers caters to a broad customer base and leverages growth opportunities in various geographical industries. For instance, in October 2023, Bayer AG announced a new cell therapy manufacturing facility in Berkeley, California, USA, with a $250 million investment. This will facilitate the production of materials for clinical trials and an experimental cell therapy for the treatment of Parkinson’s Disease.

Key U.S. Cell Therapy Company Insights

Increasing development and application of CRISPR-Cas9 and other precise gene-editing tools for creating innovative cell therapy products and rising emphasis on off-the-shelf or allogeneic cell therapies are driving market growth. Moreover, the adoption of M&A activities, collaborations, and the introduction of innovative cell therapies boost market growth.

• Key U.S. Cell Therapy 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

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