U.S. Cell Therapy Manufacturing Market Revenue to Attain USD 5.24 Bn by 2033

24 Dec 2024

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Table of Content

1. U.S. Cell Therapy Manufacturing Market Revenue and Trends 2023 to 2033 2. Market Overview  3. Report Highlights of the U.S. Cell Therapy Manufacturing Market 4. Major Trends in the U.S. Cell Therapy Manufacturing Market 5. U.S. Cell Therapy Manufacturing Market Coverage 6. Market News 7. U.S. Cell Therapy Manufacturing Market Key Players

U.S. Cell Therapy Manufacturing Market Revenue and Trends 2023 to 2033

The U.S. cell therapy manufacturing market revenue reached USD 1.49 billion in 2024 and is predicted to attain around USD 5.24 billion by 2033 with a CAGR of 15.04%. The rising prevalence of various life-threatening diseases and the increasing demand for cell and gene therapies are expected to boost market growth over the studied period.  

Market Overview 

The U.S. cell therapy manufacturing market is experiencing significant growth due to the increasing demand for cell therapies. Stem cells and immune cells can be used in several applications, such as regenerative medicine, tissue regeneration, oncology, autoimmune disease treatment, cardiovascular disease treatment, and treatment of other rare and chronic diseases. Cell therapy manufacturing includes the process of isolating, modifying, growing, formulating, quality testing, and storing cells for clinical cell therapies and CAR-T cells.

The increasing prevalence of chronic diseases, such as cardiovascular diseases (CVDs) and cancer, is a major factor boosting market growth. According to the National Institutes of Health (NIH), chronic diseases are among the most prevalent conditions in the U.S. Nearly half (approximately 45%, or 133 million) of all Americans suffer from at least one chronic disease, and the number is growing rapidly. Moreover, rising investments in research and development and a significant rise in clinical trials and approvals for cell therapies fuel the growth of the market.

• For instance, in March 2024, the U.S. FDA approved Bristol Myers Squibb’s Breyanzi as the first and only CAR T cell therapy for adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). It also offers personalized treatment options delivered as one one-time infusion that provides patients with a deep and durable response.
• In December 2023, the U.S. FDA approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, Casgevy is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy.

Report Highlights of the U.S. Cell Therapy Manufacturing Market

• By therapy type, the autologous cell therapy segment dominated the market in 2023 due to a lower risk of immune rejection while promoting long-term healing. This novel therapy approach involves the use of a person's cells or tissues, which are treated outside the body and then reinserted into the donor's body. They are widely used across several fields, such as orthopedics and dermatology, for therapeutic and cosmetic purposes.  
• By technology type, the somatic cell technology segment accounted for the largest share of the market in 2023. This is mainly due to the increased demand for regenerative medicines. The somatic cell technology produces cells tailored to individual patients for regenerative medicine.
• By source, the IPSC (induced pluripotent stem cell) segment registered dominance in the market in 2023 due to its potential to develop personalized medicine. IPSCs are used to create ready-made allogenic cell therapies as they can easily modify genetically, help select specific clones after modification and eliminate the need for individual cell collection.
• By application, the oncology segment dominated the market with the largest share in 2023. This is mainly due to the increased prevalence of cancer. Cell therapy improves the target of tumors while reducing off-target occurrences. Advanced biotechnology technologies help provide personalized medicines and innovative treatment methods in oncology, helping the oncologist identify, diagnose, and treat cancer in the patients.

Major Trends in the U.S. Cell Therapy Manufacturing Market

• Demand for Outsourcing Manufacturing Processes: Biopharmaceutical companies are increasingly outsourcing cell therapy manufacturing processes. Outsourcing manufacturing offers several opportunities for cell therapy manufacturing companies to improve production quality and efficiency. Moreover, it allows them to focus on other core areas.
• Need for Allogeneic Cell Therapies: These therapies provide several benefits, as they produce immune cells that target and eliminate cancer cells after chemotherapy and allow for the creation of multiple medicines. These therapies are cost-effective and are safer than other therapies.
• Rising Investments and Funding: Pharmaceutical companies are investing heavily in the development of cell therapy to meet the overall growing demand. The U.S. government is also investing in research and development of cell and gene therapies to accelerate their production and make them easily available throughout the country. Moreover, rising government initiatives to encourage the adoption of cell-based therapies contribute to market expansion. For instance, in January 2024, The Biden-Harris Administration announced today that sickle cell disease will be the first focus of the Cell and Gene Therapy (CGT) Access Model, which was initially announced in February 2023.

Country Insights

With the increasing cases of sickle cell and genetic disorders, there is a high demand for personalized treatments in the U.S., contributing to the growth of the U.S. cell therapy manufacturing market. The demand for gene, cell, and tissue-based therapeutics is on the rise. Technological advancements in cell manufacturing technologies are improving the efficiency of cell therapy production. The country is also a home to many leading pharmaceutical, biopharmaceutical, and biotechnology companies. Moreover, the regulatory landscape plays a crucial role in ensuring the safety and efficacy of cell-based therapies, further enhancing patient care and safety. For instance, the U.S. FDA established comprehensive frameworks for developing and overseeing regenerative medicine products.

U.S. Cell Therapy Manufacturing Market Coverage

Market News

• In November 2024, Seattle Children’s announced that they are enrolling participants in the first CAR T cell clinical trial for children with systemic lupus erythematosus (SLE). This is the first clinical trial in the U.S. examining CAR T cell therapy in a pediatric population.
• In April 2024, Ocugen, Inc., a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) amendment to initiate a Phase 3 clinical trial of OCU400, a modifier gene therapy product candidate being developed for retinitis pigmentosa (RP).
• In March 2024, the Atlantic Health System announced the enrollment of the first U.S. patient in the study designed to explore the safety and efficacy of the CAR-T cell for treating lupus. This Phase 1, multicenter open-label study focuses on patients with severe Refractory Systemic Lupus Erythematosus (SLE), an autoimmune disease that results in symptoms like joint pain, swelling, fever, fatigue, and damage to the heart, kidneys, brain, and lungs.

U.S. Cell Therapy Manufacturing Market Key Players

• Merck KGaA
• Thermo Fisher Scientific
• Catalent, Inc
• Bio-Techne
• Cytiva
• Lonza
• The Discovery Labs
• Novartis AG
• Bristol-Myers Squibb Company
• Gilead Sciences, Inc.

Market Segmentation

By Therapy Type

• Allogenic Cell Therapy
• Autologous Cell Therapy

By Technology Type

• Somatic Cell Technology
• Cell Immortalization Technology
• Viral Vector Technology
• Genome Editing Technology
• Cell Plasticity Technology
• 3D Technology

By Source

• IPSC (Induced Pluripotent Stem Cell)
• Bone Marrow
• Umbilical Cord
• Adipose Tissues
• Neural Stem

By Application

• Musculoskeletal
• Cardiovascular
• Gastrointestinal
• Neurological
• Oncology
• Dermatology
• Others

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