Cell Therapy Market

Cell Therapy Market Size and Share:

The global cell therapy market size was valued at USD 15.68 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 60.79 Billion by 2033, exhibiting a CAGR of 14.51% during 2025-2033. North America currently dominates the market, holding a significant market share of over 59.8% in 2024. The advancements in stem cell research are on the rise along with the development of healthcare infrastructure worldwide. Increasing patient awareness, heightened government support and broader insurance coverage are also key factors driving the market forward.

The cell therapy market is driven by advancements in regenerative medicine, increasing investment in research and development and rising prevalence of chronic diseases like cancer and autoimmune disorders. Innovations in stem cell technology and CAR-T therapies are enhancing treatment effectiveness, and driving adoption. For instance, in June 2024, researchers at USC developed a non-invasive imaging method using machine learning to study hematopoietic stem cells. This breakthrough allows for real-time tracking of stem cell behavior and metabolism improving understanding of their replication and differentiation with potential implications for therapies like bone marrow transplants and regenerative medicine. Regulatory approvals and growing clinical trials further boost market growth. The demand for personalized medicine is fostering interest in cell based therapies while expanding healthcare infrastructure and reimbursement policies to support accessibility. Additionally, collaborations between biotech companies and research institutions are accelerating breakthroughs making cell therapies a promising solution for unmet medical needs in global healthcare.

The United States cell therapy market is fueled by growing demand for innovative treatments for chronic diseases, particularly cancer and autoimmune disorders. According to data published by the National Cancer Institute, in 2024 the United States will witness approximately 2,001,140 new cancer cases with 611,720 deaths. Common cancers include breast, prostate, lung and colorectal comprising 48% of diagnoses in men and 51% in women. Rising incidence of cancer is driving the demand for cell therapy across the country. Advancements in CAR-T cell therapy and stem cell research are key contributors to market expansion. Robust government funding, increasing clinical trials and faster regulatory approvals enhance the development pipeline. The adoption of personalized medicine is accelerating the use of cell therapies supported by improved healthcare infrastructure and reimbursement frameworks. Additionally, collaborations between biotech firms, academic institutions and pharmaceutical companies are fostering innovation.

Cell Therapy Market Trends:

Increasing Prevalence of Various Diseases, Such as Cancer and Cardiac Abnormalities

The increasing prevalence of various diseases particularly cancer and cardiac abnormalities is favorably impacting the market. The global burden of these diseases has steadily risen due to factors like aging populations, lifestyle changes and environmental influences. According to the World Health Organization (WHO), cancer accounted for approximately 19.3 million new cases globally in 2020, highlighting the urgent need for innovative therapies. By using the regenerative and reparative capabilities of specialized cells, cell therapy has enormous potential for treating and even curing various diseases. For cancer, cell-based immunotherapies such as CAR-T cell therapy have shown remarkable success in targeting and eliminating cancer cells. In the case of cardiac abnormalities stem cell-based therapies aim to repair damaged heart tissue and improve cardiac function. The urgent need for effective treatments for these widespread and life-threatening diseases propels extensive research, development, and investment in cell therapy approaches.

Rising Number of Clinical Studies for Cell-based Therapies

The rising number of clinical studies for cell based therapies is fueling the cell therapy market growth with over 2,000 active clinical trials globally as of 2024, according to ClinicalTrials.gov. Clinical trials play a fundamental role in validating the safety and efficacy of these innovative treatments. The need for innovative treatments to treat a range of illnesses, including cancer, autoimmune diseases, and degenerative disorders, is increasing as clinical research expands. These studies are being actively carried out by biotechnology firms, pharmaceutical corporations, and academic institutions to commercialize cell-based medicines. The wealth of data generated from these studies demonstrates the therapeutic potential of cell therapies but also aids in refining treatment protocols and identifying the most suitable patient populations. Moreover, regulatory agencies like the FDA in the United States actively support and expedite the approval process for cell-based therapies further incentivizing the initiation of clinical trials. Consequently, a rising number of clinical trials propels the development of cell therapies, encouraging creativity and boosting their availability to patients in need. This factor underscores the significant role clinical research plays in propelling the market.

Expanding Healthcare Industry Worldwide

The growing healthcare sector across the globe is creating a positive market outlook. As populations grow, age and face an increasing burden of chronic diseases the demand for advanced medical treatments rises significantly. The healthcare sector's expansion includes the development of cutting-edge therapies like cell-based treatments. Global healthcare systems are realizing that cell therapy can be used to treat a variety of illnesses, including autoimmune diseases, neurological disorders, cardiovascular diseases, and cancer. This recognition translates into increased investment, research and clinical trials in regenerative medicine and cell therapy. Furthermore, access to cutting-edge medical treatments, such as cell therapies, is increasing in emerging nations as healthcare infrastructure advances. Additionally, over 1,200 clinical trials globally are currently evaluating cell therapies highlighting growing research efforts. This global expansion of healthcare services broadens the potential patient pool for cell-based treatments driving market growth.

Cell Therapy Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global cell therapy market report, along with forecasts at the global, regional and country levels for 2025-2033. Our report has categorized the market based on cell type, therapy type, therapeutic area, and end user.

Analysis by Cell Type:

• Stem Cell
  • Bone Marrow
  • Blood
  • Umbilical Cord-Derived
  • Adipose-Derived Stem Cell
  • Others
• Non-stem Cell
   

Stem cells with their remarkable regenerative potential and ability to differentiate into various cell types have garnered significant attention in the medical field. These versatile cells are instrumental in treating a wide spectrum of diseases including degenerative disorders, neurological conditions and hematological malignancies. The increasing prevalence of age-related diseases and chronic conditions has intensified the demand for effective stem cell-based treatments. Moreover, ongoing research and clinical trials continue to unveil new therapeutic possibilities for stem cells further fueling market growth. Pharmaceutical and biotechnology firms heavily invest in stem cell research focusing on developing innovative therapies. Furthermore, regulatory agencies are recognizing the importance of stem cell therapies, streamlining approval processes and safety standards. This facilitates the commercialization of stem cell-based treatments making them more accessible to patients worldwide. The stem cell segment is a powerful driver of growth in the cell therapy market promising revolutionary solutions for numerous medical challenges.

Analysis by Therapy Type:

• Autologous
• Allogeneic
   

Autologous leads the market with around 91.6% of market share in 2024. Autologous therapies involve the extraction, manipulation and reinfusion of a patient's cells minimizing the risk of rejection and adverse reactions. This personalized approach has gained prominence in treating various conditions including cancer, autoimmune diseases and degenerative disorders. The increasing demand for therapies with higher safety profiles and reduced immune complications has fueled the adoption of autologous cell therapies. These treatments harness the regenerative potential of a patient's cells addressing unmet medical needs while minimizing the risks associated with allogeneic treatments where cells are sourced from donors.

Furthermore, advancements in cell processing techniques such as CAR-T cell therapies for cancer treatment showcase the remarkable potential of autologous therapies. Regulatory agencies are also streamlining approval pathways for these personalized treatments expediting their availability to a wider patient population. As a result the autologous therapy segment is a pivotal driver of growth in the cell therapy market offering innovative and patient-centric solutions for various medical conditions.

Analysis by Therapeutic Area:

• Malignancies
• Musculoskeletal Disorders
• Autoimmune Disorders
• Dermatology
• Others
   

Malignancies including various types of cancer present one of the most challenging healthcare concerns globally. Cell therapies such as CAR-T have emerged as groundbreaking treatments for these conditions. The growing incidence of cancer and the increasing demand for more effective and targeted therapies have propelled the development and adoption of cell based treatments. These therapies harness the patient's immune system or engineered cells to target and eliminate cancer cells. Their remarkable success in clinical trials and real-world applications underscores their potential to transform cancer treatment.

Moreover, regulatory agencies are expediting approvals for cell therapies in oncology streamlining their path to market. As a result, the malignancies focused segment serves as a critical driver of growth in the cell therapy market offering renewed hope to cancer patients and contributing to the evolution of cancer care. The cell therapy market forecast anticipates sustained growth driven by the demand for innovative and targeted treatments like CAR-T therapy particularly within the oncology segment.

Analysis by End User:

• Hospitals and Clinics
• Academic and Research Institutes
   

Hospitals and clinics serve as primary end users of cell therapy due to their advanced infrastructure and skilled medical staff. These facilities support a range of therapies including regenerative treatments for chronic diseases, cancer and autoimmune disorders. The growing prevalence of conditions requiring cell-based solutions combined with increasing patient awareness drives the adoption of cell therapy in these settings. Moreover, advancements in stem cell banking and enhanced government funding for hospital based research further strengthen their role in the cell therapy market.

Academic and research institutes are key end users in the cell therapy market driving innovation and development. These centers study cellular mechanisms, test new therapies, and conduct clinical trials. Their access to specialized labs and collaborative networks enables the development of cutting-edge treatments. Government and private funding initiatives for R&D alongside partnerships with biotech firms amplify their contributions to the market. These institutions are vital for translating scientific breakthroughs into clinical applications.

Regional Analysis:

• North America
  • United States
  • Canada
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

In 2024, North America accounted for the largest market share of over 59.8%. North America boasts a robust and highly developed healthcare infrastructure including advanced research institutions, hospitals and clinical centers. These institutions actively engage in cell therapy research and clinical trials accelerating the development and adoption of innovative cell-based treatments. The substantial investments in the biotechnology and pharmaceutical sectors facilitate the advancement of cell therapies. Pharmaceutical companies and biotech firms in the region actively contribute to cell therapy research and development resulting in a steady stream of new therapies.

The regulatory agencies in North America such as the FDA in the United States play a crucial role in streamlining the approval process for cell therapies ensuring they meet rigorous safety and efficacy standards. This regulatory support expedites the commercialization of these treatments. Moreover, the increasing prevalence of chronic diseases including cancer fuels the demand for effective and advanced therapies making cell therapies an attractive option for patients and healthcare providers.

Key Regional Takeaways:

United States Cell Therapy Market Analysis

In 2024, the United States accounted for a share of 92.80% of the North America market. With immense investment in R&D and clinical advancements, the U.S. cell therapy market is booming. According to the Alliance for Regenerative Medicine, global cell and gene therapy investment has hit USD 23.1 Billion in 2023; most of which have come from the United States. The high prevalence of chronic diseases such as cancer and diabetes fuels the adoption of therapies like CAR-T and stem cell treatment, together with favorable FDA policies. Focus is put on innovation, as from 2023 when over 2,000 clinical trials for cell therapy had already been running. Leading players in this space include companies from Novartis and Gilead Sciences, with new pipeline growth from collaboration with academia and biotech companies. In developing initiatives, the government-initiated schemes, such as the 21st Century Cures Act, are complemented by collaboration with payers over the cost issues. The US is also using export opportunities to build on its leadership position worldwide in cell therapy.

Europe Cell Therapy Market Analysis

Europe has a growing cell therapy market, thanks to strong R&D support, advances in regulations, and increasing healthcare budgets. In 2023, more than 150 ATMPs, including cell therapies, were in some form of clinical trials according to EMA. Germany is on top with considerable funding that was allocated to regenerative medicine projects last 2022 to the tune of USD 200 Million. The growth in the region is driven by CAR-T cell therapies for oncology and mesenchymal stem cells for degenerative diseases. The Association of the British Pharmaceutical Industry stated that there are over 90 cell therapy companies in the UK, which contribute highly to exports and employment. The EU regulations focus on safety and innovation, which encourages the use of innovative technologies. The collaboration between universities and biotech firms is enhancing the competitiveness of the market in the global arena. Such is the case for France and the Netherlands.

Asia Pacific Cell Therapy Market Analysis

 The Asia Pacific cell therapy market is growing rapidly owing to the increasing investments and regional advancements in health care. India's Biotechnology Industry Research Assistance Council released USD 500 Million in 2023 for translational research. Japan's Act on the Safety of Regenerative Medicine and streamlined regulatory routes have accelerated market growth, with more than 30 cell therapies approved by 2023. Several countries, such as South Korea and Australia, are leading early clinical trials for new therapies via state-sponsored work. The partnerships between regional biotech companies and global leaders, like the CAR-T collaboration by Fosun Kite Biotechnology, are drivers of technology transfer. Also, low manufacturing cost in the region will give the Asia Pacific a critical place in the global cell therapy landscape.

Latin America Cell Therapy Market Analysis

Government support and increased local manufacturing drive Latin America's momentum in cell therapy. According to ProMedica International, biopharmaceuticals are allocated to the tune of USD 1.5 Billion, as announced in 2022 by Brazil. Clinical trials in Mexico will be focused on the increasing number of infrastructures; 50 or more trials were ongoing at the end of 2023. Other conditions that require regenerative medicine are type 2 diabetes and cardiovascular diseases. Colombia is also investing in stem cell research. Academic collaborations and government funding support the effort. A leader in the industry is Cellavita in Brazil, which is increasing production capacity to meet both the local and export markets. In addition, innovations in manufacturing cost-effective cell therapy help improve healthcare access in this region. Partnerships with global biotechnology companies will further strengthen Latin America's position in the global market while promoting regional R&D capabilities.

Middle East and Africa Cell Therapy Market Analysis

Middle East and Africa the cell therapy market is steadily growing on account of healthcare modernization and research investment. For instance, in 2023, the International Trade Administration reported that Saudi Arabia has allocated a budget to healthcare amounting to about USD 50.4 Billion to support improvements in the area of regenerative medicine. South Africa is regional frontrunner for the stem cell-based therapy initiatives developed and supported by the country's Department of Science and Innovation. The UAE is developing cell therapy research medical hubs through joint work with global institutions, the country's focus centers around sickle cell disease and diabetes treatments, issues within the region. By forming partnerships with international entities and acquiring government funding grants, the manufacturing capabilities to ensure these products are affordable, available, and accessible by increasing healthcare infrastructure, Africa and the Middle East are bound to be one of the rising contributors in the Cell Therapy market.

Competitive Landscape:

Major companies are bolstering the market with an array of offerings and methods. These pioneers in the field place a high priority on thorough research and development, constantly expanding the possibilities of cell therapies through the investigation of new cell types, delivery systems, and uses. They conduct rigorous clinical trials, substantiating the safety and efficacy of their therapies and obtaining regulatory approvals that enhance market credibility. They can take advantage of the combined expertise and resources of research institutions, biotech companies, and healthcare organizations through strategic alliances and collaborations. Leading businesses frequently broaden their market reach internationally, enabling a larger patient pool to access cell therapies. Maintaining strict compliance with regulatory standards ensures that their therapies meet stringent safety and quality requirements, instilling confidence among healthcare professionals and patients. Additionally, their crucial role in developing cell therapies and promoting market expansion is further reinforced by patient access improvement programs, educational campaigns, and strategic acquisitions.

The report has provided a comprehensive analysis of the competitive landscape in the cell therapy market. Detailed profiles of all major companies have also been provided.

• AlloSource
• Anterogen Co. Ltd.
• Cells for Cells
• Holostem Terapie Avanzate S.r.l.
• JCR Pharmaceuticals
• Kolon TissueGene Inc.
• MEDIPOST
• Mesoblast Limited
• NuVasive
• Stemedica Cell Technologies Inc.
• Stempeutics Research Pvt. Ltd
• Vericel Corporation

Latest News and Developments:

• December 2024: MEDIPOST, Inc. announced five senior executive appointments to strengthen its U.S. operations. These appointments support advancing CARTISTEM®, its flagship regenerative therapy, toward a Phase III clinical trial in North America.
• July 2024: Kolon TissueGene announced that they have completed dosing 1,066 patients in two US Phase III trials for TG-C, a cell and gene therapy for knee osteoarthritis, marking significant progress.
• May 2024: Holostem Terapie Avanzate S.r.l., announced that the European Commission approved Holostem’s project on cell and gene therapy as an Important Project of Common European Interest (IPCEI Med4Cure) in the health sector.
• March 2024: The FDA has determined that Mesoblast's data for Remestemcel-L cell therapy is adequate to support a BLA filing focused on pediatric SR-aGVHD. The company intends to file the BLA in the second quarter of 2024.
• July 2023: AlloSource received FDA 510(K) clearance for AceConnex pre-sutured fascia for hip labral reconstruction and augmentation.

Cell Therapy Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the cell therapy market from 2019-2033.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the global cell therapy market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyse the level of competition within the cell therapy industry and its attractiveness.
• The competitive landscape allows stakeholders to understand their competitive environment and provides insight into the current positions of key players in the market.