Cell Therapy Market

Market Definition

Cell therapy focuses on utilizing living cells to treat a wide range of medical conditions by repairing, regenerating, or replacing tissues and organs which are damaged. Major applications of cell therapy include cancer treatment (such as CAR-T cell therapies), regenerative medicine, neurological conditions, and the management of autoimmune diseases.

Cell therapies are increasingly being researched and developed in the areas of tissue engineering, wound healing, and cardiovascular diseases.

Breakthroughs in stem cell technology and genetic modification are accelerating innovations, making cell therapies a promising and transformative treatment approach in personalized medicine, with potential to address growing demands and increasing medical needs to improve patient outcomes across different therapeutic areas.

Cell therapy Market Overview

Global Cell Therapy Market size was valued at USD 9.70 billion in 2023, which is estimated to be valued at USD 10.84 billion in 2024 and reach USD 26.59 billion by 2031, growing at a CAGR of 13.67% from 2024 to 2031. The acceleration of the market is due to significant innovations in stem cell technology and gene editing, such as CRISPR-Cas9, aiding in more precise and effective treatments.

These breakthroughs are supporting the development of personalized therapies, specifically in regenerative medicine, cancer treatment, and autoimmune disease management.

Major companies operating in the global Cell therapy market are Bristol-Myers Squibb Company, Gilead Sciences, Inc., Johnson & Johnson Services, Inc., Novartis AG, Sorrento Therapeutics, Inc., Sanofi, Amgen Inc., F. Hoffmann-La Roche Ltd, BioNTech SE., Charles River Laboratories., Adaptimmune., Takeda Pharmaceutical Company Limited., Mallinckrodt company., JW Therapeutics (Shanghai) Co., Ltd., IOVANCE Biotherapeutics, Inc., and others.

Increase in funds for research and strategic collaborations between academic institutions, biotech companies, and big players in the healthcare sector is accelerating the pace of discovery and clinical applications. These collaborations are  boosting the development of more efficient and more scalable manufacturing processes, which are crucial for the global adoption of cell therapies.

Moreover, advancements in tissue engineering and regenerative medicine are enabling better solutions for repairing and replacing damaged tissues, offering an effective method for treating chronic conditions and injuries that were previously difficult to address. The rising demand for personalized medicine is further bolstering market growth, as patients seek tailored therapies for improved outcomes.

Regulatory support and improved reimbursement policies are also contributing to market expansion, making cell therapies more accessible to a broader patient population. These factors combined are shaping a promising future for the market.

Key Highlights:

1. The global cell therapy market size was recorded at USD 9.70 billion in 2023.
2. The market is projected to grow at a CAGR of 13.67% from 2024 to 2031.
3. North America held a market share of 46.78% in 2023, with a valuation of USD 4.54 billion.
4. The oncology segment garnered USD 6.81 billion in revenue in 2023.
5. The t-cells segment is expected to reach USD 13.78 billion by 2031.
6. The allogenic therapies segment is set to record a staggering CAGR of 14.62% over the forecast period.
7. Asia Pacific is anticipated to grow at a CAGR of 15.15% over the forecast period.

Market Driver

"Rising Cancer Cases and Innovations in CAR-T"

The cell therapy market is experiencing huge growth due to the increasing burden of chronic diseases, such as cancer, autoimmune disorders, and genetic conditions, resulting in a strong demand for new treatment solutions. CAR-T cell therapies, stem cell advancements, and gene-editing technologies are also revolutionizing personalized medicine, providing effective therapies for untreatable conditions.

• In May 2024, the Food and Drug Administration (FDA) approved the first chimeric antigen receptor (CAR) T-cell therapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
• In May 2024, the FDA approved lisocabtagene maraleucel (Breyanzi) for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi). 

Additionally, rising healthcare investments, more focus on research and development, and supportive regulatory environments are accelerating market growth.

Governments are promoting initiatives to support regenerative medicine, while healthcare providers are adopting advanced therapies, aiding and accelerating the expansion of the market worldwide. The growing focus on regenerative medicine and improved healthcare infrastructure further boosts the market's expansion.

Market Challenge

"Treatment Costs and Regulatory Implications"

The industry faces key challenges, including expensive treatment costs, which limit affordability and patient access. The complexities in manufacturing and scalability of cell therapies pose operational hurdles. Regulatory approval processes remain time-consuming and costly, potentially delaying market entry.

Long-term safety and efficacy concerns, along with the potential for adverse reactions, create uncertainties for both patients and healthcare providers. The lack of standardized protocols and practices in cell therapy also hampers its widespread adoption and leads to inconsistencies  in treatment outcomes across regions.

Market Trend

"Advancements in CAR-T and Stem Cell Treatments"

The cell therapy market is experiencing significant growth, driven by advancements in regenerative medicine and personalized treatments. Key trends include the increasing adoption of CAR-T cell therapies for cancer and the expanding use of stem cell therapies for various chronic and genetic diseases. The market is also benefitting from rising healthcare investments and government support for innovative therapies.

• In March 2024, Capstan Therapeutics closed a USD 175 million Series B financing round with backing from old and new investors including J&J, BMS, Bayer, Eli Lilly, Pfizer, and Novartis-all lining up to advance Capstan’s lead in vivo CAR-T candidate to early clinical proof-of-concept studies in autoimmune disorders.
• In September 2024, ArsenalBio announced USD 325 million in funding to promote clinical development of programmable cell therapy programs.

Additionally, collaborations between biotech firms and pharmaceutical companies are accelerating research and development. Technological advancements in manufacturing and improved clinical trial outcomes are making cell therapy accessible. The growing focus on personalized medicine and precision therapies is expected to further propel market expansion.

Cell therapy Market Report Snapshot

Market Segmentation:

• By Application (Oncology, Cardiovascular Diseases, Neurological Disorders, Autoimmune Diseases, Others): The oncology segment earned USD 6.81 billion in 2023 due increasing adoption of cell-based cancer therapies.
• By Cell type (T-Cells, Stem Cells, Others): T-Cells held 48.56% of the market in 2023,  primarily due to their key role in cancer treatments like CAR-T therapies.
• By Therapy type (Allogenic Therapies, Autologous Therapies): The autologous therapies segment is projected to reach USD 13.38 billion by 2031, due to their personalized approach and lower risk of immune rejection

Cell therapy Market Regional Analysis

The regional analysis of the cell therapy market showed North America as the largest market, holding 46.78% of the share in 2023, driven by advanced healthcare infrastructure, strong R&D investments, and a robust regulatory framework. The U.S. leads this region due to major biotech companies, extensive clinical trials, and high healthcare spending.

North America's dominance in the market is driven by advanced healthcare infrastructure, significant investments in research and development, and a robust regulatory framework. The presence of major pharmaceutical and biotechnology companies, along with strong government support for clinical trials and innovation, further strengthens its leadership.

Meanwhile, the Asia-Pacific region is experiencing rapid growth due to increasing healthcare spending, expanding patient populations, and rising awareness of advanced therapies. Additionally, favorable regulatory environments in countries like Japan and China, along with improving medical infrastructure, are aiding the adoption of cell therapies in the region.

However, Asia-Pacific is anticipated to experience the fastest growth, at a projected CAGR of 15.15%. Countries like China, India, and Japan are investing heavily in healthcare infrastructure, biotechnology, and cell therapy research. An increase in patient awareness, favorable government policies, and a rising incedence of chronic diseases are aiding the adoption of cell-based therapies in the region.

Regulatory Framework Also Plays a Significant Role in Shaping the Market

• In the North America region, FDA’s the Center for Biologics Evaluation and Research (CBER)  regulates cellular therapy products, and certain devices related to cell and gene therapy. The FDA’s Accelerated Approval Program allows for earlier approval of drugs and therapies that treat serious conditions, and fulfil unmet medical needs.
  • In August 2024, the Food and Drug Administration approved TECELRA, by Adaptimmune, LLC, a genetically modified autologous T-cell immunotherapy for adults with unresectable or metastatic synovial sarcoma who have already received chemotherapy.
• The European Medicines Agency (EMA) supervises cell therapies in the European Union (EU). The Committee for Advanced Therapies (CAT) under the EMA is responsible for evaluating advanced therapy medicinal products (ATMPs), including cell therapies, tissue-engineered products, and gene therapies.
  • In August 2024, Bristol Myers Squibb's application for CAR-T cell therapy Breyanzi for relapsed or refractory follicular lymphoma was validated by the EMA.
• In APAC, China’s National Medical Products Administration (NMPA) is responsible for developing policies to regulate cell therapies, including stem cell. NMPA has introduced expedited approval pathways for innovative treatments. China’s NMPA focuses on advancing cell therapy while ensuring safety and efficacy.
• In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) is  responsible for approving and regulating cell therapies and drugs. PMDA ensures the safety, efficacy, and quality of cell therapies, including stem cell treatments.
• The World Health Organization (WHO) develops and governs international standards, guidelines for regulating cell therapies, and frameworks for human cell therapy. The authority calls for global cooperation in addressing ethical concerns while supporting scientific advancements.

Competitive Landscape:

The global cell therapy market is characterized by established corporations and rising organizations. Key market participants include Bristol-Myers Squibb Company, Gilead Sciences, Inc., Johnson & Johnson Services, Inc., Novartis AG, Sorrento Therapeutics, Inc., Sanofi, Amgen Inc., F. Hoffmann-La Roche Ltd, BioNTech SE., Charles River Laboratories., Adaptimmune., Takeda Pharmaceutical Company Limited., Mallinckrodt company., JW Therapeutics (Shanghai) Co., Ltd., IOVANCE Biotherapeutics, Inc., and others.

To achieve a competitive advantage in this rapidly evolving cell therapy market, these organizations aggressively pursue a variety of strategic initiatives. Major strategies include new product launches, collaborations and alliances, corporate expansions, and mergers and acquisitions.

• For instance, in April 2024, Century Therapeutics announced plans to expand the clinical development of CNTY-101, its CD19-targeting iNK cell therapy, into additional autoimmune indications. Supported by a USD 60 million private placement, Century also acquired Clade Therapeutics, enhancing its iPSC-derived pipeline across cancer and autoimmune diseases.

An in-depth investigation of these strategies reveals possible income prospects and development trends, as well as insights into how businesses deal with technical hurdles in the market.

List of Key Companies in Cell therapy Market:

• Bristol-Myers Squibb Company
• Gilead Sciences, Inc.
• Johnson & Johnson Services, Inc.
• Novartis AG
• Sorrento Therapeutics, Inc.
• Sanofi
• Amgen Inc.
• Hoffmann-La Roche Ltd
• BioNTech SE.
• Charles River Laboratories.
• Adaptimmune
• Takeda Pharmaceutical Company Limited.
• Mallinckrodt company.
• JW Therapeutics (Shanghai) Co., Ltd.
• IOVANCE Biotherapeutics, Inc., and
• Others

Recent Developments (M&A/Partnerships/Agreements/New Product Launch)

• In November 2024, F. Hoffmann-La Roche Ltd acquired Poseida Therapeutics, Inc. for approximately USD 1.5 billion. This acquisition gives Roche a stronger position in the emerging field of donor-derived off-the-shelf cell therapies by enabling a variety of potentially first- and best-in-class treatments in the fields of oncology, immunology, and neurology.
• In November 2024, Kadimastem announced a merger with NLS Pharmaceutics. This merger combines Kadimastem's cell therapy expertise with NLS Pharmaceutics' drug platform, creating a combined focus on advancing treatments for neurodegenerative diseases and diabetes through innovative therapies.
• In April 2024, Kincell Bio. announced a strategic manufacturing and process development partnership with Imugene Limited to acquire Imugene’s CGMP-compliant cell therapy manufacturing facility in North Carolina. The collaboration would enable Imugene to focus on its core expertise in the development of innovative cancer cell therapies and also ensure the necessary operational scalability and expertise to support Imugene’s growth in the cell therapy space.
• In February 2024, AstraZeneca announced the acquisition of Gracell Biotechnologies Inc. With GC012F, a new, clinical-stage FasTCAR-enabled BCMA and CD19 dual-targeting autologous chimeric antigen receptor T-cell (CAR-T) treatment, the acquisition enhanced AstraZeneca's cell therapy portfolio and improve patient outcomes in oncology and autoimmune disease management.
• In February 2024 BioNTech SE. and Autolus Therapeutics collaborated on CAR-T cell therapy to advance the pipeline which includes therapeutic programs that are in various stages of development and expand late-stage programs. BioNTech agreed to invest USD 200 million in Autolus. By leveraging shared resources and expertise, this collaboration enhances companies' capabilities in developing innovative CAR-T therapies, addressing unmet needs of the rapidly growing market.
• In January 2024, Pluri Inc. launched an advanced global cell therapy contract development and manufacturing organization (CDMO) to support the rapidly growing market. This new CDMO will leverage Pluri’s proprietary technology platform to provide end-to-end solutions for the development, manufacturing, and commercialization of cell therapies, offering services such as process development, clinical and commercial manufacturing, and quality assurance.