Global Cell Therapy Market - 2024-2031

Overview

The global cell therapy market reached US$ 4.17 billion in 2023 and is expected to reach US$ 42.44 billion by 2031, growing at a CAGR of 30.67% during the forecast period 2024-2031.Cell therapy is a therapeutic strategy in which live cells are transferred into a patient to treat or prevent disease. This procedure can use either autologous cells grown from the patient's own body or allogeneic cells obtained from a donor. The main objective of cell therapy is to repair or improve the function of damaged or diseased tissues and organs.

The growing utilization of advanced delivery methods drives the global cell therapy market over the forecast period. For instance, as of the end of 2023, 76 cell and gene therapies had been launched worldwide. More than double the number of therapies that had been launched by 2013. Over the previous five years, 3,285 trials have begun to examine cell and gene therapies in patients across all sponsor types, with 631 expected in 2023.

Market Dynamics: Drivers & Restraints

Growing utilization of advanced delivery methods

The growing utilization of advanced delivery methods propels the market growth. Cell therapies are becoming more efficient and effective as manufacturing technology advances. Microfluidics and Encapsulation Technologies improve cell culture methods, enabling more efficient handling and manipulation of cells during therapeutic production. The utilization of automated procedures and single-use systems saves money and time in production, making medicines more accessible. The distinction between in-vivo and ex-vivo technologies enables more personalized approaches to gene delivery, with in-vivo methods acquiring a substantial market share due to their direct use within the patient's body. Regulatory organizations are increasingly realizing the importance of improved delivery techniques to improve patient access to treatments. The US FDA and the UK MHRA are encouraging decentralized manufacturing approaches that allow for faster and more efficient therapy delivery directly to patients.

In recent times, there have been collaborations between organizations that utilize advanced delivery methods. For instance, the collaborations between Thermo Fisher Scientific and Arsenal Biosciences aim to create robust manufacturing procedures for next-generation cancer treatments. Such collaborations use specialized knowledge and resources to expedite manufacturing and improve delivery capabilities. This utilization of advanced delivery methods is increasing the demand for cell therapy products and it drives the market.

Limitations associated with cell therapy

Factors such as limitations associated with cell therapy are expected to hamper the market. The limitations such as Accessibility Issues, Manufacturing Challenges, safety and toxicity concerns, efficacy limitations, Patient-Specific Variability, and stringent regulatory requirements. While cell therapy has enormous potential for treating a variety of diseases, its limits underscore the importance of continued research and innovation to increase accessibility, safety, and efficacy. For more details on this report - Request for Sample

Segment Analysis

The global cell therapy market is segmented based on source, cell type, application, end-user, and region.

Cell Type:

Non-stem cells is expected to dominate the cell therapy market share

Non-stem cells segment is expected to dominate the cell therapy market share. One of the key drivers driving this market shift is the increasing number of regulatory approvals for autologous non-stem cell therapies. These approvals make it easier to introduce novel therapies that address previously difficult-to-treat conditions. The increasing focus on personalized medicine is also contributing to this development, as autologous medicines may be adjusted to particular patient needs, improving treatment outcomes.

For instance, in November 2024, The FDA (Food and Drug Administration) approved obecabtagene autoleucel (Aucatzyl, Autolus Inc.), a CD19-directed genetically engineered autologous T cell immunotherapy, for people with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This application was granted regenerative medicine advanced therapy designation and orphan drug designation.

Moreover, in March 2024, the Food and Drug Administration (FDA) approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

Stem cell segment is the fastest growing segment in the cell therapy market share

The immunodeficiency disorders segment is the fastest growing segment in the cell therapy market share. The increased spectrum of applications for stem cells in treating numerous ailments, particularly chronic diseases such as cancer, neurological disorders, and cardiovascular diseases, has been a primary driver of this surge. Stem cells have unique features that allow them to develop into multiple cell types and stimulate tissue regeneration, making them a perfect fit for novel treatment techniques.

For instance, in September 2024, BlueRock Therapeutics LP announced that the US Food and Drug Administration (FDA) approved their investigational new drug application (IND) for OpCT-001, an induced pluripotent stem cell (iPSC)-derived cell therapy for the treatment of primary photoreceptor disorders.

Application:

Oncology segment is expected to dominate the cell therapy market share

The oncology segment holds a major portion of the cell therapy market share and is expected to continue to hold a significant portion of the food as a medicine market share during the forecast period. Cell therapy, particularly the use of Chimeric Antigen Receptor (CAR) T-cell therapy, has emerged as a revolutionary strategy for the treatment of different diseases, particularly hematological malignancies such as leukemia and lymphomas. This novel treatment uses the patient's immune system by genetically altering T cells to better recognize and destroy cancer cells. The method consists of several important steps, each of which is meant to improve the effectiveness of the immune response against malignancies.

For Instance, in September 2024, MOC Cancer Care & Research Centre in Mumbai implemented CAR-T cell therapy, giving Indian patients access to one of the most advanced treatments for certain blood cancers, such as leukemia, lymphoma, and myeloma. This ground-breaking therapy has already demonstrated great success in nations where it is available, and MOC hopes to make it both accessible and inexpensive in India.

Immunodeficiency disorders segment is the fastest growing segment in the cell therapy market share.

The immunodeficiency disorders segment is the fastest growing segment in the cell therapy market share. Cell therapy is developing as a potential treatment for autoimmune conditions, including breakthrough approaches like Chimeric Antigen Receptor (CAR) T-cell therapy. This strategy substantially transforms the management of autoimmune illnesses by targeting and changing the immune system to diminish or eliminate the pathogenic responses that define these diseases. Day by day the treatment of autoimmune diseases by cell therapy is growing due to technological advancements and increased focus on research and development.

For instance, in September 2024, Candid Therapeutics launched with $370 million in investment. Its purpose is to produce bispecific T-cell engagers (TCEs) to treat autoimmune diseases. The company not only received a large series A funding round but also acquired two clinical-stage TCE antibody assets, CND106 and CND261, through a merger with biotechs Vignette Bio and TRC 2004.

Geographical Analysis

North America is expected to hold a significant position in the cell therapy market share

North America is expected to hold a significant portion of the cell therapy market. North America is well known for its advanced biotechnology industry. The increasing prevalence of chronic diseases, recent launches, and approvals, advanced research and development activities, presence of major players, and increasing investments and funds by organizations across the region are the main factors contributing to the market growth in the region.

The increasing prevalence of chronic diseases such as cancer, increases need for the cell therapy which drives the market. For instance, according to an article published by the National Institute of Health, in January 2024, 2,001,140 new cancer cases and 611,720 cancer deaths are projected to occur in the United States. Moreover, according to the Zerocancer Organization, in 2024, the United States is facing an alarming rise in cancer incidence, set to surpass 2 million new cases. Prostate, breast, endometrial, pancreatic, kidney, and melanoma cancers contribute to this surge.

The investment for the establishment of cell therapeutics is increasing in this region which contributes to advanced cell therapy research and development and drives the market in this region. For instance, in February 2024, AstraZeneca extended its manufacturing footprint in the United States in order to accelerate next-generation cell therapy discovery and development. AstraZeneca has invested $300 million in a revolutionary laboratory in Rockville to launch its vital cell therapy platforms in the United States for key cancer studies and long-term commercial supplies. AstraZeneca is developing a cell treatment portfolio with the goal of empowering and equipping the immune system's T-cells to better combat cancer. The company's research teams are researching new ways to target and arm CAR-Ts to improve their efficacy in solid tumors by overcoming the immune-suppressive tumor microenvironment.

Asia Pacific is growing at fastest pace in the cell therapy market.

Asia Pacific region is expected to grow at the fastest pace over the forecast period. The increasing prevalence of chronic diseases and increased research and development activities of various products help drive the market in this region. The Asia Pacific cell therapy industry is quickly expanding, owing to major advances in biotechnology and an increasing emphasis on cost-effective healthcare solutions.

The increasing prevalence of chronic diseases and recent launches drive the Asia Pacific market. For instance, according to the National Institute of Health, New cancer diagnoses in the country reached about 1.6 million in 2023, up from approximately 980,000 in 2010. Cancer is anticipated to harm 800,000 people each year, a figure that is expected to rise significantly in the future decades. For instance, according to the National Institute of Health, New cancer diagnoses in the country reached about 1.6 million in 2023, up from approximately 980,000 in 2010. Cancer is anticipated to harm 800,000 people each year, a figure that is expected to rise significantly in the future decades.

Competitive Landscape

The major global players in the global cell therapy market include Gilead Sciences, Inc., Novartis, AG, Vericel Corporation, CO.DON GmbH, Bristol Myers Squibb Company, IOVANCE Biotherapeutics, Inc., Dendreon Pharmaceuticals LLC, Enzyvant Therapeutics GmbH, CellTrans, Gamida Cell Inc. among others.

Emerging Players

Fate Therapeutics, Affini-T Therapeutics Inc., Allogene Therapeutics among others.

Key Developments

• In August 2024, The Food and Drug Administration (FDA) has approved a cellular therapy known as afamitresgene autoleucel, or afami-cel (Tecelra), to treat individuals with metastatic synovial sarcoma, a type of soft tissue sarcoma. This is the first time the agency has approved a T-cell receptor (TCR) therapy for cancer.

Why Purchase the Report?

• To visualize the global cell therapy market segmentation based on source, cell type, application, end-user, and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of cell therapy market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as Excel consisting of key products of all the major players.

The global cell therapy market report would provide approximately 53 tables, 47 figures, and 176 pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies