Cell Therapy Market

Cell Therapy Market Size (2023 to 2028)

The global cell therapy market is expected to reach USD 9.0 Billion by 2028 from USD 4.5 Billion in 2023, with a CAGR of 14.6% during the forecast period 2023 to 2028.

Human cells are transplanted during cellular therapy (CT) in order to replace or restore harmed tissue or cells. Numerous different types of cells may be used as part of a therapy or treatment for a number of diseases and disorders with the help of new technologies, inventive products, and endless imagination.  Hematopoietic (blood-forming) stem cells (HSC), skeletal muscle stem cells, mesenchymal stem cells, lymphocytes, dendritic cells, and pancreatic islet cells are a few of the cells that could be used. The most popular kind of cell therapy for treating a range of hematologic and blood cancers is hematopoietic stem cell transplantation, often known as a bone marrow transplant. Cell therapies are frequently used to treat conditions like cancer, autoimmune disorders, urinary issues, infectious infections, and spinal cord injuries as well as to restore damaged cartilage in joints and treat patients with neurological abnormalities. Manufacturers, marketers, researchers, and physicians must be aware of the FDA's regulatory recommendations for cell therapy products. Under Title 21 of the Code of Federal Regulations (CFR) Part 1271.3(d), also known as [21 CFR Part 1271.3(d)], the FDA defines human cells, tissues, and cellular and tissue-based products (HCT/P).

MARKET DRIVERS:

The growing number of approvals for cell-based therapies drives market growth. Cell therapies are getting approved by government agencies like FDA. As a result, FDA-approved medicines are easy to find in developing nations, and this is what is expected to fuel the market for cell therapy throughout the forecasted period. For example, in Apr 2023, the U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection. The product is meant to be used by adults and children 12 years of age and older who have blood cancers and are scheduled to receive an umbilical cord blood transplant after undergoing a myeloablative conditioning regimen (a course of treatment like radiation or chemotherapy).

The increase in R&D activities in the application of human cells in cell therapy research and technological advances have driven the market of cell therapy and will continue to escalate in the coming future. The employment of highly innovative safety technologies based on (1) switch-based control systems, including universal CAR designs, (2) combinatorial antigen recognition strategies, (3) stimuli-responsive constructions, and (4) multiple-targeting CARs, will hopefully allow for finely tuned and redirect CAR-T cells activity to avoid undesired toxicities. The future generation of CAR technology is progressing toward the creation of multifunctional smart T-cells with the potential to produce complex synthetic immune responses. Thus, CAR-T will surge the rise in demand for stem cell therapy.

Regenerative medicine drives the market of Cell Therapy. It can repair or replace tissues and organs that have been harmed by disease, trauma, and aging, as well as normalize congenital defects. For instance, ISCRM researchers are exploring stem cell-based therapies that might replace injured or lost heart tissue, studying the impact of microgravity on cardiovascular health, and even launching heart tissue into space.  This factor is highly trending in the field of medical engineering, organoids, 3D organ printing, etc. The rising incidence of chronic diseases such as cancer, diabetes, and heart disease is rising worldwide. Cell therapy has grown a lot because of active chronic disease cases globally. Based on the report provided by DBT India, 73% of all deaths are caused by chronic disease globally. And in diabetes count, India is a leading country with 77 million cases.

MARKET RESTRAINTS:

Limited clinical indications, high production costs, and high patient costs are the issues associated with cell therapies that need to be addressed by ongoing and future clinical trials. Other obstacles preventing the development of cell therapies are linked to safety, which with some products like CAR-T cells could result in toxicities that could be fatal. However, despite the unchallenged clinical outcomes of CAR-T cells in the hemato-oncological field, their activity has been associated with severe side effects, such as cytokine release syndrome and neurotoxicity, while the underlying mechanisms remain unknown. Secondly, a lack of skilled and trained workforce could be a barrier for the manufacturers and clinical laboratories, which in turn will affect the growth of the market.

Impact of COVID-19 on the Cell Therapy Market:

The COVID-19 pandemic has transformed the market for cell therapy significantly, both positively and negatively. The disease outbreak spurred intensive research and development efforts geared towards achieving innovative advancements within this field. One notable achievement was Personalised Stem Cell Inc.'s Investigational New Drug application meant for treating COVID-19 patients using stem cells that got FDA approval in April 2020: A crucial milestone for Cadili Biotherapeutics' partners. By innovating Chimeric Antigen Receptor T-cell therapy or CAR-T cells that target specific malignant tumors through genetic modification of T-cells, the Swedish Cancer Institute displayed an unprecedented positive impact on cell therapy growth immensely. Nevertheless, devastating setbacks emerged as clinical experiments suffered interruptions stemming from changing healthcare priorities during the pandemic. Reduced usage of CAR-T transplantation services resulted from these interruptions limiting access to key treatments among patients needing such services critically.

REPORT COVERAGE:

This research report on the global cell therapy market has been segmented and sub-segmented based on technology, type, cell source, application, end-users, and region.

Cell Therapy Market - By Technology:

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

Based on technology, the somatic cell technology segment is expected to account for the leading share of the global cell therapy market during the forecast period. The most common technology is somatic cell technology which involves the placement of a human gene into a living person’s somatic cells (non-reproductive cells). Thus, used to treat many disorders like muscular dystrophy, cancer, cystic fibrosis, etc., followed by the cell immortalization technology segment has been rising over the past few years.

Cell Therapy Market - By Type:

• Autologous
• Allogeneic

Based on type, the autologous segment is anticipated to hold the leading share of the worldwide market in the coming years due to rising cases of chronic diseases and an increase in the aging population.

Cell Therapy Market - By Source:

• Bone Marrow
• Adipose Tissues
• Neural Stem Cell
• iPSCs
• Umbilical Cord Blood-Derived Cells

Based on the source, the umbilical cord blood-derived cells segment dominated the market in the recent past and is expected to continue to rise during the forecast period. An increase in awareness of the importance of stem cell banking and its procedures majorly propels segmental growth.

The bone marrow segment is positioned second in the cell therapy market and is expected to grow at a healthy CAGR during the forecast period owing to the rise in leukemia disorders over the year.

Cell Therapy Market – By Application:

• Cardiovascular
• Gastrointestinal
• Neurological
• Oncology
• Musculoskeletal
• Dermatology
• Wounds & Injuries
• Ocular
• Others

Based on application, the cardiovascular segment is expected to be growing at a higher CAGR and will dominate the market during the forecast period. According to WHO, 17.9 million death globally occurs due to CVDs. On world heart day 2022, it was declared that the number of deaths due to heart attacks in India has remained consistently over 25,000 in the last four years and over 28,000 in the last three years. The second leading segment is oncology due to the rising number of cancer patients worldwide.

Cell Therapy Market - By End-users:

• Hospitals & Clinics
• Diagnostic & Research Centres
• Regenerative Medicine Centres
• Others

Based on end-users, the hospitals & clinics segment is predicted to lead the global market during the forecast period, followed by research centers, responsible for taking out new discoveries and innovation in this field. Also, government initiatives and funding play a key role in keeping research centers working.

Cell Therapy Market - By Region:

• North America
• Europe
• Asia-Pacific
• Latin America
• The Middle East & Africa

By region, the North American cell therapy market is anticipated to be the fastest-growing region in healthcare globally. It accounted for approximately 53% of the market share with rising CVD incidence primarily driving this market.

The European market was the second leading market by region. The rise in clinical research and private and government funding kept the market of cell therapy constant over the years.

Asia-pacific is showing significant growth with innovative ideas and discoveries. China and Japan are leading in terms of diagnosis and research.

Latin America and Middle East Africa are expected to have a moderate market share during the forecast period.

KEY MARKET PLAYERS:

Some of the notable companies in the market of cell therapy include Thermo Fisher Scientific Inc., Lonza Group, Osiris Therapeutics, Inc., Danaher Corporation, Becton, Merck KGaA, Dickinson and Company, Corning Incorporated, Mesoblast Ltd., Fresenius Medical Care AG & Co., Avantor Inc., Hemasoft, STEMCELL Technologies, SIRION Biotech GmbH and FJIFILM Irvine Scientific.

RECENT MARKET DEVELOPMENTS:

• In May 2023, an area that has witnessed significant breakthroughs over recent years has been that of cell and gene therapies. The market for these emerging therapies is projected to grow at a compound annual rate of 22.41% between 2022 and 2030, driven by an expanding pipeline and increasing regulatory approvals.
• In Apr 2023, FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce the Risk of Infection Following Stem Cell Transplantation.
• In June 2022, U.S. FDA Approved Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi® for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy.