Cell Therapy Market

Market Overview

The global cell therapy market size was valued at USD 10,118.3 million in 2022. It is estimated to reach USD 32,645.4 million by 2031, growing at a CAGR of 13.9% during the forecast period (2023–2031). It is anticipated that regenerative medicine will make significant strides toward the creation of effective treatments for chronic illnesses. This is expected to propel market growth over the forecast period. Automation, hiring, and supply chain management are all advancing toward the same goal.

Cell therapy is the therapeutic use of cells to treat medical problems or illnesses. This treatment entails transplanting cells or tissues into a patient's body to repair or replace damaged cells or tissues. Cell therapy can cure various illnesses, including cancer, cardiovascular disease, neurological disorders, and autoimmune diseases. It includes a variety of cells, including stem cells, immune cells, and cells from other organs. Cell therapy is used in the clinic as a therapeutic technique for various illnesses and medical problems. It is utilized in research to investigate cells' and tissues' basic features and processes.

Market Dynamics

Global Market Drivers

Rising Number of Clinical Studies for Cellular Therapies

Cellular therapies hold great therapeutic promise across various clinical applications. This has resulted in a significant global investment in research and clinical translation. Rapid breakthroughs in stem cell research have the potential to meet the unmet needs of the pharmaceutical, biotech, and medical sectors in disease management. Numerous undisclosed treatments are currently being evaluated in clinical studies. Moreover, the rise in the quantity of current clinical trials can be attributed to the consistent provision of grants by government and corporate funding bodies, which aim to assist initiatives at different phases of clinical trials. Thus, the factor mentioned above is going to drive the global market.

Growing Adoption of Regenerative Medicine

Significant progress in regenerative medicine is expected, leading to the development of viable remedies for chronic ailments. Numerous enterprises operating within expanding markets, such as Canada, are actively leading the way to exploit these markets' untapped potential. For example, RepliCel is investing in multiple products in regenerative medicine. In 2017, three cell therapy products were currently undergoing clinical research. Moreover, their dermal injection device, which facilitates the subcutaneous administration of the product, is utilized annually.

Global Market Restraints

Ethical Concerns Related to Stem Cell Research

Human embryonic stem cell research is fraught with ethical difficulties. Harvesting embryonic stem cells necessitates the destruction of human embryos, which raises ethical concerns. Similarly, severe rules for securing Intellectual Property Rights (IPR) for research items or materials are key impediments to commercializing these services. Obtaining ethical approval for preserving cell lines and tissues in biorepositories is necessary to control the use of tissue for illicit purposes or identify proxy illnesses to submit an insurance claim. Moreover, concerns surrounding the use of embryonic stem cells for research stymie market expansion in several nations.

Global Market Opportunities

Approval of Kymriah and Yescarta across Various Countries

Kymriah and Yescarta's promising results in treating leukemia and lymphoma have led to accelerated regulatory approvals for these products across various jurisdictions. They have secured approval from the FDA, EMA, Health Canada, and Japanese regulatory bodies. Similarly, Kymriah will receive approval from Chinese regulatory authorities in the next few years. These approvals have led to a rapid increase in trials developing CAR T-cell therapies across various cancers. Dramatic progress is anticipated in adoptive cell transfer-based treatment modes in the next few years. At the end of Q1 2018, Kymriah was manufactured for 11 countries and 35 certified treatment centers.

On the other hand, 61 cancer centers were authorized to administer Yescarta. This has significantly driven revenue growth in the cell therapy market opportunities, further expediting the approval of other promising products. Moreover, as CAR-T space expects future product approvals across a wider range of indications, the potential budget impact on payers is largely positive.

Regional Analysis

Based on region, the global cell therapy market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global cell therapy market shareholder and is estimated to exhibit a CAGR of 14.8% over the forecast period. Several reasons drive the North American market, including the rising frequency of chronic illnesses, increased investment in research and development, and favorable government measures encouraging cell therapy use. Moreover, the significant number of clinical trials undertaken in North America propels the region's market expansion.

Furthermore, increased demand for personalized treatment and public awareness of the benefits of cell therapy is projected to open up new market prospects in the area. The North American market is very competitive, with established businesses and new entrants. The market's top competitors are increasing their footprint through collaborations, partnerships, and acquisitions to acquire a competitive advantage. Overall, the North American cell therapy market share will likely increase significantly, driven by rising demand for novel medicines and a greater emphasis on personalized medicine.

Asia-Pacific is anticipated to exhibit a CAGR of 12.3% over the forecast period. Established businesses and recent arrivals in the Asia-Pacific market are concentrating on alliances, teamwork, and new product introductions to gain a competitive edge. China and Japan are the region's top markets, with India emerging as a prominent market due to the region's increased use of cell treatments. The Asia-Pacific market is also growing due to favorable government efforts encouraging the use of cell treatments, increased investments in research and development, and expanding public awareness of personalized medicine. Overall, the Asia-Pacific market is predicted to rise significantly in the coming years, owing to rising demand for new cell treatments, an increase in the frequency of chronic illnesses, and investments in research and development.

In Europe, the rising frequency of chronic illnesses, improvements in stem cell research, and favorable government measures encouraging cell therapy adoption are driving the growth of the cell therapy market. Increased expenditure on R&D activities and the presence of established companies in the area are driving market expansion. Moreover, expanding awareness of the benefits of cell therapy and rising demand for personalized treatment are projected to open up new market prospects in the area. Established companies and emerging players in the European cell treatment market are prioritizing product development, expansion, and collaboration as strategies to maintain a competitive edge.

In Latin America, the increasing frequency of chronic illnesses, a growing elderly population, and a rising need for personalized treatment all contribute to the growth of the market. Similarly, favorable government efforts and well-established competitors in the area are propelling market expansion. Moreover, growing awareness of the benefits of cell therapy and the availability of superior medical facilities are opening up new market potential in the area. Existing companies and new entrants in the Latin American market are focused on product development, growth, and cooperation to keep ahead of the competition.

South Africa is the region's largest market in the Middle East and Africa, followed by the United Arab Emirates. Rising chronic illness prevalence, an aging population, and developments in healthcare infrastructure are significant drivers driving market expansion in the area. The regional market is fiercely competitive, with established companies and newer startups focusing on product development, partnerships, and alliances to stay ahead. Moreover, favorable government efforts and increasing funding for R&D activities fuel the expansion of the Middle East and Africa market.

Segmental Analysis

The global market is bifurcated into cell type, therapeutic area, and therapy type.

Based on cell type, the global cell therapy market is bifurcated into stem cell therapies and non-stem cell therapies.

The stem cell therapies segment dominates the global market and is expected to exhibit a CAGR of 6.5% over the forecast period. Despite ethical and legal issues, stem cell therapies have gained significant attention from entities involved in disease management. Doctors are using stem cells derived from bone marrow or blood in transplant procedures to treat patients with cancer, blood disorders, and immune-related disorders. Increased funding from government and private organizations to support cell therapy clinical trials, the introduction of effective guidelines for cell therapy manufacturing, and the proven efficacy of products are some of the primary drivers of the market. Moreover, declining prices of stem cell therapies are expected to boost their adoption, thereby driving the market.

Based on therapeutic areas, the global cell therapy market is segmented into malignancies, musculoskeletal disorders, autoimmune disorders, dermatology, and other research uses.

The malignancies segment dominates the global market and is predicted to exhibit a CAGR of 16.3% during the forecast period. Cell therapies employing stem cells and other cells have been shown to have significant potential in cancer treatment. Stem cells can be employed as novel delivery platforms to target both primary and metastatic tumor foci. This is due to the unique characteristics of stem cells, such as secretion of bioactive factors, migration toward cancer cells, and immunosuppression. These characteristics help address challenges in cancer management. Various types of cancers treated by stem cell transplantation include multiple myeloma, non-Hodgkin lymphoma, acute myeloid leukemia, neuroblastoma, ovarian cancer, and germ-cell tumors.

In addition, the advent of chimeric antigen receptor (CAR) T cells signifies the role of engineered immune cells as a powerful new class of cancer therapeutics. Nevertheless, there are scientific concerns about cell therapy usage, which necessitate further studies for the validation of preclinical findings.

Based on therapy type, the global cell therapy market is divided into allogenic therapies and autologous therapies.

The autologous therapies segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 17.8% over the forecast period. This is due to a number of benefits associated with autologous transplants. The use of own cells, easy availability, no need to find an HLA-matched donor, a lower risk of life-threatening complications, no risk of GVHD, no need for immunosuppressive therapy, the fact that graft failure occurs rarely, mortality is less than 5% in most studies, and the fact that elderly patients tolerate treatment relatively well are just a few of the benefits. Moreover, autologous therapies are affordable when compared to allogeneic therapies. The high survival rate associated with this transplant type and the relatively high adoption rate are factors expected to boost segment growth over the forecast period.

Recent Developments

• May 2023: The FDA awarded Novartis' Kymriah CAR T-cell therapy expedited approval for treating pediatric acute lymphoblastic leukemia.
• February 2023: Yescarta, a CAR T-cell therapy approved by the FDA for treating relapsed or refractory diffuse large B-cell lymphoma, was developed by Kite Pharma, a subsidiary of Gilead Sciences.