Autologous Cell Therapy Market Report

The increasing prevalence of skeletal disorders among the worldwide population is projected to drive the musculoskeletal disorders segment. According to the World Heart Organization's (WHO), around 1.71 billion individuals globally suffer musculoskeletal disorders. Low back pain is the single biggest cause of disability in 160 countries, making musculoskeletal diseases the leading contributor to disability globally. Low back pain is the most common musculoskeletal condition, affecting 568 million individuals globally. According to the same source, the world's ageing population is growing, as is the number of individuals with musculoskeletal disorders. With over 149 million YLDs, or 17% of all YLDs globally, musculoskeletal conditions are also the main cause of years lived with disability (YLDs). As a result, the growing incidence of musculoskeletal ailments is anticipated to raise the demand for effective therapies such as autologous therapies, adding to market growth.

Stem cell therapy-related ethical concerns have been the subject of ongoing discussion for many years. Scientists and policymakers are constantly debating the development of embryonic stem cells. The scientific community and decision-makers have long been concerned about the potential application of human embryonic stem cells in research. Replication of embryonic stem cells and the destruction of embryos to create cell lines are two of the difficulties. Furthermore, there have always been concerns about the safety, scientific purity, and authorization to allow the use of human embryonic stem cell lines for research purposes. Additionally, stem cell treatment requires animal research and clinical trials. With rising ethical concerns throughout the world, government bodies must regulate animal testing in order to reduce the use of animals in research. As a result, the prevalence of ethical challenges may hamper current research in stem cell treatment and hinder market growth throughout the forecast period.

Major industry leaders utilize strategies that focus on launching new products, merging with competitors, and purchasing companies to grow their customer base and enhance their range of products. In February 2024, BioNTech SE and Autolus Therapeutics plc announced a strategic partnership to accelerate the commercialization of their autologous CAR-T therapies, pending regulatory approvals. This collaboration, highlighted by a license and option agreement alongside a securities purchase agreement, underscores a significant advancement in the global autologous cell therapy market. The alliance aims to leverage both companies’ expertise to push forward innovative treatments for cancer and serious diseases, potentially setting new standards in personalized immunotherapy.

Furthermore, In May 2024, Bristol Myers Squibb's Breyanzi, a CD19-directed CAR T cell therapy, received FDA approval for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have undergone at least two prior systemic therapies, including a BTK inhibitor. This approval expands Breyanzi’s indications to four distinct non-Hodgkin lymphoma subtypes, highlighting its broad application in B-cell malignancies. Administered as a one-time infusion, Breyanzi delivers 90 to 110 million CAR-positive T cells, addressing a critical need in the autologous cell therapy landscape. However, Autolus Therapeutics plc, a biopharmaceutical company focusing on developing advanced programmed T cell therapies in the clinical stage, selected Cardinal Health Inc. In April 2023 to support the introduction and commercialization of its CAR T-cell therapies in the US, pending FDA approval.

North America is projected to dominate the autologous cell therapy market. This is due to a variety of factors, including the increased occurrence of chronic diseases such as a blood disorder, cancer and other diseases, as well as the availability of improved healthcare infrastructure. In the United States, it is anticipated that there will be 1.9 million new cancer cases identified in 2023, according to the American Cancer Society's report 2023. Additionally, 80% of cancer patients in the United States are aged 55 and above, with 57% being 65 or older. As a result of the high frequency of cancer and an increasing afflicted geriatric population, the country's requirement for diagnostics and treatment is also significant, which is likely to fuel the expansion of the market in the United States. Acute myeloid leukaemia is the most common type of acute leukaemia in adults, according to the National Cancer Institute.  Furthermore, according to the Leukaemia & Lymphoma Society's, an estimated 397,501 persons in the United States are living with or in remission from leukaemia. The rising prevalence of blood diseases such as leukaemia is expected to boost demand for autologous cell treatment, adding to the market's expansion in this region.