Growing Demand for Effective Drugs for Treatment of Cardiac & Degenerative Disorders Is A Primary Driver of Market
The demand for effective drugs to treat cardiac and degenerative disorders has increased significantly. There was no effective medicine to treat a damaged heart prior to the introduction of autologous cell therapies. The identification of potential cardiac autologous cells opened up new possibilities for repairing damaged heart tissue caused by coronary artery disease. Approximately 19 product candidates are being developed for the treatment of cardiac diseases. Shire, Japan Regenerative Medicine, Athersys, MyoCell, and Celyad are some of the companies involved in developing these medications. Furthermore, in November 2023, exclusive licensing agreement between Legend Biotech Corporation and Novartis Pharma AG for the CAR-T cell therapy targeting DLL3, including LB2102, illustrates significant advancements in the global autologous cell therapy market. This deal exemplifies growing confidence and investment in targeted cell therapies, driven by their potential to address severe diseases. Novartis's application of its T-Charge platform to manufacture these therapies underscores the market's focus on innovative production techniques, enhancing scalability and accessibility. Such high-profile partnerships are likely to propel market expansion and drive the development of next-generation therapies.
Musculoskeletal Disorders Segment Is Fuelling Autologous Cell Therapy Market Growth
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.
Recent Trends in the Autologous Cell Therapy Industry:
- Significant R&D investments are enhancing autologous cell therapies by refining processing, growth, and delivery.
- Autologous cell therapies, notably CAR-T, are expanding into autoimmune, cardiovascular, and neurodegenerative treatments.
- The move towards personalized medicine accelerates autologous cell therapy growth, enhancing precision.
- Efficient, scalable manufacturing processes, including automation and advanced cell expansion, drive market growth.
- Digital tools, such as AI and machine learning, enhance cell therapy development efficiency and precision.
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Stem Cell Research's Ethical Concerns Will Challenge the Global Autologous Cell Therapy Market
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.
FDA Approval Expands CAR-T Therapy Applications Among Strategic Industry Moves
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.
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.
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Increasing Prevalence of Blood Diseases and Rising Geriatric Population Drive Market Expansion
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.
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The report provides a detailed overview of the autologous cell therapy market insights in regions including North America, Latin America, Europe, Asia-Pacific, Oceania, and the Middle East and Africa. The country-specific assessment for autologous cell therapy market has been offered for all regional market share, along with forecasts, market scope estimates, price point assessment, and impact analysis of prominent countries and regions. Throughout this market research report, Y-o-Y growth and CAGR estimates are also incorporated for every country and region, to provide a detailed view of the autologous cell therapy market. These Y-o-Y projections on regional and country-level markets brighten the political, economic and business environment outlook, which are anticipated to have a substantial impact on the growth of the autologous cell therapy market. Some key country and region included in the autologous cell therapy market report as follows:
| Regions | Countries |
|---|---|
| North America | United States, Canada |
| Latin America | Brazil, Mexico, Argentina, Colombia, Chile, Rest of Latin America |
| Europe | Germany, United Kingdom, France, Italy, Spain, Russia, Netherlands, Switzerland, Belgium, Sweden, Austria, Norway, Denmark, Finland, Ireland, Czech Republic, Rest of Europe |
| Asia Pacific | China, India, Japan, South Korea, Australia & New Zealand, Singapore, Thailand, Malaysia, Indonesia, Philippines, Rest of Asia Pacific |
| Middle East and Africa | China, India, Japan, South Korea, Australia & New Zealand, Singapore, Thailand, Malaysia, Indonesia, Philippines, Rest of Asia Pacific |
Autologous Cell Therapy Market Research Report Covers In-depth Analysis on:
- Autologous cell therapy market detailed segments and segment-wise market breakdown
- Autologous cell therapy market dynamics (Recent industry trends, drivers, restraints, growth potential, opportunities in autologous cell therapy industry)
- Current, historical and forthcoming 10 years market valuation in terms of autologous cell therapy market size (US$ Mn), share (%), Y-o-Y growth rate, CAGR (%) analysis
- Autologous cell therapy market demand analysis
- Autologous cell therapy market regional insights with region-wise market breakdown
- Competitive analysis – key companies profiling including their market share, product offerings, and competitive strategies.
- Latest developments and innovations in autologous cell therapy market
- Regulatory landscape by key regions and key countries
- Autologous cell therapy market sales and distribution strategies
- A comprehensive overview of parent market
- A detailed viewpoint on autologous cell therapy market forecast by countries
- Mergers and acquisitions in autologous cell therapy market
- Essential information to enhance market position
- Robust research methodology
- Frequently Asked Questions -
What are the key drivers of growth in the autologous cell therapy market?
The growth is driven by advancements in technology, increasing prevalence of chronic diseases and a rise in investments in regenerative medicine research.
What are the challenges faced by the autologous cell therapy market?
Key challenges include high treatment costs, regulatory hurdles, and complexities associated with cell processing and handling.
Which regions are expected to see significant growth in the autologous cell therapy market?
North America and Europe are anticipated to witness significant growth due to advanced healthcare infrastructure and robust research activities.
What is the impact of regulatory policies on autologous cell therapy market?
Regulatory policies influence market dynamics by setting standards for safety and efficacy, impacting the approval process and market entry of new therapies.
