Autologous Cell Therapy Market
Industry: Healthcare
Published Date: July-2024
Format: PPT*, PDF, EXCEL
Delivery Timelines: Contact Sales
Number of Pages: 155
Report ID: PMRREP34713
The autologous cell therapy market size was estimated at US$5.3 Bn in 2024 and is expected to be valued at US$12.1 Bn by 2031. The market for autologous cell therapy is expected to reach an expanding, robust CAGR of 12.6% from 2024 to 2031.
Key Highlights of the Market
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Attributes |
Key Insights |
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Market Size (2024E) |
US$5.3 Bn |
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Projected Market Value (2031F) |
US$12.1 Bn |
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Global Market Growth Rate (CAGR 2024 to 2031) |
12.6% |
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Historical Market Growth Rate (CAGR 2018 to 2023) |
11.8% |
The autologous cell therapy market share is rapidly increasing within the broader cell therapy market. Autologous cell therapies involve using a patient's own cells for therapeutic purposes, offering personalized treatment options. This market is expected to witness significant growth in the coming years, driven by various factors such as increasing applications in treating a variety of conditions, advancements in technology, and the rising prevalence of autoimmune disorders, cancer, and blood-related disorders.
The market is projected to expand from US$5.3 Bn in 2024 to US$12.1 Bn by 2031, with a compound annual growth rate (CAGR) of 12.6% between 2024 and 2031. The wide range of applications is contributing to the market's growth.
The market has been supported by the steady introduction of new technologies that enable the development of sophisticated treatments. One of them is a personalized treatment approach, which minimizes the risk of rejection and improves treatment outcomes.
Additionally, the rising prevalence of autoimmune disorders, cancer, and blood-related disorders is expected to be a significant driver for autologous cell therapy market expansion.
Autologous cell therapies have shown promising results in the treatment of these conditions. All these market trends contribute to increased demand and safety for patients.
The autologous cell therapy industry has witnessed significant growth in recent years and is expected to continue its upward trajectory in the future. In 2019, the autologous cell therapy market was valued at US$3.0 Bn. The market has experienced robust growth, with a compound annual growth rate (CAGR) of 11.8% from 2019 to 2023.
The autologous cell therapy sector is expected to continue its growth trajectory in the coming years. The autologous cell therapy market is projected to expand from US$5.3 Bn in 2024 to US$12.1 Bn by 2031, with a CAGR of 12.6% between 2024 and 2031.
Increasing applications of autologous cell therapy in treating a variety of conditions, such as autoimmune disorders, cancer, and blood-related disorders, will drive market growth.
Advancements in technology will further enhance the efficacy and safety of autologous cell therapies, contributing to market expansion. The market will benefit from the personalized treatment approach offered by autologous cell therapy, which uses a patient's own cells, minimizing the risk of rejection and improving treatment outcomes.
Ongoing research and development activities in the field of autologous cell therapy are expected to lead to the introduction of new therapies and treatment options, driving market growth. Further, the continuous increase in FDA approvals for innovative therapies is poised to unlock further growth opportunities for the market.
Increasing Prevalence of Chronic Diseases and Conditions
The rising prevalence of chronic diseases and conditions such as cancer, autoimmune diseases , and blood-related disorders is a significant driver for the autologous cell therapy market growth.
Autologous cell therapy offers a personalized treatment approach by using a patient's own cells, which minimizes the risk of rejection and improves treatment outcomes.
With the growing burden of chronic diseases globally, the demand for effective and personalized therapies like autologous cell therapy is expected to increase, driving market growth.
Advancements in Technology and Research
Advancements in technology and ongoing research in the field of autologous cell therapy are key drivers for market growth. The development of innovative techniques for cell isolation, expansion, and modification has improved the efficacy and safety of autologous cell therapies.
Additionally, the discovery of novel cell types and the use of gene editing tools have expanded the therapeutic potential of autologous cell therapies. These advancements are attracting investment and driving the autologous cell therapy market demand.
Favorable Regulatory Environment
The presence of a favorable regulatory environment and increasing approvals by regulatory authorities, particularly the U.S. Food and Drug Administration (FDA), act as growth drivers for autologous cell therapy expansion.
The FDA has been granting accelerated approvals for innovative autologous cell therapies, facilitating their commercialization and adoption. This regulatory support provides confidence to researchers, investors, and clinicians, encouraging further development and commercialization of autologous cell therapies.
The streamlined regulatory pathway and increasing approvals contribute to market growth by expanding the availability of these therapies to patients.
Regulatory Challenges, and Uncertainties
The autologous cell therapy market faces persistent regulatory challenges and uncertainties, which impede its prospects for translation and commercialization. Existing regulatory frameworks present substantial translational challenges, particularly in terms of manufacturing and scale-out production.
The complex supply logistics and the need to scale out production to multiple manufacturing sites or potentially near the patient within hospital settings pose unique challenges.
Cost and Manufacturing Complexity
Autologous cell therapy manufacturing involves patient-specific production, which can be cost-intensive and complex. The process typically begins with extracting cells or tissues from the patient's body, processing and expanding them in a laboratory, and then reintroducing them back into the individual.
The personalized nature of autologous cell therapy requires individualized manufacturing for each patient, leading to higher costs and logistical challenges.
Expansion of Indications and Therapeutic Applications
The future of the autologous cell therapy market holds significant opportunities for expansion in indications and therapeutic applications. As research and development efforts continue, there is a growing understanding of the potential of autologous cell therapies in treating a wide range of diseases and conditions.
Beyond the current applications in cancer, autoimmune disorders, and musculoskeletal disorders, there is potential for the use of autologous cell therapy in areas such as dermatology, neurodegenerative diseases, cardiovascular diseases, and more. The exploration of new indications and therapeutic applications will open up new avenues for growth in the market.
Advancements in Manufacturing and Scalability
Advancements in manufacturing techniques and scalability are expected to create future opportunities and fuel the market sales. Currently, the personalized nature of autologous cell therapy presents challenges in terms of cost and complexity.
However, ongoing research and development efforts are focused on developing more efficient and scalable manufacturing processes. The development of automated systems, bioreactors, and closed-system manufacturing platforms can streamline the production of autologous cell therapies, reducing costs and improving scalability. These advancements will enhance the commercial viability and accessibility of autologous cell therapies, driving market growth.
Immunotherapies Lead the Therapy Segment with Effective Diagnosis
Based on therapy, in 2023, the autologous cellular immunotherapies segment accounted for more than 49.7% of the autologous cell therapy market share. It involves collecting immune cells from the patient and modifying them to improve their ability to identify and combat specific target diseases.
Autologous cellular immunotherapies, including CAR-T cell therapy, aim to enhance the patient's immune system's effectiveness in fighting diseases, particularly cancer. These therapies harness the power of the patient's immune cells to provide targeted and enhanced disease-fighting capabilities.
Cancer Remains the Key Area of Application for Autologous Cell Therapy
Based on application, the cancer segment held a dominant market share of 29.9% in 2023, driven by the increasing burden of cases and demand for autologous cell therapy in cancer treatment.
The American Cancer Society predicts 1,958,310 new cancer cases and 609,820 fatalities in the US in 2023. In August 2022, Anixa Biosciences administered the first dose of its targeted autologous cell therapy to an ovarian cancer patient in a Phase I trial.
The wound healing segment is projected to experience significant growth from 2024 to 2031 due to the rising prevalence of chronic wounds like diabetic ulcers and venous ulcers, influenced by the aging population and diabetes incidence.
Bone Marrow Dominates Based on Source
Based on the source, in 2023, the bone marrow segment accounted for the largest market share at 29.9%. It is a major source of autologous cell therapy, where healthy stem cells are collected from the patient's bone marrow or blood.
Autologous cell therapy using bone marrow offers advantages over donor stem cells. The other segment, which includes amniotic fluid and dental pulp sources, is expected to experience significant growth from 2024 to 2031.
Amniotic fluid-derived stem cells (AFSCs) and dental pulp stem cells (DPSCs) show promise in various medical applications, such as osteoarthritis, wound healing, and tissue engineering. Successful clinical trials and increasing demand for minimally invasive therapies contribute to the growth prospects of this segment.
Academics and Research Become Leading End Users
Based on end-use, the academics and research segment held the largest autologous cell therapy market share of 39.05% in 2023 and is projected to grow rapidly from 2024 to 2031.
Autologous cell therapy is gaining global interest and undergoing extensive research as an emerging field of science that utilizes living cells for disease treatment and prevention.
Academics and research primarily focus on studying bone marrow, epidermis, mesenchymal stem cells, hematopoietic stem cells, and chondrocytes. For example, Terumo Blood and Cell Technologies initiated a study in October 2023 with BioCentriq to generate public data on CAR-T cell production, aiming to expedite the delivery of CAR-T therapies to patients using advanced systems and platforms.
North America Surpasses Others Through Government Support
In 2023, the autologous cell therapy market in the U.S. held the largest share in North America and is projected to grow rapidly. The FDA's approval of multiple autologous cell therapies for different indications has instilled confidence in the market and attracted investments.
The presence of a strong healthcare system and robust intellectual property protection laws also contribute to market expansion. In January 2024, the FDA approved a manufacturing process change for Kite's Yescarta CAR T-cell therapy, reducing the turnaround time for leukapheresis to product release in the U.S. from 16 to 14 days.
Europe Establishes Ground for Market Expansion with Increasing Developments
The demand for autologous cell therapy in Europe was highly lucrative, driven by the supportive regulatory environment of the European Medicines Agency (EMA) for advanced therapies. The market shares reached US$ 2.43 Bn in 2023.
The EU's commitment to funding research, such as through programs like Horizon 2020, has contributed to the development of dedicated bioreactors for autologous cell therapy. Additionally, the growing prevalence of chronic diseases in the region has created a large patient pool for autologous cell therapies.
In the UK, a robust healthcare system, research activities in stem cell therapies, and supportive regulatory frameworks are driving the autologous cell therapy market. Partnerships between universities and biotech companies are also fostering advancements in the sector.
Asia Pacific Strives for Excellence with Growing Awareness
The Asia Pacific autologous cell therapy market is expected to experience rapid growth due to factors such as the increasing burden of diseases, strong research activities in autologous cell therapies, a well-established biotechnology sector, developing healthcare facilities, and growing awareness for cell therapies.
In May 2024, Cytiva and Gilead Sciences' Kite Pharma introduced Sefia, an advanced cell therapy manufacturing platform designed to address challenges in production. This innovation caters to the rising demand for autologous cell therapies, supported by over 1,000 clinical trials worldwide and the presence of approved CAR-T therapies across multiple regions.
In May 2024, Baylor College of Medicine's GD2-Directed CAR T-Cell Therapy has shown promising results in treating relapsed or refractory neuroblastoma patients. The therapy, which targets GD2, has shown intermittent persistence of the transgene at low levels in patients for over a decade. The study aimed to track the cell therapy's safety, tolerability, T-cell persistence, and treatment efficacy. The treatment is effective in treating breast cancer stem cells, which may express GD2 and may indicate that T cells are responding to that expression.
In Apr 2024, Obsidian Therapeutics, Inc., a biotechnology company focused on engineered cell and gene therapies, has completed a successful Series C financing round, raising $160.5 million. The funding will be directed towards advancing Obsidian's OBX-115, a novel engineered tumor-derived autologous T cell immunotherapy (TIL) therapy, through ongoing clinical trials. The therapy, equipped with pharmacologically regulatable membrane-bound IL15 (mbIL15), holds promise for patients with advanced or metastatic melanoma and other solid tumors.
In the autologous cell therapy market, companies are actively pursuing growth through acquisitions and fostering innovation. The emergence of startups with unique offerings adds to the competitive landscape.
To stay ahead, companies are investing heavily in expanding production capabilities and enhancing technological features. Their aim is to develop innovative functionalities and seamlessly integrate technologies into this evolving sector, ensuring successful market entry and widespread adoption.
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Attributes |
Details |
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Forecast Period |
2024 to 2031 |
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Historical Data Available for |
2018 to 2023 |
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Market Analysis |
US$ Billion for Value |
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Key Country Covered |
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Key Market Segments Covered |
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Key Companies Profiled |
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Report Coverage |
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Customization & Pricing |
Available upon request |
By Therapy
By Application
By Source
By End-use
By Geographical Regions
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The market is predicted to rise from US$5.3 Bn in 2024 to US$12.1 Bn by 2031.
Increasing applications in treating various conditions, technological advancements, and the rising prevalence of autoimmune disorders, cancer, and blood-related disorders are driving market growth.
BrainStorm Cell Therapeutics, Holostem Terapie Avanzate S.R.L, Pharmicell Co. Inc, Opexa Therapeutics, Lonza, and Bristol Myers Squibb are some examples of key industry players.
Challenges like persistent regulatory challenges, uncertainties, and cost-intensive and complex production processes are restraining market expansion.
Continuous research and development efforts and advancements in manufacturing techniques are the key opportunities in the market.
