Autologous Cell Therapy Market Size, Share & Trends Analysis Report By Application (Cancer, Neurodegenerative Disorders), Source (Bone Marrow, Mesenchymal Stem Cells), By End-use, By Region, And Segment Forecasts, 2024 - 2030

Autologous Cell Therapy Market Trends

The global autologous cell therapy market size was estimated at USD 4.32 billion in 2023 and is projected to grow at a CAGR of 22.20% from 2024 to 2030. The key factors driving the market growth include numerous immunological advantages, a rise in the proportion of the geriatric population across the globe, and a reduced risk of autologous cell therapy rejection. Autologous cell therapy is widely used in a range of diseases such as cancer, neurodegenerative disorders, cardiovascular disorders, autoimmune disorders, orthopedics, wound healing, and others.

Autologous cell therapy's immunological benefits significantly drive its market growth. By using the patient's cells, the therapy minimizes the risk of immune rejection, creating a safer treatment option. This approach has shown considerable promise, particularly in cancer treatments, where immune compatibility is crucial for therapy success. Personalized treatments leveraging these advantages are becoming increasingly sought after, reflecting a broader trend toward individualized medicine.

The global population of individuals aged 65 and older is projected to more than double by 2050, reaching over 1.5 billion. This demographic shift increases the prevalence of age-related diseases such as cardiovascular disorders and neurodegenerative diseases. These conditions are key application areas for autologous cell therapy, which, in turn, stimulates market growth as demand for effective treatments rises.

The autologous approach significantly reduces the risk of therapy rejection which is a major advantage over allogeneic therapies (using donor cells). This not only improves patient outcomes but also simplifies the path to regulatory approval. The clinical and regulatory efficiency of autologous cell therapies encourages investment and innovation in this sector, responding to the critical need for compatible and effective therapeutic options. In November 2023, Novartis secured global rights to a selection of Legend Biotech’s CAR-T cell therapies, including a promising candidate for lung cancer and large cell neuroendocrine carcinoma, in a deal worth over USD 1.0 billion. This agreement allows Novartis to leverage its T-Charge platform for developing and manufacturing these therapies.

Market Concentration & Characteristics

Degree of innovation in the market is currently high. This stems from technological advancements enabling new therapy cell types such as iPSCs and CAR-T cells, offering significant improvements over traditional methods by targeting specific cancer cell antigens and enabling mass cell production. Advancements in manufacturing processes make these therapies efficient and cost-effective. For instance, in March 2024, the FDA approved Breyanzi by Bristol Myers Squibb for adults with CLL or SLL that is relapsed or refractory. This CAR-T cell therapy is given as a one-time infusion. In the TRANSCEND trial, 20% of patients had a complete response to Breyanzi, which is also approved for treating relapsed or refractory large B-cell lymphoma.

To improve their market position, several companies participate in mergers and acquisitions. These activities boost their market expertise, diversify their product offerings, and enhance their skills. In December 2023, AstraZeneca announced its acquisition of Gracell Biotechnologies Inc., a clinical-stage biotech company specializing in cell therapies for cancer and autoimmune diseases. This deal aimed at boosting AstraZeneca's cell therapy portfolio, introducing a promising CAR-T therapy for multiple myeloma and other diseases.

The regulation of autologous cell therapies involves complex and varying rules across different countries. In the U.S., the FDA oversees these therapies as biologics, demanding strict safety and efficacy standards. Similarly, the European Medicines Agency (EMA) in Europe classifies them as advanced-therapy medicinal products (ATMPs), requiring detailed clinical and manufacturing benchmarks for approval. These regulations, while ensuring safety, also impose significant financial and time burdens on developers, potentially limiting market entry for smaller entities due to the stringent and costly requirements for clinical trials and manufacturing compliance.

Autologous cell therapies are not cost-efficient due to complex manufacturing processes and often lead patients and healthcare providers to opt for lower-cost alternatives such as allogeneic cell therapy, despite associated risks. Technological advances introduce more affordable and potentially more effective options, such as gene therapies and tissue engineering. Furthermore, stricter regulatory guidelines and increasing competition are pushing for the adoption of these alternative treatments over autologous cell therapies, influencing both cost and accessibility.

The market has witnessed significant regional expansion over the past few years, with key growth areas including North America, Europe, and Asia-Pacific. This trend can be attributed to several factors, including technological advancements and increasing demand for personalized medicine.

Application Insights

The cancer segment dominated the market and accounted for a share of 29.9% in 2023. According to the American Cancer Society, it is anticipated that 1,958,310 new instances of cancer and 609,820 fatalities due to the disease. In 2023 in the U.S. Autologous cell therapy is anticipated to find its major demand in cancer application with the growing burden of cases and demand for treatment and therapy. In August 2022, Anixa Biosciences mentioned that it had administered the first dose of its follicle-stimulating hormone receptor (FSHR)- targeted autologous cell therapy to an ovarian cancer patient in a Phase I trial.

The wound healing segment is projected to grow at a significant CAGR from 2024 to 2030. The segment’s growth is driven by the increasing prevalence of chronic wounds such as diabetic ulcers and venous ulcers. World Health Organization (WHO) reporting that roughly 2.0% of global diabetes incidence, is a key contributor to non-healing wounds. The aging population plays a significant role in the rise of chronic wounds. Autologous cell therapy, using the patient's cells, offers advantages such as reduced infection risk and faster healing compared to traditional methods. Technological advancements in cell isolation and expansion, as seen with Acelity Labs and MiMedx, are making this therapy more accessible and cost-effective by improving cell processing efficiency.

Source Insights

The bone marrow segment held the largest share of 29.9% in 2023. The bone marrow in autologous cell therapy has been successfully used to treat different diseases. It is one of the major sources used for cell therapy where the patient’s healthy stem cells are collected from the bone marrow or blood before treatment starts. Alternatively, autologous cell therapy with bone marrow provides certain benefits over a donor’s stem cells.

The other segment is anticipated to grow significantly from 2024 to 2030. This segment includes amniotic fluid, and dental pulpsouces. Amniotic fluid-derived stem cells (AFSCs) and dental pulp stem cells (DPSCs) both show promise due to their multilineage differentiation capacities and potential in various medical applications, including osteoarthritis, wound healing, and tissue engineering. The success in clinical trials and growing demand for minimally invasive therapies contribute to the growth prospects of this segment.

End-use Insights

The academics & research segment held the largest share of 39.05% in 2023 and is anticipated to grow rapidly from 2024 to 2030. Autologous cell therapy is garnering an increasing amount of interest worldwide and is being extensively studied. It is an emerging field of science that uses the living cellular to treat and prevent disease. Academics and research mostly conduct research in bone marrow, epidermis, mesenchymal stem cells, haematopoietic stem cells, and chondrocytes.  For instance, In October 2023, Terumo Blood and Cell Technologies started a study with BioCentriq to produce public data on CAR-T cell production using Terumo BCT’s Quantum Flex Cell Expansion System and Finia Fill and Finish System, combined with BioCentriq’s LEAP Platform, aimed at speeding up the delivery of CAR-T therapies to patients.

The hospital segment is anticipated to witness significant CAGR from 2024 to 2030. The increasing burden of cancer, autoimmune diseases, cardiovascular diseases, and neurodegenerative disorders has led to the rising requirement for treatment and therapies. in October 2022, Allogene Therapeutics mentioned the new survey of the U.S academic institutes that specialized in the administration of CAR T, which discovered that 82.0% of respondents agreed that CAR T therapies have assisted in the management of cancer.

Regional Insights

North America autologous cell therapy market accounted for 36.68% share in 2023. The market is highly competitive since most of the major market players such as BrainStorm Cell Therapeutics and Bristol Myers Squibb operate in this region. Furthermore, the growing burden of the geriatric population, numerous immunological advantages, and the reduced risk of autologous cell therapy rejection have created new growth opportunities for the autologous cell therapy Market.

U.S. Autologous Cell Therapy Market Trends

The autologous cell therapy market in the U.S. held the largest share in the North American region in 2023 and is expected to grow rapidly over the forecast period. In the US, the FDA’s approval of several autologous cell therapies for various indications has boosted market confidence and investment. The presence of a robust healthcare system and strong intellectual property protection laws further support market growth. In January 2024, the FDA approved a manufacturing process change for Kite's Yescarta CAR T-cell therapy, reducing the median U.S. turnaround time for leukapheresis to product release from 16 to 14 days. 

Europe Autologous Cell Therapy Market Trends

The Europe autologous cell therapy market was a lucrative region in this industry. The European Medicines Agency’s (EMA) supportive regulatory environment for advanced therapies is driving market growth. The EU’s commitment to funding research through programs like Horizon 2020 supports the development of a dedicated bioreactor for the expansion of tumor-infiltrating lymphocytes (TILs) for autologous cell therapy (ACT)  contributing to market expansion. In addition to these factors, the growing prevalence of chronic diseases across all these regions is creating a large patient pool for autologous cell therapies.

The autologous cell therapy market in the UK is driven by the presence of a robust healthcare system, growing research activities in stem cell therapies, and supportive regulatory frameworks. Moreover, partnerships between universities and biotech companies are contributing to advancements in this sector.

France autologous cell therapy market is expected to grow rapidly from 2024 to 2030. The market is driven by the country’s strong focus on research & development in the biotechnology and pharmaceuticals sectors, supportive regulatory environment, and growing awareness about regenerative medicine. Additionally, collaborations between academic institutions and industry players are playing a crucial role in market growth.

The growth of the autologous cell therapy sector in Germany is propelled by the country's aging demographic, enhanced government investment in research efforts, and beneficial reimbursement schemes. Additionally, partnerships between academic institutions and industry participants are fueling advancements in this area.

Asia Pacific Autologous Cell Therapy Market Trends

Asia Pacific autologous cell therapy market is anticipated to witness fastest growth over the forecast period. owing to the rising burden of diseases, strong research activities in autologous cell therapies, the presence of a well-established biotechnology sector, developing healthcare facilities, and growing awareness for cell therapies. In May 2024, Cytiva, in collaboration with Gilead Sciences' Kite Pharma, unveiled Sefia, a cutting-edge cell therapy manufacturing platform designed to overcome challenges like dependency on manual labor, limited capacity, and risk of batch failures. This innovation caters to the increasing demand for autologous cell therapies, highlighted by over 1,000 clinical trials worldwide and the presence of 10 approved CAR-T therapies across the U.S., Europe, and the Asia-Pacific region.

The autologous cell therapy market in China is witnessing the rapid economic growth and increasing healthcare expenditures which have led to a surge in investments in biotechnology research and development. The Chinese government’s focus on developing its domestic biotech industry is also fueling the growth of the autologous cell therapy market such as China National Science and Technology Development Plan.

The Japan autologous cell therapy market is expected to grow from 2024 to 2030. The Japanese market's growth can be attributed to the country’s aging population and increasing government investments in regenerative medicine. In addition, collaborations between academic institutions and industry players are fostering innovation in this field. In April 2022, Metcela Inc. strengthened its development of cardiac stem cell-based therapies by acquiring Japan Regenerative Medicine Co., Ltd. (JRM), previously under Kidswell Bio. Following a partnership established with Kidswell Bio in January, Metcela enhanced this relationship by allotting new shares to Kidswell Bio.

Latin America Autologous Cell Therapy Market Trends

The autologous cell therapy market in the Latin America is expected to grow rapidly due to factors such as the region's aging population, the increasing prevalence of chronic diseases, and supportive government initiatives. A key driver of this growth is the aging population, which is more susceptible to conditions treatable by autologous cell therapy, like cancer and neurological disorders. The rising incidences of chronic diseases, including diabetes and cardiovascular diseases fuel demand for these personalized treatments. Moreover, initiatives by governments, as seen with Brazil's National Health Surveillance Agency (ANVISA) approving autologous cell therapy products, further propel market expansion.

Brazil autologous cell therapy market is expected to grow from 2024 to 2030 due to increased awareness of regenerative medicine, significant government support for R&D, including efforts by the Brazilian Health Ministry through the National Stem Cell Bank (BNHuCel), and the contribution of academic institutions like the Universidade de São Paulo. This growth is also spurred by the rising prevalence of chronic diseases, such as diabetes and Parkinson’s disease, highlighting the demand for innovative treatments.

Middle East and Africa Autologous Cell Therapy Market Trends

The autologous cell therapy market in MEA was identified as a lucrative region in this industry. The autologous cell therapy market in the Middle East and Africa is growing due to increased adoption of cell-based therapies, advances in stem cell research, and rising awareness about the benefits of autologous cell therapies. Government efforts to boost biotechnology and partnerships between academia and industry are also supporting market expansion. For example, South Africa's Department of Health is planning a National Stem Cell Bank to encourage regenerative medicine research. Additionally, collaborations like the one between the University of Cape Town and Novartis for developing CAR T-cell therapies showcase the innovation in the region, promising new and tailored treatments for the local population.

Saudi Arabia autologous cell therapy market is driven by an increased need for advanced treatments for diseases like cancer and heart conditions. Government support, regulatory improvements by the Saudi Food and Drug Authority, and public-private partnerships are boosting the sector's development. Collaborations with international firms are spurring innovation, while growing awareness among patients and doctors about the therapy's benefits is increasing demand.

Key Autologous Cell Therapy Company Insights

The market players operating in the market are undertaking strategies such as new launches, collaborations, expansion to strengthen their market presence. In February 2024, BioNTech and Autolus entered into a strategic collaboration to advance their CAR-T cell therapy programs. The partnership focuses on utilizing manufacturing and commercial capabilities to bring their autologous CAR-T therapies to market. BioNTech will use Autolus’ manufacturing for trials in CLDN6+ tumors and support the expansion of Autolus' obe-cel program, receiving royalties on its sales. Additionally, BioNTech has co-commercialization rights for Autolus’ AUTO1/22 and AUTO6NG programs. Some of the prominent players in the global autologous cell therapy market include:

Recent Developments

• In November 2023, Selecta Biosciences and Cartesian Therapeutics announced their merger, forming a new entity under Cartesian Therapeutics that focuses on developing RNA cell therapies for autoimmune diseases. Trading on Nasdaq with the ticker "RNAC," the merged company, based in Watertown, Massachusetts, combines Selecta’s and Cartesian's resources, aiming for a pro forma cash balance exceeding USD 110 million.

• In March 2023, Adaptimmune and TCR2 Therapeutics announced a strategic combination in an all-stock transaction to form a leading cell therapy company targeting solid tumors. This merger is expected to enhance clinical development and product delivery, extending the combined company's cash runway into 2026.

• In January 2022, ProKidney merged with Chamath Palihapitiya’s SPAC, receiving USD 825 million to fund phase 3 trials for their kidney disease cell therapy, ReACT. If ProKidney captures 1% of its market at USD 360,000 per patient, it could earn USD16 billion.

Autologous Cell Therapy Market Report Scope

Global Autologous Cell Therapy Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global autologous cell therapy market report based on application, source, end-use, and region:

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Cancer

  • Neurodegenerative disorders

  • Cardiovascular disorders

  • Autoimmune disorders

  • Orthopedics

  • Wound healing

  • Others

• Source Outlook (Revenue, USD Million, 2018 - 2030)

  • Bone Marrow

  • Epidermis

  • Mesenchymal stem cells

  • Haematopoietic stem cells

  • Chondrocytes

  • Others

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals & Clinics

  • Ambulatory Centers

  • Academics & Research

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • Kuwait

    • UAE