Number of pages: 100 | Report Format: PDF | Published date: June 30, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
Report Attribute |
Details |
Market Size Value in 2022 |
US$ 5.9 billion |
Revenue Forecast in 2031 |
US$ 28.5 billion |
CAGR |
19.05% |
Base Year for Estimation |
2022 |
Forecast Period |
2023 to 2031 |
Historical Year |
2021 |
Segments Covered |
Source, Application, End User, and Region |
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global autologous cell therapy market was valued at US$ 5.9 billion in 2022 and is expected to register a revenue CAGR of 19.05% to reach US$ 28.5 billion by 2031.
Autologous Cell Therapy Market Fundamentals
Autologous cell therapy, also known as autologous cellular therapy or autologous stem cell therapy, is a form of regenerative medicine that utilizes a patient's cells for therapeutic purposes. It involves the extraction of cells from a patient, their processing or manipulation in a laboratory setting, and their subsequent reintroduction to promote tissue repair, regeneration, or immune system modulation.
Autologous Cell Therapy Market Dynamics
The increasing prevalence of chronic diseases such as cancer, cardiovascular diseases, neurodegenerative disorders, and autoimmune diseases is driving the demand for innovative treatment options. Nearly 212.3 million prevalent cases of COPD were recorded globally, suffering from COPD accounting for 3.3 million deaths and 74.4 million DALYs, in 2019. As per the WHO 2021 report, it was noted that about 1.71 billion people suffered from musculoskeletal conditions worldwide. Significant advancements in cell therapy technologies, including cell isolation, expansion, modification, and delivery techniques, have paved the way for more effective and reliable autologous cell therapies. These technological advancements have improved autologous cell therapies safety, efficacy, and scalability, driving market growth. Additionally, collaborations and partnerships between academia, industry, and research institutions have accelerated the development and commercialization of autologous cell therapies.
The shift towards personalized medicine and patient-centric care is driving the demand for autologous cell therapies. Initially focused on limited therapeutic areas, the field of autologous cell therapy is expanding to include a broader range of indications and therapeutic applications. Furthermore, the global increase in healthcare expenditure, particularly in emerging economies, is providing a conducive environment for the growth of the autologous cell therapy market. The availability of financial resources and the willingness to invest in advanced treatment modalities support the adoption and commercialization of autologous cell therapies.
However, the high costs associated with cell isolation, processing, and manipulation and the need for specialized facilities and expertise can pose challenges for widespread adoption. Additionally, reimbursement policies and coverage for autologous cell therapies vary across healthcare systems, limiting patient access and affordability. The regulatory landscape for autologous cell therapies is evolving and can be complex. Ensuring compliance with regulatory requirements and navigating the regulatory pathways for clinical trials and commercialization can be time-consuming and resource intensive. Standardization of manufacturing processes, characterization of cells, and treatment protocols are essential to ensure consistent quality and reproducibility of outcomes. However, these remain challenging due to the personalized nature of autologous cell therapies. There is a limited pool of experts with the necessary knowledge and skills to develop and deliver autologous cell therapies. Expanding the availability of expertise through training programs and collaborations is essential to overcome this challenge. Autologous cell therapies may not suit all patients due to disease stage, cell availability, and overall health status. Some patients may have limited cell sources or compromised cell function, which can affect the feasibility and efficacy of autologous cell therapies in those cases.
Autologous Cell Therapy Market Ecosystem
The global autologous cell therapy market has been analyzed from the following perspectives: by source, application, end user, and region.
Autologous Cell Therapy Market by Source
Based on the source, the global autologous cell therapy market is segmented into mesenchymal stem cells, bone marrow, chondrocytes, epidermis, hematopoietic stem cells, and others.
Bone marrow dominates the global market with nearly 43.03% of the total revenue. Bone marrow is a rich source of hematopoietic stem cells (HSCs) and mesenchymal stem cells (MSCs). HSCs can differentiate into various types of blood cells, while MSCs have the potential to differentiate into cells of different tissue lineages. The abundance and versatility of stem cells in bone marrow make it an attractive source for autologous cell therapy applications. Bone marrow has been extensively studied and utilized in clinical applications for decades. The long-standing use of bone marrow in HSCT has contributed to its dominance in the autologous cell therapy market.
Bone marrow-derived stem cells' multipotent and immunomodulatory properties make them versatile and attractive for autologous cell therapy applications. Extensive research and clinical development have focused on bone marrow-derived stem cells. Numerous studies have explored the therapeutic potential of these cells in various diseases and conditions. The robust scientific and clinical evidence supporting the efficacy and safety of bone marrow-derived stem cells has led to their widespread adoption and dominance in the autologous cell therapy market.
Autologous Cell Therapy Market by Application
Based on the application, the global autologous cell therapy market is segmented into orthopedics, cancer, cardiovascular disorders, wound healing, neurodegenerative disorders, autoimmune disorders, and others.
Cancer accounts for the largest revenue share of 21.5% globally in 2022. Cancer is a major global health concern, with a high prevalence across different regions and populations. According to a CDC report, In the United States in 2020, 1,603,844 new cancer cases were recorded and 602,347 cancer deaths were recorded. 403 new cancer cases were recorded for every 100,000 individuals, and 144 died from cancer. The growing incidence of various types of cancer has led to a significant demand for effective treatment options.
Autologous cell therapy, particularly in immunotherapies, has shown promising results in treating certain types of cancer, including hematological malignancies (e.g., leukemia, lymphoma) and solid tumors (e.g., melanoma). Autologous cell therapy is closely associated with developing and advancing immunotherapies, such as chimeric antigen receptor (CAR) T-cell therapy and tumor-infiltrating lymphocyte (TIL) therapy. These therapies involve the extraction of a patient's own immune cells, modifying or enhancing them in the laboratory, and reintroducing them into the patient to target and destroy cancer cells. The significant progress and success of immunotherapies in cancer treatment have contributed to the dominance of the Cancer segment in the autologous cell therapy market. Several autologous cell therapies, particularly in oncology, have received regulatory approvals and have been commercialized for treating specific cancer indications. For instance, in May 2023, Anixa Biosciences, Inc. stated that treatment of the second patient in the current clinical study of its innovative chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer has begun in collaboration with its partner Moffitt Cancer Centre. There has been significant research and investment focused on the development of autologous cell therapies for cancer treatment.
Autologous Cell Therapy Market by End User
Based on the end user, the global autologous cell therapy market is segmented into academics & research, hospitals & clinics, ambulatory centers, and others.
Hospitals and clinics led the global market with nearly 46.1% revenue share in 2022. Hospitals and clinics are well-equipped with the necessary infrastructure and facilities to support developing, manufacturing, and delivering autologous cell therapies. These healthcare institutions have specialized laboratories, cleanrooms, and advanced technologies required for cell processing, isolation, and expansion. Additionally, this setting provides a wide range of medical experts and multidisciplinary teams comprising physicians, surgeons, hematologists, oncologists, immunologists, and other healthcare professionals. Hospitals and clinics are well-versed in regulatory compliance and quality assurance requirements, ensuring adherence to guidelines and standards set by regulatory authorities. The seamless integration of autologous cell therapies within hospitals and clinics allows for comprehensive patient management and facilitates coordinated care delivery. Hospitals and clinics have established relationships with insurance providers and are familiar with the insurance coverage and reimbursement processes. Autologous cell therapies can be costly, and insurance coverage and reimbursement are crucial in making these therapies accessible to patients. The involvement of hospitals and clinics in the delivery of autologous cell therapies increases the likelihood of insurance coverage. It facilitates the reimbursement process, making the therapies more affordable for patients. Patients often have an existing relationship with their healthcare providers in hospitals and clinics, leading to higher trust and confidence in the care they receive. Therefore, the dominance of hospitals and clinics in the autologous cell therapy market is driven by patient preference and the trust associated with these healthcare institutions.
Autologous Cell Therapy Market by Region
Based on the region, the global autologous cell therapy market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
North America dominates the global market with more than 42% revenue share in 2022, attributed to the high prevalence of several chronic diseases. According to the American Cancer Society’s report 2022, over 1.9 million new cancer cases are expected to be diagnosed in the United States in 2022. North America boasts a well-developed healthcare infrastructure, including state-of-the-art hospitals, specialized clinics, and research institutions. This region also has a robust research and development ecosystem, with numerous academic institutions, biotechnology companies, and pharmaceutical companies actively developing autologous cell therapies. North America has witnessed early clinical adoption and market maturity of autologous cell therapies, particularly in cancer treatment and regenerative medicine. Clinical trials and real-world evidence have demonstrated the safety and efficacy of autologous cell therapies, leading to their incorporation into clinical practice. North America's early adoption and market maturity have further solidified its dominance in the autologous cell therapy market. North America provides a supportive funding and investment environment for developing autologous cell therapies. Various funding sources, including government grants, venture capital firms, and private investors, actively support regional research and commercialization efforts. The availability of funding and investment opportunities has fueled the growth and dominance of North America's autologous cell therapy market.
Competitive Landscape
The prominent players operating in the global autologous cell therapy market are:
Strategic Developments
Autologous cell therapy is a distinctive method of treatment in which an individual's cells are cultivated and expanded outside of the patient's body before being reintroduced into the donor. It entails collecting, isolating, and manipulating cells from the patient, generally from blood, bone marrow, or adipose tissue.
Novartis AG, Holostem Terapie Avanzate S.r.l, and Pharmicell Co. Inc. are some of the major market players in the global autologous cell therapy market.
The high cost of autologous cell therapy and stringent regulatory policies are some of the restraints obstructing the growth of the global market.
The bone marrow segment dominates the global autologous cell therapy market.
The Rising prevalence of chronic diseases and growing demand for tailored therapies are some of the major factors driving the market.
*Insights on financial performance are subject to the availability of information in the public domain