Mesenchymal Stem Cells Market

Market Overview

The global mesenchymal stem cells market size was valued at USD 3.0 billion in 2023 and is projected to reach a value of USD 9.4 billion by 2032, registering a CAGR of 13.3% during the forecast period (2024-2032). The rising frequency of chronic diseases such as diabetes, cancer, and autoimmune disorders, combined with stem cells' growing role in treating these chronic conditions, are expected to drive worldwide mesenchymal stem cell market share.

Mesenchymal stem cells (MSCs) are adult stem cells in many body tissues, including bone marrow, adipose tissue, umbilical cord tissue, and the dental pulp. These cells have the unique ability to develop into a wide range of cell types, including osteoblasts (bone cells), chondrocytes (cartilage cells), adipocytes (fat cells), myocytes (muscle cells), and other cells involved in tissue repair and regeneration.

The mesenchymal market growth is related to the increased need for pluripotent tissue in disease modeling, drug research and development, stem cell banking, tissue engineering, toxicology, and other applications. Furthermore, the growing number of instances and the lack of adequate treatment for genetic and uncommon diseases worldwide has increased demand for these products and services, and manufacturers are active in meeting that demand. 

Highlights

• Product accounts for the largest share of the market by product and service.
• Culture and Cryopreservation occupy the maximum share of the market by workflow.
• Allogeneic led the market by Type.
• Bone Marrow holds a significant market share by source of isolation.
• Cardiovascular Disease influenced the market by indication.
• Disease Modelling dominates the market by application.

Market Dynamics

Global Mesenchymal Stem Cells Market Drivers

Increasing Prevalence of Chronic Diseases

The expanding prevalence of chronic diseases, such as cardiovascular disorders, orthopedic ailments, autoimmune diseases, and neurological disorders, has increased the demand for novel therapeutic approaches. MSC-based therapies can potentially improve tissue repair, regeneration, and immunomodulation in patients with various chronic illnesses, hence boosting market expansion. According to a World Health Organization (WHO) report from May 2023, noncommunicable diseases (NCDs) account for over three-quarters of all fatalities worldwide each year. Cardiovascular diseases (CVDs) are the leading cause of death worldwide, claiming an estimated 17.9 million lives each year. Other NCDs that cause death include cancer (9.3 million), chronic respiratory diseases (4.1 million), and diabetes (2.0 million).

Furthermore, according to a 2023 study, 7.6% of the global population, or about 600 million people, suffer from osteoarthritis (OA). This makes OA the most common type of arthritis, affecting 15% of the world's population over 30. OA is a prominent source of disability, with far-reaching consequences for both health and economic growth. Researchers predict that OA rates will skyrocket by 2050, particularly for knee and hip disease, with roughly 1 billion people expected to have OA by then. 

Thus, MSC-based therapies have the potential to provide solutions for tissue repair, regeneration, and immunomodulation in patients with chronic diseases, opening up chances for market expansion and innovation in the field of regenerative medicine. As research and clinical studies continue to show that MSC-based treatments are effective and safe, they can improve outcomes and quality of life for patients with chronic diseases.

Global Mesenchymal Stem Cells Market Restraints

Regulatory Challenges

The regulatory landscape for cell-based therapeutics, particularly MSC-based products, is complex and varies significantly by region and country. For example, the European Union (EU) has developed a centralized regulatory framework for advanced therapy medical products (ATMPs), which includes MSC-based medicines. Before marketing approval may be obtained, these requirements involve thorough preclinical and clinical research, manufacturing process validation, and a review of product quality, safety, and efficacy.

Furthermore, in the United States, MSC-based products are controlled by the Food and Drug Administration (FDA) through the Investigational New Drug (IND) application procedure for clinical studies. To obtain FDA approval for MSC-based medicines, preclinical research and well-designed clinical trials must be conducted to demonstrate safety, effectiveness, and manufacturing consistency. In growing markets such as China, the regulatory regulations for MSC-based medicines are constantly changing. The China Food and Drug Administration (CFDA) has imposed controls on cell therapy products, including MSCs, to assure their quality, safety, and efficacy. However, navigating the regulatory approval procedure in China can be difficult due to variances in regulatory criteria and documentation standards from Western countries.

Moreover, these regulatory constraints can considerably impact the development, commercialization, and market access of MSC-based medicines. Companies and research institutes participating in MSC research and development must devote resources and expertise to navigating the complicated regulatory landscape, meeting regulatory requirements, and ensuring compliance with applicable legislation. Delays in regulatory clearances, increased development costs, and uncertainty about market access can all impede investment and innovation in the MSC industry, restricting the availability of innovative medicines for patients in need.

Global Mesenchymal Stem Cells Market Opportunity

Expanding Therapeutic Application

MSCs can potentially treat various diseases and ailments across medical specialties, including orthopedics, cardiology, neurology, immunology, and oncology. MSCs' versatility in tissue repair, immunomodulation, and regenerative medicine opens up possibilities for developing new therapeutics for chronic and degenerative disorders, autoimmune diseases, inflammatory conditions, and cancer. A clinical experiment published in Stem Cells Translational Medicine looked at the safety and efficacy of intra-articular injections of autologous MSCs in treating knee OA. The study found that MSC therapy patients had better pain, function, and cartilage volume than those who received a placebo, indicating that MSCs can regenerate cartilage and alleviate OA symptoms. 

Beyond orthopedics, MSC-based therapies are being studied for various medical illnesses, including cardiovascular disease, neurological disorders, autoimmune diseases, and cancer. Clinical trials investigating the safety and efficacy of MSCs in these indications are expanding, fuelled by rising interest among researchers, doctors, and patients.

Therefore, the growing therapeutic applications of MSCs in orthopedics and other medical specialties create enormous prospects for market expansion and innovation in the MSCs sector. MSC-based therapeutics have the potential to transform healthcare delivery and enhance patient outcomes around the world by addressing unmet medical needs and giving alternative treatment options for patients with chronic and degenerative diseases.

Regional Analysis

The global mesenchymal stem cells market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global mesenchymal stem cells market shareholder and is estimated to grow at a CAGR of 12.6% over the forecast period. In the United States, numerous clinical trials are being conducted to determine the efficacy and safety of mesenchymal stem cells as a potential treatment for various life-threatening diseases. Furthermore, many vital enterprises that supply and commercialize MSCs are based in North America. Furthermore, supportive government laws, expanding demand for new medicines, and increased market participants' efforts to develop advanced mesenchymal stem cell therapies for chronic disease management. These characteristics have helped the area maintain its market supremacy.

Asia-Pacific is anticipated to exhibit a CAGR of 13.5% over the forecast period. The growth is attributed to a large patient base and increased investment by regional market players. The region has a sizable population, a rapidly expanding economy, and increased investment in healthcare facilities. China, Japan, South Korea, and India are the region's largest MSC markets. China is the largest market for MSCs, with a significant number of clinical trials and research projects underway. The Chinese government has provided considerable financing for developing MSC-based products and therapies, boosting the country's MSC market growth. 

Furthermore, Asia-Pacific has numerous significant players actively developing and commercializing MSC-based products and therapies. These enterprises use the region's enormous patient pool and favorable regulatory environment to expand their operations and gain market share.

Investments and funding initiatives from significant market participants and other public and private organizations accompany European countries' stem cell research and development facilities. As a result, the mesenchymal tissue research and development sector is likely to drive regional growth.

Segmental Analysis

The global mesenchymal stem cells market is segmented based on products and services.

The market is further segmented by product and services into Products and services.

The product segment dominated the market, accounting for 80% of total revenue. This comprises a variety of MSCs, such as cell lines, cell-based products, and cell therapy products, which are produced and distributed for research, clinical, or commercial purposes. MSC products can be made from various tissue sources, including bone marrow, adipose tissue, umbilical cord tissue, and dental pulp, processed and described per specified manufacturing standards and quality control methods. 

The cells and cell lines category has emerged as a significant revenue generator among the products. Several market participants are working to capitalize on untapped market opportunities through various efforts, such as new product development and business growth. These players provide mesenchymal stem cells and cell lines to the research community. 

Based on workflow, the market is fragmented into Cell Sourcing and Isolation, Culture and Cryopreservation, Differentiation, and Characterization.

The culture and cryopreservation segment had the highest revenue share of 45% in 2023. MSCs must be cultured and expanded in vitro after isolation to create significant cell numbers for research or clinical usage. This phase entails cultivating MSCs in appropriate culture conditions supplemented with growth hormones and nutrients to promote cell proliferation and preserve stemness features. Temperature, pH, oxygen levels, and substrate composition are tuned for MSC growth and viability.

Additionally, the rising demand for cryopreservation services, the availability of improved healthcare infrastructure, and increased research activities in MSC culture effectiveness are expected to boost market growth. For example, in June 2020, Malaysian researchers released a systematic evaluation to analyze the use of microcarriers in MSC cultivation. According to the study, MSCs can multiply in a microcarrier culture system, further promoting cell differentiation. Merck KgaA, R&D Systems, and STEMCELL Technologies are key firms in this market.

By Type, the market is divided into Autologous and allogeneic.

The allogeneic MSCs segment had the highest revenue share, at 60%. Allogeneic MSCs are collected from tissue donors, such as healthy volunteers or umbilical cord tissue donors, and then processed and expanded in vitro before being given to patients. Allogeneic cell therapies provide various benefits, including off-the-shelf availability, scalability, and standardized production techniques. They eliminate the requirement for patient-specific tissue harvesting and can be applied to several patients, lowering therapy costs and increasing accessibility. 

Furthermore, the rise is attributable to allogeneic mesenchymal stem cells' superior safety profile in therapeutic applications. Furthermore, because of their low immunogenicity and immunosuppressive qualities, allogeneic MSC implantation is poised to become a pioneering cell-based therapeutic method. These features provide a decreased immune response, which adds to the effectiveness of allogeneic MSC implantations. 

Based on the source of isolation, the market is fragmented into bone marrow, cord blood, peripheral blood, fallopian tube, fetal liver, lung, and adipose tissue.

The bone marrow category dominated the market in 2023, accounting for 25% of the total revenue. Bone marrow is a crucial source of mesenchymal stem cells (MSCs), widely employed for their collection and culture. MSCs from bone marrow are acquired through aspiration and commonly performed on the donor's iliac crest or sternum. Bone marrow-derived MSCs have been widely investigated and characterized for their multipotent differentiation capacity and immunomodulatory capabilities. They are used in various research and clinical settings, such as orthopedics, cardiology, and regenerative medicine. The expanding demand for MSCs and the increased use of mesenchymal stem cells in disease modeling and medication discovery are expected to drive sector expansion.

Based on indication, the market is sub-segmented into bone and cartilage repair, cardiovascular Disease, inflammation and immunological diseases, liver diseases, cancer, and GvHD.

The cardiovascular diseases sector dominated the Mesenchymal Stem Cells (MSCs) market, accounting for 25% of the revenue in 2023. Several preclinical investigations have indicated that transplanting mesenchymal stem cells promotes cardiovascular healing, boosting MSCs' penetration in cardiovascular disease indications. This is also due to MSCs' capabilities, which include boosting apoptosis resistance, promoting cardiac cell differentiation, suppressing fibrosis, lowering inflammatory levels, and stimulating angiogenesis. 

The market can be bifurcated by application into Disease Modelling, Drug Development and Discovery, Stem Cell Banking, Tissue Engineering, and Toxicology Studies.

The disease modeling application category dominated the market, accounting for 30% of total revenue. Utilizing cellular disease models with patient-specific MSCs is an excellent tool for pathological research. Mesenchymal stem cells produced from patient-induced pluripotent stem cells could be used to simulate diseases. Many research papers have used mesenchymal stem cell models to investigate the underlying causes of chronic diseases. Furthermore, MSCs are used as models in evaluating non-hematological mesenchymal malignancies such as sarcomas, contributing to the segment's domination.

Recent Developments

• April 2024- Thermo Fisher Scientific announced an animal-free formulation to support the scaling of cell therapy manufacturing.
• March 2024- Axol launched the axoCells™ Atrial Cardiomyocyte kit, an all-in-one bundle that enables iPSC technology for in vitro arrhythmia and cardiotoxicity research.
• March 2024- STEMCELL Technologies received FDA de novo classification for its EasySep™ CD138 Positive Selection Kit, which supports cancer diagnostic tests.