Global MSC Report 2025: 1,670+ Trials, 12 Approvals, Path to 50 by 2040

Comprehensive Market Report Highlights Transformative Role of Mesenchymal Stem Cells Across Therapeutics, Cosmetics, and Cultured Meat Industries

A newly published strategic intelligence report titled “Mesenchymal Stem Cells/Medicinal Signaling Cells (MSCs) – Advances & Applications, 2025” has been added to the extensive catalog of ResearchAndMarkets.com, offering a deep dive into one of the most dynamic and rapidly evolving sectors in biotechnology. Mesenchymal stem cells—also increasingly referred to as medicinal signaling cells or mesenchymal stromal cells—are multipotent adult stem cells renowned for their remarkable versatility, regenerative potential, and immunomodulatory capabilities. These cells can differentiate into a range of lineages, including osteoblasts (bone), chondrocytes (cartilage), myocytes (muscle), and adipocytes (fat), making them indispensable across multiple high-growth industries.

Beyond their differentiation capacity, MSCs exert powerful paracrine effects through the secretion of bioactive molecules such as cytokines, growth factors, and exosomes. These secreted factors promote tissue repair, reduce inflammation, inhibit fibrosis, and modulate immune responses—properties that have positioned MSCs at the forefront of regenerative medicine. Critically, their low immunogenicity allows for safe allogeneic (donor-to-recipient) transplantation without the need for perfect HLA matching, significantly broadening their therapeutic applicability.

Globally, MSCs are being leveraged not only in advanced cell therapies but also in cosmeceuticals, where exosome-based formulations are gaining traction for anti-aging and skin rejuvenation, and in the emerging field of cultivated meat, where MSCs serve as progenitors for muscle and fat tissue to replicate the sensory experience of conventional meat.

To date, 12 MSC-based therapies have received regulatory approval worldwide, with South Korea leading the charge with five approved products: Queencell and Cupistem (Anterogen), Cellgram AMI (Pharmicell), Cartistem (Medipost), and NeuroNata-R (Corestem). Japan has approved two—Temcell HS (JCR Pharmaceuticals) and Stemirac (Nipro)—while the European Medicines Agency (EMA) has cleared Holoclar (Chiesi) for corneal repair and Alofisel (TiGenix/Takeda) for Crohn’s-related fistulas. Additional approvals include Stempeucel (India), MesestroCell (Iran), and Remestemcel-L (Australia). Notably, the U.S. Food and Drug Administration (FDA) has not yet approved any MSC therapy, though it is actively reviewing Mesoblast’s Remestemcel-L (also known as Ryoncil) for pediatric steroid-refractory acute graft-versus-host disease (GvHD).

The cosmeceutical sector is experiencing a surge in MSC-derived innovations, particularly exosome-infused serums and creams. Industry giants like L’Oréal and Johnson & Johnson are investing heavily in this space, recognizing the potent regenerative signaling properties of MSC secretomes. Simultaneously, cultivated meat companies such as Upside Foods and Good Meat—both of which received landmark U.S. regulatory approval for lab-grown chicken in 2023—are utilizing MSCs to generate authentic muscle fibers and intramuscular fat, enhancing flavor, texture, and nutritional profile.

Another frontier is MSC-based gene editing, where researchers engineer cells to overexpress therapeutic proteins or anti-tumor agents, transforming MSCs into targeted delivery vehicles for cancer and chronic diseases. Additionally, advances in 3D bioprinting and organoid development are incorporating MSCs as structural and functional components in engineered tissues, with predictions of functional bioartificial organs within the next decade.

A pivotal innovation is the rise of induced pluripotent stem cell-derived MSCs (iPSC-MSCs or iMSCs), which overcome limitations of donor variability and scalability. Companies like Cynata Therapeutics are pioneering industrial-scale iMSC production, and at least eight firms—including Eterna Therapeutics, Bone Therapeutics, Fujifilm Cellular Dynamics, and Kiji Therapeutics—are now advancing iMSC-based therapeutics through preclinical and clinical pipelines.

The clinical landscape is robust: over 1,670 MSC-related trials are registered on ClinicalTrials.gov. Approximately 75% focus on regenerative medicine, targeting conditions such as osteoarthritis, myocardial infarction, spinal cord injury, and autoimmune disorders. Another 14% use MSCs for disease modeling, while 11% apply them in drug screening and toxicity testing. Despite this momentum, challenges persist—particularly in maintaining MSC potency, phenotype stability, and functionality during large-scale expansion.

To support this growing ecosystem, a robust supply chain for research-grade MSCs has emerged. RoosterBio stands out for industrializing MSC production through standardized, cGMP-compatible cell banks and media systems. Other key suppliers include Lonza, Thermo Fisher Scientific, STEMCELL Technologies, Miltenyi Biotec, PromoCell, Bio-Techne (R&D Systems), ScienCell, and ATCC, all expanding their portfolios to meet surging demand from academia and industry.

The report provides exhaustive coverage across 13 major sections, including:

  • A detailed overview of MSC biology, covering sources (bone marrow, adipose tissue, umbilical cord), surface markers (CD73+, CD90+, CD105+; CD34–, CD45–), differentiation potential, and secretome profiles.
  • Global clinical trial analysis by geography, phase, disease indication (e.g., GvHD, Crohn’s, Parkinson’s, Type 1 diabetes), and autologous vs. allogeneic usage.
  • Patent landscape insights, highlighting jurisdictions with the most filings (U.S., China, EU), key applicants (universities, biotechs, pharma), and emerging areas like exosome and iMSC patents.
  • Scientific publication trends from PubMed, tracking research output in MSC-based immunotherapies, gene therapy, tissue engineering, and aesthetics.
  • Manufacturing platforms, from traditional 2D culture to scalable bioreactor systems, alongside challenges in automation, staffing, and outsourcing to CDMOs like Catalent, Charles River, and Samsung Biologics.
  • Bioengineering strategies to enhance MSC efficacy—such as genetic modification, small-molecule priming, and microparticle delivery—for applications in oncology, neurology, and cardiovascular repair.
  • Disease-specific applications, with dedicated analyses of MSC use in autoimmune diseases, neurodegenerative disorders, bone/cartilage repair, kidney failure, and wound healing.
  • Recent industry collaborations (2020–2024), including strategic partnerships between RoosterBio and Sartorius, Cynata and Fujifilm, and Catalent with BrainStorm Cell Therapeutics.
  • Commercial product landscape, listing all approved MSC therapies and marketed biomaterial-integrated products like Osteocel, Grafix, MACI, and Trinity ELITE.
  • Market sizing and forecasts through 2031, segmented by geography (North America, Europe, Asia-Pacific) and application (therapeutics, research, cosmetics, food tech).

The report profiles over 125 leading companies, ranging from clinical-stage biotechs like Longeveron and Pluri to global CDMOs and raw material suppliers. It also identifies key market drivers—such as aging populations, rising chronic disease burden, and regulatory tailwinds—as well as barriers like manufacturing complexity and reimbursement uncertainty.

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