December 9, 2023

Regenerative Medicine Market Share: Evaluating Recent Developments

The field of regenerative medicine (RM) is poised for exponential growth as it emerges as a multifaceted and transformative force in the world of medical therapy. With its capacity to range from wound healing to potentially curing diseases, RM is increasingly viewed as a paradigm shift from conventional long-term treatments to potential disease cures. Stem cell therapy and advancements in nanotechnology are expected to be pivotal factors propelling the regenerative medicine market to new heights. The escalating prevalence of chronic diseases, a surge in emergency trauma cases, and the rise of degenerative diseases further contribute to the sector’s rapid expansion.

One of the significant challenges addressed by regenerative medicine is the complexities surrounding organ transplantation, including the shortage of donor organs. Nevertheless, technological advancements in surgery and disease monitoring are complementing the market’s growth. Regenerative medicines are not traditional pharmaceutical products; instead, they represent novel therapeutic interventions, making their integration into the pharmaceutical value chain a unique challenge.

Robust Drug Pipeline Fuels Demand for Innovative Regenerative Medicine

Currently, approximately 300 gene therapy and stem cell products are in various stages of industrial development, with an additional 20% being developed by academic and research institutions. Notably, 54 regenerative medicine products have gained regulatory approvals from internationally recognized agencies such as the US Food and Drug Administration (FDA), the European Union’s (EU) European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency, and South Korea’s Ministry of Food and Drug Safety.

A robust pipeline of products signals a promising outlook for market growth, with numerous products poised to enter the market. Globally, there are currently 1,087 ongoing clinical trials, with 97 in advanced Phase 3, 587 in Phase 2, and 394 in Phase 1. Oncology leads the way in terms of indications, with 665 ongoing trials, reflecting the substantial growth in clinical activities for diverse and prevalent conditions.

Resilience Amid Global Challenges: COVID-19

Despite the unprecedented challenges posed by the global COVID-19 pandemic, the regenerative medicine sector displayed remarkable resilience in the first half of 2020. The sector witnessed robust investment, raising $10.7 billion during this period, surpassing the total amount raised in the entire year of 2019 ($9 billion).

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The sector continues to attract significant investments from both private and government institutions, propelling growth in the forecast period. Financing remains strong across venture capital and partnerships, with notable merger and acquisition activities in the cell and gene therapy sector.

Market Access Challenges: High Costs of Treatment and Reimbursement

The high costs associated with cell and gene therapies pose challenges for traditional reimbursement arrangements, which are primarily designed for chronic care. Pricing disparities exist across regions, with treatments such as Kymriah, Yescarta, Luxturna, and Zolgensma carrying substantial price tags in the absence of long-term follow-up data.

Untapped Potential in Asia’s Clinical Landscape

North America and Europe are currently leading the global regenerative medicine market due to growing research activities, the introduction of groundbreaking therapies like CAR-T, and increasing awareness of personalized medicine. The evolving biopharmaceutical needs and a high degree of unmet demands in these regions present significant growth opportunities for players in the regenerative medicine value chain.

A Highly Fragmented Market with Dominance by Small & Medium-Sized Biotech Companies

The regenerative medicine market comprises over 1,000 small and medium-sized therapeutic developers globally, with 415 in the clinical stage. North America is home to 543 companies, while Europe hosts 238. Big pharmaceutical companies are cautiously embracing this field, with fewer than 20% of stem-cell and gene therapies currently in development being undertaken by major pharma giants.

Key Players in the Regenerative Medicine Market

Prominent players in the global regenerative medicine market include APAC BIOTECH, Anges, Avexis, Dendreon, Avita Medical, Anterogen, Bellicum Pharma, BioCardia, BioLife Solutions, BioMarin, BioStage, bluebird bio, Inc., Bone Therapeutics, BrainStorm Cell Therapeutics, Cabaletta Bio, Caladrius Bio, Capricor Therapeutics, Cardinal Health, Celgene (BMS), Cellect Bio, CBMG, CombiGene, CRISPR Therapeutics, Cryoport Systems, CSL Limited, Cynata Therapeutics, Editas Medicine, Fate Therapeutics, Fibrocell Science, Flexion Tx, Fresenius Kabi, FUJIFILM Cellular Dynamics, Inc., Gamida Cell, GE Healthcare, Genprex, GenSight Biologics, Gilead, GlaxoSmithKline, Healios K.K., Hitachi Chemical Advanced Therapeutics Solutions, Homology Medicines, Intellia Therapeutics, Iovance, IVERIC Bio, Johnson & Johnson, Lonza Biologics, Novartis International AG, Novo Nordisk A/S, Oxford BioMedica, Pfizer Inc, Pluristem Therapeutics Inc, Precision Bio, Regeneus, Rocket Pharma, Sanofi S.A., Thermo Fisher Scientific, Spark Therapeutics, CHIESI FARMACEUTICI, NIPRO CORP, TEGO SCIENCES, Vericel, Collplant, Terumo BCT, Orgenesis, and J-TEC.

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Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2023-2030 – By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)

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This press release first seen on Brilad