Regenerative Medicine Market Set to Grow Strong as Their Potential Gains Recognition in Medical World
Predominantly fueled by an alarming rate of chronic disease prevalence, regenerative medicine (RM) has been gaining ground as a multifaceted and complex world of medication therapy. While the potential effectiveness of RM can range from wound healing to entire disease control, it is increasingly being perceived as a potential disease cure rather than the conventional approach, i.e., long-term treatment. Strong emergence of stem cell therapy, and the rise of nanotechnology will be among the strongest factors supporting regenerative medicine market growth in future. The rising rate of emergency trauma cases and climbing prevalence of degenerative diseases are some of the important factors driving the growth of market.
Complicated challenges associated with organ transplantation, including dearth of organs, will also remain a key factor propelling demand for regenerative medicine in the global market. On the other side, technological advancements in surgery and disease monitoring are complementing the market expansion. Regenerative medicines require a controlled process, from intervention by doctors to application in patients. These are not traditionally manufactured drug products but more of novel therapeutic interventions, which makes it challenging to integrate them into the stereotypical pharmaceutical value chain.
Robust Drug Pipeline Underpins Demand for Innovative Regenerative Medicine
There are ~300 gene therapy and stem cell products that are in their industrial development phase, while another ~20% are developed by academic and research institutions. Currently, ~54 regenerative medicine products are marketed with regulatory approvals from internationally recognised regulatory 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.
Robust pipeline of products is pointing towards a strong market growth outlook as several more products are poised to enter the market. There are ~1087 ongoing clinical trials worldwide. Phase-wise distribution of these trials shows 97 at an advanced stage (Phase 3), 587 at Phase 2, and 394 in Phase 1. In recent times, clinical activities for diverse and more prevalent indications have witnessed incremental growth. For indications, oncology has the strongest pipeline with 665 ongoing trials, which is more than half of all the ongoing trials on a global level.
Strong Investment Influxes Overridden Global COVID-19 Challenge
Despite unprecedented challenges thrown by the global COVID19 pandemic, the regenerative medicine sector displayed remarkable resilience during the first half of 2020. Investment in the sector was robust. Globally, the sector has raised $10.7 Bn during the first half of 2020, outnumbering the entire amount raised in all of 2019 ($9 Bn).
Strong investment inflows into research and development of regenerative medicines, from both private and government institutions, will boost the growth momentum in the forecast period. Financing remains strong across venture capital and partnerships space, with M&A activities highlighting large and middle cap pharma’s interest in the cell & gene therapy business.
High Cost of Treatment and Reimbursement Remain Detrimental to Market Access
Conventional reimbursement arrangements focused toward provision of chronic care are unable to cope with the high costs of cell and gene therapies. Kymriah indicated for pediatric leukemia and advanced lymphoma costs US$ ~375,000-475,000 in the US, whereas the same treatment is priced at ~US$ 306,000 in Japan, and ~US$ 413,000 in Australia. In the US, Yescarta, a treatment for adults with large B-cell lymphoma, is priced at ~US$ 373,000. Luxturna, prescribed for a specific type of inherited retinal dystrophy, costs ~US$ 850,000, while Zolgensma, a lifesaving gene therapy for pediatric spinal muscular atrophy (SMA), is priced at whopping ~US$ 1.5 million per patient. In the absence of long-term follow-up data and the nascent stage of these technologies, there are contradictory views among payers, providers, patients, and marketers on what constitutes reasonable price levels for these therapies.
Underdeveloped Clinical Landscape of Asia Presents Key Opportunities to Stand out
North America and Europe are the leading regions in market mainly due to growing research activities, introduction of novel and pathbreaking therapies such as CAR-T, and rising awareness about personalised medicine. The evolving biopharma needs, the growing RM pipeline, and a high degree of unmet needs are likely to create tremendous growth opportunities for players fulfilling the RM value chain that includes contract development and manufacturing organisations (CDMO) and contract research organisations (CROs). Besides regenerative medicine therapy developers, the value chain fulfilling players, viz. cell banks and third-party logistics companies providing ultra-cold chain solutions to cell transportation during the cell harvest in Asia Pacific.
Highly Fragmented Market, Dominated by Small & Medium Size Biotech Companies
There are more than 1,000 small and medium size therapeutic developers active in this space worldwide. Of those, 415 are in the clinical stage. This dominance is mainly due to presence of large number of companies and higher investment ratio in these regions. North America houses 543 companies whereas 238 companies are head quartered in the Europe region.
Less than 20% of stem-cell and gene therapies currently on the way are being developed by big pharma giants. Big pharma companies have adopted in-licensing strategy to integrate new technologies at a relatively advanced development state. The cautious approach is driven by precaution and the wish to bet only on proven concepts.
Competition Landscape: Regenerative Medicine Market
A large number of key players operating in the global regenerative medicine market are 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, 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.