The Global Market: Regenerative Medicine + Stem Cell Therapy

According to the majority of global market research analysts, regenerative medicine is primed for expansive growth in the coming years. Regenerative-based treatments are expected to offer cures for degenerative and life-threatening diseases, provide alternatives to surgical solutions, and promote vast technological advances in biologics, genes, and stem cells.

Projected valuations for the regenerative medicine market are widely spread. The more conservative reports reflect a moderate growth rate reaching $38 billion by 2021. Others far more optimistic in their projections anticipate the market to exceed $100 billion by 2022. Regardless of the value, there is broad consensus that the global stem cell market will be the driving force.

Cellular therapies are heralding the arrival of the next transformation in healthcare. This highly promising area of biotechnology is fueling a fast-paced search for novel treatments that can replace traditional approaches that have failed to deliver the desired outcomes. For many, advancements in stem cell research also hold the answer to escalating healthcare costs, as early successes segue into viable products and treatments that can drive costs down while yielding greater results. Harvard Professor of Stem and Cell Biology Mark Fishman calls it the “third wave of transformative medicine” – one that will change the surgical status quo and lead to a significant shift in the pharmaceutical industry primarily through the advancement of stem cell therapies.

The fastest growing segment of the emerging marketplace is stem cell therapy, the leader in global clinical trials. Currently responsible for 30% of the market share, the US accounts for nearly three-fourths of clinical trials worldwide, with nearly 6,000 stem cell studies as of June 2017. The Napa Medical Research Foundation is a proud contributor to this emerging market with three clinical studies currently underway and two pilot trials being developed for our therapeutic pipeline.

Cardiovascular disease is the target for the greatest number of novel clinical trials involving stem cells with much of the progress driven by small-to-medium sized, privately held biotech companies. However, for those working in orthopedics and musculoskeletal disorders, it is commonly assumed the share of the global stem cell market will get bigger. This is largely due to three factors: 1) the availability of stem cell products; 2) the pervasiveness of bone and joint disease and dysfunction; and 3) patient demand for improved treatment strategies.

Stem cell treatments in orthopedics are the most commonly explored and have yielded some of the most promising results to-date. Basic science research and translational studies already demonstrate a significant potential for the use of stem cell therapies in treating a broad number of injuries and conditions. Together with patient demand for effective and early treatment strategies, this climate provides unique opportunities to move highly innovative therapies from the lab bench to the patient quickly and effectively.

Amid the general optimism towards the global expansion of the stem cell, and regenerative medicine, markets, there are critical factors that may place significant barriers on market growth expectations including the high costs associated with product development, potential regulatory complications and unrealistic claims that may damage the credibility of this sill-emerging field.

The high cost of bringing any drug to market has plagued the pharmaceutical industry for decades. With highly restrictive parameters already in place on the development and delivery of cellular therapies, the costs of these non-traditional regenerative treatments will be even higher and may prohibit widespread access. Regulatory oversight continues to be debated around the globe, though countries like Japan and Australia are making great strides to ensure they will be at the forefront of the stem cell revolution. With a growing range of private-public collaborations and more liberal laws surrounding stem cell technologies, these regional markets are pushing research to drive economic growth.

Regenerative medicine does represent the future for both surgical and pharmaceutical medicine. It is more a question of when these global market predictions will be realized, not if.

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All the research conducted through the Napa Medical Research Foundation, a 501(c)(3) nonprofit organization, is fully funded through generous donations received from individuals and family foundations.

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