The Potential of Regenerative Medicine

August 23, 2018

We are committed to helping our health care R&D clients identify trends and plan for the future.  A component of our work is to constantly scan the horizon for emerging and valuable technologies and help place those in context for our clients.  As part of this research, we’ve developed a deeper understanding and appreciation for regenerative medicine.  We believe that regenerative medicine (RM) is a technology platform that R&D leaders should be following, because of its transformative potential for specific disease conditions, and because the technical advances that enable RM to come to fruition will likely have ripple effects across the health care industry.  To quote the Food and Drug Administration (FDA), “the regeneration of human body parts is no longer the stuff of science fiction.”  The promise and impact of RM are real.

As a component of our innovation work, we track emerging technologies with high transformative potential.  Over the past decade, we’ve seen interest in RM grow because of its prospects in treating the underlying causes of chronic diseases, congenital disorders, and damaged tissues. RM therapies harness the healing power of the human body by applying “tissue science, tissue engineering, and related biological and engineering principles that restore the structure and function of damaged tissues and organs,” to quote the US Department of Health and Human Services. The field is striving to shift the modern therapeutic paradigm in specific diseases from substitution to regeneration.

Experts suggest that regenerative medicine can be a game changer in the way treatments and even cures are provided to patients, and the technology is approaching an inflection point.  Robert Preti, Chairman of the Alliance for Regenerative Medicine, called 2017 an inflection point for the sector. This is true for the following reasons:

  • Significant regulatory changes.  Congress passed the 21st Century Cures Act in 2017 which established the Regenerative Medicine Advanced Therapy Designation, which should expedite both the development and more importantly the review of eligible regenerative therapies.
  • Increased investments in regenerative medicine.  In 2017 over $800 million dollars was invested in regenerative medicine therapies.  Investments in RM have increased 34% year on year for several years.
  • Dramatic increase in clinical trials for RM. In 2017 there were over 900 clinical trials underway globally, an approximate 50 percent increase over 2015.

These factors suggest that RM is approaching or may have passed an important tipping point, and that all health care providers should actively engage with RM technologies.

Regenerative medicine will be critical to the future of health care because it offers the possibility of:

  • Permanently improving patient health through the treatment of chronic or life-threatening disorders.
  • Addressing previously untreatable medical conditions with patient-specific therapies like engineered renal tissues, grown from a patient’s own cells to restore functionality.
  • Improving the quality of patients’ lives and outcomes, while containing rising healthcare costs by curing diseases that have a long-term economic burden on the healthcare system.

Our focus in regenerative medicine technologies

Regenerative medicine is diverse and encompasses an array of technologies and therapeutic strategies. In our research we focus on technologies in three areas: gene therapy, cell therapy, and tissue engineering.  Of these, we believe that tissue engineering will be the first to transition into mainstream clinical practice.  We believe this because engineered tissue constructs serve as the delivery platforms for a range of treatment alternatives, including cell therapies.  In fact, great strides have been made in constructing three-dimensional living tissues that are being used to test new drugs and may soon be used to cure previously untreatable wounds and diseases. 

We believe that tissue engineering holds significant promise. While there are many reasons for this, two reasons stand out. First is the tremendous manufacturing potential. While TE treatments utilize patient-specific approaches (much like cell and gene therapies that require a personalized development approach) TE is focused primarily on developing techniques that maximize the scale-up potential of biomanufacturing technologies. Second, TE has enormous potential to address the long-term goal of personalized medical care through the development of engineered scaffolds. These scaffolds are integral to the healthcare community as they are employed to deliver drugs, and build therapeutic tissues and biological molecules, for example.  

Enabling technology to watch:  bioprinting

One of the most vexing challenges in RM is how to move from small batch production to large-scale manufacturing. While there are several competitive technologies under development to address this challenge, we believe that bioprinting has the most promise. Early studies have shown that bioprinting has unparalleled levels of accuracy and reproducibility. While the bioprinting market is young, it is the closest to producing engineered tissue with commercial potential.  Several companies have had early success developing and selling synthetic 3D printed tissue products, including Organovo, Regenovo, BioDan, Prellis Biologics and Aspect Biosystems. Such advances have been noticed by investors.  According to Grand View Research, the valuation of the bioprinting sector is expected to reach $2.6B by 2024. 

Translating the promise of regenerative medicine

Given the interest in regenerative medicine and the growing demand for research on the supporting technologies, we’ve codified our thinking and perspectives in a trendspotting report that provides a deeper examination of regenerative medicine with a specific focus on the potential of bioprinting. In our next post, we’ll share more of our research and thinking about the future of bioprinting.

If you’d like to know more about how we can support your work in regenerative medicine or about our Bioprinting landscaping report, contact us.

 

About the Authors 

Leslie Wainwright, Ph.D. leads our health practice; is passionate about entrepreneurship and innovation; and has experience that spans academic research, pharma/biotechnology, and healthcare delivery. She has worked with executive teams from multi-national organizations and startups alike to design growth strategies, create alternative business models, and evaluate emerging clinical and care delivery technologies. Additionally, she spent several years addressing innovation and how healthcare organizations build their own sustainable innovation competencies. Leslie is a speaker and facilitator on the future of health care, enabling technologies, disruptive innovation, and emerging business models, domestically and abroad. She is passionate about STEM education and is on the Women’s Board of the Field Museum in Chicago, where she works to expand opportunities for girls in science. Leslie received her Ph.D. in microbiology at Northwestern University, completed postdoctoral research training at the University of Maryland’s Center for Vaccine Development, and received a BA in biology from DePauw University.

Yogesh Abichandani conducts technology and market assessments, scouts technology, and oversees voice of customer studies for our nonprofit and commercial clients who want to develop effective market strategies. He has a track record managing and leading diverse teams to conduct opportunity assessments, evaluate emerging markets, and identify global technology trends across the pharmaceutical and medical device market. With his engineering background combined with technology commercialization and market research experience across industries, he’s uniquely positioned to deliver data-driven insights. Yogesh traded India’s heat and rain for Texas’ sun and eventually Massachusetts’ cooler temperatures and abundant snow before settling in North Carolina. Yogesh received his M.S. in Business of Bioscience from Texas A&M University and B.E. in Biotechnology Engineering from the University of Mumbai.

 

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