Disrupting regenerative medicine with cell therapy




The increased prevalence of chronic diseases, aging populations, and the shortage of organ donors has motivated the development of innovative therapies that can regenerate and repair damaged cells and tissues. Regenerative Medicine (RM) is an emerging interdisciplinary field that applies biomedical engineering and life science to promote cell and tissue regeneration. Currently, commercially available products are transforming medical practice in several clinical areas, offering unique and highly innovative approaches to treating complex ailments, and improving both treatment outcomes and patients’ quality of life, while also reducing long-term treatment costs. With hundreds of new RM technologies in the development pipeline, the RM market will continue to grow and is poised to revolutionise medical practice as we know it.
In this Insight, we provide a comprehensive overview of the emerging field of regenerative medicine (RM), and explain why it will play an increasing role in medical practice, and why it has attracted interest from multinational pharmaceutical companies and government funding programmes. We summarize the RM market segment, and consider its growth potential over the next five years. We also examine the current RM product development pipelines and ongoing clinical trials, highlighting key examples of in-development and successfully commercialised RM technologies.


The Opportunity Of RM
Modern healthcare providers are facing progressively more complex ailments due to aging populations and the increasing incidence of chronic diseases. This challenging scenario requires solutions that can limit organ dysfunction and tissue degeneration, or offer treatments that allow for their replacement. Organ transplantation offers one solution, but poses the risk of transplant rejection by the recipient body, and requires lifelong treatment with immunosuppressive therapy. Additionally, the number of patients on waiting lists for organ transplants is significantly greater than the number of available organ donors. RM overcomes these limitations by applying biomedical engineering and developmental biology-based solutions to regenerate damaged cells, tissues, and organs.
RM approaches include cell therapies (e.g., the transplantation of cells to replace or repair damaged tissues or organs) and tissue engineering (e.g., the combination of cells, engineering, biomaterials, and biochemical factors to improve or replace biological functions). This emerging field can revolutionise medical practice by replacing many conventional treatments, improving patients’ quality of life, and reducing long-term healthcare costs. Although RM treatments may sound futuristic, since 1980, more than 300,000 patients in the U.S. alone have received RM cell therapy treatments for pathologies including ulcers, wounds, burns, cartilage repair, and musculoskeletal defects. RM products have generated over $1 billion in sales, and with ongoing research and clinical testing of new RM therapies, further growth of this market is expected.

The Key RM Technology Players
The development of a new RM product can take as long as 10 to 15 years, comparable to development timelines for other biotechnologies. The RM development process has been accelerated, however, by a network of worldwide collaborations among specialised biotech companies, multinational pharmaceutical corporations, and academic research centres. Major players such as Mesoblast Ltd, Vericel Corp., Celgene Corp., and StemCells Inc. are adopting growth strategies such as partnerships and collaborations, joint ventures, mergers, and pursuing acquisitions in order to keep pace with the evolving industry. One of the most prominent public initiatives is the California Institute for Biomedical Research (Calibr). In 2012, Merck & Co, Inc. made a seven-year, $92 million commitment to Calibr, providing the academic collaborators with industry know-how and infrastructure support.

The Current Status Of Cell Therapy
With more than 250 companies developing RM products for almost every imaginable disease, cell therapies (CT) are currently being tested in over 1,900 clinical trials worldwide. Many of these new therapies have been in development for over a decade, but are now nearing approval, and in Phase II or III of the clinical trial process. The increasing funding from governments and private organisations and increased global awareness about stem-cell research are propelling the growth of this market segment. The global market for CT is expected to grow at an astonishing compound annual growth rate (CAGR) of nearly 38% by 2020. Wider therapeutic applications, easier production scale-up, and a larger number of clinical trials have prepared the donor-derived CT segment to grow at an even faster rate than the patient-derived CT segment. One example of a donor-derived CT, Osteocel Bone Grafts® (marketed by NuVasive, Inc. since 2005) have been successfully used as a substitute for traditional bone grafts in spinal fusion surgery, and has already improved the quality of life of more than 140,000 patients in the United States.
Many other types of CT products are commercially available, and are transforming their therapy in their areas. For example, Carticel® (marketed by Vericel Corp. since 1995) is the first FDA-approved biologic orthopaedics product used to treat focal articular cartilage defects, which often leads to large high grade lesions, and can progress to osteoarthritis. This RM treatment uses patient’s own cells to rebuild the cartilage layer, thus avoiding the use of surgery while also improving the patient’s quality of life. Another potentially disruptive technology is ENCAPTRA® (ViaCyte); currently in Phase 1/2a clinical trials, this RM therapy is designed to fill the current void for diabetes type 1 treatments by re-establishing the body’s insulin production with injectable stem cells. This treatment would offer a new paradigm in diabetes therapeutics, freeing patients from the need for lifelong insulin therapy.

"With MORE THAN 250 COMPANIES developing RM products

for almost every imaginable disease, cell therapies are currently

being tested in over 1,900 CLINICAL TRIALS WORLDWIDE."

The Current Status Of Tissue Engineering
Alongside the recent developments in replacement and reconstructive surgery, tissue engineering (TE) technologies have also made significant advances, and in 2015, the TE market was valued at $5 billion. TE uses synthetic and biological materials combined with cells to aid in tissue reconstruction and tissue healing. Its applications, previously confined to orthopaedics (50% of current TE applications), have now expanded to many other treatment areas, such as burn and wound healing, and ocular tissue replacement. For example, Apligraf® (marketed by Organogenesis, Inc. in 2000) is the first FDA-approved mass-produced TE product for the treatment of diabetic foot ulcers that contains live human cells. In 2014, an improved version called Dermagraft® enabled faster healing rates and allowed for the healing of wounds that were previously unresponsive to common treatments. These two products currently lead the TE field, with more than one million units sold. Ongoing clinical trials and increasing research funding are expected to increase the TE segment’s CAGR by approximately 23% through 2021.


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