By Reenita Das
Partner and Senior Vice President
Healthcare and Life Sciences
Frost & Sullivan
Regenerative medicine is one of the fastest growing biomedical industries in the world because patients are being cured of diseases that were once incurable. Regenerative medicine represents a new paradigm in human health because the vast majority of treatments for chronic and life-threatening diseases focus on treating the symptoms, not curing the disease. In fact, there are few therapies in use today capable of curing or significantly changing the course of a disease. New regenerative medicine is changing this by engineering, growing, and regenerating tissues and organs using biological processes similar to those normally used in humans. There are already over 500 regenerative medicine products available on the market.
Figure 1 shows the current status of this treatment:
Knee Replacements will be Unnecessary in the Next Five Years
Cell therapy makes up over 60% of the regenerative medicine market, most of which is in the area of stem cell therapy. Adult stem cells can be used in the areas of cardiology; musculo-skeletal, including neurology; optometry; dermatology; cosmology; wound healing; and cancer. Stem cell therapy, when combined with immune and gene therapy, shows even greater potential to cure diseases. This new combination of regenerative cell therapies will open a new age of medicine, forever changing how it is practiced. For example, in the future, knee replacements may no longer be needed with regenerative cell therapy.
Regenerative medicine is not only driven by new evidence indicating these therapies are capable of curing diseases, but also by the fact that the world’s population is aging. In Japan, 25% of the population is over the age of 65. In the U.S., by 2030, 19% of the population will be over 65. By 2030, there will be more people older than 60 than younger than 10, globally. Today, there are fewer children under the age of five than adults over the age of 60. In addition, healthcare systems in many countries are burdened by costly treatments for their aging and increasingly ailing populations. There are few solutions for containing the rising costs of healthcare; therefore, countries like Japan are helping regenerative medicine companies gain a foothold with new products. In doing so, they are hoping to keep their populations healthier longer, thus reducing the cost of healthcare.
Figure 2 shows the geographical activity in this space, with US leading currently:
In the U.S., there are hundreds of clinics offering non-FDA-approved stem cell interventions for a wide range of conditions. Clinics charge $7,000 to $10,000 per treatment, multiple treatments are often required, and no insurance coverage is available. The 2014 FDA guidelines indicate it will be necessary for clinics to offer stem cell therapy in order to have an approved Biological License Application (BLA). If the stem cell isolation procedure is “more than minimally invasive,” it may need to be licensed as if it were a drug. The following are companies with technology with the potential to innovate regenerative medicine:
- Orthofix International; Texas, U.S.A. company providing reconstructive and regenerative orthopedic and spine solutions
- BioStim; an electrical stimulation to enhance healing of the spine and neck
- VersaShield; a thin hydrophilic amniotic membrane to cover wounds and is derived from human placental layers amnion and chorion
- COLLAGE™; a synthetic bone graft substitute product that has demonstrated biocompatibility and safety of collagen in over 10 million implants.
- Capricor Therapeutics; California, U.S.A. company focusing on the prevention and treatment of heart failure and heart attacks
- CAP -1002; a leading product using cardiosphere-derived cells to treat post-myocardial infarction (heart attack), advanced heart failure, and Duchenne Muscular Dystrophy.
Pfizer has created its own unit, Neusentis, in Massachusetts, U.S. Neusentis’ main focus is to develop cell-based therapies for age-related macular degeneration. Celgene and Teva Pharma Celgene has a 4.5% stake in Mesoblast to develop an Acute Graft Versus Host Disease (GVHD) program. Teva Pharma holds a 20% stake in Mesoblast and is a major partner in the Chronic Congestive Heart Failure (CCHF) program, in phase III clinical trials. Johnson & Johnson Johnson & Johnson invested 12.5 million in Capricor Therapeutics (CAPR) for support in a stem cell therapy program. The investment could increase to $325 million, depending on milestone attainment. The program has also received $20 million from the California Institute for Regenerative Medicine. Phase II trials for treatment of cardiovascular disease have been scheduled.
The global healthcare consumer demand for stem cell therapies is very high, with stem cell therapy tourism gaining popularity – mostly from the U.S. Globally, many stem cell therapies are not clinically proven or tested, with only a few resulting in positive clinical results. These international clinics are charging anywhere from $20,000 to $100,000 per treatment, and they are not covered by insurance. In most cases, more than one treatment is required. Transnational supply-side economics is driving the market; there is low regulation and multiple offerings for numerous conditions, with some being offered to treat life-threatening diseases. Regenerative medicine has the potential to ultimately change the way medicine is practiced throughout the world.
This article was written with contributions from Jane Andrews, Ph.D., Senior Consultant with Frost & Sullivan’s Transformation Health Program. For more information on regenerative medicine, please visit http://bit.ly/1MWo63Y.