Tissue engineering involves taking either autologous, allogeneic or xenogeneic cells and redirecting those cells to carry out fundamental processes. Often the researcher will use a biomaterial matrix and seed the cells into this matrix. The redirection may take the form of stimulating the cells to become stem cells or precursor cells, or it may mean genetic modification of those cells. The processes which may be carried out seem almost infinite in variety: from regenerating heart muscle cells (myocytes) damaged from a heart attack, to regrowing islet cells to answer the body’s need for insulin and glucose regulation, to regrowing a thumb, including bone, cartilage, vasculature and skin. According to current industry and academic research, the potential exists to cure neurological and immunological disorders such as Parkinson’s, multiple sclerosis, and many cancers; to regrow most or all of an organ that has been damaged through disease or trauma, including the kidney, liver, intestine, bone, skin and pancreas; to take a cell sample from a patient and grow it into a new tooth bud which can be transplanted into the patient’s jaw to replace a missing tooth; and to grow blood vessels for use in coronary artery bypass graft, thereby avoiding the surgical process and pain inherent in harvesting the saphenous vein. It seems that tissue engineering and cell therapy may find applications in every system in the body.
At least 250 companies in the US, Europe and the Far East are working in tissue engineering and regenerative medicine. The larger pharmaceutical and medical device companies have initially been cautious about investing in and/or developing tissue engineering therapeutics, but a consensus recognizes that a full consideration of the device or drug industry's competitive landscape is incomplete if not factoring the possibilities of tissue engineered or cell therapy solutions.
The US alone spends nearly $35 billion annually to care for patients with end stage organ failure. The alternatives are basically organ transplant, living on indefinite hold with an organ substitute such as kidney dialysis, if such a substitute exists, or death. According to the United Network for Organ Sharing (UNOS), at any one time in the US there are some 80,000 people waiting for donated organs, many of whom die before a suitable organ or tissue becomes available. If a suitable organ can be procured, the transplant procedure itself is very expensive, and not always successful. If it succeeds and the organ functions as intended, then the patient usually must take expensive immuno-suppressive drugs for life. Physicians and researchers have long sought other means to treat these patients, and tissue engineering is one avenue of significant promise.
The major areas of clinical need for alternative treatments are generally also those areas most attractive to companies, which must ultimately recoup their heavy research and development investments. These areas include cardiology, neurology, orthopedics, urology, skin, dental and organ replacement and regeneration.
Research and development in tissue engineering and cell therapy have been accelerating, which has led to a steady stream of commercial developments, including product launches. The existing market therefore already stands at over $500 million and the growth curve on the markets for these technologies does not appear to be leveling soon, with compound annual growth rates for the aggregate of tissue/cell therapy markets exceeding 20%.
The global market for tissue engineering, cell therapy and tissue/organ transplantation is the subject of pending report #S520, from MedMarket Diligence.