Tissue Engineering and Cell Therapy, Two Thrusts of a Huge Global Market

May 14, 2010 - PRLog -- Autologous, autonomous, allogeneic, xenotransplanted and engineered tissue grafts are in routine use in skin/integumentary, orthopedic, cardiology and other clinical practices.  Newer engineered tissue, extracellular matrices and other tissue-related materials are also penetrating clinical practice, providing more complex solutions to disorders/disease and trauma.  The market for tissue engineering has balloon from a billion dollars only a few years ago to in excess of $6 billion now.

Conversely, the field of cell therapy -- including but not limited to adult stem cells, embryonic stem cells, placental derived stem cells, pluripotent cells and others -- is a largely nascent industry that was forced into a more challenging research climate under the federal funding ban of embryonic stem cells that was initiated by President Bush and overturned by President Obama in 2009.  Scientifically and commercially, cell therapies have made enormous strides and now represent several hundred million dollars of sales worldwide in approved clinical applications.

Both sides of this aggregate market are addressed in the 2010 report, "Worldwide Tissue Engineering, Cell Therapy and Transplantation, 2009-2018", published by MedMarket Diligence. See http://www.mediligence.com/rpt/rpt-s520.htm.

"Cell therapy has generated a great deal of headlines, but tissue engineering has generated a great deal of revenue" says Patrick Driscoll of MedMarket Diligence.  According to Driscoll, while the huge potential for cell therapy and its restricted development under the Bush federal funding ban was cause for a lot of press, the volume of active business in cell- and tissue-engineered therapeutics has grown dramatically over the past five years, resulting in current global, annual revenues in excess of $6 billion.  These products, approved and in clinical use, run the gamut of clinical applications in skin/integumentary, cardiology, orthopedics, spine, neurology, urology, dental/oral, ophthalmology, and others.

And while cell therapy is in routine use, a  limited number of stem cell therapies (embryonic or adult) are approved.  Technology, regulatory and other challenges persist for additional stem and other cell therapies reaching the market, but the market potential has been sufficiently evident that literally hundreds of companies are active in the development race.

For the sake of clarity, cell therapy and tissue engineering must be differentiated.

Cell therapy is defined as a process whereby new cells are introduced into tissue as a method of treating disease; the process may or may not include gene therapy. Forms of cell therapy can include: transplantation of autologous (from the patient) or allogeneic (from a donor) stem cells , transplantation of mature, functional cells, application of modified human cells used to produce a needed substance, xenotransplantation of non-human cells used to produce a needed substance, and transplantation of transdifferentiated cells derived from the patient’s differentiated cells.

Once considered a segment of biomaterial technologies, tissue engineering has evolved into its own category and now comprises a combination of cells, engineering and suitable biochemical and physiochemical factors to improve or replace biological functions. These include ways to repair or replace human tissue with applications in nearly every medical specialty. Regenerative medicine is often synonymous with tissue engineering but usually focuses on the use of stem cells.

In the aggregate, tissue engineering and cell therapy comprise bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration. These often comprise a combination of biotechnology, medical device and pharmaceutical technologies.

Researchers have been examining tissue engineering and cell therapy for roughly 30 years. While some products in some specialties (such as wound care) have reached market, many others are still in research and development stages. In recent years, large pharmaceutical and medical device companies have provided funding for smaller biotech companies in the hopes that some of these products and therapies will achieve a highly profitable, commercial status. In addition, some companies have been acquired by larger medical device and pharmaceutical companies looking to bring these technologies under their corporate umbrellas. Many of the remaining smaller companies received millions of privately funded dollars per year in research and development. In many cases it takes at least ten years to bring a product to the point where human clinical trials may be conducted. Because of the large amounts of capital to achieve this, several companies have presented promising technologies only to close their doors and/or sell the technology to a larger company due to lack of funds.

The MedMarket Diligence report #S520 (http://www.mediligence.com/rpt/rpt-s520.htm) on Tissue Engineering and Cell Therapy reveals in detail the status and opportunities for technologies, applications and markets in tissue engineering, cell therapy and tissue/cell transplantation. The report reviews therapeutic tissue engineering, tissue reconstruction, cell therapies, tissue/organ transplantation and related technologies under various stages of development at nearly 150 companies. The report details the technology development, projected market introduction dates and/or current and forecast market size and competitor shares for products being developed to address major causes of death and disease spanning applications in cardiovascular, neurological, orthopaedic, urological, skin, dental, ophthalmological, gastrointestinal, organ transplant, cancer and others. The report details the status of product development and assesses the current and forecast worldwide market for tissue engineering, cell therapy and transplantation.  The report provides market size and share data, with forecast market data to 2018, for the U.S., Europe, Asia/Pacific and Rest of World. The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market over a ten-year forecast and assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

The MedMarket Diligence report on cell therapy and tissue engineering may be ordered for download at http://www.mediligence.com/store/page32.html or purchased via order form at http://www.mediligence.com/order_forms/s520_order.pdf.

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MedMarket Diligence provides data and insight to the medical products, investment and other industries on advanced medical technologies through focused medical technology market and assessment Reports and the Medtech Startups Database.