The emergence of regenerative medicine marks a substantial development in the field of medical research. Advancements in new cell therapy, gene therapy, tissue engineering, small molecules and biologics have largely been augmented by the rising prevalence of chronic diseases.
The clinically unmet needs for organ transplantation is another major driving force behind the regenerative medicine market. By revolutionizing the way a person heals, regenerative technologies tap on the basic natural wound-healing mechanisms in the human body. Creation of organ scaffolds and use of biodegradable synthetic polymers to imitate organ tissues form a major part of tissue engineering. Three-dimensional bioprinting of complex organs such as liver, heart and kidney is another exciting possibility proposed by regenerative medicine. As technology scales new heights, the medical industry is set to explore new avenues. All these are capturing the attention of medical researchers and doctors worldwide due to its phenomenal prospects.
In terms of material used, the regenerative medicine market covers synthetic, genetically engineered, biologically derived materials and pharmaceuticals. The market size is huge in each of these categories and promises ample growth opportunities. Analysts at Allied Market Research have made a detailed study of the entire market, and focused on the trends and recent developments in this field. Medical science is expected to grow by leaps and bounds keeping in view the dynamic nature of the market.
Tissue engineering—Hope for organ transplantation
According to a recent statistic revealed by the National Kidney Foundation, there are currently 121,678 patients waiting for lifesaving organ transplants in the U.S. This is a whopping figure and testimony to the major challenge associated with the process of organ transplantation faced by surgeons. Organ failure and damage in patients need to be replaced, as most treatments are only palliative in nature. Moreover, there is a crippling gap between demand-supply of organ donors. Doctors also face a medical dilemma when it comes to organ compatibility with donor. These major issues cause many glitches connected with organ transplantation.
The development of technology in tissue engineering has given a ray of hope for this issue. It involves the engineering of entirely new organs, without the risk of rejection by the recipient's immune system. In principle, cells from a dead organ are removed. The protein scaffold left behind after removal of the dead cells, is then repopulated with stem cells matched immunologically with the patient's unique need. This process has proved successful in the replication of tracheas and bladders. Even in absence of the dead organ scaffold, a new scaffold can be created for the organ from protein, synthetic polymers or biodegradable plastic. Researchers are engaged extensively in replicating the major organs such as kidneys, liver and heart. Currently, FDA is considering approval after taking in commercial viability and successful clinical application. Once sanctioned, this can open up new pathways for the regenerative medicine market.
Widespread approval for cell therapy boosts market
The research and implementation of cell therapies, in particular is gaining popularity. In the past few years, doctors and clinical scientists have explored the therapeutics benefits promised by the injection of stem cells in targeted organs. Stem cell therapy has found clear acceptance in medicine with even FDA granting approval for its usage in leukemic, spinal and orthopedic treatments. The regenerative medicine market has witnessed a major growth spurt with extensive commercialization of this therapy. Stem cells possess differentiation qualities that can be transformed into specialized pluripotent cells. The application of this therapy is proving beneficial in the treatment of cancer, brain-related genetic disorders, cardiovascular diseases and spinal cord damage. Apart from this, the usage of cord blood from embryonic cells has also gained prominence. The best trait of these cells is that it can be extracted from the patient's own body, thus eliminating the issues related to cell compatibility.
Earlier, there were many ethical issues that hindered the full-fledged approval of cell therapies. Stem cells were reported causing side-effects in the long run, creating furor over its usage. This controversy set a limitation to the scope of cell therapies in oncological treatments. FDA regulations became more rigid and there was careful monitoring of clinical trials to ensure it did not cause new ill-effects on the participants. However, scientists in Germany sought to overcome this problem and developed a new approach to stem cell therapy. A team of researchers led by Andreas Beilhack and Harald Wajant of the University Hospital Wurzburg proved that their method prevents leukemia and lymphoma patients from developing graft-versus-host disease (GvHD) after bone marrow transplants. The test, conducted on mice, was achieved by development of a protein called STAR2. This protein can stimulate the formation of the transplant recipient's own T reg cells in vivo. Beilhack and colleagues found that a slightly modified version of STAR2 has a similar outcome on human T reg cells, pointing that the approach could also prevent GvHD in leukemia and lymphoma patients after bone marrow or stem cell transplants.
"Furthermore, this strategy may be beneficial for other pathological settings in which elevated numbers of regulatory T cells are desirable, such as autoimmune diseases and solid organ transplantation," Beilhack says. With progressive findings such as these, the scope and potential of regenerative medicine market is reinstated.
The world regenerative medicine market is a dynamic and evolving one. More and more innovative therapies undergo clinical trials to gain approval from regulatory bodies. The advancements in the medical equipment industry have also facilitated the growth of regenerative medicine as a translational science. It has witnessed a significant increase in the number of companies in the market. There is an active involvement by key competitors such as Integra Lifesciences Corporation, CryoLife, Inc, Organogenesis Inc., and U.S. Stem Cell, Inc. Higher investment in R&D projects is done to explore the prospects of different segments. The market has a strong presence in developed regions, such as North America and Europe, since they possess the resources to explore and implement regenerative medicines. In developing economies, for example India and China, there is greater awareness and need for regenerative therapies due to higher incidence of trauma-related cases. The cost of research and experiments is comparatively high, and this might act as a hindrance for certain underdeveloped nations that cannot tap this market potential. The evolution of regenerative medicine market has done much to save lives and improve life expectancies. With so many stakeholders involved in the industry, the regenerative medicine market promises to modify the perception of traditional healing.
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