Therapeutics
REGENERATIVE
MEDICINE a paradigm shift in healthcare
The regenerative medicine market offers phenomenal opportunities for growth in the next few decades. However, there are still major issues to be addressed to enable this nascent industry to truly flourish, especially with regard to investment and the attitudes of regulatory agencies and reimbursement bodies in an area which is relatively new to them.
T
raditional pharmacological approaches to medicine and healthcare have been highly successful in developing treatments for many acute and chronic disease and disorders. With these discoveries also came scientific advances in understanding the underlying mecha- nisms of disease, leading to innovative therapies that focus on addressing the causes of the disease instead of just treating symptoms. Unfortunately, far too many patients suffer from diseases for which there is no treatment. Regenerative medicine (RM) represents a para- digm shift in healthcare therapies and treatment by focusing on the underlying causes of disease by repairing, replacing, or regenerating damaged cells in the body. By focusing on problems at a cellular level, these therapies have the potential to cure or significantly reduce the disease burden for some of the most common chronic and acute conditions including stroke, heart disease, progressive neuro- logical conditions, autoimmune diseases and trau- ma. Successful development of novel stem cell and regenerative medicine therapies could greatly improve the quality of life for millions of patients living with these debilitating diseases and condi- tions. Regenerative medicine is also important from a national healthcare perspective, as these technologies have the potential to create less cost-
Drug Discovery World Spring 2011
ly and more effective therapies for some of the most expensive and devastating conditions plagu- ing our society.
This potential is already being realised by the multiple regenerative medicine products on the market, with many more promising products and technologies in mid- and late-stage clinical trials for common conditions including stroke, diabetes, Parkinson’s disease and heart disease. As the pop- ulation ages and the need for these innovative ther- apies grow, however, numerous commercial, finan- cial and regulatory obstacles continue to hinder the advancement of the field. The industry, working with other stakeholders, is now taking steps to col- lectively address the greatest barriers to widescale clinical success.
Shifting demographics are creating higher burden of chronic disease The market for RM products – as well as the potential economic impact of the industry – is growing. The populations of developed countries are ageing rapidly, and with this demographic shift we will see an increased number of the eld- erly living longer and spending more on health- care. According to the latest census, the percent- age of the US population that is over the age of 65 is projected to increase from 13% to 19% from
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By Michael Werner, Morrie Ruffin and Elizabeth West
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