Promise and Potential

We are on the Brink of a New Era of Medicine

Regenerative medicine represents a new paradigm in human health, with the potential to resolve unmet medical needs by addressing the underlying causes of disease.

Regenerative medicine research translates fundamental knowledge in biology, chemistry and physics into materials, devices, systems and a variety of therapeutic strategies that augment, repair, replace or regenerate organs and tissues. This rapidly evolving, interdisciplinary field in healthcare is transforming the practice of medicine, medical innovation and the production of medical devices and therapies.

Why Is Regenerative Medicine So Important to the Future of Healthcare?

Currently, the vast majority of treatments for chronic and/or life-threatening diseases are palliative. Others delay disease progression and the onset of complications associated with the underlying illness. Very few therapies in use today are capable of curing or significantly changing the course of disease. The result is a healthcare system burdened by costly treatments for an aging, increasingly ailing population, with few solutions for containing rising costs.

The best way to significantly improve the economics of our current healthcare system is to develop more effective treatments for the most burdensome diseases and conditions—diabetes, neurodegenerative disorders, stroke and cardiovascular disease, for example—to facilitate longer, healthier and more productive lives.

Regenerative medicine is uniquely capable of altering the fundamental mechanisms of disease; however, to realize its potential, we must think differently about therapeutic development and commit to investing in these transformative technologies. A more effective, sustainable healthcare system is possible through regenerative medicine, but it will require the combined efforts of patients, payers, healthcare providers, biotech and pharmaceutical companies, private investors and governments working together.

Regenerative Medicine Already a Commercial and Medical Reality

Even though the majority of people perceive regenerative medicine as something of the future, it is actually here and now. A significant number of regenerative medicine products are already commercially and clinically successful. In addition to over 60,000 stem cell transplants annually performed worldwide for the treatment of oncology and blood-based disorders, it is estimated by ARM that in 2012 cell therapy products distributed by biotherapeutic companies generated over $900 million with 160,000 patients receiving treatments. It is widely believed that these numbers are easily doubled when including non-cell-based regenerative medicine products such as scaffolds and other materials.

A Maturing and Increasingly Diversified Clinical Pipeline

At the same time, more products are being approved and new data are becoming available from mid-stage and late-stage regenerative medicine clinical trials. For example, in 2012, seven cell therapy products were approved by regulatory agencies around the world in contrast with five such approvals in the three previous years, and none from 2002 to 2008. Going forward, the industry expects to see multiple approvals annually.

Analysts suggest there are at least 2,500 ongoing regenerative medicine clinical trials involving tens of thousands of patients for a myriad of clinical indications. An estimated 15 percent of this is industry-sponsored, and the remainder is being sponsored by leading academic centers around the world.

Stakeholder Coordination— A Critical Factor for Success

Delivering cures through regenerative medicine requires coordination amongst a broad range of stakeholder groups from industry, academia, government, healthcare professionals, the investment community and consumer advocates. The Alliance for Regenerative Medicine is the voice for these groups, drawing them together to create an influential and unified community that is paving the way for a healthier future with many new life saving therapies.