Over the past few decades, cell-based medical technologies have helped treat many patients with cancer, blood disorders, vision disorders, and other ailments. In 2012 alone, these products treated more than 160,000 patients. Though this relatively new industry has been growing significantly—with annual U.S. revenue above $1 billion—its potential is still far from being fully realized.
New and emerging cell-based healthcare products, such as cell therapies, engineered tissues, medical devices, and drug discovery and testing platforms, could help manage and even cure many conditions and diseases that are intractable, chronic, and even terminal today, including cancer, heart failure, paralysis from spinal cord injuries, and autoimmune disorders. Advanced cell-based technologies can help meet the needs of an aging population, accelerate recovery from injuries, and reduce the number of people on transplant lists—currently more than 120,000. Cell-based technologies could also advance screening platforms for predictive and personalized medicine, allowing earlier treatment of some diseases such as cancer and diabetes, and could facilitate the discovery of safer and more efficient drugs. Though cells are the building blocks of all of these products, most U.S. investment in this field to date has neglected the advancement of cell manufacturing. Federal agencies—including the National Institutes of Health, Department of Defense, Department of Veterans Affairs, National Science Foundation, Food and Drug Administration, National Nuclear Security Administration, and National Institute of Standards and Technology—invested nearly $3 billion in regenerative medicine from 2012–2014, most of which was focused on basic and clinical research of new therapies. Bringing these new life-changing cell-based medical products to market critically depends on the large-scale, cost-effective, reproducible manufacturing of a variety of cell types.
Through a collaborative, strategic effort as called for in this roadmap and the support of public-private-philanthropic partnerships, the U.S. cell manufacturing industry can lead the advancement of cell manufacturing and enable the increased availability of innovative cellbased technologies. A dedicated translational effort and funding on the order of several hundred million dollars per year—or at least 10%–20% of investments in regenerative medicine—over the next 10 years would greatly accelerate this progress, maintaining the United States’ foothold in the industry and its contributions to the entire global cell manufacturing and cell-based products community.