Regenerative medicine: A growing global industry, ARM reports

SAN FRANCISCO – Last year at this time the regenerative medicine and advanced therapies industry had begun its coming-out party riding a wave of promising clinical data readouts that ignited strong investor interest and catalyzed involvement and interest from big pharma companies. This momentum has continued to increase during the past year, said Edward Lanphier, chair of the Alliance for Regenerative Medicine (ARM) at their state of the industry briefing delivered at the Biotech Showcase meeting here. In fact the sector, which comprises enterprises focused in the areas of cell therapy, tissue engineering and biomaterials and gene and gene-modified cell therapies and genome editing, has now evolved into a global industry, currently 500-plus companies strong, that continues to grow.

Lanphier presented the major highlights from a year that has seen a broad array of products in the pipeline grow substantially in 2014.

ARM has identified just over 300 companies in the U.S. operating in the space with 157 in Europe and 53 in Asia. Encouragingly these firms are involved in over 378 clinical trials and 65 percent of these have advanced to the phase II and phase III stages.

In terms of fundraising 2014 was an exceptional year, noted Lanphier, with $6.3 billion raised by regenerative medicine and advanced therapies companies representing a year-over-year growth of 112 percent. Approximately $3 billion of this amount was raised by those companies involved in gene and gene-modified cell therapy compared with almost $500 million in 2013.

The white-hot biotech initial public offering (IPO) market also embraced companies in the field that collectively raised $1.3 billion. Among them was Juno Therapeutics Inc., of Seattle, which generated $304 million from its IPO – making it the largest U.S. biotech IPO in the last 15 years. Juno's debut in December 2014 followed one day after fellow cellular immunotherapy firm Bellicum Pharmaceutical Inc. raised $140 million.

Also contributing to the breakout year for the sector was a robust period of partnering activity. Among the many deals included U.K.-based Adaptimmune Ltd. that inked a $350 million deal with Glaxosmithkline plc for its lead program NY-ESO-1, an autologous T-cell product targeting the cancer testis antigen. As an encore, U.S. investors put $104 million into the company to fund a significant expansion of their clinical development program.

Among ARM's 2015 advocacy aims include support of the enactment of the Regenerative Medicine Promotion Act and 21st Century Cures and the facilitation of expedited approval for regenerative medicine products and the promotion of a clear, predictable regulatory pathway.

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