Alliance for Regenerative Medicine Releases Q3 2016 Data Report, Highlighting Sector Trends and Metrics

– November 9, 2016

WASHINGTON, D.C., November 10, 2016 – The Alliance for Regenerative Medicine (ARM) today announced the release of its quarterly data report, offering an in-depth look at cell therapy, gene therapy, tissue engineering and broader global regenerative medicine sector trends and metrics in the third quarter of 2016.

Using information provided by ARM’s data partner Informa, the quarterly data report details industry-specific statistics compiled from more than 730 cell therapy, gene therapy, tissue engineering and other regenerative medicine companies worldwide, including total financings, partnerships and other deals, clinical trial information, key clinical data events and current legislative and regulatory priorities.

The Q3 2016 data report includes sections featuring ARM member organization and key stakeholder perspectives, highlighting important focus areas for the sector:

  • The large pharma perspective on the cell and gene therapy and regenerative medicine sector, with commentary from GSK’s Vice President, Head of Cell Therapy Development Sven Kili and Shire’s Vice President, New Products TA Lead, Gene Therapy, Neuroscience, Oncology & Ophthalmology Andrea Hunt.
  • The investor perspective on cell and gene therapy financing, with commentary from Raymond James & Associates, Inc.’s Senior Biotechnology Analyst Reni Benjamin.

“Over the third quarter of 2016, financing and deal making activity among companies in gene and cell therapy coupled with strategic partnerships and acquisitions fueled continued growth in the sector,” said Morrie Ruffin, ARM’s managing director. “Moving into Q4 and in the coming year, we anticipate a number of significant approval filings as several of these therapies approach commercialization.”

Highlighted findings from the Q3 2016 data report include:

  • Globally, companies active in gene and cellular therapies and other regenerative medicines raised more than $3.5 billion in the first three quarters of 2016. The report also includes data broken out by technology and financing type.
  • There were 801 clinical trials underway worldwide at the close of the third quarter of 2016. The report includes figures on clinical trials by phase and indication.
  • Areas of regulatory and legislative focus moving into Q4 2016 include: activities following the U.S. presidential election and outreach to the new Administration’s transition team; global reimbursement issues; industry-wide standards development; optimizing the regulatory and review pathways; EU GMP for ATMP; EU hospital exemption; FDA guidance on minimal manipulation; international regulatory convergence; gene editing and related bioethics issues; PDUFA reauthorization; and more.

ARM will continue to update this information through new reports to be released after the close of each quarter, tracking sector performance, key financial information, clinical trial numbers and clinical data events.

The report is available online here. For more information, please visit or contact Lyndsey Scull at

About The Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 250 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit