The Alliance for Regenerative Medicine (ARM) today announced the release of its 2016 annual data report, offering an in-depth look at trends and metrics for the cell therapy, gene therapy, tissue engineering and broader global regenerative medicine sector.

Using data provided by ARM’s data partner Informa and compiled and analyzed by ARM’s staff, the report details industry-specific statistics compiled from more than 730 leading cell therapy, gene therapy, tissue engineering and other regenerative medicine companies worldwide. Key features of the report include total financings for the sector, partnerships and other deals, clinical trial information, major clinical data events, current legislative and regulatory priorities and ARM’s strategic priorities for 2017.
The 2016 report includes several sections featuring stakeholder perspectives from ARM member organizations, and highlights important focus areas for the sector:

  • The landscape for cell and gene therapies in 2017, with commentary from bluebird bio, GE Healthcare, Kite Pharma, Pfizer and Tmunity Therapeutics;
  • Gene editing technologies, with commentary from Editas Medicine, Intellia Therapeutics and Sangamo Therapeutics;
  • Manufacturing and infrastructure in cell and gene therapy development, with commentary from Caladrius Biosciences, GE Healthcare, Lonza Pharma & Biotech and Pfizer.

“2016 was a pivotal year for the regenerative medicine sector, as we have seen many novel therapies progressing through the clinic and demonstrating signs of true therapeutic potential,” said Morrie Ruffin, ARM’s managing director. “We expect this progress to continue in 2017 and 2018 with several significant approval filings addressing areas of significant unmet medical need. We also anticipate steady clinical progress in the sector will lead to growing capital investments and continue to attract partnership interests from pharma and large cap biotech companies.”

Highlighted findings from the 2016 annual report include:

  • Globally, companies active in gene and cellular therapies and other regenerative medicines raised more than $5.22 billion in 2016. The report also includes data broken out by technology and financing type.
  • There were 804 clinical trials underway worldwide by year-end 2016, a 21% increase over 2015. The report includes figures on clinical trials by phase, technology type and indication.
  • The 21st Century Cures Act, passed in late 2016, recognizes the therapeutic potential of products in this space and optimizes their approval pathway while maintaining FDA’s high product approval standards.
  • Areas of strategic focus for ARM in 2017, including international regulatory harmonization; market access and reimbursement policies; capital formation; industrialization and manufacturing standards; key stakeholder engagement 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.

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


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