Calling 2017 a “banner year for regenerative and advanced therapies,” the Alliance for Regenerative Medicine (ARM) reported Monday that gene and gene-modified cell therapy saw a 164 percent funding bump in 2017 compared to 2016, to the tune of $4.5 billion for the sector.
The 2017 Annual Data Report from the group also found a 78.5 percent leap in global funding for regenerative medicine overall to more than $7.5 billion in 2017 as well as 946 clinical trials underway in 2017. It called the Food and Drug Administration approvals of regenerative medicine-related therapies “historic.”
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The approvals include those for the CAR T-cell therapies Kymriah developed by Novartis that won FDA approval in August. And in October, FDA blessed Kite Pharma for Yescarta that Gilead acquired.
“These groundbreaking product approvals and continued clinical momentum in 2017 fostered growing investor and overall public interest regarding the truly transformative potential of these therapies,” wrote Janet Lambert in her “Letter from the CEO” included in the report.
A look ahead suggests more growth for 2018, with ARM saying that “there is every reason to be optimistic about what 2018 will bring.”
Among developments to watch for stateside: the FDA’s Center for Biologics Evaluation and Research plans to update disease-specific guidance on gene therapy manufacturing and safety, beginning with gene therapy and hemophilia. The FDA also is expected to clarify its 2017 policy framework for RM.
Nuggets of information from the report include a whopping $7.5 billion in funding for the RM sector in 2017 and some major increases in some areas. Cell therapy’s 2017 funding increase globally was 122 percent over 2016, at $4 billion. Tissue engineering brought up the rear, with a small 5 percent upward tweak in 2017, for a total of $446.1 million.
Clinical trials also boomed in 2017, with their numbers climbing 18 percent over 2016. Of the 946 trials underway in 2017, a total of 497, or 53 percent, were in oncology. Coming in a distant second were cardiovascular disease trials, taking up almost 10 percent of the RM trial real estate in 2017. Of the total trials, 82 were phase III.
The actual real estate for the 854-plus companies engaging in the RM sector is primarily in North America, which has 460 RM companies, and Israel/Europe, with 234-plus companies. In the European market, the UK, Israel, Germany, and France host the most firms. Meanwhile, Africa has a single RM-focused enterprise and South America has 15 as of 2017.
The report also highlights last year’s dozen regenerative medicine advance therapy designations from the FDA, including for Athersys’s MultiStem for ischemic stroke and Juno’s JCAR017 for relapsed and refractory aggressive large B cell non-Hodgkin lymphoma.
ARM, which was founded in 2009, focuses on advocating for policies that favor advances in the RM field.
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