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The Next Decade In Gene Therapy Innovation — 6 Critical Questions (And Answers)
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The Next Decade In Gene Therapy Innovation â 6 Critical Questions (And Answers)
By Kyle M. OâNeil and Brendan J. Wang, Back Bay Life Science Advisors
As the gene therapy field has tackled delivery vectors as described in “An Analysis Of The Gene Therapy Viral Vector Landscape,” several clinical and commercial questions lowered expectations for gene therapy sales, leading sell-side forecasts to fall more than 50% since 2018.
1 However, more than $6.5 billion in 2026 projected gene therapy sales remain across Duchenne muscular dystrophy (DMD), hemophilia A/B, sickle cell disease, Fabry disease, Huntington’s disease, and Leber congenital amaurosis type 10 (LCA10) alone, putting pressure on industry-leading gene therapy companies to deliver.
An Analysis Of The Gene Therapy Viral Vector Landscape
By Kyle M. O’Neil and Brendan J. Wang, Back Bay Life Science Advisors
Over the last five years, multiple gene therapies have been approved by regulatory agencies and a bolus of late-stage pipeline assets are approaching the market. As the first few gene therapies realize their potential as transformative treatments for the genetic rare diseases, the space is seen as a crucial part of growth for the biopharmaceutical industry. However, as the first gene therapies began to post early wins, several challenges have emerged. With these challenges in mind, leading companies have begun to search for new delivery technologies. Only after addressing delivery will gene therapies be able to achieve their longstanding potential to transform patient outcomes, expand into larger diseases, and ultimately provide returns for investors.
First In Line: FDA Vs. EMA Biopharma Approval Times
By Brendan Wang and Christian Thienel, Back Bay Life Science Advisors
The vast majority of biopharma companies place the most emphasis on the U.S. market as the pillar of their business case and commercial strategy. The conventional wisdom is that price potential is significantly larger in the U.S. and the lack of time-intensive healthcare technology assessment (HTA) processes like those seen in Europe are the key drivers of this phenomenon. However, often lost in this discussion is whether the regulatory agencies themselves have a major impact namely whether there is any difference in approval timelines between the FDA and EMA.
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