Missed Opportunities: Why Small Biotech Needs To Plan Ahead For Global Reach

If small biotech does more to plan ahead for ex-US market requirements, companies and their investors – and crucially patients – will benefit.

World connected
• Source: Alamy

Global R&D spending by biotech has been well ahead of the rest of industry according to 2021 statistics. Publicly traded biotech spending on R&D was more than three times that of the industry as a whole between 2001 and 2020. This R&D investment is leading to regulatory success. By the end of 2020 the US FDA had approved 478 products, compared to 127 at the end of 2001.

Despite the regulatory success this is not translating into consistent commercial success. L.E.K. analysis found that 40% of all US biotech launches between 2006 and 2016 underperformed projections by more...

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