2018 FDA approvals hit all-time high — but average value slips again

Boston Consulting Group, München, Germany.

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Boston Consulting Group, Boston, MA, USA.

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Boston Consulting Group, Zürich, Switzerland.

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In 2018, the FDA approved an all-time record of 62 new therapeutic drugs (NTDs; see Fig. 1 for the definition and the difference compared with new molecular entities). This is consistent with the increase we predicted last year (Nat. Rev. Drug Discov. 17, 87; 2018) and the overall resurgence of R&D in the last 5 years, with an average of 51 approvals per year in this period even with a low count in 2016. This is substantially more than the average of 31 approvals per year in the period 2000–2013 (Fig. 1).

Fig. 1 | FDA approvals of new therapeutic drugs and aggregate projected peak global annual sales: 2000–2018. We analysed 2018 FDA approvals of new therapeutic drugs (NTDs), defined as new molecular entities approved by the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), but with two adjustments: first, we excluded diagnostic imaging agents; and second, we included combination products with at least one new molecular entity as an active ingredient. The analysis is based exclusively on approvals by the FDA and the year in which the first indication approval took place. All peak sales values were obtained from EvaluatePharma and were inflation-adjusted to 2018 using standard global GDP-based inflators sourced from the Economist Intelligence Unit. To arrive at peak sales for each NTD, we reviewed both historical actual sales as well as the full range of forecast sales that are available from EvaluatePharma and selected the highest value. Sources: EvaluatePharma, FDA and Boston Consulting Group analysis.

However, projected peak annual sales for NTDs approved in 2018 total US$45 billion — lower than 2017’s $58 billion — and the value of the average peak sales per product has continued to trend down to only $720 million per drug in 2018, the lowest figure in almost a decade. The decline is driven both by fewer blockbusters at the top end, as well as a proliferation of very small products at the bottom end. We believe the underlying driver of both these trends — more approvals but smaller markets per approval — is better understanding of biology fostering precision medicine.

Similar to previous years, biologics contributed about one-third of approvals and peak sales value. Oncology accounted for the most approvals (26% of all NTDs) but only 20% of the total value, again in line with the growth of precision medicine, which has had the most impact in this therapeutic area. Big pharma’s share of approvals has also continued to shrink. In the period 2010–2014, the top 20 companies accounted for ~70% of approvals, whereas in 2018 this was down to 37%. Looking forward to 2019, we expect approval counts to moderate somewhat, but the overall trends described above to continue.

Nature Reviews Drug Discovery 18, 90 (2019)

doi: 10.1038/d41573-019-00004-z
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Competing Financial Interests

The authors of this article are employees of The Boston Consulting Group (BCG), a management consultancy that works with the world's leading biopharmaceutical companies. The research for this specific article was funded by BCG's Health Care practice.