FDA approved 56 new drugs in 2020

In 2020, the FDA approved 56 new drugs, and the number of large companies approved a record low.

On January 15, 2021, Nature Reviews Drug Discovery analyzed the new drugs approved by the U.S. FDA in 2020 and their sales. Although the epidemic has a global impact, it does not seem to affect the FDA’s new drug approval.

The photo report pointed out that in 2020, the FDA Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approved 56 new therapeutic drugs (NTD). This is much higher than the average level since 2014 and is in line with our positive outlook from the beginning of 2020.

As in previous years, new vaccines were also included in the list, and, given their expected widespread use before full FDA approval, we also assessed the contribution of the two COVID-19 vaccines granted emergency use authorization to sales forecasts .

Figure 1 | New therapeutic drugs approved by the FDA and projected peak global annual sales (2000-2020)

New therapeutic drugs (NTDs) here are defined as new molecular entities approved by the FDA 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;

Second, we include combination products that have at least one new molecular entity as the active ingredient.

For 2020, if two COVID-19 vaccines with emergency use authorization are counted as ntd, the corresponding values ​​will also be displayed. The analysis is based entirely on the FDA approval and the year of first indication approval.

All sales peaks are obtained from EvaluatePharma, and the standard inflation index based on global GDP provided by the Economist Intelligence Unit is used to adjust inflation to 2020.

In order to reach the peak sales of each NTD, we reviewed the historical actual sales and all forecast sales provided by EvaluatePharma, and selected the highest value. (Source: EvaluatePharma, FDA and Boston Consulting Group analysis.)

Total sales are expected to be lower than the historical average:

The total annual peak sales of the NTDs approved in 2020 are expected to be lower than the long-term average at US$39 billion, but sales of the two COVID-19 vaccines are expected to increase by approximately 7 billion US dollars.

The average peak sales forecast and median peak sales forecast for each new drug are US$700 million and US$400 million, respectively. If the COVID-19 vaccine is added, the average will rise slightly to 800 million U.S. dollars, while the median will remain at 400 million U.S. dollars.

The number of new drugs contributed by large pharmaceutical companies has dropped to 35%:

After a small increase in 2019, the share of large pharmaceutical companies in NTD approvals will drop again in 2020. The top 20 pharmaceutical companies only contributed 35% of all approvals and contributed less than 50% of the estimated annual peak sales.

Anti-tumor and anti-infective drugs are still important areas for new drugs: oncology and anti-infective drugs (including the COVID-19 vaccine) are the largest therapeutic areas, accounting for 31% and 17% of all analytical approvals, respectively. The corresponding value share is higher, with tumors accounting for 36% and anti-infectives accounting for 21%.

The epidemic has brought new experience in R&D: Despite COVID-19, it still maintains a high number of approvals and sufficient channels in 2020, which further proves that R&D productivity in recent years has broken through the “inverted Moore’s law” (revealing that drug development faces Dilemma: Since 1950, the number of new drugs approved to invest $1 billion in research and development has been halved every 9 years).

We also expect that the drug development models during the epidemic, such as dispersed or mixed trials, main program research, adaptive trial design, and model-informed drug development, will bring beneficial experience in future drug research and development. It is hoped that this experience will be used in the future. R&D trends.

(source:internet, reference only)

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