Although developing a new drug is generally considered to be a pricey proposition, the median cost of the pivotal trials needed to win regulatory approval is just $19 million, according to a new study.

In other words, the key scientific evidence used to persuade the Food and Drug Administration to endorse a new medicine is a small fraction of the overall development costs regularly attributed to the efforts undertaken to bring a new medicine to market.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!


What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • Online intelligence briefings
  • Frequent opportunities to engage with veteran beat reporters and industry experts
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.

Leave a Comment

Please enter your name.
Please enter a comment.

  • This article is somewhat misleading, as the cost of developing drugs that fail greatly exceeds the cost of developing drugs that make it to market. A back-of-the-envelope estimation multiplies the entire cost of development of a successful drug by at least a factor of 3 to estimate what a company actually expends to take a drug to the marketplace.

  • I don’t doubt this is true. But this is just Phase 3 — and it takes lots of money and too often lots of failures to get to Phase 3.

    Oftentimes Phase 2 trials can be equally large, in part because they explore multiple doses. And we know lots of Phase 2 trials fail.

Your daily dose of news in health and medicine

Privacy Policy