Incubate Launches Life Sciences Rare Disease Tracker to Measure Research Setbacks Tied to U.S. Policy Environment

Incubate, a coalition of life sciences investors, today unveiled the Life Sciences Rare Disease Tracker, a tool designed to measure the impact of federal policy changes – including the Inflation Reduction Act’s limited orphan drug exclusion – on critical investment, research, and development in rare disease treatments. 

The tracker compiles data from SEC filings, earnings calls, company announcements, clinical trial registries, and FDA orphan drug designations to present a comprehensive, data-driven view of the consequences unfolding across the rare disease research and development pipeline. It reveals a troubling trend: investment in rare disease innovation is declining while 30 million Americans wait for life-saving treatments. 

Incubate's Executive Director, John Stanford, issued the following statement:

“Our rare disease tracker confirms what we’re hearing from investors and innovators alike. Federal policies, like IRA price controls, are pushing companies to abandon otherwise promising therapies. Every halted clinical trial or shelved research program represents a lost opportunity for rare disease patients who can’t afford to wait. Congress must build on recent momentum to fix the orphan drug exemption and restore a climate that rewards innovation.”

Under the IRA, orphan drugs are exempt from Medicare drug price setting – but only if the drug has been approved to treat a single rare disease. That exemption doesn’t apply if the drug is approved for multiple rare conditions. This limited orphan drug exclusion discourages research into whether existing rare disease treatments could benefit patients with other conditions. Of more than 10,000 rare diseases, just 5% have an FDA-approved treatment.

Incubate’s new resource builds on its broader efforts to track how policy shifts are chilling investment in biomedical innovation. In Incubate’s recent survey of biotech companies, more than two-thirds of respondents reported that IRA drug pricing provisions have directly reduced capital formation for rare disease programs. A survey of biotech investors produced similar findings, with a majority of investors less interested in rare disease therapies due to IRA.

To learn more, visit lifesciencetracker.com/rare.

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About Incubate 

Incubate is a 501(c)(4) organization of venture capital firms representing the patient, corporate, and investment communities. Our primary aim is to educate policymakers on the role of venture capital in bringing promising treatments to patients in need.