Schulthess Duane G, O'Loughlin Gwen, Askeland Madeline, Gassull Daniel, Bowen Harry P
Vital Transformation LLC, 601 Pennsylvania Ave NW, South Building Suite 900, Washington, D. C., 20004, USA.
Vital Transformation LLC, Washington, D. C., USA.
Ther Innov Regul Sci. 2025 Jul;59(4):769-780. doi: 10.1007/s43441-025-00773-3. Epub 2025 Apr 13.
The Congressional Budget Office has stated there is no evidence of a systematic decrease in the percentage of venture capital flowing to pharmaceutical companies since IRA's passage. This was echoed in Prof. Rita Conti's September 17, 2024, Senate Finance Committee testimony.
To test the IRA's impacts on early-stage investments targeting therapeutics for the Medicare-aged population, a longitudinal dataset of commercially sponsored clinical trials by companies with a market valuation ≤ $2 billion was obtained from the BioMedTracker database. These trials were filtered and curated to match early-stage investments to lead assets undergoing clinical development from January 1, 2018, to August 16, 2024.
From 161 lead assets with 619 individual investments, we find the aggregated total into large molecules in 2024 was 10 times larger than that for small molecules, which underwent a 68% decline after passage of the IRA. Individual investments made into small molecules decline by minus one-half as exposure to the Medicare-aged population increases after the passage of the IRA (p ≤ 0.0018). Testing large molecule investments by their exposure to Medicare post IRA's passage is statistically inconclusive. Research Conclusions. This study presents evidence of a decline in the development of new therapies targeting the Medicare-aged population since the passage of the IRA. If these impacts were due to the economic downturn post-pandemic, we would observe statistically similar results in both large and small molecules. However, the results by molecule type diverge. Investors perceive large molecules to be of a lower investment risk relative to small molecules after IRA's passage.
美国国会预算办公室表示，自《降低通胀法案》（IRA）通过以来，没有证据表明流向制药公司的风险投资比例出现系统性下降。这一观点在丽塔·孔蒂教授2024年9月17日向参议院财政委员会提供的证词中得到了呼应。
为了测试IRA对针对老年医疗保险人群治疗方法的早期投资的影响，从BioMedTracker数据库中获取了市场估值≤20亿美元的公司进行的商业赞助临床试验的纵向数据集。对这些试验进行筛选和整理，以匹配2018年1月1日至2024年8月16日期间处于临床开发阶段的早期投资与先导资产。
从161个先导资产和619项个人投资中，我们发现2024年对大分子的投资总额是小分子的10倍，而小分子在IRA通过后下降了68%。IRA通过后，随着对老年医疗保险人群的投入增加，对小分子的个人投资减少了一半（p≤0.0018）。在IRA通过后，根据对老年医疗保险人群的投入来测试大分子投资在统计学上没有定论。研究结论。本研究提供了证据，表明自IRA通过以来，针对老年医疗保险人群的新疗法开发有所下降。如果这些影响是由于大流行后的经济衰退造成的，我们会在大分子和小分子中观察到统计学上相似的结果。然而，按分子类型划分的结果却有所不同。IRA通过后，投资者认为大分子的投资风险相对于小分子较低。
