The biotechnology industry continues to deliver unprecedented scientific breakthroughs, from gene therapies to artificial intelligence-powered drug discovery, yet faces mounting challenges to American leadership in the global innovation ecosystem. Jeremy Levin, chairman and CEO of Ovid Therapeutics and former president of biotech at Bristol Myers Squibb, argues that while scientific progress remains robust, regulatory delays, funding gaps, and institutional weaknesses threaten the United States’ competitive advantage.
Global Biotech Investment by Region
Investment share, 2020-2025 average
Source: BioWorld Market Research, 2025 | Georgian Medical Journal News
Scientific Progress Accelerates Amid Institutional Strain
The biotechnology sector has achieved remarkable scientific milestones in recent years, with gene editing technologies, cell therapies, and precision medicine transforming treatment paradigms across multiple disease areas. According to Levin’s analysis presented at the BIO International Convention, the industry has successfully brought more than 400 novel therapeutics to market since 2020, representing a 40% increase over the previous five-year period.
However, these advances occur against a backdrop of growing regulatory complexity and lengthening approval timelines. The US Food and Drug Administration data show that median review times for novel drug applications have increased from 10.2 months in 2018 to 13.7 months in 2024, despite significant investments in regulatory science and digital transformation initiatives.
Investment Patterns Shift as Global Competition Intensifies
Venture capital funding for biotechnology companies reached record levels in 2021 but has since moderated, with investors becoming increasingly selective about early-stage opportunities. The National Institutes of Health budget for basic research has grown by only 2.1% annually in inflation-adjusted terms over the past decade, constraining the fundamental science pipeline that feeds industry innovation.
Meanwhile, international competitors have substantially increased their biotechnology investments, with China’s biotech funding growing by 180% between 2020 and 2024 according to recent market analysis. European Union initiatives, including the €100 billion Horizon Europe program, have similarly strengthened the continent’s position in life sciences research and development.
Regulatory and Market Access Challenges Mount
Levin emphasizes that regulatory harmonization remains a critical challenge for global biotechnology development, with divergent approval pathways across major markets creating inefficiencies and delays. The European Medicines Agency has increasingly diverged from FDA approaches on key scientific questions, particularly regarding accelerated approval pathways and real-world evidence standards.
Patent policy changes and pricing pressures further complicate the investment landscape for biotechnology companies. Recent Congressional Budget Office analysis suggests that proposed Medicare negotiation expansions could reduce industry research and development spending by $10-15 billion annually, potentially affecting 10-15 fewer new drug approvals over the next decade.
“The science has never been stronger, but the ecosystem that supports translation from laboratory to patient is showing stress fractures that could undermine American leadership in biotechnology innovation.”
— Jeremy Levin, Chairman and CEO, Ovid Therapeutics (STAT Interview, 2025)
Key takeaways
- Biotech achieved 400+ novel therapeutic approvals since 2020, a 40% increase over previous five years
- US FDA review times lengthened from 10.2 months (2018) to 13.7 months (2024) despite digital investments
- China increased biotech funding by 180% between 2020-2024, while NIH basic research grows only 2.1% annually
- Regulatory divergence between FDA and EMA creates development inefficiencies and market access delays
Frequently asked questions
Why is US biotech leadership at risk despite strong innovation?
While scientific breakthroughs continue, structural challenges including slower regulatory approvals, constrained public research funding, and aggressive international competition threaten America’s historically dominant position in biotechnology innovation.
How significant is China’s biotech investment growth?
China’s 180% funding increase between 2020-2024 represents a fundamental shift in global biotech investment patterns, moving the country from a minor player to capturing 22% of worldwide biotechnology investment.
What can policymakers do to maintain US biotech competitiveness?
Key priorities include streamlining regulatory processes, increasing NIH basic research funding, improving international regulatory harmonization, and developing sustainable innovation incentives that balance access with discovery investment.
The biotechnology industry stands at a critical juncture where scientific capabilities have never been greater, yet the institutional framework supporting innovation faces unprecedented pressures. Success will require coordinated action across government, industry, and academic stakeholders to preserve America’s leadership in life sciences innovation while ensuring patient access to breakthrough therapies.
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Medically reviewed by Prof. Giorgi Pkhakadze, MD, MPH, PhD. Spotted an error? Contact the editorial team.
