Revitalizing the antibiotic pipeline by implementing new R&D pull incentives

Context and Urgency

• Antimicrobial resistance (AMR) is a critical global health threat, already causing ~5 million deaths annually, with projections of 39 million direct deaths by 2050.

• Effective antibiotics are vital not only for treating infections but also for safeguarding modern medicine (e.g., cancer care, surgery).

• The antibiotic innovation system is failing: only 10 antibiotics were approved globally between 2017–2023, of which just 2 were WHO-classified as innovative.

• Small biotech firms, key drivers of innovation, face bankruptcies due to fragile business models.

Core Challenge

• The economic model for antibiotics is broken:

  • High R&D costs, but sales are deliberately limited to preserve effectiveness.

  • Returns are too low to attract investors, especially in late-stage clinical trials.

  • Without reform, the pipeline will decline further, leaving few options post-2030.

Current Incentives

• Push incentives (e.g., CARB-X, GARDP, BARDA, AMR Action Fund) de-risk early research but are insufficient in scale and cannot solve long-term sustainability.

• Pull incentives are urgently needed to reward successful development and guarantee predictable returns independent of sales volumes.

Pull Incentive Models Considered

1. Market Entry Rewards (MERs): One-off payments at approval.

2. Subscription Models / Revenue Guarantees: Annual payments for guaranteed access, decoupled from sales.

3. Transferable Exclusivity Vouchers (TEVs): Developers gain tradable extensions of exclusivity on other products.

Industry remains model-agnostic but stresses scale, predictability, and alignment.

Design Principles for Effective Pull Incentives

• Effective: Provide sufficient global value (~USD 4.2 billion per antibiotic, in 2019 USD).

• Appropriate: Eligibility criteria linked to unmet medical need and stewardship.

• Predictable: Long-term, transparent frameworks to guide private investment.

• Practicable: Quickly implementable within existing health systems.

• Globally aligned & fairly shared: G7/EU contribute proportionally to GDP; other countries encouraged to develop regional or national solutions.

Economic Case

• Government investment in pull incentives yields high returns:

  • 5x return over 10 years for G7/EU.

  • Up to 20–28x over 30 years when accounting for macroeconomic and health system savings.

Call to Action

• By 2029 (next UN High-Level Meeting on AMR):

  • G7 and EU must fully implement sustainable pull incentives, with annual progress tracking.

  • Pilot programs should transition to permanent, large-scale solutions.

  • G20 and other countries should join, aligning regionally and supporting access models.

  • Regulatory harmonization, procurement reforms, and surveillance must complement R&D incentives.

Conclusion

Urgent, coordinated implementation of global pull incentives is essential to revitalize antibiotic R&D, ensure a robust pipeline, and secure access to life-saving antibiotics. Industry stands ready to partner with governments to make this happen by 2029.

 

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