2024-12-18-世界卫生组织-WHO_Global_Market_Study_on_RSV_Immunization_Products_14页_465kb

报告摘要

Authorized Products:
- 2 adult vaccines
- 1 maternal vaccine
- 3 infant monoclonal antibodies (mAbs)
Prices (HICs/UMICs public sector):
- Maternal RSV vaccine: US$184–260
- Adult RSV vaccine: US$75–196
- Infant mAb: US$231–730

Respiratory Syncytial Virus (RSV) is a leading cause of infant mortality and hospitalization, particularly in low-/middle-income countries (LICs, LMICs).
RSV affects all age groups: infants, older adults, and those with comorbidities.
Immunization Products: Two products (maternal vaccine and infant mAb) protect infants, while vaccines target adults and those with comorbidities.
Current Products: Sanofi’s maternal vaccine is available. Pfizer, GSK, and Moderna offer adult vaccines. Sanofi, AstraZeneca, and Pfizer provide infant mAbs.
Pipeline: 25 vaccines and 3 mAbs in clinical development.

To analyze market dynamics, demand, supply, pricing, and access challenges for RSV immunization products.
To identify barriers to equitable access, especially for LICs and LMICs.
To support policy-making and implementation strategies.

Demand Projections: By 2040, global PDR (Program Dose Requirement) for RSV products will reach ~170 million doses annually, with HICs accounting for ~70–80% of demand.
- Infant protection products (maternal vaccine and infant mAb) will make up ~36% of the total PDR.
- Adult protection products will constitute ~54% of the demand.
LICs/LMICs Lag: Adoption in lower-income countries is expected to be delayed by several years due to affordability, regulatory hurdles, and implementation barriers.

Supply is sufficient in the short term based on authorized products.
Up to ~200% growth in supply is projected as more products enter the market.
Key challenges include limited manufacturer diversity (mostly from high-income countries) and pipeline concentration.

Prices for RSV vaccines and mAbs (e.g., $175–$730 per dose) are comparable to recently introduced vaccines but significantly higher than some others.
Tiered pricing is used by some manufacturers, but affordability in LICs and LMICs remains a concern.
mAbs are costlier than vaccines due to production and R&D expenses.

Market Characteristics: High demand in HICs and UMICs; slow adoption likely in LICs/LMICs.
Supply Challenges:
- Sufficient supply short-term; investments needed for scaling up.
- mAb market depends on balancing supply, demand, and pricing.
Access Barriers:
- High prices and limited affordability in LICs/LMICs.
- Operational barriers in low-resource settings, including crowded immunization schedules and weak health infrastructure.

Dual Market: Demand exists in both high-income and low-income countries.
Priority Populations: Understanding target groups is critical for supply and demand planning.
Need for Strategy: Equitable pricing, technology transfer, and financial support from global health partners are essential for LICs/LMICs.
Key Stakeholders: Collaboration between countries, manufacturers, and global partners is vital.

Generate Evidence: Support country decision-making with cost-effectiveness and impact data.
Supplier Engagement: Develop equitable pricing and supply strategies for LICs and LMICs.
Monitor Dynamics: Track supply, demand, and pipeline progress.
Market Shaping: Use procurement data and targeted actions to drive affordability and access.
Support Implementation: Strengthen country infrastructure and secure funding through programs like Gavi and financing mechanisms.

PDR Assumptions: Based on proxy indicators for vaccine coverage and country priorities.
Gaps: Requires refinement with actual country data and real-world adoption trends.