WHO Global Market Study on RSV Immunization Products

Industry Overview - Respiratory Syncytial Virus (RSV) is a leading cause of infant mortality and hospitalization, with over 95% of RSV-associated acute lower respiratory infections and 97% of RSV-associated childhood deaths occurring in low- and middle-income countries (LICs and MICs) [92] - RSV also causes significant morbidity and mortality in older adults, with over 30,000 adults older than 60 years dying from RSV annually in high-income countries (HICs) [92] - Prevention through passive immunization with monoclonal antibodies (mAbs) and maternal vaccines, or active immunization with adult vaccines, plays a crucial role in reducing RSV-related morbidity and mortality [92] Market Dynamics - The RSV immunization market is dual, with demand and supply expected for the same products in both HICs and countries with limited resources [14] - Commercialization strategies have prioritized HICs and some upper-middle-income countries (UMICs) due to higher demand predictability and profitability [65] - Demand from HICs is expected to expand quickly across all populations by 2030, while demand in LICs and LMICs is expected to evolve at a much slower pace, with inclusion into National Immunization Programmes (NIPs) likely beginning 6-8 years later than HICs [97] Supply and Demand Analysis - Global programmatic dose requirement (PDR) for all RSV vaccines and mAbs is forecasted to increase from less than 50 million doses in 2024 to peak at ~170 million doses annually in 2040 [69] - HICs are likely to account for ~70-80% of PDR for all RSV products in the medium-term, while LICs and MICs could make up to ~75% of PDR by 2040 due to progressive adoption and implementation of RSV immunization programmes [69] - PDR for maternal RSV vaccine and infant mAbs is forecasted to grow to annual volumes of ~58 million and ~17 million doses, respectively, by 2040, representing ~36% of global PDR across the forecast timeframe [70] Key Players and Products - Currently, there are three authorized RSV vaccines for older adults and one maternal vaccine indicated during pregnancy to protect young infants [63] - The maternal vaccine is available from one supplier (Pfizer's ABRYSVO), and the same vaccine also has an indication for older adults [12] - For infant mAbs, products are available from only one to two suppliers (Sanofi AstraZeneca's BEYFORTUS and AstraZeneca's SYNAGIS), with limited potential for manufacturing scale-up [12] Pricing Analysis - Public market prices in the US are $395 for RSV mAb,$221 for maternal vaccine, and $175-196 for adult vaccines [81] - In other countries, available sources show a broader price range for mAbs in the public sector, with HICs prices varying between$231 and $730 per dose [83] - Maternal and adult vaccines have more limited price ranges, between$205 and $234 per dose and$175 and $196, respectively [83] Future Outlook - The current and future manufacturer base is not sufficiently diversified, with a limited number of suppliers for RSV mAbs and maternal vaccines [43] - Licensing and technology transfer could positively alter the supply ecosystem, supporting regional manufacturing, ensuring supply security, and enhancing supplier diversity and competition [43] - Efforts to accelerate equitable access will require actions on both the demand and supply side, including generation of comprehensive evidence base, engagement with developers and manufacturers, and financial support for countries with limited budgets [46]