Blueprint to Close the Women%E2%80%99s Health Gap 2025

2.3.2 Metric 5: Assets in the pipeline Definition: Assessment of innovative assets relative to burden for conditions Source: Pharmaprojects, IHME Period: April 2023–June 2024 Assets in the pipeline for women’s health conditions – pharmaceutical assets in clinical trials in progress from preclinical to Phase 3 – can be an indicator of where pharmaceutical companies and researchers are focusing efforts for treatments and medical interventions. These assets were assessed by the McKinsey Health Institute (MHI) team in collaboration with the Forum to understand the level of innovation and readiness to market for pharmaceutical interventions. To capture year-on-year impact, the initial data, comprising Year 0, was taken from April 2023, and an updated view on Year 1 was captured in June 2024 from the Pharmaprojects database. Innovation and readiness to market were assessed for three categories of pipeline products: 1. New assets that have entered the pipeline in the past year 2. New assets that have entered the pipeline for that indication in the past year 3. Phase 3 assets The absolute number of assets in the pipeline may not capture the full potential for innovation: e.g. a condition may have many assets that lead to incremental improvement or few approvals for actual treatments if over-indexed on early-stage development; others may have few assets, although those assets may lead to a leapfrog impact. That said, the more assets in the pipeline for a condition, the more likely an intervention for a condition may come to market and have potential to improve the standard of care over time. Assessing pipeline assets as a proxy to understanding potential shifts in care delivery is complex. Given the long development times and resources required to ensure assets are making it to late-stage trial phases, a fraction of pipeline assets is approved out of total pipeline trials. Understanding innovation and where the standard of care may be improved is nuanced. Innovation and quantity of innovative assets for each prioritized condition were measured to track impact, with an additional focus on later-stage (Phase 3) assets that may come to market sooner. Readiness to market was also measured, with assets in later stages possibly more likely to come to market earlier, alongside those with similar assets on the market already in the indication and medications that are similar receiving expedited review designation. From speaking with experts, looking at novel, first- in-class assets for mechanisms of action is a core indicator of innovation, meaning assets that are the first of their kind for the mechanism of action in an indication. However, there are other specific criteria for innovation on an individual asset and indication basis that make the assessment challenging to scale to all indications. One such example is assets already launched and entering the pipeline for a new indication. This challenge is particularly complex when looking at oncology indications. It is often the case that early-stage oncology assets are trialled across multiple tumours, given the broad focus of oncology research and development initially. Once in trials, the indications narrow, and assets come to market specifically for indications. In this analysis, for example, there are assets in preclinical and Phase 1 stages that fall into both breast and cervical cancer indications. With this in mind, assessing innovation by first-in-class for the indication is less applicable for oncology, even though often relevant once assets are advanced to later trial stages. 2.3.3 Metric 6: Number of clinical trials Definition: Number of clinical trials per condition Source: clinicaltrials.gov Period: June 2023–May 2024 Clinical trial data can be used to indicate research and funding focus areas and potential innovations in the care delivery pipeline. Clinical trial data can be a useful proxy for understanding industry and academic priorities. Active clinical trials with women enrolees registered with clinicaltrials.gov were assessed (1 June 2023 to 31 May 2024) to understand the location of trial settings, as compared to the burden of conditions in different income archetype regions. To understand the locations and number of clinical trials, clinicaltrials.gov and the international clinical trials registry platform were used. Condition-specific queries were created using the terms mentioned earlier, and the trials tagged under those conditions over the past year were downloaded and analysed. Trials were analysed for the location, split into the four income archetypes. Blueprint to Close the Women’s Health Gap: How to Improve Lives and Economies for All 42