Women Health Diagnostics Market Trends

Growth Drivers

• Government investment in advanced diagnostics: Medicare Part B spending on genetic tests, including those related to womens health diagnostics, increased by over 27% in 2023. This increase reflects a 40% growth in test volumes, demonstrating that there is a growing focus on precision medicine and early detection approaches in women's health.
• Emphasis on preventative services: Medicare covers a variety of preventative services important to women's health, including screenings for breast and cervical cancers and sexually transmitted infections. These services are, in many cases, provided at low or no out-of-pocket costs for beneficiaries, which encourages early detection and intervention.
• Increase in demand for reproductive health services: More than one million women of reproductive age (20 to 49 years of age) have access to Medicare. These women are often of minority backgrounds and have lower incomes. This highlights the need for better diagnostic access to reproductive health. Although Medicare covers many preventive services, it lacks in certain areas, such as contraceptive coverage.
• Move toward value-based care: Medicare is changing its payment model from fee-for-service to value-based care models. It aligns facilities with diagnosing low-cost interventions that can demonstrate better patient outcomes and decreased utilization of healthcare services. Organizations such as the Foundation for Innovative New Diagnostics (FIND), which partner with a variety of organizations the world over to develop and implement diagnostic tools, specifically in low- and middle-income countries. Collaborations address global health disparities for access to necessary diagnostics.

Historical Patient Trends: A Catalyst For Global Womens Health Diagnostics Expansion

Throughout 2010 to 2020, the global market experienced significant changes as a result of increased disease burden, demographic shifts, mandatory screening programs, and access to preventive healthcare services.
Specifically, the U.S. addressed screening with an extension of programs to ensure coverage under the Affordable Care Act. Similarly, European countries, such as Germany and France, expanded national screening programs for breast and cervical cancer coverage. In the Asia-Pacific region, Japan billed more than 55% of its population through its obligatory health insurance and had improved prenatal care.

This past growth phase in the care continuum has set in place the capacity for strong market scalability. Now, the diagnostic manufacturers also have the opportunity to put forth AI-enhancing diagnostics, home testing kits, and integrated drugs with devices. The patient path from 2010–2020 will be considered as a major input in revenue prediction models, as personalized medicine and digital health platforms provide equal access to patients in the rural and semi-urban categories of Asia and Latin America. Given the continued growth, manufacturers of all sizes, from corporates to start-ups, have to structure their products and support along special access methods.

Historical Patient Growth Data (Womens Health Diagnostics Users, 2010–2020)

Revenue Feasibility Models Shaping the Future of the Market

Manufacturers operating in the womens health diagnostics (WHD) space utilized a variety of regional expansion strategies from 2020 to 2024, including various levels of regional partnerships, working with government agencies, and developing value-based innovations. For instance, distributors operating in India were able to apply a decentralized distribution model by utilizing public-private partnerships that strengthened rural access to diagnostics. In China, diagnostic procurement spikes have been seen as a result of government-funded programs that improve maternal health.

Feasibility Expansion Models – Statistical Summary (2022–2024)

Challenges

• High costs of diagnostics and their impact on Medicaid coverage:  In the USA, in 2023, costs of advanced diagnostics for breast and cervical cancer exceeded USD 1,100 per patient. Medicaid's coverage is limited to 47% of eligible women based on the budget restrictions placed on the coverage. Consequently, as a result, this was an affordability gap across low-income populations.
• Regulatory slowdowns in Japan: Japan's 2022 update to the Pharmaceuticals and Medical Devices Law (PMDL) accelerated the amount of diagnostic innovation. This resulted in the average approval period extending 7-8 months, affecting the overseas manufacturer go to market period.