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SHW 25.07.21

Kalorama Information's "Women's Health Diagnostic Markets: Global Outlook and Forecast to 2030" offers a comprehensive, data-driven analysis of the global landscape for diagnostic tests that specifically address women's health across clinical, point-of-care (POC), and over-the-counter (OTC) settings. As global demographics shift-with women living longer than men-healthcare systems are under increasing pressure to recognize and address sex-based differences in disease risk, screening, and treatment. Diagnostics are at the core of this transformation, offering the ability to deliver personalized and timely interventions across a woman's life span.

This in-depth report forecasts global market revenues for diagnostic tests and systems through 2030, providing regional segmentation and trend analysis across a broad spectrum of diagnostic categories relevant to female health. The study encompasses both established and emerging technologies used in the detection, screening, and monitoring of conditions unique to, or highly prevalent among, women. Market sizing reflects product and system sales, including associated services such as instrument installation and software support.

Key diagnostic sectors covered in the report include:

  • Breast and Reproductive Health Imaging: Mammography, CADe/CADx, OB/GYN ultrasound, and breast ultrasound imaging.
  • Prenatal and Carrier Screening: Non-invasive prenatal testing (NIPT), carrier screening, and maternal-fetal diagnostics.
  • Infectious and Sexually Transmitted Diseases: HPV diagnostics, TORCH immunoassays, and molecular urinary tract infection (UTI) testing.
  • Fertility and Pregnancy Testing: Lab-based and POC tests for ovulation, fertility hormones, and pregnancy status.
  • Cancer and Chronic Disease Monitoring: Pap tests, ovarian cancer biomarkers, and female-specific autoimmune immunoassays.
  • Bone Health and Preventive Diagnostics: Bone densitometry testing and colposcopy systems for early cancer detection.

Each chapter explores the scientific foundations and technological innovations driving growth in its respective category while addressing challenges such as regulatory shifts, reimbursement, market access, and product differentiation. The report draws on interviews with industry experts, input from clinical labs, and extensive primary and secondary research to inform market forecasts and trend assessments.

A diverse group of diagnostic players-ranging from dominant multinationals to nimble niche firms-are profiled in each category. Companies covered include BD, GE Healthcare, Hologic, Roche, Siemens Healthineers, and Thermo Fisher, among others. These firms are actively shaping the future of women's diagnostics through innovation in biomarkers, automation, digital imaging, and home-based testing.

At a time when diagnostic testing influences more than 70% of medical decisions, this report positions women's health diagnostics not only as a growing market but also as a critical component of precision medicine. The insights contained herein are essential for stakeholders focused on expanding access, improving clinical outcomes, and investing in the next generation of diagnostic solutions tailored to women's evolving health needs.

Table of Contents

About Kalorama Information

Chapter 1: Executive Summary

  • Overview
  • Scope and Methodology
  • Market Overview and Potential
    • Figure 1-1: World Markets for Key Women's Health Diagnostics, by Product Segment, 2024-2030 ($ million) [Autoimmune immunoassay, Bone densitometry, CADe/CADx, Colposcopy systems, Female HPV IVD tests, Lab based fertility immunoassay, Lab based TORCH immunoassay, Mammography, Molec. prenatal, carrier, NIPT, Molecular UTI tests for females, Ovarian cancer immunoassays, Pap tests, POC pregnancy & fertility, Ultrasound breast imaging, Ultrasound OB/GYN]
    • Table 1-1: World Markets for Key Women's Health Diagnostics, by Product Segment, 2024-2030 ($ million) [Autoimmune immunoassay, Bone densitometry, CADe/CADx, Colposcopy systems, Female HPV IVD tests, Lab based fertility immunoassay, Lab based TORCH immunoassay, Mammography, Molec. prenatal, carrier, NIPT, Molecular UTI tests for females, Ovarian cancer immunoassays, Pap tests, POC pregnancy & fertility, Ultrasound breast imaging, Ultrasound OB/GYN]

Chapter 2: Introduction

  • Female Health: Room for Improvement
  • Perspective on Women's Health
  • Women and Men Develop Some Diseases Differently
    • Pain
    • The Heart
    • The Brain
    • Emotions
    • Bone Structure
    • Alcohol
    • Drug Side Effects
    • Smoking
    • Fertility
    • STIs and HIV
    • Autoimmune Disease
    • Cancer
    • Leading Female Cancers
    • Musculoskeletal Health
    • Congenital Abnormalities
    • Urinary Tract Infections (UTIs)
  • Key Trends and Issues in Women's Health Diagnostics
    • Ovarian Cancer Diagnostics and Biomarkers
    • HPV Testing
    • Broader Carrier Screening and NIPT
    • Multiplex and Molecular Testing for UTIs
    • Imaging and AI
    • Pregnancy and Ovulation
    • Autoimmune Laboratory Immunoassays

Chapter 3: Mammography

  • Introduction
    • Transition to Digital
    • Economics of Routine Screening
    • Digital Breast Tomosynthesis (DBT or 3D Mammography)
  • Mammography Market
    • Table 3-1: World Mammography Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 3-1: World Mammography Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 3-2: World Mammography Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
    • Figure 3-3: World Mammography Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Computer-Aided Detection/Diagnosis (CADe/CADx)
    • Table 3-2: World CADe/CADx Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 3-4: World CADe/CADx Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 3-5: World CADe/CADx Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
    • Figure 3-6: World CADe/CADx Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Artificial Intelligence Adoption in Breast Imaging
    • Key Trends in AI-Driven CAD
    • Trends
  • Regulatory Changes
  • Competitive Landscape
    • Fujifilm Holdings Corp.
    • GE HealthCare
    • Hologic
    • Siemens Healthineers

Chapter 4: Ultrasound

  • Introduction
    • Table 4-1: Key Applications for Medical Ultrasound
  • Obstetrics and Gynecology
  • Breast Imaging
  • Market Trends
  • Obstetric and Gynecological Ultrasound Trends
    • Table 4-2: World Ultrasound OB/GYN Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 4-1: World Ultrasound OB/GYN Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 4-2: World Ultrasound OB/GYN Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
    • Figure 4-3: World Ultrasound OB/GYN Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Breast Imaging Market
    • Table 4-3: World Ultrasound Breast Imaging Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 4-4: World Ultrasound Breast Imaging Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 4-5: World Ultrasound Breast Imaging Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
    • Figure 4-6: World Ultrasound Breast Imaging Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Competitive Landscape
    • GE HealthCare
    • Hologic
    • Philips
    • Siemens Healthineers

Chapter 5: Prenatal and Carrier Screening

  • Introduction
  • NIPT
  • Advances in Genetics Bring New Challenges
  • Carrier Screening
  • Test Adoption Trends
  • Inherited Diseases
    • Inflammatory Bowel Disease (IBD) and Crohn's Disease
    • Autism Spectrum Disorder (ASD)
    • Alzheimer's Disease (AD)
    • Cardiovascular Disease (CVD)
    • Psychiatric Disorders
  • M&A, Partnerships
  • NIPT and Carrier Screening Markets
    • Table 5-1: World Prenatal and Carrier Test, NIPT Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 5-1: World Prenatal and Carrier Test, NIPT Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 5-2: World Prenatal and Carrier Test, NIPT Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
    • Figure 5-3: World Prenatal and Carrier Test, NIPT Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Competitive Landscape
    • Agilent
    • Illumina
    • Qiagen
    • Revvity
    • Thermo Fisher Scientific

Chapter 6: HPV Testing

  • Introduction
  • Overview
    • HPV Infection
    • Infection in Females
    • High-Risk Types and Cervical Cancer
    • HPV Testing
  • HPV IVD Test Market
    • Table 6-1: World Female HPV IVD Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 6-1: World Female HPV IVD Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 6-2: World Female HPV IVD Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
    • Figure 6-3: World Female HPV IVD Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • HPV Testing and Global Screening Programs
  • Competitive Landscape
    • BD (Becton, Dickinson and Company)
    • Hologic
    • QIAGEN
    • Roche

Chapter 7: Pregnancy and Ovulation

  • Introduction
  • Perspective on Testing
  • Digital Testing
  • Lab Testing
  • Trends
  • Market
    • POC Pregnancy and Fertility Test Market
      • Table 7-1: World POC Pregnancy Test Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
      • Figure 7-1: World POC Pregnancy Test Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
      • Figure 7-2: World POC Pregnancy Test Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
      • Figure 7-3: World POC Pregnancy Test Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
      • Table 7-2: World Lab-Based Fertility Immunoassay Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
      • Figure 7-4: World Lab-Based Fertility Immunoassay Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
      • Figure 7-5: World Lab-Based Fertility Immunoassay Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
      • Figure 7-6: World Lab-Based Fertility Immunoassay Market, Share by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Products
  • TORCH Testing
    • Table 7-3: World Lab-Based TORCH Immunoassay Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 7-7: World Lab-Based TORCH Immunoassay Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 7-8: World Lab-Based TORCH Immunoassay Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
    • Figure 7-9: World Lab-Based TORCH Immunoassay Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Competitive Landscape
    • Market Participants
    • NowDiagnostics Inc.
    • Salignostics
    • Sekisui
    • Acon
    • Major Companies
    • Abbott
    • Beckman Coulter (Danaher)
    • bioMerieux
    • Church & Dwight
    • Roche
    • Siemens Healthineers

Chapter 8: Pap Smears

  • Introduction
  • Testing for Cervical Cancer
  • Trends
  • Pap Test Market
    • Table 8-1: World IVD Traditional Pap Test Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 8-1: World IVD Traditional Pap Test Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 8-2: World IVD Traditional Pap Test Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
    • Figure 8-3: World IVD Traditional Pap Test Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Competitive Landscape
    • BD (Becton Dickinson)
    • Hologic

Chapter 9: Autoimmune Disease

  • Introduction
  • Genetic Factors
  • Impact on Female Patients
  • Recent Developments
  • Female Autoimmune Lab-Based Immunoassay Market
    • Table 9-1: World Female Lab-Based Autoimmune Immunoassay Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 9-1: World Female Lab-Based Autoimmune Immunoassay Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 9-2: World Female Lab-Based Autoimmune Immunoassay Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World] ($ million)
    • Figure 9-3: World Female Lab-Based Autoimmune Immunoassay Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Competitive Landscape
    • Bio-Rad
    • Euroimmun (Revvity)
    • Thermo Fisher Scientific

Chapter 10: Bone Density Testing

  • Introduction
  • Alarming Rise in Osteoporosis
  • Propelling the Need for Measurement
  • Trends in DEXA and Competing Technologies
    • DEXA: The Gold Standard
    • Emerging Trends and Accessibility
  • Bone Densitometry Market
    • Table 10-1: World Bone Densitometry for Female Testing Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 10-1: World Bone Densitometry for Female Testing Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 10-2: World Bone Densitometry for Female Testing Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
    • Figure 10-3: World Bone Densitometry for Female Testing Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Competitive Landscape
    • DMS Imaging (European Medical Solutions)
    • GE HealthCare
    • Hologic

Chapter 11: Colposcopy

  • Introduction
  • Cervical Cancer Screening and Diagnosis
  • Trends
  • Colposcopy Systems Market
    • Table 11-1: World Colposcopy Systems Market Share, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 11-1: World Colposcopy Systems Market Share, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 11-2: World Colposcopy Systems Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
    • Figure 11-3: World Colposcopy Systems Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Competitive Landscape
    • Apgar Danmark A/S
    • CooperSurgical
    • Olympus

Chapter 12: Urinary Tract Infections

  • Introduction
  • Leading Cause of Morbidity and Death
  • Impact
  • Trends
  • Technological Advances Outpace Clinical Guidelines
  • Next-Generation Sequencing (NGS)
  • Multiplex PCR, qPCR
  • UTI Molecular Test Market
    • Table 12-1: World Molecular UTI Test Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 12-1: World Molecular UTI Test Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 12-2: World Molecular UTI Test Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
    • Figure 12-3: World Molecular UTI Test Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Competitive Landscape
    • Potential in Small Companies
    • Company Highlights
    • BioGX
    • Camtech
    • PathogenDx
    • Randox Laboratories
    • RayBiotech
    • Thermo Fisher Scientific

Chapter 13: Ovarian Cancer

  • Introduction
  • Types of Ovarian Cancer
  • CA-125
  • Trends
  • Multivariate Index Assays and Genomic Tests
  • Ovarian Cancer Biomarker Market
    • Table 13-1: World Ovarian Cancer Biomarkers Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 13-1: World Ovarian Cancer Biomarkers Market, by Region, 2024-2030 ($ million) [APAC, Europe, North America, Rest of World]
    • Figure 13-2: World Ovarian Cancer Biomarkers Market Share, by Region, 2024 (%) [APAC, Europe, North America, Rest of World]
    • Figure 13-3: World Ovarian Cancer Biomarkers Market Share, by Region, 2030 (%) [APAC, Europe, North America, Rest of World]
  • Competitive Landscape
    • Company Highlights
    • Abbott
    • Fujirebio
    • Illumina
    • Roche
    • Thermo Fisher Scientific
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