미국의 불임 진단 시장 규모, 점유율, 동향 분석 보고서 : 시술 유형별, 기술 유형별, 임상 현장별, 지역별 및 부문별 예측(2026-2033년)

U.S. Fertility Diagnostic Market Summary

The U.S. fertility diagnostic market size was valued at USD 1.07 billion in 2025 and is projected to reach USD 1.92 billion by 2033, growing at a CAGR of 7.6% from 2026 to 2033. The rise in infertility and high rate of identifiable causes are key factors driving the U.S. market for fertility diagnostics.

In addition, the increasing emphasis on comprehensive diagnostic evaluations is supporting the continued growth and technological advancement of fertility diagnostic solutions. The section below outlines key market factors such as research and development and trends shaping the fertility diagnostic market. It reflects technological advancements, the impact of demographics, and other factors that are strengthening diagnostic capabilities, improving early infertility detection, and expanding access to advanced fertility testing solutions across the U.S.

U.S. Fertility Diagnostic Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. fertility diagnostic market report based on procedure type, technology, clinical setting, and region.

• Procedure Type Outlook (Revenue, USD Billion, 2021 - 2033)
• X-ray-Based Tubal Patency Testing
• Ultrasound-Based Tubal Patency Testing
  • HyCoSy (Hysterosalpingo-Contrast Sonography)
  • HyFoSy (Hysterosalpingo-Foam Sonography)
  • Others
• Proprietary Controlled Contrast Systems Subdermal Implants
• Structural & Morphologic Imaging
• Others
• Technology Outlook (Revenue, USD Billion, 2021 - 2033)
• X-Ray-Based Technologies
• Ultrasound-Based Technologies
• Proprietary Diagnostic Devices
• Clinical Setting Outlook (Revenue, USD Billion, 2021 - 2033)
• Fertility & Reproductive Medicine Clinics
• Gynecology / Women's Health Practices
• Radiology & Imaging Centers
• Hospital Outpatient Departments
• Others
• Region Outlook (Revenue, USD Million, 2021 - 2033)
• West
• Southwest
• Southeast
• Midwest
• Northeast

Table of Contents

Chapter 1 Report Scope & Research Methodology

• 1.1 Market Segmentation
  • 1.1.1 Segment Definition
    • 1.1.1.1 Procedure Type
    • 1.1.1.2 Technology type
    • 1.1.1.3 Clinical setting
• 1.2 Estimates and Forecast Timeline
• 1.3 Research Methodology
  • 1.3.1 Information Procurement
  • 1.3.2 Purchased Database 16
  • 1.3.3 GVR's Internal Database
  • 1.3.4 Secondary Sources
  • 1.3.5 Primary Research
  • 1.3.6 Details Of Primary Research
• 1.4 Information or Data Analysis
  • 1.4.1 Data Analysis Models
• 1.5 Market Formulation & Validation
• 1.6 Model Details
  • 1.6.1 Three Pillars of Market Estimation
    • 1.6.1.1 Secondary market research
    • 1.6.1.2 Primary market intelligence
      • 1.6.1.2.1 In-depth interviews (IDIs)
      • 1.6.1.2.2 Online survey program
  • 1.6.2 Market Modeling & Forecasting
    • 1.6.2.1 Model 1: Procedure Type volume analysis
    • 1.6.2.2 Model 2: Technology adoption allocation
    • 1.6.2.3 Model 3: Device utilization modeling
    • 1.6.2.4 Model 4: Revenue estimation (Volume X Price)
    • 1.6.2.5 Top-down validation (Manufacturer revenue benchmarking)
    • 1.6.2.6 CAGR/forecasting calculations & assumptions
      • 1.6.2.6.1 Key forecasting drivers and weights
      • 1.6.2.6.2 Scenario framework (2026 - 2033)
      • 1.6.2.6.3 Factor-based impact assessment
• 1.7 List of Secondary Sources
• 1.8 List of Abbreviations
• 1.9 Research Objectives
  • 1.9.1 Objective - 1
  • 1.9.2 Objective - 2
  • 1.9.3 Objective - 3

Chapter 2 Executive Summary

• 2.1 Market Snapshot
• 2.2 Procedure Type and Technology Type Snapshot
• 2.3 Clinical Setting Snapshot
• 2.4 Competitive Landscape Snapshot

Chapter 3 Market Variables, Trends & Scope

• 3.1 Market Dynamics
  • 3.1.1 Market Driver Analysis
    • 3.1.1.1 Delayed parenthood and changing demographics
      • 3.1.1.1.1 Case study published by the U.S. Census Bureau in January 2026: Reducing U.S. population growth and its implications for the fertility diagnostic market
    • 3.1.1.2 Rising prevalence of infertility
    • 3.1.1.3 Growth of assisted reproductive technologies (ART)
      • 3.1.1.3.1 Case study published in Gray Local Media Station in February 2026: Expansion of IVF clinics to meet rising ART demand in the U.S.
  • 3.1.2 Market Restraint Analysis
    • 3.1.2.1 High costs and limited reimbursement
    • 3.1.2.2 Technological and data integration challenges
  • 3.1.3 Market Opportunity Analysis
    • 3.1.3.1 At home & point of care diagnostic solutions
    • 3.1.3.2 Expansion of male fertility diagnostics
  • 3.1.4 Market Challenge Analysis
    • 3.1.4.1 Regulatory complexity & approval delays
• 3.2 Fertility Diagnostic Products: Regulatory Framework and Reimbursement Scenario
• 3.3 Technology Landscape
  • 3.3.1 Case study published by the National Library of Medicine in March 2024: accuracy of Hystero-Salpingo-Foam Sonography (Hyfosy) for tubal patency testing
• 3.4 Industry Analysis Tools
  • 3.4.1 Porter's Five Forces Analysis
  • 3.4.2 Pestle Analysis

Chapter 4 U.S. Infertility Market Analysis

• 4.1 U.S. Infertility Market, 2021 - 2033 (USD Billion)
• 4.2 Prevalence/Incidence of Infertility in the U.S., by Gender, 2025
• 4.3 Impact of Infertility Prevalence/Incidence on Demand for Fertility Diagnostics
  • 4.3.1 Case study published by National Library of Medicine: impact of infertility prevalence on demand for fertility diagnostics
  • 4.3.2 Case study published by Raveco Medical in September 2025: importance of early infertility evaluation and its impact on fertility diagnostics demand

Chapter 5 U.S. Fertility Diagnostic Market: TAM, SAM, and SOM Analysis

• 5.1 Total Addressable Market (TAM) Analysis, 2021 to 2033 (USD Billion)
• 5.2 Serviceable Addressable Market (SAM) Analysis, 2021 to 2033 (USD Billion)
• 5.3 Serviceable Obtainable Market (SOM) Analysis, 2021 to 2033 (USD Billion)

Chapter 6 U.S. Fertility Diagnostic Market: Procedure Type Estimates & Trend Analysis

• 6.1 U.S. Fertility Diagnostic Market: Procedure Type Segment Dashboard
• 6.2 Procedure Type Movement & Market Share Analysis, 2025 & 2033
• 6.3 U.S. Fertility Diagnostic Market Estimates & Forecasts, By Procedure Type, 2021 - 2033 (USD Million)
  • 6.3.1 X-Ray-Based Tubal Patency Testing
    • 6.3.1.1 X-ray-based tubal patency testing market, 2021 - 2033 (USD Million)
    • 6.3.1.2 X-ray-based tubal patency testing market, 2021 - 2033 (Annual procedure type estimates in thousands)
  • 6.3.2 Ultrasound-Based Tubal Patency Testing
    • 6.3.2.1 Ultrasound-based tubal patency testing market, 2021 - 2033 (USD Million)
    • 6.3.2.2 Ultrasound-based tubal Patency testing market, 2021 - 2033 (Annual procedure type estimates in thousands)
    • 6.3.2.3 HyCoSy (hysterosalpingo-contrast sonography)
      • 6.3.2.3.1 HyCoSy (hysterosalpingo-contrast sonography) market, 2021 - 2033 (USD Million)
      • 6.3.2.3.2 HyCoSy (hysterosalpingo-contrast sonography) market, 2021 - 2033 (Annual Procedure Type Estimates in Thousands)
    • 6.3.2.4 HyFoSy (hysterosalpingo-foam sonography)
      • 6.3.2.4.1 HyFoSy (hysterosalpingo-foam sonography) market, 2021 - 2033 (USD Million)
      • 6.3.2.4.2 HyFoSy (hysterosalpingo-foam sonography) market, 2021 - 2033 (Annual procedure type estimates in thousands)
    • 6.3.2.5 Others
      • 6.3.2.5.1 Others market, 2021 - 2033 (USD Million)
      • 6.3.2.5.2 Other markets, 2021 - 2033 (Annual procedure type estimates in thousands)
  • 6.3.3 Proprietary Controlled Contrast Systems
    • 6.3.3.1 Proprietary controlled contrast systems market, 2021 - 2033 (USD Million)
    • 6.3.3.2 Proprietary controlled contrast systems market, 2021 - 2033 (Annual procedure type estimates in thousands)
  • 6.3.4 Structural & Morphologic Imaging
    • 6.3.4.1 Structural & morphologic imaging market, 2021 - 2033 (USD Million)
    • 6.3.4.2 Structural & morphologic imaging market, 2021 - 2033 (Annual procedure type estimates in thousands)
  • 6.3.5 Others
    • 6.3.5.1 Others market, 2021 - 2033 (USD Million)
    • 6.3.5.2 Other markets, 2021 - 2033 (Annual procedure type estimates in thousands)

Chapter 7 U.S. Fertility Diagnostic Market: Technology Type Estimates & Trend Analysis

• 7.1 U.S. Fertility Diagnostic Market: Technology Type Segment Dashboard
• 7.2 Technology Type Movement & Market Share Analysis, 2025 & 2033
• 7.3 U.S. Fertility Diagnostic Market Estimates & Forecasts, By Technology Type, 2021 - 2033 (USD Million)
  • 7.3.1 X-Ray-Based Technologies
    • 7.3.1.1 X-ray-based technologies market, 2021 - 2033 (USD Million)
  • 7.3.2 Ultrasound-Based Technologies
    • 7.3.2.1 Ultrasound-based technologies market, 2021 - 2033 (USD Million)
  • 7.3.3 Proprietary Diagnostic Devices
    • 7.3.3.1 Proprietary diagnostic devices market, 2021 - 2033 (USD Million)

Chapter 8 U.S. Fertility Diagnostic Market: Clinical Setting Estimates & Trend Analysis

• 8.1 U.S. Fertility Diagnostic Market: Clinical Setting Segment Dashboard
• 8.2 Clinical Setting Movement & Market Share Analysis, 2025 & 2033
• 8.3 U.S. Fertility Diagnostic Market Estimates & Forecasts, By Clinical Setting, 2021 - 2033 (USD Million)
  • 8.3.1 Fertility & Reproductive Medicine Clinics
    • 8.3.1.1 Fertility & reproductive medicine clinics market, 2021 - 2033 (USD Million)
  • 8.3.2 Gynecology / Women's Health Practices
    • 8.3.2.1 Gynecology / women's health practices market, 2021 - 2033 (USD Million)
  • 8.3.3 Radiology & Imaging Centers
    • 8.3.3.1 Radiology & imaging centers market, 2021 - 2033 (USD Million)
  • 8.3.4 Hospital Outpatient Departments
    • 8.3.4.1 Hospital outpatient departments market, 2021 - 2033 (USD Million)
  • 8.3.5 others
    • 8.3.5.1 Others market, 2021 - 2033 (USD Million)

Chapter 9. U.S. Fertility Diagnostic Market: Region Estimates & Trend Analysis

• 9.1 U.S. Fertility diagnostic Market: Region Movement Analysis
• 9.2. U.S. Fertility Diagnostic Market: Region Segment Dashboard
• 9.3. Region Movement & Market Share Analysis, 2025 & 2033
• 9.4. U.S. Fertility Diagnostic Market Estimates & Forecast, by Region
• 9.5. West
  • 9.5.1. West Market, 2021 - 2033 (USD Million)
• 9.6. Southeast
  • 9.6.1. Southeast Market, 2021 - 2033 (USD Million)
• 9.7. Southwest
  • 9.7.1. Southwest Market, 2021 - 2033 (USD Million)
• 9.8. Midwest
  • 9.8.1. Midwest Market, 2021 - 2033 (USD Million)
• 9.9. Northeast
  • 9.9.1. Northeast Market, 2021 - 2033 (USD Million)

Chapter 10 U.S. Fertility Diagnostic Market Competitive Landscape

• 10.1 Participants' Overview
• 10.2 Financial Performance
• 10.3 Product Benchmarking
  • 10.3.1 Gedeon Richter
    • 10.3.1.1. Overview
    • 10.3.1.2. Financial Performance
    • 10.3.1.3 Product Benchmarking
      • 10.3.1.3.1 Sonography
  • 10.3.2 Femvue (Femasys Inc.)
    • 10.3.2.1. Overview
    • 10.3.2.2. Financial Performance
    • 10.3.2.3 Product Benchmarking
      • 10.3.2.3.1 Tube testing
  • 10.3.3 Thomas Medical (MedGyn)
    • 10.3.3.1. Overview
    • 10.3.3.2. Financial Performance
    • 10.3.3.3 Product Benchmarking
      • 10.3.3.3.1 Infertility care
  • 10.3.4 Koninklijke Philips N.V.
    • 10.3.4.1. Overview
    • 10.3.4.2. Financial Performance
    • 10.3.4.3 Product Benchmarking
      • 10.3.4.3.1 Gynecology ultrasound
  • 10.3.5 Ge Healthcare
    • 10.3.5.1. Overview
    • 10.3.5.2. Financial Performance
    • 10.3.5.3 Product Benchmarking
      • 10.3.5.3.1 Ultrasound
  • 10.3.6 Samsung Healthcare
    • 10.3.6.1. Overview
    • 10.3.6.2. Financial Performance
    • 10.3.6.3 Product Benchmarking
      • 10.3.6.3.1 Reproductive endocrinology and infertility
  • 10.3.7 Cooper Surgical, Inc.
    • 10.3.7.1. Overview
    • 10.3.7.2. Financial Performance
    • 10.3.7.3 Product Benchmarking
      • 10.3.7.3.1. Andrology testing
      • 10.3.7.3.2 Embryo assessment diagnostics
      • 10.3.7.3.3 Hormone & biochemical fertility testing
      • 10.3.7.3.4 Milex support pessaries
  • 10.3.8 Mindray Ds Usa, Inc.
    • 10.3.8.1. Overview
    • 10.3.8.2. Financial Performance
    • 10.3.8.3 Product Benchmarking
      • 10.3.8.3.1 Ultrasound solutions
      • 10.3.8.3.2 In vitro diagnostics
  • 10.3.9 Vio Healthtech Inc
    • 10.3.9.1 OvuSense tracker
    • 10.3.9.1. Overview
    • 10.3.9.2. Financial Performance
    • 10.3.9.3 Product Benchmarking
      • 10.3.9.3.1 Ovusensor tracker.
  • 10.3.10 Fujifilm Sonosite, Inc.
    • 10.3.10.1. Overview
    • 10.3.10.2. Financial Performance
    • 10.3.10.3 Product Benchmarking
      • 10.3.10.3.1 Portable ultrasound machines
  • 10.3.11 Olympus
    • 10.3.11.1. Overview
    • 10.3.11.2. Financial Performance
    • 10.3.11.3 Product Benchmarking
      • 10.3.11.3.1 Microscopes & others
  • 10.3.12 Canon Medical Systems
    • 10.3.12.1. Overview
    • 10.3.12.2. Financial Performance
    • 10.3.12.3 Product Benchmarking
      • 10.3.12.3.1 Ultrasound
  • 10.3.13 Stryker
    • 10.3.13.1. Overview
    • 10.3.13.2. Financial Performance
    • 10.3.13.3 Product Benchmarking
    • 10.3.13.4 Imaging systems
• 10.4 Participant Categorization
• 10.5 Company Market Position Analysis, 2025
• 10.6 Company Market Share Analysis, by Procedure Type, 2025
• 10.7 Strategy Mapping
  • 10.7.1 New Product Launch
  • 10.7.2 Mergers & Acquisitions
  • 10.7.3 Partnership & Collaboration
  • 10.7.4 Market Expansion
  • 10.7.5 Product Approvals