남성 불임 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the male infertility market size is expected to grow from USD 4.10 billion in 2025 to USD 4.25 billion in 2026 and is forecast to reach USD 5.08 billion by 2031 at 3.65% CAGR over 2026-2031.

This report is Segmented by Test Type (Conventional Semen Analysis, CASA, and More), Treatment (Medication & Hormone Therapy, ART, and More), Product (Diagnostic Kits & Devices, Therapeutic Drugs, ART Equipment), Distribution Channel (Hospitals & Fertility Clinics, Diagnostic Centres, and More), End User (Fertility Clinics, and More), and Geography. The Market Forecasts are Provided in Terms of Value (USD).

Global Male Infertility Market Trends and Insights

Rising Global Infertility Prevalence in Men

Meta-analysis confirms sperm concentration has fallen 1.2% yearly since 1973 and the decline accelerated after 2000 across Africa, Asia and South America. Environmental endocrine disruptors and lifestyle factors such as obesity are linked to poorer motility and DNA integrity, while the median paternal age now exceeds 32 years in most OECD nations. The wider age window for first-time fatherhood overlaps cumulative toxicant exposure, enlarging the male infertility market. Diagnosis still trails prevalence because stigma delays testing by three to five years in many countries.

Growth of Employer-Funded Fertility Benefits

A quarter of large United States employers paid for in-vitro fertilization by late 2024 and federal guidance issued in 2025 clarified that certain diagnostics are excepted benefits under the Affordable Care Act, removing regulatory ambiguity. Plans usually cap lifetime benefits between USD 15,000 and USD 25,000, insufficient for multiple cycles, and often exclude advanced male diagnostics, pushing out-of-pocket spending. European companies are following Germany's model of partial reimbursement, encouraging platform providers to negotiate bundled laboratory services, which realigns referral patterns and raises the profile of male factor testing.

High Out-of-Pocket Costs and Uneven Reimbursement

In the United States a single intracytoplasmic sperm injection cycle costs USD 15,000-30,000, and fewer than 20% of commercial plans pay the full amount. Advanced male diagnostics add USD 1,000-2,500 and are seldom reimbursed. Public systems in France or Israel fund most ART, while India covers fewer than 10% of eligible couples. The funding gap forces 42% of couples into debt greater than USD 10,000, and 28% abandon therapy altogether.

Other drivers and restraints analyzed in the detailed report include:

1. Rapid Adoption of At-Home Digital Semen Testing
2. AI-Enabled Sperm Selection Improving ART Success
3. Limited Specialist Workforce and Laboratory Infrastructure

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Conventional semen analysis held 42.18% sector revenue in 2025 yet the sub-segment of genetic and epigenetic panels is growing at 5.22% CAGR through 2031, outpacing all other tests. Falling sequencing costs now allow identification of Y-chromosome deletions or CFTR variants in under 48 hours for less than USD 1,000. Computer-assisted systems equipped with AI tracking reduce technician variability and push laboratories toward standardized protocols. DNA fragmentation assays, although unstandardized today, are adopted in clinics managing recurrent implantation failure, a pattern that hints at future reimbursement when ISO guidance arrives in 2027. Oxidative stress testing and acrosome reaction assays remain niche, limited to research settings. The male infertility market therefore continues to hinge on basic microscopy while transitioning toward molecular diagnostics that promise higher predictive power.

Laboratory-developed genetic tests now fall under the United States Food and Drug Administration's May 2024 rule that expands pre-market review, increasing compliance costs for small stand-alone centers. National health systems diverge on coverage; France reimburses genetic workups after two failed IVF attempts, while most U.S. plans demand abnormal conventional results first, delaying access. These discrepancies influence the male infertility market size for advanced diagnostics, with Asia-Pacific labs adopting multiplex panels faster due to large urban patient pools and commercial pay models.

Assisted reproductive technology commanded 55.21% of segment revenue in 2025 because intracytoplasmic sperm injection is applied in more than 70% of global IVF cycles. Medication and hormone therapy, however, is expanding at 4.65% CAGR as urologists prescribe clomiphene citrate or letrozole to men with idiopathic oligospermia. A 2024 randomized trial showed clomiphene improved concentration by 8.4 million/mL and led to natural pregnancy in 32% of partners. Recombinant follicle-stimulating hormone remains limited to hypogonadotropic cases but biosimilars are reducing prices in Europe.

Microsurgical varicocelectomy retains a role for clinically palpable lesions, yet American Urological Association guidelines of 2024 limit surgery for subclinical cases. Lifestyle interventions and antioxidant supplements stay fragmented with limited high-quality evidence. Pipeline gene therapy candidates may shift the male infertility market share beyond 2030 if efficacy and safety hold, but current uptake is confined to clinical trials.

Geography Analysis

North America generated 38.25% of global revenue in 2025, supported by eleven United States states and the District of Columbia mandating infertility coverage and more than 450 Society for Assisted Reproductive Technology registered clinics. Rising employer benefits and early adoption of AI-enabled equipment sustain stable growth but reimbursement gaps restrain broader male testing.

Asia-Pacific is the fastest growing region at 5.68% CAGR through 2031. China cut review timelines for imported ART devices to nine months in 2024 and several provinces added male diagnostics to provincial insurance lists. India's ART Act spurred a 22% uptick in licensed centers by 2025 yet public funding remains limited, steering demand to private providers. Urban centers in South Korea, Japan and Australia add volume through aging parental demographics, helping the male infertility market outpace global averages.

Europe stands as the second largest region; France now funds ART for single women and same-sex couples, boosting partner screening volumes, while Germany reimburses 50% of ART cost for married couples under 40. The Middle East and Africa trail other regions due to workforce shortages; South Africa handles over 60% of Sub-Saharan cycles, and Dubai clinics draw international clients. Latin America sees growing cross-border traffic as patients bypass limited public capacity in Brazil and Argentina by traveling to the United States.

1. AdvaCare
2. Andrology Solutions
3. Aytu BioScience
4. Caerus Biotech
5. CinnaGen
6. The Cooper Companies
7. Ferring International
8. Genea Biomedx
9. Halotech DNA
10. Hamilton Thorne
11. Intas Pharmaceuticals
12. LabCorp
13. Legacy
14. Merck
15. Microptic S.L.
16. MotilityCount (SwimCount)
17. Posterity Health
18. Vitrolife
19. Zydus Lifesciences

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising global infertility prevalence in men
  • 4.2.2 Growth of employer-funded fertility benefits
  • 4.2.3 Rapid adoption of at-home digital semen testing
  • 4.2.4 AI-enabled sperm-selection improving ART success
  • 4.2.5 Government infertility?insurance mandates in new geographies
  • 4.2.6 Pipeline gene- and cell-based therapies for spermatogenic failure
• 4.3 Market Restraints
  • 4.3.1 High out-of-pocket costs & uneven reimbursement
  • 4.3.2 Limited specialist workforce & lab infrastructure in LMICs
  • 4.3.3 Social stigma deterring male testing in key cultures
  • 4.3.4 Absence of globally-standardised advanced diagnostic protocols
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Test Type
  • 5.1.1 Conventional Semen Analysis
  • 5.1.2 Computer-Assisted Semen Analysis (CASA)
  • 5.1.3 DNA Fragmentation Tests
  • 5.1.4 Oxidative Stress Analysis
  • 5.1.5 Genetic & Epigenetic Panels
  • 5.1.6 Other Test Types
• 5.2 By Treatment
  • 5.2.1 Medication & Hormone Therapy
  • 5.2.2 Assisted Reproductive Technology (IVF, ICSI)
  • 5.2.3 Varicocele & Microsurgical Procedures
  • 5.2.4 Lifestyle, Supplements & Counselling
• 5.3 By Product
  • 5.3.1 Diagnostic Kits & Devices
  • 5.3.2 Therapeutic Drugs
  • 5.3.3 ART Equipment & Disposables
• 5.4 By Distribution Channel
  • 5.4.1 Hospitals & Fertility Clinics
  • 5.4.2 Diagnostic Centres
  • 5.4.3 At-home Testing / DTC Platforms
  • 5.4.4 Online & Retail Pharmacies
• 5.5 By End User
  • 5.5.1 Fertility Clinics
  • 5.5.2 Hospitals
  • 5.5.3 Diagnostic Laboratories
  • 5.5.4 Home-care Users
• 5.6 Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 India
    • 5.6.3.3 Japan
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 AdvaCare Pharma
  • 6.3.2 Andrology Solutions
  • 6.3.3 Aytu BioScience
  • 6.3.4 Caerus Biotech
  • 6.3.5 CinnaGen Co.
  • 6.3.6 CooperSurgical
  • 6.3.7 Ferring International
  • 6.3.8 Genea Biomedx
  • 6.3.9 Halotech DNA
  • 6.3.10 Hamilton Thorne
  • 6.3.11 Intas Pharmaceuticals
  • 6.3.12 LabCorp
  • 6.3.13 Legacy
  • 6.3.14 Merck KGaA (EMD Serono)
  • 6.3.15 Microptic S.L.
  • 6.3.16 MotilityCount (SwimCount)
  • 6.3.17 Posterity Health
  • 6.3.18 Vitrolife AB
  • 6.3.19 Zydus Lifesciences

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment