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

According to Mordor Intelligence, the infertility drugs market size was valued at USD 4.22 billion in 2025 and estimated to grow from USD 4.47 billion in 2026 to reach USD 5.93 billion by 2031, at a CAGR of 5.83% during the forecast period (2026-2031).

This report is Segmented by Drug Class (Gonadotropins, Selective Estrogen Receptor Modulators (SERMs), and More), Patient Gender (Female and Male), Route of Administration (Oral, and More), Distribution Channel (Hospital Pharmacies, and More), Geography (North America, Europe, Asia-Pacific, The Middle East and Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Infertility Drugs Market Trends and Insights

Rising Infertility Prevalence Worldwide

Roughly 186 million people live with infertility, and age-standardized prevalence now stands at 1,354.76 per 100,000 in males and 2,764.62 per 100,000 in females, trends linked to delayed childbearing, obesity and lifestyle factors. Asia-Pacific shows the sharpest rise, with secondary infertility surpassing primary infertility and polycystic ovary syndrome (PCOS) acting as a pivotal demand driver. In low-income markets, ART costs exceed 200% of GDP per capita, underscoring untapped demand once health financing improves. Urbanization and shifting career priorities lengthen the window for family planning, embedding infertility therapy in mainstream care pathways. Epidemiological projections anticipate higher infertility incidence through 2036, ensuring sustained need for pharmacologic interventions worldwide.

Increasing Government and Private Reimbursement Support

All EU member states now subsidize at least one IVF cycle, and five nations fund up to six cycles. California's Senate Bill 729 will compel large-group insurers to cover fertility treatments from July 2025, with small-group plans required to offer coverage options. In the corporate sector, partnerships such as Cigna Healthcare with Progyny offer bundled fertility journeys, reducing out-of-pocket costs from USD 15,000-30,000 to more affordable co-pay levels. Reimbursement expansion across the United States and Europe is steering patient volumes into covered channels and reinforcing the growth of the infertility drugs market.

High Treatment Costs and Limited Insurance Coverage

IVF medication prices rose 84% over the past decade, reaching USD 1,279 per cycle and accounting for 35% of total IVF costs, a burden that excludes many low-income patients. Average European IVF cycles cost EUR 4,000-5,000 (USD 4,300-5,400), while public wait lists can stretch to one year in several countries. In low-income regions, ART exceeds 200% of GDP per capita, rendering treatment out of reach. Although biosimilars and insurer mandates are lowering barriers, affordability remains a pivotal short-term restraint for the infertility drugs market.

Other drivers and restraints analyzed in the detailed report include:

1. Advancements in Biosimilar and Novel Hormonal Formulations
2. Expanding Access to Fertility Services in Emerging Markets
3. Stringent and Divergent Regulatory Approval Pathways

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

Segment Analysis

Gonadotropins retained 43.78% infertility drugs market share in 2025, supported by entrenched IVF protocols and physician familiarity. Organon's Follistim AQ recorded USD 63 million in Q3 2024, a 16% rise year-over-year, illustrating robust baseline demand. Nevertheless, aromatase inhibitors are gaining traction; letrozole's superior ovulation and live-birth rates have spurred an 8.05% CAGR forecast through 2031. Evidence from randomized trials showing a 13% higher ovulation rate versus clomiphene is accelerating guideline revisions.

Second-tier classes remain relevant. Selective estrogen receptor modulators continue to anchor first-line treatment in resource-constrained settings. Biguanides, particularly metformin, are prescribed adjunctively to improve metabolic parameters in PCOS, though they represent a small revenue slice. Dopamine agonists like cabergoline prevent ovarian hyperstimulation syndrome; comparative trials indicate equivalent efficacy to hydroxychloroquine with better tolerability. As dosing research evolves-sequential 2.5 mg letrozole/FSH protocols have achieved 72.7% cumulative pregnancy versus 59.1% for 5 mg regimens-the infertility drugs market is expected to tilt further toward targeted, lower-dose options.

Female indications generated 70.76% of 2025 revenue owing to established clinical pathways and broader drug labels. Demand remains solid for ovulation-induction agents as delayed motherhood becomes common in developed economies. The male segment, however, is catching up with an 8.62% CAGR to 2031, driven by increased screening and destigmatization. Ferring Pharmaceuticals teamed with Posterity Health to roll out a Male Fertility Program, acknowledging that male factors contribute to half of infertility cases.

Therapeutic advances bolster this growth. Weekly low-dose letrozole restored fertility in 12 obese men with hypogonadotropic hypogonadism in a Canadian cohort pilot. Oxidative stress management is another frontier, as antioxidants target the 20-30% of male infertility linked to reactive oxygen species. Bioactive compounds such as resveratrol and curcumin are being explored for patients facing cancer-therapy infertility, especially prepubertal males unable to bank sperm. Simultaneous couple evaluation protocols are shifting prescribing patterns to encompass both partners, expanding the addressable pool for the infertility drugs market.

Complete Report Scope:

• By Drug Class
  • Gonadotropins
  • Selective Estrogen Receptor Modulators (SERMs)
  • Aromatase Inhibitors
  • Biguanides (Metformin)
  • Dopamine Agonists
  • Other Drug Classes
• By Patient Gender
  • Female
  • Male
• By Route Of Administration
  • Oral
  • Injectable (SC / IM)
  • Transdermal / Intranasal
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online & Specialty Pharmacies
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 35.12% of global revenue in 2025, anchored by insurance mandates and well-resourced IVF centers. California's upcoming coverage law is expected to add more than 2 million insured lives to the fertility cohort, reinforcing demand momentum. Corporate benefit packages, typified by Cigna-Progyny bundles, are reshaping employer offerings for millennial and Gen-Z workforces.

The Asia-Pacific region is the fastest-growing geography at a 7.18% CAGR through 2031. Declining birth rates in China, Japan and South Korea spur government support for ART, while nations such as Thailand and Malaysia compete for medical tourists. Single-injection rhFSH-CTP trials in Chinese women show clinical parity to western protocols, demonstrating home-grown research strength. Price differentials-USD 10,200 per IVF cycle in Singapore versus USD 2,700 in India-are channeling cross-border patient flows, expanding the infertility drugs market across ASEAN.

Europe presents a mature but still expanding landscape. All EU states now fund at least one IVF cycle, yet only five provide up to six fully reimbursed cycles, driving patients into private clinics to avoid long wait times. Middle East & Africa's pharmaceutical spend rose to USD 32.6 billion in 2024, but infertility care remains nascent. Demographic infertility in MENA reaches 22.6%, signaling strong future upside if regulatory and financing frameworks improve iqvia.com. South America is at an earlier stage but is seeing rising ART uptake as Brazil, Argentina and Chile expand public financing.

1. Merck
2. Ferring Pharmaceuticals
3. Pfizer
4. Bayer
5. Novartis
6. Teva Pharmaceutical Industries
7. Theramex
8. Mankind Pharma
9. Livzon Pharmaceutical
10. Organon
11. ASKA Pharmaceutical
12. Zydus Lifesciences
13. Gedeon Richter PLC
14. Ipsen
15. Sun Pharmaceuticals Industries
16. Cipla
17. Myovant Sciences

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 Infertility Prevalence Worldwide
  • 4.2.2 Growing Adoption of Assisted Reproductive Technologies
  • 4.2.3 Increasing Government and Private Reimbursement Support
  • 4.2.4 Advancements in Biosimilar and Novel Hormonal Formulations
  • 4.2.5 Expanding Access to Fertility Services in Emerging Markets
• 4.3 Market Restraints
  • 4.3.1 High Treatment Costs and Limited Insurance Coverage
  • 4.3.2 Stringent and Divergent Regulatory Approval Pathways
  • 4.3.3 Social, Ethical, and Cultural Barriers to Treatment Acceptance
  • 4.3.4 Drug Safety Concerns Including Ovarian Hyperstimulation Risk
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Bargaining Power Of Suppliers
  • 4.7.2 Bargaining Power Of Buyers
  • 4.7.3 Threat Of New Entrants
  • 4.7.4 Threat Of Substitute Products
  • 4.7.5 Intensity Of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Drug Class
  • 5.1.1 Gonadotropins
  • 5.1.2 Selective Estrogen Receptor Modulators (SERMs)
  • 5.1.3 Aromatase Inhibitors
  • 5.1.4 Biguanides (Metformin)
  • 5.1.5 Dopamine Agonists
  • 5.1.6 Other Drug Classes
• 5.2 By Patient Gender
  • 5.2.1 Female
  • 5.2.2 Male
• 5.3 By Route Of Administration
  • 5.3.1 Oral
  • 5.3.2 Injectable (SC / IM)
  • 5.3.3 Transdermal / Intranasal
• 5.4 By Distribution Channel
  • 5.4.1 Hospital Pharmacies
  • 5.4.2 Retail Pharmacies
  • 5.4.3 Online & Specialty Pharmacies
• 5.5 Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 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 Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
  • 6.3.1 Merck KGaA
  • 6.3.2 Ferring Pharmaceuticals Inc
  • 6.3.3 Pfizer, Inc.
  • 6.3.4 Bayer AG
  • 6.3.5 Novartis AG
  • 6.3.6 Teva Pharmaceuticals Industries
  • 6.3.7 Theramex
  • 6.3.8 Mankind Pharma
  • 6.3.9 Livzon Pharmaceutical
  • 6.3.10 Organon & Co.
  • 6.3.11 ASKA Pharmaceutical
  • 6.3.12 Zydus Lifesciences
  • 6.3.13 Gedeon Richter PLC
  • 6.3.14 Ipsen Pharma
  • 6.3.15 Sun Pharma
  • 6.3.16 Cipla Ltd.
  • 6.3.17 Myovant Sciences

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment