Female infertility is typically defined as the inability to achieve pregnancy after one year of attempting conception. A wide range of factors may cause female infertility, such as age, obesity, type 2 diabetes, and endometriosis. As such, there are numerous avenues to help these patients successfully conceive, including pharmacologic agents such as clomiphene citrate and follicle-stimulating hormone (e.g., Merck KGaA's Gonal F), as well as assisted reproductive technologies including in vitro fertilization. Thus, patient-specific considerations are often needed to determine the optimal plan for initiation of treatment. Pipeline agents (e.g., ObsEva’s nolasiban) are seeking to capitalize on unmet need for improving pregnancy rates, particularly for patients undergoing assisted reproductive technology-based procedures.


  • How large is the prevalent population of females patients suffering from infertility?
  • What are the most common causes of female infertility? Is this expected to change in the next 10 years?
  • What are current treatment options for female infertility? How do reproductive endocrinologists approach different underlying causes of female infertility?
  • What unmet needs remain for the treatment of different drivers of infertility?
  • What are the most promising pipeline agents? How do experts believe these will fit into future treatment paradigms?


Niche & Rare Disease Landscape & Forecast provides comprehensive market intelligence providing world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.


July 2018


United States and EU5


  • Six country-specific interviews with thought-leading reproductive endocrinologists
  • Supported by survey data collected for this study


Total, diagnosed, and drug-treated prevalent cases of female infertility by country, total prevalent cases by etiology, number of procedures due to female infertility


Drug-level sales and patient share of key female infertility therapies in 2027


Phase III/PR: 1 drugs. Phase II: 2 drugs. Coverage of select preclinical and Phase I products.

Table of contents

  • Female Infertility - Landscape And Forecast - Disease Landscape And Forecast
    • Commercial Outlook
      • Key Findings
        • Regional Sales of Key Therapies to Treat Female Infertility in 2027
        • Female Infertility SWOT Analysis
      • Drivers and Constraints
        • What Factors Are Driving Sales in Female Infertility?
        • What Factors Are Constraining Sales in Female Infertility?
      • Segment-Specific Trends
        • Estrogen Modulators
        • Gonadotropins
        • Oxytocin Receptor Modulators
    • Forecast
      • Sales of Key Therapies in Female Infertility
    • Etiology and Pathophysiology
      • Disease Overview
        • Etiology
          • Pathophysiology
            • Key Pathways and Drug Targets
            • Epidemiology
              • Key Findings
                • Epidemiology Populations
                  • Disease Definition
                  • Methods
                  • Sources Used for Prevalence of Female Infertility
                  • Total Prevalent Cases of Female Infertility: 2017-2027
                  • Diagnosed Prevalent Cases of Female Infertility: 2017-2027
                  • Drug-Treated Prevalent Cases of Female Infertility: 2017-2027
              • Current Treatment
                • Key Findings
                  • Diagnosis
                    • Components of Routine Examination for the Diagnosis and Etiology Classification of Female Infertility
                    • Treatment Providers and Referral Patterns
                    • Expert Insight: Diagnosis of Female Infertility
                  • Treatment Goals
                    • Key End Points Used in Clinical Trials for Female Infertility
                  • Key Current Therapies
                    • Overview
                    • Mechanism of Action of Key Current Drug Classes Used for Female Infertility
                    • Current Treatments Used for Female Infertility
                    • Clinical Trial Outcomes for Clomiphene
                    • Advantages and Disadvantages of Clomiphene
                    • Expert Insight: Clomiphene
                    • Letrozole
                    • Clinical Trial Outcomes for Letrozole
                    • Advantages and Disadvantages of Letrozole
                    • Expert Insight: Letrozole
                    • Clinical Trial Outcomes for Gonadotropins
                    • Advantages and Disadvantages of Gonadotropins
                    • Expert Insight: Gonadotropins
                    • Clinical Trial Outcomes for GnRH Modulators
                    • Advantages and Disadvantages of Gonadotropin-Releasing Hormone Modulators
                    • Expert Insight: GnRH Modulators
                    • Clinical Trial Outcomes for Dopamine Agonists
                    • Advantages and Disadvantages of Dopamine Agonists
                    • Expert Insight: Dopamine Agonists
                    • Clinical Trial Outcomes for Antidiabetics
                    • Advantages and Disadvantages of Antidiabetics
                    • Expert Insight: Antidiabetics
                  • Medical Practice
                    • Overview
                    • Treatment Guidelines
                    • Female Infertility Treatment Guidelines
                    • Factors Influencing Drug Selection in Female Infertility
                    • Generalized Treatment Decision Tree for Female Infertility
                • Unmet Need Overview
                  • Current and Future Attainment of Unmet Needs in Female Infertility
                  • Top Unmet Needs in Female Infertility: Current and Future Attainment
                  • Expert Insight: Unmet Need in Female Infertility
                • Emerging Therapies
                  • Key Findings
                    • Pipeline Trends for Female Infertility
                  • Key Emerging Therapies
                    • Notable Developments Among Key Emerging Therapies for Female Infertility
                    • Key Therapies in Development for Female Infertility
                    • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Female Infertility
                    • Nolasiban Profile
                    • Analysis of the Clinical Development Program for Nolasiban
                    • Expert Insight: Nolasiban
                    • Expectations for Launch and Sales Opportunity of Nolasiban in Female Infertility
                  • Early-Phase Pipeline Analysis
                    • Notable Developments in the Early-Phase Pipeline for Female Infertility
                    • Select Phase II Compounds in Development for Female Infertility
                    • Select Phase I and Preclinical Development Programs for Female Infertility
                  • Patient Registries
                    • Patient Registries for Female Infertility
                • Access & Reimbursement Overview
                  • Region-Specific Reimbursement Practices
                    • Key Market Access Considerations in Female Infertility: United States
                    • General Reimbursement Environment: United States
                    • Key Market Access Considerations in Female Infertility: EU5
                    • General Reimbursement Environment: EU5
                  • Looking for More?
                • Methodology
                  • Bottom-Up Forecasting Overview
                    • Patient Populations
                    • Drug-Specific Assumptions
                  • Bottom-Up Forecast Assumptions
                    • General Sources of Data
                    • Drug-Treatment Rate Assumptions in Female Infertility
                    • Patient-Share Assumptions in Female Infertility
                    • General Statements About Pricing
                    • Sources for Drug Prices
                    • 2017 Exchange Rates
                    • Price per Treated Day: 2027
                    • Dosing, Days of Therapy, and Compliance
                    • Out-Year Forecasting
                    • Emerging Therapy Prices
                  • Primary Market Research
                    • Experts Interviewed
                • Appendix
                  • Key Abbreviations Related to Female Infertility
                  • Brands, Marketers, and Generic Availability of Key Therapies for Female Infertility by Market
                  • Female Infertility Bibliography

              Author(s): Michael Breen, PhD; Ema Rodrigues, DSc, MPH

              Michael is a business insights analyst on the Infectious, Niche, and Rare Diseases team. He has authored reports on cystic fibrosis, nonalcoholic steatohepatitis, vaccines, and  respiratory syncytial virus, and will author a report on cytomegalovirus. He also provides coverage for Decision Resources’ Company & Drug Insights covering anti-infectives, vaccines, and transplant therapy areas.

              Michael received his Bachelor’s degree from Hunter College with a dual major in biology and biochemistry. He received his Ph.D. in biochemistry from Boston University School of Medicine. His postdoctoral research was carried out at Brigham and Women’s Hospital/Harvard Medical School, with a focus on identifying novel pathways regulating thermogenesis in search of a therapeutic for obesity and diabetes.

              Ema is an epidemiologist with expertise in forecasting incident and prevalent populations within oncology, as well as some cardiovascular indications such as venous thromboembolism. She has significant experience with statistical methods such as multivariate linear regression, conditional logistic regression, principal components analysis, mixed models, hierarchical modeling, and path analysis to account for the complex relationships among various predictors of health outcomes, particularly correlated variables.

              She completed her master’s and doctoral degree (MPH, D.Sc.) in Environmental Health at Boston University School of Public Health, where she worked on projects investigating significant predictors of various health outcomes including central nervous system cancer, cognitive function, and birth outcomes.