여성 불임 시장 : 인사이트, 역학, 시장 예측(2034년)

Key Highlights:

• Female infertility is the inability to conceive after 12 months of unprotected intercourse, often linked to ovulatory disorders, endometriosis, or structural issues. It carries significant emotional, social, and financial impacts on affected women.
• Our secondary research indicates that in the US, approximately 11% of women experience female infertility, highlighting its substantial burden and the widespread challenges it poses for reproductive health and quality of life.
• In the UK, female infertility affects women across all age groups, with prevalence estimated at 7% in those aged 16-24, rising to 17% in ages 25-34, and peaking at 25% in ages 35-44. Notably, infertility remains prevalent beyond the prime reproductive years, affecting 17% of women aged 45-54, 18% of those aged 55-64, and 16% in the 65-74 group, reflecting its lasting impact on health and quality of life.
• MENOPUR (menotropins for injection) from Ferring Pharmaceuticals and GONAL-F RFF (follitropin alfa) from Merck are cornerstone FDA-approved therapies for female infertility. Both play a critical role in assisted reproductive technologies by stimulating ovarian follicle development, thereby enhancing the likelihood of successful conception and representing major advancements in fertility treatment.
• Emerging therapies in female infertility, including OXO-001 by Oxolife, point to a growing focus on innovative approaches aimed at improving implantation success and expanding treatment options beyond existing ovarian stimulation methods.

DelveInsight's comprehensive report titled "Female Infertility - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of female infertility. The report presents historical and projected epidemiological data covering total prevalent cases of female infertility, total diagnosed prevalent cases of female infertility, age-specific diagnosed prevalent cases of female infertility and treated cases of female infertility. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in female infertility. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Female Infertility Overview

Female infertility is defined as the inability to conceive after 12 months of regular, unprotected sexual intercourse, and it can result from a variety of hormonal, anatomical, genetic, or unexplained factors affecting reproductive function. It affects women of reproductive age, with prevalence influenced by age, underlying health conditions, and lifestyle factors. Causes can include ovulatory disorders, tubal abnormalities, endometriosis, diminished ovarian reserve, or male factor infertility, among others. The severity and impact vary, ranging from mild difficulty conceiving to prolonged infertility that can significantly affect emotional well-being, relationships, and quality of life. While age-related decline in fertility is a well-recognized factor, infertility can also arise from medical treatments, endocrine disorders, or genetic conditions. Comprehensive evaluation is often necessary to identify underlying causes and guide targeted treatment strategies, including lifestyle interventions, pharmacologic therapies, and assisted reproductive technologies.

Female Infertility Diagnosis and Treatment Overview

Female infertility is diagnosed primarily through comprehensive clinical evaluation, beginning with a detailed patient history, menstrual and reproductive history, and assessment of lifestyle and environmental factors. There are no single tests that universally confirm infertility, but targeted investigations, including hormonal profiling, ovulatory function assessment, and imaging of the reproductive organs, and semen analysis for male partners, help identify underlying causes such as ovulatory disorders, tubal blockage, endometriosis, diminished ovarian reserve, or male factor infertility. Additional testing is guided by age, medical history, and previous treatments to rule out secondary contributors such as thyroid disease, hyperprolactinemia, or genetic abnormalities.

Treatment for female infertility is highly individualized, as no single approach is effective for all patients. Strategies aim to restore fertility, improve ovulation, and enhance the chances of conception, often requiring a combination of medical, surgical, or assisted reproductive techniques. Approaches are tailored based on the underlying cause, patient-specific factors, and overall reproductive goals. Supportive measures, including lifestyle optimization, weight management, stress reduction, and counseling, can further improve outcomes and help patients navigate the emotional and practical challenges of infertility.

Female Infertility Epidemiology

The epidemiology section of the female infertility market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the total prevalence rate of female infertility, supported by relevant tables and graphs to provide a clear and concise understanding of the data. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

• In the US, female infertility shows a strong age-related trend and varies with parity. Among women with no previous births, infertility affects about 20% of those aged 15-29 years, 36% of those aged 30-39 years, and 44% of those aged 40-49 years. For women with one or more births, the rates are slightly higher at 29%, 33%, and 38%, respectively, highlighting how both advancing age and prior childbirth influence reproductive potential.
• Based on our secondary analysis in Germany, 8.91% of women of reproductive age experience infertility, highlighting a significant burden and the need for increased awareness, timely diagnosis, and expanded treatment options.
• In the UK, around 12.5% of women of reproductive age face infertility, highlighting the widespread impact on women's reproductive health and the growing need for effective support, timely interventions, and comprehensive care options.
• In Japan, infertility affects about 10-15% females of reproductive age, highlighting a notable impact on reproductive health and emphasizing the need for effective support, timely interventions, and comprehensive care options.

Female Infertility Market Outlook

The female infertility therapeutics market is further expected to increase by the major drivers, such as the rising prevalent population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

Female infertility is managed through a range of medical, surgical, and assisted reproductive interventions, tailored to the underlying cause and patient-specific factors. Common approaches include ovulation induction, surgical correction of anatomical abnormalities, and assisted reproductive technologies such as in vitro fertilization, all aimed at improving the chances of conception. Supportive measures, such as lifestyle optimization, weight management, stress reduction, and counseling, play an important role in enhancing outcomes and addressing the emotional challenges associated with infertility. Advances in diagnostic tools and treatment strategies continue to expand options, providing more personalized, effective, and patient-centered care for women seeking to achieve pregnancy.

With ongoing research and continued dedication, the future holds promise for even more effective treatments and, ultimately, a potential cure for this challenging condition. According to DelveInsight, the female infertility market in the 7MM is expected to change significantly during the forecast period (2025-2034).

Female Infertility Drug Chapters

Marketed Drugs

MENOPUR (menotropins for injection): Ferring Pharmaceuticals

MENOPUR developed by Ferring Pharmaceuticals and known generically as menotropins for injection, is a key therapy for female infertility. By providing a balanced combination of follicle-stimulating hormone (FSH) and Luteinizing Hormone (LH), it directly stimulates ovarian follicle development, addressing ovulatory dysfunction. Used in ovulation induction and assisted reproductive technologies like IVF, MENOPUR allows individualized dosing to optimize outcomes and enhance the chances of successful conception.

• In March 2014, Ferring Pharmaceuticals received US FDA approval for the first mixed-protocol IVF treatment, combining MENOPUR (menotropins for injection) and BRAVELLE (urofollitropin for injection, purified) in a single syringe, streamlining ovarian stimulation and simplifying administration for patients undergoing assisted reproductive technologies.

GONAL-F RFF (follitropin alfa): Merck

GONAL-F RFF, generically known as follitropin alfa, is an advanced, recombinant FSH therapy developed by Merck for the management of female infertility. By directly stimulating ovarian follicle development, it addresses the underlying ovulatory dysfunction rather than simply supporting conception attempts. This mechanism enables precise control over follicular growth, positioning GONAL-F RFF as a leading option for ovulation induction and assisted reproductive technologies, including in vitro fertilization.

• In November 2017, Merck received US FDA approval of the GONAL-F RFF Redi-ject prefilled pen, a new version of the GONAL-F (follitropin alfa injection) prefilled pen, designed to simplify ovarian stimulation and improve ease of administration for women undergoing assisted reproductive treatments.
• In February 2016, Merck, received European approval from the European Medicines Agency for the GONAL-F prefilled pen 2.0. Originally launched in 2011, the updated version incorporates advanced features aimed at providing patients with greater confidence and ease during their fertility treatments. The drug is also available in Japan.

OVIDREL (choriogonadotropin alfa): Merck

OVIDREL, generically known as choriogonadotropin alfa, is a recombinant human chorionic gonadotropin (hCG) therapy developed for the management of female infertility. By triggering final oocyte maturation and ovulation, it addresses the critical step in the reproductive cycle rather than merely supporting conception attempts. This mechanism allows precise timing of ovulation, positioning OVIDREL as a key therapy for ovulation induction and assisted reproductive technologies, including in vitro fertilization.

• In June 2025, Merck Healthcare reported a supply constraint affecting OVIDREL. As a result, intermittent shortages of OVIDREL are anticipated from till 30th September 2027. Following due process, Merck has notified the Therapeutic Goods Administration (TGA), that OVIDREL will be listed as having 'Limited Availability' on the TGA medicines shortages database throughout this period.

Emerging Drugs

OXO-001: OXOLIFE

OXO-001, developed by Oxolife, is an investigational therapy being studied for the treatment of female infertility. The company is developing OXO-001 as a first-in-class, non-hormonal oral drug that acts directly on the endometrium to enhance and improve the embryo implantation process, representing a potential breakthrough in reproductive medicine. This sodium tungstate-based compound is designed to target ovarian and endometrial function, offering a potentially safer and more targeted alternative to conventional hormone-based fertility treatments.

• In May 2025, Oxolife published the results of a Phase I clinical trial in the International Journal of Fertility & Sterility, evaluating the safety, tolerability, and pharmacokinetics of OXO-001 in healthy women of childbearing age.

Female Infertility Market Segmentation

DelveInsight's "Female Infertility - Market Insights, Epidemiology, and Market Forecast - 2034" report provides a detailed outlook of the current and future female infertility market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Female Infertility Market Size by Countries

The female infertility market size is assessed separately for various countries, including the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) female infertility market, primarily attributed to the country's higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Female Infertility Drugs Uptake

This section focuses on the sales uptake of potential female infertility drugs that have recently been launched or are anticipated to be launched in the female infertility market between 2025 and 2034. It estimates the market penetration of female infertility drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the female infertility market.

The emerging female infertility therapies are analyzed based on various attributes such as efficacy and safety in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the female infertility market.

Female Infertility Market Access and Reimbursement

DelveInsight's "Female Infertility - Market Insights, Epidemiology, and Market Forecast - 2034" report provides a descriptive overview of the market access and reimbursement scenario of female infertility. This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current female infertility market trends and to fill gaps in secondary findings, we interview KOLs' and SMEs' working in the female infertility domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or female infertility market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the female infertility unmet needs.

Female Infertility: KOL Insights

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as University of Texas MD Anderson Cancer Center, US; University Medical Center Hamburg-Eppendorf, Germany; PSL Research University, France; University of Campania "Luigi Vanvitelli, Italy; Complutense University, Spain; Liverpool John Moores University, UK; and Keio University School of Medicine, Japan; among others.

As per KOLs from the US, "Female infertility poses a substantial emotional and physical burden, with causes and severity varying widely among women. Experts emphasize that emerging non-hormonal therapies, such as targeted endometrial modulators, are reshaping management by addressing underlying reproductive dysfunction. Leading voices also highlight the importance of personalized treatment approaches, given the diverse etiologies, reproductive goals, and patient-specific needs in fertility care."

As per KOLs from Germany, "Despite advances in reproductive medicine, a significant unmet need remains for effective, non-hormonal therapies that improve fertility outcomes without the risks associated with conventional hormone-based treatments. Experts stress the importance of integrating multidisciplinary support, including lifestyle optimization, mental health counseling, and individualized care plans, to better address the broad physical and emotional impact of infertility."

As per KOLs from Japan, "The reported rates of female infertility may underestimate the true burden due to underdiagnoses and social stigma around reproductive challenges. Specialists highlight the need for increased awareness and accessible treatment options, particularly non-hormonal therapies, to address the unique clinical and social challenges faced by Japanese women seeking to conceive."

Competitive Intelligence Analysis

We conduct a competitive and market intelligence analysis of the female infertility. Market, utilizing various Competitive Intelligence tools such as SWOT analysis and market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Female Infertility Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for female infertility. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging female infertility therapies.

Female Infertility Report Insights

• Female Infertility Patient Population
• Therapeutic Approaches
• Female Infertility Pipeline Analysis
• Female Infertility Market Size and Trends
• Female Infertility Market Opportunities
• Impact of Upcoming Therapies

Female Infertility Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Female Infertility Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Female Infertility Market
• Female Infertility Drugs Uptake

Female Infertility Report Assessment

• Female Infertility Current Treatment Practices
• Unmet Needs
• Female Infertility Product Profiles
• Female Infertility Market Attractiveness

Key Questions:

• How common is female infertility?
• What are the key findings of female infertility epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for female infertility?
• What are the disease risk, burden, and unmet needs of female infertility?
• At what CAGR is the female infertility market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the female infertility market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of female infertility in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of female infertility?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the female infertility market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the attribute analysis section to provide visibility around leading classes.
• Highlights of Market Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What are the treatment goals for female infertility?

The primary treatment goals for female infertility are to restore normal ovulatory and reproductive function, improve the chances of conception, and achieve a healthy pregnancy. Additional objectives include addressing underlying causes such as hormonal imbalances, tubal or ovarian dysfunction, or male factor infertility, minimizing treatment-related risks and side effects, and providing personalized, effective interventions. Treatments aim to support women in achieving their reproductive goals while maintaining overall health, well-being, and quality of life throughout the fertility journey.

2. What are the challenges in managing female infertility?

The challenges in managing female infertility include the wide range of underlying causes, such as ovulatory disorders, tubal abnormalities, endometriosis, diminished ovarian reserve, and male factor infertility, which require individualized diagnostic and treatment approaches. Additional difficulties arise from delayed diagnosis, variability in treatment response, psychological stress, and the financial and logistical burden of fertility therapies. Clinicians must also navigate patient-specific factors such as age, comorbidities, and reproductive goals, while balancing efficacy, safety, and accessibility of interventions to optimize outcomes.

3. What are the key factors driving the growth of the female infertility market?

Key factors driving the growth of the female infertility market include increasing awareness of reproductive health issues, a rising number of women delaying childbirth, and greater demand for effective, personalized fertility treatments. The approval and adoption of novel therapies, including non-hormonal and targeted interventions, advancements in assisted reproductive technologies, and expanding access to fertility care also fuel market expansion. Additionally, ongoing research, improved patient education, and supportive regulatory frameworks enhance treatment availability and uptake.

4. How will the female infertility market and epidemiology forecast report benefit the clients?

The female infertility market and epidemiology forecast report provides clients with comprehensive insights into disease prevalence, patient demographics, and market trends. It enables identification of unmet needs, assessment of competitive landscapes, and strategic planning for product development and market access. The report supports informed decision-making by offering analysis of regulatory frameworks, emerging therapies, and forecasted growth, helping stakeholders optimize investments and policy strategies.

Table of Contents

1. Key Insights

2. Report Introduction

3. Female Infertility Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Female Infertility by Therapies in the 7MM in 2024
• 3.2. Market Share (%) Distribution of Female Infertility by Therapies in the 7MM in 2034

4. Epidemiology and Market Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Types
• 7.3. Causes
• 7.4. Pathophysiology
• 7.5. Symptoms
• 7.6. Risk Factor
• 7.7. Diagnosis
  • 7.7.1. Diagnostic Algorithm
  • 7.7.2. Diagnostic Guidelines
• 7.8. Treatment and Management
  • 7.8.1. Treatment Algorithm
  • 7.8.2. Treatment Guidelines

8. Epidemiology and Patient Population

• 8.1. Key Findings
• 8.2. Assumptions and Rationale:7MM
  • 8.2.1. Total Prevalent Cases of Female Infertility
  • 8.2.2. Total Diagnosed Prevalent Cases of Female Infertility
  • 8.2.3. Age-specific Diagnosed Prevalent Cases of Female Infertility
  • 8.2.4. Treated Cases of Female Infertility
• 8.3. Total Diagnosed Prevalent Cases of Female Infertility in the 7MM
• 8.4. The United States
  • 8.4.1. Total Prevalent Cases of Female Infertility
  • 8.4.2. Total Diagnosed Prevalent Cases of Female Infertility
  • 8.4.3. Age-specific Diagnosed Prevalent Cases of Female Infertility
  • 8.4.4. Treated Cases of Female Infertility
• 8.5. EU4 and the UK
  • 8.5.1. Total Prevalent Cases of Female Infertility
  • 8.5.2. Total Diagnosed Prevalent Cases of Female Infertility
  • 8.5.3. Age-specific Diagnosed Prevalent Cases of Female Infertility
  • 8.5.4. Treated Cases of Female Infertility
• 8.6. Japan
  • 8.6.1. Total Prevalent Cases of Female Infertility
  • 8.6.2. Total Diagnosed Prevalent Cases of Female Infertility
  • 8.6.3. Age-specific Diagnosed Prevalent Cases of Female Infertility
  • 8.6.4. Treated Cases of Female Infertility

9. Patient Journey

10. Marketed Therapies

• 10.1. Key Cross Competition
• 10.2. MENOPUR (menotropins for injection): Ferring Pharmaceuticals
  • 10.2.1. Product Description
  • 10.2.2. Regulatory Milestones
  • 10.2.3. Other Development Activities
  • 10.2.4. Clinical Trials Information
  • 10.2.5. Safety and Efficacy
• 10.3. GONAL-F RFF (follitropin alfa): Merck
  • 10.3.1. Product Description
  • 10.3.2. Regulatory Milestones
  • 10.3.3. Other Development Activities
  • 10.3.4. Clinical Trials Information
  • 10.3.5. Safety and Efficacy
• 10.4. OVIDREL (choriogonadotropin alfa): Merck
  • 10.4.1. Product Description
  • 10.4.2. Regulatory Milestones
  • 10.4.3. Other Development Activities
  • 10.4.4. Clinical Trials Information
  • 10.4.5. Safety and Efficacy

11. Emerging Therapies

• 11.1. Key Cross Competition
• 11.2. OXO-001: OXOLIFE
  • 11.2.1. Drug Description
  • 11.2.2. Other Development Activities
  • 11.2.3. Clinical Trials Information
  • 11.2.4. Safety and Efficacy
  • 11.2.5. Analyst's View

12. Female Infertility: Seven Major Market Analysis

• 12.1. Key Findings
• 12.2. Market Outlook
• 12.3. Attribute Analysis
• 12.4. Key Market Forecast Assumptions
  • 12.4.1. Cost Assumptions and Rebates
  • 12.4.2. Pricing Trends
  • 12.4.3. Analogue Assessment
  • 12.4.4. Launch Year and Therapy Uptake
• 12.5. Total Market Size of Female Infertility in the 7MM
• 12.6. Market Size of Female Infertility by Therapies in the 7MM
• 12.7. The United States Market Size
  • 12.7.1. Total Market Size of Female Infertility
  • 12.7.2. Market Size of Female Infertility by Therapies in the US
• 12.8. EU4 and the UK Market Size
  • 12.8.1. Total Market Size of Female Infertility
  • 12.8.2. Market Size of Female Infertility by Therapies in EU4 and the UK
• 12.9. Japan Market Size
  • 12.9.1. Total Market Size of Female Infertility
  • 12.9.2. Market Size of Female Infertility by Therapies in Japan

13. Key Opinion Leaders' Views

14. Unmet Needs

15. SWOT Analysis

16. Market Access and Reimbursement

17. Appendix

• 17.1. Bibliography
• 17.2. Abbreviations and Acronyms
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight