Female Infertility in Major Markets, Disease Management, Epidemiology, Pipeline Assessment, Unmet Needs and Drug Forecast to 2033

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1            Female Infertility: Executive Summary

1.1         Female infertility will grow moderately during the forecast period, reaching sales of $2.3 billion in

2033.

1.2         R&D strategies focused largely on improved versions of current drugs.

1.3         Despite major progress in treating patients, unmet needs exist in the space.

1.4         Sparse pipeline, but potential new addition highly intriguing to physicians

1.5         What do physicians think?

2            Introduction

2.1         Catalyst

2.2         Related reports

2.3         Upcoming reports

3            Disease Overview

3.1         Etiology and pathophysiology

3.1.1     Diminished ovarian reserve and ovulation disorders.

3.1.2     Endometriosis

3.1.3     Fallopian tube abnormalities/pelvic adhesions

3.1.4     Uterine factors

3.1.5     Unexplained infertility

3.1.6     Other factors

4            Epidemiology

4.1         Disease background

4.2         Risk factors and comorbidities

4.3         Global and historical trends

4.4         7MM forecast methodology.

4.4.1     Sources

4.4.2     Forecast assumptions and methods.

4.4.3     Forecast assumptions and methods: diagnosed incident cases of female infertility.

4.4.4     Forecast assumptions and methods: total prevalent cases of impaired fecundity.

4.4.5     Forecast assumptions and methods: total prevalent cases of impaired fecundity.

4.4.6     Forecast assumptions and methods: total prevalent cases of female infertility by etiologic factors.

4.5         Epidemiological forecast for female infertility and impaired fecundity (2023-33)

4.5.1     Diagnosed incident cases of female infertility.

4.5.2     Age-specific diagnosed incident cases of female infertility

4.5.3     Total prevent cases of female infertility.

4.5.4     Age-specific total prevalent cases of female infertility

4.5.5     Total prevent cases of female infertility by major etiologic factors.

4.5.6     Total prevalent cases of impaired fecundity

4.5.7     Age-specific total prevalent cases of impaired fecundity

4.6         Discussion

4.6.1     Epidemiological forecast insight

4.6.2     COVID-19 impact.

4.6.3     Limitations of analysis

4.6.4     Strengths of the analysis

5            Disease Management

5.1         Diagnosis and treatment overview

5.2         KOL insights on disease management

6            Current Treatment Options

6.1         Overview

6.2         Ovulation induction

6.2.1     Clomiphene citate and aromatase inhibitors

6.2.2     Gonadotropins

6.3         Assisted reproductive technology (ART)

6.3.1     Gonadotropins

6.3.2     GnRH agonists

6.3.3     GnRH antagonists

6.3.4     Dopamine agonist receptors

6.3.5     Luteal phase support

7            Unmet Needs and Opportunity Assessment

7.1         Overview

7.2         Patient-friendlier progesterone administration for luteal phase support.

7.3         Novel treatments for poor responders

7.4         Enhancing IVF outcomes.

7.5         Development of non-injectable fertility medication

7.6         Access to fertility treatment

8            R&D Strategies

8.1         Overview

8.1.1     Long-acting FSH analogue

8.1.2     Pre-filled pen injection devices

8.2         Clinical trial design

8.2.1     Current clinical trial design

8.2.2     Incomplete reporting of outcomes

9            Pipeline Assessment

9.1         Overview

9.2         Promising drugs in clinical development

10          Pipeline Valuation Analysis

10.1       Overview

10.2       Competitive assessment

11          Current and Future Players

11.1       Overview

11.2       Deal-making trends

12          Market Outlook

12.1       Global markets

12.1.1   Forecast

12.1.2   Drivers and barriers – global issues

12.2       US

12.2.1   Forecast

12.2.2   Key events

12.2.3   Drivers and barriers

12.3       5EU

12.3.1   Forecast

12.3.2   Key events

12.3.3   Drivers and barriers

12.4       Japan

12.4.1   Forecast

12.4.2   Key events

12.4.3   Drivers and barriers

13          Appendix

13.1       Bibliography

13.2       Abbreviations

13.3       Methodology

13.3.1   Forecasting methodology

13.4       Primary research – KOLs interviewed for this report.

13.4.1   KOLs

13.5       Primary research – Prescriber survey

13.6       About the Authors

13.6.1   Analyst

13.6.2   Therapy area director

13.6.3   Epidemiologist

13.6.4   Reviewers epidemiologist

13.6.5   Vice president of disease intelligence and epidemiology

13.6.6   Global head of pharma research, analysis, and competitive intelligence

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Table 1: Female infertility: key metrics in the 7MM

Table 2: Classification of female infertility

Table 3: Risk factors and comorbidities associated with female infertility

Table 4: Treatment guidelines for female infertility

Table 5: Top 10 deals by value, 2018–24

Table 6: Female infertility market – global drivers and barriers, 2023–33

Table 7: Key events impacting sales for female infertility in the US, 2023–33

Table 8: Female infertility market – drivers and barriers in the US, 2023–33

Table 9: Key events impacting sales for female infertility in the 5EU, 2023–33

Table 10: Female infertility market – drivers and barriers in the 5EU, 2023–33

Table 11: Key events impacting sales for female infertility in Japan, 2023–33

Table 12: Female infertility market – drivers and barriers in Japan, 2023–33

Table 13: High-prescribing physicians (non-KOLs) surveyed, by country

Figure 1: Global sales forecast by country for female infertility in 2023 and 2033

Figure 2: Analysis of the company portfolio gap in female infertility during the forecast period

Figure 3: Competitive assessment of the late-stage pipeline agents that GlobalData expects to be licensed for the treatment of female infertility during the forecast period

Figure 4: Major etiologic factors of female infertility

Figure 5: 7MM, diagnosed incidence of female infertility, women, cases per 100,000 population, ages 15–44 years, 2023

Figure 6: 7MM, total prevalence of female infertility and impaired fecundity, women, cases per 100,000 population, ages 15–44 years, 2023

Figure 7: 7MM, sources used and not used to forecast the diagnosed incident cases of female infertility

Figure 8: 7MM, sources used and not used to forecast the total prevalent cases of female infertility

Figure 9: 7MM, sources used and not used to forecast the total prevalent cases of impaired fecundity

Figure 10: 7MM, sources used and not used to forecast the total prevalent cases of female infertility by major etiologic factors

Figure 11: 7MM, diagnosed incident cases of female infertility, N, women, ages 15–44 years, 2023

Figure 12: 7MM, diagnosed incident cases of female infertility by age, N, women, 2023

Figure 13: 7MM, total prevalent cases of female infertility, N, women, ages 15–44 years, 2023

Figure 14: 7MM, total prevalent cases of female infertility by age, N, women, 2023

Figure 15: 7MM, total prevalent cases of female infertility by major etiologic factors, N, women, ages 15–44 years, 2023

Figure 16: 7MM, total prevalent cases of impaired fecundity, N, women, ages 15–44 years, 2023

Figure 17: 7MM, total prevalent cases of impaired fecundity by age, N, women, 2023

Figure 18: An overview of the treatment of female infertility including the main decision points and treatment suggestions

Figure 19: Unmet needs and opportunities in female infertility

Figure 20: Overview of the development pipeline in female infertility

Figure 21: Key late-stage trials for the promising pipeline agents that GlobalData expects to be licensed for female infertility in the 7MM during the forecast period

Figure 22: Competitive assessment of the promising pipeline agents that GlobalData expects to be licensed for female infertility in the 7MM during the forecast period

Figure 23: Competitive assessment of the pipeline drug linzagolix choline benchmarked against the standard of care (SOC), GnRH antagonist ganirelix acetate

Figure 24: Competitive assessment of the pipeline drug Menopur benchmarked against the standard of care (SOC), FSHR agonist, LHR agonist hCG

Figure 25: Competitive assessment of the pipeline drug subcutaneous progesterone benchmarked against the standard of care (SOC), progesterone receptor agonist intramuscular progesterone

Figure 26: Analysis of the company portfolio gap in female infertility during the forecast period

Figure 27: Global (7MM) sales forecast by country for female infertility in 2023 and 2033

Figure 28: Sales forecast by class for female infertility in the US in 2023 and 2033

Figure 29: Sales forecast by class for female infertility in the 5EU in 2023 and 2033

Figure 30: Sales forecast by class for female infertility in Japan in 2023 and 2033