Female Infertility – Opportunity Analysis and Forecasts to 2028

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Female Infertility: Executive Summary

2.1 Moderate Growth in the Female Infertility Market Expected Between 2018 and 2028, Driven by US and EU Sales

2.2 R&D Strategies Focused Largely on Improved Versions of Current Drugs

2.3 Despite Major Progress in Treating Patients, Unmet Needs Exists in the Space

2.4 Sparse Pipeline, But Potential New Addition Highly Intriguing to Physicians

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

4 Disease Overview

4.1 Etiology

4.1.1 Diminished Ovarian Reserve & Ovulation Disorders

4.1.2 Endometriosis

4.1.3 Fallopian tube abnormalities/pelvic adhesions

4.1.4 Uterine factors

4.1.5 Unexplained infertility

4.1.6 Other factors

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources Used

5.4.2 Forecast Assumptions and Methods: Total Prevalent Cases of Female Infertility and Impaired Fecundity

5.4.3 Forecast Assumptions and Methods: Total Prevalence of Female Infertility by Major Etiological Factors

5.4.4 Forecast Assumptions and Methods: Total Prevalence of Impaired Fecundity by Treatment Type

5.5 Epidemiological Forecast for Female Infertility and Impaired Fecundity (2018–2028)

5.5.1 Total Prevalent Cases of Female Infertility

5.5.2 Total Prevalent Cases of Impaired Fecundity

5.5.3 Age-Specific Total Prevalent Cases of Female Infertility

5.5.4 Age-Specific Total Prevalent Cases of Impaired Fecundity

5.5.5 Total Prevalent Cases of Female Infertility by Major Etiological Factors

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of the Analysis

5.6.3 Strengths of the Analysis

6 Current Treatment Options

6.1 Overview

6.2 Ovulation Induction

6.2.1 Clomiphene Citrate

6.2.2 Aromatase Inhibitors

6.2.3 Gonadotropins

6.3 Assisted Reproductive Technologies

6.3.1 Gonadotropins

6.3.2 GnRH Agonists

6.3.3 GnRH Antagonists

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Improved IVF Success Rates Per Cycle

7.3 Oral and Longer-Acting Drugs that Simplify the IVF Process

7.4 Patient-Friendlier Progesterone Administration for Luteal Phase Support

7.5 Novel Treatments for Poor Responders

7.6 Non-Surgical Treatments for Uterine Fibroid-Related Infertility

7.7 Reducing High IVF Treatment Patient Dropout Rates

7.8 Early Detection of High-Risk Patients

8 R&D Strategies

8.1 Overview

8.1.1 Long-Acting FSH Analogue

8.1.2 Pre-Filled Pen Injection Devices

8.1.3 Fixed Combination of Follitropin Alfa + Lutropin Alfa

8.2 Clinical Trials

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

9.2.1 Nolasiban (OBE001)

9.2.2 MVT-602

9.2.3 Milprosa (DR-2011, Progesterone Vaginal Ring)

9.2.4 Off-Label Potential for Oral GnRH Antagonists

9.3 Other Drugs in Development

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.1.1 Nolasiban

10.1.2 MVT-602

10.1.3 Milprosa

10.2 Commercial Benchmark of Key Pipeline Drugs

10.3 Competitive Assessment

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Percent Drug-Treated Patients

11.3.3 Drugs Included in Each Therapeutic Class

11.3.4 Launch and Patent Expiry Dates

11.3.5 General Pricing Assumptions

11.3.6 Individual Drug Assumptions

11.3.7 Generic Erosion

11.3.8 Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.4.1 KOLs

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Therapy Area Director

11.6.3 Therapy Area Associate Director

11.6.4 Epidemiologists

11.6.5 Epidemiology Reviewers

11.6.6 Global Director of Therapy Analysis and Epidemiology

11.6.7 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

Table 1: Female Infertility: Key Metrics in the 7MM

Table 2: Classification of Female Infertility

Table 3: Risk Factors and Comorbid Conditions Associated with Female Infertility

Table 4: Treatment Guidelines for Female Infertility

Table 5: Common on-label drugs for clinical use as part of female infertility treatments

Table 6: Off-Label Treatments for Female Infertility

Table 7: Comparison of Therapeutic Classes in Development for Female Infertility, 2018–2028

Table 8: Other Drugs in Development for Female Infertility, 2019

Table 9: Clinical Benchmark of Nolasiban Against Off-Label Use of Atosiban

Table 10: Clinical Benchmark of MVT-602 Against SOC

Table 11: Clinical Benchmark of Milprosa Against SOC

Table 12: Commercial Benchmark of Nolasiban

Table 13: Commercial Benchmark of MVT-602

Table 14: Commercial Benchmark of Milprosa

Table 15: Key Events Impacting Sales for Female Infertility, 2018–2028

Table 16: Female Infertility Market – Global Drivers and Barriers, 2018–2028

Table 17: Key Historical and Projected Launch Dates for Female Infertility

Table 18: Key Historical and Projected Patent Expiry Dates for Female Infertility

Table 19: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figure 1: Global Sales Forecast by Country for Female Infertility in 2018 and 2028

Figure 2: Competitive Assessment of Pipeline Drug Nolasiban Benchmarked Against Off-Label Use of Atosiban During Embryo Transfer

Figure 3: Competitive Assessment of the Pipeline Drug MVT-602 Benchmarked Against the Trigger Shot SOC Options hCG and GnRH agonists

Figure 4: Competitive Assessment of the Pipeline Drug Milprosa Benchmarked Against the Luteal Phase Support SOC IM and Vaginal Progesterone

Figure 5: Major Etiologic Factors of Female Infertility

Figure 6: 7MM, Total Prevalence of Female Infertility (%), Ages 15–44 Years, 2018

Figure 7: 7MM, Total Prevalence of Impaired Fecundity (%), Ages 15–44 Years, 2018

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 Etiological Factors

Figure 11: 7MM, Total Prevalent Cases of Female Infertility, N, Ages 15–44 Years, 2018

Figure 12: 7MM, Total Prevalent Cases of Impaired Fecundity, N, Ages 15–44 Years, 2018

Figure 13: 7MM, Age-Specific Total Prevalent Cases of Female Infertility, N, Ages 15–44 Years, 2018

Figure 14: 7MM, Age-Specific Total Prevalent Cases of Impaired Fecundity, N, Women, Ages 15–44 Years, 2018

Figure 15: 7MM, Total Prevalent Cases of Female Infertility by Major Etiological Factors, N, Ages 15–44 Years, 2018

Figure 16: Unmet Needs and Opportunities in Female Infertility

Figure 17: Overview of the Development Pipeline in Female Infertility

Figure 18: Key Phase II/III Trials for the Promising Pipeline Agents

Figure 19: Competitive Assessment of the Pipeline Drug Nolasiban Benchmarked Against the Off-Label Use of Atosiban

Figure 20: Competitive Assessment of the Pipeline Drug MVT-602 Benchmarked Against the SOC, hCG and GnRH Agonist

Figure 21: Competitive Assessment of the Pipeline Drug Milrposa Benchmarked Against the SOC, IM and Vaginal Progesterone

Figure 22: Global (7MM) Sales Forecast by Country for Female Infertility, 2018 and 2028

Figure 23: Global Sales Forecast by Class for Female Infertility, 2018 and 2028

Figure 24: Sales Forecast by Class for Female Infertility in the US, 2018 and 2028

Figure 25: Sales Forecast by Class for Female Infertility in the 5EU, 2018 and 2028

Figure 26: Sales Forecast by Class for Female Infertility in Japan, 2018 and 2028