Female Infertility – Opportunity Analysis and Forecasts to 2028
- Pages: 134
- Published: September 2019
- Report Code: GDHC103POA
Female infertility (FI) is a complex disorder defined as the inability to conceive after at least one year of timed, unprotected intercourse. The etiology of the condition spans a wide range of disorders that can be broadly classified into the following categories: diminished ovarian reserve & ovulation disorders, endometriosis, fallopian tube abnormalities, uterine factors and unexplained infertility. Several factors may be considered before a treatment decision is made, including treatment effectiveness (live birth rate), treatment burden (such as number of required injections and monitoring appointments), safety (such as risk of multiple gestation or ovarian hyperstimulation), and cost of therapy. Overall, the most common treatments include ovulation induction drugs and/or advanced techniques, referred to as Assisted Reproductive Technology (ART), such as in vitro fertilization (IVF).
KEY QUESTIONS ANSWERED
Despite progress made in the management of female infertility since the introduction of ART and other improvements in treating patients, KOLs thought challenges associated with treatment remain, throughout the 7MM.
• Which unmet needs are the most pressing in the 7MM?
• Where should pharmaceutical companies focus drug development efforts in order to become a significant player in the space?
GlobalData expects that pipeline development of nolasiban will contribute significantly to the growth of the FI market going forward.
• How much is nolasiban expected to generate over the forecast period?
• What other assets are under development and how do KOLs see them competing against current treatment options?
Although female infertility is a prevalent condition, it remains a niche indication on the industry level.
• Which have been historically the companies leading the way?
• What new companies are emerging in the space?
Overview of Female Infertility including epidemiology, etiology and current treatment options, namely ovulation induction and ART
Topline Female Infertility market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.
Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting Female Infertility therapeutics sales in the 7MM.
Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
Analysis of the current and future market competition in the global Female Infertility therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
The greatest drivers of growth in the global FI market are a growing number of women are postponing pregnancy until later in life and at a reproductively older age when fertility has generally decreased and the launch of nolasiban in the US and 5EU, the first major innovation in this indication in many years.
The main barriers to growth in the female infertility market include the sparse pipeline for new female infertility treatments, and the limited number of innovative drugs under development.
Among the late-stage pipeline products, the launch of nolasiban early in the forecast period will add significant growth to sales by 2028.
The most important unmet needs in FI include further improving IVF success rates, orally and less frequently administered drugs involved in IVF, additional treatment options for reproductively older infertile women and young women with diminished ovarian reserve (DOR), development of novel non-surgical treatment options for the management of uterine fibroid-related infertility and reducing high IVF treatment patient dropout rates.
Reasons to buy
The report will enable you to:
Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
Develop business strategies by understanding the trends shaping and driving the global Female Infertility therapeutics market.
Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global Female Infertility market in the future.
Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
Track drug sales in the global Female Infertility therapeutics market from 2018-2028.
Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Merck & Co
Teva Pharmaceutical Industries
IBSA Farmaceutici Italia
Table of Contents
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?
3.2 Related Reports
4 Disease Overview
4.1.1 Diminished Ovarian Reserve & Ovulation Disorders
4.1.3 Fallopian tube abnormalities/pelvic adhesions
4.1.4 Uterine factors
4.1.5 Unexplained infertility
4.1.6 Other factors
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
5.6.1 Epidemiological Forecast Insight
5.6.2 Limitations of the Analysis
5.6.3 Strengths of the Analysis
6 Current Treatment Options
6.2 Ovulation Induction
6.2.1 Clomiphene Citrate
6.2.2 Aromatase Inhibitors
6.3 Assisted Reproductive Technologies
6.3.2 GnRH Agonists
6.3.3 GnRH Antagonists
7 Unmet Needs and Opportunity Assessment
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
8.1.1 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
9.2 Promising Drugs in Clinical Development
9.2.1 Nolasiban (OBE001)
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
10.2 Commercial Benchmark of Key Pipeline Drugs
10.3 Competitive Assessment
10.4 Top-Line 10-Year Forecast
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
11.5 Primary Research – Prescriber Survey
11.6 About the Authors
11.6.2 Therapy Area Director
11.6.3 Therapy Area Associate Director
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
List of Tables
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
List of Figures
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