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OpportunityAnalyzer: Endometriosis - Opportunity Analysis and Forecast to 2025

OpportunityAnalyzer: Endometriosis - Opportunity Analysis and Forecast to 2025

Summary

Endometriosis is an estrogen-dependent, chronic, inflammatory disease characterized by the appearance and growth of endometrial cells or tissues in locations outside the uterus. It is a common gynecological condition; however the disease is underdiagnosed due to the invasive nature of laparoscopy that confirms diagnosis. GlobalData estimates the endometriosis prevalence, including suspected and confirmed cases, to grow from 9.6 million to 11.3 million worldwide between 2015 and 2025. Current FDA-approved therapies for endometriosis comprise drugs that suppress ovulation and/or induce a hypoestrogenic state including gonadotrophin-releasing hormone (GnRH) analogues, progestins, and danazol. Off-label medical treatment for endometriosis, commonly prescribed before definitive diagnosis is made, include NSAIDs and hormonal contraceptives. The endometriosis market will undergo a moderate growth from 1.72 billion to reach sales of $2.04 billion over the 10-year period. This growth will primarily be driven by the increasing diagnosed endometriosis patients in the 7MM and the highly anticipated arrival of the novel GnRH antagonist, elagolix, due to be released in the US and 5EU in 2018. Nevertheless, patent expiries of some branded drugs and the sparsely populated endometriosis pipeline will curtail market growth during the forecast period.

Highlights

Key Questions Answered

  • Oral contraceptives are among the market leaders for endometriosis, prescribed off-label as first-line of therapy to alleviate endometriosis-associated pain. Second-line therapies, such as GnRH agonists, are effective treatments; however their undesirable hypoestrogenic side effects and failure to prevent symptom recurrence limit their use. Another limitation of hormonal regimens is that their use prevents conception. Therefore, there are considerably high unmet needs within the indication. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the endometriosis market?
  • The current late-stage endometriosis pipeline encompasses one novel therapeutic drug class, GnRH antagonists, of which elagolix will be the first to enter the market. Will the late-stage drugs make a significant impact on the endometriosis market? Will elagolix become the market leader over the 10-year forecast period, and why?
  • We have seen considerable efforts over the past years to raise awareness and to identify biomarkers for endometriosis. How will epidemiological changes impact the growth of the future market?
Key Findings
  • The main driver of moderate growth in the endometriosis market will be the increase in the diagnosed prevalence of endometriosis as well as the uptake of the novel GnRH antagonist, elagolix.
  • The major global barrier for the endometriosis market will be the lack of entry of novel targeted drugs that could be used safely as continuous therapy.
  • The dynamics of the endometriosis market will not change drastically over the next 10 years in terms of the current and future players in the endometriosis market and GlobalData expects that AbbVie and Bayer will continue to have a strong presence, as they are undertaking various strategies to bring novel therapeutics into the endometriosis market. Other companies with new chemical entities may also come near to surface by the end of the forecast period.
  • The endometriosis space has considerable unmet needs. One of the largest unmet needs is a need for therapies that would target the pathogenic processes of the disease and have the potential to eradicate the disease and stop recurrence. The market is in need for safe and effective long-term therapies with minimal side effects that could also be given to adolescent patients and/or patients with mild disease. Developing therapies with non-contraceptive properties is also an untapped area of the endometriosis market. Low diagnosis rates due to lack of disease awareness and the lack of reliable noninvasive diagnostic tools are major hurdles of successful treatment.
Scope
  • Overview of endometriosis, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized endometriosis therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the endometriosis therapeutics market.
  • 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 endometriosis therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to buy

The report will enable you to -
  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
  • Develop business strategies by understanding the trends shaping and driving the global Endometriosis therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global Endometriosis therapeutics market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing 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 Endometriosis therapeutics market from 2013-2023.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
3 Disease Overview
3.1 Etiology
3.2 Pathophysiology
3.3 Symptoms and Diagnosis
3.4 Clinical Prognosis
3.5 Quality of Life
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global Trends
4.3.1 US
4.3.2 5EU
4.3.3 Japan
4.4 Forecast Methodology
4.4.1 Sources Used Tables
4.4.2 Forecast Assumptions and Methods
4.4.3 Sources Not Used
4.5 Epidemiological Forecast for Endometriosis (2015-2025)
4.5.1 Diagnosed Incident Cases
4.5.2 Diagnosed Prevalent Cases
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 Limitations of the Analysis
4.6.3 Strengths of the Analysis
5 Current Treatment Options
5.1 Overview
5.2 GnRH Agonists
5.2.1 Zoladex (Goserelin Acetate)
5.2.2 Lupron Depot (Leuprolide Acetate)
5.2.3 Synarel (Nafarelin Acetate Nasal Spray)
5.2.4 Buserelin Acetate
5.2.5 Triptorelin
5.3 Progestins/Progestogens
5.3.1 Dienogest
5.3.2 Depo-SubQ Provera 104 (Medroxyprogesterone Injection)
5.4 Off-Label Treatment: Hormonal Contraceptives, NSAIDs, and Aromatase Inhibitors
5.4.1 Hormonal Contraceptives
5.4.2 Nonsteroidal Anti-inflammatory Drugs
5.4.3 Aromatase Inhibitors
6 Unmet Needs Assessment and Opportunity Analysis
6.1 Overview
6.2 Noninvasive Diagnostics
6.2.1 Unmet Needs
6.2.2 Gap Analysis
6.2.3 Opportunity
6.3 Disease Awareness and Education of Medical Professionals
6.3.1 Unmet Needs
6.3.2 Gap Analysis
6.3.3 Opportunity
6.4 More Effective Drugs with Long-Term Safety and Tolerability
6.4.1 Unmet Needs
6.4.2 Gap Analysis
6.4.3 Opportunity
6.5 Non-hormonal Therapies
6.5.1 Unmet Needs
6.5.2 Gap Analysis
6.5.3 Opportunity
6.6 Better Understanding of the Disease Etiology and Pathophysiology
6.6.1 Unmet Needs
6.6.2 Gap Analysis
6.6.3 Opportunity
7 Research and Development Strategies
7.1 Overview
7.2 Reformulations and Label Expansion
7.3 The Race for the Development of GnRH Antagonists
7.4 Development of Novel Non-hormonal Therapies
7.5 Alliances and In-Licensing Strategies
7.6 Maximizing Return-on-Investment by Targeting Secondary Indications
8 Clinical Trial Design
8.1 Overview
8.2 Defining Efficacy in Endometriosis Clinical Trials
8.2.1 Pain Scales
8.2.2 Quality-of-Life Assessment as an Efficacy Tool
8.3 Selection of an Active Comparator
8.4 Diversity of the Endpoints Used
8.5 Future Trends in Endometriosis Clinical Trial Design
9 Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Late-Stage Development
9.2.1 Elagolix
9.2.2 Relugolix
9.3 Innovative Early-Stage Approaches
9.3.1 Overview
9.3.2 GnRH Antagonists
9.3.3 Aromatase Inhibitors
9.3.4 Selective Progesterone Receptor Modulators
9.3.5 Selective Estrogen Receptor Modulators
9.3.6 Novel Hormonal Therapies
9.3.7 Anti-inflammatory Approaches
9.3.8 Anti-angiogenic Agents
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
10.4.1 US
10.4.2 5EU
10.4.3 Japan
10.5 Drivers and Barriers
11 Appendix
11.1 Bibliography
11.2 Abbreviations
11.3 Methodology
11.4 Forecasting Methodology
11.4.1 Prevalent Cases of Endometriosis
11.4.2 Patient Population Segmentation
11.4.3 Percentage of Drug-Treated Patients
11.4.4 Drugs Included in Each Therapeutic Class
11.4.5 Launch and Patent Expiry Dates
11.4.6 General Pricing Assumptions
11.4.7 Individual Drug Assumptions
11.4.8 Pricing of Pipeline Agents
11.4.9 Generic Erosion
11.5 Physicians and Specialists Included in this Study
11.6 About the Authors
11.6.1 Author
11.6.2 Therapy Area Director
11.6.3 Epidemiologist
11.6.4 Global Director of Therapy Analysis and Epidemiology
11.7 About GlobalData
11.8 Disclaimer
1.1 List of Tables
Table 1: Role of the Different Theories in the Pathogenesis of Endometriosis
Table 2: Symptoms of Endometriosis
Table 3: Most Commonly Used Guidelines by Country
Table 4: Risk Factors and Comorbidities for Endometriosis
Table 5: Stages of Endometriosis According to the American Society for Reproductive Medicine Criteria
Table 6: 7MM, Sources of Epidemiological Data Used for the Forecast of Laparoscopy-Confirmed Diagnosed Incident Cases of Endometriosis
Table 7: 7MM, Sources of Epidemiological Data Used for the Forecast of Laparoscopy-Confirmed Diagnosed Prevalent Cases of Endometriosis
Table 8: 7MM, Sources of Epidemiological Data Used for the Classification of Laparoscopy-Confirmed Diagnosed Prevalent Cases of Endometriosis According to the ASRM Stages I-IV
Table 9: 7MM, Sources of Epidemiological Data Used for the Classification of Laparoscopy-Confirmed Diagnosed Prevalent Cases of Endometriosis According to the Phenotype
Table 10: Sources Used to Forecast Laparoscopy Confirmation Status for Diagnosed Incident Cases and Diagnosed Prevalent Cases of Endometriosis
Table 11: 7MM, Sources Not Used in Epidemiological Analysis of Endometriosis
Table 12: 7MM, Laparoscopy-Confirmed Diagnosed Incident Cases of Endometriosis, Ages 12-54 Years, Women, N, 2015-2025
Table 13: 7MM, Age-Specific Laparoscopy-Confirmed Diagnosed Incident Cases of Endometriosis, Women, N (Row %), 2015
Table 14: 7MM, Laparoscopy-Confirmed Diagnosed Prevalent Cases of Endometriosis, Ages 12-54 Years, Women, N, 2015-2025
Table 15: 7MM, Age-Specific Laparoscopy-Confirmed Diagnosed Prevalent Cases of Endometriosis, Women, N (Row %), 2015
Table 16: Drugs Approved for Endometriosis
Table 17: Product Profile - Zoladex
Table 18: SWOT Analysis - Zoladex
Table 19: Product Profile - Lupron
Table 20: SWOT Analysis - Lupron
Table 21: Product Profile - Synarel
Table 22: SWOT Analysis - Synarel
Table 23: Product Profile - Buserelin Acetate
Table 24: SWOT Analysis - Suprefact
Table 25: Product Profile - Triptorelin
Table 26: SWOT Analysis - Decapeptyl SR
Table 27: Product Profile - Visanne
Table 28: SWOT Analysis - Visanne
Table 29: Product Profile - Depo-SubQ Provera 104
Table 30: SWOT Analysis - Depo-SubQ Provera 104
Table 31: Hormonal Contraceptives Commonly Used Off-Label for Endometriosis
Table 32: Unmet Need and Opportunity in Endometriosis
Table 33: Range of Novel and Well-Known Non-hormonal Compounds Under Academic Investigation for Endometriosis and Endometriosis-Related Systemic Inflammation
Table 34: Common Primary and Secondary Outcome Measures in Endometriosis Clinical Trials
Table 35: Design of the Most Relevant Current Phase II and III Clinical Trials in Endometriosis
Table 36: GnRH Antagonists in Phase III and Phase II Development - 2016
Table 37: Product Profile - Elagolix
Table 38: SWOT Analysis - Elagolix
Table 39: Product Profile - Relugolix
Table 40: SWOT Analysis - Relugolix
Table 41: Early-Stage Pipeline Products for Endometriosis
Table 42: Clinical Benchmark of Key Pipeline Products for Endometriosis
Table 43: Commercial Benchmark of Key Pipeline Drugs for Endometriosis
Table 44: Top-Line Sales Forecasts ($M) for Endometriosis, 2015-2025
Table 45: Key Events Impacting Sales for Endometriosis, 2015-2025
Table 46: Endometriosis Market - Drivers and Barriers, 2015-2025
Table 47: Key Launch Dates
Table 48: Key Patent Expiries
Table 49: High-Prescribing Physicians (Non-KOLs), Surveyed by Country, 2016
1.2 List of Figures
Figure 1: Sources of Estradiol in Endometriosis Tissue and Targets of the Current Medical Therapy
Figure 2: 7MM, Laparoscopy-Confirmed Diagnosed Incident Cases of Endometriosis, Ages 12-54 Years, Women, N, 2015-2025
Figure 3: 7MM, Laparoscopy-Confirmed Diagnosed Incident Cases of Endometriosis by Age Group, Women, N, 2015
Figure 4: 7MM, Age-Standardized Laparoscopy-Confirmed Diagnosed Incidence of Endometriosis (Cases per 100,000 Population), Ages 12-54 Years, Women, 2015
Figure 5: 7MM, Diagnosed Incident Cases of Endometriosis Segmented by Laparoscopy Confirmation Status, Ages 12-54 Years, Women, N, 2015
Figure 6: 7MM, Laparoscopy-Confirmed Diagnosed Prevalent Cases of Endometriosis, Ages 12-54 Years, Women, N, 2015-2025
Figure 7: 7MM, Age-Specific Laparoscopy-Confirmed Diagnosed Prevalent Cases of Endometriosis, Women, N, 2015
Figure 8: 7MM, Age-Standardized Laparoscopy-Confirmed Diagnosed Prevalence of Endometriosis (%), Ages 12-54 Years, Women, 2015
Figure 9: 7MM, Diagnosed Prevalent Cases of Endometriosis Segmented by Laparoscopy Confirmation Status, Ages 12-54 Years, Women, N, 2015
Figure 10: 7MM, Laparoscopy-Confirmed Diagnosed Prevalent Cases of Endometriosis Segmented by ASRM Disease Stages, Ages 12-54 Years, Women, N, 2015
Figure 11: 7MM, Laparoscopy-Confirmed Diagnosed Prevalent Cases of Endometriosis Segmented by Phenotype, Ages 12-54 Years, Women, N, 2015
Figure 12: Endometriosis Pipeline by Phase, 2016
Figure 13: Advantages of GnRH Antagonists Over GnRH Agonists
Figure 14: Competitive Assessment of Key Pipeline Drugs for Endometriosis, 2015-2025
Figure 15: Sales for the Endometriosis Market, 7MM, 2015-2025
Figure 16: Global Sales for Endometriosis by Drug Class, 2015 and 2025

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