OpportunityAnalyzer: Endometriosis - Opportunity Analysis and Forecasts to 2017

Summary

Endometriosis is a gynecological disorder affecting women of childbearing age. This inflammatory condition is characterized by the growth of endometrial tissues outside of the uterus, and can cause chronic painful menstruation, painful intercourse, and infertility. For many women, endometriosis-associated pain can be so debilitating that it affects their ability to perform daily functions and significantly deters their quality of life.

The KOL’s agree- patients with endometriosis have significant unmet needs due to the lack of approved treatment options that have both continuous efficacy and a favorable long-term safety profiles. Although the KOLs are optimistic about the potential approval of GnRH antagonists, they still foresee that unmet needs will persist. Being orally active is a major benefit for GnRH antagonists. As such GlobalData foresees they will rapidly shift market share away from GnRH agonists. However their price will limit penetration in other patient segments. Ultimately, since none of the marketed, off-label, or pipeline drugs are curative, significant opportunity will remain for safe, efficacious therapies that target the root cause of the condition.

In 2012, the global market was largely dominated by the US, with sales of $1.1bn. Combined sales in the 5EU were estimated to be $137.6m. By 2017, GlobalData forecasts global endometriosis therapeutics sales to grow slowly to $1.2bn at a compound annual growth rate (CAGR) of 0.19%.

Highlights

Key Questions Answered

- The endometriosis therapeutics market has had weak competition due to a lack of approved therapies, and high rates of off-label drug use. What are the underlying unmet needs in this market? What opportunities will remain after elagolix is launched?
- The late-stage pipeline is comprised of GnRH antagonists. What sort of impact will these therapies have on this market? Which will emerge as market leaders? How will these products fare against existing therapies?
- The endometriosis therapeutics market has considerable unmet needs due to low diagnosis rates, minimal disease awareness, and lack of a well-tolerated long-term treatment options. Which drivers and barriers will affect the market landscape? What trends can be expected in each of US and 5EU?

Key Findings

- The single most important driver of growth will be the launch of novel agents with superior safety and more convenient oral formulations
- GnRH agonists will rapidly shift market share from GnRH agonists however their price will limit penetration in other patient share segments
- Incomplete knowledge regarding disease pathogenesis and pathophysiology creates a major obstacle in the development of novel therapeutics
- Ultimately, since none of the marketed, off-label, and pipeline drugs are curative, significant opportunity will remain for safe, efficacious therapies that target the root cause of the condition.

Scope

- Overview of endometriosis, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

- Annualized endometriosis therapeutics market revenue, annual cost of therapy, and top line US and 5EU market forecasts from 2012 to 2017.

- Key topics covered include: strategic competitor assessment, market characterization, unmet needs, 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

- 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 2012-2017.

- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

1 Table of Contents
1 Table of Contents 7


2 Introduction 14
2.1 Catalyst 14
2.2 Related Reports 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology 15
3.2 Etiology 17
3.3 Pathophysiology 17
3.4 Clinical Prognosis 20
3.5 Quality of Life 20
3.6 Symptoms and Diagnosis 21
4 Epidemiology 22
4.1 Risk Factors and Comorbidities 22
4.1.1 Family history is a strong predictor for the risk of endometriosis 22
4.1.2 Late age at menarche protects women from developing endometriosis. 23
4.1.3 Higher parity decreases the risk for endometriosis 24
4.2 Global Trends 26
4.2.1 US 27
4.2.2 5EU 27
4.2.3 Forecast Methodology 28
4.2.4 Sources Used 29
4.2.5 Sources Not Used 32
4.2.6 Forecast Assumptions and Methods 32
4.3 Epidemiological Forecast for Endometriosis (2012-2022) 35
4.3.1 Diagnosed Prevalent Cases of Endometriosis 35
4.3.2 Age-Specific Prevalent Cases of Endometriosis 36
4.3.3 Age-Standardized Diagnosed Prevalence of Endometriosis 38
4.3.4 Diagnosed Prevalent Cases of Endometriosis by Stage 39
4.4 Discussion 41
4.4.1 Epidemiological Forecast Insight 41
4.4.2 Limitations of the Analysis 42
4.4.3 Strengths of the Analysis 43
5 Current Treatment Options 45
5.1 Overview 45
5.2 Product Profiles - Major Brands 48
5.2.1 Zoladex (goserelin acetate) 48
5.2.2 Lupron (leuprolide acetate depot) 51
5.2.3 Synarel (nafarelin nasal spray) 53
5.2.4 Visanne (dienogest) 56
5.2.5 Depo-SubQ Provera 104 (medroxyprogesterone injection) 59
5.2.6 Danazol (Danocrine) 61
5.2.7 Off-Label Treatment: Combined Oral Contraceptives, Progestins, and NSAIDs 63
6 Unmet Needs Assessment and Opportunity Analysis 67
6.1 Overview 67
6.2 Unmet Needs Analysis 68
6.2.1 Unmet Need: Non-Invasive Diagnostics 68
6.2.2 Unmet Need: Non-Hormonal Therapies 69
6.2.3 Unmet Need: Better Pain Management 69
6.2.4 Unmet Need: Better Understanding of the Disease Pathology to Prevent Recurrence 70
6.2.5 Unmet Need: Identification of Biomarkers 71
6.2.6 Unmet Need: Transparency in Clinical Trials 71
6.3 Opportunity Analysis 72
6.3.1 Opportunity: Biomarkers Identification 72
6.3.2 Opportunity: Treatment Options for Adolescents 73
6.3.3 Opportunity: Drugs Targeting Pain Pathways 73
6.3.4 Opportunity: Novel Targets 74
6.3.5 Opportunity: Efficacious Treatments Suitable for Long-Term Use 74
6.4 Research and Development Strategies 75
6.4.1 Overview 75
6.4.2 The Race for the Development of GnRH Antagonists 76
6.4.3 Alliances and In-Licensing Strategies 76
6.4.4 Maximizing Return-on-Investment by Targeting Secondary indications 77
6.5 Clinical Trial Design 78
6.5.1 Overview 78
6.5.2 Defining Efficacy in Endometriosis Clinical Trials 78
6.5.3 Future Trends in Endometriosis Clinical Trial Design 83
7 Pipeline Assessment 84
7.1 Overview 84
7.2 Promising Drugs in Development 85
7.2.1 Elagolix (ABT-602) 86
7.2.2 Relugolix (TAK-385) 90
7.2.3 ASP-1707 92
7.3 Innovative Early-Stage Approaches 94
7.3.1 Overview 94
7.3.2 Anti-Inflammatory Approaches 96
7.3.3 Cellular Adhesion 97
7.3.4 Angiogenesis Endometriotic Implants 97
7.3.5 Selective Progesterone Receptor Modulators 98
7.3.6 Aromatase Inhibitors 99
8 Pipeline Valuation Analysis 100
8.1 Overview 100
8.2 Clinical Benchmarking of Key Pipeline Drugs 100
8.3 Commercial Benchmarking of Key Pipeline Drugs 104
8.4 Competitive Assessment 105
8.5 Top-Line, Five-Year Forecasts 106
8.5.1 Overview 106
8.5.2 US 109
8.5.3 5EU 110
9 Appendix 112
9.1 Bibliography 112
9.2 Abbreviations 123
9.3 Methodology 126
9.4 Forecasting Methodology 126
9.4.1 Diagnosed Endometriosis Patients 127
9.4.2 Percent Drug Treated Patients 128
9.4.3 Drugs Included in Each Therapeutic Class 129
9.4.4 Launch and Patent Expiry Dates 129
9.4.5 General Pricing Assumptions 130
9.4.6 Individual Drug Assumptions 130
9.4.7 Generic Erosion 133
9.4.8 Pricing of Pipeline Agents 133
9.5 Physicians and Specialists Included in This Study 134
9.6 About the Authors 135
9.6.1 Author 135
9.6.2 Epidemiologist 135
9.6.3 Global Director of Epidemiology and Health Policy 136
9.6.4 Global Head of Healthcare 136
9.7 About GlobalData 137
9.8 Disclaimer 137

1.1 List of Tables
Table 1: ICD-9-CM Codes for Endometriosis and Pelvic Pain 16
Table 2: Stages of Endometriosis 18
Table 3: Symptoms of Endometriosis 21
Table 4: Risk Factors for Endometriosis 22
Table 5: Epidemiological Sources for the Diagnosed Prevalence and Stages of Endometriosis 29
Table 6: 6MM, Diagnosed Prevalent Cases of Endometriosis, Ages 15-49 Years, N, 2012-2022 35
Table 7: 6MM, Diagnosed Prevalent Cases of Endometriosis, by Age, N, Row (%), 2012 37
Table 8: Leading Branded Treatments for Endometriosis 47
Table 9: Product Profile - Zoladex 49
Table 10: SWOT Analysis - Zoladex 50
Table 11: Product Profile - Lupron 51
Table 12: SWOT Analysis - Lupron 53
Table 13: Product Profile - Synarel 54
Table 14: SWOT Analysis - Synarel 55
Table 15: Product Profile - Visanne 56
Table 16: SWOT Analysis - Visanne 58
Table 17: Product Profile - Depo-SubQ Provera 104 59
Table 18: SWOT Analysis - Depo-SubQ Provera 104 61
Table 19: Product Profile - Danazol 62
Table 20: SWOT Analysis - Danazol 63
Table 21: Branded Hormonal Contraceptives Commonly Used Off Label for Endometriosis 64
Table 22: Progestins Commonly Used Off Label for Endometriosis 65
Table 23: Overall Unmet Needs - Current Level of Attainment 68
Table 24: Common Primary and Secondary Outcome Measures in Endometriosis Clinical Trials 79
Table 25: Design of the Most Relevant Current Phase II and III Clinical Trials in Endometriosis 81
Table 26: Endometriosis - Late-Stage Pipeline, 2012 85
Table 27: Product Profile - Elagolix 87
Table 28: SWOT Analysis - Elagolix 89
Table 29: Product Profile - Relugolix 91
Table 30: SWOT Analysis - Relugolix 92
Table 31: Product Profile - ASP-1707 93
Table 32: SWOT Analysis - ASP-1017 94
Table 33: Early-Stage Pipeline Products for Endometriosis 95
Table 34: Clinical Benchmarking of Key Pipeline Drugs for Endometriosis 101
Table 35: Commercial Benchmarking of Key Pipeline Drugs for Endometriosis 104
Table 36: Top Line Sales Forecasts ($) for Endometriosis, 2012-2017 107
Table 37: Endometriosis Therapeutics Market - Drivers and Barriers, 2012 - 2017 109
Table 38: Key Events Influencing Sales for Endometriosis, 2012-2017 109
Table 39: Key Launch Dates 129
Table 40: Key Patent Expiries 129

1.2 List of Figures
Figure 1: 6MM, Diagnosed Prevalent Cases of Endometriosis, Ages 15-49 Years, N, 2012-2022 36
Figure 2: 6MM, Diagnosed Prevalent Cases of Endometriosis, by Age, N, 2012 37
Figure 3: 6MM, Age-Standardized Diagnosed Prevalence (%) of Endometriosis, Ages 15-49 Years, 2012 39
Figure 4: 6MM, Diagnosed Prevalent Cases of Endometriosis by Stage, Ages 15-49 Years, 2012 40
Figure 5: Endometriosis Pipeline by Phase, 2012-2017 85
Figure 6: Advantages of GnRH Antagonists Over GnRH Agonists 86
Figure 7: Competitive Assessment of Late-Stage Pipeline Agents in Endometriosis Therapeutics, 2012-2017 106
Figure 8: Global Sales for Endometriosis Therapeutics by Region, 2012-2017 108

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