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OpportunityAnalyzer: Endometriosis - Opportunity Analysis and Forecasts to 2017
Publication Date Feb 2014
Publisher GlobalData
Product Type Report
Pages 132
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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%.

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.

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.

Key Benefits
- 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.

List of Companies
Astellas
Astra Zeneca
Balonco
Bayer
ElexoPharm
Euroscreen
Evestra
Evotec
Forendo Pharma
Kissei
Lipicard
Neurocrine
Orphagen
Pfizer
QuatRX
Sanofi
SK Chemicals
Takeda
Teva
ValiRX
Warner Chilcott

Report at a Glance
Number of Companies Mentioned – 23
Classes of Marketed and Pipeline Drugs Forecasted – 5
Major Pipeline Drugs Profiled – 1 Phase III and 2 Phase II drugs
Markets Covered – US, France, Germany, Italy, Spain, UK

1    Table of Contents    1

1.1    List of Tables    6

1.2    List of Figures    8

2    Executive Summary    9

2.1    Global Endometriosis Therapeutics Market Expected to Decrease at a Compound Annual Growth Rate of 0.19% During 2012–2017    10

2.2    Endometriosis Market Plagued by High Unmet Need    11

2.3    GnRH Antagonists will Replace GnRH Agonists, but Their High Price Will Limit Further Adoption    12

2.4    Opportunity Remains High for Innovative Therapies    13

2.5    What Do Physicians Think?    13

3    Introduction    15

3.1    Catalyst    15

3.2    Related Reports    15

4    Disease Overview    16

4.1    Etiology and Pathophysiology    16

4.2    Etiology    18

4.3    Pathophysiology    18

4.4    Clinical Prognosis    20

4.5    Quality of Life    21

4.6    Symptoms and Diagnosis    21

5    Epidemiology    23

5.1    Risk Factors and Comorbidities    23

5.1.1    Family history is a strong predictor for the risk of endometriosis    23

Late age at menarche protects women from developing endometriosis.    24

5.1.2    Higher parity decreases the risk for endometriosis    25

5.2    Global Trends    26

5.2.1    US    27

5.2.2    5EU    28

5.2.3    Forecast Methodology    28

5.2.4    Sources Used    30

5.2.5    Sources Not Used    32

5.2.6    Forecast Assumptions and Methods    33

5.3    Epidemiological Forecast for Endometriosis (2012–2022)    35

5.3.1    Diagnosed Prevalent Cases of Endometriosis    35

5.3.2    Age-Specific Prevalent Cases of Endometriosis    36

5.3.3    Age-Standardized Diagnosed Prevalence of Endometriosis    38

5.3.4    Diagnosed Prevalent Cases of Endometriosis by Stage    39

5.4    Discussion    41

5.4.1    Epidemiological Forecast Insight    41

5.4.2    Limitations of the Analysis    42

5.4.3    Strengths of the Analysis    43

6    Current Treatment Options    45

6.1    Overview    45

6.2    Product Profiles – Major Brands    47

6.2.1    Zoladex (goserelin acetate)    47

6.2.2    Lupron (leuprolide acetate depot)    50

6.2.3    Synarel (nafarelin nasal spray)    53

6.2.4    Visanne (dienogest)    55

6.2.5    Depo-SubQ Provera 104 (medroxyprogesterone injection)    58

6.2.6    Danazol (Danocrine)    60

6.2.7    Off-Label Treatment: Combined Oral Contraceptives, Progestins, and NSAIDs    62

7    Unmet Needs Assessment and Opportunity Analysis    65

7.1    Overview    65

7.2    Unmet Needs Analysis    67

7.2.1    Unmet Need: Non-Invasive Diagnostics    67

7.2.2    Unmet Need: Non-Hormonal Therapies    68

7.2.3    Unmet Need: Better Pain Management    68

7.2.4    Unmet Need: Better Understanding of the Disease Pathology to Prevent Recurrence    69

7.2.5    Unmet Need: Identification of Biomarkers    69

7.2.6    Unmet Need: Transparency in Clinical Trials    70

7.3    Opportunity Analysis    70

7.3.1    Opportunity: Biomarkers Identification    70

7.3.2    Opportunity: Treatment Options for Adolescents    71

7.3.3    Opportunity: Drugs Targeting Pain Pathways    72

7.3.4    Opportunity: Novel Targets    72

7.3.5    Opportunity: Efficacious Treatments Suitable for Long-Term Use    73

7.4    Research and Development Strategies    73

7.4.1    Overview    73

7.4.2    The Race for the Development of GnRH Antagonists    74

7.4.3    Alliances and In-Licensing Strategies    75

7.4.4    Maximizing Return-on-Investment by Targeting Secondary indications    75

7.5    Clinical Trial Design    76

7.5.1    Overview    76

7.5.2    Defining Efficacy in Endometriosis Clinical Trials    76

7.5.3    Future Trends in Endometriosis Clinical Trial Design    80

8    Pipeline Assessment    81

8.1    Overview    81

8.2    Promising Drugs in Development    83

8.2.1    Elagolix (ABT-602)    84

8.2.2    Relugolix (TAK-385)    87

8.2.3    ASP-1707    89

8.3    Innovative Early-Stage Approaches    91

8.3.1    Overview    91

8.3.2    Anti-Inflammatory Approaches    93

8.3.3    Cellular Adhesion    94

8.3.4    Angiogenesis Endometriotic Implants    94

8.3.5    Selective Progesterone Receptor Modulators    95

8.3.6    Aromatase Inhibitors    95

9    Pipeline Valuation Analysis    96

9.1    Overview    96

9.2    Clinical Benchmarking of Key Pipeline Drugs    97

9.3    Commercial Benchmarking of Key Pipeline Drugs    100

9.4    Competitive Assessment    102

9.5    Top-Line, Five-Year Forecasts    103

9.5.1    Overview    103

9.5.2    US    105

9.5.3    5EU    106

10    Appendix    108

10.1    Bibliography    108

10.2    Abbreviations    118

10.3    Methodology    121

10.4    Forecasting Methodology    121

10.4.1    Diagnosed Endometriosis Patients    122

10.4.2    Percent Drug Treated Patients    123

10.4.3    Drugs Included in Each Therapeutic Class    123

10.4.4    Launch and Patent Expiry Dates    124

10.4.5    General Pricing Assumptions    124

10.4.6    Individual Drug Assumptions    125

10.4.7    Generic Erosion    127

10.4.8    Pricing of Pipeline Agents    128

10.5    Physicians and Specialists Included in This Study    128

10.6    About the Authors    130

10.6.1    Author    130

10.6.2    Epidemiologist    130

10.6.3    Global Director of Epidemiology and Health Policy    130

10.6.4    Global Head of Healthcare    131

10.7    About GlobalData    131

10.8    Contact Us    132

10.9    Disclaimer    132

List Of Tables
Table 1:    Endometriosis Therapeutics: Key Metrics in Six Major Markets (6MM), 2012–2017    9

Table 2:    ICD-9-CM Codes for Endometriosis and Pelvic Pain    17

Table 3: Stages of Endometriosis    19

Table 4: Symptoms of Endometriosis    22

Table 5: Risk Factors for Endometriosis    23

Table 6: Epidemiological Sources for the Diagnosed Prevalence and Stages of Endometriosis    30

Table 7: 6MM, Diagnosed Prevalent Cases of Endometriosis, Ages 15–49 Years, N, 2012–2022    36

Table 8: 6MM, Diagnosed Prevalent Cases of Endometriosis, by Age, N, Row (%), 2012    37

Table 9: Leading Branded Treatments for Endometriosis    47

Table 10: Product Profile – Zoladex    49

Table 11: SWOT Analysis – Zoladex    50

Table 12: Product Profile – Lupron    51

Table 13: SWOT Analysis – Lupron    53

Table 14: Product Profile – Synarel    54

Table 15: SWOT Analysis – Synarel    55

Table 16: Product Profile – Visanne    56

Table 17: SWOT Analysis – Visanne    57

Table 18: Product Profile – Depo-SubQ Provera 104    58

Table 19: SWOT Analysis – Depo-SubQ Provera 104    60

Table 20: Product Profile – Danazol    61

Table 21: SWOT Analysis – Danazol    62

Table 22: Branded Hormonal Contraceptives Commonly Used Off Label for Endometriosis    63

Table 23: Progestins Commonly Used Off Label for Endometriosis    64

Table 24: Overall Unmet Needs – Current Level of Attainment    67

Table 25: Common Primary and Secondary Outcome Measures in Endometriosis Clinical Trials    77

Table 26: Design of the Most Relevant Current Phase II and III Clinical Trials in Endometriosis    79

Table 27: Endometriosis – Late-Stage Pipeline, 2012    83

Table 28: Product Profile – Elagolix    85

Table 29: SWOT Analysis – Elagolix    87

Table 30: Product Profile – Relugolix    88

Table 31: SWOT Analysis – Relugolix    89

Table 32: Product Profile – ASP-1707    90

Table 33: SWOT Analysis – ASP-1017    91

Table 34: Early-Stage Pipeline Products for Endometriosis    92

Table 35: Clinical Benchmarking of Key Pipeline Drugs for Endometriosis    97

Table 36: Commercial Benchmarking of Key Pipeline Drugs for Endometriosis    101

Table 37:    Top Line Sales Forecasts ($) for Endometriosis, 2012–2017    103

Table 38: Endometriosis Therapeutics Market – Drivers and Barriers, 2012 – 2017    105

Table 39: Key Events Influencing Sales for Endometriosis, 2012–2017    105

Table 40: Key Launch Dates    124

Table 41: Key Patent Expiries    124

List Of Figures
Figure 1: Global Sales for Endometriosis Therapeutics by Region, 2012–2017    11

Figure 2: Competitive Assessment of Marketed and Late-Stage Pipeline Agents in Endometriosis Therapeutics, 2012–2017 13

Figure 3: 6MM, Diagnosed Prevalent Cases of Endometriosis, Ages 15–49 Years, N, 2012–2022    36

Figure 4: 6MM, Diagnosed Prevalent Cases of Endometriosis, by Age, N, 2012    38

Figure 5:    6MM, Age-Standardized Diagnosed Prevalence (%) of Endometriosis, Ages 15–49 Years, 2012    39

Figure 6: 6MM, Diagnosed Prevalent Cases of Endometriosis by Stage, Ages 15–49 Years, 2012    40

Figure 7: Endometriosis Pipeline by Phase, 2012–2017    83

Figure 8: Advantages of GnRH Antagonists Over GnRH Agonists    84

Figure 9: Competitive Assessment of Late-Stage Pipeline Agents in Endometriosis Therapeutics, 2012–2017    103

Figure 10: Global Sales for Endometriosis Therapeutics by Region, 2012–2017    104

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