OpportunityAnalyzer: Endometriosis – Opportunity Analysis and Forecasts to 2017

Pages: 138 Published: December 01, 2013 Report Code: GDHC015POA

  • Overview
  • Key Players
  • Contents
  • Tables
  • Figures
  • Listen
    iSpeech

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 Highlights

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 Players

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

Table of Contents

1Table of Contents1

1.1List of Tables6

1.2List of Figures8

2Executive Summary9

2.1Global Endometriosis Therapeutics Market Expected to Decrease at a Compound Annual Growth Rate of

0.19% During 2012–201710

2.2Endometriosis Market Plagued by High Unmet Need11

2.3GnRH Antagonists will Replace GnRH Agonists, but Their High Price Will Limit Further Adoption12

2.4Opportunity Remains High for Innovative Therapies13

2.5What Do Physicians Think?13

3Introduction15

3.1Catalyst15

3.2Related Reports15

4Disease Overview16

4.1Etiology and Pathophysiology16

4.2Etiology18

4.3Pathophysiology18

4.4Clinical Prognosis20

4.5Quality of Life21

4.6Symptoms and Diagnosis21

5Epidemiology23

5.1Risk Factors and Comorbidities23

5.1.1Family history is a strong predictor for the risk of endometriosis23

Late age at menarche protects women from developing endometriosis.24

5.1.2Higher parity decreases the risk for endometriosis25

5.2Global Trends26

5.2.1US27

5.2.25EU28

5.2.3Forecast Methodology28

5.2.4Sources Used30

5.2.5Sources Not Used32

5.2.6Forecast Assumptions and Methods33

5.3Epidemiological Forecast for Endometriosis (2012–2022)35

5.3.1Diagnosed Prevalent Cases of Endometriosis35

5.3.2Age-Specific Prevalent Cases of Endometriosis36

5.3.3Age-Standardized Diagnosed Prevalence of Endometriosis38

5.3.4Diagnosed Prevalent Cases of Endometriosis by Stage39

5.4Discussion41

5.4.1Epidemiological Forecast Insight41

5.4.2Limitations of the Analysis42

5.4.3Strengths of the Analysis43

6Current Treatment Options45

6.1Overview45

6.2Product Profiles – Major Brands47

6.2.1Zoladex (goserelin acetate)47

6.2.2Lupron (leuprolide acetate depot)50

6.2.3Synarel (nafarelin nasal spray)53

6.2.4Visanne (dienogest)55

6.2.5Depo-SubQ Provera 104 (medroxyprogesterone injection)58

6.2.6Danazol (Danocrine)60

6.2.7Off-Label Treatment: Combined Oral Contraceptives, Progestins, and NSAIDs62

7Unmet Needs Assessment and Opportunity Analysis65

7.1Overview65

7.2Unmet Needs Analysis67

7.2.1Unmet Need: Non-Invasive Diagnostics67

7.2.2Unmet Need: Non-Hormonal Therapies68

7.2.3Unmet Need: Better Pain Management68

7.2.4Unmet Need: Better Understanding of the Disease Pathology to Prevent Recurrence69

7.2.5Unmet Need: Identification of Biomarkers69

7.2.6Unmet Need: Transparency in Clinical Trials70

7.3Opportunity Analysis70

7.3.1Opportunity: Biomarkers Identification70

7.3.2Opportunity: Treatment Options for Adolescents71

7.3.3Opportunity: Drugs Targeting Pain Pathways72

7.3.4Opportunity: Novel Targets72

7.3.5Opportunity: Efficacious Treatments Suitable for Long-Term Use73

7.4Research and Development Strategies73

7.4.1Overview73

7.4.2The Race for the Development of GnRH Antagonists74

7.4.3Alliances and In-Licensing Strategies75

7.4.4Maximizing Return-on-Investment by Targeting Secondary indications75

7.5Clinical Trial Design76

7.5.1Overview76

7.5.2Defining Efficacy in Endometriosis Clinical Trials76

7.5.3Future Trends in Endometriosis Clinical Trial Design80

8Pipeline Assessment81

8.1Overview81

8.2Promising Drugs in Development83

8.2.1Elagolix (ABT-602)84

8.2.2Relugolix (TAK-385)87

8.2.3ASP-170789

8.3Innovative Early-Stage Approaches91

8.3.1Overview91

8.3.2Anti-Inflammatory Approaches93

8.3.3Cellular Adhesion94

8.3.4Angiogenesis Endometriotic Implants94

8.3.5Selective Progesterone Receptor Modulators95

8.3.6Aromatase Inhibitors95

9Pipeline Valuation Analysis96

9.1Overview96

9.2Clinical Benchmarking of Key Pipeline Drugs97

9.3Commercial Benchmarking of Key Pipeline Drugs100

9.4Competitive Assessment102

9.5Top-Line, Five-Year Forecasts103

9.5.1Overview103

9.5.2US105

9.5.35EU106

10Appendix108

10.1Bibliography108

10.2Abbreviations118

10.3Methodology121

10.4Forecasting Methodology121

10.4.1Diagnosed Endometriosis Patients122

10.4.2Percent Drug Treated Patients123

10.4.3Drugs Included in Each Therapeutic Class123

10.4.4Launch and Patent Expiry Dates124

10.4.5General Pricing Assumptions124

10.4.6Individual Drug Assumptions125

10.4.7Generic Erosion127

10.4.8Pricing of Pipeline Agents128

10.5Physicians and Specialists Included in This Study128

10.6About the Authors130

10.6.1Author130

10.6.2Epidemiologist130

10.6.3Global Director of Epidemiology and Health Policy130

10.6.4Global Head of Healthcare131

10.7About GlobalData131

10.8Contact Us132

10.9Disclaimer132

List of Tables

Table 1:Endometriosis Therapeutics: Key Metrics in Six Major Markets (6MM), 2012–20179

Table 2:ICD-9-CM Codes for Endometriosis and Pelvic Pain17

Table 3: Stages of Endometriosis19

Table 4: Symptoms of Endometriosis22

Table 5: Risk Factors for Endometriosis23

Table 6: Epidemiological Sources for the Diagnosed Prevalence and Stages of Endometriosis30

Table 7: 6MM, Diagnosed Prevalent Cases of Endometriosis, Ages 15–49 Years, N, 2012–202236

Table 8: 6MM, Diagnosed Prevalent Cases of Endometriosis, by Age, N, Row (%), 201237

Table 9: Leading Branded Treatments for Endometriosis47

Table 10: Product Profile – Zoladex49

Table 11: SWOT Analysis – Zoladex50

Table 12: Product Profile – Lupron51

Table 13: SWOT Analysis – Lupron53

Table 14: Product Profile – Synarel54

Table 15: SWOT Analysis – Synarel55

Table 16: Product Profile – Visanne56

Table 17: SWOT Analysis – Visanne57

Table 18: Product Profile – Depo-SubQ Provera 10458

Table 19: SWOT Analysis – Depo-SubQ Provera 10460

Table 20: Product Profile – Danazol61

Table 21: SWOT Analysis – Danazol62

Table 22: Branded Hormonal Contraceptives Commonly Used Off Label for Endometriosis63

Table 23: Progestins Commonly Used Off Label for Endometriosis64

Table 24: Overall Unmet Needs – Current Level of Attainment67

Table 25: Common Primary and Secondary Outcome Measures in Endometriosis Clinical Trials77

Table 26: Design of the Most Relevant Current Phase II and III Clinical Trials in Endometriosis79

Table 27: Endometriosis – Late-Stage Pipeline, 201283

Table 28: Product Profile – Elagolix85

Table 29: SWOT Analysis – Elagolix87

Table 30: Product Profile – Relugolix88

Table 31: SWOT Analysis – Relugolix89

Table 32: Product Profile – ASP-170790

Table 33: SWOT Analysis – ASP-101791

Table 34: Early-Stage Pipeline Products for Endometriosis92

Table 35: Clinical Benchmarking of Key Pipeline Drugs for Endometriosis97

Table 36: Commercial Benchmarking of Key Pipeline Drugs for Endometriosis101

Table 37:Top Line Sales Forecasts ($) for Endometriosis, 2012–2017103

Table 38: Endometriosis Therapeutics Market – Drivers and Barriers, 2012 – 2017105

Table 39: Key Events Influencing Sales for Endometriosis, 2012–2017105

Table 40: Key Launch Dates124

Table 41: Key Patent Expiries124

List of Figures

Figure 1: Global Sales for Endometriosis Therapeutics by Region, 2012–201711

Figure 2: Competitive Assessment of Marketed and Late-Stage Pipeline Agents in Endometriosis Therapeutics, 2012–201713

Figure 3: 6MM, Diagnosed Prevalent Cases of Endometriosis, Ages 15–49 Years, N, 2012–202236

Figure 4: 6MM, Diagnosed Prevalent Cases of Endometriosis, by Age, N, 201238

Figure 5:6MM, Age-Standardized Diagnosed Prevalence (%) of Endometriosis, Ages 15–49 Years, 201239

Figure 6: 6MM, Diagnosed Prevalent Cases of Endometriosis by Stage, Ages 15–49 Years, 201240

Figure 7: Endometriosis Pipeline by Phase, 2012–201783

Figure 8: Advantages of GnRH Antagonists Over GnRH Agonists84

Figure 9: Competitive Assessment of Late-Stage Pipeline Agents in Endometriosis Therapeutics, 2012–2017103

Figure 10: Global Sales for Endometriosis Therapeutics by Region, 2012–2017104

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