OpportunityAnalyzer: Endometriosis – Opportunity Analysis and Forecast to 2025

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.

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.

Key Highlights

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?

Companies mentioned

Pfizer

Bayer

Evotec

AbbVie

Nobelpharma

Takeda

Mochida

Abbott

Sanofi

AstraZeneca

Astellas Pharma

Ipsen

Ferring

Mitsubishi

Merck

Organon

Kissei

Teva

Barr Laboratories

Duramed Pharma

Resource Medical ...

Pfizer

Bayer

Evotec

AbbVie

Nobelpharma

Takeda

Mochida

Abbott

Sanofi

AstraZeneca

Astellas Pharma

Ipsen

Ferring

Mitsubishi

Merck

Organon

Kissei

Teva

Barr Laboratories

Duramed Pharma

Resource Medical

Laboratory Biodim

Rottapharm SL

Repros

PregLem

Nobelpharma

Gedeon Richter

Euroscreen

GlaxoSmithKline

Nippon Shinyaku

SK Chemicals

Evestra

Forendo Pharma

ElexoPharm

Philogen

ValiRx

Viteava Pharma

Dongkook Pharma

Luye Pharma Group

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology

3.2Pathophysiology

3.3Symptoms ...

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology

3.2Pathophysiology

3.3Symptoms and Diagnosis

3.4Clinical Prognosis

3.5Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1US

4.3.25EU

4.3.3Japan

4.4Forecast Methodology

4.4.1Sources Used Tables

4.4.2Forecast Assumptions and Methods

4.4.3Sources Not Used

4.5Epidemiological Forecast for Endometriosis (2015–2025)

4.5.1Diagnosed Incident Cases

4.5.2Diagnosed Prevalent Cases

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Current Treatment Options

5.1Overview

5.2GnRH Agonists

5.2.1Zoladex (Goserelin Acetate)

5.2.2Lupron Depot (Leuprolide Acetate)

5.2.3Synarel (Nafarelin Acetate Nasal Spray)

5.2.4Buserelin Acetate

5.2.5Triptorelin

5.3Progestins/Progestogens

5.3.1Dienogest

5.3.2Depo-SubQ Provera 104 (Medroxyprogesterone Injection)

5.4Off-Label Treatment: Hormonal Contraceptives, NSAIDs, and Aromatase Inhibitors

5.4.1Hormonal Contraceptives

5.4.2Nonsteroidal Anti-inflammatory Drugs

5.4.3Aromatase Inhibitors

6Unmet Needs Assessment and Opportunity Analysis

6.1Overview

6.2Noninvasive Diagnostics

6.2.1Unmet Needs

6.2.2Gap Analysis

6.2.3Opportunity

6.3Disease Awareness and Education of Medical Professionals

6.3.1Unmet Needs

6.3.2Gap Analysis

6.3.3Opportunity

6.4More Effective Drugs with Long-Term Safety and Tolerability

6.4.1Unmet Needs

6.4.2Gap Analysis

6.4.3Opportunity

6.5Non-hormonal Therapies

6.5.1Unmet Needs

6.5.2Gap Analysis

6.5.3Opportunity

6.6Better Understanding of the Disease Etiology and Pathophysiology

6.6.1Unmet Needs

6.6.2Gap Analysis

6.6.3Opportunity

7Research and Development Strategies

7.1Overview

7.2Reformulations and Label Expansion

7.3The Race for the Development of GnRH Antagonists

7.4Development of Novel Non-hormonal Therapies

7.5Alliances and In-Licensing Strategies

7.6Maximizing Return-on-Investment by Targeting Secondary Indications

8Clinical Trial Design

8.1Overview

8.2Defining Efficacy in Endometriosis Clinical Trials

8.2.1Pain Scales

8.2.2Quality-of-Life Assessment as an Efficacy Tool

8.3Selection of an Active Comparator

8.4Diversity of the Endpoints Used

8.5Future Trends in Endometriosis Clinical Trial Design

9Pipeline Assessment

9.1Overview

9.2Promising Drugs in Late-Stage Development

9.2.1Elagolix

9.2.2Relugolix

9.3Innovative Early-Stage Approaches

9.3.1Overview

9.3.2GnRH Antagonists

9.3.3Aromatase Inhibitors

9.3.4Selective Progesterone Receptor Modulators

9.3.5Selective Estrogen Receptor Modulators

9.3.6Novel Hormonal Therapies

9.3.7Anti-inflammatory Approaches

9.3.8Anti-angiogenic Agents

10Pipeline Valuation Analysis

10.1Clinical Benchmark of Key Pipeline Drugs

10.2Commercial Benchmark of Key Pipeline Drugs

10.3Competitive Assessment

10.4Top-Line 10-Year Forecast

10.4.1US

10.4.25EU

10.4.3Japan

10.5Drivers and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Prevalent Cases of Endometriosis

11.4.2Patient Population Segmentation

11.4.3Percentage of Drug-Treated Patients

11.4.4Drugs Included in Each Therapeutic Class

11.4.5Launch and Patent Expiry Dates

11.4.6General Pricing Assumptions

11.4.7Individual Drug Assumptions

11.4.8Pricing of Pipeline Agents

11.4.9Generic Erosion

11.5Physicians and Specialists Included in this Study

11.6About the Authors

11.6.1Author

11.6.2Therapy Area Director

11.6.3Epidemiologist

11.6.4Global Director of Therapy Analysis and Epidemiology

11.7About GlobalData

11.8Disclaimer

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 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

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 ...

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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