OpportunityAnalyzer: Endometriosis - Opportunity Analysis and Forecast to 2025

  • ID: 4051418
  • Drug Pipelines
  • 288 pages
  • GlobalData
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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. The author estimates the endometriosis prevalence, including suspected and confirmed cases, to grow from 9.6 Million to 11.3 Million worldwide between 2015 and 2025.

In 2015 sales for the endometriosis market at approximately $1.72B across the 7MM, encompassing the US, the five major European countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. By 2025, the author expects the overall market to grow at a moderate compound annual growth rate (CAGR) of 1.7% to reach sales of $2.04B over the 10-year period. The US and Japanese markets are anticipated to grow the fastest of the three regions, recording CAGRs of 2.0% and 1.8% respectively.

Major drivers of the endometriosis market during the forecast period will include:
- The launch of elagolix in 2018 will be the main driver of growth in global sales of drugs in the endometriosis market.
- Better disease awareness will mean earlier diagnoses, preventing the need for surgery and thus allowing for increased use of medications.
- Improvements in noninvasive diagnostic methods should further increase the number of early diagnoses and help avoid the need for surgery.

Despite the availability of 16 marketed therapies from seven different drug classes, the level of unmet needs in the endometriosis disease market is considerable. Current medical therapies treat endometriosis by targeting the estrogen production pathways (gonadotropin-releasing hormone [GnRH] agonists) or by modulating the menstrual cycle (hormonal contraceptives, progestins).

Edit Kovalcsik, Analyst, explains: “AbbVie’s pipeline drug elagolix, currently in Phase III development, promises to be the first oral gonadotropin-releasing hormone (GnRH) antagonist approved for endometriosis. In terms of safety and tolerability, elagolix avoids the detrimental hypoestrogenic side effects seen with GnRH agonists such as AbbVie’s Lupron and AstraZeneca’s Zoladex (goserelin acetate)”.

The report “OpportunityAnalyzer: Endometriosis - Opportunity Analysis and Forecast to 2025” provides an overview of endometriosis, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines and analysis of endometriosis therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025. Moreover, this report covers strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the endometriosis therapeutics market and provides comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs. This report also provides the analysis of the current and future market competition in the global endometriosis therapeutics market.

Companies mentioned in this report: 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.
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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

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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FEATURED COMPANIES

  • Abbott
  • Dongkook Pharma
  • Ferring
  • Laboratory Biodim
  • Nobelpharma
  • Repros
  • MORE
Endometriosis market to grow steadily, surpassing $2 billion by 2025.

The endometriosis market across the seven major countries of the US, France, Germany, Italy, Spain, the UK, and Japan, is set to rise from around $1.72 billion in 2015 to just over $2 billion by 2025, representing a compound annual growth rate (CAGR) of 1.7%, according to research.

The company’s latest report states that this modest growth will be driven by increased disease awareness and earlier diagnoses, improvements in non-invasive diagnostic methods, and, most importantly, the launch of elagolix in the US and Europe 2018.

Edit Kovalcsik, Ph.D., the Analyst covering Cardiovascular and Metabolic Disorders, explains: “AbbVie’s pipeline drug elagolix, currently in Phase III development, promises to be the first oral gonadotropin-releasing hormone (GnRH) antagonist approved for endometriosis. In terms of safety and tolerability, elagolix avoids the detrimental hypoestrogenic side effects seen with GnRH agonists such as AbbVie’s Lupron and AstraZeneca’s Zoladex (goserelin acetate).

“Based on their improved safety profile, GnRH antagonists like elagolix are likely to be priced at a premium over GnRH agonists such as Lupron, and therefore their sales will significantly contribute to the endometriosis market growth.

“According to key opinion leaders interviewed, an oral formulation will be a welcome addition to the field because it provides doctors with increased control over dosing and allows for the immediate cessation of therapy, if necessary.”

The author expects much greater sales of elagolix in the US than in the major European countries, due to the significantly larger annual cost of therapy (over $7,000 in the US compared to around $1,000 across the five European markets). Elagolix will help increase the proportion of sales made by branded products for endometriosis in the US, a market that is currently dominated by cheaper, generic drugs.

In Japan, the launch of GnRH antagonist relugolix will have a minimal impact on the endometriosis market, with the drug, anticipated to launch in 2021, only contributing 2% towards drug sales in 2025. However, the Japanese market will still undergo sustained growth during the forecast period.

Kovalcsik continues: “This can be partially explained by the enduring popularity of branded drugs for the treatment of endometriosis. Mochida’s Dinagest (dienogest) in particular is the most expensive drug used to treat endometriosis in Japan, with an annual cost of nearly $3,000. The author expects Dinagest to experience an increase in sales at a CAGR of 1.5% from 2015 to 2025, remaining the most profitable drug used to treat the condition in Japan.”

- Comments provided by Edit Kovalcsik, Ph.D., the Analyst covering Cardiovascular and Metabolic Disorders.
- Information based on the report: OpportunityAnalyzer: Endometriosis - Opportunity Analysis and Forecast to 2025.
- This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by a team of industry experts.
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  • 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
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