Pipeline Insight: Endometriosis - New therapies near market while more innovative targets still needed

Pipeline Insight: Endometriosis - New therapies near market while more innovative targets still needed published by Datamonitor in December, 2009. This report consists of Pages: 147 and the price starts from US $ 11400.

Introduction

Abstract

Introduction

Endometriosis is a common yet poorly understood gynecological disease that affects women of reproductive age. Symptoms include severe chronic pelvic pain and infertility. Endometriosis affects over 17 million women across the seven major markets. Nonetheless, its complex symptomatology contributes to difficult diagnosis and unclear etiology obstructs the discovery of disease modifying approaches.

Scope of this research

• Analysis of endometriosis etiology, symptomology, diagnosis, treatment, prevalence trends, and key unmet market needs.
• Review of the pre-clinical and clinical pipeline for new endometriosis therapies, including analysis of key R&D company strategies.
• In depth analysis of historic (200408) seven major markets and rest of the world trends with future (20092018) seven major market dynamics.
• Commercial and clinical assessment of key late-stage pipeline drugs, with opinion leader comment and region-specific sales forecasts to 2018.

Research and analysis highlights

Environmental factors, increased awareness and diagnosis will cause the incidence of endometriosis to increase in the seven major markets. Drugs in the market are not curative and do not provide long term pain relief yet there are only 13 agents in clinical development for the potential treatment of endometriosis.

Although contraceptives and progestogens are commonly used to treat endometriosis, these are mainly used off label. Bayer Schering will be able to use its sales and marketing resource to overcome the challenging task of convincing physicians to use its new endometriosis specific drug Visanne (dienogest) over other hormonal contraceptives.

Neurocrine' s elagolix is the first oral non peptide gonadotropin releasing hormone (GnRH) antagonist. Phase II trials have shown that it is effective in treating endometriosis and does not reduce bone mineral density during 6 months therapy. This will allow the drug to become market leading in 2018.

Key reasons to purchase this research

• Analyze competitive environment at time of product launch.
• Validate internal forecasts and market potential for pipeline products.
• Identify licensing opportunities based on company portfolio and market needs.

Table of Contents

OVERVIEW

• Catalyst
• Summary

EXECUTIVE SUMMARY

• Strategic scoping and focus
• Datamonitor insight into the endometriosis market
• Datamonitor pipeline assessment summary
• Related reports

1. PIPELINE OVERVIEW AND DYNAMICS

• Key findings
• Pipeline overview
  • Endometriosis research goals
  • Late-stage clinical endometriosis pipeline
  • Datamonitor pipeline assessment summary

• Key companies involved in the endometriosis pipeline
  • Bayer Schering - women' s health market leader

• Key R&D company strategies

2. ENDOMETRIOSIS - MARKET POTENTIAL

• Key findings
• Definition
  • Dynamic progression of endometriosis
  • Recurrence in endometriosis
  • Etiology
  • Symptoms
  • Risk factors
  • Diagnosis

• Patient segmentation
• Epidemiology
  • Seven major markets
  • Rest of the world

• Current treatment options
  • Treatment of pelvic pain

• Treatment guidelines
• Current gold standard
  • Lupron (leuprolide acetate, Abbott)

• Current and future seven major market overview
  • Endometriosis market definition
  • Seven major markets dynamics - endometriosis market will grow up to 2018
  • Regional dynamics - the US remains the largest market but Japan is the fastest growing.
  • Class dynamics - oral monophase contraceptives will remain market leaders for endometriosis treatment in 2018
  • Brand dynamics - key brands to lose leading status following generic incursion

• Rest of the world snapshot
  • The global endometriosis market displays weak growth
  • The rest of the world accounted for 24.3% of the global market in 2008
  • The rest of the world outstrips the seven major markets in terms of volume
  • Canada shows strong growth between 2007 and 2008 but BRIC grows more between 2004 and 2008

• Unmet need in endometriosis
  • Need for a non invasive diagnostic tool
  • Need to raise awareness both in the population and among physicians
  • Need for better drugs
  • Need for nonhormonal drugs as alternative treatments
  • Need for increased funding in the disease

• Target product profile versus current level of attainment

3. R&D APPROACH

• Key findings
• Clinical trial design in endometriosis
  • Patient inclusion
  • Clinical trial size
  • Placebo versus active control
  • Trial endpoints in endometriosis

4. PIPELINE ANALYSIS & FORECASTS

• Key findings
• Overview
  • Pipeline summary
  • Comparative forecasts

• Visanne (dienogest; Bayer Schering)
  • Drug overview
  • Drug profile
  • SWOT analysis
  • Clinical trial data
  • Datamonitor drug assessment for Visanne
  • Forecasts to 2018

• Elagolix (NBI-56418; Neurocrine)
  • Drug overview
  • Drug profile
  • SWOT analysis
  • Clinical trial data
  • Datamonitor drug assessment for elagolix
  • Forecasts to 2018

• Other drugs in development for the treatment of endometriosis
  • Tanezumab (PF-04383119; Pfizer)
  • Femathina (MPI-674; Meditrina)
  • Cetrorelix (AEterna Zentaris)

• Late-stage development compounds recently discontinued
  • Antiprogestogen development should be further investigated

5. INNOVATIVE EARLY-STAGE APPROACHES

• Key findings
• Innovative stage pipeline for endometriosis
• Blocking angiogenesis
  • Leptin receptor antagonist (Cancer Research Technology)

• Anti-inflammatory drugs
  • DXL-1215 (InNexus Biotechnology)

• 17 beta-hydroxysteroid dehydrogenase (17 beta-HSD)
  • HSD inhibitor (QuatRx Pharmaceuticals)

• The future of treatment in endometriosis
  • Genetic profiling will increase prevention of endometriosis
  • Increased incidence will drive an improvement in research leading to improved treatments

BIBLIOGRAPHY

• Journal papers
• Websites
• Datamonitor reports
• Conferences attended

APPENDIX

• Methodology
  • Market sizing methodology
  • Datamonitor forecast methodology

• Contributing experts

TABLES

• Table: R&D drug pipeline for endometriosis, 2009
• Table: Endometriosis risk factors
• Table: Diagnostic experience with endometriosis according to the type of physician seen first
• Table: Endometriosis differential diagnosis
• Table: Prevalence of endometriosis across the seven major markets, 2009
• Table: Trends in the prevalence of endometriosis across the seven major markets (000s), 2009 - 2018
• Table: Prevalence of endometriosis in women affected by chronic pelvic pain across the seven major markets, 2009
• Table: Trends in the prevalence of endometriosis in women affected by chronic pelvic pain across the seven major markets (000s), 2009 - 2018
• Table: Prevalence of endometriosis in infertile women across the seven major markets, 2009
• Table: Trends in the prevalence of endometriosis in infertile women across the seven major markets (000s), 2009 - 2018
• Table: Prevalence of endometriosis in Australia and Canada, 2009
• Table: Trends in the prevalence of endometriosis in Australia and Canada (000s), 2009 - 2018
• Table: Prevalence of endometriosis in the BRIC countries, 2009
• Table: Trends in the prevalence of endometriosis in the BRIC countries (000s), 2009 - 2018
• Table: Drugs approved for the treatment of endometriosis in the seven major markets, 2009
• Table: Lupron ( leuprolide acetate - drug profile, 2009
• Table: Lupron (leuprolide acetate, Abbott) side-effect profile in endometriosis patients
• Table: Lupron (leuprolide acetate, Abbott) effect on bone mineral density in patients with endometriosis
• Table: ICD-10 codes used to define the endometriosis market
• Table: Seven major market sales ($m) dynamics of the endometriosis market, 2004 - 2018
• Table: Seven major market sales ($m) for endometriosis by ATC class, 2004 - 2018
• Table: Seven major market sales ($m) for key brands in endometriosis treatment, 2004 - 2018
• Table: Global sales ($m) dynamics of the endometriosis market, 2004 - 08
• Table: Global endometriosis market sales ($m) split by region, 2004 - 08
• Table: Key biomarkers investigated for the diagnosis of endometriosis, 2009
• Table: Endometriosis support groups across the seven major markets, 2009
• Table: Summary of pharmacotherapy side effects in endometriosis
• Table: Ability of Lupron (leuprolide, Abbott) to meet unmet needs in endometriosis in the seven major markets, 2009
• Table: Endpoints for endometriosis trials
• Table: Summary of the Initiative on Methods, Measurements and Pain Assessments in Clinical Trials (IMMPACT) recommendations
• Table: Endometriosis severity profile scoring system based upon the Biberoglu and Behrman Scale (1981)
• Table: Summary of studies showing endometriosis effect on quality of life, 2009
• Table: Key products in late-stage R&D pipeline for endometriosis, 2009
• Table: Sales forecasts for key drugs in late-stage development for endometriosis in the seven major markets, 2009 - 2018 ($m)
• Table: Forecast assumptions for key products in late-stage development for endometriosis across the seven major markets, 2009 - 2018
• Table: Visanne (dienogest) - drug profile, 2009
• Table: Summary of key clinical trials for Visanne (dienogest)
• Table: Datamonitor drug assessment summary of Visanne (dienogest, Bayer Schering) for endometriosis, 2009
• Table: Receptor selectivity of various progestins
• Table: Sales forecasts for Visanne in endometriosis in the seven major markets, 2009 - 2018 ($m)
• Table: Impacting factors on the revenues of Visanne in endometriosis, 2009 - 2018
• Table: Elagolix - drug profile, 2009
• Table: Elagolix: summary of key clinical trials
• Table: Elagolix: Petal-702 study primary endpoint - preliminary results
• Table: Elagolix: Petal-603 study primary endpoint - final results
• Table: Elagolix: Phase II Tulip Petal study - key facts
• Table: Datamonitor drug assessment summary of elagolix (Neurocrine) for endometriosis, 2009
• Table: Elagolix: bone safety determined in the Petal-603 clinical trial
• Table: Sales forecasts for elagolix in endometriosis in the seven major markets, 2009 - 2018 ($m)
• Table: Impacting factors on the revenues of elagolix in endometriosis, 2009 - 2018
• Table: Recently discontinued projects in endometriosis
• Table: Preclinical pipeline for the treatment of endometriosis, 2009
• Table: Rest of the world diagnostic value application
• Table: Datamonitor drug assessment scorecard for late stage endometriosis drugs, 2009

FIGURES

• Figure: Datamonitor endometriosis pipeline assessment summary, 2009
• Figure: Endometriosis clinical pipeline by development stage, 2009
• Figure: Endometriosis clinical pipeline by target, 2009
• Figure: Endometriosis clinical pipeline by mode of administration, 2009
• Figure: Datamonitor endometriosis pipeline assessment summary, 2009
• Figure: Bayer Schering genitourinary therapy area sales performance ($m), 2004 - 08
• Figure: Common endometrial lesion sites
• Figure: Anatomy of retrograde menstruation
• Figure: Endometriosis breakdown of symptoms
• Figure: American Academy Family Physicians (AAFP) endometriosis treatment guidelines
• Figure: European Society of Human Reproduction and Embryology (ESHRE) endometriosis treatment guidelines
• Figure: Sales performance of Lupron (leuprolide, TAP Pharmaceutical) in endometriosis across the seven major markets, 2004 - 2018
• Figure: Endometriosis market sales ($m) across the seven major markets, 2004 - 2018
• Figure: Endometriosis market volume sales (IMS standard units sold) across the seven major markets, 2004 - 2018
• Figure: Regional endometriosis market value sales ($m) in the across the seven major markets, 2004 - 08
• Figure: Regional endometriosis market value sales ($m) in the across the seven major markets, 2008 - 2018
• Figure: Seven major markets endometriosis-specific sales ($m) by ATC class, 2004 - 2018
• Figure: Seven major market sales ($m) for key brands in endometriosis treatment, 2004 - 2018
• Figure: Global endometriosis market sales value by region, 2004 - 08
• Figure: Global hormonal endometriosis sales ($m) dynamics, 2004 - 08
• Figure: Global endometriosis market volume (IMS standard units sold) and value ($) sales by region, 2008
• Figure: Rest of the World endometriosis market sales value ($m), 2004 - 08
• Figure: Rest of the world endometriosis regional market dynamics ($m), 2004 - 08
• Figure: Unmet needs in endometriosis, 2009
• Figure: Datamonitor endometriosis pipeline assessment summary, 2009
• Figure: Visanne (dienogest; Bayer Schering) SWOT analysis, 2009
• Figure: Datamonitor drug assessment summary of Visanne (dienogest, Bayer Schering) for endometriosis, 2009
• Figure: Sales forecasts for Visanne (dienogest, Bayer Schering) in endometriosis in the seven major markets, 2009 - 2018 ($m)
• Figure: Elagolix (Neurocrine) SWOT analysis, 2009
• Figure: Datamonitor drug assessment summary of elagolix (Neurocrine) for endometriosis, 2009
• Figure: Sales forecasts for elagolix (Neurocrine) in endometriosis in the seven major markets ($m), 2014 - 18

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