Abstract
Overview
Introduction
Endometriosis is a painful, menstrual-related disorder that is thought to affect approximately 10% of the female population of reproductive age. Despite this large patient potential, growth of the endometriosis market has been limited by low levels of investment, poor awareness among physicians and the public, problematic diagnosis, and lack of effective therapies.
Scope
- Review of treatments and players in the seven major markets including their strategies for success.
- Movement of patients, depending on their treatment goal, through the referral and the treatment pathway.
- Overview of the pipeline including coverage of each of the novel mechanisms of action currently being explored.
- Identification of the unmet need, supported by international opinion leader insight.
Report Highlights
Supporting celebrity spokespeople is a useful strategy for pharmaceutical companies to adopt in the endometriosis market in order to destigmatize the disease and expand the patient population, as witnessed in the erectile dysfunction and osteoporosis markets.
Imaging techniques, in particular ultrasonography, have the potential to become the new gold-standard diagnostic procedure. Biomolecular and genetic diagnostic tests, to replace CA-125, would be well received by physicians and several are being trialed currently.
In the current litigious climate and given the return on investment based on the potential patient population, opinion leaders advise that manufacturers of new products would be justified in pursuing a specific endometriosis label.
Reasons to Purchase
- Quantify the number of reproductively aged women with endometriosis in the general population and in gynecologic populations in the US, 5EU, and Japan
- Understand opinion leaders' views on topical issues and unmet need in the endometriosis market.
- Assess the competitive environment upon launch of a product based on the analysis of key pipeline products and R&D strategies.
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Women' s Health pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Contributing experts
- Datamonitor insight into the Endometriosis market
- Related reports
- CHAPTER 2 MARKET DYNAMICS
- Endometriosis market definition
- Limitations in sizing the endometriosis market with IMS data
- Current market overview
- Market size has yet to recover from 2006 fall
- US market changes have contributed to 7MM market shrink
- Political changes have boosted sales in Spain
- POCs are the most common treatment option for endometriosis
- Lupron remains the most popular GnRH agonist treatment
- Market size has yet to recover from 2006 fall
- Endometriosis market definition
- CHAPTER 3 DISEASE OVERVIEW
- Definition of endometriosis
- Classification of endometriosis: Re-AFS
- Etiology of endometriosis: still not well understood
- Retrograde menstruation and implantation
- Lymphatic/vascular dissemination
- Developmental coelomic metaplasia
- Genetic predisposition
- Environmental factors
- Immunological susceptibility
- Dynamic progression of endometriosis
- Recurrence in endometriosis
- Symptoms of endometriosis
- Epidemiology of endometriosis
- Socio-demographic contributors to endometriosis prevalence
- Limitations of endometriosis epidemiology analysis
- Factors specific to endometriosis:
- Factors generalized to all epidemiology analysis:
- The gold standard endometriosis epidemiology study
- Prevalence estimates: the general versus gynecologic population
- Prevalence of endometriosis in the general population is assumed to be 10%
- Prevalence of endometriosis in the gynecologic population may be more representational
- Unmet need in endometriosis
- Understanding the etiology of endometriosis will aid the development of prophylactic and specific treatments
- Non-invasive diagnostic procedures will lower morbidity
- Physician education will quicken time to diagnosis
- Patient education promotes treatment seeking
- Better pain management concepts will help women cope
- Definition of endometriosis
- CHAPTER 4 TREATMENT TRENDS
- Endometriosis patient diagnosis and referral algorithm
- ' Under-diagnosed and over treated'
- Treatment of endometriosis
- Combined oral contraceptives: first-line therapy
- Short term efficacy is similar to that of GnRH agonists
- Progestogen treatments are most commonly used therapy
- Antiprogestogen use is limited to gestrinone
- Androgens: Danazol-first treatment indicated for endometriosis
- Efficacious for pain relief
- Side effects limit usefulness of product
- Danazol remains useful for niche patients
- GnRH agonists: short-term efficacy at the expense of side effects
- Characteristics of successfully marketed GnRH agonists
- Lupron: the ' gold standard'
- Lupron with add-back makes side effects more manageable
- Surgery for severe and non-responsive endometriosis
- Laparoscopic surgery: a range of techniques can reduce pain
- Hysterectomy: the last treatment option
- Combined oral contraceptives: first-line therapy
- Patient treatment goals
- Pain reduction
- Pregnancy
- Endometriosis patient diagnosis and referral algorithm
- CHAPTER 5 RESEARCH AND DEVELOPMENT
- The ideal drug for the treatment of endometriosis
- Efficacy must prevent recurrence
- Safety essential in a young patient population
- Side-effects profile must be improve compliance
- Cost must be kept low for long-term use
- Pipeline overview
- Considerable variety in mechanism, delivery mode, and manufacturer
- Large pipeline is beginning to mature
- New methods of drug delivery attempt to fulfill unmet need
- Nasal administration may be hindered by unwelcome irritation
- Vaginal route unpopular in conservative patient population
- Late-stage products offer some hope to patients
- Visanne progestogen could benefit from specific endometriosis label
- Balance will need marketing partner to realize Libra' s full potential
- FP-1096 benefits from a novel drug delivery technique
- Mechanisms of action of pipeline products
- Aromatase inhibitors may offer long-term remission
- Chemokine receptor antagonists center on inflammatory and immune
response
- Immunomodulators are still regarded warily
- Combination products will not radically alter treatment
- Promising estrogen receptor beta agonists require more research
- GnRH antagonists have important advantages over agonists
- Progestogen agonists are as effective as marketed therapies
- Selective progestogen receptor modulators
- Clinical trial design in endometriosis
- Difficulties inherent in clinical trials of endometriosis therapies
- Patient recruitment must be carefully considered
- Endpoints in clinical trial design
- Arguably pain is the endpoint of most relevance to the patient
- That lesion size should be a secondary endpoint is a contentious issue
- Quality of life scale expands on the endpoint of pain
- Difficulties inherent in clinical trials of endometriosis therapies
- The ideal drug for the treatment of endometriosis
- CHAPTER 6 CURRENT MARKET ISSUES
- Raising the profile of endometriosis
- Breaking the taboo
- Raising awareness: lessons from other disease areas
- The EEA takes the lead in lobbying in Europe
- Breaking the taboo
- Current issues in diagnosis of endometriosis
- Biomolecular and genetic diagnostics are desirable but not trusted
- Current research
- CA-125 testing has had a mixed response
- Imaging diagnostics currently offer the most promise
- Biomolecular and genetic diagnostics are desirable but not trusted
- The endometriosis indication
- Physicians find specific labeling increasingly useful
- The potential of endometriosis as a secondary indication
- Uterine fibroids
- Menorrhagia (excessive bleeding)
- Raising the profile of endometriosis
- BIBLIOGRAPHY
- Journal papers
- Websites
- APPENDIX
- IMS data
- Medical sales data caveats
- Medical sales data methodology
- Contributing experts
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare' s therapy area capabilities
- About the Disease analysis team
- Disclaimer
- List of Tables
- Table 1: ICD-10 codes used to define the endometriosis market
- Table 2: Frequency and location of endometriosis implants in the pelvis
- Table 3: Frequency of symptoms among surgically diagnosed endometriosis patients, 2007
- Table 4: Common symptoms of endometriosis and other conditions
- Table 5: Epidemiology overview of endometriosis, 2007
- Table 6: Endometriosis prevalence in the 7MM general population, 2007
- Table 7: Endometriosis prevalence in the CPP (gynecological) population, 2007
- Table 8: Endometriosis prevalence in the infertile (gynecologic) population across the seven major markets, 2007
- Table 9: Summary of endometriosis treatment with danazol
- Table 10: Endometriosis-specific sales of GnRH agonists in the seven major markets combined, by molecule, 2006-07
- Table 11: Cost of select GnRH agonists in the UK, 2007
- Table 12: Lupron product range, 2007
- Table 13: Overview of the endometriosis pipeline, 2007
- Table 14: Mechanism of action of the drugs in the endometriosis pipeline, 2007
- Table 15: Action taken by the European Endometriosis Alliance in H1, 2007
- List of Figures
- Figure 1: The seven major endometriosis markets by country, 2003-07
- Figure 2: The five major European (EU) endometriosis markets. 2003-07.
- Figure 3: Seven major endometriosis market size, split by region, 2003--07
- Figure 4: Volume sales of products within endometriosis treatment types in the seven major markets combined, 2007
- Figure 5: Market share and market growth of key GnRH agonists in the seven major endometriosis markets, 2006-07
- Figure 6: Prevalence of CPP and endometriosis in the female population and prevalence of endometriosis in the CPP population (000s), 2007
- Figure 7: Causes of infertility for US couples undergoing assisted reproductive technology using fresh, non-donor eggs or embryos, 2004
- Figure 8: Prevalence of infertility and endometriosis in the female population and prevalence of endometriosis in the infertile population (000s), 2007
- Figure 9: Unmet needs in endometriosis as identified by key opinion leaders, 2007
- Figure 10: Patient diagnosis referral pathway in endometriosis, according to key opinion leaders, 2007
- Figure 11: Side-effect versus efficacy profile of key treatments on the endometriosis market according to interviewed EU and US opinion leaders, 2007
- Figure 12: An endometriosis patient treatment pathway dependent on treatment goal
- Figure 13: Frequency of products in the pipeline, by development stage, 2007
- Figure 14: Breakdown of pipeline products by delivery method, where known, in 2007
- IMS data
