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Published by: Datamonitor
Published: Oct. 10, 2007 - 189 Pages
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 infertility market
- Key metrics
- Datamonitor pipeline assessment summary
- CHAPTER 2 DISEASE OVERVIEW
- Definition of infertility
- Unassisted reproduction
- Etiology of infertility
- The causes of female infertility
- Polycystic ovary syndrome
- Endometriosis
- Uterine fibroids
- The causes of male infertility
- Correctable conditions in the male
- Combined infertility
- Unexplained infertility
- CHAPTER 3 EPIDEMIOLOGY AND PATIENT BASED MARKET FORECASTS
- Epidemiologically-derived infertility market size
- Epidemiologic methodology of sizing the US and 5EU patient population
- Female population eligible for infertility treatment (1)
- Relationship status: marriage assumed necessary (2)
- Prevalence of infertility (3)
- Presentation rates (4)
- Diagnosis rates of a specialist physician (5)
- Treatment initiation (6)
- Epidemiologic methodology of sizing the Japanese patient population
- Patient derived infertility market forecasts
- Patient derived forecast methodology
- Trending the treatment seeking rate
- Trending the marriage rate
- Segmentation of the patient population by treatment cycles
- Cost per treatment cycle
- Market value
- Epidemiological trends
- The ageing population will prevent dramatic market growth
- The prevalence of infertility by etiology
- Almost 20% of couples seeking treatment require therapy for multiple-factor infertility
- CHAPTER 4 TREATMENT OPTIONS AND TRENDS
- Segmentation of infertility treatment
- ART treatment options
- Ovulation induction
- Intrauterine insemination
- In vitro fertilization
- Intracytoplasmic sperm injection
- Gamete intrafallopian transfer
- Zygote intrafallopian transfer
- Classification of infertility products
- Follicle stimulating hormones-follitropins (FSH)
- Luteinizing hormone (LH)
- Human menopausal gonadotrophins-menotropins (hMG)
- Human chorionic gonadotrophin (hCG)
- Gonadotrophin releasing hormone (GnRH) analogs
- Pharmaceutical treatment pathways
- Over 193,000 treatment cycles occurred in the 5EU in 2001
- Future treatment trends
- IVF more frequently chosen as first-line therapy
- GnRH agonists versus GnRH antagonists
- The advantages of antagonists
- Efficacy studies fail to identify superior analog
- Physician choice will divide future market share equally
- Volume reduction as mild stimulation protocols strive to reduce multiple births
- Urinary and recombinant products must fulfill different niches
- r-FSH versus menotropins
- Unmet need in the infertility market
- Education of non-specialist physicians will aid diagnosis and referral
- Complicated treatment cycles detract from success rates
- Patient-friendly delivery devices help to prevent discontinuation
- Simplified treatment regimens ease patient stress levels
- Neutrality in clinical trials to avoid bias
- CHAPTER 5 MARKET DYNAMICS
- Market sizing using prescription data
- Dynamics of the current infertility market
- Slow growth recoups market value to 2003 level
- Gonadotrophins are the integral part of infertility treatment
- GnRH antagonists gain on agonists in 2006 but still have some way to go
- Regional sales are influenced by country-specific legislation
- Follitropin products lead the market
- Product use is not exclusive to infertility
- Key companies involved in the infertility market
- Three companies hold 84.6% share of the total infertility market
- Change at the top means competition will be fierce
- Smaller portfolios suit current market climate
- Successful companies generate strong relationships with physicians
- Organon capitalizes on Puregon to become 2006 market leader
- Merck Serono loses share despite extensive portfolio
- Innovation allows Ferring greatest growth
- IBSA's geographical experience is a threat to 7MM players
- SWOT analysis of the infertility market
- Opportunities
- Trend towards later parenthood will increase demand for fertility services
- New embryological techniques expand treatable population
- Infertility support websites can increase brand awareness among patients
- Threats
- Restrictive guidelines are unlikely to slacken in the near future
- Influx of low-priced alternatives will increase price competition
- CHAPTER 6 R&D PIPELINE OVERVIEW AND CLINICAL TRIAL DESIGN
- Pipeline overview: limited pipeline dominated by existing market players
- Infertility pipeline lacks direction and innovation
- Development needs to diversify
- Pergoveris is the initial threat to marketed products
- Top three market players overwhelm pipeline
- Merck Serono's pipeline structure optimizes timing of market entry
- Organon's pipeline indicates long-term focus
- Small companies should capitalize on outlicensing
- Clinical trial design in infertility and subfertility research
- Code of best practice
- Analysis must stem from 'intention to treat' patient numbers
- Controversial crossover trials may inflate results
- First-cycle enrolment avoids carry-over effects
- Sample size estimation to be derived from patient number
- Lack of superiority is not the same as equivalence
- Should singleton live birth rate replace live birth rate as primary outcome?
- CHAPTER 7 FOLLITROPIN LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview for the follitropin class
- Comparative forecasts
- Comparative Datamonitor drug assessment summary
- Definition of current comparator therapy: Puregon
- Puregon's key clinical trials
- Marketing and patient factors
- Org-36286 (extended-release corifollitropin alpha)
- Drug overview
- Datamonitor drug assessment summary
- Forecasts to 2016
- Marketing factors
- Patient potential
- Clinical trial data
- Phase III
- Phase II
- CHAPTER 8 MENOTROPIN LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview for the menotropin class
- Comparative forecasts
- Comparative Datamonitor drug assessment summary
- Definition of current comparator therapy: Menopur
- Menopur's key clinical trials
- Marketing and patient factors
- Pergoveris (follitropin alpha and lutropin alpha)
- Drug overview
- Datamonitor drug assessment summary
- Forecasts to 2016
- Marketing factors
- Patient potential
- Clinical trial data
- Primary Phase II/III bridging study
- Secondary Phase II/III bridging study
- CHAPTER 9 GLOBAL MARKET ISSUES
- Globalization of the infertility market
- E7 markets are a useful guide to worldwide market growth
- Despite growth, E7 markets will not rival 7MM in the short term
- Inter-market differences: the impact of legislation
- Reproductive tourism
- A multitude of inter-related factors promote reproductive tourism
- Case study: Observing patient migration from Italy
- Responding to the impact of reproductive tourism
- Pharma must strengthen portfolios in stable or recipient markets
- Physician behavior is vital to maintain the respectability of reproductive travel
- Reproductive tourism is the best solution for patients in the absence of ethical agreement
- BIBLIOGRAPHY
- Journal papers and articles
- Websites
- APPENDIX A
- Forecasting methodology
- Datamonitor forecast methodology
- Epidemiological patient-based forecasts
- IMS forecasts
- Contributing experts
- APPENDIX B
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- About the Disease analysis team
- Disclaimer
- List of Tables
- Table 1: Infertility market top down forecast across the seven major markets, 2006-2016
- Table 2: Top down forecast of key pipeline infertility products in 2016 ($000s)
- Table 3: Infertility market bottom-up forecast based on patient numbers in the US, Japan and 5EU, 2006-2016
- Table 4: Causes of female infertility
- Table 5: Causes of male infertility
- Table 6: Patient population of women receiving infertility treatment in the 7MM, 2006
- Table 7: Infertility market value ($m) patient based forecasts, 2003-2009
- Table 8: Infertility market value ($m) forecast derived from patient numbers, 2010-2016
- Table 9: Patient numbers by female infertility etiology in the US and 5EU, 2006
- Table 10: Classification of the infertility market according to Datamonitor's definition
- Table 11: Branded follitropins available in the 7MM, 2006
- Table 12: Branded menotropins available in the 7MM, 2006
- Table 13: Branded chorionic gonadotrophins available in the 7MM, 2006
- Table 14: Branded GnRH agonists available in the 7MM, 2006
- Table 15: Branded GnRH antagonists available in the 7MM, 2006
- Table 16: Treatment cycles in the 7MM, 2000 and 2001
- Table 17: Studies investigating the efficacy of GnRH analogs
- Table 18: ICD-10 codes used to define the infertility market
- Table 19: Country-specific ART practices, 2007
- Table 20: Organon's infertility franchise, 2007
- Table 21: Merck Serono's infertility franchise, 2007
- Table 22: Ferring's infertility franchise, 2006
- Table 23: IBSA's infertility franchise, 2007
- Table 24: Infertility patient websites, 2007
- Table 25: Legislation governing ART in the 7MM, 2007
- Table 26: Infertility market pipeline, 2007
- Table 27: Key companies involved in the infertility pipeline, 2007
- Table 28: Methodological considerations of infertility trials
- Table 29: Key products in late-stage R&D pipeline for follitropins, 2007
- Table 30: Puregon: key facts
- Table 31: Key products in late-stage R&D pipeline for menotropins, 2007
- Table 32: Menopur: key facts
- Table 33: E7 infertility market sales, 2006 and CAGR, 2003-06
- Table 34: E7 infertility markets: key facts, 2007
- Table 35: Datamonitor drug assessment parameters
- List of Figures
- Figure 1: Datamonitor pipeline infertility drug assessment summary
- Figure 2: Algorithm for the treatment of male infertility
- Figure 3: Number of women aged between 20 and 45 years old in the seven major infertility markets, 2006-2021
- Figure 4: Females patients willing and able to receive infertility treatment in the 7MM from 2006 to 2016
- Figure 5: Causes of infertility for US couples undergoing ART using fresh, non-donor eggs or embryos, 2004
- Figure 6: ART treatment options
- Figure 7: Infertility treatment pathway in the seven major markets
- Figure 8: Schematic overview of trends expected in infertility treatment, 2007-2016
- Figure 9: Unmet need in the infertility market, 2007
- Figure 10: Growth of the seven major infertility markets, 2003-06
- Figure 11: Breakdown of the gonadotrophin class by molecule, 2006
- Figure 12: Infertility market size by country, 2003-06
- Figure 13: Sales performance of the top five infertility brands across the 7MM, 2005-06
- Figure 14: Percentage breakdown of total brand sales by indication of the top five infertility products in the 7MM, 2006
- Figure 15: Market share and growth of the top three companies in the infertility market, 2005-06
- Figure 16: Organon's 7MM infertility franchise by brand, 2006
- Figure 17: Merck Serono's 7MM infertility franchise by brand, 2006
- Figure 18: Ferring's seven major market infertility franchise by brand, 2006
- Figure 19: SWOT analysis of the infertility market across the seven major markets, 2007
- Figure 20: Mother's age at first birth in France, Germany, Spain and Italy, 1985-2000
- Figure 21: Ferring's fertility website
- Figure 22: Breakdown of fertility market pipeline by development status, 2007
- Figure 23: Datamonitor's comparative forecast of sales for the follitropins across the IMS-derived, seven major markets ($m), 2007-2016
- Figure 24: Datamonitor's competitive positioning analysis for Puregon and Org-36286 in the IMS derived, seven major markets, 2007-2016
- Figure 25: Historical sales for the follitropins, Puregon and Gonal-F, 2003-06
- Figure 26: Datamonitor's competitive positioning analysis for Org-36286 in the IMS-derived, seven major markets, 2007-2016
- Figure 27: Datamonitor's forecast of sales for Org-36286 across the seven major markets ($m), 2007-2016
AbstractIntroduction
The market for infertility drugs is a complex and dynamic arena shaped by numerous factors such as changing social attitudes, national legislation, and prescriber preferences. Brand strength and diverse portfolios have allowed Organon, Merck Serono and Ferring to secure a firm foothold in the market, worth over $1 billion in 2006, and represent tough competition.
Scope
Analysis of patient potential, unmet needs, market dynamics, and clinical trial design in infertility, supported by opinion leader comment Assessment of pipeline drugs and future treatment trends and their impact on prescribing patterns and behavior Patient based and sales based market forecasts to 2016, the latter providing a breakdown by region, drug class, marketed brands and pipeline drugs Coverage of emerging infertility markets which, in light of reproductive tourism, may offer revenue growth potential
Highlights
Key differentiators will permit Organon's Org-36286 (corifollitropin alpha) and Merck Serono's Pergoveris (r-FSH and r-LH), to cannibalize some share from their proprietors' franchise leading therapies. However, these agents do not appear to satisfy unmet need and this will prevent sales from rivaling Puregon and Menopur (hMG). The lack of education of non-specialist physicians limits the number of women receiving treatment. It should be a primary goal of the market to make these doctors more knowledgeable and to implement incentives to encourage patient referral. New opportunities exist in the development of products to support embryological techniques; cryopreservation, microarrays and in vitro maturation. These procedures will expand the treatable patient population as all women with the intention of preserving and protecting embryos will be eligible for treatment, not just those that are infertile.
Reasons to Purchase
Quantify the future size of the infertility market and the number of women eligible for infertility treatment to 2016 in the US, 5EU, and Japan Understand unmet needs and opportunities in the infertility market based on key opinion leader comments Benchmark key late-stage infertility compounds against current market leading brands
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