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Therapeutic

Pipeline Insight: Benign Prostatic Hyperplasia - Novel therapeutics and reformulations will drive market growth

 

Publication Date April 2009
Publisher Datamonitor
Product Type
Pages 194
ISBN Number not applicable
Product Code DAT01759

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Summary

Introduction

BPH is a chronic urological condition involving the non-cancerous enlargement of the prostate affecting over 15 million men across the seven major markets. The market for BPH drugs that aim to alleviate the symptoms and reduce prostate size was worth $3.7bn in 2008. The BPH market is expected to continue growing over the next 10 years driven by the launch of new improved treatments.

Scope

  • Analysis of BPH etiology, symptomology, diagnosis, treatment, current and future prevalence, and the key unmet market needs.
  • Review of the complete pre-clinical and clinical pipeline for new BPH therapies, including analysis of key R&D company strategies.
  • In depth analysis of historic (200408) and future (20092018) market dynamics, including profiles of Flomax and Avodart (dutasteride).
  • Commercial and clinical assessment of key late-stage pipeline drugs, with opinion leader comment and region-specific sales forecasts to 2018.

Highlights

Generic market share is predicted to grow substantially by 2018 and prospective players in the symptomatic relief drug class in particular can expect tough competition. Commercial and clinical differentiation is key for a new drug's success and GlaxoSmithKline's Duodart (tamsulosin + dutasteride) appears well placed to achieve this.

BPH is an indication expansion opportunity for drugs approved for prostate cancer. In addition, there seems to be a general R&D effort to find therapies that will substitute the need of BPH related surgery. One such example is the development of intraprostatic injections that provide local prostate tissue loss while minimizing systemic effects.

Drugs with novel mechanisms of action, such as Nymox's NX-1207 (intraprostatic injection), are commercially attractive, demanding a price premium over current treatments. By offering alternative treatment to patients with severe BPH who would otherwise have undergone surgery, NX-1207 has potential to grow the market, although safety is a concern.

Reasons to Purchase

  • 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.

Contents

  • ABOUT DATAMONITOR HEALTHCARE
    • About the Genitourinary pharmaceutical analysis team
  • CHAPTER 1 EXECUTIVE SUMMARY
    • Scope of the analysis
    • Datamonitor insight into the benign prostatic hyperplasia market
    • Key metrics
    • Datamonitor pipeline assessment summary
    • Contributing experts
  • CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
    • Pipeline overview: Benign prostatic hyperplasia pipeline is dominated by novel therapeutic targets
    • Key companies involved in the benign prostatic hyperplasia pipeline
    • GlaxoSmithKline - expanding presence
    • Urology and sexual health disorders therapy area sales driven by Avodart
    • GlaxoSmithKline applies its tried and tested fixed dose combination strategy to maintain market share
    • Fixed combination of therapy gold standards will allow GlaxoSmithKline to secure market leadership
    • Key R&D company strategies
    • Move towards localized efficacious therapies to reduce benign prostatic hyperplasia-related surgery
    • Indication expansions increase the market potential of pipeline drugs
    • Benign prostate hyperplasia as a secondary indication to prostate cancer
  • CHAPTER 3 BENIGN PROSTATIC HYPERPLASIA - PATIENT POTENTIAL
    • Definition of benign prostatic hyperplasia
    • Etiology
    • Symptoms
    • Diagnosis
    • Urologists statistics
    • Treatment
    • Watchful waiting
    • Pharmacotherapy
    • Surgery
    • Segmentation of benign prostatic hyperplasia
    • Epidemiology of benign prostatic hyperplasia
    • There are over 15 million people with clinical benign prostatic hyperplasia across the seven major markets
    • Prevalence of benign prostatic hyperplasia increases with age
    • Aging population will lead to a rise in benign prostatic hyperplasia cases
    • Current and future market overview
    • Market definition
    • Current overall market dynamics
    • Both market volume and value grew steadily across the seven major markets between 2004-08
    • Regional dynamics
    • The US is the largest and fastest growing major market
    • Class dynamics
    • Alpha blocker class dominates market
    • G4C ATC class dominates the BPH market
    • Brand dynamics
    • Flomax is the clear market leader, but Avodart is fastest growing
    • Future market dynamics
    • The market is expected to grow to 2018 after a brief slump due to generic tamsulosin incursion
    • Japan will be the biggest growth region over the forecast period
    • Unmet need in benign prostatic hyperplasia
    • Unmet need 1: Efficacy
    • Current medical therapy often only delays the need for a surgical intervention
    • Treatment needs to provide sustained symptomatic relief
    • Opportunity for drugs that modify the natural course of the disease in a shorter period of time
    • Unmet need 2: Reduced side-effect profiles
    • Side effects are the major cause for therapy interruption
    • Other unmet needs
    • Prevention
    • Increased awareness
  • CHAPTER 4 R&D APPROACH
    • Classification of pipeline products
    • Symptomatic relief
    • Tamsulosin has established itself as the therapy gold standard
    • Alpha-adrenoreceptor antagonists limited by effectiveness and side effects
    • Phosphodiesterase 5 inhibitors seek alternative indication approval
    • Disease-modifying agents
    • 5-alpha reductase inhibitors
    • Gonadotropin releasing hormone antagonists
    • Gonadotropin releasing hormone antagonist can potentially treat benign prostatic hyperplasia
    • Cytostatic agents
    • Vitamin D3 analogs
    • Clinical trial design in benign prostatic hyperplasia
    • Recruitment criteria
    • Primary endpoints
    • The International Prostate Symptom Score to determine therapy efficacy
    • Secondary endpoints
  • CHAPTER 5 SYMPTOMATIC RELIEF LATE-STAGE DRUG ANALYSIS & FORECASTS
    • Overview of late-stage symptomatic pipeline drugs
    • Pipeline summary
    • Comparative forecasts
    • Definition of current comparator therapy
    • Flomax (tamsulosin, Boehringer Ingelheim, Astellas)
    • Drug overview
    • Historic sales
    • Forecast to 2018
    • Key Phase III clinical trials
    • SWOT analysis
    • Key late stage products
    • Silodosin (Watson, Recordati, and Kissei)
    • Drug overview
    • Forecasts to 2018
    • Datamonitor drug assessment summary
    • Marketing factors
    • Patient potential
    • Satisfaction of unmet needs
    • Clinical trial data
    • Tadalafil (Cialis, Eli Lilly)
    • Drug overview
    • Forecasts to 2018
    • Datamonitor drug assessment summary
    • Marketing factors
    • Patient potential
    • Satisfaction of unmet needs
    • Clinical trial data
    • Other drugs in symptomatic relief class
    • Botox (botulinum toxin type-A, Allergan)
    • BPH symptoms were improved following intraprostatic injection of Botox
    • Further research is required to understand the full potential and the safety of Botox in BPH treatment
  • CHAPTER 6 DISEASE-MODIFYING LATE-STAGE DRUG ANALYSIS AND FORECASTS
    • Overview of late-stage disease-modifying pipeline drugs
    • Pipeline summary
    • Comparative forecasts
    • Definition of current comparator therapy
    • Avodart (dutasteride, GlaxoSmithKline)
    • Drug overview
    • Historic sales
    • Forecast sales to 2018
    • Key clinical trials
    • SWOT analysis
    • Key late stage products
    • Duodart (dutasteride + tamsulosin, GlaxoSmithKline)
    • Drug overview
    • Forecasts to 2018
    • Datamonitor drug assessment summary
    • Marketing factors
    • Patient potential
    • Satisfaction of unmet needs
    • Clinical trial data
    • NX-1207 (Nymox)
    • Drug overview
    • Forecasts to 2018
    • Datamonitor drug assessment summary
    • Marketing factors
    • Patient potential
    • Satisfaction of unmet needs
    • Clinical trial data
    • Cetrorelix (gonadotropin releasing hormone antagonist, Aeterna Zentaris)
    • Drug overview
    • Forecasts to 2018
    • Datamonitor drug assessment summary
    • Marketing factors
    • Patient potential
    • Satisfaction of unmet needs
    • Clinical trial data
    • Elocalcitol (BioXell)
    • Drug overview
    • Forecasts to 2018
    • Datamonitor drug assessment summary
    • Marketing factors
    • Patient potential
    • Satisfaction of unmet needs
    • Clinical trial data
    • Other drugs in the disease modifying class for benign prostatic hyperplasia
    • PRX-302 (Protox Therapeutics)
    • Protox announces the start of new Phase II clinical trials
    • Phase II open-label trial successfully meets endpoints
    • Ozarelix (gonadotropin releasing hormone antagonist, Spectrum and Aeterna Zentaris)
    • Further data are required to determine if ozarelix is an efficacious BPH treatment
  • CHAPTER 7 INNOVATIVE EARLY-STAGE PROJECTS
    • Key Phase I and preclinical compounds in benign prostatic hyperplasia
    • LS11 (talaporfin sodium)
    • Mechanism of action - a light activated drug to provide localized drug action
    • Clinical studies have begun
    • Delivery method will hinder patient potential
    • BIBLIOGRAPHY
    • Journal papers and abstracts
    • Websites
    • Datamonitor reports
  • APPENDIX
    • Methodology
    • Market sizing methodology
    • Sales calculations
    • Datamonitor forecast methodology
    • Product forecasts
    • Definition of a standard unit
    • Forecast assumptions
    • Datamonitor drug assessment summary
    • Contributing experts
    • About Datamonitor
    • About Datamonitor Healthcare
    • Datamonitor Healthcare's therapy area capabilities
    • About the Disease analysis team
    • Disclaimer
  • List of Tables
    • Table 1: Key epidemiological parameters of benign prostatic hyperplasia for the seven major markets, 2009-2025
    • Table 2: Key market parameters of benign prostatic hyperplasia for the seven major markets, 2008-2018
    • Table 3: Forecast sales ($m) of key pipeline products in benign prostatic hyperplasia across the seven major markets, 2008-2018
    • Table 4: R&D drug pipeline for benign prostatic hyperplasia, 2009
    • Table 5: Additional therapeutic indications obtained or sought by marketed and pipeline drugs for benign prostatic hyperplasia, 2009
    • Table 6: Summary of benign prostatic hyperplasia symptoms
    • Table 7: International Prostate Symptom Score questionnaire
    • Table 8: Number of urologists available to the benign prostatic hyperplasia at-risk age group in the seven major markets, 2009
    • Table 9: Alpha blocker key marketed brands for benign prostatic hyperplasia across the seven major markets, 2009
    • Table 10: Key marketed 5-alpha reductase inhibitor brands in benign prostatic hyperplasia across the seven major markets, 2009
    • Table 11: Summary of available benign prostatic hyperplasia treatments, 2009
    • Table 12: Prevalence of benign prostatic hyperplasia in the seven major markets, 2009
    • Table 13: Prevalence of symptomatic benign prostatic hyperplasia by age
    • Table 14: Increase of symptomatic benign prostatic hyperplasia cases across the seven major markets, 2009-2025
    • Table 15: Indication-specific sales performance of the key ATC classes used for benign prostatic hyperplasia across the seven major markets, 2004-08
    • Table 16: Summary of the performance of the top four benign prostatic hyperplasia brands in the seven major markets, 2004-08
    • Table 17: Key products in the late-stage symptomatic relief class pipeline for benign prostatic hyperplasia drug, 2009
    • Table 18: Flomax: key facts, 2009
    • Table 19: Methodology of Flomax pivotal clinical trials in benign prostatic hyperplasia
    • Table 20: Summary of results of pivotal Flomax clinical trials in benign prostatic hyperplasia
    • Table 21: Silodosin: key facts, 2009
    • Table 22: Impacting factors on the revenues of silodosin in the seven major markets, 2009-2018
    • Table 23: Summary of key Phase III clinical trials for silodosin in benign prostatic hyperplasia
    • Table 24: Silodosin Phase III trial results (clinical trial 1)in benign prostatic hyperplasia
    • Table 25: Tadalafil: key facts, 2009
    • Table 26: Impacting factors on the revenues of Cialis for benign prostatic hyperplasia in the seven major markets, 2009-2018
    • Table 27: US price of Cialis versus Flomax, 2008
    • Table 28: Summary of key Phase II clinical trials for tadalafil in benign prostatic hyperplasia, 2009
    • Table 29: Cialis (tadalafil) Phase II clinical trial results benign prostatic hyperplasia
    • Table 30: Cialis (tadalafil) dose finding study results in benign prostatic hyperplasia
    • Table 31: Phase II/III trial of Cialis (tadalafil) in men with benign prostatic hyperplasia to determine efficacy, dose response and safety
    • Table 32: Phase III trial of Cialis (tadalafil) in men with benign prostatic hyperplasia to determine safety of combination treatment with alpha blockers
    • Table 33: Phase III trial of Cialis (tadalafil) in men with benign prostatic hyperplasia (BPH) to determine efficacy of reducing BPH symptoms
    • Table 34: Phase II trial of Cialis (tadalafil) in Japanese men with benign prostatic hyperplasia to determine safety and efficacy
    • Table 35: Botox (botulinum toxin type-A) key facts, 2009
    • Table 36: Botox (botulinum toxin type-A) Phase II clinical trial results summary in benign prostatic hyperplasia
    • Table 37: Phase II study to determine safety and efficacy of different Botox (botulinum toxin type-A) dosages for the treatment of benign prostatic hyperplasia
    • Table 38: Phase II/III study to determine the safety and efficacy of Botox (botulinum toxin type-A) to treat benign prostatic hyperplasia
    • Table 39: Phase II study to determine the scope for Botox (botulinum toxin type-A) in the management of benign prostatic hyperplasia
    • Table 40: Key products in the late-stage disease-modifying drug class pipeline for benign prostatic hyperplasia, 2009
    • Table 41: Avodart (dutasteride): key facts, 2009
    • Table 42: Avodart (dutasteride) clinical studies methodology in benign prostatic hyperplasia
    • Table 43: Summary of results for pivotal Avodart (dutasteride) clinical trials in benign prostatic hyperplasia
    • Table 44: Duodart (dutasteride + tamsulosin): key facts, 2009
    • Table 45: Impacting factors on the revenues of Duodart for benign prostatic hyperplasia in the seven major markets, 2009-2018
    • Table 46: Summary of the CombAT clinical trial in benign prostatic hyperplasia
    • Table 47: NX-1207: key facts, 2009
    • Table 48: Impacting factors on the revenues of NX-1207 for benign prostatic hyperplasia in the seven major markets, 2009-2018
    • Table 49: Summary of NX-1207 clinical trials in benign prostatic hyperplasia, 2009
    • Table 50: Cetrorelix: key facts, 2009
    • Table 51: Impacting factors on the revenues of cetrorelix for benign prostatic hyperplasia in the seven major markets, 2009-2018
    • Table 52: Summary of cetrorelix clinical trials, 2009
    • Table 53: Cetrorelix BPH Phase I clinical trial results for benign prostatic hyperplasia
    • Table 54: Results of cetrorelix Phase II benign prostatic hyperplasia clinical trial
    • Table 55: Phase III study to determine the most efficacious regimen of cetrorelix for the treatment of benign prostatic hyperplasia
    • Table 56: Phase III open-label study to determine safety and efficacy of cetrorelix for the treatment of benign prostatic hyperplasia
    • Table 57: Phase III study to determine efficacy of cetrorelix for the treatment of benign prostatic hyperplasia
    • Table 58: Elocalcitol: key facts, 2009
    • Table 59: Impacting factors on the revenues of elocalcitol for benign prostatic hyperplasia in the seven major markets, 2009-2018
    • Table 60: Summary of elocalcitol clinical trials, 2009
    • Table 61: Summary of BPH Phase II elocalcitol clinical trial design
    • Table 62: Elocalcitol Phase II results for benign prostatic hyperplasia
    • Table 63: Other late-stage pipeline disease modifying agents for benign prostatic hyperplasia, 2009
    • Table 64: TRIUMPH clinical trial design
    • Table 65: Summary of products in Phase I clinical trials for the treatment of benign prostatic hyperplasia
    • Table 66: Summary of products in preclinical trials for the treatment of benign prostatic hyperplasia, 2009
    • Table 67: Summary of LS11 light infusion therapy development status
    • Table 68: Patent expiry dates for key marketed brands in benign prostatic hyperplasia in the seven major market regions, 2009
    • Table 69: Estimated launch dates for key late stage pipeline products and marketed brands in the seven major market regions, 2009-2018
    • Table 70: Datamonitor symptomatic relief drug assessment parameters
    • Table 71: Datamonitor disease modifying drug assessment parameters
  • List of Figures
    • Figure 1: Datamonitor drug assessment summary of symptomatic relief treatments for benign prostatic hyperplasia, 2009
    • Figure 2: Datamonitor drug assessment summary of disease modifying treatments for benign prostatic hyperplasia, 2009
    • Figure 3: Percentage of R&D products in development for benign prostatic hyperplasia by Phase, 2009
    • Figure 4: Benign prostatic hyperplasia drug pipeline split by delivery method, 2009
    • Figure 5: GlaxoSmithKline benign prostatic hyperplasia franchise revenue across the seven major markets, 2004-2018
    • Figure 6: The prostate
    • Figure 7: Proposed benign prostatic hyperplasia etiology
    • Figure 8: Benign prostatic hyperplasia development
    • Figure 9: Benign prostatic hyperplasia symptoms and consequences
    • Figure 10: Relationship between benign prostatic hyperplasia and other diseases
    • Figure 11: Benign prostatic hyperplasia treatment algorithm
    • Figure 12: Branded alpha-adrenoreceptors market share for benign prostatic hyperplasia in the seven major markets, 2008
    • Figure 13: 5-alpha reductase inhibitors market share for benign prostatic hyperplasia in the seven major markets, 2008
    • Figure 14: Natural products market share for benign prostatic hyperplasia (BPH) in the seven major markets, 2008
    • Figure 15: Prevalence of histological benign prostatic hyperplasia by age
    • Figure 16: Growth in symptomatic benign prostatic hyperplasia population 2009-2025
    • Figure 17: Sales ($m) value of the benign prostatic hyperplasia market across the seven major markets, 2004-08
    • Figure 18: Regional sales ($m) dynamics of the benign prostatic hyperplasia market, 2004-08
    • Figure 19: Benign prostatic hyperplasia drug class sales ($m) dynamics across the seven major markets, 2004-08
    • Figure 20: ATC class dynamics of the benign prostatic hyperplasia market, 2004-08
    • Figure 21: ATC class dynamics of the benign prostatic hyperplasia market (excluding G4C and C2A), 2004-08
    • Figure 22: The top four benign prostatic hyperplasia product sales ($m) performance across the seven major markets markets, 2004-08
    • Figure 23: Benign prostatic hyperplasia market value ($ billion) across the seven major regions, 2004-2018
    • Figure 24: Regional sales forecast ($ billion) dynamics of the benign prostatic hyperplasia market, 2008-18
    • Figure 25: Unmet needs in benign prostatic hyperplasia, 2009
    • Figure 26: Additional benign prostatic hyperplasia unmet needs, 2009
    • Figure 27: Datamonitor drug assessment summary of symptomatic relief treatments for benign prostatic hyperplasia, 2009
    • Figure 28: Sales ($m) forecast for key pipeline drugs for benign prostatic hyperplasia symptomatic relief in the seven major markets, 2004-2018
    • Figure 29: Sales ($m) of key alpha-1- adrenoreceptor antagonist brands for benign prostatic hyperplasia across the seven major markets, 2004-08
    • Figure 30: Sales ($m) for Flomax in benign prostatic hyperplasia across the seven major markets, 2004-2018
    • Figure 31: SWOT analysis for Flomax (tamsulosin) in benign prostatic hyperplasia, 2009
    • Figure 32: Sales ($m) for silodosin in benign prostatic hyperplasia across the seven major markets to 2018
    • Figure 33: Datamonitor's competitive positioning analysis for silodosin in benign prostatic hyperplasia, 2009
    • Figure 34: Sales ($m) forecast for Cialis (tadalafil) in benign prostatic hyperplasia across the seven major markets to 2018
    • Figure 35: Datamonitor's competitive positioning analysis of Cialis in benign prostatic hyperplasia, 2009
    • Figure 36: Datamonitor drug assessment summary of key disease-modifying treatments for benign prostatic hyperplasia, 2009
    • Figure 37: Sales($m) forecast for key disease modifying pipeline drugs for benign prostatic hyperplasia in the seven major markets, 2009-2018
    • Figure 38: Sales ($m) of Proscar (finasteride) and Avodart (dutasteride) in benign prostatic hyperplasia across the seven major markets, 2004-08
    • Figure 39: Sales ($m) for Avodart (dutasteride) for benign prostatic hyperplasia across the seven major markets,, 2004-2018
    • Figure 40: Avodart (dutasteride) SWOT analysis in benign prostatic hyperplasia, 2009
    • Figure 41: Sales ($m) forecast for Duodart in benign prostatic hyperplasia across the seven major markets to 2018
    • Figure 42: Datamonitor's competitive positioning analysis of Duodart for benign prostatic hyperplasia in the seven major markets, 2009
    • Figure 43: Summary of CombAT trial results in benign prostatic hyperplasia
    • Figure 44: Sales ($m) forecast for NX-1207 in benign prostatic hyperplasia across the seven major markets to 2018
    • Figure 45: Datamonitor's competitive positioning analysis of NX-1207 for benign prostatic hyperplasia in the seven major markets, 2009
    • Figure 46: NX-1207 Phase II clinical trial results in benign prostatic hyperplasia
    • Figure 47: Sales ($m) forecast for cetrorelix in benign prostatic hyperplasia across the seven major markets to 2018
    • Figure 48: Datamonitor's competitive positioning analysis of cetrorelix, 2009
    • Figure 49: Cetrorelix BPH Phase II clinical trial design in benign prostatic hyperplasia
    • Figure 50: Sales ($m) forecast for elocalcitol in benign prostatic hyperplasia across the seven major markets to 2018
    • Figure 51: Datamonitor's competitive positioning analysis of elocalcitol, 2009
    • Figure 52: PRX-302 Phase II clinical trial results in benign prostatic hyperplasia
    • Figure 53: Datamonitor drug assessment summary of disease modifying treatments for benign prostatic hyperplasia, 2009