Dmhc2263.qxp

Stakeholder Opinion: Erectile
Dysfunction – Identifying Product
Differentiation and Patient
Segmentation Strategies
Providing you with:
• Patient potential, unmet needs and
• Pipeline overview including key company
• Case study analysis of market leaving
brands: Pfizer's Viagra; ICOS-Lilly's Cialis; Use this report to.
• Analysis of the future direction of the
Understand opinion leaders' views on topical issues in the erectile dysfunction Stakeholder Opinion: Erectile Dysfunction – Identifying Product Differentiation and Patient Segmentation Strategies Introduction
The erectile dysfunction market grew 3.5 percent from 2005 to be worth $1.95 billion in 2005 and is almost entirely composed of sales from three brands: Viagra (sildenafil), Cialis (tadalafil) and Levitra (vardenafil). Despite the dominance of these products, several opportunities exist for a successful market entry.
Erectile dysfunction is defined as 'the persistent inability to attain and maintain a penile erection adequate for sexual performance.' Treatment of the condition was limited until the launch of Viagra, a PDE-5 inhibitor, in 1998 and the later arrival of Cialis and Levitra in 2004-04. PDE-5 inhibitors are a safe and efficacious treatment for the majority of men. However, a considerable number do not respond to PDE-5 inhibitor treatment. Manufacturers of new drugs can target this patient subset and focus on several niche market opportunities to see a return on Key findings and highlights
• PDE-5 inhibitors will remain the mainstay of ED treatment, having an excellent efficacy and safety profile. New PDE-5 inhibitors need a unique clinical advantage to compete with the established products. Udenafil goes some way to achieve this, offering a rapid onset of action and a favorable half-life, but is unlikely to surpass market leaders.
• An estimated 30 percent of the ED patient population is refractory to PDE-5 inhibitors and this represents a considerable target market for manufactures of novel products. In terms of new mechanisms of action, opinion leaders are unconvinced by what is in the current pipeline. They are encouraged, however, by the new drug delivery methods in development.
• Developing treatments for niche patient subgroups provides an opportunity to minimize competition with established therapies. Diabetes-related ED, prostatectomy patients and cardiovascular disease may be commercially viable groups. This chronic treatment of ED may require once-daily dosing and hence represents an avenue for companies to explore.
Reasons to buy
• Understand opinion leaders' views on topical issues in the erectile dysfunction market
• Formulate product launch strategies based on current market dynamics and the successful
• Assess the competitive environment upon launch of a product based on the analysis of key
pipeline products and R&D strategies.
Contact us.
email: [email protected] email: [email protected] Sample pages from the report
Stakeholder Opinion: Erectile Dysfunction – Identifying Product Differentiation and Patient Segmentation Strategies The erectile dysfunction market grew 3.5% from 2005 to be worth $1.95 2005 and is almost entirely composed of sales from three brands: Viagr (sildenafil), Cialis (tadalafil) and Levitra (vardenafil). Despite the these products, several opportunities exist for a successful market en Erectile dysfunction is defined as 'the persistent inability to attain and maintain adequate for sexual performance.' Treatment of the condition was limited until the Viagra, a PDE-5 inhibitor, in 1998 and the later arrival of Cialis and Levitra in inhibitors are a safe and efficacious treatment for the majority of men. However, a number do not respond to PDE-5 inhibitor treatment. Manufacturers of new drugs can this patient subset and focus on several niche market opportunities to see a retur w w w. d a ta m o n i t o r. c o m / h e a l t h c a r e • PDE-5 inhibitors will remain the mainstay of ED treatment, having an excellent safety profile. New PDE-5 inhibitors need a unique clinical advantage to compete established products. Udenafil goes some way to achieve this, offering a rapid o action and a favorable half-life, but is unlikely to surpass market leaders.
• An estimated 30% of the ED patient population is refractory to PDE-5 inhibitor represents a considerable target market for manufactures of novel products. In t mechanisms of action, opinion leaders are unconvinced by what is in the current The Nesbitt procedure is also a form of surgery for ED, straightening penile curvature brought about by Peyronie’s disease and reinstating erectile function (Pryor et al., They are encouraged, however, by the new drug delivery methods in development.
• Developing treatments for niche patient subgroup Epidemi s provides an opportunity to m
competition with established therapies. Diabetes-related ED, prostatectomy patie Wealth of studies show considerable variability cardiovascular disease may be commercially viable group been studied extensively and consequently many estimates exist, including those detailed in review papers (Kubin et al., 2003; Prins et may require once-daily dosing and hence represent al., 2002). K s an avenue for comp ubin’s review concluded that the prevalence of moderate anies to e was 5–20% and Prins found that prevalence ranged from 2% to 86% in 20–80 year olds, demonstrating the difficulty of obtaining a ‘true’ result. Datamonitor found the following confounds in studies that attempted to measure ED: the definition of ED used to elicit response varies widely, including terminology describing ‘impotence’, ‘erectile difficulty’ and ‘erectile disability’. In one past study no definition was given; ED can be classified into ‘mild’, ‘moderate’ or ‘severe’ but this classification i Figure 12:
sActive pipeline Erectile Dysfunction therapies by mechanism of
action, 2006
opinion leaders' views on topical issues in the erectile dysfunction m Stakeholder Opinion: Erectile Dysfunction – Identifying Product Differentiation and Patient Segmentation Strategies as ED increases with age it is important to understand its breakdown by age product launch strategies based on current market dynamics and the suc category. This information is not available in some studies, which instead provide age-adjusted estimates, or age brackets selected by one author do not correlate with those chosen by another; the sample population varies in size, age, representativeness of the general the competitive environment upon launch of a product based on the analysi responses are elicited with a range of cross-sectional and longitudinal pipeline products and R&D strategies.
methodologies. Longitudinal studies vary in the frequency of the second Source: MedTRACK, October 2006, Copyright Datamonitor Plc; IDdB, October D A T A M O N I T O R
authors used standardized questionnaires, single-question measures and interviews, occasionally in combination.
An opinion leader states that PDE-5 inhibitors are also in trials with people with congestive heart failure. If a once-a-day formulation PDE-5 inhibitor became indicated With such differences between studies, it is often difficult to say whether country- for this and other cardiovascular conditions, its patient potential would be greatly The ED market is highly receptive to novel drug classes because of the large specific estimates differ based on cultural nuances or because of the methodology - New delivery modes will have mixed success in percentage of patients who are unresponsive to PDE-5 inhibitors. • Datamonitor's therapeutic area studies comprise “The [PDE-5 inhibitors] revolutionized the field because they’re easy to Chronic versus immediate treatment Stakeholder Opinions: Erectile Dysfunction take, they’re relatively safe and they work in a lot of people. But there are - Eroxon creates speculation about over-the-counter The treatment of patients with ED is likely to divide into two groups. Those with eatment needs. Any times the nerves are damaged or cut chronic disease are likely to go on once-a-day dosing and other patients, probably This report is a licensed product and is not to be photocopied these pills will not work…and of course you’ve got the groups that just are younger men with ED only, will continue to receive one pill as and when they need it not responsive to PDE-5 inhibitors.” US opinion leader
“Patients with diabetes and other cardiovascular risk factors such as oking for as excitement is a new oral agent.” hypertension will be treated with daily doses…the younger ones without severe end-organ failure will continue to be treated as an emergency US opinion leader
case and take a pill before sexual engagement. I guess that each field • Datamonitor insight into the erectile dysfunction has showed different directions in which the management of erectile It is interesting to note that, with the exception of the PDE-5 inhibitors, there is no one dysfunction is going for the future.” class of drug highly represented in the pipeline. Instead, researchers are exploring a - Invicorp (aviptadil and phentolamine mesylate) variety of target mechanisms of therapeutic action that can potentially compete with EU opinion leader
current therapies. This could also suggest the failure of pharmaceutical companies to find a definitive new and efficacious mechanism. New delivery modes will have mixed success in challenging oral Stakeholder Opinions: Erectile Dysfunction The oral delivery mode of PDE-5 inhibitors is one of the main factors contributing their success; the tablets can be administered with ease and without pain. Hepatic This report is a licensed product and is not to be photocopied metabolism reduces the efficacy of an oral product but for patients this is more acceptable than the administration of the product directly in to the penis. However, new delivery modes, including topical cream and intranasal drugs, are present in the pipeline with potential to offer an acceptable alternative to oral delivery, - Pathophysiology of erectile dysfunction “I think patients are as happy to use a cream or an intranasal insufflation US opinion leader
- Wealth of studies show considerable variability • Generating brand familiarity to rival Viagra Stakeholder Opinions: Erectile Dysfunction - Previously reported prevalence estimates This report is a licensed product and is not to be photocopied • Me-toos can compete based on a lower price point - Need for treatment options for patients - Improved patient guidance is needed to control “.The tablets revolutionized the field because they're easy to work in a lot of people. But there are gaps in our treatment n nerves are damaged or cut these pills won't work…and of course groups that aren't responsive to PDE-5 inhibitors.
Stakeholder Opinion: Erectile Dysfunction – Identifying Product Differentiation and Patient Segmentation Strategies Comparison of the three market leading PDE-5 Selected studies to obtain prevalence rates f - Varied pipeline looks to capitalize on gaps in the combined moderate and severe ED in the - Small companies look for opening in erectile Target population for erectile dysfunction - PDE-5 inhibitors will remain the mainstay of Analysis of key brands for erectile dysfuncti - Can other mechanisms of action challenge PDE-5 Pipeline products for erectile dysfunction, 2 2006 erectile dysfunction pipeline products - Gaps in treatable patient population creates “.The tablets revolutionized the field because they're easy to take, relatively safe and work in a lot of people. But there are gaps in our treatment needs. Any times the nerves are damaged or cut these pills won't work…and of course you've got the groups that aren't responsive to PDE-5 inhibitors.” Stakeholder Opinion: Erectile Dysfunction – Identifying Product Differentiation and Patient Segmentation Strategies Stakeholder Opinion: Erectile Dysfunction – Identifying Product Differentiation and Patient Segmentation Strategies Table of contents
ABOUT DATAMONITOR HEALTHCARE
- New delivery modes will have mixed success in • Datamonitor's therapeutic area studies comprise
the following features:
- Eroxon creates speculation about over-the-counter • Key pipeline company analysis
EXECUTIVE SUMMARY
• Objective of the analysis
• Key pipeline product profiles
• Datamonitor insight into the erectile dysfunction
- Invicorp (aviptadil and phentolamine mesylate)- Udenafil/ MARKET OVERVIEW
• Introduction and scope
• Market definition for this report
• Etiology
- Pathophysiology of erectile dysfunction • Treatment
Overview
CASE STUDY ANALYSIS
• Introduction
• Epidemiology
- Wealth of studies show considerable variability • Generating brand familiarity to rival Viagra
- Previously reported prevalence estimates • Me-toos can compete based on a lower price point
• Unmet
- Need for treatment options for patients - Improved patient guidance is needed to control BIBLIOGRAPHY
• References
• Market
dynamics
• Websites
APPENDIX
- Brand analysis by region- Full-year 2006 forecasts TABLES
Table 1:
Comparison of the three market leading PDE-5 PIPELINE ANALYSIS
• Pipeline
overview
Selected studies to obtain prevalence rates for - Varied pipeline looks to capitalize on gaps in the - Small companies look for opening in erectile Target population for erectile dysfunction - PDE-5 inhibitors will remain the mainstay of Analysis of key brands for erectile dysfunction - Can other mechanisms of action challenge PDE-5 Pipeline products for erectile dysfunction, 2006 2006 erectile dysfunction pipeline products - Gaps in treatable patient population creates Contact us.
email: [email protected] email: [email protected] Incidence of adverse events in populationstaking Viagra compared with placebo PDE-5 inhibitor price per tab in the US and UK,2006 Table 10: Segmentation of the male population suitable for ED therapy aged 25-54 years by age andregion, 2005 (000s) Table 11: Segmentation of the male population suitable for ED therapy aged 55-74 years by age andregion, 2005 (000s) FIGURES
Figure 1: Total sales of the seven major erectile
Figure 2: Total sales of the five European erectile Figure 3: The top six selling products in the seven major Figure 4: The top five brands in the French erectile dysfunction market with sales over $1m in 2005 Figure 5: The top five brands in the German erectile dysfunction market with sales over $1m in 2005 Figure 6: The top five brands in the UK erectile dysfunction market with sales over $1m in 2005 Figure 7: Total sales of the two products in the Japanese Figure 8: Datamonitor's predicted sales performance for the top six selling products in the seven majormarkets, 2006 Figure 9: Datamonitor's predicted change in market growth for the six leading products in the sevenmajor markets for 2005-06 Figure 10: Datamonitor's predicted change in market share for the six leading products in the sevenmajor markets for 2005-06 Figure 11: Active pipeline Erectile Dysfunction therapies by mechanism of action and developmentphase, 2006 Figure 12: Active pipeline Erectile Dysfunction therapies Figure 13: Frequency of reported erectile improvement in placebo-controlled trials of men taking Viagra,by treatment option.
Figure 14: Sales of PDE-5 inhibitors in the 5EU and US “.What will happen, I'm quite sure, in the future we'll have a separation between Stakeholder Opinion: Erectile Dysfunction – Identifying Product Differentiation and Patient Segmentation Strategies Stakeholder Opinion: Erectile Dysfunction – Identifying Product Differentiation and Patient Segmentation Strategies Datamonitor: Your total information solution
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