Table of Contents

Stakeholder Opinions: Skin Infections - Where In The Antibacterial Lifecycle? - An overview of the community management of skin infections across the seven major markets, including disease definitions, class overviews and analysis of recent market events

Product Code: dmhc2002

Publication Date: 09-Jun-2004

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Overview

Introduction

Bacterial skin and skin structure infections are among the most common infections treated within the community setting. There are a wide range of different types of infection, each with individual symptoms, epidemiology and etiology. However, the majority require antibacterial treatment and, as a result, represent potential lucrative targets for novel product development and indication expansion.

Scope

· Disease definitions, symptoms, epidemiology and risk factors for key skin and skin structure infections

· Detailed seven country market analysis by class and indication, including volume and value assessments

· Breakdown of prescriptions for key skin infections by physician type, across the seven major markets

· Strategic analysis and recommendations for maximizing the potential of the skin infections sector

Report Highlights

Prescriptions associated with skin infections account for only a small percentage of total community antibacterial sales (e.g. 3% of US drugstore sales). Companies developing and marketing broad-spectrum antibacterials should consider skin infections as a secondary target, focusing primary resources on higher value indications.

High unmet need in the management of skin infections involving resistant pathogens increases the likelihood of gaining fast-track designation in the US. The potential for rapid market entry, reduced development costs and focused physician targets presents an attractive proposition for smaller players with limited resources.

There is a clear lack of synergy between acne and other bacterial infections, in terms of prescribing physicians and focus classes. Companies involved in antibacterial product development or life-cycle management should bear this in mind when considering indication expansions.

Reasons to Purchase

· Effectively prioritize skin infections within your antibacterial portfolio with detailed prescription and sales data

· Target detailing campaigns more effectively with in-depth understanding of physicians involved in the management of skin infections

· Identify key strategies to maximize the potential of bacterial skin infections for both key players and new market entrants

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CHAPTER 1 EXECUTIVE SUMMARY	3
Scope of the analysis	3
Datamonitor insight into the skin infection market	4
While skin infections represent one of the most common types of bacterial infection, prescriptions associated with these conditions only account for a relatively limited percentage of total community antibacterial sales (e.g. 3% of US drugstore sales in 2003 attributable to skin infections.) Companies developing and marketing broad-spectrum antibacterials should consider skin infections as a secondary target, focusing resources on higher value indications, such as respiratory tract infections.	4
High unmet need in the management of skin infections involving resistant pathogens increases the likelihood of gaining fast-track designation in the US, as demonstrated by Cubist's Cubicin (daptomycin) and Basilea's novel cephalosporin, BAL5788. The potential for rapid market entry, reduced development costs and focused physician targets presents an attractive proposition for smaller players with limited resources.	5
While the management of acne generates almost $200m per year in antibacterial sales, differences in physician involvement in the management of this condition, relative to other bacterial infections, limit the potential of indication expansion into this area. Across the seven major markets, the majority of acne patients are treated by dermatologists (73% of acne antibacterial sales - IMS Health, Prescribing Insights, April 2004), whereas other bacterial infections are managed predominantly by GPs, family practitioners and pediatricians. Companies should consider the clear lack of synergy between acne and other bacterial infections when evaluating product development and life-cycle management options.	7
Summary	9
Key metrics	10
TABLE OF CONTENTS	13
CHAPTER 2 DISEASE DEFINITION AND EPIDEMIOLOGY	19
Disease definition	19
Furunculosis	20
Folliculitis	21
Impetigo	23
Staphylococcal scalded skin syndrome	23
Cellulitis	24
Erysipelas	27
Necrotising fasciitis	28
Myositis	29
Acne	30
Staphylococcus aureus - the most common cause	31
Staphylococcus aureus toxins	31
Staphylococcus aureus resistance in skin infections	31
CHAPTER 3 PRESENTATION, DIAGNOSIS AND TREATMENT	34
Presentation	34
Initial presentation and care	34
Referral patterns	35
Case study: United Kingdom	36
Hospital vs. community management	37
Reasons for hospital admission	38
Diagnosis	39
CHAPTER 4 MARKET ANALYSIS BY DRUG CLASS	40
Market definition	40
Diagnoses included in the analysis	40
The importance of skin infections	41
Penicillins	44
Macrolides	48
Cephalosporins	53
Fluoroquinolones	56
Zyvox	60
CHAPTER 5 MARKET ANALYSIS BY INDICATION	64
Impetigo	64
Therapeutic choice	64
Treating physicians	66
Analyst comment	68
Cellulitis	68
Therapeutic choice	69
Treating physicians	72
Analyst comment	73
Acne	74
Therapeutic choice	76
Treating physicians	77
Analyst comment	80
CHAPTER 6 STRATEGIC ANALYSIS	82
Community prescriptions - hard to influence?	82
Large target audience?	82
Geographical dispersion of target audience	83
Increasing involvement and variability of stakeholders	84
Increasing competition necessitates greater differentiation	85
SSTIs - line-extension or quick route in?	85
Indication expansion	85
Skin infections - route of entry for smaller players?	87
Supporting data	90
Opinion leader transcripts	91
List of tables	124
List of figures	124
Bibliography	125
Report methodology	129
About Datamonitor	130
About Datamonitor Healthcare	130
Datamonitor Healthcare's research and analysis methodologies	131
Datamonitor Healthcare's therapy area capabilities	131
About the infectious disease analysis team	132
Datamonitor Healthcare's Consulting expertise	133
Key therapy team members	134
Disclaimer	136
List of Tables
Table 1: Reported bacterial infections in the seven major markets	10
Table 2: Relative costs of SSTI prescriptions for penicillins in Italy and Spain, 2003	47
Table 3: Relative costs per SSTI prescription of macrolides in France and Italy, 2003	51
Table 4: Relative costs of cephalosporin prescriptions for SSTIs in France and Italy, 2003	55
Table 5: Antibacterial prescriptions for Impetigo attributable to individual classes across the EU, 2003	65
Table 6: Clinical costs of Cubist's VRE comparative study, 2002	88
List of Figures
Figure 1: Niche products or line extensions - where do skin infections fit into the antibacterial life-cycle?	9
Figure 2: Antibacterial prescriptions and value for skin and soft tissue infections in the community in Italy and France, 2003	11
Figure 3: Community cellulitis prescriptions by class, Japan, US and Spain (2003)	12
Figure 4: Simplistic classification of skin and soft tissue infections	19
Figure 5: Antibacterial prescriptions and value for skin and soft tissue infections in the community in Italy and France, 2003	35
Figure 6: Contribution of skin infections to total antibacterial sales and prescriptions in the community in Italy by quarter, 2001-2003	41
Figure 7: Contribution of skin infections to total antibacterial sales and prescriptions in the community in France by quarter, 2001-2003	42
Figure 8: Quarterly diagnostic value of skin infections in the community in France by class, 2001-2003	43
Figure 9: Penicillin use in the treatment of skin and soft tissue infections in the community inFrance, 2001-2003	45
Figure 10: Penicillin use in the treatment of skin and soft tissue infections in the community in Italy, 2001-2003	46
Figure 11: Contribution of SSTIs to penicillin value in the community in France and Italy, 2001-2003	48
Figure 12: Macrolide use in the treatment of skin and soft tissue infections in the community in France, 2001-2003	49
Figure 13: Macrolide use in the treatment of skin and soft tissue infections in Italy, 2001-2003	50
Figure 14: Contribution of SSTIs to macrolide value in the community in France and Italy, 2001-2003	52
Figure 15: Cephalosporin use in the treatment of skin and soft tissue infections in the community in France, 2001-2003	53
Figure 16: Cephalosporin use in the treatment of skin and soft tissue infections in the community in Italy, 2001-2003	54
Figure 17: Contribution of SSTIs to cephalosporin value in France and Italy community sectors, 2001-2003	56
Figure 18: Fluoroquinolone use in the treatment of skin and soft tissue infections in the community in France, 2001-2003	57
Figure 19: Fluoroquinolone use in the treatment of skin and soft tissue infections in the community in Italy, 2001-2003	58
Figure 20: Contribution of SSTIs to fluoroquinolone value in France and Italy community settings, 2001-2003	59
Figure 21: Contribution of skin infections to quarterly US drug store sales of Zyvox, 2001-2003	61
Figure 22: Zyvox prescriptions and diagnostic value by type of skin infection, US drug stores (2001-2003)	62
Figure 23: Zyvox prescriptions by physician type, US drug stores (2001-2003)	63
Figure 24: Proportion of antibacterial prescriptions for Impetigo attributable to individual classes across the EU community sectors, 2003	65
Figure 25: Antibacterial prescriptions for Impetigo attributable to the leading five individual molecules across the EU community sectors, 2003	66
Figure 26: Antibacterial prescriptions for impetigo by physician type in the community, Japan, US and Spain (2003)	67
Figure 27: Cellulitis prescriptions by class in the community, Japan, US and Spain (2003)	70
Figure 28: Cellulitis therapy by class, US drug stores 2003	71
Figure 29: Cellulitis prescriptions by physician type in the community in Japan, the US and Spain, 2003	72
Figure 30: Cellulitis prescriptions by physician type in the community, Spain 2003	73
Figure 31: Value of community prescriptions for the treatment of acne across the seven major markets, community sector 2003 ($m)	74
Figure 32: Value of community antibacterial prescriptions for the treatment of acne across the seven major market, community sector 2003 ($m)	75
Figure 33: Antibacterial contribution to overall community acne diagnostic value in the community, 7 major markets 2003 ($m)	76
Figure 34: Value of community antibacterial prescriptions for acne across the seven major markets by class in the community, 2003 ($m)	77
35: Physicians responsible for the community prescription of pharmaceutical therapy for acne in the community, 7 major markets (2003)	78
Figure 36: Community antibacterial prescriptions in the US by physicians type and drug class in the community, 2003	79
Figure 37: Community antibacterial prescriptions in Spain by physicians type and drug class in the community, 2003	80
Figure 38: Key indication expansions for Levaquin and Cipro in the US, 1998-2002	86
Figure 39: Contribution of SSTIs to total antibacterial diagnostic value, US drugstores and Spain retail (2003)	90
Figure 40: Datamonitor's Healthcare Consultancy	133
Figure 41: Datamonitor Healthcare's Therapeutic Consulting capabilities	134

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