抗菌剤市場における規制、抵抗力、後発品

Overview

Introduction

Antibacterial players are currently facing significant hurdles in terms of increasing and maintaining product revenue. These include growing resistance across classes, greater restrictions relating to the use of antibacterials and an expected increase in generic competition following the expiry of a number of key patents in the next 2-3 years.

• In-depth analysis of country-specific environmental factors that affect the performance of antibacterial products
• Review of recent and expected product specific events and other aspects that will impact sales of leading products
• Country-specific sales forecasts to 2014 of leading brands and classes, for each for the seven major markets
• Detailed case-study analysis of life-cycle management strategies such as follow-up products and reformulations

Increased regulatory scrutiny, drug resistance and generic competition have placed greater pressure on antibacterial profit margins. This explains the lack of significant activity in the current antibacterial pipeline. Datamonitor predicts that, by 2014, pipeline compounds will only account for 10.9% of total antibacterial revenue.

Regulatory scrutiny and pharmacovigilance responsibilities are becoming ever more intense. Key players should support initiatives aimed at easing product approval processes and should also tighten compliance practices throughout their businesses in order to reduce the risk of heavy fines and reductions to ROI.

Novel formulations can allow access to additional market segments while even minor clinical advantages can drive uptake of follow-ups, provided they are accompanied by improvements in cost-efficiency. Datamonitor believes that key players will need to increase their focus on such activities in order to maintain their market position.

• Quantify future size and scope of the antibacterial market and potential for new products
• Understand key drivers and predict the future performance of key compounds
• Evaluate a range of lifecycle-management strategies to combat the threat of generic incursion

ABOUT DATAMONITOR HEALTHCARE

• About the Infectious Diseases pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

• Objective of the analysis
• Datamonitor insight into the antibacterials market

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

• Market definition for this report
• Current market situation
• Limited growth driven by price increases
• The US is the key market
• Hospital growth is more rapid than community
• Four classes dominate antibacterials sector
• Generic products limit market growth
• Highly segmented market with niche opportunities
• Strategic scoping and focus

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

• Current and future opportunities and threats in the antibacterials market
• Global opportunities and threats
• Opportunities
• Threats
• US: opportunities and threats
• Antibacterial market overview
• Opportunities
• Threats
• Japan: opportunities and threats
• Antibacterial market overview
• Opportunities
• Threats
• France: opportunities and threats
• Antibacterial market overview
• Threats
• Germany: opportunities and threats
• Antibacterial market overview
• Opportunities
• Threats
• Italy: opportunities and threats
• Antibacterial market overview
• Opportunities
• Threats
• Spain: opportunities and threats
• Opportunities
• Threats
• UK: opportunities and threats
• Antibacterial market overview
• Opportunities
• Threats
• Summary of environmental issues affecting antibacterial market size

CHAPTER 4 FORECAST ANALYSIS

• Assumptions and events
• Market events
• Changing age structure of key markets
• Patent expiries
• Watchful waiting paradigm
• Macrolide events
• Ketek in Japan
• US launch of Ketek (2004)
• Trial results boost uptake of Ketek
• Zithromax approved for once daily 3 day ABS therapy
• Discontinuation of Zithromax 500mg tablets (x3) in the UK
• Cephalosporin events
• Continued impact of Japanese launch of Rocephin 1g bag
• Basilea lose Roche as partner for BAL5788
• Omnicef recommended for acute bacterial sinusitis
• Flomox sales do not meet expectation in Japan
• Increased generic competition limits Ceftin sales
• Penicillin events
• Novartis and GSK settle over Augmentin dispute
• Strawberry flavor Augmentin recaptures market share
• Generics firms expand formulations of Augmentin copies
• Augmentin ES better than Zithromax in AOM
• Carbapenem events
• Uptake of Merrem in meningococcal and purulent meningitis
• Merrem warning and application for cSSTIs
• Fluoroquinolone events
• Impact of Cipro patent expiry (2004+)
• Continued uptake of Cipro XR
• Reddys launch 100mg ciprofloxacin in the US
• Cystitis study boosts uptake of ciprofloxacin
• Levaquin gains mild CAP indication
• Generic levofloxacin gains tentative approval
• Avelox gains indication for multi-drug resistant S. pneumoniae
• Avelox patent secure to 2014
• Avelox shows efficacy in AECB
• Avelox beats levofloxacin resistant strains
• Gatifloxacin competes for acute otitis media indication
• Other class events
• Trials demonstrate Zyvox benefits
• Synercid may support vancomycin therapy
• Tobramycin for injection re-launched
• TOBI foundation
• Pipeline product launches
• Limitations of data
• Standard units
• Japanese market data
• Regional launch dates for new products
• Forecasts

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

• Introduction
• Case studies
• Follow-up products - worth the investment?
• Augmentin, Augmentin XR and Augmentin ES
• Cipro and Cipro XR
• Biaxin and Biaxin XL
• Insight and recommendations
• Line extensions - driving sales growth
• New indications, new patient targets
• New formulations allow access to new patient groups
• Complete product management - improving Zosyns performance
• Driving sales growth - Wyeths strategies

APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS

• Global antibacterial market data
• Aminoglycosides market data
• Carbapenems market data
• Cephalosporins market data
• Fluoroquinolones market data
• Glycopeptides market data
• Macrolides market data
• Others market data
• Penicillins market data
• Tetracylines market data

APPENDIX B

• Bibliography
• Report methodology
• About Datamonitor
• About Datamonitor Healthcare
• About the Infectious Diseases analysis team
• Key therapy team members
• John Savopoulos, Lead Analyst, Infectious Diseases
• Contact details: tel. +44 20 7675 7615, email jsavopoulos@datamonitor.comDisclaimer
• Disclaimer
• List of Tables
• Table 1: Antibacterial sales across the seven major markets by class, 1999-2003
• Table 2: Key players in the antibacterial market
• Table 3: Antibacterial sales in the US by class, 1999-2003
• Table 4: Antibacterial sales in Japan by class, 2000-2003
• Table 5: Breakdown of primary and secondary care facilities in Japan, 2001
• Table 6: Antibacterial sales in France by class, 1999-2003
• Table 7: Antibacterial sales in Germany by class, 1999-2003
• Table 8: Antibacterial sales in Italy by class, 1999-2003
• Table 9: Antibacterial sales in Spain by class, 1999-2003
• Table 10: Antibacterial sales in the UK by class, 1999-2003
• Table 11: Oral antibiotics and indications considered suitable for nurse prescribing, UK 2004
• Table 12: Impact of changes in age breakdown on community antibacterial prescriptions in the US, 2003-2010
• Table 13: Impact of changes in age breakdown on community antibacterial prescriptions in Spain, 2003-2010
• Table 14: Impact of changes in age breakdown on community antibacterial prescriptions in Japan, 2003-2010
• Table 15: Key patent expiries assessed in the country specific forecasts
• Table 16: Patent expiry models used in the country-specific forecasts
• Table 17: Comparator model used to assess impact of patent expiry
• Table 18: R&D pipeline in antibacterials, December 2003
• Table 19: Expert opinion regarding late-phase antibacterials
• Table 20: Sales revenue ($) per standard unit of amoxicillin-clavulanic acid products in the US, 1999-2003
• Table 21: Comparison of the cost of Augmentin and Augmentin ES in the management of otitis media in the US, 2003
• Table 22: Comparison of the cost of Augmentin and Augmentin XR in the management of community-acquired pneumonia in the US, 2003
• Table 23: Sales revenue ($) per standard unit for ciprofloxacin products in the US, 1999-2003
• Table 24: Cost comparison of Cipro and Cipro XR in the management of uncomplicated and complicated urinary tract infections, US 2003
• Table 25: Cost comparison of Biaxin and Biaxin XL in the treatment of AECB, AMS and CAP, US 2003
• Table 26: Zosyn key event screen
• Table 27: Historical sales data used for the forecasts, seven major markets 2000-2003 ($m)
• Table 28: TOBI: key facts
• Table 29: Zienam: key facts
• Table 30: Merrem: key facts
• Table 31: Invanz: key facts
• Table 32: Farom: key facts
• Table 33: Rocephin: key facts
• Table 34: Cefzil: key facts
• Table 35: Omnicef/Cefzon: key facts
• Table 36: Flomox: key facts
• Table 37: Fortum: key facts
• Table 38: Maxipime: key facts
• Table 39: Zinnat: key facts
• Table 40: Levaquin/Cravit/Tavanic: key facts
• Table 41: Ciproxin: key facts
• Table42: Ciprofloxacin Barr: key facts
• Table 43: Avelox: key facts
• Table 44: Tequin: key facts
• Table 45: Targocid: key facts
• Table 46: Vancocin: key facts
• Table 47: Zithromax: key facts
• Table 48: Biaxin/Klacid/Clarith: key facts
• Table 49: Dalacin C: key facts
• Table 50: Erythrocin: key facts
• Table 51: Ketek: key facts
• Table 52: Zyvox: key facts
• Table 53: Synercid: key facts
• Table 54: Augmentin: key facts
• Table 55: Novartis generic Augmentin: key facts
• Table 56: Tevas generic Augmentin key facts
• Table 57: Tazocin: key facts
• Table 58: Unasyn: key facts
• Table 59: Dynacin (generic Minocin): key facts
• Table 60: Doryx: key facts
• List of Figures
• Figure 1: Antibacterial sales across the seven major markets, 1999-2003
• Figure 2: Antibacterial volume use across the US and EU5, 1999-2003
• Figure 3: Antibacterial sales across the seven major markets by region, 1999-2003
• Figure 4: Antibacterial sales by sector across the US and EU5, 1999-2003
• Figure 5: Antibacterial sales across the seven major markets by class, 1999-2003
• Figure 6: Generic incursion in the antibacterial field, seven major markets 1999-2003
• Figure 7: Antibacterial generic incursion by class across the US and EU, 2003
• Figure 8: Proportion of population over the age of 65, 1991 and 2000
• Figure 9: Proportion of antibacterial value attributable to the over 65s, US drugstores 2003
• Figure 10: Antibacterial prescriptions per capita by key age-group, US Drugstores 2003
• Figure 11: Streptococcus pneumoniae susceptibility to leading antibacterials, seven major markets, 2003
• Figure 12: The development of resistance can lead to premature sales erosion
• Figure 13: Leading antibacterial products in the US, 2003
• Figure 14: Generic incursion in the US antibacterial sector, 1999-2003
• Figure 15: Leading antibacterial brands in Japan, 2003
• Figure 16: Leading antibacterial brands in France, 2003
• Figure 17: Leading antibacterial brands in Germany, 2003
• Figure 18: Leading antibacterial brands in Italy, 2003
• Figure 19: Leading antibacterial brands in Spain, 2003
• Figure 20: Leading antibacterial brands in the UK, 2003
• Figure 21: Securing nurse formulary status will become more important as more surgeries implement triage style systems
• Figure 22: Summary of regional opportunities and threats
• Figure 23: Quarterly Omnicef sales in the US, 1999-2003
• Figure 24: Quarterly US sales performance of Cipro, Cipro XR and generic ciprofloxacin tablets, 2002-2003
• Figure 25: Clinical cure rates for uncomplicated cystitis, treated with ciprofloxacin and amoxicillin-clavulanate
• Figure 26: Avelox sales in the US by sector, 1999-2003
• Figure 27: Global Augmentin sales by quarter, Q1 2001 - Q1 2004
• Figure 28: Sales and volume use of Augmentin, Augmentin ES and Augmentin XR in the US, 1999-2003
• Figure 29: Amoxicillin-clavulanate sales in the US by product, 2001-2003
• Figure 30: Estimated impact of Augmentin XR and Augmentin ES on maintaining brand share
• Figure 31: Promotional spend for amoxicillin-clavulanate products in the US, 1999-2003
• Figure 32: US sales of Cipro and Cipro XR, 2002-03
• Figure 33: Estimated impact of Cipro XR on maintaining market share
• Figure 34: Proportion of ciprofloxacin prescriptions for key indications, US drugstores 2003
• Figure 35: US retail promotional spend for Cipro and Cipro XR, 1999-2003
• Figure 36: US sales of Biaxin and Biaxin XL, 1999- 2003
• Figure 37: Volume use of Biaxin and Biaxin XL in the US, 1999-2003
• Figure 38: Infectious Diseases Society of America treatment guidelines for CAP, 2003
• Figure 39: Continued indication expansion has helped to maintain Levaquins sales growth in the US
• Figure 40: Prescriptions of Levaquin by indication, US Drugstores 2001-2003
• Figure 41: New indications and new formulations help to boost Avelox sales in the US
• Figure 42: Prescriptions of Avelox by indication, US Drugstores 2001-2003
• Figure 43: Quarterly promotional spend and sales of Levaquin and Avelox in the US community, 1999-2003
• Figure 44: Promotional effectiveness of Levaquin and Avelox in the US community, 1999-2003
• Figure 45: IV formulation of Avelox boosts hospital sales of oral formulation in the US, 2001-2003
• Figure 46: IV formulation drives hospital use of all Tequin formulations, US 1999-2003
• Figure 47: US Drugstore sales and prescriptions of Omnicef by age group, 2003
• Figure 48: Omnicef prescriptions in the 0-9 age-group by formulation, US drugstores 2003
• Figure 49: Global Zosyn sales, 1995-2002
• Figure 50: Zosyn sales growth, 1993-2002
• Figure 51: Quarterly sales of Zosyn (Tazocin) in the EU & Pacific Rim, 1998-2001
• Figure 52: Quarterly sales of Zosyn in the US, 1998-2001
• Figure 53: Quarterly sales in selected new Zosyn (Tazocin) markets, 1998-2001