抗菌剤市場動向

Abstract

Overview

Introduction

The global antibacterial market, valued at $25.5 billion in 2005, is highly mature. Modest growth (CAGR 2001-2005: 5.1%) is fuelled by ageing, immunosuppression and emerging resistances, especially in the hospital and former niche markets (e.g. MRSA). The community market, however, is facing a value loss following the patent expiries of several blockbusters (e.g. Pfizer' s Zithromax) in 2005.

Scope

• In-depth analysis of the current antibacterial market situation across the major Western markets
• Thorough assessment of underlying commercial and clinical influencers shaping the antibacterial market
• Detailed sales forecasts for key antibacterial classes, molecules and brands in each of the seven major markets
• Case study analysis of life-cycle-management strategies for Zithromax (Pfizer), Rocephin (Roche) and Biaxin (Abbott) and assessment of their success

Report Highlights

In 2005 the global antibacterial market was valued at approximately $25.5 billion with a modest CAGR of 5.1% since 2001. The fastest growing classes were the carbapenems, glycopeptides and "others" (e.g. Pfizer' s Zyvox (linezolid)). The best selling drug was J&J' s/Sanofi-Aventis' s Levaquin (levofloxacin) with global sales of $2.4 billion.

Although gram-positive infections such as MRSA have been a key focus over recent years, Datamonitor' s opinion leader research revealed new concerns about gram-negative organisms such as acinetobacter, pseudomonas and ESBL producing strains.

Ageing, immunosuppression and resistances contribute to the rising incidence of severe infections and fuel the growth of the hospital market. In contrast, the community market is facing a value loss resulting from the patent expiries of blockbusters such as Zithromax (azithromycin) and the incursion of cheap generics.

Reasons to Purchase

• Review the clinical and commercial factors driving new product decisions in antibacterials, and the opportunities and threats facing the market
• Gain insight into future trends and lifecycle management strategies through a detailed market forecast and real case study analyses
• Understand where concerns, unmet needs and future opportunities lie by learning about the views of key antibacterial opinion leaders.

Table of Contents

• ABOUT HEALTHCARE
  • About the Respiratory and 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
    • ATC classes covered
    • Classification of pathogens and sites of infection
      • Gram staining
      • Bacterial growth conditions
      • Site of infection
    • Hospital and community market
  • Current market situation
    • Although highly mature, the antibacterial market is still growing
    • Four classes dominate the antibacterial market
      • Penicillins
      • Cephalosporins
      • Fluoroquinolones
      • Macrolides and ketolides
    • The antibacterial market is highly segmented
    • Several blockbusters share the market lead
      • Cephalosporins are ahead in terms of sales
      • Penicillins remain the most widely used class
    • Most large pharma companies are active in the antibacterial market
    • The antibacterial market is highly genericized
    • Although the community market is still dominant, the hospital market is gaining in importance
    • The US continues to be the biggest market for antibacterials
    • Key unmet needs lie in the treatment of infections caused by MRSA and gram-negative pathogens
  • Strategic scoping and focus
• CHAPTER 3: COUNTRY MARKET ASSESSMENTS
  • Global opportunities and threats
    • Opportunities
      • Increasing age of the population and higher likelihood of bacterial infections among the elderly will expand the antibacterial market
      • The increasing number of immunocompromised patients constitutes a large future patient pool
      • New market opportunities arise because of increasing resistances against available drugs
      • Acceleration and harmonization of approval procedures
    • Threats
      • Patent expiry and cost containment drive generic incursion
      • Governments impose pricing pressure on drug manufacturers as a consequence of cost containment needs
      • Parallel trade - illegal in the US, encouraged in Europe
      • New vaccination strategies reduce the need for antibacterial treatment
      • Increasing drug resistance promotes new treatment guidelines and restrics antibacterial use
  • US: opportunities and threats
    • Antibacterial market overview
    • Opportunities
      • Direct-to-consumer advertising
      • Branded products achieve high prices as a result of the free pricing system
    • Threats
      • Initiatives by public and private health providers aim to encourage cost containment
      • Further genericization is encouraged by legislation and public programs
      • Although still illegal, parallel trade is likely to be legalized in the medium term
  • Japan: opportunities and threats
    • Antibacterial market overview
    • Opportunities
      • Acceleration of the drug approval process maximizes profit opportunities
      • Separation of manufacturing and marketing entities will benefit both local companies and foreign investors
      • Enhanced R&D activity as a result of new legislation allowing outsourcing
    • Threats
      • Genericization is slowly taking off
      • More restrictive cost containment measurements are under discussion
  • France: opportunities and threats
    • Antibacterial market overview
    • Opportunities
      • Critical attitude towards MRP slows down generic penetration
      • High prescription volume boosts drug revenues
      • The creation of HAS facilitates P&R approval
      • Reimbursement system favors use of innovative drugs
    • Threats
      • Cost containment policies aim at reducing the expenditure for prescription drugs
      • Genericization has increased recently and is further supported
  • Germany: opportunities and threats
    • Antibacterial market overview
    • Opportunities
      • Legalization of mail order provides new distribution channels
      • Free pricing system and culture of innovation encourages novel drug development
      • Fewer cost containment restrictions make the hospital sector a valuable opportunity
    • Threats
      • Jumbo Reference Pricing is threatening drug revenue growth
      • Increasing genericization is strongly supported by the government
  • Italy: opportunities and threats
    • Antibacterial market overview
    • Opportunities
      • The ageing population and the increasing incidence of severe infections fuel a growth in the hospital market
      • Low levels of generic penetration as a result of lack of confidence
      • Reimbursement levels are determined by negotiations rather than regulations
    • Threats
      • Unpredictability of regulations hampers reliable strategic planning
      • Reference pricing might result in downward price spirals and support genericization
  • Spain: opportunities and threats
    • Antibacterial market overview
    • Opportunities
      • Legislation and reimbursement schemes support innovation
      • Decentralization of the healthcare system provides localized opportunities
    • Threats
      • Cost containment measurements restrict manufacturer' s profit margins
      • Government encourages generic use
  • UK: opportunities and threats
    • Antibacterial market overview
    • Opportunities
      • Decreasing incentives for pharmacists to prescribe generics as a result of new DoH initiative
      • Promising niche markets as a result of MRSA and other superbugs
      • OTC is a possible long-term opportunity
    • Threats
      • Price reduction for branded products after PPRS change in 2004
      • Complex structures for P&R negotiations elongate time to market
      • High generic penetration is a large challenge for brand manufacturers
  • Summary of environmental issues affecting the antibacterial country markets
• CHAPTER 4: FORECAST ANALYSIS
  • Assumptions and events
    • Events excluded from the forecast
    • Product- and class-specific events
      • Patent expiries and genericization
      • Additional indications and major clinical trials
      • Cephalosporins
      • Fluoroquinolones
      • Macrolides
      • Penicillins
      • Carbapenems
      • Aminoglycosides
      • All others
    • New product launches
      • Regional launch date for new products
  • Data definitions, limitations and assumptions
    • Standard units
    • Japanese market data
    • Derivation of sales forecasts and pricing trends
  • Forecasts
  • Forecast methodology
• CHAPTER 5: COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES
  • Avoiding the crash - lifecycle management strategies of big pharma facing blockbuster patent expiries
    • Pfizer, Abbott, Roche: Key 2005 lifecycle management strategies in the US antibacterial market
      • Pfizer: bouncing back from Zmax failure with generic azithromycin
      • Abbott: successful switch to Biaxin XL
      • Roche - exiting the antibacterial market after Rocephin' s fall
    • Line extensions - top or flop?
      • Statistical data are overall supportive of line extensions
      • Examples show that careful planning of line extensions is neccessary
• APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS
  • Summary antibacterials market data
  • CEPHALOSPORINS (J1D1, J1D2) market data
  • FLUOROQUINOLONES (J1G1, J1G2) market data
  • MACROLIDES (J1F0) market data
  • PENICILLINS (J1C1, J1C2, J1H1) market data
  • CARBAPENEMS (J1P2) market data
  • GLYCOPEPTIDES (J1X1) market data
  • AMINOGLYCOSIDES (J1K0) market data
  • TETRACYCLINES (J1A0) market data
  • All others (J1X) market data
• APPENDIX B - BIBLIOGRAPHY
  • Journal articles
  • Publications by governmental or regulatory authorities
  • Company Press Releases
  • News articles
  • Analyst reports
  • Report methodology
  • About Datamonitor
    • About Datamonitor Healthcare
    • About the Antibacterials analysis team
    • Key therapy team members
      • Holger Rovini, Head of Respiratory and Infectious Diseases
      • Hedwig Kresse, Associate Analyst, Infectious Diseases
    • Disclaimer
  • List of Tables
    • Table 1: Definition of combined antibacterial classes used throughout the report
    • Table 2: Key players in the antibacterial market
    • Table 3: Global antibacterial sales by class, 2001-2005
    • Table 4: CAGRs across the US, EU5 and Pacific Rim, 2001-2005
    • Table 5: Loss of sales of blockbuster antibacterials in the first year after patent expiry
    • Table 6: Antibacterial vaccines in advanced clinical development, 2006
    • Table 7: Antibacterial sales in the US by class, 2001-2005
    • Table 8: Antibacterial sales in Japan by class, 2001-2005
    • Table 9: Leading brands in the Japanese market developed by Japanese companies
    • Table 9: Antibacterial sales in France by class, 2001-2005
    • Table 10: Antibacterial sales in Germany by class, 2001-2005
    • Table 12: Antibacterial market in Italy by class, 2001-2005
    • Table 11: Antibacterial market in Spain by class, 2001- 2005
    • Table 12: Antibacterial market in the UK by class, 2001-2005
    • Table 13: Developmental antibacterials in Phase III
    • Table 15: Impact of generic incursion in the US following loss of patent protection on brand sales for brands with and without follow-up products
    • Table 14: Definition of the Pacific Rim in terms of countries and channels included
    • Table 15: Summary market data US
    • Table 16: Summary market data key countries Pacific Rim
    • Table 17: Summary market data EU5
    • Table 20: Rocephin: key facts
    • Table 21: Omnicef: key facts
    • Table 22: Flomox: key facts
    • Table 23: Fortaz: key facts
    • Table 24: Maxipime: key facts
    • Table 25: Vantin/Orelox: key facts
    • Table 26: Cefzil: key facts
    • Table 27: Meiact/Spectracef: key facts
    • Table 28: Flumarin: key facts
    • Table 29: Suprax: key facts
    • Table 30: Ceftin/Zinnat: key facts
    • Table 31: Sulperazon: key facts
    • Table 32: Pansporin: key factss
    • Table 33: Ceclor: key facts
    • Table 34: Levaquin: key facts
    • Table 35: Cipro: key facts
    • Table 36: Avelox: key facts
    • Table 37: Tequin: key facts key facts
    • Table 38: Floxin: key facts
    • Table 39: Zithromax: key facts
    • Table 40: Biaxin: key facts
    • Table 41: Ketek: key facts
    • Table 42: Cleocin: key facts
    • Table 43: Zosyn: key facts
    • Table 44: Augmentin: key facts
    • Table 45: Unasyn: key facts
    • Table 46: Primaxin: key facts
    • Table 47: Merrem: key facts
    • Table 48: Invanz: key facts
    • Table 49: Vancomycin: key facts
    • Table 50: Targocid: key facts
    • Table 51: Tobi: key facts
    • Table 52: Doxycycline hyclate (molecule): key facts
    • Table 54: Zyvox: key facts
    • Table 55: Cubicin: key facts
    • Table 56: Pyostacine: key facts
  • List of Figures
    • Figure 1: Antibacterial sales across the seven major markets by sales and volume, 2001-2005
    • Figure 2: Market shares (sales) of the leading antibacterial drug classes
    • Figure 3: Global antibacterial sales by class, 2001-2005
    • Figure 4: Global antibacterial volume use by class, 2001-2005
    • Figure 5: Generic incursion in penicillin subclasses, 2005
    • Figure 6: Leading companies in the antibacterial market, 2005
    • Figure 7: Generic sales and volume use in antibacterials by geographic area, 2005
    • Figure 8: Global generic sales and volume use by class, 2005
    • Figure 9: Sales and volume use in the hospital vs the community market, excluding Japan, 2001-2005
    • Figure 10: Sales and volume use of parenteral vs oral subclasses in the hospital vs the community market excluding Japan, 2001-2005
    • Figure 11: Share of antibacterial sales and volumes across the US, EU5 and Pacific Rim by geographical area, 2001-2005
    • Figure 12: Ageing populations in the seven major markets, 1996-2016
    • Figure 13: US market shares of leading antibacterial brands by value, 2005
    • Figure 14: Japan market share of leading antibacterial brands by value, 2005
    • Figure 15: France market shares of leading antibacterial brands by value, 2005
    • Figure 16: Germany market shares of leading antibacterial brands by value, 2005
    • Figure 17: Italy market shares of leading antibacterial brands by value, 2005
    • Figure 18: Spain market shares of leading antibacterial brands by value, 2005
    • Figure 19: UK market shares of leading antibacterial brands by value, 2005
    • Figure 20: A range of bodies having an impact on drug prescription in the UK
    • Figure 21: Summary of global and country-specific opportunities and threats
    • Figure 22: Appropriate LCM strategy depends on time and financial investment
    • Figure 23: Zithromax sales in the US, Q1/2005-Q2/2006
    • Figure 24: Pfizer' s US marketing spend for azithromycin (Q3/2004-Q4/2005) is shifting from Zithromax to Zmax
    • Figure 25: Generic azithromycin: US market share (first half of 2006)
    • Figure 26: Pfizer still dominates the US azithromycin market (Q1/2005-Q2/2006)
    • Figure 27: Regional amount of generic incursion for clarithromycin, 2005
    • Figure 28: US clarithromycin sales, 1H2003-1H2006
    • Figure 29: Regional amount of generic incursion for ceftriaxone, 2005
    • Figure 30: US sales of ceftriaxone, Q1/2005-Q2/2006
    • Figure 31: Roche: global antibacterial sales Q1/2005-Q2/2006