[Report] Antibacterials Market Research, Trends, Analysis TOC

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

Commercial Insight: Antibacterials - Growth in resistance rates drives niche indications

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