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Commercial Insight: Antibacterials

Pharma Strikes Antibac

Publication Date   August 2005
Publisher   Datamonitor
Product Type   Strategic Report
Pages   277
ISBN Number   not applicable
Product Code   DAT340
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Price £8,000.00

approximately: $15,844 | €10,169

Summary


Rapid uptake of products focused on drug-resistant infections, such as Pfizer's Zyvox (linezolid), has been driven by the increasing numbers of immunocompromised patients in hospitals. Despite these pockets of strong growth, the market for antibacterials, valued at $24 billion in the seven major markets, still faces significant revenue loss in the period 2005-2007 due to major patent expiries.

Highlights

  • In 2004 the global antibacterial market was valued at approximately $24 billion with modest growth on 2000 (CAGR 4.4%). The fastest growing classes during this period were the carbapenems and "others" with notable products such as Pfizer's Zyvox (linezolid).
  • Although drug resistant infections such as MRSA have been a key focus over recent years, Datamonitor's opinion leader research reveals new concerns with Gram negative organisms such as actineobacter, pseudomonas and ESBL producing strains.
  • Pfizer's acquisition of Vircuron's dalbavancin and Johnson's and Johnson's investment in both doripenem and ceftobipole brings much need reinvestment to the antibacterial sector and a commitment to combating serious hospital infections.

Scope

  • Highlights epidemiological trends in bacterial infections across the major Western markets
  • In-depth value analysis per product, class and country, with an assessment of underlying commercial and clinical influencers
  • Case study analysis of Pfizer's Zmax single dose formulation for respiratory tract infections, including the impact of generic azithromycin
  • Examines the outlook for branded Rocephin in the key US market discussion of Sandoz, Lupin, and Hospira strategies for generic ceftriaxone

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 the product lifecycle management strategies of the top antibacterial players through real case study analyses
  • Understand why 2005 has brought new investment to a previously neglected therapeutic sector

Content


  • 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
    • The hospital versus the community market
    • Current market situation
    • Despite being highly mature, the antibacterial market is still growing
    • Injectable antibacterials and those with activity against resistant strains are the main growth drivers
    • Four classes with sales over $4 billion dominate the antibacterial market
    • Cephalosporins
    • Fluoroquinolones
    • Macrolides and ketolides
    • Penicillins
    • The cephalosporins generate the highest sales in terms of value
    • The penicillins remain the most widely used class
    • The impact of patent expiry and genericization
    • While the UK antibacterial market is highly genericized, in Italy, generic incursion represents only 10% of yearly sales
    • The US is the largest market in terms of value
    • The antibacterial market is highly segmented
    • Leading antibacterial products
    • Leading antibacterial players with sales over $1 billion in 2004
    • Strategic scoping and focus
  • Chapter 3 Country Market Assessments
    • Current and future opportunities and threats in the antibacterial market
    • Global opportunities and threats
    • Opportunities
    • Threats
    • US: opportunities and threats
    • Antibacterial market overview
    • Opportunities
    • Threats
    • Japan: opportunities and threats
    • Antibacterial market overview: Pacific Rim
    • Opportunities
    • Threats
    • France: opportunities and threats
    • Antibacterial market overview
    • Opportunities
    • Threats
    • Germany: opportunities and threats
    • Antibacterial market overview
    • Opportunities
    • Threats
    • Italy: opportunities and threats
    • Antibacterial market overview
    • Opportunities
    • Threats
    • Spain: opportunities and threats
    • Antibacterial market overview
    • 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
    • Events excluded from the forecast
    • Product-specific events
    • Study shows efficacy of Avelox for the treatment of pneumonia in the elderly
    • Avelox demonstrates faster symptom relief and hospital discharge for pneumonia patients
    • Study shows Avelox is better than comparators for IAIs
    • Antibacterial patent expiries
    • Launch of new drugs with activity against resistant bacterial strains
    • Country-specific events
    • US
    • Japan
    • Limitations of data
    • Standard units
    • Japanese market data
    • Regional launch dates for new products
    • Forecasts
  • Chapter 5 Case Studies
    • Product lifecycle management strategies can delay or limit generic incursion
    • Line extension is a popular LCM strategy to minimize generic incursion
    • Augmentin - generic incursion still driving down sales
    • Cipro - alliance with a generics manufacturer fails to achieve the desired result
    • Biaxin - will Biaxin XL withstand generic clarithromycin?
    • Are line extensions worth the effort?
    • Zithromax and Zmax - single hope in a single dose?
    • Zithromax - pending patent expiry
    • Zithromax - possible revenue scenarios
    • Rocephin - a giant falls in 2005
    • US brand value dominance to disappear
    • Generic ceftazidime - slow on the uptake
    • Portfolio management of the top antibacterial players
    • Antibacterial market dynamics - sales trends shift market share
    • Pfizer is currently market leader
    • 2005 - a year of change
    • Antibacterial portfolio analysis - a variety of management tools are being employed
    • Pfizer - strong presence in the community, niche in the hospital
    • Is GSK giving up on antibacterials?
    • Johnson & Johnson - planning ahead
    • Abbott - an overcast outlook
    • Roche - it's all about injectables
    • Niche markets: the only money spinners left?
    • The community treatment market - is there any value left?
    • Drug-resistance sparks developmental activity
  • Appendix A - Market Data And Major Brand Key Facts
    • Definition of the Pacific Rim
    • Global antibacterial market data
    • CEPHALOSPORINS (J1D1, J1D2) market data
    • FLUOROQUINOLONES (J1G1) 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
    • Journals
    • Epidemiology
    • Press releases
    • Datamonitor
    • Miscellaneous
    • Websites
    • Report methodology
  • List of Tables
    • Table 1: Definition of combined antibacterial classes used throughout the report
    • Table 2: Four antibacterial classes with the highest growth between 2000 and 2004, seven major markets
    • Table 3: Antibacterial sales across the seven major markets by class, 2000-04
    • Table 4: Sales and growth rates of the top ten branded parenteral cephalosporins across the seven major markets, 2000-04
    • Table 5: Combined annual growth rates (CAGRs) across the seven major antibacterial markets, 2000-04
    • Table 6: Key players in the antibacterial market
    • Table 7: Several bestselling drugs are expected to experience patent expiry in the US, 2005-07
    • Table 8: Antibacterial vaccines in advanced clinical development
    • Table 9: Antibacterial market in the US by class, 2000-04
    • Table 10: Antibacterial market in the Pacific Rim by class, 2000-04
    • Table 11: The five leading brands in the Pacific Rim were originally developed by Japanese companies
    • Table 12: The number of beds in hospitals is significantly higher than in GP clinics, 2001
    • Table 13: Antibacterial market in France by class, 2000-04
    • Table 14: French healthcare funding, 2002
    • Table 15: Antibacterial market in Germany by class, 2000-04
    • Table 16: Antibacterial market in Italy by class, 2000-04
    • Table 17: Number of private and public hospital beds
    • Table 18: Drivers and resistors for genericization in the Italian pharmaceutical market
    • Table 19: Antibacterial market in Spain by class, 2000-04
    • Table 20: Antibacterial market the UK by class, 2000-04
    • Table 21: Developmental antibacterials in Phase II or higher
    • Table 22: Overview of 2004 sales for original brands and their follow-up products in the US
    • Table 23: Augmentin, Augmentin ES-600 and Augmentin XR prescription summary
    • Table 24: Price per unit for original Augmentin and follow-up products, US, 2000-2004
    • Table 25: Price per unit for branded versus generic amoxicillin/clavulanic acid, in the US, 2004
    • Table 26: Price per standards unit for branded versus generic ciprofloxacin
    • Table 27: Despite decreasing sales due to generic incursion, Bayer did not reduce Cipro's price in the US
    • Table 28: Cipro and follow-up product sales, US, 2000-04
    • Table 29: Impact of generic incursion following loss of patent protection on brand sales for brands with and without follow-up products
    • Table 30: Revenue scenarios for Zithromax, sales for 2005-08
    • Table 31: Major acquisitions by Novartis/Sandoz generics, 2001-05
    • Table 32: Total, infectious disease and antibacterial portfolio performance of the antibacterial market leaders, seven major markets, 2004
    • Table 33: Since it was first approved in the US in 1996, Levaquin has been extensively lifecycle managed through various indication expansions
    • Table 34: Price per gram of key hospital and community antibacterials, 2004
    • Table 35: Antibacterial compounds in development for the treatment of drug-resistant bacterial infections
    • Table 36: Zyvox is more cost-effective than Synercid
    • Table 37: Definition of the Pacific Rim in terms of countries and channels included
    • Table 38: Historical sales data used for the forecasts, seven major markets, 2001-04
    • Table 39: Rocephin: key facts
    • Table 40: Omnicef: key facts
    • Table 41: Fortaz: key facts
    • Table 42: Flomox: key facts
    • Table 43: Cefzil: key facts
    • Table 44: Vantin/Orelox: key facts
    • Table 45: Maxipime: key facts
    • Table 46: Ceftin/Zinnat: key facts
    • Table 47: Spectracef: key facts
    • Table 48: Sulperazon: key facts
    • Table 49: Suprax: key facts
    • Table 50: Pansporin: key facts
    • Table 51: Ceclor: key facts
    • Table 52: Levaquin/Cravit/Tavanic: key facts
    • Table 53: Cipro: key facts
    • Table 54: Avelox: key facts
    • Table 55: Tequin: key facts
    • Table 56: Floxin: key facts
    • Table 57: Zithromax: key facts
    • Table 58: Biaxin/Klacid/Clarith: key facts
    • Table 59: Cleocin: key facts
    • Table 60: Ketek: key facts
    • Table 61: Erythromycin (molecule): key facts
    • Table 62: Augmentin: key facts
    • Table 63: Zosyn: key facts
    • Table 64: Unasyn: key facts
    • Table 65: Primaxin: key facts
    • Table 66: Merrem: key facts
    • Table 67: Invanz: key facts
    • Table 68: Farom: key facts
    • Table 69: Vancomycin (molecule): key facts
    • Table 70: Targocid: key facts
    • Table 71: Tobi: key facts
    • Table 72: Gentamicin (molecule): key facts
    • Table 73: Habekacin: key facts
    • Table 74: Doxycycline hyclate (molecule): key facts
    • Table 75: Minocin: key facts
    • Table 76: Zyvox: key facts
    • Table 77: Pyostacine: key facts
    • Table 78: Cubicin: key facts
    • Table 79: Synercid: key facts
  • List of Figures
    • Figure 1: Antibacterial sales across the seven major markets by sales and volume use, 2000-04
    • Figure 2: Growth rates of individual antibacterial classes between 2000 and 2004 differed significantly, seven major markets
    • Figure 3: Market share of the leading antibacterial classes across the seven major markets, 2004
    • Figure 4: Branded and generic ceftriaxone sales across the seven major markets, 2004
    • Figure 5: Antibacterial sales across the seven major markets by class, 2000-04
    • Figure 6: Antibacterial volume use across the seven major markets by class, 2000-04
    • Figure 7: Parenteral penicillins are the penicillin sub-class least affected by generic incursion across the seven major markets, 2004
    • Figure 8: Genericization across the seven major markets by sales and volume use, 2004
    • Figure 9: Generic sales and volume use across the seven major markets by class, 2004
    • Figure 10: Antibacterial sales across the seven major markets by geographical area, 2000-04
    • Figure 11: Top seven antibacterial players across the seven major markets registering sales over $1 billion, 2004
    • Figure 12: The population in the developed word is aging
    • Figure 13: US market shares of leading antibacterial brands by value, 2004
    • Figure 14: Pacific Rim market shares of leading antibacterial brands by value, 2004
    • Figure 15: Contribution of the three key sources to the Japanese healthcare system, 2001
    • Figure 16: France market shares of leading antibacterial brands by value, 2004
    • Figure 17: Germany market shares of leading antibacterial brands by value, 2004
    • Figure 18: Parallel trade in the German antibacterial market, 2004
    • Figure 19: Italy market shares of leading antibacterial brands by value, 2004
    • Figure 20: Spain market shares of leading antibacterial brands by value, 2004
    • Figure 21: UK market shares of leading antibacterial brands by value, 2004
    • Figure 22: Number of MRSA bacteremias reported in England since the introduction off the DoH's mandatory MRSA surveillance system in acute Trusts in England, 2001-05
    • Figure 23: Summary of global and country-specific opportunities and treats
    • Figure 24: Antibacterial sales forecasts, 2005-15, and key patent expiries
    • Figure 25: In the US, Omnicef is expected to continue growing until the loss of patent protection in 2007
    • Figure 26: Total GSK antibacterial sales, seven major markets, 2000-04
    • Figure 27: Augmentin follow-up products succeeded in reducing but not preventing sales erosion due to generic incursion
    • Figure 28: Contributions of the original and the follow-up products to overall Augmentin sales, US, 2002 and 2004
    • Figure 29: Relative sales and volume use of branded and generic amoxicillin/clavulanic acid, 2004
    • Figure 30: Cipro, Cipro XR and Cipro IV sales, 2000-04
    • Figure 31: Cipro's sales in the US declined by 26.7% following the launch of Barr's generic ciprofloxacin
    • Figure 32: Sales of branded and generic ciprofloxacin, US, 2002 and 2004
    • Figure 33: US sales for Biaxin and follow-up products, 2000-04
    • Figure 34: Zithromax sales in the US, 2000-04
    • Figure 35: Zithromax product types and approved indications
    • Figure 36: ZMax data presented at the 44th ICAAC, 2004
    • Figure 37: Perceived strengths and weaknesses of ZMax
    • Figure 38: Zithromax revenue scenarios after patent expiry
    • Figure 39: Branded and generic ceftriaxone markets ($m) in 2004
    • Figure 40: Rocephin use by site of infection across the seven major markets (%)
    • Figure 41: Regional focus on branded versus unbranded ceftriaxone, 2004
    • Figure 42: Branded and generic ceftazidime markets in terms of sales value, 2004
    • Figure 43: Regional focus on branded versus unbranded ceftazidime, 2004
    • Figure 44: Antibacterial market share for the seven top companies with sales over $1 billion, seven major markets, 2000, 2002 and 2004
    • Figure 45: Antibacterial market share for the seven top companies with sales over $1 billion, seven major markets, 2005, 2010 and 2015
    • Figure 46: Pfizer's antibacterial portfolio, 2005
    • Figure 47: Pfizer's antibacterial portfolio in 2015, leading brands only
    • Figure 48: Despite generic sales erosion, Augmentin is still GSK's leading antibacterial
    • Figure 49: GSK's antibacterial portfolio, leading drugs
    • Figure 50: GSK's antibacterial portfolio in 2015, leading brands only
    • Figure 51: The Levaquin (levofloxacin) brand accounted for 99.4% of J&J's antibacterial sales in 2004 in the seven major markets
    • Figure 52: J&J's antibacterial portfolio, leading drugs
    • Figure 53: Levaquin sales, US, 1999-2004
    • Figure 54: J&J's antibacterial portfolio in 2015, leading brands only
    • Figure 55: In the US, Abbott derived 98% of its antibacterial sales from leading products Biaxin and Omnicef in 2004
    • Figure 56: Abbott's antibacterial portfolio, leading drugs
    • Figure 57: Abbott's antibacterial portfolio in 2015
    • Figure 58: Roche's antibacterial portfolio, leading drugs
    • Figure 59: Roche's lead antibacterial Rocephin is expected to lose two-thirds of its value to generics by 2015
    • Figure 60: Blockbuster sales in each therapy area in 2004, seven major markets
    • Figure 61: Ketek sales, seven major markets, 2000-04
    • Figure 62: Ketek forecast, 2005-2015, seven major markets
    • Figure 63: Zyvox versus Synercid, seven major markets, 2000-04
    • Figure 64: 2004 sales of leading hospital antibacterials, seven major markets
    • Figure 65: Zyvox forecast, 2005-2015, seven major markets
    • Figure 66: Early Zyvox website product positioning