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Commercial Insight: Antibacterials - Pharma Strikes Antibac

Published by: Datamonitor

Published: Aug. 3, 2005 - 277 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE

About the Infectious Disease 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


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


Penetration of the resistance market poses several challnges

What it takes to be successful in the drug-resistance niche: Zyvox versus Synercid






APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS

Definition of the Pacific Rim

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

Disclaimer




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: Rocephin: key facts

Table 39: Omnicef: key facts

Table 40: Fortaz: key facts

Table 41: Flomox: key facts

Table 42: Cefzil: key facts

Table 43: Vantin/Orelox: key facts

Table 44: Maxipime: key facts

Table 45: Ceftin/Zinnat: key facts

Table 46: Spectracef: key facts

Table 47: Sulperazon: key facts

Table 48: Suprax: key facts

Table 49: Pansporin: key facts

Table 50: Ceclor: key facts

Table 51: Levaquin/Cravit/Tavanic: key facts

Table 52: Cipro: key facts

Table 53: Avelox: key facts

Table 54: Tequin: key facts

Table 55: Floxin: key facts

Table 56: Zithromax: key facts

Table 57: Biaxin/Klacid/Clarith: key facts

Table 58: Cleocin: key facts

Table 59: Ketek: key facts

Table 60: Erythromycin (molecule): key facts

Table 61: Augmentin: key facts

Table 62: Zosyn: key facts

Table 63: Unasyn: key facts

Table 64: Primaxin: key facts

Table 65: Merrem: key facts

Table 66: Invanz: key facts

Table 67: Farom: key facts

Table 68: Vancomycin (molecule): key facts

Table 69: Targocid: key facts

Table 70: Tobi: key facts

Table 71: Gentamicin (molecule): key facts

Table 72: Habekacin: key facts

Table 73: Doxycycline hyclate (molecule): key facts

Table 74: Minocin: key facts

Table 75: Zyvox: key facts

Table 76: Pyostacine: key facts

Table 77: Cubicin: key facts

Table 78: 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

Abstract

Introduction
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.

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
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.

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


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