Market Report Source

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 7 major markets (US, Japan, France, Germany, Italy, Spain, UK)
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 lifecycle management strategies for Zithromax (Pfizer), Rocephin (Roche) and Biaxin (Abbott) and assessment of their success

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’ 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

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

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