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Pipeline Insight: Antibacterials Product Image

Pipeline Insight: Antibacterials

  • ID: 1667970
  • February 2011
  • 149 pages
  • Datamonitor

Introduction

The antibacterial pipeline is robust with regards to new drugs for the treatment of Gram-positive pathogens, particularly methicillin-resistant Staphylococcus aureus (MRSA). However, there is a lack of late-stage candidates for Gram-negative pathogens. Datamonitor believes that the launch of nine new drugs during the forecasted period (2010–19) will inject $1.98bn into the antibacterial market.

Features and benefits

- Overview of the antibacterial drugs pipeline across the US, Japan, France, Italy, Germany, Spain and the UK.
- Detailed ten-year sales forecasts for key late-stage pipeline antibacterial drugs in each of the seven major markets.
- Discussion of unmet needs driving the sales prospects for new antibacterials.
- Review of R&D trends and clinical trial design in the antibacterials sector.

Highlights

- Among the late-stage antibacterial pipeline drugs, Trius Therapeutics/Dong-A Pharmaceutical‘s torezolid, Forest Laboratories/Takeda/Abbott’s ceftaroline fosamil and Paratek/Novartis’ PTK 0796 have the best outlook.
- Whereas the Gram-positive segment is relatively well covered, the most important READ MORE >

Executive Summary
Scope of the analysis
Datamonitor insight into the antibacterials market
Related reports
Upcoming reports
OVERVIEW
Catalyst
Summary
1. PIPELINE OVERVIEW AND DYNAMICS
Key findings
Pipeline overview
Several promising antibacterial candidates have reached late stages of clinical development
Quinolones and fluoroquinolones dominate the antibacterial drugs pipeline
Key companies active in antibacterial development
Biotech and small pharmaceutical companies dominate the antibacterial pipeline
Key R&D company strategies
Future outlook: combination products as new strategy to beat resistance
2. EPIDEMIOLOGY
Key findings
Segmentation of bacterial diseases
Site of infection
Type of pathogen
Hospital and community-acquired infections
Epidemiology of bacterial infections
Respiratory tract infections: decreasing threat from S. pneumoniae and H. influenzae
Skin and soft tissue infections: MRSA remains key concern
Urinary tract infections are common in both hospital and community settings
Surgical site infections remain a significant problem in hospitals
Efficacious treatment options for bloodstream infections are decreasing
3. UNMET NEEDS IN ANTIBACTERIALS
Key findings
Overview of unmet needs
Drugs with improved activity against Gram-negative pathogens are the most important unmet need
Improved activity against multidrug-resistant pathogens is the second most important unmet need
Drugs with an improved safety and tolerability profile are important in both hospital and community settings
Shorter treatment courses would improve patient convenience
Particularly with regards to community drugs, affordability is a key concern
Oral/IV switch capacity is a further important unmet need
4. R&D APPROACH
Key findings
Classification of pipeline products
Overview of key antibacterial classes
Beta-lactams
Glycopeptides
Quinolones/fluoroquinolones
Oxazolidinones
Macrolides
Tetracyclines
Aminoglycosides
Clinical trial design for antibiotics
Clinical trial endpoints in bacterial infections
Additional considerations
Development of drugs for resistant pathogens
Lack of standardized data on available antibacterials is a major challenge for clinical trial design of new drugs
Prevailing regulatory uncertainty for antibiotic trials is deterring investment in the sector
The FDA has issued guidance to facilitate the development of antibacterial drugs
5. PEPTIDES AND GLYCOPEPTIDES
Key findings
Overview of peptides and glycopeptides
Late-stage pipeline summary
Definition of current comparator therapy
Oritavancin (The Medicines Company)
Drug overview
Drug profile
Clinical trial data
Clinical and commercial attractiveness
Satisfaction of unmet needs
SWOT analysis
Datamonitor drug assessment score card for oritavancin
Forecasts to
Dalbavancin (Durata Therapeutics)
Drug overview
Drug profile
Clinical trial data
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Datamonitor drug assessment score card for dalbavancin
Forecasts to
Key early-stage peptides/glycopeptides in clinical development
6. CEPHALOSPORINS
Key findings
Overview of cephalosporins
Late-stage pipeline summary
Definition of current comparator therapy
Teflaro (ceftaroline fosamil; Forest Laboratories/Takeda/AstraZeneca)
Drug overview
Drug profile
Clinical trial data
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Datamonitor drug assessment score card for Ceftaroline
Forecasts to
Zeftera (ceftobiprole; Basilea)
Drug overview
Clinical trial data
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Datamonitor drug assessment score card for Zeftera (ceftobiprole)
Forecasts to
Key early-stage cephalosporins in clinical development
7. MACROLIDES AND KETOLIDES
Key findings
Overview of macrolides and ketolides
Pipeline summary
Definition of current comparator therapy
Fidaxomicin (Optimer Pharmaceuticals/Biocon/Astellas)
Drug overview
Clinical trial data
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Datamonitor drug assessment score card for fidaxomicin
Forecasts to
Restanza (cethromycin; Advanced Life Sciences/Pfizer)
Drug overview
Drug profile
Clinical trial data
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Datamonitor drug assessment score card for Restanza (cethromycin)
Forecasts to
Key early-stage macrolides/ketolides in clinical development
8. QUINOLONES AND FLUOROQUINOLONES
Key findings
Overview of quinolones and fluoroquinolones
Pipeline summary
Definition of current comparator therapy
Delafloxacin (Rib-X Pharmaceuticals)
Drug overview
Drug profile
Clinical trial data
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Datamonitor drug assessment score card for delafloxacin
Forecasts to
Key early-stage quinolones/fluoroquinolones in clinical development
9. OTHER ANTIBACTERIALS
Key findings
Overview of other antibacterials
Pipeline summary
Torezolid (Trius Therapeutics/Dong-A Pharmaceutical)
Drug overview
Drug profile
Clinical trial data
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Forecasts to
PTK 0796 (Paratek/Novartis)
Drug overview
Drug profile
Clinical trial data
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Datamonitor drug assessment score card for torezolid and PTK
Forecasts to
10. INNOVATIVE EARLY-STAGE APPROACHES
Key findings
Biologics as antibacterials
Investigational combination therapies (combinations of two or more antibiotics)
BIBLIOGRAPHY
Online books and journals
Websites
Company press releases
Datamonitor reports
APPENDIX
Methodology
Datamonitor forecast methodology
Derivation of sales forecasts and pricing trends
Exchange rates
Datamonitor drug assessment scorecard
Contributing experts

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