Report: Infectious Diseases Drugs Markets TOC

1. Overview

1.1 Statement of Report
1.2 Scope of the Report
1.3 Methodology
1.4 Executive Summary

2. Clinical Syndromes and Therapy

2.1 Head and Neck
- 2.1.1 Sinusitis
- 2.1.2 Pharyngotonsillitis
- 2.1.3 Deep Neck Infections
- 2.1.4 Otitis Media and Externa
- 2.1.5 Acute Suppurative Thyroiditis
2.2 Eye
- 2.2.1 Conjunctivitis
- 2.2.2 Keratitis
- 2.2.3 Iritis
- 2.2.4 Retinitis
- 2.2.5 Endophthalmitis
2.3 Skin and Lymph Nodes
- 2.3.1 Complicated Skin and Skin Structure Infections (cSSSI)
- 2.3.2 Lymphadenitis
2.4 Respiratory Tract
- 2.4.1 Bronchitis
- 2.4.2 Laryngitis
- 2.4.3 Pneumonia
- 2.4.4 Influenza
- 2.4.5 Avian Bird Flu
- 2.4.6 Swine Flu
- 2.4.7 Respiratory Syncytial Virus
- 2.4.8 Tuberculosis
2.5 Heart and Blood Vessels
- 2.5.1 Endocarditis
- 2.5.2 Acute Pericarditis
- 2.5.3 Myocarditis
- 2.5.4 Vascular Infection
2.6 Gastrointestinal Tract, Liver and Abdomen
- 2.6.1 Acute Viral Hepatitis
- 2.6.2 Chronic Hepatitis
- 2.6.3 Biliary Tract Infection
- 2.6.4 Pancreatitis
- 2.6.5 Esophageal Infections
- 2.6.6 Gastroenteritis
- 2.6.7 Peritonitis
2.7 Genitourinary Tract
- 2.7.1 Urethritis
- 2.7.2 Prostatitis
- 2.7.3 Urinary Tract Infection
- 2.7.4 Pelvic Inflammatory Disease
- 2.7.5 Candiduria
- 2.7.6 Human Papilloma Virus
- 2.8 Nervous System
- 2.8.1 Bacterial Meningitis
- 2.8.2 Viral Encephalitis
- 2.8.3 Reye' s Syndrome
- 2.8.4 Myelitis and Peripheral Neuropathy
- 2.9 Musculoskeletal System
- 2.9.1 Osteomyelitis
- 2.9.2 Polyarthritis
- 2.9.3 Bursitis
- 2.9.4 Psoas Abscess
2.10 Human Immunodeficiency Virus (HIV) Infection
2.11 Blood-borne Infections
- 2.11.1 Malaria
- 2.11.2 West Nile Virus

3. Anti-infective Agent Markets

3.1 FDA Approvals of New Anti-infective Therapy
3.2 Anti-infective Agents in Current Pharmaceutical Developmental Programs
3.3 Factors Determining Anti-infective Drug Development
3.4 Pharmaceutical R&D Expenditures

4. Description of Anti-infective Therapeutic Agents

4.1 Anti-bacterials
- 4.1.1 Anti-bacterial Therapeutic Agents in Current Formulation
  - 4.1.1.1 β-lactam Antibiotics
  - 4.1.1.2 Fluoroquinones
  - 4.1.1.3 Glycopeptides
  - 4.1.1.4 Macrolides
  - 4.1.1.5 Oxazolidinones
  - 4.1.1.6 Other Classes of Anti-bacterial Agents
- 4.1.2 Older Classes of Antibiotics
4.2 Anti-virals
- 4.2.1 Overview
- 4.2.2 Anti-viral Therapy
- 4.2.3 Anti-viral Market Leaders
- 4.2.4 Principles of Anti-viral Therapy
4.3 Anti-fungals
- 4.3.1 Overview
- 4.3.2 Major Classes of Anti-fungal Therapy
- 4.3.3 Anti-fungal Agent Resistance
- 4.3.4 Anti-fungal Agent Market Leaders
4.4 Vaccines
- 4.4.1 Overview
- 4.4.2 Principles of Vaccine Therapy
- 4.4.3 Vaccine Market Leaders

5. Market for Anti-infective Agents and Vaccines

5.1 Molecular Diagnostics in Determining Demand

6. Decision-making Activity in the Anti-infective Market

6.1 Net Present Value in Making Decisions to Develop and Market Antibiotics

7. Economics of Anti-microbial Drug Resistance: The Persistent need for Anti-bacterials

7.1 Resistance and Antibiotic Usage

8. Global Market Analysis of Anti-infective Agents

8.1 Market Size
8.2 Market Share
8.3 Market Drivers

9. Global Market for Anti-bacterial Therapies

9.1 Amoxicillin
9.2 Nafcillin
9.3 Ticarcillin
9.4 Imipenem
9.5 Ceftriaxone
9.6 Cefotetan
9.7 Dalbavancin
9.8 Doripenem

10. Global Market for Anti-fungal Therapies

10.1 Amphotericin B
10.2 Azoles
10.3 Echinocandins
10.4 Flucytosine

11. Global Market for Anti-viral Therapies

11.1 Antiretroviral Market
- 11.1.1 The Viral Drug Resistance Crisis
- 11.1.2 Emtricitabine
- 11.1.3 CCR5 Receptor Antagonists
- 11.1.4 Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
11.2 HCV Infections
- 11.2.1 Pegintron Alpha
- 11.2.2 Ribavirin
- 11.2.3 Boceprevir
11.3 Acyclovir
11.4 Adefovir
11.5 Cidofovir
11.6 Entecavir
11.7 Fomivirsen
11.8 Foscarnet
11.9 Ganciclovir

12. Market, Demographic and Economic Trends

12.1 Emerging Trends in Infectious Diseases Worldwide
12.2 Global Burden of Infectious Disease
12.3 The AIDS Model
12.4 Dead-end Transmission of Zoonotic and Vector-borne Diseases
12.5 Environmentally Persistent Organisms
12.6 Old Microbes Cause New Disease
12.7 Microbial Agents and Chronic Diseases
12.8 Remerging and Resurging Infections
12.9 Geographical Spread of Infectious Disease
12.10 Drug-resistant Microbes
12.11 Opportunistic Re-emerging Infections
12.12 Re-emerging Zoonotic and Vector-borne Diseases
12.13 Influenza
12.14 Deliberately Emerging Infections
12.15 Meeting the Challenge of Emerging Diseases

13. Political/Legal Trends

13.1 AATF and Legislation
13.2 Bioterrorism and Biowarfare

14. Technological Trends

14.1 Anti-microbial Discovery in the Post-genomic Era
- 14.1.1 Anti-bacterial Polypharmacology
- 14.1.2 Topology of Targets
- 14.1.3 Designer Polypharmacology and Designing HIV-Therapies

15. Socio-Cultural Trends

16. Competitive Landscape

16.1 Introduction
16.2 Strengths and Weaknesses in Anti-microbial Drug Discovery - Commercial
16.3 Strengths and Weaknesses in Anti-microbial Drug Discovery - Academic
16.4 Regulatory Hurdles
16.5 Business Hurdles
16.6 Strategic Alliances, Licensing Activity, and Mergers & Acquisitions in the Anti-infectives Landscape

17. Sales Performance amongst the Leading Players: Detailed Analysis of Leading Anti-infective Players

17.1 GlaxoSmithKline
- 17.1.1 Overview
- 17.1.2 Sales Focus by Drug Class
- 17.1.3 Marketed Product Portfolio
- 17.1.4 R&D Pipeline Analysis
- 17.1.5 Strategic and Growth Analysis
17.2 Merck
- 17.2.1 Overview
- 17.2.2 Sales Focus by Drug Class
- 17.2.3 Marketed Product Portfolio
- 17.2.4 R&D Pipeline Analysis
- 17.2.5 Strategic and Growth Analysis
17.3 Pfizer
- 17.3.1 Overview
- 17.3.2 Sales Focus by Drug Class
- 17.3.3 Marketed Product Portfolio
- 17.3.4 R&D Pipeline Analysis
- 17.3.5 Strategic and Growth Analysis
17.4 Novartis
- 17.4.1 Overview
- 17.4.2 Sales Focus by Drug Class
- 17.4.3 Marketed Product Portfolio
- 17.4.4 R&D Pipeline Analysis
- 17.4.5 Strategic and Growth Analysis
17.5 Gilead Sciences
- 17.5.1 Overview
- 17.5.2 Sales Focus by Drug Class
- 17.5.3 Marketed Product Portfolio
- 17.5.4 R&D Pipeline Analysis
- 17.5.5 Strategic and Growth Analysis
17.6 Abbott
- 17.6.1 Overview
- 17.6.2 Sales Focus by Drug Class
- 17.6.3 Marketed Product Portfolio
- 17.6.4 R&D Pipeline Analysis
- 17.6.5 Strategic and Growth Analysis
17.7 Wyeth
- 17.7.1 Overview
- 17.7.2 Sales Focus by Drug Class
- 17.7.3 Marketed Product Portfolio
- 17.7.4 R&D Pipeline Analysis
- 17.7.5 Strategic and Growth Analysis
17.8 Sanofi-Aventis
- 17.8.1 Overview
- 17.8.2 Sales Focus by Drug Class
- 17.8.3 Marketed Product Portfolio
- 17.8.4 R&D Pipeline Analysis
- 17.8.5 Strategic and Growth Analysis
17.9 Bristol-Myers Squibb
- 17.9.1 Overview
- 17.9.2 Sales Focus by Drug Class
- 17.9.3 Marketed Product Portfolio
- 17.9.4 R&D Pipeline Analysis
- 17.9.5 Strategic and Growth Analysis
17.10 Johnson & Johnson
- 17.10.1 Overview
- 17.10.2 Sales Focus by Drug Class
- 17.10.3 Marketed Product Portfolio
- 17.10.4 R&D Pipeline Analysis
- 17.10.5 Strategic and Growth Analysis
17.11 Roche Pharma AG
- 17.11.1 Overview
- 17.11.2 Sales Focus by Drug Class
- 17.11.3 Marketed Product Portfolio
- 17.11.4 R&D Pipeline Analysis
- 17.11.5 Strategic and Growth Analysis

18. Company Profiles

18.1 Abraxis BioScience, Inc.
18.2 Acambis
18.3 Achillion Pharmaceuticals, Inc.
18.4 Adlyfe, Inc.
18.5 Advanced Life Sciences Holdings, Inc.
18.6 Affinium Pharmaceuticals
18.7 Akonni Biosystems
18.8 Alnylam Pharmaceuticals
18.9 APP Pharmaceuticals
18.10 Aquapharm Biodiscovery
18.11 Arbor Vita Corporation
18.12 Arpida Ltd.
18.13 Avexa Ltd.
18.14 Basilea Pharmaceutica AG
18.15 Baxter International, Inc.
18.16 Biophage Pharma, Inc.
18.17 CEL-SCI Corporation
18.18 Cerexa, Inc. (Subsidiary of Forest Laboratories)
18.19 CombiMatrix Corporation
18.20 Cubist Pharmaceuticals, Inc.
18.21 Daiichi Sankyo Co., Ltd.
18.22 Hospira, Inc.
18.23 Incyte Corporation
18.24 Idenix Pharmaceuticals, Inc.
18.25 Medivir AB
18.26 Meiji Holdings Co., Ltd.
18.27 MerLion Pharmaceuticals
18.28 Mutabilis
18.29 NanoBio Corporation
18.30 Nanosphere, Inc.
18.31 Nanoviricides, Inc.
18.32 Novabay Pharmaceuticals, Inc.
18.33 Obetech, LLC
18.34 Optimer Pharmaceuticals, Inc.
18.35 Panacos Pharmaceuticals, Inc.
18.36 Paratek Pharmaceuticals, Inc.
18.37 Pharmasset, Inc.
18.38 Pico Pharmaceuticals, Inc.
18.39 PolyMedix, Inc.
18.40 PowderMed Ltd. (Subsidiary of Pfizer)
18.41 Presidio Pharmaceuticals, Inc.
18.42 Progenics Pharmaceuticals, Inc.
18.43 Protez Pharmaceuticals (a Novartis Subsidiary)
18.44 Ribomed Biotechnologies, Inc.
18.45 Rib-X Pharmaceuticals, Inc.
18.46 Targanta Therapeutics Corporation, Inc.
18.47 Theravance, Inc.
18.48 Trius Therapeutics
18.49 Vertex Pharmaceuticals, Inc.
18.50 X-GEN Pharmaceuticals, Inc.

Appendix 1: FDA Compliance Policies Regarding Approved New Drug and Antibiotic Drug Products

Appendix 2: Anti-HCV Drugs in Development

Appendix 3: The Market for Anti-infectives in Animal Health

Appendix 4: Diagnostics for Infectious Agents

INDEX OF FIGURES

Figure 1.1: Leading Causes of Death in the U.S., 1958-2005
Figure 1.2: Global Distribution of Anti-infective Agent Sales by Geography
Figure 2.1: Incidence Rates of Invasive Methicillin-resistant S. aureus (MRSA) Infections by Age
Figure 2.2: U.S. Child Death Rate from Preventable Diseases, 2007
Figure 2.3: Infection Rate of Serotype 19A by Age Group in the U.S., 1998-2006
Figure 2.4: U.S. Hospitalizations for Types of Respiratory Diseases in Children Under 15 Years of Age, 2005
Figure 2.5: Economic Burden of Select Lung Diseases in the U.S., 2007
Figure 2.6: Infection Rate of Invasive Pneumococcal Disease in the U.S., 1998-2006
Figure 2.7: Status of H5N1 Avian Influenza, 2009
Figure 2.8: Number of Reported and Confirmed Cases of Influenza H1N1 Strain Worldwide, 2009
Figure 2.9: Distribution of H1N1 Flu in the U.S., August 2009
Figure 2.10: Novel H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group
Figure 2.11: Number of Tuberculosis (TB) Cases among U.S. - and Foreign-born Persons, by Year Reported in the U.S., 1993-2008
Figure 2.12: Rate of Tuberculosis (TB) Cases among U.S. - and Foreign-born
Persons, by Year Reported in the U.S., 1993-2008
Figure 2.13: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2008
Figure 2.14: U.S.-born TB Cases by Ethnicity, 2008
Figure 2.15: Rate of New Hepatitis A, Hepatitis B and Hepatitis C Infections in the U.S., 1982-2006
Figure 2.16: Countries Reporting Outbreaks of Cholera, 2006-2008
Figure 2.17: U.S. Rates of Sexually-Transmitted Diseases, 1940-2007
Figure 2.18: Rate of New Cases and Deaths of Cervical Cancer by Age Group Worldwide, 2008
Figure 2.19: Global Trend of HIV Infection, 1991-2007
Figure 2.20: Worldwide Percentage of Adults Living with HIV, 1990-2006
Figure 2.21: Worldwide Rate of New HIV Cases, 1990-2007
Figure 2.22: Percentage of Adult Population in African Countries with HIV, 2007
Figure 2.23: Ethnic Distribution of AIDS Patients in the U.S., 2007
Figure 2.24: Ten Best Selling AIDS Drugs in the U.S., 2008
Figure 2.25: U.S. Rates for New HIV Cases, 2008
Figure 2.26: Global Malaria-Endemic Areas in the Eastern Hemisphere
Figure 2.27: Anti-Malarial Vaccine Pipeline, 2009
Figure 2.28: Global Anti-Malarial Drug Pipeline, 2008
Figure 2.29: West Nile Virus Activity in the U.S., 2009
Figure 3.1: Anti-infective Drug Market Projections, 2006-2013
Figure 3.2: Leading Companies in Anti-infectives Market Share, 2008
Figure 3.3: Number of New Anti-bacterial Agents Approved by the FDA in the U.S., 1983-2008
Figure 3.4: Total Spending on Healthcare in the U.S., 1960-2008
Figure 3.5: Percentage Breakdown of U.S. Healthcare Spending, 2008
Figure 3.6: International per Capita Healthcare Spending by Country, 2006
Figure 3.7: Generic Drug Applications and Approvals in the U.S., 1995-2006
Figure 3.8: Savings Generated by Generic Use in the U.S., by Therapeutic Category, 1999-2008
Figure 3.9: Anti-bacterial and Anti-HIV New Molecular Entities (NMEs) Approved by the FDA, 1993-2007
Figure 3.10: Cost for New Drugs by Primary Indication, 2007
Figure 4.1: Market Share by Leading Anti-bacterial Drug Class
Figure 4.2: Anti-virals in the Marketplace, 2004
Figure 4.3: Anti-viral Market by Indication, Excluding HIV and HCV
Figure 4.4: Anti-viral Therapeutics Market, by Drug Class
Figure 4.5: Global Distribution of the Lack of Childhood Vaccination
Figure 4.6: GAVI Alliance Members
Figure 4.7: Global Vaccines Market, 2008
Figure 4.8: GlaxoSmithKline' s Vaccine Pipeline, 2008
Figure 4.9: The Vaccine Market by Geographical Area, 2008
Figure 5.1: Global Market for Molecular Diagnostics, 2002-2013
Figure 6.1: Number of Non-elderly Americans without Health Insurance Coverage, 1994-2007
Figure 6.2: Percentage of Non-elderly Americans without Health Insurance Coverage, 1994-2007
Figure 7.1: Global Multidrug Susceptibility in P. aeruginosa
Figure 7.2: Global Frequency of Vancomycin-resistant Enterococci, 2006
Figure 7.3: MRSA Trends According to Patient Location, 1998-2005
Figure 9.1: Projected Growth in Market for Injectable Anti-bacterials, 2008 and 2013
Figure 9.2: Real and Projected Market Shares for Major Anti-bacterial Classes, 2008 and 2013
Figure 9.3: Frequency of S. aureus in Skin and Soft Tissue Infections
Figure 11.1: Current and Projected Market Size for Injectable Antiretrovirals by Class, 2008 and 2013
Figure 11.2: Market Share for Injectable Antiretrovirals by Drug Class, 2008
Figure 11.3: The Changing Face of the HCV Market: Growth and Projections by Drug Class, 2008 and 2013
Figure A3.1: Growth in Global Sales of Antibiotic Products in Animal Health, 2005-2012
Figure A4.1: FIND Pipeline for TB Diagnostics

INDEX OF TABLES

Table 1.1: Top Ten Causes of Death Worldwide
Table 1.2: Leading Pharmaceutical Companies in the Anti-infective Market Total Global Sales, 2008
Table 2.1: Annual Rates of Global Infectious Diseases
Table 2.2: Drugs in Development for Chronic Hepatitis B, 2009
Table 2.3: Global HIV Statistics, 2007
Table 3.1: Top Selling Anti-infective Agents, 2008
Table 3.2: Sales for Leading Companies' Infectious Diseases Segments, 2008
Table 3.3: Current Drug Development Times and Rates, by Therapeutic Indication
Table 3.4: Emerging Therapeutic Approaches
Table 3.5: New Drug Approvals in all Categories from FDA, 2000-2008
Table 3.6: Top Ten Global Pharmaceutical Markets, 2008
Table 3.7: BRIC countries, Percentage of GDP Spent on Healthcare, 2008
Table 3.8: Percentage of GDP Healthcare Spending by Country, 2008
Table 3.9: Top 20 Generic Drugs by Prescriptions, 2008
Table 3.10: Anti-bacterial Agents Undergoing Clinical Development
Table 3.11 Leading Tuberculosis R&D Candidates
Table 3.12: Pipeline for Repositioned Drugs
Table 4.1: Potential Anti-bacterial Protein Drug Targets
Table 4.2: In vitro Susceptibility of Staphylococci to New Agents in Development
Table 4.3: Anti-staphylococcal Vaccines and Immunoglobulins in the Late Stage Pipeline, 2009
Table 4.4: Bacterial Targets of Antibiotics and Resistance Mechanisms
Table 4.5: Guideline Summary for Antibiotic Selection for Skin and Soft Tissue Infections
Table 4.6: Selected Anti-viral Drugs
Table 4.7: Anti-reterovirals in Development, 2008
Table 4.8: New Types of HIV Drugs
Table 4.9: Recommended Daily Dosage of Seasonal Influenza Anti-viral Medications for Treatment and Chemoprophylaxis in the U.S., 2008-2009
Table 4.10: Percentage Drug Resistance for Common Influenza Virus Strains, 2009
Table 4.11: Selected HCV Drugs in Development, 2009
Table 4.12: Therapeutic Agents in Development for Treating Hepatitis B, 2008
Table 4.13: Anti-fungal Compounds in Late Stage Development
Table 4.14: New Vaccines Licensed, 2005-2008
Table 4.15: Global Top Selling Blockbuster Vaccines, 2008
Table 4.16: Selected Anti-infective Monoclonal Antibodies in Clinical Development, 2009
Table 5.1: FDA-approved Commercial Kits for the Detection of Infectious Agents
Table 5.2: Examples of Personalized Medicine in Treatment of Infectious Disease
Table 6.1: Competitive Landscape for Anti-viral Drugs in Development, 2009
Table 6.2: Competitive Landscape for Anti-biotic Drugs in Development, 2009
Table 8.1 Anti-HIV Therapeutics Approved by the FDA
Table 9.1: Major Classes of Antibiotics
Table 10.1: Major Classes of Anti-fungals
Table 11.1: CCR-5 Receptor Agonists in Development, 2009
Table 12.1: Major Pathogens Identified in the Last 30 Years
Table 12.2: Emerging and Re-emerging Infectious Diseases and their Geographical Location
Table 16.1: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2008
Table 16.2: International Regulatory Measures Indicated by the International Forum of Anti-bacterial Resistance
Table A2.1: Anti-HCV Pipeline, 2009
Table A3.1: U.S. Volume of Animal Health Antibiotics Used, 2000-2006
Table A3.2: European Sales of Animal Health Antibiotics, 2005-2012
Table A3.3: Use of Antibiotics as Growth Promotants
Table A4.1: The Market Structure for Infectious Disease Diagnostics
Table A4.2: Rapid Strep Tests on the Market
Table A4.3: Rapid Tests for Chlamydia
Table A4.4: Rapid Tests for Gonorrhea
Table A4.5: The Burden of Influenza
Table A4.6: Global Market Potential for TB Diagnostic Testing
Table A4.7: Global Market for HBV Diagnostic Testing
Table A4.8: U.S. Market for HBV Diagnostic Testing
Table A4.9: Serological Diagnosis of Hepatitis B Virus Infections
Table A4.10: Lower Detection Limits of HBV DNA Assays
Table A4.11: Summary of Hepatitis B Test Technology
Table A4.12: Global Market for HCV Diagnostic Testing
Table A4.13: Efficiency of Available HCV Screening Tests
Table A4.14: Recommendations for Diagnostic Testing for Hepatitis C

Infectious Diseases Drugs Markets

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