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Infectious Diseases Drugs Markets

Published by: Trimark Publications

Published: Oct. 1, 2009 - 244 Pages


Table of Contents


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 ß-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., 1958-2006

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, 2006

Figure 2.3: Infection Rate of Serotype 19A by Age Group in the U.S., 1998-2


Figure 2.4: U.S. Hospitalizations for Types of Respiratory Diseases in Children Under15 Years of Age, 2006

Figure 2.5: Economic Burden of Select Lung Diseases in the U.S., 2006

Figure 2.6: Infection Rate of Invasive Pneumococcal Disease in the U.S., 1998-2006

Figure 2.7: Status of H5N1 Avian Influenza, 2006

Figure 2.8: Number of Reported and Confirmed Cases of Influenza H1N1 Strain Worldwide, 2006

Figure 2.9: Distribution of H1N1 Flu in the U.S., August 2006

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., 1993-2006

Figure 2.12: Rate of Tuberculosis (TB) Cases among U.S. - and Foreign-born Persons, by Year Reported in the U.S., 1993-2006

Figure 2.13: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2006 Figure 2.14: U.S.-born TB Cases by Ethnicity, 2006

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, 20066-2006

Figure 2.17: U.S. Rates of Sexually-Transmitted Diseases, 1940-2006

Figure 2.18: Rate of New Cases and Deaths of Cervical Cancer by Age Group Worldwide, 2006

Figure 2.19: Global Trend of HIV Infection, 1991-2006

Figure 2.20: Worldwide Percentage of Adults Living with HIV, 1990-2006

Figure 2.21: Worldwide Rate of New HIV Cases, 1990-2006

Figure 2.22: Percentage of Adult Population in African Countries with HIV, 2


Figure 2.23: Ethnic Distribution of AIDS Patients in the U.S., 2006

Figure 2.24: Ten Best Selling AIDS Drugs in the U.S., 2006

Figure 2.25: U.S. Rates for New HIV Cases, 2006

Figure 2.26: Global Malaria-Endemic Areas in the Eastern Hemisphere

Figure 2.27: Anti-Malarial Vaccine Pipeline, 2006

Figure 2.28: Global Anti-Malarial Drug Pipeline, 2006

Figure 2.29: West Nile Virus Activity in the U.S., 2006

Figure 3.1: Anti-infective Drug Market Projections, 20066-201

Figure 3.2: Leading Companies in Anti-infectives Market Share, 2006

Figure 3.3: Number of New Anti-bacterial Agents Approved by the FDA in the U.S., 1983-2006

Figure 3.4: Total Spending on Healthcare in the U.S., 1960-2006

Figure 3.5: Percentage Breakdown of U.S. Healthcare Spending, 2006

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, 1999-2006

Figure 3.9: Anti-bacterial and Anti-HIV New Molecular Entities (NMEs) Approved by the FDA, 1993-2006

Figure 3.10: Cost for New Drugs by Primary Indication, 2006

Figure 4.1: Market Share by Leading Anti-bacterial Drug Class

Figure 4.2: Anti-virals in the Marketplace, 2006

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, 2006

Figure 4.8: GlaxoSmithKline’s Vaccine Pipeline, 2006

Figure 4.9: The Vaccine Market by Geographical Area, 2006

Figure 5.1: Global Market for Molecular Diagnostics, 2002-2013

Figure 6.1: Number of Non-elderly Americans without Health Insurance Coverage, 1994-20067

Figure 6.2: Percentage of Non-elderly Americans without Health Insurance Coverage, 1994-20067

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, 1998-20065

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, 20068 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, 20068 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, 2006

Table 2.1: Annual Rates of Global Infectious Diseases

Table 2.2: Drugs in Development for Chronic Hepatitis B, 2006

Table 2.3: Global HIV Statistics, 2006

Table 3.1: Top Selling Anti-infective Agents, 2006

Table 3.2: Sales for Leading Companies’ Infectious Diseases Segments, 2006

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, 20060-2006

Table 3.6: Top Ten Global Pharmaceutical Markets, 2006

Table 3.7: BRIC countries, Percentage of GDP Spent on Healthcare, 2006

Table 3.8: Percentage of GDP Healthcare Spending by Country, 2006

Table 3.9: Top 20 Generic Drugs by Prescriptions, 2006

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, 2006

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, 2006

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., 20068-2006

Table 4.10: Percentage Drug Resistance for Common Influenza Virus Strains, 2


Table 4.11: Selected HCV Drugs in Development, 2006

Table 4.12: Therapeutic Agents in Development for Treating Hepatitis B, 2006

Table 4.13: Anti-fungal Compounds in Late Stage Development

Table 4.14: New Vaccines Licensed, 20065-2006

Table 4.15: Global Top Selling Blockbuster Vaccines, 2006

Table 4.16: Selected Anti-infective Monoclonal Antibodies in Clinical Development, 2006

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, 20069

Table 6.2: Competitive Landscape for Anti-biotic Drugs in Development, 20069

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, 20069

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, 20068

Table 16.2: International Regulatory Measures Indicated by the International Forum of Anti-bacterial Resistance

Table A2.1: Anti-HCV Pipeline, 20069

Table A3.1: U.S. Volume of Animal Health Antibiotics Used, 20060-20066

Table A3.2: European Sales of Animal Health Antibiotics, 20065-2012

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 241

Abstract

According to the World Health Organization (WHO), six infectious diseases--pneumonia, tuberculosis, diarrheal diseases, malaria, measles and HIV/AIDS--account for half of all premature deaths worldwide, killing mostly children and young adults. What’s more, threatening pandemics such as swine flu (H1N1 influenza A virus) are adding significant pressure to already strained healthcare budgets of governments around the world. This report provides a detailed description of the current infectious diseases drugs market and highlights the existing and developing anti-infective agents used to ameliorate diseases’ afflictions on humankind. Anti-infective agents include: anti-viral therapeutics, antibiotics, anti-fungal agents and prophylactic treatments such as vaccines. Particular attention is paid to the clinical market segment and the pharmaceutical/biotechnology companies involved in anti-infective agents, with specific emphasis on each company’s sales focus, product portfolio and R&D pipeline. To date, the most successful anti-infective agents target the human immunodeficiency virus (HIV, the virus that causes AIDS), the herpes virus (HSV-1 and HSV-2), bacterial infections and hepatitis C (HCV). A number of exciting novel anti-viral and antibiotic compounds are currently revolutionizing the infectious diseases drugs market, including Truvada and Valtrex, which are anti-HIV and anti-herpes therapies, respectively. Significant resources are also being dedicated toward hepatitis A (HAV), hepatitis B (HBV) and Staph infections, including MRSA. What’s more, this study will examine the existing and developing anti-infective agents targeted at infectious diseases that continue to devastate developing countries, including: cholera, dengue fever, meningitis, rotavirus, typhoid, yellow fever and onchocerciasis (“river blindness”).

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