Molecular Diagnostics in Infectious Disease Testing Industry 2016: Global Market Size, Share, Growth and Forecast to 2020

This report describes the specific segment of the in vitro diagnostics market known as molecular diagnostics testing for infectious disease. In the current medical diagnostics market, molecular diagnostics in infectious disease testing offers one of the most promising areas for growth and innovation. The confluence of breakthroughs in genomics and proteomics–along with the development of microarray devices to measure analytes in the blood–has led to this revolutionary market development. Specifically, molecular diagnostics offers the power of advanced analytical techniques to diagnose infectious diseases. Whereas before, the detection of many infectious agents was slow and expensive due to reliance upon culturing methods, researchers are now at the cusp of overcoming such limitations via the use of nucleic acid-mediated molecular diagnostics testing.

The purpose of this report is to describe the emerging field of molecular diagnostics in infectious disease testing. The infectious disease space is the most dominant and profitable sector of molecular diagnostics. Topics covered in this study include: 1) the existing and emerging technologies in the field, 2) the U.S. and global market size for molecular diagnostic products and 3) the profiles of companies that are focusing on the molecular diagnostic sector. The research examines drivers and restraints for sales growth, market share and technical trends. In addition, an in-depth analysis of the competitive situation of prominent market venders is provided with five-year sales forecasts.

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Table of Contents

1. Overview 15

2. Introduction to Molecular Diagnostics for Infectious Disease Testing 30

3. Infectious Disease Diagnostics Molecular Testing Market 52

4. Molecular Diagnostic Testing Technology for Infectious Disease Testing 247

5. Business 265

6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for Infectious Disease 302

7. Regulatory Requirements 316

8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease Testing 331

9. Economics of Anti-Microbial Drug Resistance: The Persistent Need for Antibacterials 343

10. Company Profiles 350

List of Figures

Figure 2.1: Relationship of DNA Testing to Key Areas of Clinical Diagnosis 30

Figure 2.2: Finding Genes with Microassays 31

Figure 2.3: The Use of Microassays for Studying Gene Expression 32

Figure 2.4: Overall Structure of Nucleic Acid Testing Market 42

Figure 3.1: Global Market for Molecular Diagnostics, 2009-2020 52

Figure 3.2: Global Market for Molecular Diagnostics Testing, 2014 54

Figure 3.3: Share of Molecular Diagnostics Testing by Testing Type, 2014 55

Figure 3.4: Key Players Market Share in Global Molecular Diagnostics Testing Markets, 2014 56

Figure 3.5: Global Market for Infectious Disease Treatments, 2008-2014 57

Figure 3.6: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2020 59

Figure 3.7: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2020 60

Figure 3.8: Infectious Disease Testing Revenue Market Share of the Total U.S. Molecular Diagnostics Market, 2012 and 2018 60

Figure 3.9: European Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2020 61

Figure 3.10: Japanese Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2020 62

Figure 3.11: Rest of World (ROW) Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2020 63

Figure 3.12: Infectious Disease Testing Revenue Market Share by Region, 2013 and 2020 64

Figure 3.13: Total Global Infectious Disease Molecular Diagnostics Markets, 2014 65

Figure 3.14: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2014 65

Figure 3.15: Total Global Infectious Disease Molecular Diagnostics Markets, 2020 66

Figure 3.16: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2020 67

Figure 3.17: Global Trend of HIV Infection, 1991-2012 71

Figure 3.18: Number of People Living with HIV, Newly Infected with HIV and Number of AIDS Deaths in the World, 1990-2012 71

Figure 3.19: Worldwide Rate of New HIV Cases, 1990-2012 72

Figure 3.20: Percentage of Adult Population in African Countries with HIV, 2011 73

Figure 3.21: Ethnic Distribution of AIDS Patients in the U.S., 2014 75

Figure 3.22: Global View of HIV Infection 75

Figure 3.23: Ten Best Selling AIDS Drugs in the U.S., 2014 76

Figure 3.24: U.S. Rates for New HIV Cases, 2014 76

Figure 3.25: U.S. Rates for New HIV Cases in Men, 2014 77

Figure 3.26: U.S. Rates for New HIV Cases in Women, 2014 77

Figure 3.27: Proposed HIV Testing Algorithm 86

Figure 3.28: Distribution of HIV Molecular Diagnostic Testing by Purpose 88

Figure 3.29: Estimated Market for Global HIV Molecular Diagnostic Testing, 2011-2020 89

Figure 3.30: Estimated Market for U.S. HIV Molecular Diagnostic Testing, 2011-2020 90

Figure 3.31: Market Share Viral Load HIV Molecular Diagnostic Testing 91

Figure 3.32: Geographic Distribution of Chronic HBV Infection 98

Figure 3.33: Incidence of Acute Hepatitis B by Age Group—U.S., 2000-2011 99

Figure 3.34: Global Prevalence of Hepatitis C 108

Figure 3.35: Primary Causes of Chronic Liver Disease 110

Figure 3.36: Incidence of Acute Hepatitis C by Age Group—U.S., 2000-2011 111

Figure 3.37: Hepatitis C Infection by Source 111

Figure 3.38: Growth and Projections of HCV Therapies by Drug Class, 2008 and 2013 112

Figure 3.39: U.S. Market Share of HCV Molecular Diagnostic Market, 2013 123

Figure 3.40: Global Market Share (Excluding U.S.) of HCV Molecular Diagnostic Market, 2013 124

Figure 3.41: Rate of New Cases and Deaths of Cervical Cancer by Age Group Worldwide, 1980-2010 132

Figure 3.42: Hybrid Capture 2 (HC2) versus PCR—Analytical Sensitivity and Clinical Sensitivity 135

Figure 3.43: Basic Steps in Hybrid Capture 2 Technology 136

Figure 3.44: U.S. Market Share of HPV Molecular Diagnostic Market, 2014 141

Figure 3.45: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic Market, 2014 141

Figure 3.46: Market Share Estimates for Molecular Diagnostic HPV Testing, 2014 142

Figure 3.47: Number of Reported and Confirmed Cases of Influenza by Virus Sub-Type Worldwide, 2013 155

Figure 3.48: Distribution of H1N1 Flu in the U.S., 2013 156

Figure 3.49: H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group 156

Figure 3.50: U.S. Rates of Sexually Transmitted Diseases, 1940-2012 165

Figure 3.51: U.S. Market Share of Chlamydia/Gonorrhea Molecular Diagnostic Market, 2013 167

Figure 3.52: Global Market Share (Excluding U.S.) of Chlamydia/Gonorrhea Molecular Diagnostic Market, 2013 167

Figure 3.53: Chlamydia Infection Rates: Total and by Gender: U.S., 1989-2012 171

Figure 3.54: Chlamydia U.S. Prevalence by Age Group and Race/Ethnicity 172

Figure 3.55: U.S. and Outlying Areas Gonorrhea Infection Rates, 1941-2012 179

Figure 3.56: U.S. Gonorrhea Infection Rates by Race/Ethnicity, 2007-2012 181

Figure 3.57: Pipeline for TB Diagnostics, 2005-2015 190

Figure 3.58: The Development Pipeline for New TB Drugs, July 2012 191

Figure 3.59: Number of Tuberculosis Cases Among U.S. and Foreign-Born Persons in the U.S., 1993-2012 191

Figure 3.60: Rate of Tuberculosis Cases Among U.S- and Foreign-Born Persons in the U.S., 1993-2012 192

Figure 3.61: Rate of Tuberculosis Cases by State/Area in the U.S., 2014 193

Figure 3.62: U.S.-Born Tuberculosis Cases by Ethnicity, 2014 194

Figure 3.63: Reported Tuberculosis Cases in the U.S., 1983-2012 199

Figure 3.64: Global Market Share of Tuberculosis Molecular Diagnostic Testing 201

Figure 3.65: Global Market Share of Tuberculosis Molecular Diagnostic Testing by Region, 2014 201

Figure 3.66: Incidence Rates of Invasive MRSA Infections by Age 209

Figure 3.67: MRSA Trends According to Patient Location, 1998-2005 209

Figure 3.68: Incidence of Healthcare-Associated MRSA Infections, 2005-2008 210

Figure 3.69: U.S. Market Share of MRSA Molecular Diagnostic Market, 2014 214

Figure 3.70: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic Market, 2014 215

Figure 3.71: Global Frequency of Vancomycin-Resistant Enterococci, 2006 220

Figure 3.72: U.S. Market Share of VRE Molecular Diagnostic Market, 2014 224

Figure 3.73: Estimated Market for Global Blood Screening Product Sales, 2007-2020 240

Figure 3.74: Blood Screening Product Market Share by Company, 2014 242

Figure 4.1: Using DNA Microassays to Measure Gene Expression 247

Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 248

Figure 4.3: Personalized Medicine in Treatment of Infectious Disease 253

Figure 5.1: FDA Co-Developed Products as a Model for Collaboration 273

Figure 5.2: Market Growth of Molecular Diagnostic Infectious Disease Tests 299

Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making 304

Figure 9.1: Global Multidrug Susceptibility in Pseudomonas aeruginosa 345

Figure 9.2: Global Frequency of Vancomycin-Resistant Enterococci, 2006 346

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