Infectious Disease Diagnostic Markets

The ubiquity of infections makes thier detection a healthcare priority and an ongoing opportunity for IVD companies. The aging of the population, and emerging threats - MRSA, swine flu, and others have had an impact on this market recently and will continue to in years to come. Kalorama Information has been observing diagnostic markets for over a decade and has assembled in this report, Infectious Disease Diagnostics, Kalorama Informatio...

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The ubiquity of infections makes thier detection a healthcare priority and an ongoing opportunity for IVD companies. The aging of the population, and emerging threats - MRSA, swine flu, and others have had an impact on this market recently and will continue to in years to come. Kalorama Information has been observing diagnostic markets for over a decade and has assembled in this report, Infectious Disease Diagnostics, Kalorama Information has assembled its best primary and secondary research.

This report focuses on products used for the diagnosis of bacterial and viral infections. The major consideration is given to bacterial infections because (a) they are the most frequent type of infections, and (b) the practical aspects of diagnosis and therapy are more meaningful based both on medial considerations and on market considerations. On the other hand, viral infections are becoming of greater importance due to (a) the discovery of new viral infections, (b) advances in the development of viral therapeutics, and (c) the mutation viruses that cause drug resistance.


Included in this report:

• Market Size and Forecast for (Immunoassays, Rapid, DNA, ID/MIC )


• Overview of Key Infections and Their Impact on the Market


• Long-Term (10 Year) Trend in the Infectious Disease Diagnostics Market


• Seven Conclusions and Recommendations


• Key Product Summary: Immunoassay Products, Molecular Diagnostic Products, Amplification Products


• Discussion and Listing of 'Home Brew' Products


• Discussion of Leading Competitors in the Market


• Increasing Use of Non Traditional Technologies in ID (FISH, Flow Cytometry, etc.)


• The Role of NAT Testing Near-Term and Long-Term


• A Glossary of Important Terms


• Best Opportunities for IVD Companies

Market analysis in this report considers primarily the epidemiological considerations and the sizes patient groups both in the United States and globally, where available. We have accumulated the most recent data available, understanding that virtually no organization does extensive studies on these applications on a regular basis.



As with most Kalorama reports, this is a work of both market description and analysis, along with recommendations. The analysis presented in this report is based on data from a combination of company, government, industry, institutional and private sources. It includes information from extensive literature reviews and discussions with experts in the field, including microbiologists, pathologists, hospital authorities, research scientists, business development managers and marketing managers.


In this report global (world) revenue numbers are presented based on reported and estimated manufacturer revenue.

Medical Devices Industry in the United States

CHAPTER ONE: EXECUTIVE SUMMARY

Overview

Scope and Methodology

Market Considerations

Trends Affecting Infectious Disease Diagnosis Applications

Opportunity for Diagnostic Products in Infectious Disease

Drug Resistance

Have Immunoassays Peaked?

Need for Faster Tests

“Controlled Growth” of NAT

Drug Susceptibility and Resistance Testing Markets

A Need for Simplification

CHAPTER TWO: OVERVIEW OF INFECTIOUS DISEASES

General

Infectivity

Primary Pathogens

Zoonoses

Opportunistic Pathogens

Disease Susceptibility

Bacterial Infections

Criteria

Viral Infections

Viral Drug Resistance

Swine Flu and the IVD Industry

Origin of Flu Virus Mixes

PCR Test Development

Late-Breaking Research Developments

Use of Rapid Tests in Current Epidemic

CHAPTER THREE: TECHNOLOGY AND PRODUCTS

Bacterial Cultures: Diagnosis and Susceptibility

Blood Culture

Throat Culture

Sputum Cultures

Spinal Fluid Cultures

Stool Cultures

Urine Cultures

Viral Culture

Immunoassays

Agglutination Immunoassays

Nephelometry

Indirect Immunofluorescence

Enzyme Immunoassay (ELISA, EIA)

Fluorescence and Luminescence Immunoassay

Magnetic Immunoassay

Molecular Diagnostics

Amplification Technologies

Probe Technologies

CHAPTER FOUR: INFECTIOUS DISEASE DIAGNOSTICS MARKETS

Increasing Use of Non-Traditional Systems

FISH

Cell Counting by Flow Cytometry

Laser Based Microbial Detection

Market Analysis

Microbial Identification and Antimicrobial Sensitivity Tests

Rapid Tests

Immunoassays - Lab based

STDs

Supplies

Competition

Probe Technology

Key Company Synopses

AdvanDx

Beckman Coulter

bioMerieux

BioRad -

Cepheid -

Gen-Probe

Roche Molecular Diagnostics

Siemens Healthcare Diagnostics -

CHAPTER FIVE: CONCLUSIONS AND STRATEGIC IMPLICATIONS

First Conclusion

Second Conclusion

Third Conclusion

Fourth Conclusion

Fifth Conclusion

Sixth Conclusion

Seventh Conclusion

GLOSSARY

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY:

Figure 1-1: Worldwide Infectious Disease Diagnostics Sales

Figure 1-2: Trend in Revenue in Infectious Disease Diagnostics Long-Term (NAT, Rapid, Immunoassays)

CHAPTER TWO: OVERVIEW OF INFECTIOUS DISEASES

Table 2-1: Classification of Common Pathogenic Bacteria

Table 2-2: Common Mechanisms of Antibacterial Resistance

CHAPTER THREE: TECHNOLOGY AND PRODUCTS

Table 3-1: Key Immunoassay Products Used for Clinical Testing for Bacterial Infections

Table 3-2: Molecular Diagnostics Technologies

Table 3-3: Gene Amplification Technologies

Table 3-4: Commonly Used Signal Amplification Technologies for Genetic Analysis

Table 3-5: Key Molecular Assay Products for the Diagnosis of Infectious Diseases (Company, Analyte, Test Category, Product, Technology)

Table 3-6: Key “Home Brew” Molecular Assays for Infectious Diseases

CHAPTER FOUR: INFECTIOUS DISEASE DIAGNOSTICS MARKETS

Table 4-1: Companies Engaged in the Market for Bacterial Culture Products

Table 4-1: PCR, FISH, Flow and Cell Imaging Systems for Bacteria / Virus Detection, 2008 and 2012 ($million)

Table 4-2: Worldwide Microbiology/Virology Sales by Type (Immunoassays, Rapid, DNA, ID/MIC ) 2008-2013

Table 4-3 : ID/MIC Revenue Breakdown (Automated Panels and Reagents, Manual Panels and Reagents, Blood Culture, Rapid Micro) and Supplies

Table 4-4: Selected Chromogenic Growth Media (Company, Location, Media)