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The World Market for Molecular Diagnostics: Potential and Reality, What's Hot
and What's Not
March 1, 2011
This report The World Market for Molecular Diagnostics: Potential and Reality, What's
Hot and What's Not estimates the market for molecular diagnostics and provides a
realistic look at the role of molecular testing and its future in various market segments.
Analyst Shara Rosen, R.T. MBA, reviews the competitors in the market and their latest
moves.
There have been many predictions made about a molecular revolution in diagnostics.
Indeed some of those changes are now taking place, while other predictions have not
turned out to be true. How can companies sort out what is effective and what is not in
this market? For over a decade, Kalorama Information's lead diagnostics analyst Shara
Rosen, R.T., MBA has reviewed the molecular diagnostics market. A lot has changed,
and a lot has stayed the same. There is intense competition but also opportunities for
entrants in some areas. This report The World Market for Molecular Diagnostics:
Potential and Reality, What's Hot and What's Not provides current market data for
business planning but also goes beyond the numbers to fully assess what is going on in
the market.
What are the important developments in the market? Who are the small innovators in
this industry and how are the big players reacting to them? Which developments are
"hot" and which trends have not caught on? In this report, Rosen provides answers to
these questions.
The Rewards, Pitfalls and Competition of This High Potential Market
As we enter the second decade of the 21st century the investment in molecular biology,
in bioinformatics, in disease management research and the unraveling of the human
genome is bearing fruit. Almost every day the discovery of new molecular markers for
cancer, cardiac disease, diabetes, arthritis, neurological diseases and psychiatric
conditions are announced.

2. Far from being a cheerleader of what is clearly a growth market, The World Market for
Molecular Diagnostics -Potential and Reality, What's Hot and What's Not provides a
detailed examination of molecular testing today. Among the data points the report
provides are the following:
Current Market Size and Forecast for Molecular Segments (Infectious Disease,
Blood Screening, Histology, Oncology, Prenatal, Coagulation, Tissue Typing,
Inherited Diseases, Pharmacodiagnostics and Other)
Infectious Disease Molecular Sales by Disease (Hepatitis, HIV, GC/Chlamydia,
HAI, Respiratory, Organism ID, Mycobacteria/TB, others)
Revenues of Top Molecular Diagnostic Companies
Recent Mergers and Acquisitions
Revenue of Test Service Companies
Geographic Breakout of Molecular Diagnostics Market by Region (North
America, Europe, Asia, ROW)
Sample Prep Market, 2010 and 2015
Breakout of Molecular Histology/Cytology Market (in situ hybridization, HPV,
Tissue Microarrays), 2010 and 2015
Important CLIA Lab Developments, 2008-2010
More and more laboratories offer complex panels of tests that help physicians evaluate
disease risk and make therapeutic decisions. Government and private healthcare
payors have recognized the value of new molecular tools and have agreed to pay for
them.
This renewed interest in IVDs in general and more particularly in molecular diagnostics
has lead to the commercialization of a number of technological tools that make more
sensitive and specific tests possible. Some of these technological innovations include:
cost-effective, multiplexed testing platforms coupled with high-powered software
capabilities. In addition analyses using saliva, urine, and blood instead of biopsied
tissue make for more patient-friendly test systems.
Extensive Company Profiles
Kalorama provides profiles of over 110 companies participating in the market. All of
these companies have different strategies and compete in different areas, and
Kalorama acknowledges this by separating the companies in a triage system based on
where they stand in the molecular in vitro diagnostics market.
"The Majors" -companies who are the top IVD companies and participate in
multiple IVD markets.
"The Participants"- Molecular diagnostic companies who are by now
established in the market.
"The Stars"- Those companies that have shown better than average results
"Newcomers"- Companies who have novel or interesting approaches to keep an
eye on

3. "High Potentials"- Companies that could show explosive growth but also could
fall based on market developments
"Specialists" in various areas (microbiology, histology, quality control, sample
prep)
A Realistic Look at The Need-To-Know Trends
Molecular diagnostics is a complicated market that requires a thorough analysis to
understand. Many reports make bold predictions which later are proved incorrect by
market events. In this report, Kalorama Information provides revenues and market
forecasts, but also looks deeply at some of the trends in the market and what might
impact results in the future. The report summarizes what is working and what is not
working in the past few years. Shara Rosen, RT, MBA, looks at these trends, including
'Hot' Trends, and 'Lukewarm' Trends, including
New Platforms Making Their Mark Based on based on Miniaturization and
Biochips
The Growing Significance of Quality Control Products and Innovations in this
area.
The Sequence Begins: Innovations in DNA Sequencing, Key Players and its
Future in Clinical Medicine
Pharmacodiagnostics and Where it Stands in 2011.
The Latest Growth Numbers of LDTs, regulatory activity, and their impact on the
Market.
The $1000 Genome - If and When
Miniaturization and Multiplexing
The Ongoing Saga of Patents
Healthcare Reform and Reimbursement Trends
Integrated Sample Preparation and System Automation - A Growing Number of
Competitors
Developments in Mass Spectroscopy
Screening for Wellness The Latest on Consumer Tests
Market size and forecasts in the report are for manufacturer's revenues. Secondary and
primary resources, including: trade publications, annual report and interviews with key
executives in molecular diagnostics were used for this study.
Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
Introduction
Scope and Methodology
Size and Growth of the Market
Market Trends
CHAPTER TWO: INTRODUCTION
Background - Developments since 2000

4. New Platforms
Quality Control Products
Building a strong future - hot, hot, hot
The sequence begins
Personalizing Risk and Therapies
LDTs reign
The $1000 Genome - If and When
Luke warm Trends
Miniaturization and Multiplexed Assays
Integrated Sample Preparation and System Automation
Mass Spectroscopy
Screening for Wellness
CHAPTER THREE: THE COMMERCIALIZATION CONUNDRUM
Background
Reimbursement of Novel Tests
Regulatory Issues and Molecular Assays
Commercializing Molecular Diagnostics -
Physician Acceptance
U.S. Health Care Reform and Molecular Testing
CHAPTER FOUR: MARKET ANALYSIS
Background
Worldwide opportunities for molecular tests
The United States
Europe
Japan
China
India
Molecular diagnostics and target markets
The market for molecular assays in cancer management
Liquid Biopsies - CTCs
Tumor Markers
Sequencing
Chromosome Analysis
The market for molecular Assays in hematology
The market for molecular Assays in coagulation
The market for molecular Assays in histopathology/cytology
Overview
The Pap Smear & HPV testing
FISH Goes Digital, Multiplexed and Quantitative
Tissue Microarrays
Pharmacodiagnostic Test Applications
CHAPTER FIVE: CONCLUSIONS AND STRATEGIC IMPLICATIONS - 2015 AND
BEYOND
Conclusion One

5. Implication
Conclusion Two
Implication
Conclusion Three
Implication
Conclusion Four
Implication
Conclusion Five
Implication
Conclusion Six
Implication
Conclusion Seven
Implication
Conclusion Eight
Implication
CHAPTER SIX: MAJOR COMPANIES AND VENDORS TO WATCH
Background
Acquisitions, Alliances and Collaborations in Molecular Diagnostics
Company Triage
The Majors
Abbott Diagnostics
Recent Revenue History )
Key Comment
Molecular Histology
Molecular Diagnostics
Microbiology
Molecular Sample Prep
Alere (formerly Inverness Medical Innovations)
Recent Revenue History
Key Comment
Becton, Dickinson and Company (BD)
Recent Revenue History
Key Comment
Histology
Microbiology
Expanding Molecular Testing Capabilities.
Beckman Coulter Inc.
Recent Revenue History
Key Comment
Research Markets
bioMérieux Inc.
Marcy L'etoile, France www.bioMérieux.fr Recent Revenue History
Key Comment
Molecular
Gen-Probe Inc.
Recent Revenue History

6. Key Comment
GTI acquisition
Transplant/HLA testing
Infectious Diseases
Blood Bank
Oncology
Hologic, Inc.
Recent Revenue History
Key Comment
Histology
Instrumentation Laboratory (IL)
Recent Revenue History
Key Comment
QIAGEN N.V.
Recent Revenue History
Key Comment
Histology
Infectious Diseases
Oncology
Roche Diagnostics
Recent Revneue History
Key Comment
Histology
H1N1/ Applied Sciences
PCR
Infectious Diseases
Blood Bank
Personalized Medicine - Companion Tests
Research
Siemens Healthcare Diagnostics
Recent Revenue
Key Comment
Sysmex Corporation
Recent Revenue History:
Key Comment
Thermo Fisher Scientific Inc.
Recent Revenue History
Key Comment
THE PARTICIPANTS
Affymetrix, Inc.
Recent Revenue History
Key Comment
Agendia BV
Recent Revenue History
Key Comment
Agilent Technologies Inc.

7. Recent Revenue History
Key Comment
Asuragen, Inc.
Recent Revenue History
Key Comment
AviaraDx (biomerieux)
Ambry Genetics
Recent Revenue History
Key Comment
Bio-Reference Laboratories, Inc. (BRLI)
Recent Revenue History
Key Comment
Caliper Life Sciences, Inc.
Recent Revenue History
Key Comment
China Medical Technologies, Inc.
Recent Revenue History
Key Comment
Clarient Inc. (formerly ChromaVision)
Recent Revenue History
Key Comment
deCode genetics ehf
Recent Revenue History
Key Comment
and others...
THE STARS
AdvanDx, Inc.
Recent Revenue History
Key Comment
Celera Diagnostics
Recent Revenue History
Key Comment
Berkeley HeartLab (BHL)
Product Development
Cepheid
Key Comment
Instrumentation
DxS Ltd.
Recent Revenue history
Key Comment
and others...
NEWCOMERS
Akonni Biosystems Inc.
Applied BioCode, Inc.
Arrayit Diagnostics Inc.

8. Exiqon A/S
and others...
HIGH POTENTIAL COMPANIES
AdnaGen AG
Allegro Diagnostics
and others...
HISTOLOGY SPECIALISTS
Advanced Cell Diagnostics
Perceptronix Medical Inc. (PMI Labs)
MICROBIOLOGY SPECIALISTS
Adnavance Technologies Inc.
CapitalBio Corporation
Cooperative Diagnostics, LLC
and others...
QUALITY CONTROL SPECIALISTS
AcroMetrix
Bio-Rad Laboratories Inc.
ParagonDx LLC (formerly Gentris Diagnostics Inc.)
SAMPLE PREP SPECIALISTS
Arcxis Biotechnologies
Argylla Technologies LLC
Biomatrica, Inc.
and others...
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-2: Worldwide Molecular Test Sales, 2010-2015 (Infectious Disease,
Blood Screening, Histology, Oncology, Prenatal, Coagulation, Tissue Typing,
Inherited Diseases, Pharmacodiagnostics and Other)
Figure 1-1: Market Share of Molecular Diagnostics Market, 2010
CHAPTER TWO: INTRODUCTION
Table 2-1: Selected Novel Nucleic Acid Testing Platforms, 2008-2010
Table 2-2: Selected Molecular QC Products, 2008-2010
Table 2-3: Selected innovations in sequencing
Table 2-4: Selected Drug/Test Pharmacodiagnostic Combinations
Table 2-5: Selected collaborations between IVD and pharmaceutical companies
Table 2-7: Selected Advanced Sample Preparation Devices, 2008-2010
CHAPTER THREE: THE COMMERCIALIZATION CONUNDRUM

9. Table 3-1: Selected Drug PGx Targets in the U.S.
Table 3-2: Selected Drugs that Require PGx Testing in Europe
Table 3-3: U.S. Patents for Selected Molecular Test Platforms
CHAPTER FOUR: MARKET ANALYSIS
Table 4-1: Worldwide Molecular Test Sales, 2010-2015
Table 4-2: Selected LDT Service Provider Revenues, 2007-2010
Table 4-3: Market Penetration of Clinical Molecular Diagnostics, by geographic
area, 2010-2015
Table 4-4: Selected Company Sponsored Accredited Labs
Table 4-5: Selected Molecular Tumor Marker Test Innovations, 2008-2010
Table 4-6: Selected Companies Involved in Chromosomal Analysis of Cancer
Cells
Table 4-7: Selected Molecular Tests for Coagulation Testing, 2008-2010
Table 4-8: Worldwide Molecular Histology/Cytology Sales, 2010-2015 (in situ
hybridization, HPV, Tissue Microarrays) 118
Table 4-9: Selected HPV Tests, 2008-2010
Table 4-10: Selected Molecular Histology Innovations, 2008-2010
Table 4-11: Selected tissue microarray products, 2008-2010
Table 4-12: Molecular Test Sales, Infectious Diseases, 2010-2015 (Hepatitis,
HIV, GC/Chlamydia, HAI, Respiratory, Organism ID, Mycobacteria/TB, others)
130
Table 4-13: Selected Infectious Disease Molecular Test Innovations, 2009-2010
Table 4-14: Selected molecular tests for prenatal analysis, 2008-2010
Table 4-15: Most Frequently Requested Genetic Tests
Table 4-16: Selected Molecular Tests for Inherited Diseases, 2008-2010
Table 4-17: Selected PGx Test Innovations, 2008-2010
CHAPTER SIX: MAJOR COMPANIES AND VENDORS TO WATCH
Table 6-1: Selected Molecular Company Acquisitions, 2008-2010
Table 6-2: Selected Molecular Company Collaborations, 2008-2010
Table 6-3: Selected Molecular Company Distribution Agreements, 2008-2010
Table 6-4: Selected Molecular Company Licensing Agreements, 2008-2010
Table 6-6: Selected CLIA Lab Developments, 2008-2010
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