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. Kalorama Information's lead diagnostics analyst Shara Rosen, R.T., MBA, also reviews the competitors in the market and their latest moves.

There have been many predictions made about a molecular revolution in diagnostics. Indeed some 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?

World Market for Molecular Diagnostics: Potential and Reality, What's Hot and What's Not provides the insights needed to gain a clear picture of the industry, helping you to make better strategic decisions. It not only contains current market data for business planning but also goes beyond the numbers to fully assess what is going on in the market. For over a decade, Shara Rosen 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.

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 investments in molecular biology, in bioinformatics, in disease management research and the unraveling of the human genome are bearing fruit. Almost every day the discovery of new molecular markers for cancer, cardiac disease, diabetes, arthritis, neurological diseases and psychiatric conditions are being announced.

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
Revenues of Test Service Companies
Geographic Breakout of the 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 payers have recognized the value of new molecular tools and have agreed to pay for them.

This renewed interest in IVD 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" - the top IVD companies participating in multiple IVD markets
"The Participants"- Molecular diagnostic companies that are by now established in the market
"The Stars"- Those companies that have shown better than average results
"Newcomers"- Companies that have novel or interesting approaches to keep an eye on
"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 the 'Hot' Trends and the 'Lukewarm' Trends, including:

New Platforms Making Their Mark 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.

CHAPTER ONE: EXECUTIVE SUMMARY
Introduction
Scope and Methodology
Size and Growth of the Market
Market Trends

CHAPTER TWO: INTRODUCTION
Background - Developments since 2000

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

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
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.

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.
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

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
Table 6-1: Molecular Test Revenues of Selected IVD Vendors, 2007 - 2010