The World Market for Molecular Diagnostics, 4th. Edition (Infectious Disease, Oncology, Blood Screening, Pre-Natal and Other Areas): Potential and Reality, What's Hot and What's Not

Mar 1, 2011
550 Pages - Pub ID: KLI2879023
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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.

All Kalorama reports advertise the single user price. Use is limited to one user. We also feature department and global pricing for reports that we be utilized by more than one user at your company. Please consult ask your sales representative or select the correct license on our website.

For Kalorama's take on the healthcare news of the week, based on our analysis of healthcare markets, follow Kalorama Information's Key Point Blog at http://kaloramakeypoint.blogspot.com/

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

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