Abstract
Protein biomarkers have become the hot application area for mass spectrometry (MS) and other proteomics-related technologies in the last few years. In the short term, this move towards biomarkers and clinical proteomics research has happened mainly in the drug discovery and development process. However, they also have broad abilities to generate richer information about a disease state, drug response, and/ or the relation between the two; which can be used for diagnostic, prognostic, or various other purposes in the pharmaceutical, diagnostics, and defense industries. MS has the necessary abilities to rapidly identify biochemicals such as DNA, proteins, or carbohydrates, and thus is currently being used as the workhorse for discovering and validating biomarkers in clinical research, whether for drug development, diagnostic, or other applications. MS technology also far outperforms any alternative for this purpose, due to its particular ability to identify large numbers of components in complex mixtures. These increased abilities have drawn large numbers of life science researchers to procure MS instruments or use available core lab facilities for proteomics experiments.
This report focuses on MS technologies as they are applied to protein biomarker research. It provides in-depth analysis of the markets for:
- MS Instrumentation,
- MS Software, and
- MS Services
In addition to a thorough review of MS products and competitors and the technological and business trends shaping the marketplace, the report provides market data and forecasts for the following as they relate to protein biomarker research:
- Revenues and growth through 2011 of MS instrumentation
- Competitive market share by leading supplier
- Market share by type of MS (Ion Trap, MALDI-TOF, Triple Quad, etc.)
- Estimated market share by therapeutic area of research
- Revenues and growth through 2011 for MS services
- Revenues and growth through 2011 for MS software
The report profiles the top suppliers of MS instrumentation, reviews the regulatory environment, surveys competitive and disruptive technologies, and the details the extensive research collaborations and deals currently underway.
Table of Contents
Chapter One: Executive Summary
- Proteomics Tools, Approaches in Drug Discovery, Biomarker Discovery
- Biomarker Validation, Diagnostics, Prognostics
- Sources of Samples
- Biomarkers in Pharmaceutical Industry, Diagnostics Industry
- Drug Discovery and Development
- Diagnostics
- Scope and Outline
- Market Summary
Chapter Two: Introduction
- Historical Background
- Definitions
- Biomarkers
- Screening Markers
- Prognostic Markers
- Staging Markers
- Stratification Markers
- Efficacy Markers
- Target Markers
- Toxicity Markers
- Antecedent Markers
- Translation Markers
- Surrogate Markers
- Positive Predictive Value (PPV)
- Sensitivity
- Specificity
- Value of Biomarkers in Industry
- Mass Spectrometry in Proteomics
- Software
- Tandem Mass Spectrometry
- Types of Mass Spectrometers Used for Protein Biomarkers
- MALDI-TOF
- TOF / TOF
- Triple Quad
- Quadrupole TOF
- Quadrupole Ion Trap
- Fourier Transform MS (FTMS / FT-ICR-MS)
- Biomarker Discovery
- MS in Biomarker Applications
- Biomarker Discovery Process in Diagnostics
- Biomarker Discovery in Drug Development
- Biomarker Validation
- Validation Process in Drug Discovery and Development
- Validation Process in Diagnostics
Chapter Three: Disease Application Areas
- Cancer
- Prostate
- Prostate Cancer Related Articles:
- Breast
- Breast Cancer Related Articles:
- Lung
- Ovarian / Endometrial
- Ovarian Cancer Related Articles:
- Oral / Lymphoma
- Oral Cancer Related Articles:
- Liver
- Other / Multiple Cancers
- General Cancer Related Articles:
- Cardiovascular Disease
- Neurological Disease
- Parkinson' s Disease
- Alcohol Abuse
- Sleep Apnea
- Cerebral Injury
- Amyotrophic Lateral Sclerosis (ALS)
- Diabetes
- Aging
- Aging Related Articles:
- Sepsis
Chapter Four: Proteomics Tools
- Introduction
- 2D Gel Electrophoresis (2DGE)
- Recent Developments in 2DGE
- Liquid Chromatography (LC)
- Recent Developments in LC
- Protein Chips
Chapter Five: Trends
- Industry Trends
- MS Vendors Creating Biomarker Divisions, Collaborations
- Some Acquisition, Consolidation Trends in Recent Years
- Regulatory Environment Becoming More Clearly Defined
- Drug Companies' Woes Bringing Growth in Biomarkers
- Intellectual Property Defines Companies' and Instruments' Territories
- Diagnostics Industry Facing Uncertain IP Issues
- Globalization and Diversity Converging Rapidly
- Technology Trends
- Ongoing Debate, Confusion Over Protein Patterns Vs Identified Markers
- Emphasis on Sample Preparation, Fractionation
- High Abundance, Low Abundance, Both
- LC and ESI Approaches Growing Relative To 2DGE and MALDI
- New Combinations of LC, ESI, and MALDI
- Integration and Automation
- Advances in Labels to Address Focused Applications
- Biomarkers for Classes of Drugs
- Chemogenomics / Chemoproteomics Techniques Further Driving Advances
- Direct Analysis of Tissue
- Shift to Solid-State Lasers
- Field Applications Driving Miniaturization
Chapter Six: MS Software Market
- Products and Competitors
- Agilent Technologies
- GeneSpring MS
- MassHunter
- SpectrumMill
- Applied Biosystems / MDS Sciex
- Analyst
- MarkerView
- Pro QUANT
- ProteinPilot
- Bruker Biosciences
- ClinProTools
- flexImaging
- Cerno Biosciences
- MassWorks
- Correlogic Systems
- Proteome Quest
- GeneData AG
- Expressionist Pro
- GenoLogics Life Sciences Software
- Proteus
- Insightful Corp
- S+Proteome
- Genstruct
- Molecular Epistemics platform
- Matrix Science
- Mascot
- Nonlinear Dynamics
- Progenesis PG600
- Thermo
- SIEVE
- Public Domain Tools and Databases
- Revenue and Growth Forecast
Chapter Seven: MS Services Market
- Competitors
- BG Medicine
- Biophysical Corporation
- Caprion Pharmaceuticals
- Celera Diagnostics
- Compugen
- Panatecs
- Power3 Medical Products
- Predictive Diagnostics
- Protein Discovery, Inc
- RxGen PrimaTox
- SurroMed
- Revenue and Growth Forecast
Chapter Eight: MS Instrumentation Market
- Products
- Agilent Technologies (Palo Alto, CA)
- Agilent 1200 Series HPLC-Chip/MS System
- Agilent 3100 OFFGEL Fractionator
- Agilent 6210 TOF
- Agilent 6340 Ion Trap Liquid Chromatograph/Mass Spectrometer (LC/MS)
- Agilent 6510 Q-TOF LC/MS
- Multiple Affinity Removal System 7 LC Column and Spin Tube
- Applied Biosystems / MDS Sciex (Foster City, CA ; Ontario, Canada)
- 3200 Q TRAP LC/MS/MS System for Proteomics Applications
- 4000 Q TRAP LC/MS/MS System for Proteomics Applications
- 4800 MALDI-TOF/TOF
- ICAT Reagents
- iTRAQ Reagents
- QSTAR Elite LC/MS/MS
- MIDAS TRAQ Systems
- Becton Dickinson (Franklin Lakes, NJ)
- P100 Sample Collection Tubes
- Beckman Coulter (Fullerton, CA)
- ProteomeLab IgY-12 Partitioning Chemistries
- Bruker Biosciences (Billerica, MA)
- apex-Qe
- autoflex II, autoflex II TOF/TOF
- ClinProt Large-Protein Beads
- ClinProt Micro
- ClinProtRobot
- Isotope Coded Protein Labels (ICPL) Triplex Kit
- MALDI Molecular Imager
- microflex, microflex LT
- Protein Post-Translational Modification (PTM) Discovery Tool
- ultraflex, ultraflex TOF/TOF
- Expression Pathology (Gaithersburg, MD)
- Liquid Tissue MS Protein Prep Kit
- PerkinElmer (Wellesley, MA)
- prOTOF 2000 MALDI O-TOF
- Qiagen (Venlo, The Netherlands)
- MSXpress Protein Chip
- Shimadzu / Kratos (Kyoto, Japan)
- LCMS-IT-TOF
- Thermo Electron (Waltham, MA)
- LTQ XL
- LTQ FT
- LTQ Orbitrap
- MDLC LTQ LC-MS
- Waters (Milford, MA)
- LCT Premier XE
- micro MX
- Protein Expression System
- Q-Tof Premier
- Total Market Size and Growth Forecast
- The Market by Disease Area
- Competitive Analysis: Market Share by Vendor
- Market Share by Product Type
Chapter Nine: Consortia and Alliances
- The Biomarker Alliance
- Biomarkers Research Initiatives in Mass Spectrometry (BRIMS)
- Clinical Proteomic Technologies Initiative for Cancer
- Clinical Plasma Profiling Consortium
- Early Detection Research Network (EDRN)
- HUPO Plasma Proteome Project
- Oncology Biomarker Qualification Initiative (OBQI)
- Pharmacogenomics Research Network (PGRN)
- Predictive Safety Testing Consortium
Chapter Ten: Company Profiles
- Agilent Technologies (Palo Alto, CA)
- Applied Biosystems / MDS Sciex (Foster City, CA ; Ontario, Canada)
- Bruker BioSciences (Billerica, MA)
- Ciphergen Biosystems (Fremont, CA) (Bio-Rad)
- GE Healthcare Bio-Sciences (Little Chalfont, United Kingdom) -
- formerly Amersham Biosciences (Uppsala, Sweden)
- PerkinElmer (Wellesley, MA)
- Thermo Electron (Waltham, MA)
- Waters (Milford, MA)
Chapter Eleven: Deals
Chapter Twelve: Academic / Government / Non-Profit Research
- The Center for Biomarker Research
- Johns Hopkins Center for Biomarker Discovery
- Plasma Proteome Institute
Chapter Thirteen: Competitive or Disruptive Technologies
- Protein Arrays, Chips
- Invitrogen ProtoArray
- Protneteomix Protein, Peptide and Antibody Arrays
- Whatman Schleicher & Schuell Serum Biomarker Chip
- Array of Micromachined Ultra Sonic Electrospray (AMUSE)
- Monogram Biosciences' (formerly Aclara) eTag Technology
- Imaging-Based Techniques
- ELISA
Chapter Fourteen: Challenges
- Debate Over Serum Proteomics and Biomarkers
- Advances in Competing, Complementary Techniques, Software Erode Sales
- Reproducibility is Key Priority But Elusive
- Clinical Research Not Yet Experienced With Biomarkers, Procedures
- Blockbuster Mentality Creates Obstacles for Biomarkers
- Gap Between Pharmaceuticals and Diagnostics Still Wide
- Large Investment Required for Biomarker Validation Creates Gap
- Dropping Prices Hurt Revenues, Confuse Customers
- Regulatory and Ethical Issues Not Completely Resolved
- Feasibility of Biomarker Approaches Still Unproven
- Data Analysis Bottleneck Slows Momentum
Chapter Fifteen: Strategic Recommendations
- Recommendation 1: Software
- Recommendation 2: Consumables
- Recommendation 3: Standards, Quality, and Data Exchange
- Recommendation 4: Reliability and User-Friendliness
- Recommendation 5: Systems Biology
- Recommendation 6: Partnering for Novel Technologies
- Recommendation 7: Drug and Diagnostics Partnerships
- Recommendation 8: Training and Education
List of Exhibits
Chapter One: Executive Summary
- Figure 1-1: Market Summary: MS for Protein Biomarker Applications 2005-2011
Chapter Six: MS Software Market
- Table 6-1: The World Market for Protein Biomarker MS Software (Revenues) 2005-2011
- Figure 6-1: Trending in the Revenues for Protein Biomarker MS Software 2005-2011
- Table 6-2: The World Market for Protein Biomarker MS Software (Growth) 2005-2011
- Figure 6-2: Trending in the Growth of Protein Biomarker MS Software 2005-2011
Chapter Seven: MS Services Market
- Table 7-1: The World Market for Protein Biomarker Services (Revenues) 2005-2011
- Figure 7-1: Trending in the Revenues for Protein Biomarker Services 2005-2011
- Table 7-2: The World Market for Protein Biomarker Services (Growth) 2006-2011
- Figure 7-2: Trending in the Growth of Protein Biomarker Services 2006-2011
Chapter Eight: MS Instrumentation Market
- Table 8-1: The World Market for MS Instruments for Protein Biomarker Applications (Revenues) 2005-2011
- Figure 8-1: Trending in the Revenues for MS Instruments for Protein Biomarker Applications 2005-2011
- Table 8-2: The World Market for MS Instruments for Protein Biomarker Applications (Growth) 2006-2011
- Figure 8-2: Trending in the Growth of MS Instruments for Protein Biomarker Applications 2006-2011
- Table 8-3: Protein Biomarker MS Revenues and Market Share by Disease Area 2005
- Figure 8-3: Protein Biomarker MS Market Share by Disease Area 2005
- Table 8-4: Protein Biomarker MS Revenues and Market Share by Leading Supplier 2005
- Figure 8-4: Protein Biomarker MS Market Share by Leading Supplier 2005
- Table 8-5: Protein Biomarker MS Revenues and Market Share by Product Type (Ion Trap, MALDI-TOF, Triple Quad, QqTOF, FTMS, Other, Service/Support) 2005
- Figure 8-5: Protein Biomarker MS Market Share by Product Type 2005
Chapter Nine: Consortia and Alliances
- Table 9-1: Early Detection Research Network (EDRN) Awardees (Institution, Organ Focus, Technology/Approach, Industry Collaboration)
Chapter Eleven: Deals
- Table 11-1: Recent Deals, Collaborations, and Alliances
