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Published by: Takeda Pacific
Published: Jun. 1, 2007 - 130 Pages
Table of Contents
- 1. The Biomarker Market for Pharma/ Biotech Drug R&D
- Drug Industry R&D Spending and Productivity
- Limited Drug Effectiveness, Safety and Unmet Medical Needs
- Many Drug Types Do Not Work Well for Patients
- Drug- Related ADRs Impact Large Populations
- Key Unmet Medical Needs
- Personalizing Medicine with Biomarkers and Key Technologies
- Molecular Biomarkers and Pharmaco-genomics (PGx)
- Government Agencies, Biomarkers and PGx
- Market Ecosystem
- 2. Biomarkers For Drug R&D
- Defining Biomarkers
- Healthcare and Biomarkers
- Evolving Definition of Biomarkers
- The Regulatory Definition of Biomarkers and Tests for Drug R&D
- Biomarkers and Tests
- Nucleic Acids, Proteins, Profiles and Metabolites
- Biomarkers, Pharmacogenomics (PGx) and Personalized Medicine
- New Clinical Trial Designs and Patient Stratification
- Drug-Test Synergies for Companion Tests
- Biomarkers Generate Industry Buzz
- FDA’s Biomarker Activities (2004-2007)
- FDA’s VXDS Program and International Participation
- Other US Government Initiatives in Personalized Medicine
- SNPs, Molecular Patterns and Gene Expression Profiles Measure Complex Diseases
- The Goal to Drive Down the Cost of SNP Tests
- Using RNA Interference For Screening for Biomarkers
- Protein Patterns Demonstrated as Biomarkers
- Developing Biomarkers and Tests
- 3. Alliances and M&As in Biomarker R&D
- Alliances in Biomarkers and Drug R&D
- Alliances in Biomarkers By Major Diseases
- Alliance Details 2005 to May-2007
- 4. Technologies for Biomarkers and Drug R&D
- PGx Tests for Drug R&D
- Biomarker Testing and Analysis Technologies
- Genomic Biomarker Testing
- Direct Detection with Blots and ELISAs
- PCR-based Target Amplification Technology
- Non-PCR Target Amplification and Signal Amplification
- Signal Amplification
- Microarrays and Microfluidic Systems
- Microarrays
- Microfluidic Systems (Lab-on-a-chips)
- Proteomic Biomarker Testing
- Metabolomic Biomarker Testing
- Bioinformatic Software Enables Biomarker Analysis
- 5. WW Pharma/ Biotech Biomarker R&D Spending, Market Size and Forecast
- WW Pharma/ Biotech Biomarker R&D Spending Trends
- WW Pharma/ Biotech Biomarker R&D Spending Market Shares
- WW Pharma/ Biotech Biomarker R&D Market Size by Application Segments
- WW Pharma/ Biotech Biomarker R&D Market Size by Application/ Clinical Phase
- WW Pharma/ Biotech Biomarker R&D by Tools and Services
- Pharma/ Biotech Biomarker R&D Spending by WW Region
- 6. Trends and Future Directions
- Biomarkers for Drug R&D
- Government Initiatives Foster Drug R&D - Biomarker/ Test Co-development
- Biomarkers, a Key Opportunity on the Critial Path to Personalized Medicine
- The Critical Path Linked to VXDS Program
- Biomarkers Enable New Clinical Trial Designs
- Future Direction of PGx Tests and Targeted Therapies
- Personalized Medicine is Here and is Set for Growth
- Cancer Biomarkers and Tests
- Future Direction for CNS Disease Tests
- Infectious Disease Testing
- 7. Selected Companies Working in Biomarker-Related Drug R&D
- Affymetrix, Inc.
- Agendia B.V.
- Agilent Technologies, Inc., LSCA group
- Applied Biosystems
- BioSite, Inc.
- Caliper Life Sciences, Inc.
- Celera Group
- Cepheid
- CombiMatrix Corp (Acacia Research)
- Dako A/S
- diaDexus, Inc.
- Epigenomics AG
- Fluidigm Corporation
- Gene Logic, Inc.
- Illumina, Inc.
- Innogenetics NV
- Invitrogen Corporation
- Luminex Corporation
- Myriad Genetics, Inc.
- Nanogen, Inc.
- Nanosphere, Inc.
- NimbleGen Systems, Inc.
- Nymox Pharmaceutical Corporation
- Orion Genomics LLC
- Qiagen NV
- Roche Molecular Diagnostics
- Sequenom, Inc.
- Sigma-Aldrich
- Spotfire, Inc.
- Third Wave Technologies, Inc.
- Veridex, LLC (J&J Co.)
- 8. Appendices
- WW Populations by Diseases
- Goals and Uses of Biomarker Tests for Pharma/ Biotech R&D
- New PGx Tests for Pharma/ Biotech R&D Enable Personalized Medicine
- Clinical PGx in the Pharma/ Biotech R&D Path
- Biomarker Tests for Pharma/ Biotech
- Biomarker Test Products Can Reach Market Quickly
- About Takeda Pacific
- About the Authors
AbstractThis report focuses on the market for biomarkers and tests used in pharma/ biotech drug R&D. The study reviews the market by looking at key alliances, pharma/ biotech research and development spending, trends, major diseases, applications and technologies. The research analyzed the future direction of biomarkers and related ‘-omic’ or pharmacogenomic (PGx) tests used in drug R&D. This report estimates the worldwide market value and growth (CAGR) of biomarkers and tests for pharma/ biotech R&D for the next five years.
Research-based pharma/ biotech companies face numerous challenges that are being overcome with newer business strategies or approaches that are discussed in this report. This business area is set for strong continued growth as biomarkers and tests in drug R&D enable new opportunities.
The report discusses ongoing government initiatives that foster worldwide development in targeted therapeutics, biomarkers and personalized medicine opportunities. Their expectation is to streamline commercializing new, safer, drugs and co-developed tests by integrating biomarkers and PGx tests into the critical path of drug R&D.
Traditional clinical trial designs will undergo key changes that integrate biomarkers and tests to provide more useful information in order for drug makers to make better product decisions. Some drug company executives expect biomarkers to enable a ‘sea change’ in how new drugs are developed as the blockbuster business model fades and transitions to new focused therapeutic approaches that gain traction in a few years.
Targeted therapies such as Herceptin, Gleevec, Erbitux, or Irressa are among new drug products that work in just a sub-set of patients that pass special pharmcogenomic tests designed for each product. Many drug companies are routinely using biomarkers in R&D and are increasingly adding drug-test projects to their product pipelines. The era of personalized medicine has arrived.
This study uses more than 42 figures and tables to illustrate its useful findings. The report offers detailed information including data tables about strategic alliances, technologies and so on. Thirty-one leading companies are profiled with details such as contact information, business overview, financial details and product information.
This report would benefit people with job titles including CEO, VPs, Director of Business Development, Research Directors, Entrepreneurs, Venture Capitalists, Investment Planners, Research Scientists, Consultants or Industry Analysts.
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