バイオマーカー市場動向

Abstract

Personalized medicine, the use of therapies that are targeted to the individual patient, is a reality today, thanks to a growing emphasis on biomarker research. Biomarkers are anatomic, physiologic, biochemical or molecular parameters that are associated with the presence and severity of specific diseases and illnesses. Biomarkers promise a smoother integration of diagnostics and therapeutics, and most importantly a reduction in time and cost for Phase I and II clinical trials.

Anyone looking to take advantage of the opportunities the market for biomarker research offers will find Kalorama' s Biomarkers: A Market Briefing an essential study of this emerging market. Not only does the report explain the types of biomarkers and their myriad diagnostic applications, it tracks current revenue and forecasts revenue for the following diagnostic segments:

• Cancer (Breast, Ovarian, Prostate, Bladder and Cervical)
• EGFR Testing
• Stroke Diagnosis

Recently, interest in biomarkers has soared due to their proven ability to speed up pharmaceutical R&D efforts. While the FDA has made significant progress in accelerating premarket product review processes, the number of applications for new innovative products reaching the FDA has not accelerated. The productivity of the drug industry is low and is not significantly improving.

Biomarkers can increase the efficiency and reduce the risks of the drug development process. New trial designs and clear guidelines for using efficacy and safety biomarkers in product development will increase the pace and reduce the cost of developing safe and effective medical products.

Biomarkers have been shown to reduce time and cost for Phase I and II clinical trials by replacing clinical endpoints. This is expected to produce the most profitable segment of the market for companies in this industry. Kalorama' s Biomarkers: A Market Briefing provides detailed information on how this promising application for biomarkers is already shaping the market, producing over $200 million in revenue and expected to quintuple in the next four years. The report details the revenues associated with clinical trials biomarker application through 2009, including data on geographic regional revenues.

Biomarkers: A Market Briefing discusses the major products currently marketed in each disease category as well as the important issues and trends that serious entrants into this market must take notice of. In-depth profiles of need-to-know companies in this market are provided, including:

• Biophysical Corp.
• Charles River Laboratories Inc.
• Cyclacel Pharmaceuticals Inc.
• DeCODE Genetics
• Diologic Corp.
• Health Discovery Corp.
• Illumina Inc.
• Imgenex Corp.
• Insilicos LLC
• Metabolon Inc.
• Millennium Pharmaceuticals Inc.
• Peakadilly
• PPD Inc.
• Proteome Sciences plc
• Rules-Based Medicine Inc.
• Targeted Molecular Diagnostics LLC

Kalorama' s trusted information-gathering process provides the most accurate study of the market for biomarkers available today. Information and analysis presented in this report is based on extensive interviews with senior management of top companies and in the biomarker arena. While major research literature and government information is culled, information is corroborated and key market insights originate from interviews with industry leaders.

Product managers, marketing managers, business development executives, advertising agency or investment firm executives, and information and research center librarians are among the individuals who will find this briefing on the emerging market for biomarkers essential.

Table of Contents

Chapter One: Executive Summary

• The Importance of Biomarkers
  • Speed Drug Development
  • Predictive Diagnostics
• Key Applications
  • Selected Clinical Trial Applications
  • Key Diagnostics
• World Market Summary
  • Clinical Diagnostics
  • Clinical Trials
• Methodology

Chapter Two: Introduction

• In Perspective
  • What Are Biomarkers?
  • Surrogate Endpoints
• Types of Biomarkers
  • Applications
    • Diagnostics
    • Drug Development
    • Imaging Biomarkers
  • Issues and Concerns

Chapter Three: Markets

• Overview
• Key Diagnostics Segments
  • Cancer
  • EGFR Testing
  • Stroke
  • Drug Development
  • Clinical Trials

Chapter Four: COMPANY Profiles

• 4.1 Biophysical Corp.
• 4.2 Charles River Laboratories Inc.
• 4.3 Cyclacel Pharmaceuticals Inc.
• 4.4 deCODE Genetics
• 4.5 Enodar Biologic Corp.
• 4.6 Health Discovery Corp.
• 4.7 Illumina Inc.
• 4.8 Imgenex Corp.
• 4.9 Insilicos LLC
• 4.10 Metabolon Inc.
• 4.11 Millennium Pharmaceuticals Inc.
• 4.12 Peakadilly
• 4.13 PPD Inc.
• 4.14 Proteome Sciences plc
• 4.15 Rules-Based Medicine Inc.
• 4.16 Targeted Molecular Diagnostics LLC

List of Exhibits

• Exhibit 1-1: World Market for Biomarkers in HER2 Breast Cancer Diagnostics 2006-2010
• Exhibit 1-2: World Market for Biomarkers in Ovarian Cancer Diagnostics 2006-2010
• Exhibit 1-3: World Market for Biomarkers in Cervical Cancer Diagnostics 2006-2010 Revenues (in millions)
• Exhibit 1-4: Summary: World Market for Biomarkers in Clinical Trials 2006-2010
• Exhibit 3-1: U.S. Market for HER2-Based Biomarkers for Breast Cancer 2006-2010
• Exhibit 3-2: World Market for HER2-Based Biomarkers for Breast Cancer 2006-2010 Revenues (in millions)
• Exhibit 3-3: US Market for Biomarkers for Ovarian Cancer 2006-2010
• Exhibit 3-4: Market for Biomarkers for Ovarian Cancer 2006-2010
• Exhibit 3-5: Market for Biomarkers for Cervical Cancer 2006-2010
• Exhibit 3-6: World Market for Biomarkers for Cervical Cancer 2006-2010
• Exhibit 3-7: US Market for Biomarkers for Prostate Cancer 2006-2010
• Exhibit 3-8: World Market for Biomarkers for Prostate Cancer 2006-2010
• Exhibit 3-9: US Market for Biomarkers for Bladder Cancer 2006-2010
• Exhibit 3-10: World Market for Biomarkers for Bladder Cancer 2006-2010
• Exhibit 3-11: US Market for Biomarkers for EGFR Testing 2006-2010
• Exhibit 3-12: World Market for Biomarkers for EGFR Testing 2006-2010
• Exhibit 3-13: US Market for Biomarkers for Stroke Diagnosis 2006-2010
• Exhibit 3-14: World Market for Biomarkers for Stroke Diagnosis 2006-2010
• Exhibit 3-15: U.S. Clinical Trial Market for Biomarkers by Phase (Number of Trials, Patients, Biomarker Patients, Cost per Test, Market Size) 2006
• Exhibit 3-16 : World Clinical Trial Market for Biomarkers by Geographical Region (U.S., European Union, Asia) 2006
• Exhibit 3-17: U.S. Clinical Trial Market for Biomarkers by Phase (Number of Trials, Patients, Biomarker Patients, Cost per Test, Market Size) 2007
• Exhibit 3-18 : World Clinical Trial Market for Biomarkers by Geographical Region (U.S., European Union, Asia) 2007
• Exhibit 3-19: U.S. Clinical Trial Market for Biomarkers by Phase (Number of Trials, Patients, Biomarker Patients, Cost per Test, Market Size) 2008
• Exhibit 3-20 : World Clinical Trial Market for Biomarkers by Geographical Region (U.S., European Union, Asia) 2008
• Exhibit 3-21: U.S. Clinical Trial Market for Biomarkers by Phase (Number of Trials, Patients, Biomarker Patients, Cost per Test, Market Size) 2009
• Exhibit 3-22 : World Clinical Trial Market for Biomarkers by Geographical Region (U.S., European Union, Asia) 2009
• Exhibit 3-23: U.S. Clinical Trial Market for Biomarkers by Phase (Number of Trials, Patients, Biomarker Patients, Cost per Test, Market Size) 2010
• Exhibit 3-24 : World Clinical Trial Market for Biomarkers by Geographical Region (U.S., European Union, Asia) 2010