薬剤研究開発および医療における分子画像：技術、応用および市場

Abstract

The rapidly emerging field of molecular imaging is poised to open new vistas for basic researchers, scientists working in drug discovery and development, and physicians. This new report delves fully into:

• The history, evolution, and potential of molecular imaging
• The technologies in use today and under development for the future
• Applications in drug development and diagnostic medicine
• Market dynamics that are shaping and reshaping commerce in molecular imaging instruments and reagents
• Regulatory aspects of the field
• Interviews with experts active as either providers or users of molecular imaging
• Results of an online survey of individuals in pharmaceutical and biotechnology companies and institutional researchers

Source: © Cambridge Healthtech Institute, Insight Pharma Reports, "Molecular Imaging in Drug R&D and Medical Practice," January 2008

Little more than 5 years old, the postgenomic field of molecular imaging is undergoing rapid research and commercial development, driven largely by big pharma' s burgeoning interest in biomarkers as crucial for decision support in preclinical and early clinical development.

The term biomarker is often associated with the detection or measurement (in vitro) of expressed genes, proteins, or metabolites in biological fluids. To drug developers, however, biomarker can refer equally well to morphological, functional, or molecular measurements made in vivo using medical imaging equipment, such as:

• Computed tomography (CT)
• Magnetic resonance imaging (MRI)
• Positron emission tomography (PET)
• Ultrasound
• Optical scanners

Progress in molecular imaging biomarkers for preclinical development, which do not need regulatory approval, potentially leads to biomarkers for human clinical trials, which do require such approval. Those biomarkers deemed useful in routine medical practice may then graduate to become part of the physician' s diagnostic armamentarium. Molecular imaging requires probes or tracer molecules, and few such molecules have yet been approved for use in humans. Although a number more are in development, the expense in dollars and time required currently limit the rate of expansion of the molecular imaging field. A number of companies, both large and small, have set out to remedy this situation.

Molecular Imaging in Drug R&D and Medical Practice: Technologies, Applications, Markets offers thorough insight into the molecular imaging marketplace, which consists of 3 main supplier factions: large corporations, small corporations, and contract research organizations (CROs). Researchers in the commercial sector provide new instrument and reagent technologies, but academic researchers also have a significant role to play in generating new concepts and testing their feasibility. On the consumption end, pharmaceutical and biotechnology companies use instruments and reagents for preclinical and clinical development directly in-house and indirectly through CROs and academic centers. This report is a valuable tool for all involved in the field.

Table of Contents

Chapter 1 INTRODUCTION

• 1.1. Biomarker Definitions
• 1.2. Organization of the Report

Chapter 2 IN VIVO MOLECULAR IMAGING TECHNOLOGIES

• 2.1. Historical Introduction
• 2.2. Imaging Technologies
  • Computed Tomography
  • Positron Emission Tomography
  • Single Photon Emission Computed Tomography
  • Magnetic Resonance Imaging
  • Ultrasound
  • Optical Imaging
• 2.3. Combination Technologies
• 2.4. Molecular and Functional Imaging

Chapter 3 IMAGING BIOMARKERS IN DRUG DEVELOPMENT

• 3.1. Preclinical Development
• 3.2. Clinical Development
• 3.3. Therapeutic Areas
  • Cancer
    • Cell Proliferation or Metabolism
    • Apoptosis
    • Angiogenesis
    • Hypoxia
    • Other Parameters
  • Neurological Disease
    • Alzheimer' s Disease
    • Parkinson' s Disease
  • Cardiovascular Disease
  • Inflammatory and Autoimmune Disease

Chapter 4 MOLECULAR IMAGING IN DIAGNOSTICS

• 4.1. Cancer
• 4.2. Cardiovascular Disease
• 4.3. Neurological Disease

Chapter 5 CONSORTIA, GOVERNMENT, AND REGULATORY CONSIDERATIONS

• 5.1. Consortia and Professional Society Involvement
  • Biomarkers Consortium
  • Oncology Biomarker Qualification Initiative (OBQI)
  • Uniform Protocols for Imaging in Clinical Trials (UPICT)
  • Imaging Response Assessment Teams (IRATs)
• 5.2. Government Involvement
  • NIH Molecular Libraries and Imaging Roadmap
  • Network for Translational Research: Optical Imaging (NTROI)
  • Alzheimer' s Disease Neuroimaging Initiative (ADNI)
  • Institute for Molecular Technology (IMT)
  • National Oncologic PET Registry (NOPR)
• 5.3. FDA Regulatory Guidance
• 5.4. National Academy of Sciences Report

Chapter 6 MARKET CONSIDERATIONS

• 6.1. The Molecular Imaging Market Ecology
  • Radiopharmaceuticals
  • Instruments
  • Software
• 6.2. Market Analysis and Dynamics
  • Facilitation of Imaging Agent Development
  • PET Versus SPECT
• 6.3. Drug Discovery and Development Market
  • Large Company Business Models
  • The Convergence of In Vitro and In Vivo Diagnostics
• 6.4. Deals in Molecular Imaging
  • Categorization of Deals
  • Market Size and Growth Projects

Chapter 7 EXPERT INTERVIEWS

• Sudeep Chandra, PhD, General Manager of Molecular Imaging, Philips Healthcare
• Terry A. Colip, Managing Partner and CFO, Cell>Point, LLC
• J. James Frost, MD, PhD, Professor of Radiology and Psychiatry, Yale University, School of Medicine
• Antony Gee, PhD, Director of PET and Radiotracer Development, GlaxoSmithKline
• Franz Hefti, PhD, Chief Scientific Officer, Avid Radiopharmaceuticals
• Patrick McConville, PhD, Director of Imaging, MIR Preclinical Services
• Jean-Luc Vanderheyden, PhD, Global Molecular Imaging Leader, GE Healthcare

APPENDIX

• INSIGHT PHARMA REPORTS MOLECULAR IMAGING SURVEY-OCTOBER 2007
• Observations from the Survey

References

• Company Index with Web Addresses