纳米科技对药物开发过程的影响

Summary:

Pharmaceutical and biotechnology companies are under immense pressures to produce a steady stream of innovative, well-differentiated drugs at reduced costs. Currently it takes an estimated 7-10 years to develop and market a drug at a cost that exceeds $800 million. In simple terms, drug discovery requires the identification of a disease, knowledge of the disease mechanism and identification of a target (point of intervention). The human genome project is expected to identify approximately 100,000 targets that will require evaluation against many compound libraries to compare gene sequences and structure. This represents a very time-consuming process and a major bottleneck in the drug discovery process as millions of compounds can be screened for each target. Novel discovery and validation technologies can expand the hit rate for promising compounds in the pipeline, and expedite their progress through to market. The introduction of microarrays and lab-on-a-chip technologies has already revolutionized the drug discovery process. Where once it took the effort of a single chemist to view anything from one to 12 gene variations at a time, microarrays can view thousands in the same time frame. Now, nanotechnology promises to exponentially increase even the volume of microarrays by working at a level far smaller than conventional microarrays and according to one source the pharmaceutical market will represent approximately $180 billion of the forecasted $1 trillion nanotech industry.

Nanotechnology can enhance the drug discovery process, through miniaturization, automation, speed and reliability of assays. Although at an embryonic stage of development, nano-enabled drugs are already bringing clinical benefits to thousands of patients. This report provides an overview and a detailed analysis of the major drivers, restraints and challenges for current and emerging applications of nanotechnology in drug discovery. Areas covered include nano-enabled drug discovery technologies/tools, nano-enabled drugs and an assessment of key market engineering parameters. The technologies/tools covered include, nanoarrays, nanomasspectrometry, nanolithography arrays, biological chips, congruent force intermolecular test and solubility and reformulation methods. This report provides global market coverage and discusses funding, regulatory and ethical issues in the major industrial countries, with worldwide market forecasts over a 5-year forecast period. This report will be of vital interest to strategic planners, marketing managers and product development managers at all pharmaceutical, diagnostic, life science and biotechnology companies that may be interested in nanotechnology. This report may also benefit individuals and investors who track advances in the evolving nanotechnology market, including venture capitalists, healthcare equity analysts, academic research and scientific staff.

Table of Contents

Executive Summary

E.1 Introduction

E.2 Drivers, Restraints and Challenges Affecting the Growth of Nano-Enabled Drug Discovery

E.3 The Pharmaceutical Market, Regulatory Factors and Sources of Funding for Nanotechnology

E.4 Which Countries will Lead in Nano-Enabled Drug Discovery?

E.5 Nano-enabled Drug Discovery Technologies and Products

E.6 The Players

E.7 Market Forecast Summaries

Chapter One: Introduction

1.1 Overview

1.2 Objectives

1.3 Scope of the Report/Research Methodology and Information Sources

1.4 Plan of Report

Chapter Two: Drivers, Restraints, Challenges, Regulatory Issues and Government Funding Policies

2.1 Introduction

2.2 Drivers for the Growth of Nano-enabled Drug Discovery

2.2.1 Social and economic drivers

2.2.2 Technological Drivers

2.2.3 Increased Funding Drives Nano-enabled Drug Discovery

2.3 Factors Restricting the Market Growth of Nano-enabled Drug Discovery

2.3.1 Uncertainty

2.3.2 Public Awareness and Perception

2.3.3 Environmental Concerns

2.3.4 Detection of Incurable Diseases Could Place Immense Pressure on Pharmaceutical Companies

2.3.5 Huge Expectations May Not Be Realized

2.4 Technology Challenges

2.4.1 Nanotechnologies are Required to Meet the Demands for Drug-Discovery Applications

2.4.2 The Long-Term Stability of Nanomaterials Causes Concern

2.4.3 Technical Issues In Nano-Assembly and Molecular Manufacturing are Affecting Rapid Commercialization

2.4.4 Overcoming Barriers to Collaboration

2.4.5 Lack of Test Standardization

2.4.6 Scalability Posing a Challenge to Nanomedicine Initiatives

2.4.7 Pharmaceutical Companies May Be Reluctant to Invest In Nanotechnology

2.5 The Pharmaceutical Market, Regulatory Factors and Sources of Funding for Nanotechnology

2.5.1 United States

2.5.2 Canada

2.5.3 Europe

2.5.3.1 Belgium and the Netherlands

2.5.3.2 Denmark

2.5.3.3 Finland

2.5.3.4 Sweden

2.5.3.5 France

2.5.3.6 Germany

2.5.3.7 United Kingdom

2.5.3.8 Ireland

2.5.3.9 Switzerland

2.5.3.10 Italy

2.5.4 Japan

2.5.5 Taiwan

2.5.6 Singapore

2.5.7 South Korea

2.5.8 China

2.5.9 Australia

2.5.10 Israel

Chapter Three: Applications of Nanotechnology in Drug Discovery

3.1 A Historical Overview of the Drug Discovery Process

3.2 An Introduction to Nanotechnology in Drug Discovery and Development

3.3 Nano-enabled Drug Discovery Tools

3.3.1 Atomic Force Microscopy (AFM) and the Congruent Force Intermolecular Test

3.3.2 Field-Ion Microscope

3.3.3 Near-field Scanning Optical Microscope (SNOM or NSOM)

3.3.4 Surface Plasmon Resonance

3.3.5 Nano-Mass Spectroscopy

3.3.6 Dip-Pen Nanolithography (DPN)

3.4 Microarrays and Nanoarrays

3.5 Microfluidics and Nanofluidics

3.6 Nanoparticles for Drug Discovery

3.6.1 Quantum Dots (QDots) and Gold Nanoparticles for High-Content and Initial Drug Screening

3.6.2 Nanoshells for Raman Spectroscopy

3.6.3 Nanobarcode Particles

3.7 Nanomaterial Drugs

3.7.1 Abraxane

3.7.2 RenaZorb

3.7.3 Antimicrobial Emulsions

3.7.4 Antioxidant and Anti-HIV Fullerenes

3.8 Future Developments

Chapter Four: The Players

4.1 Introduction

4.2 3DM Inc. (PuraMatrix)

4.3 Aclara BioSciences

4.4 Advion BioSciences, Inc.

4.5 Agilent Technologies

4.6 Alnis BioSciences, Inc.

4.7 American Pharmaceutical Partners, Inc. (Abraxis Oncology)

4.8 BioCrystal, Ltd.

4.9 BioForce Nanosciences, Inc.

4.10 BioTrove, Inc.

4.11 Caliper Life Sciences

4.12 Cepheid

4.13 CombiMatrix Corporation

4.14 CrystalPlex Corporation

4.15 C Sixty

4.16 Eksigent Technologies, LLC

4.17 Evident Technologies Inc.

4.18 Fluidigm Corporation

4.19 GeneFluidics

4.20 Gyros AB

4.21 NanoBio Corporation

4.22 Nanogen

4.23 NanoHorizons Inc.

4.24 Nanosphere

4.25 Nanostream, Inc.

4.26 PharmaSeq, Inc.

4.27 Protiveris Inc.

4.28 Quantum Dot Corp.

4.29 Sequenom

4.30 Zyomyx, Inc.

Chapter Five: Eight-Year Projections of Nano-enabled Drug Discovery Revenues

5.1 A Justification for Forecasting

5.2 Forecasting Goals and Methodology

5.2.1 Size of Addressable Markets

5.3 Forecast of Nano-enabled Drug Discovery Revenues

5.3.1 Forecast of Lab-on-Chip/Array-Based Nano-enabled Drug Discovery Revenues 5.3.1.1 Competitive Structure

5.3.2 Forecast of Nanoparticle-Based Nano-enabled Drug Discovery

5.3.2.1 Competitive Structure

5.3.3 Forecast of Self-Assembly Nano-enabled Drug Discovery

5.3.3.1 Competitive Structure Acronyms and Abbreviations Used in this Report

List of Exhibits

• Exhibit E-1 Market Drivers, Restraints and Challenges Facing the Growth of Nano-Enabled Drug Discovery
• Exhibit E-2 Summary of the Pharmaceutical Market Size and Nanotechnology Funding Initiatives by Geographical Demography
• Exhibit E-3 Assessment and Summary on Whether (or not) a Particular Country is Likely to Emerge as a Center for Nano-Enabled Drug Discovery
• Exhibit E-4 Nano-enabled Drug Discovery Product Developers and Producers
• Exhibit E-5 Eight-Year Forecasts of Worldwide Nano-enabled Drug Discovery Revenues by Application ($ Millions)
• Exhibit 2-1 Market drivers fuelling the growth rate of nano-enabled drug discovery
• Exhibit 2-2 Technology challenges
• Exhibit 2-3 National Nanotechnology Initiative (Contribution of key agencies $ Millions)
• Exhibit 3-1 Drug development process during the 1950s and 1960s
• Exhibit 3-2 Drug discovery process during the 1980s
• Exhibit 3-3 Drug Discovery Process Today
• Exhibit 3-4 Examples of bottom-up and top-down techniques in manufacturing
• Exhibit 3-5 A schematic diagram illustrating how antibodies specific to individual proteins are targeted using Atomic Force Microscopy
• Exhibit 3-6 Advions ESI Chip for MS (Courtesy of Advion Bioscience)
• Exhibit 3-7 (a) An image showing the expression in cells using QDots 125
• Exhibit 5-1 Nano-enabled Drug Discovery Revenue Forecasts ($ Million) and Growth Rates 199
• Exhibit 5-2 Nano-enabled Drug Discovery Revenue Forecasts by Market Segments
• Exhibit 5-3 Lab-on-Chip (LOC)/Array-based Nano-Enabled Drug Revenue Forecasts
• Exhibit 5-4 Lab-on-Chip (LOC)/Array-based Nano-enabled Drug Discovery Revenues Forecasts ($ Million) and Growth Rates by Application Area
• Exhibit 5-5 Lab-on-Chip (LOC)/Array-based Technology Market Share by Product Application
• Exhibit 5-6 Market Share Trends of Major Market Participants in Lab-on-Chip (LOC)/Array-based Technologies
• Exhibit 5-7 Revenue Forecasts ($ Million) and Growth Rates for Nanoparticle Materials in Drug Discovery
• Exhibit 5-8 Nanoparticulate Revenue Forecasts ($ Million) and Growth Rates by Drug Discovery Application Area
• Exhibit 5-9 Nanoparticulate Drug Discovery Market Share by Product Application
• Exhibit 5-10 Market Share Trends of Major Market Participants in Nanoparticulate Drug Discovery
• Exhibit 5-11 Revenue Forecasts ($ Million) and Growth Rates for Self-Assembly in Nano-enabled Drug Discovery
• Exhibit 5-12 Self Assembly Nano-enabled Drug Discovery Revenue Forecasts ($ Million) and Growth Rates by Drug Discovery Application Area 213
• Exhibit 5-13 Self-Assembly Nano-enabled Drug Discovery Market Share by Product Application
• Exhibit 5-14 Market Share Trends of Major Market Participants in Self Assembly Nano-enabled Drug Discovery