市場調査報告書：世界の創薬技術

Abstract

INTRODUCTION

This study examines trends in drug discovery. Drug discovery is an enormous field, and this report focuses on a selection of the major workhorse technologies, including liquid chromatography and mass spectrometry, as well as on newer approaches, such as systems biology, high content screening, and bioinformatics.

Trends in financing and business approaches are examined, as are strategies for commercializing new products. The report also makes predictions about technologies and approaches and how they are likely to perform in the next 5 years.

SCOPE OF STUDY

This report contains:

Descriptions of various drug discovery-related products including bioanalytical instruments, high throughput screening, informatics and microarrays
The current market status of drug discovery technologies, trends and forecasts for growth over the next 5 years
Discussion of new methods of research important to the market including compound discovery, compound optimization, efficacy testing in vitro and in vivo, toxicology testing, pharmacokinetics, and stability testing
An analysis of patents and their importance to the industry.

METHODOLOGY AND INFORMATION SOURCES

The material for this report was gathered from interviews with individuals in the industry, as well as a thorough review of technology gathered from secondary sources. These sources include company annual, 10K and 10Q reports, company literature, trade literature, trade associations, and online sources. Note that the author of this report is herself involved in the development of a compound for amyotrophic lateral sclerosis.

Projections were based on current and historical levels of funding and revenues, potential end users, likely unit prices, and rates of consumption. Final projections are based on the analysis of information from primary and secondary sources. All dollar projections are presented in year 2007 constant dollars.

Drug Discovery Technologies
Chapter 1 - EXECUTIVE SUMMARY
- Summary Table: REVENUES FOR SELECTED DRUG DISCOVERY-RELATED PRODUCTS, WORLDWIDE FORECAST, THROUGH 2012 ($ MILLIONS)
- Summary Figure: REVENUES FOR SELECTED DRUG DISCOVERY-RELATED PRODUCTS, WORLDWIDE FORECAST, 2006-2012 ($ MILLIONS)
  - DRUG DISCOVERY TECHNOLOGIES AND R&D EFFORTS
  - OVERALL DRUG DISCOVERY MARKET TO 2012
Chapter 2 - OVERVIEW
- OVERVIEW
- GOVERNMENT REGULATIONS
  - INTRODUCTION
  - DRUG DISCOVERY
  - PRECLINICAL TESTING AND SUBMISSION OF AN IND
  - CLINICAL TRIALS
  - TIMELINE AND COSTS
  - SUBMISSION OF NDA OR BLA
  - POST-FDA APPROVAL
  - NEW DRUG APPROVALS
- Figure 1 FDA APPROVALS OF NEW MOLECULAR ENTITIES SINCE 1993
- Table 1 NEW MOLECULAR ENTITIES APPROVED BY THE FDA, 1990-OCTOBER 2007
  - DO CURRENT CORPORATE MANAGEMENT PRACTICES HAVE A ROLE IN R&D SHORTFALLS?
    - Blockbuster Drugs
- Table 2 NME APPROVALS BY DISORDER, 2004-OCTOBER 30, 2007
  - Other Successful Therapeutic Agents
- Table 3 BOTOX SALES, 1993-2012 ($ MILLIONS)
  - IS THE NIH FUNDING CRISIS CONTRIBUTING TO SHORTFALLS IN DRUG DISCOVERY?
  - IS THE NIH FUNDING CRISIS CONTRIBUTINGý(CONTINUED)
Chapter 3 - TRENDS IN BIG PHARMA DRUG DISCOVERY AND INVESTMENTS IN DRUG DISCOVERY
- BIG PHARMA
- Table 4 THE WORLD PHARMACEUTICALS MARKET, THROUGH 2012 ($ BILLIONS)
- Figure 2 THE WORLD PHARMACEUTICALS MARKET, 2005-2012 ($ BILLIONS)
  - BIG PHARMA (CONTINUED)
- Table 5 COMPARATIVE PERCENTAGES OF REVENUES AT THE SIX LARGEST U.S. PHARMACEUTICAL COMPANIES
- Table 6 COMPARISON OF FDA APPOVED NME DRUGS DEVELOPED IN HOUSE OR THROUGH IN-LICENSING, 2006 AND H1 2007
  - VENTURE CAPITAL
    - VENTURE CAPITAL (CONTINUED)
Chapter 4 - LIQUID CHROMATOGRAPHY (LC)
- Table 7 WORLD MARKETS FOR HPLC, THROUGH 2012 ($ MILLIONS)
- Figure 3 WORLD MARKETS FOR HPLC, 2006-2012 ($ MILLIONS)
  - HPLC AND UHPLC: THEORY
    - HPLC AND UHPLC: THEORY (CONTINUED)
  - ULTRA-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (UHPLC, UPLC)
  - HPLC & UPLC INSTRUMENTS
    - Sample Injection Systems
    - Pumps
    - Columns
  - DRIVERS OF GROWTH IN LIQUID CHROMATOGRAPHY SYSTEMS
    - Proteomics Research
    - FDA and Other Regulatory Body Requirements
    - Drug Discovery Research in Small and Medium Sized Companies
    - The Growth of the Research Enterprise Overseas
    - New Instrument Designs
  - CHALLENGES TO GROWTH IN LIQUID CHROMATOGRAPHY SYSTEMS
    - Technology Maturity
    - Throughput Speed
    - Stagnation and/or Reduction of the NIH Budget
  - MARKET LEADERS
- Table 8 MARKET LEADERS IN HPLC, 2006 (%)
Chapter 5 - MASS SPECTROMETRY (MS)
- Table 9 MARKETS FOR MASS SPECTROMETRY, THROUGH 2012 ($ MILLIONS)
- Figure 4 MARKETS FOR MASS SPECTROMETRY, 2006-2012 ($ MILLIONS)
  - MASS SPECTROMETRY (CONTINUED)
- Table 10 MARKET LEADERS IN MASS SPECTROMETRY, 2006 (%)
  - MASS SPECTROMETRY: THEORY AND INSTRUMENT TYPES
    - IONIZATION SOURCES
      - Matrix-assisted Laser Desorption/Ionization (MALDI)
      - Electropsray Ionization (ESI)
      - Atmospheric Pressure Chemical Ionization (APCI)
    - MASS ANALYZERS
- Table 11 TYPES OF MASS SPECTROMETRY ANALYZERS USED IN PHARMACEUTICAL APPLICATIONS
  - Quadrupole
  - Time-of-Flight Mass Spectrometry
  - Quadrupole-Time-of-Flight (Q-TOF)
- Table 12 SELECTED Q-TOF MODELS
  - ION TRAP MASS SPECTROSCOPY
- Table 13 SELECTED ION TRAP MASS SPECTROMETER MODELS
  - DRIVERS OF GROWTH AND CHALLENGES IN MASS SPECTROMETRY
    - Drivers of Growth and Challengesý(Continued)
Chapter 6 - COMPANY PROFILES: LIQUID CHROMATOGRAPHY AND MASS SPECTROMETRY
- COMPANY PROFILES
  - DETAILED PROFILES
    - Agilent Technologies
    - Applera Corp.
    - Applied Biosystems
    - Beckman Coulter
    - Bruker Daltonics
    - Dionex
    - Eksigent
    - ESA Biosciences
    - Jasco, Inc.
    - JEOL USA
    - MDS Sciex
    - PerkinElmer Corporation
    - Phenomenex Corporation
    - Shimadzu
    - Thermo Fisher Scientific
    - Varian, Inc.
    - Waters Corp.
  - BRIEF PROFILES
    - Aapttec LLC
    - Advanced Chemistry Development, Inc. (ACD/Labs)
    - Advanced Chromatography Technologies (ACE)
    - Advanced Scientific Instruments: See Knauer
    - Advanced Separation Technologies (Astec)
    - Advion
    - Alpha Omega Technologies
    - Ametek Process and Analytical Instruments (Ametek PI)
    - Ampersand International, Inc.
    - Analytical Scientific Instruments, Inc. (ASI)
    - Applied Research Europe GmbH
    - Ardara Technologies, LP
    - B/R Instrument Corporation
    - Bischoff Chromatography
    - BioTrove
    - BSG, Inc.
    - Burle Electro-Optics/ Photonis Group
    - Cecil Instruments Ltd.
    - Cerno Bioscience
    - Chrom Tech, Inc.
    - Dychrom
    - ES Industries
    - Gilson
    - International Equipment Trading (IET) Ltd.
    - IonSense, Inc.
    - Ion Square Technology, Inc.
    - Isolation Technologies, Inc.
    - Justrite Manufacturing Co.
    - Knauer/Advanced Scientific Instruments
    - Konik Instruments
    - Kromasil/Akzo Nobel
    - Lab Alliance/Scientific Systems Inc. (SSI)
    - Macherey-Nagel, GmbH & Co. KG
    - Moeller Medical GmbH
    - Molnar Institute
    - NCSRT Inc.
    - Nova Biotech
    - Ocean Optics Inc.
    - Optimize Technologies Inc.
    - Phytronix Technologies, Inc.
    - Quantum Analytics
    - Sonntek
    - Spark Holland BV
    - SRI Instruments
    - VICI Valco Instruments Company Inc.
    - YMC Ltd.
    - Zinsser Analytic GmbH
Chapter 7 - HIGH CONTENT SCREENING (HCS)
- Table 14 MARKETS FOR HCS, THROUGH 2012 ($ MILLIONS)
- Figure 5 MARKETS FOR HCS, 2006-2012 ($ MILLIONS)
  - HCS: THEORY
- Table 15 HCS INSTRUMENT LINES
- Table 16 MARKET LEADERS IN HCS INSTRUMENTS, 2006
  - DRIVERS OF GROWTH IN HCS
    - Information Output
    - The Growth of Contract Research Organizations (CROs)
    - The Growth of the Research Enterprise Overseas
    - Requirements for Pathway Knowledge
  - CHALLENGES TO GROWTH IN HCS
    - Costs
    - Drug Discovery Research in Small- and Medium Sized Companies
    - Stagnation and/or Reduction of the NIH Budget
    - Complexity
  - COMPANY PROFILES
    - CELLOMICS/THERMO FISHER
    - GE HEALTHCARE
    - COMPUCYTE CORPORATION
    - TTP LABTECH
    - EVOTEC TECHNOLOGIES/PERKINELMER
    - IMSTAR SA
Chapter 8 - BIOINFORMATICS
- BIOINFORMATICS
- Table 17 THE U.S. MARKET FOR BIOINFORMATICS SOFTWARE APPLICATIONS AND DATABASES/KNOWLEDGE BASES, THROUGH 2012 ($ MILLIONS)
- Figure 6 THE U.S. MARKET FOR BIOINFORMATICS SOFTWARE APPLICATIONS AND DATABASES/KNOWLEDGE BASES, 2006-2012 ($ MILLIONS)
  - WHAT IS BIOINFORMATICS?
    - The First Wave of Bioinformatics Companies: Lessons Learned
- Table 18 ANNUAL BIOINFORMATICS-RELATED REVENUES AT SELECTED COMPANIES, 2000-2007 ($ MILLIONS, ROUNDED)
- Table 19 FREE MAJOR ONLINE SOURCES OF GENOMIC AND PROTEOMIC INFORMATION
- Table 20 SOME COMMERICAL SOURCES OF GENOMIC AND PROTEOMIC INFORMATION
- Table 20 (CONTINUED)
  - The Second Wave of Bioinformatics Companies: Lessons Applied in a Difficult Market
- Table 21 BIOINFORMATICS: MARKET LEADERS AND STRUGGLING COMPANIES
  - The Second Wave ofý(Continued)MICROARRAYS: COMBINING BIOINFORMATICS AND BENCH RESEARCH
- Table 22 MARKETS FOR COMMERCIAL MICROARRAYS ($ MILLIONS)
  - Microarrays: Combiningý(Continued)
- OPEN SOURCE TOOLS AND IN-HOUSE BIOINFORMATICS
  - Bioinformatics Software Not Related to Drug Discovery
- EMPLOYMENT OUTLOOK IN BIOINFORMATICS
  - Employment Outlook in ý (Continued)
- TYPICAL DEVELOPMENT PATTERNS IN BIOINFORMATICS
- GAPS IN BIOINFORMATICS
  - GAPS IN BIOINFORMATICS (CONTINUED)
- FUTURE TRENDS IN BIOINFORMATICS
- COMPANY PROFILES
  - ACCELRYS, INC. (NASDAQ: ACCL)
  - AFFYMETRIX, INC.
  - GENE LOGIC, INC.
  - GEOSPIZA
  - INCYTE
  - PROTEOME SYSTEMS
  - SPOTFIRE
  - VIZX LABS, INC.
  - VLST CORPORATION
  - VLST Corporation (Continued)
Chapter 9 - SYSTEMS BIOLOGY
- SYSTEMS BIOLOGY
- Table 23 THE MARKET FOR SYSTEMS BIOLOGY ($ MILLIONS)
  - CATEGORIES OF SYSTEMS BIOLOGY COMPANIES
    - Pathway providers
    - Model Makers
  - USES OF SYSTEMS BIOLOGY
    - Uses of Systems Biology (Continued)
- Table 24 SYSTEMS BIOLOGY COMPANIES ($ MILLIONS)
  - CHALLENGES IN SYSTEMS BIOLOGY
  - COMPANY PROFILES
  - ARIADNE GENOMICS
  - BG MEDICINE
  - BIOSEEK
  - ENTELOS (LONDON AIM: ENTL)
  - GENEGO
  - GENE NETWORK SCIENCES (GNS)
  - GENOMATICA
  - GENSTRUCT
  - INGENUITY SYSTEMS
Chapter 10 - U.S. PATENT ANALYSIS
- INTRODUCTION
- HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)
- GENERAL TRENDS
- Table 25 HPLC-RELATED TECHNOLOGY: U.S. PATENT TRENDS, 5/2002-8/2007
- Table 26 MS-RELATED PATENTS BY USE CATEGORY
  - TRENDS BY ASSIGNEE
- Table 27 HPLC-RELATED PATENTS BY ASSIGNEE CATEGORY
- Table 28 HPLC-RELATED PATENTS BY COMPANY
  - PATENT APPLICATION TRENDS
- Table 29 HPLC-RELATED TECHNOLOGY, U.S. PATENT APPLICATION TRENDS, 2001-8/2/2007
- Table 30 HPLC-RELATED TECHNOLOGY: U.S. PATENT APPLICATION TRENDS BY FILING DATE, 1997-8/2007
- Table 31 MS-RELATED PATENTS BY USE CATEGORY
  - MASS SPECTROMETRY (MS)
- Table 32 MS-RELATED TECHNOLOGY: U.S. PATENT TRENDS, 1976-8/7/2007
  - GENERAL TRENDS
- Table 33 MS-RELATED PATENTS BY USE CATEGORY
  - TRENDS BY ASSIGNEE
- Table 34 MS-RELATED PATENTS BY ASSIGNEE CATEGORY
- Table 35 MS-RELATED PATENTS BY COMPANY
  - PATENT APPLICATION TRENDS
- Table 36 MS-RELATED TECHNOLOGY, U.S. PATENT APPLICATION TRENDS, 2001-8/2/2007
- Table 37 MS-RELATED TECHNOLOGY, U.S. PATENT APPLICATION TRENDS BY FILING DATE, 1997-8/2007
- Table 38 MS-RELATED PATENTS BY USE CATEGORY
  - PATENT APPLICATION TRENDS (CONTINUED)
Chapter 11 - APPENDIX A: SELECTION OF OPEN-ACCESS AND FEE-BASED SOURCES FOR GENOMIC AND PROTEOMIC DATA
- GENOMICS-RELATED DATABASES
- PROTEOMICS DATABASES
  - PROTEIN INTERACTION DATABASES (INTERACTOME DATABASES)
    - Other Proteomics Databases
  - SYSTEMS BIOLOGY
  - OTHER DATABASES USEFUL FOR DRUG DISCOVERY:

世界の創薬技術市場

Drug Discovery Technologies

Abstract

INTRODUCTION

SCOPE OF STUDY

METHODOLOGY AND INFORMATION SOURCES

Table of Contents