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Pharmacogenomics: New Technologies in the Development of Personalized Therapies

Published by: BCC Research

Published: Aug. 1, 2005 - 157 Pages


Table of Contents



INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THIS STUDY

CONTRIBUTIONS TO THE STUDY AND FOR WHOM

SCOPE AND FORMAT

METHODOLOGY

INFORMATION SOURCES

AUTHOR'S CREDENTIALS

RELATED BCC REPORTS

BCC ONLINE SERVICES

DISCLAIMER

SUMMARY

Summary Table:

WORLDWIDE PHARMACOGENOMICS MARKET BY TECHNOLOGY SEGMENTS, THROUGH 2009 ($ MILLIONS)

Summary Figure:

WORLDWIDE PHARMACOGENOMICS MARKET BY TECHNOLOGY SEGMENTS, 2001-2009 ($ MILLIONS)

OVERVIEW

STREAMLINING CLINICAL TRIALS

TIME FRAME FOR DRUG APPROVAL

Table 1 DRUG DEVELOPMENT AND FDA APPROVAL PROCESS

HIGH COSTS STIFFLE INNOVATION

Table 2 NME APPROVALS GRANTED BY FDA (UNITED STATES), 1995-2004

Table 3 TOTAL SPENDING ON R&D BY PHRMA COMPANIES, 1999-2003 ($ BILLIONS)

Table 4 R&D SPENDING ON CLINICAL DEVELOPMENT BY PHRMA COMPANIES, BY DRUG DEVELOPMENT PHASE, 2002 ($ BILLIONS)

Figure 1 R&D SPENDING ON CLINICAL DEVELOPMENT BY PHRMA COMPANIES, BY DRUG DEVELOPMENT PHASE, 2002 ($ BILLIONS)

ATTRACTING TRIAL PARTICIPANTS

PHARMACOGENOMICS AS A SOLUTION

CAVEATS

IMPROVING DRUG EFFICACY

Table 5 DRUG INEFFICACY, BY THERAPY TYPE (PERCENTAGE OF PATIENTS FAILING TO RESPOND TO THERAPY)

REDUCING ADVERSE DRUG REACTIONS

FACTORS CONTRIBUTING TO ADVERSE DRUG REACTIONS

COSTS OFADVERSE DRUG REACTIONS

Table 6 ADVERSE DRUG REACTIONS IN THE UNITED STATES

MARKET DRIVERS

ROLE OF PHARMACOGENOMICS IN ADR PREVENTION

POST-MARKET DRUG FAILURE

PROMINENT DRUG WITHDRAWALS

Table 7 PROMINENT DRUGS WITHDRAWALS

Vioxx

Rezulin

Pondimin and Redux

Seldane

Posicor

Baycol (Cerivastatin)

ROLE OF PHARMACOGENOMICS IN REDUCING DRUG WITHDRAWALS

THE SNP CONSORTIUM

Table 8 SNP CONSORTIUM MEMBERS

THE INTERNATIONAL HAPMAP PROJECT

PARTICIPANTS IN THE HAPMAP PROJECT

Table 9 HAPMAP PARTICIPANTS AND FUNDING SOURCES

Table 10 STRUCTURE OF THE INTERNATIONAL HAPMAP PROJECT

Table 10 (CONTINUED)

HAPMAP POPULATIONS AND ETHICIAL CONCERNS

DATA ACCESSIBILITY AND PATENTABILITY

FOOD AND DRUG ADMINISTRATION: NEW GUIDELINES

FOOD AND DRUG ADMINISTRATION: NEW GUIDELINES (CONTINUED)

SNP IDENTIFICATION MARKET

SNP IDENTIFICATION MARKET

Table 11 GLOBAL MARKET FOR SNP IDENTIFICATION TOOLS, THROUGH 2009 ($ MILLIONS)

Figure 2 GLOBAL MARKET FOR SNP IDENTIFICATION TOOLS, 2001-2009 ($ MILLIONS)

OVERVIEW OF SNP IDENTIFICATION

STRATEGIES FOR SNP IDENTIFICATION

CANDIDATE GENE SELECTION

WHOLE GENOME LINKAGE DISEQUILIBRIUM MAPPING

Table 12 EMERGING TECHNOLOGIES IN WHOLE GENOME MAPPING

COMBINATION STRATEGIES

SNP DATABASES

Table 13 MAJOR PRIVATE SNP DATABASES

COMPUTATIONAL TOOLS FOR SNP IDENTIFICATION

SNPBROWSER, APPLIED BIOSYSTEMS

CHROMOSOMEBROWSER™, ORCHID BIOSCIENCES

REALSNP, SEQUENOM

SNP KNOWLEDGE RESOURCE, ILLUMINA

CELERA DISCOVERY SYSTEM™, CELERA

GENOTYPING MARKET

OVERALL MARKET FOR GENOTYPING TECHNOLOGIES

Table 14 GLOBAL MARKET FOR GENOTYPING TECHNOLOGIES BY PROTOCOL, THROUGH 2009 ($ MILLIONS)

Figure 3 GLOBAL MARKET FOR GENOTYPING TECHNOLOGIES BY PROTOCOL, 2001-2009 ($ MILLIONS)

GENOTYPING TECHNOLOGY OVERVIEW

ALLELIC DISCRIMINATION BY DNA POLYMERASES

Table 15 COMPARATIVE ADVANATAGES OF ALLELIC DISCRIMINATION METHODS

SINGLE-BASE EXTENSION

ALLELE-SPECIFIC EXTENSION

PYROSEQUENCING

STRUCTURE-SPECIFIC CLEAVAGE

TAQMAN ASSAY

Table 16 GLOBAL MARKET FOR ALLELE DISCRIMINATION TECHNOLOGIES BY TYPE, THROUGH 2009 ($ MILLIONS)

Figure 4 GLOBAL MARKET FOR ALLELE DISCRIMINATION TECHNOLOGIES BY TYPE, 2001-2009 ($ MILLIONS)

ALLELIC DISCRIMINATION BY HYBRIDIZATION

MICROARRAYS FOR GENOTYPING

Table 17 TOTAL GLOBAL MICROARRAY MARKET AND THAT FOR GENOTYPING APPLICATIONS, THROUGH 2009 ($ MILLIONS)

EMERGING TECHNOLOGY FOR ALLELIC DISCRIMINATION BY DNA LIGASES

DETECTION OF ALLELE-SPECIFIC PRODUCTS

Table 18 COMPARATIVE ADVANATAGES OF DETECTION METHODS

MASS SPECTROMETRY

Table 19 STRENGTHS AND WEAKENESSES OF MASS SPECTROMETRY FOR GENOTYPING

New Developments in Mass Spectrometry for DNA Analysis

Table 20 EMERGING TECHNOLOGIES IN DNA MASS SPECTROMETRY

FLUORESCENCE RESONANCE ENERGY TRANSFER

FLUORESCENCE POLARIZATION

LENGTH-BASED DETECTION SYSTEMS

Table 21 GLOBAL MARKET FOR GENOTYPING DETECTION TECHNOLOGIES BY TYPE, THROUGH 2009 ($ MILLIONS)

Figure 5 GLOBAL MARKET FOR GENOTYPING DETECTION TECHNOLOGIES BY TYPE, 2001-2009 ($ MILLIONS)

Length-based Detection Systems (continued)

COMPARISON OF COST AND THROUGHPUT

Table 22 COMPARISON OF GENOTYPING PLATFORMS COST AND THROUGHPUT

PHARMACOGENOMICS DIAGNOSTICS MARKET

OVERALL MARKET FOR PHARAMCOGENOMICS DIAGNOSTICS

Table 23 GLOBAL MARKET FOR PHARMACOGENOMICS DIAGNOSTIC TOOLS BY TYPE, THROUGH 2009 ($ MILLIONS)

Figure 6 GLOBAL MARKET FOR PHARMACOGENOMICS DIAGNOSTIC TOOLS BY TYPE, 2001-2009 ($ MILLIONS)

MICROARRAYS

TECHNOLOGY OVERVIEW

PLANAR DNA MICROARRAYS

Table 24 MAJOR SUPPLIERS OF PLANAR DNA MICROARRAYS

Table 24 (CONTINUED)

ELECTRONIC MICROARRAYS

Nanochip (Nanogen, San Diego)

BEAD MICROARRAYS

EMERGING TECHNOLOGY: NANOPARTICLE ARRAYS

Verigene (Nanosphere, Chicago, IL)

Nanoplex Technologies (Mountain View, CA)

Table 25 MAJOR SUPPLIERS OF BEAD MICROARRAYS

MARKET FOR MICROARRAYS IN PHARMACOGENOMICS

MARKET FOR MICROARRAYS IN PHARMACOGENOMICS

Table 26 GLOBAL MARKET FOR MICROARRAYS IN PHARMACOGENOMICS BY TYPE, THROUGH 2009 (MILLIONS $)

Figure 7 GLOBAL MARKET FOR MICROARRAYS IN PHARMACOGENOMICS BY TYPE, 2001-2009 (MILLIONS $)

PCR-BASED ASSAYS

Table 27 MAJOR SUPPLIERS OF PCR-BASED ASSAYS

PCR-BASED TECHNOLOGIES

LightCycler (Roche Molecular Systems, Pleasanton, CA)

TaqMan DNA probes (Applied Biosystems, Foster City, CA)

Invader (Third Wave Technologies, Madison, WI)

Tag-It Mutation Assay (Tm Bioscience)

Table 28 GLOBAL MARKET FOR PCR ASSAYS IN PHARMACOGENOMICS RESEARCH BY TYPE, THROUGH 2009 ($ MILLIONS)

Figure 8 GLOBAL MARKET FOR PCR ASSAYS IN PHARMACOGENOMICS RESEARCH BY TYPE, 2001-2009 ($ MILLIONS)

IN SITU ANALYSIS

TECHNOLOGY

HER2 FISH TESTING

COMPARISON WITH IHC

Table 29 COMPARISON OF FISH AND IHC TESTING FOR HER2

Table 30 GLOBAL MARKET FOR IN SITU ASSAYS IN PHARMACOGENOMICS OF BREAST CANCER, THROUGH 2009 ($ MILLIONS)

PHARMACOGENOMIC THERAPEUTICS BY DISEASE

CARDIOVASCULAR DISEASE

HEART FAILURE

Angiotensin I-Converting Enzyme (ACE)

BiDil

Projected Market for BiDil

Table 31 PROJECTED BIDIL® MARKET, THROUGH 2009 ($ MILLIONS)

HYPERCHOLESTROLEMIA

Table 32 MAJOR PRODUCERS OF STATINS

Mechanism of Statins

Individual Variation Affects Statin Efficacy

STRENGTH Clinical Study of Statins

BREAST CANCER

BREAST CANCER AND HER2

Regulatory Guidelines

Emerging Herceptin Combination Market

Table 33 GLOBAL MARKET FOR HERCEPTIN, BY REGION, THROUGH 2009 ($ MILLIONS)

LEUKEMIA

CHRONIC MYELOID LEUKEMIA (CML)

Genetic Marker of CML

Gleevec

Table 34 GLOBAL MARKET FOR GLEEVEC/GLIVEC, BY REGION, THROUGH 2009 ($ MILLIONS)

ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)

ACUTE MYELOID LEUKEMIA (AML)

LUNG CANCER

NON-SMALL CELL LUNG CANCER

Clinical Studies on Iressa

Fast Track Approval in the US

Fast Track Approval in Japan

Post-Market Studies of Iressa

Table 35 GLOBAL SALES OF IRESSA PRIOR TO FDA ANNOUNCEMENT, 2002-2004 ($ MILLIONS)

ASTHMA

GENETIC VARIANTS AFFECTING ASTHMA THERAPY

Table 36 GENES OF INTEREST IN THE PHARMACOGENOMICS OF ASTHMA

MAJOR PLAYERS AND DEVELOPMENTS

Table 37 MAJOR PLAYERS IN PHARMACOGENOMICS OF ASTHMA TREATMENT

Table 38 GLOBAL MARKET FOR ASTHMA THERAPIES, BY TYPE, THROUGH 2009 ($ MILLIONS)

PHARMACOGENOMICS OF HIV/AIDS

VIRAL RESISTANCE

GENETIC RESISTANCE TESTING

Table 39 MAJOR SUPPLIERS OF HIV GENOTYPIC RESISTANCE TESTS

Table 40 GLOBAL MARKET FOR HIV RESISTANCE TESTING BY REGION, THROUGH 2009 ($ MILLIONS)

Education Gap

ABACAVIR, A PHARMACOGENOMICS SUCCESS STORY

Table 41 GLOBAL MARKET FOR ABACAVIR, BY REGION, THROUGH 2009 ($ MILLIONS)

Figure 9 GLOBAL MARKET FOR ABACAVIR, BY REGION, 2000-2009 ($ MILLIONS)

Abacavir, a Pharmacogenomics Success Story (continued)

PHARMACOGENOMICS OF DRUG METABOLISM

DRUG METABOLISM BY CYTOCHROMES

P450 ISOZYMES AND PHARMACEUTICALS

Table 42 MAJOR CYTOCHROME P450 ISOZYMES

P450 Isozyme CYP3A

P450 Isozyme CYP2D6

P450 Isozyme CYP2C9

P450 Isozyme 2C19

P450 Isozyme 1A2

P450 DIAGNOSTIC TESTING

Table 43 GLOBAL MARKET FOR AMPLICHIP ARRAYS IN DIAGNOSTIC USE BY REGION, THROUGH 2009 ($ MILLIONS)

P450 TESTING FOR RESEARCH PURPOSES

Table 44 MAJOR SUPPLIERS OF CYTOCHROME P450 TESTING FOR RESEARCH PURPOSES

COMPETITION WITH PHENOTYPIC ASSAYS

TECHNOLOGY

PATENTS AND COMMERCIALIZATION ISSUES

PATENT ANALYSIS

PATENT SHARE BY APPLICATION TYPE

Table 45 PHARAMCOGENOMICS PATENTS BY TECHNOLOGY, 2004

Table 46 PHARAMCOGENOMICS PATENTS BY DISEASE TARGET, 2004

PATENT SHARE BY REGION

Table 47 PHARMACOGENOMICS PATENTS BY REGION, 2004

Table 48 PHARMACOGENOMICS PATENTS BY ASSIGNEE, JANUARY 2004- JANUARY 2005

INDUSTRY STRUCTURE

DRUG MARKET SEGMENTATION

MAJOR PHARMACOGENOMICS COMPANIES

Table 49 MAJOR PHARMACOGENOMICS COMPANIES ANNUAL SALES AND MARKET SHARES, 2004 ($ MILLIONS)

Table 49 (CONTINUED)

Figure 10 MAJOR PHARMACOGENOMICS COMPANIES ANNUAL SALES AND MARKET SHARES, 2004 (%)

COLLABORATIONS

Table 50 KEY COLLABORATIONS IN THE PHARMACOGENOMICS INDUSTRY

MYRIAD/ABBOTT

CURAGEN/PFIZER

DECODE/MERCK

DECODE/ROCHE

MILLENIUM/BAYER

ORCHID BIOSCIENCES/U.K. GOVERNMENT

LYNX/INSTITUTE FOR SYSTEMS BIOLOGY

NOVARTIS/CELERA

THIRD WAVE/RIKEN

IMPACT OF RELATED INDUSTRIES

NANOTECHNOLOGY

BIOINFORMATICS

ANALYSIS OF SUCCESSFUL COMPANIES

NOVARTIS - GLEEVEC/GLIVEC

Disease Target

Rapid Movement Through Trials

Orphan Drug Approval

Strong Brand Recognition

Continued Studies Identify New Target Populations

AFFYMETRIX, SANTA CLARA, CA

Marketing

Technical Support

Strategic Positioning

First Mover Status Maintained

Intellectual Property

INTERNATIONAL ASPECTS

UNITED STATES

CENTRALIZED PHARMGKB DATABASE

FUNDING INITIATIVES

EUROPEAN UNION

NEW DRUG APPROVALS AND INNOVATION

R&D SPENDING IN THE EUROPEAN UNION

SOCIAL FACTORS

REGULATORY ENVIRONMENT

CHEAPER CLINICAL TRIALS

MIGRATION TO THE U.S.

JAPAN

NEW DRUG APPROVALS AND INNOVATION

REGULATORY ENVIRONMENT

LIMITED ACADEMIC-INDUSTRY COLLABORATION

VENTURE CAPITAL

OTHER GEOGRAPHIC AREAS

INTELLECTUAL PROPERTY

Intellectual Property (continued)

ETHICAL CONSIDERATIONS

GENETIC EXCEPTIONALISM

PRIVACY

DEVELOPING NATIONS

DISCRIMINATION

GENES AND ENVIRONMENT

IMPLICATIONS FOR THE FUTURE OF HEALTH CARE

EDUCATED DECISION-MAKING

RESPONSIBILITY FOR FAILURES

OVER-THE-COUNTER TESTS

DEFINITION OF ORPHAN DRUGS

DEFINITION OF ORPHAN DRUGS (CONTINUED)

COMPANY PROFILES

ABBOTT LABORATORIES, ABBOTT PARK, IL

AMERSHAM (NOW GE HEALTHCARE), BUCKINGHAMSHIRE, UK

APPLERA CORPORATION, NORWALK, CT

ASTRAZENECA, ALDERLEY PARK, UK

CURAGEN CORPORATION, NEW HAVEN, CT

DAKOCYTOMATION, COPENHAGEN, DENMARK

DECODE GENETICS, REYKJAVIK, ICELAND

DXS, MANCHESTER, UK

ERAGEN, MASDISON, WI

FIVEPRIME THERAPEUTICS, SAN FRANCISCO, CA

GENAISSANCE PHARMACEUTICALS, NEW HAVEN, CT

GENENTECH, SOUTH SAN FRANCISCO, CA

GENTRIS, MORRISVILLE, NC

GLAXOSMITHKLINE, BRENTFORD, UK

HUMAN GENOME SCIENCES, ROCKVILLE, MD

ILLUMINA, SAN DIEGO, CA

INCYTE, PALO ALTO, CA

INTERLEUKIN GENETICS, WALTHAM, MA

LUMINEX CORP., AUSTIN, TX

MERCK, WHITEHOUSE STATION, NJ

MILLENIUM PHARMACEUTICALS, CAMBRIDGE, MA

MYRIAD GENETICS, INC., SALT LAKE CITY, UT

NANOGEN, SAN DIEGO, CA

NANOSPHERE, NORTHBROOK, IL

NITROMED, LEXINGTON, MA

ORCHID BIOSCIENCES, PRINCETON, NJ

PHARMASEQ, MONMOUTH JUNCTION, NJ

ROCHE (F. HOFFMANN-LA ROCHE LTD), BASEL, SWITZERLAND

SEQUENOM, SAN DIEGO, CA

THIRD WAVE, MADISON, WI

TM BIOSCIENCE CORP., TORONTO, ON, CANADA

WYETH, MADISON, NJ

LIST OF TABLES

Summary Table:

WORLDWIDE PHARMACOGENOMICS MARKET BY TECHNOLOGY SEGMENTS, THROUGH 2009 ($ MILLIONS)

Table 1 DRUG DEVELOPMENT AND FDA APPROVAL PROCESS

Table 2 NME APPROVALS GRANTED BY FDA (UNITED STATES), 1995-2004

Table 3 TOTAL SPENDING ON R&D BY PHRMA COMPANIES, 1999-2003 ($ BILLIONS)

Table 4 R&D SPENDING ON CLINICAL DEVELOPMENT BY PHRMA COMPANIES, BY DRUG DEVELOPMENT PHASE, 2002 ($ BILLIONS)

Table 5 DRUG INEFFICACY, BY THERAPY TYPE (PERCENTAGE OF PATIENTS FAILING TO RESPOND TO THERAPY)

Table 6 ADVERSE DRUG REACTIONS IN THE UNITED STATES

Table 7 PROMINENT DRUGS WITHDRAWALS

Table 8 SNP CONSORTIUM MEMBERS

Table 9 HAPMAP PARTICIPANTS AND FUNDING SOURCES

Table 10 STRUCTURE OF THE INTERNATIONAL HAPMAP PROJECT

Table 11 GLOBAL MARKET FOR SNP IDENTIFICATION TOOLS, THROUGH 2009 ($ MILLIONS)

Table 12 EMERGING TECHNOLOGIES IN WHOLE GENOME MAPPING

Table 13 MAJOR PRIVATE SNP DATABASES

Table 14 GLOBAL MARKET FOR GENOTYPING TECHNOLOGIES BY PROTOCOL, THROUGH 2009 ($ MILLIONS)

Table 15 COMPARATIVE ADVANATAGES OF ALLELIC DISCRIMINATION METHODS

Table 16 GLOBAL MARKET FOR ALLELE DISCRIMINATION TECHNOLOGIES BY TYPE, THROUGH 2009 ($ MILLIONS)

Table 17 TOTAL GLOBAL MICROARRAY MARKET AND THAT FOR GENOTYPING APPLICATIONS, THROUGH 2009 ($ MILLIONS)

Table 18 COMPARATIVE ADVANATAGES OF DETECTION METHODS

Table 19 STRENGTHS AND WEAKENESSES OF MASS SPECTROMETRY FOR GENOTYPING

Table 20 EMERGING TECHNOLOGIES IN DNA MASS SPECTROMETRY

Table 21 GLOBAL MARKET FOR GENOTYPING DETECTION TECHNOLOGIES BY TYPE, THROUGH 2009 ($ MILLIONS)

Table 22 COMPARISON OF GENOTYPING PLATFORMS COST AND THROUGHPUT

Table 23 GLOBAL MARKET FOR PHARMACOGENOMICS DIAGNOSTIC TOOLS BY TYPE, THROUGH 2009 ($ MILLIONS)

Table 24 MAJOR SUPPLIERS OF PLANAR DNA MICROARRAYS

Table 25 MAJOR SUPPLIERS OF BEAD MICROARRAYS

Table 26 GLOBAL MARKET FOR MICROARRAYS IN PHARMACOGENOMICS BY TYPE, THROUGH 2009 (MILLIONS $)

Table 27 MAJOR SUPPLIERS OF PCR-BASED ASSAYS

Table 28 GLOBAL MARKET FOR PCR ASSAYS IN PHARMACOGENOMICS RESEARCH BY TYPE, THROUGH 2009 ($ MILLIONS)

Table 29 COMPARISON OF FISH AND IHC TESTING FOR HER2

Table 30 GLOBAL MARKET FOR IN SITU ASSAYS IN PHARMACOGENOMICS OF BREAST CANCER, THROUGH 2009 ($ MILLIONS)

Table 31 PROJECTED BIDIL® MARKET, THROUGH 2009 ($ MILLIONS)

Table 32 MAJOR PRODUCERS OF STATINS

Table 33 GLOBAL MARKET FOR HERCEPTIN, BY REGION, THROUGH 2009 ($ MILLIONS)

Table 34 GLOBAL MARKET FOR GLEEVEC/GLIVEC, BY REGION, THROUGH 2009 ($ MILLIONS)

Table 35 GLOBAL SALES OF IRESSA PRIOR TO FDA ANNOUNCEMENT, 2002-2004 ($ MILLIONS)

Table 36 GENES OF INTEREST IN THE PHARMACOGENOMICS OF ASTHMA

Table 37 MAJOR PLAYERS IN PHARMACOGENOMICS OF ASTHMA TREATMENT

Table 38 GLOBAL MARKET FOR ASTHMA THERAPIES, BY TYPE, THROUGH 2009 ($ MILLIONS)

Table 39 MAJOR SUPPLIERS OF HIV GENOTYPIC RESISTANCE TESTS

Table 40 GLOBAL MARKET FOR HIV RESISTANCE TESTING BY REGION, THROUGH 2009 ($ MILLIONS)

Table 41 GLOBAL MARKET FOR ABACAVIR, BY REGION, THROUGH 2009 ($ MILLIONS)

Table 42 MAJOR CYTOCHROME P450 ISOZYMES

Table 43 GLOBAL MARKET FOR AMPLICHIP ARRAYS IN DIAGNOSTIC USE BY REGION, THROUGH 2009 ($ MILLIONS)

Table 44 MAJOR SUPPLIERS OF CYTOCHROME P450 TESTING FOR RESEARCH PURPOSES

Table 45 PHARAMCOGENOMICS PATENTS BY TECHNOLOGY, 2004

Table 46 PHARAMCOGENOMICS PATENTS BY DISEASE TARGET, 2004

Table 47 PHARMACOGENOMICS PATENTS BY REGION, 2004

Table 48 PHARMACOGENOMICS PATENTS BY ASSIGNEE, JANUARY 2004- JANUARY 2005

Table 49 MAJOR PHARMACOGENOMICS COMPANIES ANNUAL SALES AND MARKET SHARES, 2004 ($ MILLIONS)

Table 50 KEY COLLABORATIONS IN THE PHARMACOGENOMICS INDUSTRY

LIST OF FIGURES

Summary Figure:

WORLDWIDE PHARMACOGENOMICS MARKET BY TECHNOLOGY SEGMENTS, 2001-2009 ($ MILLIONS)

Figure 1 R&D SPENDING ON CLINICAL DEVELOPMENT BY PHRMA COMPANIES, BY DRUG DEVELOPMENT PHASE, 2002 ($ BILLIONS)

Figure 2 GLOBAL MARKET FOR SNP IDENTIFICATION TOOLS, 2001-2009 ($ MILLIONS)

Figure 3 GLOBAL MARKET FOR GENOTYPING TECHNOLOGIES BY PROTOCOL, 2001-2009 ($ MILLIONS)

Figure 4 GLOBAL MARKET FOR ALLELE DISCRIMINATION TECHNOLOGIES BY TYPE, 2001-2009 ($ MILLIONS)

Figure 5 GLOBAL MARKET FOR GENOTYPING DETECTION TECHNOLOGIES BY TYPE, 2001-2009 ($ MILLIONS)

Figure 6 GLOBAL MARKET FOR PHARMACOGENOMICS DIAGNOSTIC TOOLS BY TYPE, 2001-2009 ($ MILLIONS)

Figure 7 GLOBAL MARKET FOR MICROARRAYS IN PHARMACOGENOMICS BY TYPE, 2001-2009 (MILLIONS $)

Figure 8 GLOBAL MARKET FOR PCR ASSAYS IN PHARMACOGENOMICS RESEARCH BY TYPE, 2001-2009 ($ MILLIONS)

Figure 9 GLOBAL MARKET FOR ABACAVIR, BY REGION, 2000-2009 ($ MILLIONS)

Figure 10 MAJOR PHARMACOGENOMICS COMPANIES ANNUAL SALES AND MARKET SHARES, 2004 (%)

Abstract

INTRODUCTION

Pharmacogenomics and pharmacogenetics will have a major impact on the future of health care. Pharmacogenetics is the study of the genetic basis for individuals’ variable drug responses, and is being applied with increasing

frequency at the clinical level. These efforts rely on pharmacogenomics, the genome-wide analysis of the genetic determinants of drug efficacy and toxicity. The cornerstone is the ability to identify genetic variations (polymorphisms) that alter an individual’s response to a drug.

This BCC report presents a comprehensive analysis of the current market for pharmacogenomics and its future direction. Currently, the field remains immature. This leaves enormous room for growth. This growth potential over a five-year period to 2009 is assessed. Of particular interest are the markets for SNP identification, genotyping and diagnostics.

Also of interest is the market for specific drugs developed through the use of pharmacogenomics. Only a handful of such therapeutics have entered clinical use as of 2005. In each case, there is an examination of the drug development process, major challenges and achievements and where applicable, the projected market for each of these drugs through 2009.

SCOPE OF STUDY

The report contains:

  • Detailed descriptions and analyses of the SNP identification process, genotyping technologies and pharmacogenomics-related diagnostic tools
  • Determinations of the major players and current market status
  • Analysis of how pharmacogenomics is translating into new medical therapies for specific disease targets
  • Growth forecasts through 2009
  • Emphasis on scientific challenges and advances, including the latest trends
  • Examination of government regulations, major collaborations and recent patents.

METHODOLOGY

The market assessments provided have been assembled based on publicly available information from January 2001 up to and including January 2005. The base year for this report is 2004 and forecast data are provided through 2009. In cases where year-end data for 2004 were not available, figures were extrapolated from 2003 statistics and historical trends between 2001 and 2003. Market figures are based on current dollars and inflation is not computed into the projection figures. Interviews were also used to adjust market size estimates, as well as to formulate market projections.


The pharmacogenomics field is still immature and the reader is cautioned to use the report data as a guide to assess trends, developments and challenges that the industry faces. The report seeks to use the quantitative data to explore the potential of a variety of technologies and therapeutic applications.

INFORMATION SOURCES

The information contained in this report has been assembled from primary and secondary data. Primary research was conducted via telephone interviews with selected industry professionals, research scientists, and laboratory heads to discover the most recent developments in their fields of interest. Secondary data was collected via a comprehensive search of the scientific, peer-reviewed literature, industry trade media, company websites, annual reports and industry press releases.



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