The Comprehensive Report

Transcription

1 High-Throughput Screening 2002: New Strategies and Technologies The Comprehensive Report Presented by HighTech Business Decisions 346 Rheem Blvd., Suite 208, Moraga, CA Tel: (925) Fax: (925) May 2002

2 FORWARD AND ACKNOWLEDGMENTS HighTech Business Decisions conducted the market research and wrote the report, High-Throughput Screening 2002: New Strategies and Technologies to provide a comprehensive market analysis of the high-throughput screening (HTS) market worldwide. The research was specifically designed to understand HTS users perceptions, motivations, current practices, and future plans as regards targets, target types, assays, assay development, detection modes, microplate formats, outsourcing and other issues impacting current HTS operations. The complete analysis, based on both user and supplier primary research, includes market size and growth, major players, user strategies and requirements, trends and technologies, and users future plans. In-depth data collected from both users and suppliers allowed for an objective and thorough analysis. We thank the 96 respondents from pharmaceutical, biotechnology, and supplier companies who took the time to share their insights, opinions, and future plans with us. We thank our sponsoring companies, who supported this project with their ideas, suggested topics, and funding for the first few months of this four-month project. The sponsoring companies are, in alphabetical order, as follows: Amersham Biosciences, Ltd. Beckman Coulter, Inc. Corning Life Sciences EVOTEC OAI AG Invitogen Corp. Molecular Devices Corp. PanVera Corp. PerkinElmer Life Sciences, Inc. Pierce Chemical Company Quantum Dot Corp. Tecan Group The following HighTech Business Decisions analysts and staff made important contributions to this research and report: Analysts Sandra J. Fox, MBA Shauna Farr-Jones, Ph.D. Lynne Sopchak, Ph.D. Helen S. L. Wang, Ph.D. Richard G. Khoury, Ph.D. Staff Andrew Tae Chey Ellen Manning Project management, analysis, and report Supplier interviews, ADME/Tox interviews, target validation interviews, analysis, and report User interviews User interviews Supplier interviews Interview appointments, edits, production Editor We hope that our clients obtain significant value from this report to help ensure the success of their future business. Sandra J. Fox, MBA President

3 May 2002 This report is Copyright protected by HighTech Business Decisions. All rights reserved. Printed and bound in the United States of America. Neither this report, nor parts of it, may be reproduced without written permission from HighTech Business Decisions. HighTech Business Decisions has exercised due care in compiling this report, which is based on publicly available information as well as information submitted by individual companies. The company interview write-ups and profiles contained in this report are not intended to be a complete description of each company, but a paraphrased synopsis of interviews conducted with these companies in February and March of 2002, combined with submitted material. The publishers have taken due care to ensure the accuracy of this information, but shall not be held liable for any consequential damages arising from the material in this report. Copies of this report may be ordered from HighTech Business Decisions. To place an order, please call HighTech Business Decisions at (925)

4 TABLE OF CONTENTS Chapter 1: EXECUTIVE SUMMARY 1.1 Introduction Overall Market Evaluation HTS Market Overview HTS Products and Services Enabling Technologies The HTS Market Size HTS Market Growth Summary of Users Requirements Microplates Targets Compounds Use of Assays and Assay Detection Problems and Opportunities Summary of Suppliers Capabilities Suppliers Observations on Changes Marketing Suppliers Observations on Trends 1-18 Chapter 2: METHODOLOGY, DEFINITIONS, AND ACRONYMS 2.1 Research Objectives Research Methodology Definitions Acronyms 2-4 Chapter 3: HIGH-THROUGHPUT SCREENING: MARKET OVERVIEW 3.1 Characteristics of the HTS Market The Success of HTS HTS Products and Services Market Drivers and Enablers Supplier Acquisitions Determination of Market Size Investment in Drug Discovery Pharmaceutical Sales and R & D Spending Breakout of the R & D Budget Estimate of the Number of HTS Laboratories Worldwide HTS Market Estimate Based on Individual HTS Spending HTS Market Estimate Based on Suppliers Revenues Market Size for HTS Products and Services in Size of the Market by Region 3-17

5 TABLE OF CONTENTS (continued) Chapter 3: 3.3 Market Growth HTS Market Growth Estimates Opportunities in the HTS Marketplace Customer Requirements Areas of Opportunity for Suppliers 3-22 Chapter 4: ANALYSIS OF HTS LABORATORY OPERATIONS 4.1 Participating Pharmaceutical and Biotechnology Companies Locations Number of HTS Employees in HTS Laboratories Number of Years as an HTS Laboratory Titles of Survey Respondents Organization: HTS Within the Company Number of HTS Laboratories HTS Functions Secondary Screening Definitions Definitions of Hits Summary of Typical HTS Screening Activities Procedures for Dealing with Hits Integration of HTS Within the Company Sharing Data Amongst Groups and Sites Changes Expected Within the HTS Laboratories HTS Directors Overall Goals New Role of HTS in In Vitro ADME/Tox Studies Overview of In vitro ADME/Tox Goals and Strategies When In Vitro ADME/Tox Studies are Conducted The Value of Profiling Entire Compound Libraries The Expanding Role of HTS in ADME/Tox Screening Reagents Used in ADME/Tox Studies Throughput for ADME/Tox Types of Assays for ADME/Tox Detection Methods Used for ADME/Tox Assays Formats Used for In Vitro ADME/Tox Screens Respondents Observations on Trends in ADME/Tox Targets Target Identification Target Validation Number of Targets How Targets are Determined How the Number of Targets Screened is Determined Target Types Difficult Target Types 4-66

6 TABLE OF CONTENTS (continued) Chapter 4: 4.5 Throughput and Compounds Current and Future Throughput for Primary Screening Variability in Throughput Throughput for Secondary Screening Number of Compounds Tested Per Screen Pooling of Compounds Use of In Silico Tools or Virtual Screening Tools Data Management Tools for HTS Data Management Tools in Use Types of Informatics Tools Needed HTS Assays Current and Future Use of Assay Types: Primary Current and Future Use of Assay Types: Secondary Types of Detection Modes Used with Certain Assay Types Assays Used in Natural Compound Research Current and Future Use of High-Information Screening Improvements Needed for Biochemical Assays Improvements Needed for Cell-Based Assays New Assay Technologies Expected to Be Used Cell-Based Assays Current and Future Use of Cell-Based Assays Types of Cells Used Volumes of Cells Used Source of Cells Used Cell-Based Assay Reagents Assay Development Most Suitable for Targets Current Assay Development Times Acceptable Upper Range of Cost Per Data Point How Proteins for Assays are Obtained Hurdles in Assay Development New Products or Services Needed for Assay Development Detection Modes Current and Future Detection for Primary Screening Strategies Driving Detection Mode Changes Current and Future Detection for Secondary Screening New Equipment Purchases Planned Suppliers of Dyes and Labels Used Current and Future Use of Imaging Technologies Opinions on Label-Free Detection Modes 4-154

7 TABLE OF CONTENTS (continued) Chapter 4: 4.11 Microplates and Other Screening Formats Current and Future Formats Used for Primary Screens Suppliers of Microplates and Other Formats Current and Future Formats for Secondary Screening Best Formats for Biochemical vs. Cell-Based Assays Current and Future Use of Surface Chemistries Processes Used for 1536-Well Microplates Miniaturization Strategies Improvements Needed for Microplates or Other Formats Outsourcing Current and Future Outsourced Services Outsourcing Decision Factors Budgets Average Expenditures at HTS Laboratories Factors Affecting Budget Size Success of HTS in Drug Discovery Leads Generated by HTS in Drug Candidates from HTS Opinions on the Success of HTS Promising New Technologies for HTS HTS Bottlenecks and How Suppliers Can Help Opinions on Promising New Technologies Chapter 5: ANALYSIS OF COMPANIES SUPPLYING HTS PRODUCTS AND SERVICES 5.1 Supplier Company Respondents Suppliers Participating in this Survey Products and Services Company Backgrounds, Company Size, and Growth Organizational Changes at HTS Supplier Companies Organizational Changes at Respondent Companies Drug Discovery Operations Suppliers Observations Customers Organizational Changes How Genomics and Proteomics Will Impact HTS The Most Significant Challenges Facing HTS Customers Top Technology Changes Occurring in HTS Laboratories Use of 1536-Well Microplates 5-23

8 TABLE OF CONTENTS (continued) Chapter 5: 5.4 Sales and Marketing Percentage of Revenues for Marketing and Sales Ways of Attracting New Customers E-Commerce Programs Trade Shows Working With Customer Companies Suppliers Estimates of the Total Number of HTS Labs The Number of HTS Customer Laboratories Per Supplier Regional Sales Changes in the Customer-Supplier Relationship Percent of Business from Customer Collaborations Suppliers Collaborations Royalties from Customer Collaborations New Technologies and Trends New Technologies for HTS Major Trends in HTS 5-47 Appendix A: Write-Ups of Interviews with 51 HTS Directors, 4 ADME/Tox Directors, and 3 Target Validation Directors Worldwide Appendix B: Listing of HTS Suppliers Appendix C: Interview Guide for Pharmaceutical and Biotechnology Company Respondents Appendix D: Interview Guide for Supplier Company Respondents

9 Chapter 1 LIST OF TABLES Worldwide Drug Discovery Screening Expenditures in Target Types by Percentage Use Current and Expected Number of Compounds Tested Per Screen Average Percentage of Detection Modes Used Current Bottlenecks in HTS Number of Employees, Years in Business, Revenues from HTS Primary Changes at Customer Organizations as Noted by Suppliers The Most-Often Mentioned Ways to Attract New Customers Suppliers Responses to the Top Three Trade Shows for HTS 1-18 Chapter Market Research Steps List of Acronyms 2-4 Chapter Summary of Parent Companies and Subsidiaries in the HTS Market Drug Development Statistics Worldwide Drug Discovery Screening Expenditures in Number of HTS Laboratories Represented by Respondents Estimate of the Total Number of HTS Laboratories Worldwide: By Site Estimate of the Total Number of HTS Laboratories Worldwide: By Type Average Spending Per HTS Lab : High-Throughput Labs Average Spending Per HTS Lab : Medium-Throughput Labs HTS Market Size Based on Average User Spending in Estimated Market Size from Average Supplier Revenues in Regional Markets Worldwide Market Forecast: The HTS Market in 2001, 2002, Chapter Pharmaceutical and Biotechnology Company Respondents Number of Employees in HTS Laboratories Number of HTS Laboratories Per Company HTS Laboratories Screening Secondary or In Vitro ADME/Tox Definitions of Secondary Screening Changes Expected at HTS Laboratories Respondents Opinions on the Profiling of Entire Compound Libraries Reagents Used in In Vitro ADME/Tox Studies Sources of Reagents Used in In Vitro ADME/Tox by Percentage Current and Predicted Throughput for ADME/Tox Screening Assays Used in In Vitro ADME/Tox Studies by Respondents Formats Used for In Vitro ADME/Tox Screens 4-46

10 Chapter 4 LIST OF TABLES (continued) Number of Molecular Targets Screened Per Year by Respondents Number of Molecular Targets Screened by Throughput-Groups How the Number of Targets Screened Per Year is Determined Target Types by Percentage Use Current and Expected Throughput, High-Throughput Group Current and Expected Throughput, Medium-Throughput Group Current and Expected Secondary Screening Throughput Current and Expected Number of Compounds Tested Per Screen Percentage of Screens With Pooled Compounds Top Priorities for New Informatics Assay Types as a Percentage of All HTS Assays Number of Respondents Using Each Assay Type in Detection Modes Used with Each Assay Type Improvements Needed for Biochemical Assays Improvements Needed for Cell-Based Assays Summary of New Technologies HTS Directors are Using or Will Use Types of Cells Used in Cell-Based Assays Source of Reagents Used in Cell-Based Screening Time Required from Target Identification to Screen Implementation Highest Amount HTS Directors are Willing to Pay Per Data Point: US$ Consistent Hurdles in Assay Development Suggestions for Suppliers of Assay Development Products & Services Average Percentage of Detection Modes Used in Primary Screening Most Popular Detection Modes: All Groups 2001 and Number of Respondents Using FP and FI Detection Modes Average Percentage of Detection Modes Used in Primary Screening Most Popular Detection Modes: High-Throughput Group Most Popular Detection Modes: Medium-Throughput Group Drivers of Detection Mode Changes Percentage of Detection Modes Used in Secondary Screening Detection Modes, Number of Targets, Percentages and Purchases Dyes and Labels Used by Respondents Imaging Equipment HTS Directors are Using or Planning to Purchase Ideal Format for Label-Free Detection in HTS Willingness to Switch all Screening to Label-Free Detection Use of Microplates and Other Formats in Primary Screening Percentage Use of Microplates and Other Formats by Throughput Group Numbers of HTS Laboratories Using Specific Density Formats Suppliers of Microplates and Other Formats Named by Respondents Percentage Use of Microplates and Other Formats in Secondary Screening Percentage of Respondents Naming a Best Format for Assays Microplate Surface Chemistries Used By Respondents Suggested Improvements for Microplates Average Percentage of Workload Outsourced Service Suppliers Used by Respondents Top HTS Service Suppliers Based on 39 Respondents Opinions Top Assay Development Suppliers Based on 28 Respondents Opinions Outsourcing Decision Factors 4-182

11 Chapter 4 LIST OF TABLES (continued) Average Total 2001 HTS Budgets Average Budget Expenditures Per HTS Laboratory by Product Category Total Expenditures by Category Median Expected Growth Rates in Expenditures by Product Category Median Budget Expenditures by Service Category Factors Affecting Budget Size Percentage of Targets that Have Generated Leads in Number of Leads Generated by HTS Laboratories in Drug Candidates from HTS HTS Directors Opinions on the Success of HTS Current Bottlenecks in HTS Current Bottlenecks in Drug Discovery Overall Opportunities for Suppliers The Most Promising Drug Discovery Technologies Chapter HTS Product and Service Supplier Respondents Summary of Parent Companies and Subsidiaries Summary of HTS Products and Services Offered by HTS Suppliers Number of Employees, Years in Business, Revenues from HTS Revenue Growth for HTS Products and Services, 2000 to Suppliers Expectations: High-Growth Areas for the HTS Market Organizational Changes at Supplier Companies Primary Changes at Customer Organizations as Noted by Suppliers Impact of Genomics and Proteomics Information on HTS Challenges Facing HTS Customers as Observed by Suppliers Top Technology Changes at HTS Laboratories as Observed by Suppliers The Most Often Mentioned Ways to Attract New Customers Suppliers Responses to the Top Three Trade Shows for HTS Regional Sales Percentages Samples of Publicly Announced Collaborations and/or Customers Opinions on Breakthrough Technologies for HTS Trends in the HTS Market Noted by Suppliers 5-48

12 Chapter 1 LIST OF FIGURES 1-A Worldwide R&D Screening and Testing Expenditures in B Worldwide HTS Market Size in 2001 by Product/Service Category C Worldwide HTS Market Size in 2001 by Product/Service Category D HTS Market Size and Growth E Expected Role of HTS Groups in In Vitro ADME/Tox Screening F Average Percentage Use of Microplate Formats: 2001 to G Number of Molecular Targets by Throughput Group 1-11 Chapter 3 3-A Allocation of R & D Spending by Function B Worldwide R & D Screening and Testing Expenditures in C Worldwide HTS Market Size in 2001 by Product/Service Category D Worldwide HTS Market Size in 2001 by Product/Service Category E HTS Market Size and Growth 3-20 Chapter 4 4-A Respondent Groups in the 2002 HTS Study B Number of Years HTS Operations Have Been in Place C A Typical Centralized HTS Organization D Types of HTS Organizations E The Timing of In Vitro ADME/Tox Screening F Value in Using HTS to Screen Compounds for ADME/Tox Properties G Expected Role of HTS Groups in In Vitro ADME/Tox Screening H Targets from Genomic Research: 51 HTS Directors Reporting I Number of Molecular Targets by Throughput Group J Number of Molecular Targets as Compared to Number of Screens K Use of Target Types for 2001 and 2003: High-Throughput Group L Use of Target Types for 2001 and 2003: Medium-Throughput Group M Comparison of Weekly Throughput for High-Throughput Group N Comparison of Weekly Throughput for Medium-Throughput Group O Average Current and Expected Throughput (Wells Read Per Week) P Average Current and Expected Number of Compounds Tested Q Comparison of Number of Compounds Tested, High-Throughput R Comparison of Number of Compounds Tested, Medium-Throughput S Average Percentage of Screens with Pooled Compounds T Current and Possible Use of High Information Content Screening U Percentage of Respondents for Whom it is Easy to Change Assays V Expected Changes in the Percentage of Cell-Based Assays: 2001 to W Average Time Required from Target Identification to Implementation X Sources of Proteins for HTS Assays Y Major Detection Modes Used by the High-Throughput Group Z Major Detection Modes Used by the Medium-Throughput Group 4-143

13 Chapter 4 LIST OF FIGURES (continued) 4-AA Average Percentage Use of Microplate Formats: 2001 to AB Comparison of Formats Used AC Expectations of Budget Changes: 2001 to AD Number of Leads Generated by 44 Individual HTS Labs in Chapter 5 5-A Percentage of Suppliers Revenues Spent on Marketing and Sales B Percentage of Supplier Respondents with E-Commerce Web Sites C Number of HTS Customer Laboratories Served by Each Reporting Supplier D Regional Sales Percentages E Suppliers Expectation of Growth in Business From Collaborations F Percentage of Supplier Respondents Expecting Royalties 5-42