The Comprehensive Report

Transcription

1 The Comprehensive Report Presented by HighTech Business Decisions 346 Rheem Blvd., Suite 208, Moraga, CA Tel: (925) Fax: (925) October 2005

2 FORWARD AND ACKNOWLEDGMENTS HighTech Business Decisions conducted the market research and wrote the report, High Throughput Screening 2005:, 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, cell-based assays, HCS, detection modes, microplate formats, outsourcing, budgets, 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 allow for an objective and thorough analysis. We thank the 88 respondents from pharmaceutical, biotechnology, academic, and institute HTS laboratories, and HTS 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, suggestions, and funding for the first few months of this five-month project. The sponsoring companies are, in alphabetical order, as follows: BD Biosciences Beckman Coulter, Inc Cambrex Biosciences. CIS bio international GE Healthcare Biosciences Greiner Bio-One GmbH Invitrogen Corp. Kalypsys, Inc. Molecular Devices Corp. PerkinElmer Life and Analytical Sciences, Inc. Pierce Biotechnology, Inc. Promega Corp. Tecan Group The following HighTech Business Decisions analysts and staff made important contributions to this research and report: Analysts Sandra J. Fox, MBA Project management, analysis, and report Mike Biros, MBA User interviews, analysis, and report Shauna Farr-Jones, Ph.D. User and supplier interviews and edits Lynne Sopchak, Ph.D. User interviews and edits Amy Boggs, Ph.D. User interviews and edits Helen Wang Nicely Ph.D. User interviews and edits Richard G. Khoury, Ph.D. Supplier interviews and edits Dale Christensen, Ph.D. Supplier interviews and edits Staff Andrea Satin Elise Fox Samantha Edwards Data entry, edits, production Data entry Data entry 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 October 2005 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 information submitted by individual companies. The company interview write-ups and information contained in this report are not intended to be a complete description of any one company, but a paraphrased synopsis of interviews conducted with these companies in July and August of 2005, 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 Market Drivers The HTS Market Size HTS Market Growth Summary of Users Requirements Microplates Targets Use of Assays and Assay Detection Current and Future Use of HCS HTS Directors Vision of HTS in Five Years Summary of Suppliers Capabilities Suppliers Observations on Changes Marketing Suppliers Observations on Trends 1-19 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 Suppliers and Acquisitions Determination of Market Size Investment in Drug Discovery Estimate of the Number of HTS Laboratories Worldwide HTS Market Estimate Based on HTS Lab Spending HTS Market Estimate Based on Suppliers Revenues Estimate of Market Size for HTS Products & Services Size of the Market by Region 3-18

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 3-23 Chapter 4: ANALYSIS OF HTS LABORATORY OPERATIONS 4.1 Respondent Companies and Non-Commercial Labs Locations Number of HTS Employees in HTS Laboratories Number of Years as an HTS Laboratory Titles of Survey Respondents Organization of HTS within the Company or Center Number of Respondents HTS Laboratories HTS Functions Type of HTS Laboratory Integration/Organization of HTS within Drug Discovery Integration of in vitro ADME/Tox Assays with 4-19 Lead Profiling Off-Target or Non-Selective Effects of Compounds Collaborations with External Labs How the Need to Improve Efficiency in R&D Affects 4-30 Screening Plans Major Changes Occurring in HTS Operations HTS Targets Number of Targets Target Types Target Validation How Targets are Validated Use of RNAi/siRNA Assays Importance of Biomarkers Throughput and Compounds Current and Future Throughput for Primary Screening Current/Future Throughput for Secondary Screening Current and Future Throughput for HCS Number of Compounds Tested in Primary Screens Compounds Tested in Secondary Screens and HCS 4-69

6 TABLE OF CONTENTS (continued) Chapter 4: 4.6 HTS Assays Current/Future Use of Assay Types in Primary Screening Anticipated Changes in Assay Types Used Use of Multiplexing Needed Improvements in Assay Technology Cell-Based Assays Types of Cells Used Use of Cell-Based Assays and Challenges of Cell Lines Use of Fixed Cells Primary Cells Used Use of Automated Cell Culture Needs for Cell-Based Kinase Assays Need for Label-Free Assays to Measure Cellular Response Reagents and Technologies for Live Cell Screening Increasing Cell-Based Assay Robustness High Content Screening Current and Future Use of HCS Percentage Use of HCS Reasons for Using HCS Barriers and Bottlenecks in HCS Equipment Used in HCS Types of Assays and Kits Used in HCS Types of Formats Used in HCS Labeling Techniques Used in HCS Number of Images Required with Microscopy-Based HCS Substituting High Throughput Cellular Readouts for HCS HCS Data: How it Saved, Archived, Analyzed, Organized Challenges and Suggested Improvements for HCS Detection Technologies Detection Technologies for Primary Screening Strategies Driving Detection Technology Changes Assays Used with Detection Technologies New Equipment Purchases Planned Opinions on Label-Free Detection Modes Microplates and Other Screening Formats Formats Used for Primary Screening Formats Used for Secondary and ADME/Tox Screening Total Number of Plates Used Suppliers of Microplates and Other Formats Assays Used with 1536-Well Plate Formats Miniaturizations Strategies Opinions Regarding Use of Microfluidics Surface Treatments Needed 4-199

7 TABLE OF CONTENTS (continued) Chapter 4: 4.10 Microplates and Other Screening Formats Opinions Regarding Biological Plate Coatings Interest in Using Specialty Plates Improvements Needed for Microplates or Other Formats Outsourcing Current and Future Outsourced Services Outsourcing Drivers Optimal Scope of a Service Contract Budgets Budgets for Cell-Based Assays, HCS, and ADME/Tox Average Expenditures and Budgets at HTS Laboratories Expected Changes in HTS Budgets Pressures to Reduce Reagent Cost by Miniaturizing Pressures to Move Compound Storage to the HTS Lab Success of HTS in Drug Discovery Leads Generated by HTS in Drug Candidates from HTS Promising New Tools for HTS Promising Tools for Prioritizing Lead Candidates New Technologies Expected to Have Largest Impact Largest Unmet Needs in Primary/Secondary Screening HTS in the Next Five Years 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 Suppliers Observations on Growth Organizational Changes at HTS Supplier Companies Organizational Changes at Respondent Companies Suppliers Observations Customers Organizational Changes Impact of the Need for Cell-Based Assays and HCS Main Drivers for Automated Cell Culture Academic and Commercial Screening Lab Relationships How Suppliers Respond to the Need for More Efficiency Technology Trends Observed by Suppliers Unmet Needs for Reducing the Cost of Reagents Major Technology Challenges and Promising Tools 5-37

8 TABLE OF CONTENTS (continued) Chapter 5: ANALYSIS OF COMPANIES SUPPLYING HTS PRODUCTS AND SERVICES (continued) 5.4 Sales and Marketing Ways of Attracting New Customers Trade Shows The Impact of Internet Sales The Impact of the Secondary Market Measuring the Sales Process Working with Customer Companies Suppliers Estimates of the Total Number of HTS Labs The Number of HTS Customer Labs per Supplier Regional Sales Optimal Service Contract Breadth Challenges for Suppliers Areas of Growth and Future Trends Areas of Growth Major Technology Trends in HTS Major Trends in Drug Discovery Outsourcing Major Trends in the HTS Market Overall 5-71 Appendix A: Coded Write-Ups of Interviews with 54 HTS Directors Appendix B: Descriptions of New HTS Products and Services Appendix C: Interview Guide for Pharmaceutical and Biotechnology Company and Non-Commercial Laboratory Respondents Appendix D: Interview Guide for HTS Supplier Company Respondents

9 LIST OF TABLES Chapter Pharmaceutical Sales and R&D Spending Worldwide Drug Discovery Screening Expenditures in Assay Types as a Percentage of All HTS Assays Respondents Visions of HTS in Five Years 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 1-19 Chapter Market Research Steps List of Acronyms 2-4 Chapter Selected Recent Company Acquisitions and Mergers in the HTS Market Pharmaceutical Sales and R&D Spending 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 Market Estimate Determined by Average HTS Spending HTS Market Size Based on Average Spending in Estimated Market Size from Average Supplier Revenues in Size of the HTS Market by Region Worldwide Market Growth Forecast: The HTS Market in 2004 and Chapter Pharmaceutical/Biotechnology Co. and Non-Commercial Lab Respondents Number of HTS Employees in HTS Laboratories Number of HTS Laboratories at Participating Organizations Percentage of Respondents Performing Certain Drug Discovery Functions Other Labs Performing Drug Discovery Activities Other Laboratories Using HTS Technologies Number of Respondents by Type of HTS Laboratory Percentage of Respondents by Type of HTS Organization When Off-Target or Non-Selective Effects of Compounds are Identified Number of Respondents Using Collaborations Types of Collaborations and Activities Ways Respondents are Improving the Efficiency of Drug Discovery Changes in HTS Organizations: Past Two Years Changes in HTS Organizations: Next Two Years Number of Molecular Targets Screened per HTS Lab Number of Molecular Targets Screened per HTS Lab: by Throughput Group Target Types by Percentage Use Average Number of Targets Validated by HTS Labs 4-48

10 LIST OF TABLES (continued) Chapter Target Validation Techniques High Throughput Techniques Used for Target Validation General Use of RNAi/siRNA Assays Use of RNAi/siRNA Assays in HTS Laboratories Technologies Suggested for Biomarker Research Current and Expected Throughput: HTP Group Current and Expected Throughput: MTP Group Current and Expected Throughput: Non-Commercial Lab Group Current and Expected Secondary Screening Throughput Current and Expected Number of Compounds Tested Per Screen by Group Assay Types as a Percentage of All HTS Assays Number of Respondents Using Each Assay Type in 2004 in Primary and 4-75 Secondary Screening, ADME/Tox, and Target Validation Changes Expected in Assays Used Parameters Tracked and Analyzed in Multiplexed Assays Best Assays for Multiplexing Benefits of Multiplexing Barriers to Multiplexing Assay-Related Problems and Suggested Improvements Percentage of Laboratories Using Specific Cell Lines for HTS Percentage of HTS Laboratories Using Specific Cell Lines for HCS Cell-Based Assay Challenges: Cell Lines Drivers for Automated Cell Culture Use Interest in Cell-Based Kinase Assays Interest in New Label-Free Technology to Measure Cellular Response Enabling New Reagents and Technologies for Live Cell Screening Improvements Needed for Increasing Cell-Based Assay Robustness Reasons for Using HCS Barriers and Bottlenecks Regarding the Use of HCS Instrumentation Used in HCS Types of Assays Used in HCS by Averaged Percentage Types of HCS Kits Used by Respondents Formats Used in HCS: 2004 to Plate Coatings Used in HCS Labeling Techniques Used in HCS Main Challenges in HCS Top Five Detection Technologies: All Groups 2001, 2003, 2004, Expected Top Detection Modalities by Respondent Group in Average Percentage of Detection Technologies Used in Primary Screening Drivers of Detection Technology Change Detection Technologies Used by Assay Type Planned Equipment Purchases for Detection Advantages of Label-Free Technologies 4-179

11 LIST OF TABLES (continued) Chapter Average Percentage Use of Microplates/Other Formats in Primary Screening Average Percentage Use of Microplates/Other Formats by Type of Lab Average Percentage Use of Microplates/Other Formats: Secondary Screens Average Percentage Use of Microplates/Other Formats: ADME/Tox Numbers of Microplates Used by Throughput Group Suppliers of Microplates and Other Formats Named by Respondents Barriers to Further Miniaturization Miniaturization Strategies: 54 HTS Respondents Those Using Microfluidics: Benefits, Drawbacks, and Applications Those Not Using Microfluidics: Benefits, Drawbacks, and Applications Respondents Using Surface-Treated Plates Respondents Use and Interest in Coatings for Plates for Cell-Based Assays Use and Interest in Specialty Plates by Number of Respondents Suggested Improvements for Microplates Number of Respondents Outsourcing Average Percentage of Workload Outsourced by Those Who Outsource Service Suppliers Currently Used by Respondents Reasons for Outsourcing Drug Discovery Activities Optimal Scope of Assay Development/Protein Expression Service Contract Average Budget Percentages for Specific Assay Types Average Total 2004 HTS Budgets as Provided by 35 Respondents Average Budget Expenditures per HTS Lab by Product Category Summary of Growth Patterns Based on Averaged Budgets 2004 to Average Expenditures per HTS Lab Average Expenditures per HTS Lab by Product Category: HTP/MTP Median Expenditures by Service Category for Individual HTS Labs Reasons for Budgetary Changes Financial Pressure to Miniaturize to Conserve Reagents Compound Storage in the HTS Lab versus a Central Store Percentage of Targets that Generated Leads in Number of Leads Generated by HTS Labs in Drug Candidates Originally Screened in HTS by Individual HTS Labs Promising Tools Needed for Prioritizing Lead Candidates Respondents Opinions: New Technologies Impacting the Future of HTS Unmet Needs in Primary Screening Unmet Needs in Secondary Screening Respondents Visions of HTS in Five Years 4-262

12 LIST OF TABLES (continued) Chapter HTS Product and Service Supplier Respondents Selected Company Acquisitions and Organizational Changes Summary of Primary HTS Products/Services Offered by HTS Suppliers Number of Employees, Years in Business, Revenues from HTS Products Average Percentage Revenue from HTS Product and Service Categories Primary Changes at Customer Organizations as Noted by Suppliers Suppliers Opinions: Benefits/Drawbacks of Automated Cell Culture Suppliers Responses: Customers Needs for Efficient Drug Discovery Tools Technology Observations Drivers for Reagent Purchases Observations on Unmet Needs to Help Reduce the Cost of Reagents Observations on Challenges in HTS Most-Often Mentioned Ways to Attract New Customers Suppliers Responses to the Top Three Trade Shows for HTS Suppliers Opinions Regarding the Impact of Internet Sales Suppliers Opinions Regarding the Impact of the Secondary Market Methods Used to Measure the Sales Process Regional Sales as a Percentage of Total HTS Revenues Opinions Regarding the Optimal Breadth of a Service Contract Summary of Challenges for HTS Suppliers Areas of Highest Growth in the HTS Industry Trends in Drug Discovery Outsourcing 5-69

13 LIST OF FIGURES Chapter 1 1-A Worldwide R&D Screening and Pharmacological Testing Expenditures B Worldwide HTS Market Size by Product/Service Category C HTS Market Size and Growth Estimate by Segment D Percentage of Respondents Performing Drug Discovery Tasks in HTS Lab E Average Percentage Use of Microplate Formats: All Groups F Average Number of Molecular Targets per HTS Laboratory G Top Three Assays Used by Each Respondent Group H Cell-Based Assay Use by Average Respondent Group Percentage I Areas of Current and Future Use of Some High Content Screening 1-15 Chapter 3 3-A 2004 Worldwide R&D Screening and Testing Expenditures B Worldwide HTS Market Size in 2004 by Product/Service Category C Average Expenditures per HTS Lab by Category, 2004 and D HTS Market Size and Growth Estimate by Segment 3-22 Chapter 4 4-A Respondent Groups in the 2005 HTS Study B Average Percentage of Employees in Three Levels at HTS Labs C Average Number of Employees in Three Levels at HTS Labs D Number of Years HTS Operations Have Been in Place at Respondent Labs E Percentage of Respondents Performing Drug Discovery Tasks in HTS Lab F HTS Lab Organizations G A Traditional HTS Laboratory Organization H All Respondents: Integration of ADME/Tox Assays with Lead Profiling I Use of Toxicogenomic Analysis Early in Discovery J Collaborations by Number of Respondents K Average Number of Molecular Targets Screened Per Lab by Group L Average Number of Molecular Targets Compared to Primary Screens M Summary of Percentage Use of Target Types in 2004: All Respondents N Use of Target Types for 2004 and 2006: HTP Screening Group O Use of Target Types for 2004 and 2006: MTP Screening Group P Use of Target Types for 2004 and 2006: Non-Commercial HTS Labs Q Future Use of RNAi/siRNA Assays within Respondents Organizations R Use of Biomarker Research within Organizations and HTS Labs S Comparison of Throughput for Individual Labs, : HTP Group T Comparison of Throughput for Individual Labs, : MTP Group U Comparison of Throughput for Individual Labs, : 4-64 Non-Commercial Laboratories 4-V Comparison of Throughput by Individual Labs, : 4-64 Non-Commercial Laboratories (Two High Outlier HTS Labs) 4-W Current and Expected Average Throughput by Group X Median HCS Weekly Throughput by Respondent Group: 2004 and Y Changes in Number of Compounds Tested Per Screen: 2004 to Z Average Current and Expected Number of Compounds Tested Per Screen 4-69

14 LIST OF FIGURES (continued) Chapter 4 4-AA Number of Compounds Tested in Secondary Assays AB Number of Compounds Tested in HCS by Number of HTS Labs AC Changes in the Use of Cell-Based Assays AD Top Three Assays Used by Each Respondent Group by Percentage in AE Cell-Based Assay Use by Average Group Percentage: 2004 and AF Percentage of Respondents Multiplexing AG Most Common Cell Lines AH Percentage of Labs Using Fixed Cells in Primary Screening AI Current Use of Primary Cells AJ Desired Use of Primary Cells If Cost and Availability Were Not an Issue AK Use of Automated Cell Culture by Percentage of HTS Labs AL Drivers for Current and Future Use of Automated Cell Culture AM Interest in a Label-Free Technology to Measure Overall Cellular Response AN Areas of Current and Future Use of Some HCS within the Organization by Percentage of Respondents 4-AO Percentage of Each Respondent Group Performing Some HCS in Respondents HTS Labs for Primary Screening 4-AP Average Percentage Use of HCS Out of All Screening Conducted in Respondents HTS Labs: 2004 and AQ Number of Images Acquired per Well Using a Microscopy-Based HCS System 4-AR Possibility of Substituting an HT Cellular-Based Readout for HCS AS Largest Percentage-Point Increase/Decrease in Detection Modes: AT Current Use of Label-Free Technology AU Possibility of Future Use of Label-Free Detection for Primary Screening AV Average Percentage Use of Microplate Formats: All Groups 2004 to AW Comparison of Formats Used in 2004 vs. 2006: High Throughput Group AX Comparison of Formats Used in 2004 vs. 2006: Medium Throughput Group AY Comparison of Formats Used in 2004 vs. 2006: Non-Commercial Labs AZ Average Use of Formats for Secondary Screening BA Average Use of Formats for ADME/Tox Screening BB Percentage of Respondents Planning Further Miniaturization by Group BC Current Use of Surface-Treated Plates: All Respondent Groups BD Use and Interest in Specialty Plates BE Percentage of Respondents Outsourcing in BF Reasons for Outsourcing by Percentage of Responses BG Comparison of Average HTS Budget Percentages for Specific Assay Types BH Overall Budget Changes by Percentage of Respondents: 2004 to BI Average Individual HTS Lab Budgets in Thousands of US$: 2004 to BJ Financial Pressure to Miniaturize to Conserve Reagents BK Percentage of Targets That Generated Leads in 2004 at Individual HTS Labs BL Clinical Drug Candidates from HTS by Year Originally Screened in HTS 4-247

15 LIST OF FIGURES (continued) Chapter 5 5-A Suppliers Perceptions of HTS Market Growth: Past Two Years B Suppliers Perceptions of HTS Market Growth: Next Few Years C Average Percentage of Respondents Tissue Culture-Treated Microplates 5-31 Sales by Format 5-D Observations Regarding Customers Miniaturization Practices: Formats E Observations Regarding Customers Miniaturization Practices: Volumes F Number of HTS Customer Labs Served by Each Reporting Supplier G Regional Sales as a Percentage of Total HTS Revenues 5-56