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Cell-Based Assays for Drug Discovery

The area of drug discovery tools is one of the newest and most important sectors of pharmaceutical research and development. The term drug discovery tools usually refers to high-content screening (HCS) and analysis and is composed of those applications that require sufficient levels of sample throughput, whereby complex cellular events and phenotypes can be studied. Elements of drug performance like toxicity and specificity can be established simultaneously using mixed cell types-primary cells, cell lines, cell subpopulations. HCS seeks to assess the impact of phenotypic and cellular changes that are brought about by gene modification (such as with RNA interference (RNAi) approaches) and/or drug (or compound) treatment. The purpose of this examination by TriMark Publications is to describe the specific segments of the global drug discovery tools market. Within this area, the report covers those segments that are highly active in terms of innovation and growth. Specifically, this study examines the markets for small lab equipment all the way up to highly automated, large automated platforms, as well as accessory equipment such as reagents, supplies and manufacturers' original equipment manufacturer (OEM) additional equipment.

Table of Contents

TABLE OF CONTENTS

1. Overview 5

• 1.1 Objectives of the Report 5
• 1.2 Methodology 6
• 1.3 Scope of the Report 7
• 1.4 Executive Summary 8

2. Technologies and Product Offering for High-Content Analysis 11

• 2.1 Definition of High-Content Analysis and Why it is so Attractive a Discipline 12
• 2.2 Classes of Measurements Possible with High-Content Analysis Approaches and Biological Functions Investigated 15
• 2.3 Instrumentation Platforms for High-Content Analysis 19
  • 2.3.1 High-Content Screening Technology 19
• 2.4 Reagent and Assay Platforms for High-Content Analysis 26
• 2.5 Cell-based Screening Technologies in Drug Development 29
  • 2.5.1 Applications of Cell-based Assays 30
  • 2.5.2 Pharma Drug Discovery Paradigm and Compound Screening 30
  • 2.5.3 High-Content Analysis in the Biopharmaceutical Industry 31

3. Market Analysis of the High-Content Tools Space 33

• 3.1 High-Content Analysis Market Size and Growth 33
• 3.2 Market Survey to Assess Qualitative and Quantitative Parameters of the High-Content Analysis Space 33
• 3.3 Experimental and Research Trends in High-Content Analysis 35
• 3.4 Challenges and Market Drivers in High-Content Analysis 40
  • 3.4.1 Barriers to High-Content Analysis 42
  • 3.4.2 Drivers of High-Content Analysis 43
• 3.5 High-Content Analysis in Combination with RNAi 43
• 3.6 Market Landscape of Instrumentation for High-Content Analysis 45
• 3.7 Reagent and Assay Usage in High-Content Analysis 49
• 3.8 Trends in the High-Content Analysis Assays/Reagents Space—Major Product Vendors 52
• 3.9 Emerging Market Trends in High-Content Analysis 54
• 3.10 Market Forecasts for the High-Content Analysis Space 57
• 3.11 Use of HCS in Pharmaceutical Companies 58
• 3.12 Qualitative Opportunities and Challenges for Market Adoption 59

4. Strategic Analysis of the High-Content Tools Space 60

• 4.1 Analysis of the High-Content Market Structure 60
• 4.2 Description of the Drug Discovery Marketplace and Definition of the Field 60
• 4.3 Key Market Drivers and Challenges in the High-Content Analysis Space 61
• 4.4 Consolidated Picture of the High-Content Analysis Marketplace 65
• 4.5 High-Content Analysis Market Sectors and Growth Rate 66
• 4.6 Vendors of High-Content Analysis Technology 66

5. High-Content Analysis Technology Platforms 67

• 5.1 Methods of Digital Imaging 67
• 5.2 Fluorescence Microscopy 67
• 5.3 Major High-Content Analysis Instrumentation 68
• 5.3.1 High-Content Analysis Platforms to Support GPCR Screening 69
• 5.4 High-Content Analysis Reagents 69
• 5.5 Imaging Software 70
• 5.6 Enterprise-Level IT Solutions to Support High-Content Screening Experiments 70
  • 5.6.1 Image Analysis Algorithms 71
• 5.7 Use of RNAi in High-Content Analysis 73
• 5.8 Industry Alliances to Leverage RNAi and High-Content Analysis 73
• 5.9 Emerging Trends in High-Content Analysis Technology Platforms 74

6. High-Content Analysis in Drug Selection, Screening and Biomarker Discovery 75

• 6.1 Stem Cells as Tools for Drug Discovery 76
• 6.2 Cellular Systems Biology for Development of Toxicity Panels in Drug Safety Testing 76
• 6.3 Drug Discovery Companies Marketing Cell-based Assays 77
• 6.4 Companies Using Cell-based Assays in Drug Discovery Programs 80
  • 6.4.1 Phenotypic Drug Discovery (PDD) 80
  • 6.4.2 Application of Quantitative High-Throughput Screening to HCA Cell-based Assays 80
  • 6.4.3 Application of High-Content Fingerprinting to Oncology Drug Discovery: Focus on in vitro and in vivo Phenocopying and Cancer Stem Cell Analysis 81
• 6.5 Target Discovery and Validation by RNAi Screening 81
• 6.6 FLIM-FRET Methodology 81
• 6.7 Multidimensional Fluorescence Imaging (MDFI) Technology 81

7. Company Profiles 82

• 7.1 Acumen Pharmaceuticals, Inc. 82
• 7.2 Acumen Bioscience (division of TTP Group) 82
• 7.3 Applied Biosystems 82
• 7.4 BD Biosciences 84
• 7.5 DiscoveRX 84
• 7.6 Evotec Technologies (acquired by PerkinElmer) 84
• 7.7 Fisher BioImage 84
• 7.8 General Electric, GE Healthcare 85
• 7.9 Guava Technologies (now a division of Millipore) 85
• 7.10 Integral Molecular (Akceli Inc.) 86
• 7.11 LemnaTech GmbH 86
• 7.12 Millipore 86
• 7.13 Molecular Devices Corporation, now a division of MDS Analytical Techniques 88
• 7.14 NIH Chemical Genomics Center 90
• 7.15 PerkinElmer 91
• 7.16 Sangamo Biosciences, Inc. 93
• 7.17 Spotfire (acquired by TIBCO) 93
• 7.18 Thermo Scientific Cellomics 94
• 7.19 Translational Genomics Research Institute 94
• 7.20 Vala Sciences, Inc. 94

8. Glossary of Terms in the High-Content Analysis Space 96


LIST OF FIGURES

• Figure 2.1: Scope of Biological Parameters Addressed via a Typical High-Content Analysis Experiment 14
• Figure 2.2: Classes of Assays in Life Science Research and Drug Discovery Illustrating the Relationship between Cell-based Assays and High-Content Analysis 15
• Figure 2.3: New Paradigm for Drug Discovery and Development Illustrating the Central and Essential Role of Screening 17
• Figure 2.4: Cumulative Known and New Drug Targets 32
• Figure 3.1: Breakout of Market Survey Respondents by Geographical Location 33
• Figure 3.2: Breakout of Market Survey Respondents by Affiliation—Academic, Commercial, Vendor 33
• Figure 3.3: Segmentation of Respondent Pool Based upon Usage of High-Content Analysis in its Research Activities 34
• Figure 3.4: Segmentation of the Survey Respondent Pool Based upon the Length of Time they have been Using High-Content Analysis in Their Research Activities 34
• Figure 3.5: Number of Parameters Studied Simultaneously in High-Content Analysis Assays—Multivariate (Multi-Parameter) Analyses 36
• Figure 3.6: Key Biological Processes Studied Utilizing High-Content Analysis Tools 37
• Figure 3.7: Breakout of High-Content Analysis Assays Currently Performed or Expected to be Performed in the Future by Biological Pathway (or Target) 38
• Figure 3.8: Breakout of High-Content Analysis Experiments Performed Per Week (Distributed in our Respondent Pool) Across the Various Biological Pathways (and Targets) 38
• Figure 3.9: Which of the Biological Processes (Pathways/Targets) Addressed Using High-Content Analysis-based Approaches are Growing in Importance and which are Declining? 39
• Figure 3.10: In Which Environment are High-Content Analysis Assays Performed—Primary Screen, Secondary Screen, ADME/Tox Screen? 40
• Figure 3.11: Key Challenges Faced by the Research Community in its Practice of High-Content Analysis 41
• Figure 3.12: Various Drivers Leading the Research Community to Perform High-Content Analysis 42
• Figure 3.13: HCA with RNAi—Current and Future Experimental Formats 44
• Figure 3.14: HCA with RNAi—Number of Experiments Performed Per Month by the Survey Respondent Pool 44
• Figure 3.15: Growing and Steady Usage of Various Formats where RNAi is coupled with HCA 45
• Figure 3.16: Penetration of the Different High-Content Analysis Instrumentation Platforms into the Marketplace 46
• Figure 3.17: Instrumentation Platforms for High-Content Analysis Ranked by Top Choice and Second Tier 47
• Figure 3.18: High-Content Analysis Instrumentation and where they Lie on the Throughput Curve 48
• Figure 3.19: Top Instrumentation Value Drivers in the High-Content Analysis Space 48
• Figure 3.20: Important Sub-Cellular Features Studied via High-Content Analysis Approaches 49
• Figure 3.21: Breakout of End-Point Versus Kinetic Assays in the High-Content Analysis Space 50
• Figure 3.22: Types of Cellular Targets Studied Using High-Content Analysis Approaches 50
• Figure 3.23: Top-most Target Class Studied Utilizing High-Content Analysis Approaches 51
• Figure 3.24: Distribution of High-Content Analysis Experiments across the Respondent Pool—Number of Experiments Performed Per Week 51
• Figure 3.25: Average Reagent/Assay Costs Per High-Content Analysis Experiment 52
• Figure 3.26: Stratification of Reagent/Assay Suppliers into the High-Content Analysis Space 53
• Figure 3.27: Monthly Reagent/Assay Purchases for High-Content Analysis by the End-user Community from Various Vendors 53
• Figure 3.28: Growth or Decline in Importance of the Various High-Content Analysis Vendors to the End-user Community 54
• Figure 3.29: Percentage of High-Content Analysis Experiments that Involve GFP across the Market Landscape 55
• Figure 3.30: Breakout of High-Content Analysis Reagents Marketplace: Made-in-House Versus Off-the-Shelf 55
• Figure 3.31: Breakout of Spending on Various Components of the High-Content Analysis Discipline 56
• Figure 3.32: Historic/Forecast Growth of the Total Screening Space, Broken-out by Primary Screening, Secondary Screening (including High-Content Analysis as a Subset) and ADME/Tox, for 2004-2010 57
• Figure 3.33: Historic/Forecast Growth of the Screening Space—Broken-out by Cell-based Assays and Biochemical Assays, 2004-2010 58
• Figure 4.1: Drug Discovery and Development Ensemble and the Position of the Various Segments of High-Content Analysis in the Space 63
• Figure 4.2: Relative Size and Position of the High-Content Analysis Space in the Overall Scheme of the Life Science Tools Marketplace 66
• Figure 5.1: High-Content Analysis—Positional Biosensors Using Caspases and Monitoring the Translocation of a Tagged Protein from the Cytoplasm to the Nucleus 71
• Figure 6.1: HCA Target Classes: Breakout of Current Drug Targets into Their Constituent Classes 75
• Figure 6.2: GPCR Assay Technologies 76

LIST OF TABLES

• Table 2.1: Comparison of the Key Features of High-Content Analysis and High-Throughput Screening 13
• Table 2.2: Impact of High-Content Analysis on Drug Discovery—Impact of Several Drivers 13
• Table 2.3: Biological Application Areas Associated with High-Content Analysis 14
• Table 2.4: Classes of Measurements and Targets Identified Using Phenotypic Screening (High-Content Analysis) 15
• Table 2.5: Classes of Cellular Measurements Possible with Fluorescent Protein Biosensors 16
• Table 2.6: Multi-Parameter High-Content Analysis Assays to Study Biological Systems in Life Science Research and Drug Discovery, Demonstrating the Breadth and Scalability of the High-Content Analysis Approach 18
• Table 2.7: Companies Offering Systems for High-Throughput Imaging 20
• Table 2.8: Comparison of the Major Instrumentation Platforms and Their Associated Specifications for High-Content Analysis—I 21
• Table 2.9: Comparison of the Major Instrumentation Platforms and Their Associated Specifications for High-Content Analysis—II 21
• Table 2.10: Price Points and Target Markets of the Various High-Content Analysis Instrument Platforms 22
• Table 2.11: Companies Offering Flow Cytometry Products and Services 23
• Table 2.12: Integrated Product Platforms Offered by the Different High-Content Analysis Vendors 25
• Table 2.13: High-Content Analysis Assays Developed by Thermo Scientific Cellomics 26
• Table 2.14: Thermo Scientific Cellomics HCS Reagent Kits (formerly called “HitKits”) and Their Therapeutic Areas of Application 27
• Table 2.15: Millipore's HCA Assay/Reagent Portfolio 28
• Table 2.16: Cell Lines for GPCR High-Content Analysis that can be Deployed onto the BD Biosciences/Atto Pathway HT™ Instrument Platform 28
• Table 2.17: Examples of High-Content Screens 31
• Table 3.1: What Fraction of High-Content Analysis Assays are Cell-based Versus Biochemical-based 35
• Table 4.1: Comparison of the Key Features of High-Content Analysis and High-Content Screening 61
• Table 4.2: Snapshot of the Various HCA Assays, Demonstrating the Scalability of this Discipline 64
• Table 5.1: Modes of Digital Imaging 67
• Table 5.2: Modes of Fluorescence Microscopy 67
• Table 5.3: Major High-Content Analysis Instrumentation 68
• Table 5.4: Image Analysis Algorithms 71

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