CELL-BASED ASSAYS: TECHNOLOGIES AND GLOBAL MARKETS

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1 CELL-BASED ASSAYS: TECHNOLOGIES AND GLOBAL MARKETS BIO080B April 2014 Usha Nagavarapu Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA USA (toll-free within the USA), or (+1) information@bccresearch.com

2 BIO080B - Cell-based Assays: Technologies and Global Markets ABOUT BCC RESEARCH BCC Research publishes market research reports that make organizations worldwide more profitable with intelligence that drives smart business decisions. These reports cover today's major industrial and technology sectors, including emerging markets. For more than 40 years we've helped customers identify new market opportunities with accurate and reliable data and insight, including market sizing, forecasting, industry overviews, and identification of significant trends and key competitors. We partner with analysts who are experts in specific areas of industry and technology, providing unbiased measurements and assessments of global markets. Our clients include the top companies in industries around the world as well as universities, business schools, start-ups, consulting firms and investment companies. BCC Research is a unit of Eli Research LLC. Visit our website at Contact us: (+1) (U.S. Eastern time), or information@bccresearch.com. CONDITIONS OF PURCHASE The purchase of the bound or electronic copy of this report constitutes a contractual agreement between BCC Research and the purchaser. When purchased under a single-user license, this report is intended for use solely by the person who made the purchase. When purchased under a multiple-user license, this report is intended for access by the maximum number of users specified by the license. For information, information@bccresearch.com or telephone (+1) (U.S. Eastern time). The report and its contents are not to be made available to other persons, autonomous divisions, foreign subsidiaries of the same company, or other companies, unless specified by contract and/or license. It is here stipulated that terms in an authorized contract or license will supercede any other conditions cited in any other location. Reproduction of any material in this report is strictly forbidden without written permission of the publisher; editor@bccresearch.com. REPORT SUBSCRIPTIONS BCC Research offers cost-effective Report Subscription services that provide organizations with access to reports in selected industry categories, including our back catalog of reports and newly published reports. CUSTOM ANALYSES BCC Research provides custom research studies tailored to our clients needs in areas related to the subject research material but perhaps not covered in detail in this report. Please contact BCC Research to discuss such services: information@bccresearch.com or telephone (+1) (U.S. Eastern time). Copyright BCC Research, Wellesley MA USA, Website:

3 BIO080B - Cell-based Assays: Technologies and Global Markets DISCLAIMER This publication provides informative material of a professional nature. It does not constitute managerial, legal or accounting advice, nor should it serve as a corporate policy guide, laboratory manual or an endorsement of any product. This information is intended to be as accurate as possible at the time of publication, but BCC Research LLC assumes no responsibility for any losses or damages that might result because of reliance on this material. Copyright 2014 by BCC Research, Wellesley, MA USA Reproduction of any material in this report is strictly forbidden without express permission of the Publisher; editor@bccresearch.com. To receive a complete catalog of BCC Research studies, please visit our Web site at Copyright BCC Research, Wellesley MA USA, Website:

4 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION... 2 STUDY GOALS AND OBJECTIVES... 2 REASONS FOR DOING THE STUDY... 2 SCOPE AND FORMAT... 2 INTENDED AUDIENCE... 3 METHODOLOGY... 3 ANALYST CREDENTIALS... 3 RELATED BCC RESEARCH REPORTS... 3 BCC RESEARCH WEBSITE... 3 DISCLAIMER... 4 CHAPTER 2 SUMMARY... 6 SUMMARY TABLE GLOBAL MARKET FOR CELL-BASED ASSAYS, THROUGH 2018 ($... 7 SUMMARY FIGURE GLOBAL MARKET FOR CELL-BASED ASSAYS, ($... 7 CHAPTER 3 OVERVIEW... 9 INTRODUCTION... 9 DRUG DISCOVERY... 9 FIGURE 1 DRUG DISCOVERY PROCESS AND STEPS... 9 TABLE 1 CELL-BASED ASSAYS AND USES HIGH-CONTENT SCREENING INSTRUMENTATION AND SOFTWARE DATA ANALYSIS OVERVIEW: CELL-BASED ASSAYS TOOLS FOR DRUG DISCOVERY HIGH-CONTENT SCREENING History of High-Content Screening CELL-BASED SCREENING Types of Cell-Based Assays TABLE 2 TYPES OF CELL-BASED ASSAYS Proliferation Assays WST Reagents Fluorescence-Based Assays Apoptosis Assays TABLE 3 APOPTOTIC MARKERS Caspase Assays DNA Fragmentation Assays Annexin V and Cell Permeability Assays... 24

5 Mitochondrial Assays Activation Assays Assays to Measure Gene Expression Proof of Concept for Cell-Based Assays TABLE 4 PROOF OF CONCEPT FOR CELL-BASED ASSAYS Cell-Based Assays and Technology Trends Why Cell-Based Approaches? In Vitro Homogeneous Assays Cell-Based Reporter Assays Cell-Based Assays and Future Growth TABLE 5 GLOBAL MARKET AND FORECAST FOR CELL-BASED ASSAYS, THROUGH 2018 ($ FIGURE 2 GLOBAL MARKET AND FORECAST FOR CELL-BASED ASSAYS, ($ Cell-Based Assays for GPCRs Immortalized Cells Why Immortalized Cells? Future Primary Cells Stem Cells and Cell-Based Assays Embryonic Stem Cells and Cell-Based Assays New Developments: 3D Cell-Based Models CHAPTER 4 ASSAYS FOR DRUG DISCOVERY CELL-BASED APPROACHES FOR ADME/TOX SCREENING MARKET OPPORTUNITY ADME AND TOXICITY SCREENING Cytochrome P TABLE 6 BIOLOGICAL ASSAY SYSTEMS FOR THE EVALUATION OF CYTOCHROME P450 ENZYME ISOFORMS TABLE 7 HEPATOCYTE ASSAY SYSTEMS TABLE 8 ADME ASSAYS TABLE 9 COMMON TOXICITY ASSAYS Optical Oxygen Sensors Characterized Cell Lines for Cell-Based ADME and Toxicity Screening TABLE 10 TRADITIONAL METHODS OF ADME/TOX TESTING TABLE 11 CONVENTIONAL IN VITRO ADME/TOX SCREENING METHODS Predictive ADME/Tox Screening MULTIPLEXED CELL-BASED ASSAYS Compound Effects on Cells... 48

6 CELL-BASED BIOLOGICAL ASSAYS General Bioassay Guidance HIGH-THROUGHPUT IMAGING-BASED PLATFORM FOR CELL-BASED ASSAYS CELL ASSAYS IN TODAY'S DRUG DISCOVERY PROCESS LABEL-FREE CELLULAR ASSAYS: THE RELEVANT FUTURE OF DRUG DISCOVERY Label-Free Assays and Applications Benefits of Label-Free Assays TABLE 12 LABEL-FREE ASSAYS AND APPLICATIONS Advantages Major Challenges for Adoption of Label-Free Technology CONCLUSIONS CHAPTER 5 CELL BASED ASSAYS: CURRENT TECHNOLOGIES FACTORS IN CELL-BASED ASSAY DEVELOPMENT... TABLE 13 FACTORS FOR CELL-BASED ASSAY DEVELOPMENT... REPORTER GENE TECHNOLOGY... TABLE 14 DIFFERENT APPROACHES TO CELL-BASED SYSTEMS FOR DRUG... SCREENING CELL-BASED ASSAYS FOR STUDYING PROTEIN-PROTEIN INTERACTIONS CELL-BASED PROTEIN-FRAGMENT COMPLEMENTATION ASSAYS MEASURING CALCIUM SIGNALING CELL-BASED LABEL-FREE APPROACHES AUTOMATION AND MINIATURIZATION CELL PATTERNING CELL-BASED ASSAYS AND PHYSIOLOGICAL RELEVANCE CELL-BASED ASSAYS AND MULTIPLEXING... DEVELOPING REPORTER ASSAYS... REPORTER ASSAYS AND MULTIPLEXING... ULTRAHIGH-THROUGHPUT SCREENING DEVELOPMENT OF PATHHUNTER ASSAY HIGH-CONTENT SCREENING TECHNOLOGY... TABLE 15 CURRENT CONFOCAL HCS PLATFORMS... TABLE 16 WIDEFIELD HCS PLATFORMS... IMAGING CELLS FOR CELL-BASED ASSAYS... MICROSCOPIC VISUALIZATION OF CELLS... QUANTUM DOTS... LABEL-FREE IMAGING... INVESTIGATIONAL NEW DRUG (IND) STUDIES IN DRUG DEVELOPMENT... TABLE 17 STUDIES FOR FILING AN IND... TABLE 18 STUDIES FOR CLINICAL FILINGS... ROLE OF ADME IN DRUG DESIGN... PRODRUG STRATEGIES MOLECULAR MODELING SUMMARY LIMITATIONS OF THE USE OF CELL-BASED ASSAYS IN THE PROCESS OF RISK ASSESSMENT BOTTLENECKS IN CELL-BASED SCREENING... 87

7 METHODS TO IMPROVE THROUGHPUT IN CELL-BASED ASSAYS... NEW TECHNOLOGIES... DATACHIP... BIND TECHNOLOGY... SIMUGEN... MINIATURIZATION OF BIOLOGICAL ASSAYS... MICROFLUIDIC CELL-CULTURE SYSTEMS FOR DRUG RESEARCH... CONCLUSION CHAPTER 6 COMMERCIALIZATION OF CELL-BASED ASSAYS ROLE OF CELL-BASED ASSAYS DRUG DISCOVERY AND CELL-BASED ASSAYS OPPORTUNITIES FOR MARKET ADOPTION... TABLE 19 BIOLOGICAL APPLICATIONS FOR HCA... MEASURING CELL PROLIFERATION... COMPANIES OFFERING CELL PROLIFERATION ASSAYS Roche Applied Science BioVision Promega EMD Millipore MOVE TOWARD THERAPIES WITH STEM AND IMMUNE CELLS CELL-BASED SCREENING ASSAYS COMPANIES Euroscreen Arena Pharmaceuticals GPCR ORPHAN RECEPTORS SUMMARY CHAPTER 7 GLOBAL CELL-BASED ASSAY AND INSTRUMENTATION MARKET CURRENT MARKET OVERVIEW ROLE OF CELL-BASED ASSAYS CELL-BASED ASSAY MARKET... MARKET DYNAMICS... CELL-BASED ASSAYS AND PRECLINICAL DEVELOPMENT... HIGH-THROUGHPUT SCREENING TABLE 20 GLOBAL HTS MARKET, THROUGH 2018 ($ Advantages of HTS Assays Major Drivers TABLE 21 HTS TECHNOLOGIES: KEY COMPANIES DRUG DISCOVERY TECHNOLOGY MARKET... TABLE 22 GLOBAL MARKET FOR DRUG DISCOVERY TECHNOLOGIES,... THROUGH 2018 ($ FIGURE 3 GLOBAL MARKET FOR DRUG DISCOVERY TECHNOLOGIES ($ CELL-BASED ASSAYS: MARKET DRIVERS... CELLULAR BIOLOGY

8 RNA and DNA Reagents Market TABLE 23 GLOBAL MARKET FOR REAGENTS AND TOOLS USED IN DNA AND RNA RESEARCH, THROUGH 2018 ($ FIGURE 4 GLOBAL MARKET FOR REAGENTS AND TOOLS USED IN DNA AND RNA RESEARCH, ($ Life Science Tools Market TABLE 24 GLOBAL MARKET FOR LIFE SCIENCE TOOLS, THROUGH ($ FIGURE 5 GLOBAL MARKET FOR LIFE SCIENCE TOOLS, ($ Cell Biology Reagents TABLE 25 GLOBAL MARKET FOR CELL BIOLOGY REAGENTS AND TOOLS, THROUGH 2018 ($ FIGURE 6 GLOBAL MARKET FOR CELL BIOLOGY REAGENTS AND TOOLS, ($ Reagent Development CELL CULTURE MARKET TABLE 26 GLOBAL MARKET FOR CELL CULTURE TOOLS, THROUGH ($ FIGURE 7 GLOBAL MARKET FOR CELL CULTURE TOOLS, ($ Cell Culture Reagent Market TABLE 27 GLOBAL MARKET FOR CELL CULTURE REAGENTS, THROUGH 2018 ($ FIGURE 8 GLOBAL MARKET FOR CELL CULTURE REAGENTS, ($ TABLE 28 U.S. MARKET FOR CELL CULTURE REAGENTS, THROUGH ($ FIGURE 9 U.S. MARKET FOR CELL CULTURE REAGENTS, ($ Three-Dimensional Cell Culture Market TABLE 29 GLOBAL MARKET FOR 3D CELL CULTURE REAGENTS, THROUGH 2018 ($ FIGURE 10 GLOBAL MARKET FOR 3D CELL CULTURE REAGENTS, ($ CELL-BASED ASSAYS MARKET GROWTH CELL-BASED ASSAYS: KEY GROWTH FACTORS TABLE 30 CELL-BASED ASSAY COMPANIES TABLE 31 GLOBAL MARKET FOR CELL-BASED ASSAYS, THROUGH

9 ($ FIGURE 11 GLOBAL MARKET FOR CELL-BASED ASSAYS, ($ MARKET DEMAND TABLE 32 LIMITATIONS OF CELL-BASED ASSAYS CELL-BASED ASSAYS: BASIC RESEARCH TABLE 33 GLOBAL MARKET FOR CELL-BASED ASSAYS USED IN BASIC RESEARCH, THROUGH 2018 ($ FIGURE 12 GLOBAL MARKET FOR CELL-BASED ASSAYS USED IN BASIC RESEARCH, ($ STEM CELLS AND TOXICITY TESTING Market Drivers ADME AND TOXICOLOGY MARKET CYPROTEX IN VITRO PREDICTIVE TOXICOLOGY TABLE 34 GLOBAL MARKET FOR IN VITRO TOXICITY TESTS, THROUGH ($ FIGURE 13 GLOBAL MARKET FOR IN VITRO TOXICITY TESTS, ($ ADME-TOXICOLOGY TESTING MARKET SPECIALIZED CELL-BASED ASSAYS TABLE 35 GLOBAL MARKET FOR SPECIALIZED CELL-BASED ASSAYS USED IN DRUG DISCOVERY, THROUGH 2018 ($ FIGURE 14 GLOBAL MARKET FOR SPECIALIZED CELL-BASED ASSAYS USED IN DRUG DISCOVERY, ($ TABLE 36 IN VITRO PREDICTIVE TOXICOLOGY ASSAYS ADME: TOOLS AND TECHNOLOGIES ADME STUDIES FOR FDA SUBMISSIONS MARKET PLAYERS TABLE 37 GLOBAL MARKET FOR ADME ASSAYS, THROUGH 2018 ($ FIGURE 15 GLOBAL MARKET FOR ADME ASSAYS, ($ CELL-BASED ASSAYS FOR DRUG DISCOVERY: GLOBAL MARKET... TABLE 38 GLOBAL MARKET FOR CELL-BASED ASSAYS USED IN DRUG... DISCOVERY BY SEGMENT, THROUGH 2018 ($ FIGURE 16 GLOBAL MARKET FOR CELL-BASED ASSAYS USED IN DRUG... DISCOVERY BY SEGMENT, ($ CELL-BASED ASSAYS: KEY HISTORICAL FACTS TABLE 39 KEY COMPANIES CELL MIGRATION ASSAYS HIGH-CONTENT SCREENING MARKET TABLE 40 GLOBAL MARKET FOR HIGH-CONTENT SCREENING ASSAYS AND INSTRUMENTATION, THROUGH 2018 ($

10 FIGURE 17 GLOBAL MARKET FOR HIGH-CONTENT SCREENING ASSAYS... AND INSTRUMENTATION, ($ TABLE 41 HCS MARKET: MAJOR COMPANIES... HCS MARKET DRIVERS... COMPANIES Thermo Fisher Scientific Molecular Devices TABLE 42 MOLECULAR DEVICES: PRODUCTS Instruments for High-Content Screening TABLE 43 HCS SYSTEM PLATFORMS HIGH-CONTENT SCREENING KITS Companies EMD Millipore TABLE 44 MILLIPORE PRODUCTS: APPLICATIONS HIGH-CONTENT SCREENING INSTRUMENTATION MARKET... TABLE 45 GLOBAL MARKET FOR HIGH-CONTENT SCREENING... INSTRUMENTS, THROUGH 2018 ($ FIGURE 18 GLOBAL MARKET FOR HIGH-CONTENT SCREENING... INSTRUMENTS, ($ FLOW CYTOMETERS TABLE 46 KEY COMPANIES LABEL-FREE DETECTION MARKET... MICROPLATE INSTRUMENTATION AND SUPPLIES... CHALLENGES WITH CELL-BASED ASSAYS... FUTURE OF CELL-BASED ASSAYS... IN VITRO INFLAMMATION MODELS... 3D CULTURE... NEW DEVELOPMENTS Multiplex Assays for GPCR Signaling CELL-BASED ASSAYS FOR RESEARCH PURPOSES G PROTEIN-COUPLED RECEPTORS GPCR Drugs TABLE 47 GPCR-TARGETING KEY DRUGS TABLE 48 KEY COMPANIES WITH GPCR PRODUCTS Companies and Technologies Multispan DiscoveRx Omeros TABLE 49 OMEROS: GPCRS AND INDICATIONS Patent Position AB Vector Cisbio PerkinElmer Codex Biosolutions

11 ChanTest Corning Life Sciences GPCRs: A Potent Class of Drug Targets TABLE 50 ASSAY METHODS TO STUDY GPCRS (%) TABLE 51 GPCR PRIMARY SCREENING ASSAYS TABLE 52 GLOBAL MARKET FOR GPCR SCREENING AND PROFILING, ($ KEY FACTS... CELL-BASED ASSAYS: SCREENING ION CHANNELS... LABEL-FREE DETECTION... COMPANIES Life Technologies (Invitrogen Corp.) TABLE 53 LIFE TECHNOLOGIES PRODUCTS TABLE 54 INVITROGEN'S CELL-BASED TECHNOLOGIES CellSensor Assays LanthaScreen Assays TABLE 55 COMPARISON OF YEARS ENDED DEC. 31, 2011 AND ($ MILLIONS/%) Molecular Devices Roche Applied Science Thermo Fisher Scientific TABLE 56 THERMO FISHER SCIENTIFIC S ANALYTICAL TECHNOLOGIES SEGMENT REVENUE, 2012 AND 2013 ($ CONCLUSION CHAPTER 8 GLOBAL REGIONAL MARKETS GLOBAL MARKET FOR CELL-BASED ASSAYS CELL-BASED ASSAYS IN THE LEADING EMERGING MARKETS China Summary TABLE 57 GLOBAL MARKET FOR CELL-BASED ASSAYS BY REGION, THROUGH 2018 ($ FIGURE 19 GLOBAL MARKET FOR CELL-BASED ASSAYS BY REGION, ($ Emerging Economies U.S. MARKET TABLE 58 U.S. MARKET FOR CELL-BASED ASSAYS, THROUGH 2018 ($ FIGURE 20 U.S. MARKET FOR CELL-BASED ASSAYS, ($

12 Market Overview TABLE 59 KEY GROWTH DRIVERS OF THE MARKET FOR CELL-BASED ASSAYS What are Cell-Based Assays and Why the Hype? EUROPEAN MARKET TABLE 60 EUROPEAN CELL-BASED ASSAY MARKET, THROUGH 2018 ($ FIGURE 21 EUROPEAN CELL-BASED ASSAY MARKET, ($ DRUG DISCOVERY IN THE EMERGING ECONOMIES DRUG DISCOVERY IN INDIA AND CHINA China TABLE 61 CHINA S DRUG DISCOVERY OUTSOURCING MARKET, THROUGH 2018 ($ FIGURE 22 CHINA DRUG DISCOVERY OUTSOURCING MARKET, ($ Challenges India TABLE 62 INDIAN DRUG DISCOVERY MARKET, 2009 AND 2010 ($ FIGURE 23 INDIAN DRUG DISCOVERY MARKET, ($ ADVANCES IN CELL-BASED ASSAYS CONTRACT RESEARCH ORGANIZATIONS AND CELL-BASED ASSAYS OUTLOOK CHAPTER 9 KEY COMPANIES ACEA BIOSCIENCES BD BIOSCIENCES BECKMAN COULTER CELLULAR DYNAMICS INTERNATIONAL CALIPER LIFE SCIENCES CELSIS IVT CISBIO BIOASSAYS DISCOVERX CORP EMD MILLIPORE ENZO LIFE SCIENCES EVOTEC AG GE HEALTHCARE HEMOGENIX LIFE TECHNOLOGIES LONZA MOLECULAR DEVICES (DANAHER)

13 ONCOIMMUNIN ORIGENE TECHNOLOGIES PERKINELMER PROMEGA CORP ROCHE STEMCELLS INC THERMO FISHER SCIENTIFIC TTP LABTECH VIVO BIOSCIENCES VITRO BIOPHARMA CHAPTER 10 LEGAL ASPECTS OF CELL-BASED ASSAYS INTELLECTUAL PROPERTY LANDSCAPE OF CELL-BASED ASSAYS LATEST NEWS, ALLIANCES AND MERGERS Thermo Fisher Scientific to Sell Cell Culture Business D Cell Culture Start-up Vivo Biosciences, ACEA Biosciences and Roche to Develop New xcelligence System Assays for Stem Cell and Cancer Research DiscoveRx Corp. Acquires KINOMEscan Promega and Celsis In Vitro Technologies Introduced More Reliable Solutions for ADME/Tox Testing in Primary Hepatocytes Vitro Expands HemoGenix Alliance to Include Cell-Based Testing for Liver Toxicity Platypus Licenses Cell Exclusion Zone Technology to Cell Biolabs Ion Channel and GPCR Screening Services and Products LABEL-FREE TECHNOLOGIES PerkinElmer Launches the EnSpire Multimode Plate Reader SUMMARY AND OUTLOOK CHAPTER 11 BIBLIOGRAPHY

14 LIST OF TABLES SUMMARY TABLE GLOBAL MARKET FOR CELL-BASED ASSAYS, THROUGH 2018 ($... 7 TABLE 1 CELL-BASED ASSAYS AND USES TABLE 2 TYPES OF CELL-BASED ASSAYS TABLE 3 APOPTOTIC MARKERS TABLE 4 PROOF OF CONCEPT FOR CELL-BASED ASSAYS TABLE 5 GLOBAL MARKET AND FORECAST FOR CELL-BASED ASSAYS, THROUGH 2018 ($ TABLE 6 BIOLOGICAL ASSAY SYSTEMS FOR THE EVALUATION OF CYTOCHROME P450 ENZYME ISOFORMS TABLE 7 HEPATOCYTE ASSAY SYSTEMS TABLE 8 ADME ASSAYS TABLE 9 COMMON TOXICITY ASSAYS TABLE 10 TRADITIONAL METHODS OF ADME/TOX TESTING TABLE 11 CONVENTIONAL IN VITRO ADME/TOX SCREENING METHODS TABLE 12 LABEL-FREE ASSAYS AND APPLICATIONS TABLE 13 FACTORS FOR CELL-BASED ASSAY DEVELOPMENT TABLE 14 DIFFERENT APPROACHES TO CELL-BASED SYSTEMS FOR DRUG SCREENING TABLE 15 CURRENT CONFOCAL HCS PLATFORMS TABLE 16 WIDEFIELD HCS PLATFORMS TABLE 17 STUDIES FOR FILING AN IND TABLE 18 STUDIES FOR CLINICAL FILINGS TABLE 19 BIOLOGICAL APPLICATIONS FOR HCA TABLE 20 GLOBAL HTS MARKET, THROUGH 2018 ($ TABLE 21 HTS TECHNOLOGIES: KEY COMPANIES TABLE 22 GLOBAL MARKET FOR DRUG DISCOVERY TECHNOLOGIES, THROUGH 2018 ($ TABLE 23 GLOBAL MARKET FOR REAGENTS AND TOOLS USED IN DNA AND RNA RESEARCH, THROUGH 2018 ($ TABLE 24 GLOBAL MARKET FOR LIFE SCIENCE TOOLS, THROUGH 2018 ($ TABLE 25 GLOBAL MARKET FOR CELL BIOLOGY REAGENTS AND TOOLS, THROUGH 2018 ($ TABLE 26 GLOBAL MARKET FOR CELL CULTURE TOOLS, THROUGH 2018 ($ TABLE 27 GLOBAL MARKET FOR CELL CULTURE REAGENTS, THROUGH ($

15 TABLE 28 U.S. MARKET FOR CELL CULTURE REAGENTS, THROUGH 2018 ($ TABLE 29 GLOBAL MARKET FOR 3D CELL CULTURE REAGENTS, THROUGH ($ TABLE 30 CELL-BASED ASSAY COMPANIES TABLE 31 GLOBAL MARKET FOR CELL-BASED ASSAYS, THROUGH 2018 ($ TABLE 32 LIMITATIONS OF CELL-BASED ASSAYS TABLE 33 GLOBAL MARKET FOR CELL-BASED ASSAYS USED IN BASIC RESEARCH, THROUGH 2018 ($ TABLE 34 GLOBAL MARKET FOR IN VITRO TOXICITY TESTS, THROUGH 2017 ($ TABLE 35 GLOBAL MARKET FOR SPECIALIZED CELL-BASED ASSAYS USED IN DRUG DISCOVERY, THROUGH 2018 ($ TABLE 36 IN VITRO PREDICTIVE TOXICOLOGY ASSAYS TABLE 37 GLOBAL MARKET FOR ADME ASSAYS, THROUGH 2018 ($ TABLE 38 GLOBAL MARKET FOR CELL-BASED ASSAYS USED IN DRUG DISCOVERY BY SEGMENT, THROUGH 2018 ($ TABLE 39 KEY COMPANIES TABLE 40 GLOBAL MARKET FOR HIGH-CONTENT SCREENING ASSAYS AND INSTRUMENTATION, THROUGH 2018 ($ TABLE 41 HCS MARKET: MAJOR COMPANIES TABLE 42 MOLECULAR DEVICES: PRODUCTS TABLE 43 HCS SYSTEM PLATFORMS TABLE 44 MILLIPORE PRODUCTS: APPLICATIONS TABLE 45 GLOBAL MARKET FOR HIGH-CONTENT SCREENING INSTRUMENTS, THROUGH 2018 ($ TABLE 46 KEY COMPANIES TABLE 47 GPCR-TARGETING KEY DRUGS TABLE 48 KEY COMPANIES WITH GPCR PRODUCTS TABLE 49 OMEROS: GPCRS AND INDICATIONS TABLE 50 ASSAY METHODS TO STUDY GPCRS (%) TABLE 51 GPCR PRIMARY SCREENING ASSAYS TABLE 52 GLOBAL MARKET FOR GPCR SCREENING AND PROFILING, 2010 ($ TABLE 53 LIFE TECHNOLOGIES PRODUCTS TABLE 54 INVITROGEN'S CELL-BASED TECHNOLOGIES TABLE 55 COMPARISON OF YEARS ENDED DEC. 31, 2011 AND 2010 ($ MILLIONS/%) TABLE 56 THERMO FISHER SCIENTIFIC S ANALYTICAL TECHNOLOGIES SEGMENT REVENUE, 2012 AND 2013 ($ TABLE 57 GLOBAL MARKET FOR CELL-BASED ASSAYS BY REGION, THROUGH ($ TABLE 58 U.S. MARKET FOR CELL-BASED ASSAYS, THROUGH 2018 ($

16 TABLE 59 KEY GROWTH DRIVERS OF THE MARKET FOR CELL-BASED ASSAYS TABLE 60 EUROPEAN CELL-BASED ASSAY MARKET, THROUGH 2018 ($ TABLE 61 CHINA S DRUG DISCOVERY OUTSOURCING MARKET, THROUGH ($ TABLE 62 INDIAN DRUG DISCOVERY MARKET, 2009 AND 2010 ($

17 LIST OF FIGURES SUMMARY FIGURE GLOBAL MARKET FOR CELL-BASED ASSAYS, ($... 7 FIGURE 1 DRUG DISCOVERY PROCESS AND STEPS... 9 FIGURE 2 GLOBAL MARKET AND FORECAST FOR CELL-BASED ASSAYS, ($ FIGURE 3 GLOBAL MARKET FOR DRUG DISCOVERY TECHNOLOGIES ($ FIGURE 4 GLOBAL MARKET FOR REAGENTS AND TOOLS USED IN DNA AND RNA RESEARCH, ($ FIGURE 5 GLOBAL MARKET FOR LIFE SCIENCE TOOLS, ($ FIGURE 6 GLOBAL MARKET FOR CELL BIOLOGY REAGENTS AND TOOLS, ($ FIGURE 7 GLOBAL MARKET FOR CELL CULTURE TOOLS, ($ FIGURE 8 GLOBAL MARKET FOR CELL CULTURE REAGENTS, ($ FIGURE 9 U.S. MARKET FOR CELL CULTURE REAGENTS, ($ FIGURE 10 GLOBAL MARKET FOR 3D CELL CULTURE REAGENTS, ($ FIGURE 11 GLOBAL MARKET FOR CELL-BASED ASSAYS, ($ FIGURE 12 GLOBAL MARKET FOR CELL-BASED ASSAYS USED IN BASIC RESEARCH, ($ FIGURE 13 GLOBAL MARKET FOR IN VITRO TOXICITY TESTS, ($ FIGURE 14 GLOBAL MARKET FOR SPECIALIZED CELL-BASED ASSAYS USED IN DRUG DISCOVERY, ($ FIGURE 15 GLOBAL MARKET FOR ADME ASSAYS, ($ FIGURE 16 GLOBAL MARKET FOR CELL-BASED ASSAYS USED IN DRUG DISCOVERY BY SEGMENT, ($ FIGURE 17 GLOBAL MARKET FOR HIGH-CONTENT SCREENING ASSAYS AND INSTRUMENTATION, ($ FIGURE 18 GLOBAL MARKET FOR HIGH-CONTENT SCREENING INSTRUMENTS, ($ FIGURE 19 GLOBAL MARKET FOR CELL-BASED ASSAYS BY REGION, ($

18 FIGURE 20 U.S. MARKET FOR CELL-BASED ASSAYS, ($ FIGURE 21 EUROPEAN CELL-BASED ASSAY MARKET, ($ FIGURE 22 CHINA DRUG DISCOVERY OUTSOURCING MARKET, ($ FIGURE 23 INDIAN DRUG DISCOVERY MARKET, ($

19 Chapter 1 INTRODUCTION CELL-BASED ASSAYS: TECHNOLOGIES AND GLOBAL MARKETS BIO080B April 2014 Usha Nagavarapu Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA USA (toll-free within the USA), or (+1) information@bccresearch.com

20 BIO080B - Cell-based Assays: Technologies and Global Markets CHAPTER 1 INTRODUCTION STUDY GOALS AND OBJECTIVES This BCC Research market report, Cell-Based Assays: Technologies and Global Markets, provides a detailed overview and thorough analysis of the present and future global market for cell-based techniques. This report analyzes in detail the cell-based assays available and currently used and their markets. This report includes current products in this market and detailed analyses of markets and competitive environments; market for cell assays in newly emerging regions, and instrumentation and robotics and their impact on the market. The report includes information about significant products and assays, key players, issues and trends, current market status of cell-based assays, strengths, weaknesses, opportunities and threats facing various assays and developments already on the market, major issues involved in the research and development (R&D) of more effective cell-based approaches, for drug discovery, and absorption, distribution, metabolism and excretion (ADME)/toxicity assays in development and in use. REASONS FOR DOING THE STUDY Cell-based assays have emerged as a more relevant alternative to biochemical assays involving the use of purified proteins especially in the field of drug discovery. There has been growth in demand for cell-based assays. A number of cell culture and liquid-handling instruments are available on the market that allows cell-based screening. The majority of compound screening programs performed by the biopharmaceutical industry are dependent on cell-based assays for functional measures of target activation. Label-free cellular assays are also driving this market forward, with their sensitivity, robustness, ease of use and flexibility. These assays are now used routinely throughout early drug discovery from target identification and validation to primary screening, lead identification, lead optimization and into safety and toxicology. There is a need to understand the trends in this market, currently available assays and latest developments for drug discovery. SCOPE AND FORMAT This report is an update on Cell-Based Assays: Technologies and Global Markets. It will review global markets for cell-based assays and new developments and will forecast trends for use of these assays for drug discovery and safety and toxicology through Important assays, technologies and the latest developments, market share by assay type, products on the market and market share by company, and statistical information for types of cancers prevalent worldwide, with a special emphasis on the U.S. market. Copyright BCC Research, Wellesley MA USA, Website: 3

21 BIO080B - Cell-based Assays: Technologies and Global Markets The report also includes current issues and trends affecting the industry and costs, and factors influencing demand will be discussed. The report covers products in development, new technologies, trends, alliances and mergers. The report offers market data with respect to segments and geography. It also provides market trends with respect to drivers, restraints and opportunities. INTENDED AUDIENCE This report is an exhaustive study on the global market for cell-based assays, giving crucial statistics and analysis on existing technologies, latest trends, market structure, market size, key drug segments, important trends in technology development, major opportunities and market shares of key players and drugs. This report may prove crucial for the firms or investors seeking investments in the concerned sector. This report shows cell-based assays currently being used, new developments, spending trends and revenue prospects for cell-based assays in pharma. The report provides market data for 2012 to 2018 and also covers commercial prospects for cell assays in drug research and ADME/toxicity assays. METHODOLOGY Both primary and secondary research methodologies were used in preparing this report. Secondary sources include books, newspapers, trade journals, white papers, industry portals, government agencies, trade associations, monitoring industry news and developments and through access to paid databases. The base year of the report is 2012, with forecast data provided through Historical, base year and forecast data are provided for each market segment of this report. Growth rates are determined through a compilation of data, including past trends, future trends, demographics, incidence, mortality, products in R&D and current product growth. ANALYST CREDENTIALS Usha Nagavarapu is an experienced pharmaceutical professional with business development experience. She has preclinical, alliance management, discovery and technology development and marketing experience. Her strong focus areas include oncology and cardiovascular diseases, with expertise in molecular and cell biology and complex cell-based biological assays ranging from drug discovery, in vitro and in vivo screening, in vivo model development and pharmacokinetics. She has experience working with early start-ups. RELATED BCC RESEARCH REPORTS PHM017E In Vitro Toxicity Testing: Technologies and Global Markets. BIO049E Global Biochip Markets: Microarrays and Lab-on-a-Chip. HLC027B Cancer Therapies: Technologies and Global Markets. BIO061B Biomarkers: Technologies and Global Markets. Copyright BCC Research, Wellesley MA USA, Website: 4

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