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INTRODUCTION

STUDY OBJECTIVES

BCC’s goal in conducting this study is to provide an overview of the current and future characteristics of the global market for cell and tissue analysis products. The key objective is to present a comprehensive analysis of the future direction of cell and tissue products that will serve as a valuable tool for their use of.

This report explores present and future strategies within the cell and tissue analysis market, including biospecimen-preparing techniques, cell and tissue separation, and cell and tissue characterization products. The market’s improvisation, setbacks and needs are also discussed. The classifications, comparisons and usage of cell and tissue analysis products are also presented in this report.

A detailed analysis of the cell and tissue analysis industry structure has been conducted. Revenues are broken down by region, and sales figures are estimated for the five-year period from 2012 through 2017.

Applications for cell and tissue analysis products are discussed separately. The report also covers significant patents and their allotments in each category.

REASONS FOR DOING THIS STUDY

Extensive research in the field of cell and tissue analysis products has revealed their specific functionality in providing specific analysis for the healthcare and the biopharmaceutical industries. Modern industries have begun to explore the advantages of cell and tissue analysis products in their productions and processes, leading to the steady market in this area.

R&D spending, increasing competition, patent expiries and new technologies are leading this market in a new direction. The new advancements, new product launches and changing lifestyles have influenced the market to grow in the foreseeable future. This study looks at many of the systems affected by these factors.

Acquisition strategies and company collaborations are covered in this report. This study also discusses the strength and weaknesses of each type of technology in light of the new technologies, growing competition and changing customer needs.

CONTRIBUTIONS OF THE STUDY AND INTENDED AUDIENCE

This study contributes to the areas of market growth in cell and tissue analysis manufacturers and users. It will be of interest to pharmaceutical companies, biotechnical companies, research institutes and physicians.

SCOPE OF THE STUDY

The scope of this study encompasses cell and tissue analysis products in the pharmaceutical and biotechnology markets. BCC analyzes each market and its applications, regulatory environment, technology, market projection and market share. Technological issues include the latest trends and developments. The emerging markets for enzyme inhibitors include India, China, Japan, South Korea, Taiwan, Canada, Africa, Australia and New Zealand.

METHODOLOGY

Both primary and secondary research methodologies were used in preparing this study. BCC conducted a comprehensive literature search, which included technical newsletters and journals, as well as many other sources. Data were collected through interviews and correspondence with manufacturers of cell and tissue analysis products technical experts. Projections were based on estimates such as the current number of end users, potential end users, mergers and acquisitions, and market trends.

INFORMATION SOURCES

Numerous companies were surveyed to obtain data for this study, including manufacturers and end users of kinase inhibitors in therapeutic categories and various disease sectors. Data were gathered from various industry sources. BCC researchers spoke with officials within the industry and also consulted newsletters; company literature; product literature; and a host of technical articles, journals, indices and abstracts. Exhaustive investigations of databases by key terminology were completed. In addition, data were compiled from current financial, trade and government sources.

ABOUT THE AUTHOR

This study was carried out by a team of professionals in the biotechnology industry. Shalini S. Dewan, the project manager, holds a Master’s degree in pharmaceutical chemistry and has more than 14 years of industry experience. She has covered such research topics as compounds of potential pharmaceutical interest from ibuprofen and 2-naphthyl acetic acid. Shalini was awarded a Gold Medal by the Prime Minister of India for her work and has worked with top companies in India and in the U.S. Her other reports with BCC include Reagents for Chromatography; Spectroscopy: An Enduring Market; Advanced Drug Delivery Systems: Technologies and Global Markets; Orthopedic Drugs, Implants and Devices; Medical Imaging Reagents and Analysis Equipment; Pharmaceutical Regulatory Industry; The Dynamic Media, Sera and Reagent Market in Biotechnology; Contract Pharmaceutical Manufacturing, Research and Packaging: Global Markets; Chiral Technology: Global Markets; Autacoids and Related Drugs: Technologies and Global Markets; Contraceptives: Technologies and Global Markets; Liver Disease Treatments: The Global Market; Hormone Replacement Therapies and Other Hormone Therapies: Global Markets; Cardiovascular Medicine: Diagnostics, Drugs and Devices; and Cancer Therapies: Technologies and Global Markets.

Table Of Contents

Global Markets and Technologies for Cell and Tissue Analysis -- Focus on Biospecimen Preparation
TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 1
STUDY OBJECTIVES 1
REASONS FOR DOING THIS STUDY 1
CONTRIBUTIONS OF THE STUDY AND INTENDED AUDIENCE 1
SCOPE OF THE STUDY 1
METHODOLOGY 2
INFORMATION SOURCES 2
ABOUT THE AUTHOR 2
RELATED BCC RESEARCH REPORTS 2
BCC ONLINE SERVICES 3
DISCLAIMER 3
CHAPTER 2 SUMMARY 5
SUMMARY TABLE GLOBAL CELL AND TISSUE ANALYSIS MARKET BY PRODUCT TYPE,
THROUGH 2017 ($ MILLIONS) 6
SUMMARY FIGURE GLOBAL CELL AND TISSUE ANALYSIS MARKET BY PRODUCT TYPE,
2010-2017 ($ MILLIONS) 6
CHAPTER 3 OVERVIEW 8
INTRODUCTION 8
CELLS 8
CELL TYPES 8
TABLE 1 DIFFERENCES BETWEEN PROKARYOTIC CELLS AND EUKARYOTIC CELLS 9
Plant and Animal Cell Characteristics 9
TABLE 2 PLANT AND ANIMAL CELL DIFFERENCES 9
TISSUE 10
Tissue Types 10
TABLE 3 TISSUE TYPES 10
ANTIBODIES 11
ANTIGENS 11
EPITOPES 11
APOPTOSIS 12
BIOMARKERS 12
BIOSPECIMENS 12
CLASSIFICATION OF TECHNIQUES USED IN CELL AND TISSUE ANALYSIS 12
TABLE 4 CELL AND TISSUE ANALYSIS CLASSIFICATION TECHNIQUES 13
BIOSPECIMEN TECHNIQUES 15
Microarray 15
Tissue Microarrays 15
DNA Microarray (DNA Chip and Biochip) 15
Protein Microarray 15
Peptide Microarray (Peptide Chip/Peptide Epitope Microarray) 15
Cellular Microarray 16
CELL-SEPARATION TECHNIQUES 16
Mechanical Dissociators 16
Enzymes Used for Cell Dissociation 16
Laser-Capture Micro-Dissection 17
Florescence-Activated Cell Sorting 18
FIGURE 1 SCHEMATIC REPRESENTATION OF A FLOW CYTOMETER 18
Magnetism-Activated Cell Sorting 19
FIGURE 2 SCHEMATIC REPRESENTATION OF THE QUADRUPOLE MAGNETIC SORTER 20
CELL AND TISSUE CHARACTERIZATION 21
Cell-Based Assays 21
Components for Cell-Based Assay Automation 22
Antibody-Based Assay 22
High-Content Screening 23
Immunoassay 24
CHAPTER 4 REGULATORY ISSUES 26
CODE OF FEDERAL REGULATIONS 26
CLASS I: GENERAL CONTROLS 26
CLASS II: GENERAL CONTROLS WITH SPECIAL CONTROLS 26
CLASS III: GENERAL CONTROLS AND PREMARKET APPROVAL 26
DRUG APPROVALS 27
TABLE 5 FDA-APPROVED CELL AND TISSUE ANALYSIS PRODUCTS, 2010-MAY 2012 27
RECALLS 28
TABLE 6 FDA PRODUCT RECALLS FOR CELL AND TISSUE ANALYSIS PRODUCTS, 2012 29
TABLE 7 FDA PRODUCT RECALLS FOR CELL AND TISSUE ANALYSIS PRODUCTS, 2011 29
TABLE 8 FDA PRODUCT RECALLS FOR CELL AND TISSUE ANALYSIS PRODUCTS, 2010 32
TABLE 9 FDA PRODUCT RECALLS FOR CELL AND TISSUE ANALYSIS PRODUCTS, 2009 34
CHAPTER 5 NEW DEVELOPMENTS 36
TABLE 10 CELL AND TISSUE ANALYSIS PRODUCTS IN THE PIPELINE 36
TABLE 11 NEW DEVELOPMENTS AND ADVANCEMENTS, 2012 38
TABLE 12 NEW DEVELOPMENTS AND ADVANCEMENTS, 2011 40
TABLE 13 NEW DEVELOPMENTS AND ADVANCEMENTS, 2010 40
CHAPTER 6 GLOBAL MARKETS 42
MARKETS BY TYPE 42
MARKET OVERVIEW 42
MARKET REVENUE 43
TABLE 14 GLOBAL CELL AND TISSUE ANALYSIS PRODUCT MARKET BY TYPE, THROUGH
2017 ($ MILLIONS) 44
FIGURE 3 GLOBAL CELL AND TISSUE ANALYSIS PRODUCT MARKET BY TYPE, 2010-2017 ($
MILLIONS) 44
MARKET SHARE 44
TABLE 15 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE BY TYPE, 2011 (%) 45
FIGURE 4 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE BY TYPE, 2011 (%) 45
BIOSPECIMEN-PREPARING TECHNIQUES 45
MARKET OVERVIEW 46
MARKET REVENUE 47
TABLE 16 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT MARKET BY TYPE,
THROUGH 2017 ($ MILLIONS) 47
FIGURE 5 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT MARKET BY TYPE,
2010-2017 ($ MILLIONS) 47
CELL AND TISSUE SEPARATION PRODUCTS 48
MARKET OVERVIEW 48
MARKET REVENUE 49
TABLE 17 CELL AND TISSUE SEPARATION PRODUCT MARKET BY TYPE, THROUGH 2017 ($
MILLIONS) 50
FIGURE 6 CELL AND TISSUE SEPARATION PRODUCT MARKET BY TYPE, 2010-2017 ($
MILLIONS) 50
CELL AND TISSUE CHARACTERIZATION PRODUCTS 51
MARKET OVERVIEW 51
MARKET REVENUE 54
TABLE 18 CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET BY TYPE, THROUGH
2017 ($ MILLIONS) 54
FIGURE 7 CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET BY TYPE, 2010-2017 ($
MILLIONS) 54
MARKET BY REGION 55
TABLE 19 CELL AND TISSUE ANALYSIS PRODUCT MARKET BY REGION, THROUGH 2017 ($
MILLIONS) 55
FIGURE 8 CELL AND TISSUE ANALYSIS PRODUCT MARKET BY REGION, 2010-2017 ($
MILLIONS) 56
MARKET SHARE 56
TABLE 20 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE BY REGION, 2011 (%) 56
FIGURE 9 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE BY REGION, 2011 (%) 56
BIOSPECIMEN-PREPARING TECHNIQUES 57
MARKET OVERVIEW 57
MARKET REVENUE 57
TABLE 21 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE MARKET BY REGION, THROUGH
2017 ($ MILLIONS) 58
North America 58
Europe 58
Emerging Markets 58
FIGURE 10 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE PRODUCTS MARKET BY
REGION, 2010-2017 ($ MILLIONS) 59
MARKET SHARE 59
TABLE 22 BIOSPECIMEN-PREPARING TECHNIQUE PRODUCTS MARKET SHARE BY REGION,
2011 (%) 59
FIGURE 11 BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT MARKET SHARE BY REGION,
2011 (%) 59
CELL AND TISSUE SEPARATION PRODUCTS 60
MARKET OVERVIEW 60
MARKET REVENUE 60
TABLE 23 GLOBAL CELL AND TISSUE SEPARATION PRODUCT MARKET BY REGION,
THROUGH 2017 ($ MILLIONS) 60
North America 61
Europe 61
Emerging Markets 61
FIGURE 12 GLOBAL CELL AND TISSUE SEPARATION PRODUCT MARKET BY REGION,
2010-2017 ($ MILLIONS) 61
MARKET SHARE 62
TABLE 24 CELL AND TISSUE SEPARATION PRODUCT MARKET SHARE BY REGION, 2010 (%) 62
FIGURE 13 CELL AND TISSUE SEPARATION PRODUCT MARKET SHARE BY REGION, 2010 (%) 62
CELL AND TISSUE CHARACTERIZATION 63
MARKET OVERVIEW 63
MARKET REVENUE 63
TABLE 25 GLOBAL CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET BY REGION,
THROUGH 2017 ($ MILLIONS) 64
North America 64
Europe 64
Emerging Markets 64
FIGURE 14 GLOBAL CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET BY REGION,
THROUGH 2017 ($ MILLIONS) 65
MARKET SHARE 65
TABLE 26 GLOBAL CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET SHARE BY
REGION, 2011 (%) 65
FIGURE 15 GLOBAL CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET SHARE BY
REGION, 2011 (%) 65
MARKET BY END USERS 66
Market Overview 66
CELL AND TISSUE ANALYSIS 67
MARKET REVENUE 67
TABLE 27 GLOBAL CELL AND TISSUE ANALYSIS PRODUCT MARKET BY END USER,
THROUGH 2017 ($ MILLIONS) 67
FIGURE 16 GLOBAL CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET BY END
USER, 2010-2017 ($ MILLIONS) 67
MARKET SHARE 68
TABLE 28 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE BY END USER, 2011 (%) 68
FIGURE 17 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE BY END USER, 2011 (%) 68
RESEARCH AND ACADEMICS 68
MARKET OVERVIEW 68
MARKET REVENUE 69
TABLE 29 CELL AND TISSUE ANALYSIS PRODUCT CONSUMPTION IN RESEARCH AND
ACADEMICS BY REGION, THROUGH 2017 ($ MILLIONS) 70
FIGURE 18 CELL AND TISSUE ANALYSIS PRODUCTION CONSUMPTION IN RESEARCH AND
ACADEMICS BY REGION, 2010-2017 ($ MILLIONS) 70
MARKET SHARE 70
TABLE 30 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE IN RESEARCH AND
ACADEMICS BY REGION, 2011 (%) 71
FIGURE 19 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE IN RESEARCH AND
ACADEMICS BY REGION, 2011 (%) 71
BIOPHARMACEUTICALS 71
MARKET OVERVIEW 71
MARKET REVENUE 72
TABLE 31 CELL AND TISSUE ANALYSIS PRODUCT CONSUMPTION IN
BIOPHARMACEUTICALS BY REGION, THROUGH 2017 ($ MILLIONS) 73
FIGURE 20 CELL AND TISSUE ANALYSIS PRODUCT CONSUMPTION IN
BIOPHARMACEUTICALS BY REGION, 2010-2017 ($ MILLIONS) 73
MARKET SHARE 73
TABLE 22 BIOSPECIMEN-PREPARING TECHNIQUE PRODUCTS MARKET SHARE BY REGION,
2011 (%) 74
FIGURE 21 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE IN
BIOPHARMACEUTICALS BY REGION, 2011 (%) 74
HEALTHCARE AND CLINICAL 74
MARKET OVERVIEW 74
MARKET REVENUE 75
TABLE 33 CELL AND TISSUE ANALYSIS PRODUCT CONSUMPTION IN THE HEALTHCARE
AND CLINICAL INDUSTRY BY REGION, THROUGH 2017 ($ MILLIONS) 75
FIGURE 22 CELL AND TISSUE ANALYSIS PRODUCT CONSUMPTION IN THE HEALTHCARE
AND CLINICAL INDUSTRY BY REGION, 2010-2017 ($ MILLIONS) 76
MARKET SHARE 76
TABLE 34 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE IN THE HEALTHCARE
AND CLINICAL INDUSTRY BY REGION, 2011 (%) 76
FIGURE 23 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE IN THE HEALTHCARE
AND CLINICAL INDUSTRY BY REGION, 2011 (%) 76
CHAPTER 7 BIOSPECIMEN-PREPARING TECHNIQUE MARKET ANALYSIS 79
MARKET BY TYPES 79
TABLE 35 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE MARKET BY PRODUCT TYPE,
THROUGH 2017 ($ MILLIONS) 79
FIGURE 24 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE MARKET BY PRODUCT TYPE,
2010-2017 ($ MILLIONS) 79
DNA MICROARRAY 80
Market Overview 80
Market Revenue 81
TABLE 36 GLOBAL DNA MICROARRAY PRODUCT MARKET BY REGION, THROUGH 2017 ($
MILLIONS) 81
FIGURE 25 GLOBAL DNA MICROARRAY PRODUCT MARKET BY REGION, 2010-2017 ($
MILLIONS) 81
TABLE 37 GLOBAL PROTEIN MICROARRAY PRODUCT MARKET BY REGION, THROUGH 2017
($ MILLIONS) 83
FIGURE 26 GLOBAL PROTEIN MICROARRAY PRODUCT MARKET BY REGION, 2010-2017 ($
MILLIONS) 83
TISSUE MICROARRAYS 84
TABLE 38 GLOBAL TISSUE MICROARRAY PRODUCT MARKET BY REGION, THROUGH 2017 ($
MILLIONS) 84
FIGURE 27 GLOBAL TISSUE MICROARRAY PRODUCT MARKET BY REGION, 2010-2017 ($
MILLIONS) 84
MARKET BY REGION 85
TABLE 39 GLOBAL REVENUE FOR BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT
MARKET BY REGION, THROUGH 2017 ($ MILLIONS) 86
FIGURE 28 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT MARKET BY REGION,
2010-2017 ($ MILLIONS) 86
North America 87
TABLE 40 NORTH AMERICAN BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT MARKET
BY TYPE, THROUGH 2017 ($ MILLIONS) 87
FIGURE 29 NORTH AMERICAN BIOSPECIMEN-PREPARING TECHNIQUE MARKET BY TYPE,
2010-2017 ($ MILLIONS) 87
Europe 88
TABLE 41 EUROPEAN BIOSPECIMEN PREPARING TECHNIQUES MARKET BY TYPE,
THROUGH 2017 ($ MILLIONS) 88
FIGURE 30 EUROPEAN BIOSPECIMEN-PREPARING TECHNIQUE MARKET BY TYPE,
2010-2017 ($ MILLIONS) 88
Emerging Markets 89
TABLE 42 EMERGING MARKETS BIOSPECIMEN-PREPARING TECHNIQUE MARKET BY TYPE,
THROUGH 2017 ($ MILLIONS) 89
FIGURE 31 EMERGING MARKETS BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT
MARKET, 2010-2017 ($ MILLIONS) 89
MARKET BY END USERS 90
TABLE 43 BIOSPECIMENS AND TISSUE MICROARRAY PRODUCT MARKET BY END USE,
THROUGH 2017 ($ MILLIONS) 91
FIGURE 32 BIOSPECIMENS AND TISSUE MICROARRAY PRODUCT MARKET BY END USE,
2010-2017 ($ MILLIONS) 91
RESEARCH AND ACADEMIC 92
Market Overview 92
Market Revenue 92
TABLE 44 BIOSPECIMEN AND MICROARRAY PRODUCT CONSUMPTION IN RESEARCH AND
ACADEMICS BY REGION, THROUGH 2017 ($ MILLIONS) 93
FIGURE 33 BIOSPECIMEN AND MICROARRAY PRODUCT CONSUMPTION IN RESEARCH AND
ACADEMICS BY REGION, 2010-2017 ($ MILLIONS) 93
BIOPHARMACEUTICALS 93
Market Overview 93
Market Revenue 94
TABLE 45 BIOSPECIMEN AND TISSUE MICROARRAY PRODUCT CONSUMPTION IN THE
BIOPHARMACEUTICALS INDUSTRY BY REGION, THROUGH 2017 ($ MILLIONS) 94
FIGURE 34 BIOSPECIMENS AND TISSUE MICROARRAY PRODUCT CONSUMPTION IN THE
BIOPHARMACEUTICALS INDUSTRY BY REGION, 2010-2017 ($ MILLIONS) 94
HEALTHCARE AND CLINICAL 95
Market Overview 95
TABLE 46 BIOSPECIMEN AND TISSUE MICROARRAY PRODUCT CONSUMPTION IN THE
HEALTHCARE AND CLINICAL INDUSTRY BY REGION, THROUGH 2017 ($ MILLIONS) 96
FIGURE 35 BIOSPECIMEN AND TISSUE MICROARRAY PRODUCT CONSUMPTION IN THE
HEALTHCARE AND CLINICAL INDUSTRY BY REGION, 2010-2017 ($ MILLIONS) 96
INDUSTRY STRUCTURE 97
MARKET LEADERS 97
TABLE 47 BIOSPECIMEN MARKET LEADERS 97
MARKET SHARE 97
TABLE 48 BIOSPECIMEN MANUFACTURERS AND DISTRIBUTORS BY MARKET SHARE, 2011
(%) 98
FIGURE 36 BIOSPECIMEN MANUFACTURERS AND DISTRIBUTORS BY MARKET SHARE, 2011
(%) 98
DNA MICROARRAY 99
Market Leaders 99
TABLE 49 DNA MICROARRAY MARKET LEADERS 99
Market Share 99
TABLE 50 DNA MICROARRAY MANUFACTURERS AND DISTRIBUTORS BY MARKET SHARE,
2011 (%) 100
FIGURE 37 DNA MICROARRAY MANUFACTURERS AND DISTRIBUTORS BY MARKET SHARE,
2011 (%) 100
PROTEIN MICROARRAY 101
Market Leaders 101
TABLE 51 PROTEIN MICROARRAY MARKET LEADERS 101
Market Share 101
TABLE 52 PROTEIN MICROARRAY PRODUCT MANUFACTURERS AND DISTRIBUTORS BY
MARKET SHARE, 2011 (%) 102
FIGURE 38 PROTEIN MICROARRAY PRODUCT MANUFACTURERS AND DISTRIBUTORS BY
MARKET SHARE, 2011 (%) 102
TISSUE MICROARRAY 102
Market Leaders 102
TABLE 53 TISSUE MICROARRAY PRODUCT MARKET LEADERS 103
Market Share 103
TABLE 54 TISSUE MICROARRAY PRODUCT MANUFACTURERS AND DISTRIBUTORS BY
MARKET SHARE, 2011 (%) 103
FIGURE 39 TISSUE MICROARRAY PRODUCT MANUFACTURERS AND DISTRIBUTORS BY
MARKET SHARE, 2011 (%) 104
CHAPTER 8 PATENT ANALYSIS 106
PATENTS BY YEAR 106
TABLE 55 CELL AND TISSUE ANALYSIS, 2008-2012 (NO. OF PATENTS) 106
FIGURE 40 CELL AND TISSUE ANALYSIS, 2008-2012 (NO. OF PATENTS) 106
FIGURE 41 CELL AND TISSUE ANALYSIS PRODUCT PATENTS BY YEAR, 2008-2012 (%) 107
PATENTS BY CATEGORY 108
TABLE 56 CELL AND TISSUE ANALYSIS PRODUCT PATENTS BY TYPE, 2008-2012 108
FIGURE 42 CELL AND TISSUE ANALYSIS PRODUCT PATENTS BY TYPE, 2008-2012 109
PATENTS BY COMPANY 109
TABLE 57 U.S. PATENTS FOR CELL AND TISSUE ANALYSIS PRODUCTS BY COMPANY,
2008-2012 109
PATENTS BY COUNTRY 111
TABLE 58 U.S. PATENTS FOR CELL AND TISSUE ANALYSIS PRODUCTS BY COUNTRY,
2008-2012 111
FIGURE 43 U.S. PATENTS FOR CELL AND TISSUE ANALYSIS PRODUCTS BY COUNTRY,
2008-2012 112
TABLE 59 CELL AND TISSUE ANALYSIS PRODUCT PATENT SHARES BY COUNTRY, 2010-2011
(%) 112
FIGURE 44 CELL AND TISSUE ANALYSIS PRODUCT PATENT SHARES BY COUNTRY,
2010-2011 (%) 113
PATENTS BY ASSIGNEE 113
TABLE 60 CELL AND TISSUE ANALYSIS PRODUCT PATENTS BY ASSIGNEE TYPE, 2008-2012 114
FIGURE 45 CELL AND TISSUE ANALYSIS PRODUCT PATENTS BY ASSIGNEE TYPE, 2008-2012 114
TABLE 61 CELL AND TISSUE ANALYSIS PRODUCT PATENT SHARES BY ASSIGNEE TYPE,
2010-2011 (NO./%) 115
FIGURE 46 CELL AND TISSUE ANALYSIS PRODUCT PATENT SHARES BY ASSIGNEE TYPE,
2010-2011 (%) 115
CHAPTER 9 CURRENT SITUATION 117
CELL AND TISSUE ANALYSIS TECHNIQUES AS DIAGNOSTIC TOOLS 117
CURRENT CHALLENGES FOR THE CLINICAL USE AND MARKETING OF
MICROARRAYS 118
FUTURE PERSPECTIVE 119
CHAPTER 10 COMPANY PROFILES 121
ABCAM, PLC. 121
ABNOVA 121
ACCURI CYTOMETERS INC. 121
AFFYMETRIX 122
ANALYTICAL BIOLOGICAL SERVICES INC. 122
ARRAYIT CORPORATION 122
BD BIOSCIENCES 123
BECKMAN COULTER INC. 123
CARL ZEISS MICROIMAGING GMBH 124
CLONTECH LABORATORIES 124
CYBRDI INC. 125
EBIOSCIENCE INC. 125
EUROGENTEC S.A. 125
GE HEALTHCARE 126
ILLUMINA INC. 126
INVITROGEN CORPORATION 127
LC SCIENCES 127
LEICA MICROSYSTMS 127
MDS ANALYTICAL TECHNOLOGIES 128
MEDIX BIOCHEMICA 128
MERCK SERONO SA 129
MILTENYI BIOTEC 129
MILLIPORE 129
PARTEC GMBH 130
PERKIN ELMER INC. 130
ROCHE APPLIED SCIENCE 131
SIGMA-ALDRICH INC. 131
SOUTHERN BIOTECH 131
STEM CELL TECHNOLOGIES 132
STRATIGIC DIAGNOSTICS 132
TGA SCIENCES 133
THERMO FISHER SCIENTIFIC 133
WORTHINGTON BIOCHEMICAL CORPORATION 134
CHAPTER 11 APPENDIX: ABBREVIATIONS 136

LIST OF TABLES
SUMMARY TABLE GLOBAL CELL AND TISSUE ANALYSIS MARKET BY PRODUCT TYPE,
THROUGH 2017 ($ MILLIONS) 6
TABLE 1 DIFFERENCES BETWEEN PROKARYOTIC CELLS AND EUKARYOTIC CELLS 9
TABLE 2 PLANT AND ANIMAL CELL DIFFERENCES 9
TABLE 3 TISSUE TYPES 10
TABLE 4 CELL AND TISSUE ANALYSIS CLASSIFICATION TECHNIQUES 13
TABLE 5 FDA-APPROVED CELL AND TISSUE ANALYSIS PRODUCTS, 2010-MAY 2012 27
TABLE 6 FDA PRODUCT RECALLS FOR CELL AND TISSUE ANALYSIS PRODUCTS, 2012 29
TABLE 7 FDA PRODUCT RECALLS FOR CELL AND TISSUE ANALYSIS PRODUCTS, 2011 29
TABLE 8 FDA PRODUCT RECALLS FOR CELL AND TISSUE ANALYSIS PRODUCTS, 2010 32
TABLE 9 FDA PRODUCT RECALLS FOR CELL AND TISSUE ANALYSIS PRODUCTS, 2009 34
TABLE 10 CELL AND TISSUE ANALYSIS PRODUCTS IN THE PIPELINE 36
TABLE 11 NEW DEVELOPMENTS AND ADVANCEMENTS, 2012 38
TABLE 12 NEW DEVELOPMENTS AND ADVANCEMENTS, 2011 40
TABLE 13 NEW DEVELOPMENTS AND ADVANCEMENTS, 2010 40
TABLE 14 GLOBAL CELL AND TISSUE ANALYSIS PRODUCT MARKET BY TYPE, THROUGH 2017
($ MILLIONS) 44
TABLE 15 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE BY TYPE, 2011 (%) 45
TABLE 16 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT MARKET BY TYPE,
THROUGH 2017 ($ MILLIONS) 47
TABLE 17 CELL AND TISSUE SEPARATION PRODUCT MARKET BY TYPE, THROUGH 2017 ($
MILLIONS) 50
TABLE 18 CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET BY TYPE, THROUGH
2017 ($ MILLIONS) 54
TABLE 19 CELL AND TISSUE ANALYSIS PRODUCT MARKET BY REGION, THROUGH 2017 ($
MILLIONS) 55
TABLE 20 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE BY REGION, 2011 (%) 56
TABLE 21 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE MARKET BY REGION, THROUGH
2017 ($ MILLIONS) 58
TABLE 22 BIOSPECIMEN-PREPARING TECHNIQUE PRODUCTS MARKET SHARE BY REGION,
2011 (%) 59
TABLE 23 GLOBAL CELL AND TISSUE SEPARATION PRODUCT MARKET BY REGION,
THROUGH 2017 ($ MILLIONS) 60
TABLE 24 CELL AND TISSUE SEPARATION PRODUCT MARKET SHARE BY REGION, 2010 (%) 62
TABLE 25 GLOBAL CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET BY REGION,
THROUGH 2017 ($ MILLIONS) 64
TABLE 26 GLOBAL CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET SHARE BY
REGION, 2011 (%) 65
TABLE 27 GLOBAL CELL AND TISSUE ANALYSIS PRODUCT MARKET BY END USER, THROUGH
2017 ($ MILLIONS) 67
TABLE 28 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE BY END USER, 2011 (%) 68
TABLE 29 CELL AND TISSUE ANALYSIS PRODUCT CONSUMPTION IN RESEARCH AND
ACADEMICS BY REGION, THROUGH 2017 ($ MILLIONS) 70
TABLE 30 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE IN RESEARCH AND
ACADEMICS BY REGION, 2011 (%) 71
TABLE 31 CELL AND TISSUE ANALYSIS PRODUCT CONSUMPTION IN BIOPHARMACEUTICALS
BY REGION, THROUGH 2017 ($ MILLIONS) 73
TABLE 22 BIOSPECIMEN-PREPARING TECHNIQUE PRODUCTS MARKET SHARE BY REGION,
2011 (%) 74
TABLE 33 CELL AND TISSUE ANALYSIS PRODUCT CONSUMPTION IN THE HEALTHCARE AND
CLINICAL INDUSTRY BY REGION, THROUGH 2017 ($ MILLIONS) 75
TABLE 34 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE IN THE HEALTHCARE AND
CLINICAL INDUSTRY BY REGION, 2011 (%) 76
TABLE 35 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE MARKET BY PRODUCT TYPE,
THROUGH 2017 ($ MILLIONS) 79
TABLE 36 GLOBAL DNA MICROARRAY PRODUCT MARKET BY REGION, THROUGH 2017 ($
MILLIONS) 81
TABLE 37 GLOBAL PROTEIN MICROARRAY PRODUCT MARKET BY REGION, THROUGH 2017 ($
MILLIONS) 83
TABLE 38 GLOBAL TISSUE MICROARRAY PRODUCT MARKET BY REGION, THROUGH 2017 ($
MILLIONS) 84
TABLE 39 GLOBAL REVENUE FOR BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT
MARKET BY REGION, THROUGH 2017 ($ MILLIONS) 86
TABLE 40 NORTH AMERICAN BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT MARKET BY
TYPE, THROUGH 2017 ($ MILLIONS) 87
TABLE 41 EUROPEAN BIOSPECIMEN PREPARING TECHNIQUES MARKET BY TYPE, THROUGH
2017 ($ MILLIONS) 88
TABLE 42 EMERGING MARKETS BIOSPECIMEN-PREPARING TECHNIQUE MARKET BY TYPE,
THROUGH 2017 ($ MILLIONS) 89
TABLE 43 BIOSPECIMENS AND TISSUE MICROARRAY PRODUCT MARKET BY END USE,
THROUGH 2017 ($ MILLIONS) 91
TABLE 44 BIOSPECIMEN AND MICROARRAY PRODUCT CONSUMPTION IN RESEARCH AND
ACADEMICS BY REGION, THROUGH 2017 ($ MILLIONS) 93
TABLE 45 BIOSPECIMEN AND TISSUE MICROARRAY PRODUCT CONSUMPTION IN THE
BIOPHARMACEUTICALS INDUSTRY BY REGION, THROUGH 2017 ($ MILLIONS) 94
TABLE 46 BIOSPECIMEN AND TISSUE MICROARRAY PRODUCT CONSUMPTION IN THE
HEALTHCARE AND CLINICAL INDUSTRY BY REGION, THROUGH 2017 ($ MILLIONS) 96
TABLE 47 BIOSPECIMEN MARKET LEADERS 97
TABLE 48 BIOSPECIMEN MANUFACTURERS AND DISTRIBUTORS BY MARKET SHARE, 2011 (%) 98
TABLE 49 DNA MICROARRAY MARKET LEADERS 99
TABLE 50 DNA MICROARRAY MANUFACTURERS AND DISTRIBUTORS BY MARKET SHARE,
2011 (%) 100
TABLE 51 PROTEIN MICROARRAY MARKET LEADERS 101
TABLE 52 PROTEIN MICROARRAY PRODUCT MANUFACTURERS AND DISTRIBUTORS BY
MARKET SHARE, 2011 (%) 102
TABLE 53 TISSUE MICROARRAY PRODUCT MARKET LEADERS 103
TABLE 54 TISSUE MICROARRAY PRODUCT MANUFACTURERS AND DISTRIBUTORS BY
MARKET SHARE, 2011 (%) 103
TABLE 55 CELL AND TISSUE ANALYSIS, 2008-2012 (NO. OF PATENTS) 106
TABLE 56 CELL AND TISSUE ANALYSIS PRODUCT PATENTS BY TYPE, 2008-2012 108
TABLE 57 U.S. PATENTS FOR CELL AND TISSUE ANALYSIS PRODUCTS BY COMPANY,
2008-2012 109
TABLE 58 U.S. PATENTS FOR CELL AND TISSUE ANALYSIS PRODUCTS BY COUNTRY,
2008-2012 111
TABLE 59 CELL AND TISSUE ANALYSIS PRODUCT PATENT SHARES BY COUNTRY, 2010-2011
(%) 112
TABLE 60 CELL AND TISSUE ANALYSIS PRODUCT PATENTS BY ASSIGNEE TYPE, 2008-2012 114
TABLE 61 CELL AND TISSUE ANALYSIS PRODUCT PATENT SHARES BY ASSIGNEE TYPE,
2010-2011 (NO./%) 115

LIST OF FIGURES
SUMMARY FIGURE GLOBAL CELL AND TISSUE ANALYSIS MARKET BY PRODUCT TYPE,
2010-2017 ($ MILLIONS) 6
FIGURE 1 SCHEMATIC REPRESENTATION OF A FLOW CYTOMETER 18
FIGURE 2 SCHEMATIC REPRESENTATION OF THE QUADRUPOLE MAGNETIC SORTER 20
FIGURE 3 GLOBAL CELL AND TISSUE ANALYSIS PRODUCT MARKET BY TYPE, 2010-2017 ($
MILLIONS) 44
FIGURE 4 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE BY TYPE, 2011 (%) 45
FIGURE 5 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT MARKET BY TYPE,
2010-2017 ($ MILLIONS) 47
FIGURE 6 CELL AND TISSUE SEPARATION PRODUCT MARKET BY TYPE, 2010-2017 ($
MILLIONS) 50
FIGURE 7 CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET BY TYPE, 2010-2017 ($
MILLIONS) 54
FIGURE 8 CELL AND TISSUE ANALYSIS PRODUCT MARKET BY REGION, 2010-2017 ($
MILLIONS) 56
FIGURE 9 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE BY REGION, 2011 (%) 56
FIGURE 10 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE PRODUCTS MARKET BY REGION,
2010-2017 ($ MILLIONS) 59
FIGURE 11 BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT MARKET SHARE BY REGION,
2011 (%) 59
FIGURE 12 GLOBAL CELL AND TISSUE SEPARATION PRODUCT MARKET BY REGION,
2010-2017 ($ MILLIONS) 61
FIGURE 13 CELL AND TISSUE SEPARATION PRODUCT MARKET SHARE BY REGION, 2010 (%) 62
FIGURE 14 GLOBAL CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET BY REGION,
THROUGH 2017 ($ MILLIONS) 65
FIGURE 15 GLOBAL CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET SHARE BY
REGION, 2011 (%) 65
FIGURE 16 GLOBAL CELL AND TISSUE CHARACTERIZATION PRODUCT MARKET BY END
USER, 2010-2017 ($ MILLIONS) 67
FIGURE 17 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE BY END USER, 2011 (%) 68
FIGURE 18 CELL AND TISSUE ANALYSIS PRODUCTION CONSUMPTION IN RESEARCH AND
ACADEMICS BY REGION, 2010-2017 ($ MILLIONS) 70
FIGURE 19 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE IN RESEARCH AND
ACADEMICS BY REGION, 2011 (%) 71
FIGURE 20 CELL AND TISSUE ANALYSIS PRODUCT CONSUMPTION IN
BIOPHARMACEUTICALS BY REGION, 2010-2017 ($ MILLIONS) 73
FIGURE 21 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE IN
BIOPHARMACEUTICALS BY REGION, 2011 (%) 74
FIGURE 22 CELL AND TISSUE ANALYSIS PRODUCT CONSUMPTION IN THE HEALTHCARE
AND CLINICAL INDUSTRY BY REGION, 2010-2017 ($ MILLIONS) 76
FIGURE 23 CELL AND TISSUE ANALYSIS PRODUCT MARKET SHARE IN THE HEALTHCARE
AND CLINICAL INDUSTRY BY REGION, 2011 (%) 76
FIGURE 24 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE MARKET BY PRODUCT TYPE,
2010-2017 ($ MILLIONS) 79
FIGURE 25 GLOBAL DNA MICROARRAY PRODUCT MARKET BY REGION, 2010-2017 ($
MILLIONS) 81
FIGURE 26 GLOBAL PROTEIN MICROARRAY PRODUCT MARKET BY REGION, 2010-2017 ($
MILLIONS) 83
FIGURE 27 GLOBAL TISSUE MICROARRAY PRODUCT MARKET BY REGION, 2010-2017 ($
MILLIONS) 84
FIGURE 28 GLOBAL BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT MARKET BY REGION,
2010-2017 ($ MILLIONS) 86
FIGURE 29 NORTH AMERICAN BIOSPECIMEN-PREPARING TECHNIQUE MARKET BY TYPE,
2010-2017 ($ MILLIONS) 87
FIGURE 30 EUROPEAN BIOSPECIMEN-PREPARING TECHNIQUE MARKET BY TYPE, 2010-2017
($ MILLIONS) 88
FIGURE 31 EMERGING MARKETS BIOSPECIMEN-PREPARING TECHNIQUE PRODUCT MARKET,
2010-2017 ($ MILLIONS) 89
FIGURE 32 BIOSPECIMENS AND TISSUE MICROARRAY PRODUCT MARKET BY END USE,
2010-2017 ($ MILLIONS) 91
FIGURE 33 BIOSPECIMEN AND MICROARRAY PRODUCT CONSUMPTION IN RESEARCH AND
ACADEMICS BY REGION, 2010-2017 ($ MILLIONS) 93
FIGURE 34 BIOSPECIMENS AND TISSUE MICROARRAY PRODUCT CONSUMPTION IN THE
BIOPHARMACEUTICALS INDUSTRY BY REGION, 2010-2017 ($ MILLIONS) 94
FIGURE 35 BIOSPECIMEN AND TISSUE MICROARRAY PRODUCT CONSUMPTION IN THE
HEALTHCARE AND CLINICAL INDUSTRY BY REGION, 2010-2017 ($ MILLIONS) 96
FIGURE 36 BIOSPECIMEN MANUFACTURERS AND DISTRIBUTORS BY MARKET SHARE, 2011
(%) 98
FIGURE 37 DNA MICROARRAY MANUFACTURERS AND DISTRIBUTORS BY MARKET SHARE,
2011 (%) 100
FIGURE 38 PROTEIN MICROARRAY PRODUCT MANUFACTURERS AND DISTRIBUTORS BY
MARKET SHARE, 2011 (%) 102
FIGURE 39 TISSUE MICROARRAY PRODUCT MANUFACTURERS AND DISTRIBUTORS BY
MARKET SHARE, 2011 (%) 104
FIGURE 40 CELL AND TISSUE ANALYSIS, 2008-2012 (NO. OF PATENTS) 106
FIGURE 41 CELL AND TISSUE ANALYSIS PRODUCT PATENTS BY YEAR, 2008-2012 (%) 107
FIGURE 42 CELL AND TISSUE ANALYSIS PRODUCT PATENTS BY TYPE, 2008-2012 109
FIGURE 43 U.S. PATENTS FOR CELL AND TISSUE ANALYSIS PRODUCTS BY COUNTRY,
2008-2012 112
FIGURE 44 CELL AND TISSUE ANALYSIS PRODUCT PATENT SHARES BY COUNTRY, 2010-2011
(%) 113
FIGURE 45 CELL AND TISSUE ANALYSIS PRODUCT PATENTS BY ASSIGNEE TYPE, 2008-2012 114
FIGURE 46 CELL AND TISSUE ANALYSIS PRODUCT PATENT SHARES BY ASSIGNEE TYPE,
2010-2011 (%) 115

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