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Autoimmune Disease Diagnostics: Global Markets

  • September 2014
  • -
  • BCC Research
  • -
  • 128 pages

This BCC Research report estimates the global diagnostics market for autoimmune diseases, with CAGR projections for the period 2014 to 2019. Market size estimates for pre-treatment and during-treatment phases are also presented. Estimates for ex-vivo diagnostics techniques such as X-ray and other imaging-based techniques are also covered in this report.

Use this report to:
- Identify the structure of the global diagnostics market for autoimmune diseases and learn about the major challenges and opportunities it faces.
- Learn about the current industry structure and future trends.
- Review and analyze the patents awarded and assess technological trends.
- Learn about the government regulations in various countries with regard to the in vitro diagnostic industry of which the autoimmune disease diagnostics form a subset.

Highlights
- The global market value for autoimmune disease diagnostics for 2013 was valued at $11.9 billion. This is expected to reach about $12.1 billion in 2014 and $13.1 billion in 2019, with a compound annual growth rate (CAGR) of 1.6% for the five-year period, 2014 to 2019.
- The size of the global pre-treatment market is estimated to be $226.8 million in 2014 and $236.5 million by 2019, growing at a CAGR of 0.8% for the five-year period, 2014 to 2019.
- The during-treatment market is estimated to reach about $11.9 billion in 2014 and nearly $12.9 billion by 2019, growing at a CAGR of 1.7% for the five-year period, 2014 to 2019.

INTRODUCTION

STUDY GOALS AND OBJECTIVES
Autoimmune diseases arise when the immune system attacks the body’s organs, tissues and cells. There are at least 70 clinically distinct autoimmune diseases, including insulin dependent diabetes mellitus (type 1 diabetes), multiple sclerosis, systemic lupus erythematosus (SLE), rheumatoid arthritis, inflammatory bowel disease, psoriasis, uveitis and autoimmune thyroid disease. Autoimmune diseases collectively affect approximately 5% to 10% of the population of the developed world. Autoimmune
diseases disproportionately affect women at a rate of two to nine times greater than for men. This report investigates the autoimmune disease diagnostics market with supporting tables and figures to illustrate projections.

The goals of this report are to:
- Provide an overview of the autoimmune disease diagnostics industry.
- Explain the current industry structure and future trends.
- Analyze the industry for new developments and trends.
- Review and analyze the patents awarded and assess technological trends.
- Provide an estimate of global market size by disease.

SCOPE OF REPORT
The report provides a thorough background of the structure of the market and outlines the chief challenges and opportunities it faces. This report estimates the global
diagnostics market for autoimmune diseases. Market size for the years 2012, 2013, 2014 and 2019 is presented. In addition, market size by various segments, namely
geographic regions, gender and disease phase (pre-treatment and in-treatment) is included. Market size estimates for pre-treatment and during-treatment phases are presented. The pre-treatment and during-treatment analyses consider the complete spectrum of tests available, including autoimmune-specific tests and complementary tests such as routine blood analyses. The estimates also include ex-vivo diagnostics techniques such as X-ray and other imaging-based techniques.

Certain autoimmune disorders are more prevalent than others and form the bulk of the diseases. This report covers the market specifically for these more prevalent disorders, namely:
- Rheumatoid arthritis.
- Inflammatory bowel disease.
- Type 1 diabetes.
- Multiple sclerosis.
- Systemic lupus erythematous (SLE).

INTENDED AUDIENCE
This report is a valuable tool for anyone assessing the autoimmune disease diagnostics market and attempting to devise a strategy to successfully compete in this market.
The report is expected to be invaluable for business planners, acquisition specialists, licensing strategists, product managers, market research analysts, investment consultants and others interested in the autoimmune disease diagnostics market and its products, participants and future.

Table Of Contents

Autoimmune Disease Diagnostics: Global Markets
TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
SCOPE OF REPORT 2
INTENDED AUDIENCE 3
INFORMATION SOURCES 3
ANALYST CREDENTIALS 3
RELATED BCC RESEARCH REPORTS 3
BCC RESEARCH WEBSITE 4
DISCLAIMER 4
CHAPTER 2 EXECUTIVE SUMMARY 6
SUMMARY TABLE GLOBAL MARKET FOR AUTOIMMUNE DIAGNOSTICS, THROUGH
2019 ($ MILLIONS) 7
SUMMARY FIGURE GLOBAL MARKET FOR AUTOIMMUNE DIAGNOSTICS, 2012-2019
($ MILLIONS) 7
CHAPTER 3 AUTOIMMUNE DISEASE OVERVIEW 9
CAUSES OF AUTOIMMUNE DISEASES 10
INTRINSIC FACTORS 10
Immune Dysfunction 10
TABLE 1 ASSOCIATION OF IMMUNE DYSFUNCTION SYNDROMES ASSOCIATE WITH
AUTOIMMUNE DISEASES 10
Gender 11
Age 11
ENVIRONMENTAL FACTORS 12
TABLE 2 INFECTIOUS ETIOLOGIES OF SELECTED AUTOIMMUNE DISEASES 13
Lifestyle Factors 13
TABLE 3 LIST OF AUTOIMMUNE AND AUTOIMMUNE RELATED DISEASES 14
FIGURE 1 U.S. PREVALENCE OF SELECTED AUTOIMMUNE DISEASES (NUMBER OF
CASES PER 100,000) 17
CHAPTER 4 OVERVIEW OF AUTOIMMUNE DISEASE DIAGNOSTICS 20
INTRODUCTION 20
TABLE 4 AUTOANTIBODIES AND ASSOCIATED DISEASES 20
TECHNOLOGIES CURRENTLY USED FOR AUTOIMMUNE DISEASE DIAGNOSIS 21
TABLE 5 COMMON TECHNOLOGIES USED IN AUTOIMMUNE DIAGNOSTICS 22
INDIRECT IMMUNOFLUORESCENCE (IIF-ANA) 22
Indications 22
Methodology 22
FIGURE 2 IIF-ANA TEST METHODOLOGY 23
Test Results 23
TABLE 6 ANA PATTERNS AND ASSOCIATED DISEASES 24
Advantages and Limitations of the IIF-ANA Test 24
TABLE 7 CONDITIONS ASSOCIATED WITH POSITIVE IIF-ANA RESULTS 25
ENZYME-LINKED IMMUNOABSORBENT ASSAY (ELISA) FOR ANA 26
Indication 26



Methodology 26
FIGURE 3 ELISA METHODOLOGY 26
Advantages and Limitations of the ELISA Assay for ANA 27
WESTERN BLOT FOR ANA 27
Indications 27
Methodology 27
FIGURE 4 WESTERN BLOT METHODOLOGY 27
Test Results 28
Advantages and Limitations of the Western Blot assay for ANA 28
DOT BLOT 28
Indications 28
Methodology 29
Test Results 29
FIGURE 5 DOT BLOT TEST ASSAY METHODOLOGY 29
Advantages and Limitations of the Dot Blot Assay 30
LINE BLOT 30
Indications 30
Methodology 30
Test Results 30
FIGURE 6 ANA LINE ASSAY METHODOLOGY 30
Advantages and Limitations of the Line Blot Assay for ANA 31
MULTIPLEX IMMUNOASSAY 31
Flow cytometry 32
Indications 32
Methodology 32
Test Results 32
FIGURE 7 ANA FLOW CYTOMETRY ASSAY METHODOLOGY 32
Advantages and Limitations of the Flow Cytometry for ANA 32
Microarray 33
Indications 33
Methodology 33
Advantages and Limitations of Microarray for ANA 33
AGGLUTINATION 33
Indications 33
Methodology 33
FIGURE 8 ANA AGGLUTINATION ASSAY METHODOLOGY 33
Advantages and Limitations of Agglutination for ANA 34
DOUBLE IMMUNE DIFFUSION (DID) 34
Indications 34
Methodology 34
FIGURE 9 ANA DOUBLE IMMUNE DIFFUSION ASSAY METHODOLOGY 34
Advantages and Limitations of Double Immune Diffusion for ANA 35
COUNTERIMMUNOELECTROPHORESIS (CIEP) 35
Indication 35
Methodology 35
FIGURE 10 COUNTERIMMUNOELECTROPHORESIS METHODOLOGY 35
Advantages and Limitations of Counterimmunoelectrophoresis for
ANA 36



SUMMARY OF PERFORMANCE METHODS IN THE DETECTION OF
AUTOIMMUNE ANTIBODIES 37
TABLE 8 PERFORMANCE OF LABORATORY METHODS IN DETECTION OF
AUTOIMMUNE ANTIBODIES 37
AUTOIMMUNE PRODUCTS SOLD BY COMPANIES 38
TABLE 9 AUTOIMMUNE PRODUCTS SOLD BY SELECTED MULTINATIONAL
COMPANIES, BY TECHNOLOGY 38
TABLE 10 PRODUCTS SOLD BY SELECTED AUTOIMMUNE-SPECIALIZED COMPANIES,
BY TECHNOLOGY 39
EMERGING TECHNOLOGIES IN AUTOIMMUNE DIAGNOSTICS 39
BIOINFORMATICS 39
Companies and Research Institutes Using Bioinformatics 39
BIOMARKERS 40
Companies and Research Institutes Using Biomarkers 41
APPLICATIONS FOR MOBILE PHONES 42
LAB AUTOMATION 42
CHAPTER 5 GLOBAL AUTOIMMUNE DISEASE DIAGNOSTICS MARKET 45
METHODOLOGY 45
FIGURE 11 GLOBAL PREVALENCE OF THE FIVE MAJOR AUTOIMMUNE DISEASES 46
FIGURE 12 GLOBAL INCIDENCE OF THE FIVE MAJOR AUTOIMMUNE DISEASES 46
MARKET SIZE 47
PRE-TREATMENT MARKET 47
TABLE 11 MARKET SIZE FOR PRE-TREATMENT PANEL BY DISEASE TYPE, THROUGH
2019 ($ MILLIONS) 48
TABLE 12 MARKET SIZE FOR PRE-TREATMENT AUTOIMMUNE SPECIFIC TESTS BY
DISEASE TYPE, THROUGH 2019 ($ MILLIONS) 48
TABLE 13 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL BY REGION,
THROUGH 2019 ($ MILLIONS) 49
FIGURE 13 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR ALL
DISEASES BY REGION, 2019 ($ MILLIONS) 49
TABLE 14 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL BY GENDER,
THROUGH 2019 ($ MILLIONS) 50
DURING-TREATMENT MARKET 51
TABLE 15 MARKET SIZE FOR DURING-TREATMENT DIAGNOSTICS BY DISEASE TYPE,
THROUGH 2019 ($ MILLIONS) 51
TABLE 16 MARKET SIZE FOR DURING-TREATMENT DIAGNOSTICS BY REGION,
THROUGH 2019 ($ MILLIONS) 52
RHEUMATOID ARTHRITIS 53
CLINICAL BACKGROUND 53
CLINICAL MANIFESTATIONS AND SYMPTOMS 53
TABLE 17 CLASSIFICATION OF RHEUMATOID ARTHRITIS 53
CURRENT BIOMARKERS TO DIAGNOSE RHEUMATOID ARTHRITIS 54
LABORATORY TESTS 54
FIGURE 14 FREQUENCY OF ORDERING MULTIPLE AUTOANTIBODY TESTS FOR
RHEUMATOID ARTHRITIS DIAGNOSIS (%) 54
MARKET SIZE 55
TABLE 18 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR
RHEUMATOID ARTHRITIS BY REGION, THROUGH 2019 ($ MILLIONS) 56



FIGURE 15 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR
RHEUMATOID ARTHRITIS BY REGION, 2019 ($ MILLIONS) 56
TABLE 19 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR
RHEUMATOID ARTHRITIS BY GENDER, THROUGH 2019 ($ MILLIONS) 57
TABLE 20 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR
RHEUMATOID ARTHRITIS BY TEST TYPE, THROUGH 2019 ($ MILLIONS) 58
TABLE 21 MARKET SIZE FOR DURING-TREATMENT DIAGNOSIS OF RHEUMATOID
ARTHRITIS BY REGION, THROUGH 2019 ($ MILLIONS) 58
TABLE 22 MARKET SIZE FOR DURING-TREATMENT DIAGNOSIS OF RHEUMATOID
ARTHRITIS BY GENDER, THROUGH 2019 ($ MILLIONS) 59
COMPANIES SUPPLYING DIAGNOSTIC KITS 59
TABLE 23 SELECTED COMPANIES OFFERING DIAGNOSTIC KITS FOR RHEUMATOID
ARTHRITIS 59
INFLAMMATORY BOWEL DISEASE 60
CLINICAL BACKGROUND 60
CLINICAL MANIFESTATIONS AND SYMPTOMS 60
MARKET SIZE 61
TABLE 24 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR IBD BY
REGION, THROUGH 2019 ($ MILLIONS) 61
FIGURE 16 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR IBD BY
REGION, 2019 ($ MILLIONS) 62
TABLE 25 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR IBD BY
GENDER, THROUGH 2019 ($ MILLIONS) 62
TABLE 26 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR IBD BY
TEST TYPE, THROUGH 2019 ($ MILLIONS) 63
TABLE 27 MARKET SIZE FOR DURING-TREATMENT DIAGNOSIS OF IBD BY REGION,
THROUGH 2019 ($ MILLIONS) 63
TABLE 28 MARKET SIZE FOR DURING-TREATMENT DIAGNOSIS OF IBD BY GENDER,
THROUGH 2019 ($ MILLIONS) 64
CURRENT BIOMARKERS FOR IBD 64
TABLE 29 CURRENT BIOMARKERS FOR IBD DIAGNOSIS AND CLASSIFICATION 64
EMERGING BIOMARKERS 65
LABORATORY TESTS 65
COMPANIES OFFERING TESTS FOR IBD 66
TABLE 30 COMPANIES WITH TESTS FOR INFLAMMATORY BOWEL DISEASE
DIFFERENTIAL DIAGNOSIS 66
TYPE 1 DIABETES 66
CLINICAL BACKGROUND 66
CLINICAL MANIFESTATIONS AND SYMPTOMS 66
Symptoms 67
CURRENT BIOMARKERS FOR TYPE 1 DIABETES 67
EMERGING BIOMARKERS 67
LABORATORY TESTS 67
MARKET SIZE 68
TABLE 31 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL OF TYPE 1
DIABETES BY REGION, THROUGH 2019 ($ MILLIONS) 68
FIGURE 17 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL OF TYPE 1
DIABETES BY REGION, 2019 ($ MILLIONS) 69
TABLE 32 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR TYPE 1
DIABETES BY GENDER, THROUGH 2019 ($ MILLIONS) 69



TABLE 33 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR TYPE 1
DIABETES BY TEST TYPE, THROUGH 2019 ($ MILLIONS) 70
TABLE 34 MARKET SIZE FOR DIAGNOSTIC DURING-TREATMENT OF TYPE 1
DIABETES BY REGION, THROUGH 2019 ($ MILLIONS) 70
TABLE 35 MARKET SIZE FOR DIAGNOSTIC DURING-TREATMENT OF TYPE 1
DIABETES BY GENDER, THROUGH 2019 ($ MILLIONS) 71
COMPANIES OFFERING TESTS FOR TYPE 1 DIABETES 71
TABLE 36 SELECTED COMPANIES WITH TESTS FOR TYPE 1 DIABETES DIFFERENTIAL
DIAGNOSIS 71
MULTIPLE SCLEROSIS 72
CLINICAL BACKGROUND 72
CLINICAL MANIFESTATIONS AND SYMPTOMS 72
CURRENT BIOMARKERS 73
EMERGING BIOMARKERS 73
LABORATORY TESTS 73
MARKET SIZE 74
TABLE 37 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR MULTIPLE
SCLEROSIS BY REGION, THROUGH 2019 ($ MILLIONS) 74
FIGURE 18 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR MULTIPLE
SCLEROSIS BY REGION, 2019 ($ MILLIONS) 75
TABLE 38 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR MULTIPLE
SCLEROSIS BY GENDER, THROUGH 2019 ($ MILLIONS) 75
TABLE 39 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR MULTIPLE
SCLEROSIS BY TEST TYPE, THROUGH 2019 ($ MILLIONS) 76
TABLE 40 MARKET SIZE FOR DURING-TREATMENT DIAGNOSTIC PANEL FOR
MULTIPLE SCLEROSIS BY REGION, THROUGH 2019 ($ MILLIONS) 76
TABLE 41 MARKET SIZE FOR DURING-TREATMENT DIAGNOSTIC PANEL FOR
MULTIPLE SCLEROSIS BY GENDER, THROUGH 2019 ($ MILLIONS) 77
COMPANIES SUPPLYING DIAGNOSTIC KITS FOR MS 77
TABLE 42 SELECTED COMPANIES OFFERING DIAGNOSTIC KITS FOR MS 77
SYSTEMIC LUPUS ERYTHEMATOSUS 78
CLINICAL BACKGROUND 78
SYMPTOMS 78
CURRENT BIOMARKERS 78
LABORATORY TESTS 78
MARKET SIZE 79
TABLE 43 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL OF SLE BY
REGION, THROUGH 2019 ($ MILLIONS) 79
FIGURE 19 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL OF SLE BY
REGION, 2019 ($ MILLIONS) 79
TABLE 44 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR SLE BY
GENDER, THROUGH 2019 ($ MILLIONS) 80
TABLE 45 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL OF SLE BY TEST
TYPE, THROUGH 2019 ($ MILLIONS) 81
TABLE 46 MARKET SIZE FOR DIAGNOSTIC PANEL DURING-TREATMENT OF SLE BY
REGION, THROUGH 2019 ($ MILLIONS) 81
TABLE 47 MARKET SIZE FOR DIAGNOSTIC DURING-TREATMENT OF SLE BY GENDER,
THROUGH 2019 ($ MILLIONS) 82
COMPANIES OFFERING DIAGNOSTIC KITS FOR SLE 82
TABLE 48 COMPANIES WITH DIAGNOSTIC KITS FOR SLE 82



CHAPTER 6 INDUSTRY ANALYSES 84
TABLE 49 AUTOIMMUNE DISEASE DIAGNOSTICS INDUSTRY VALUE CHAIN 84
DEMAND CHAIN ANALYSIS 84
CUSTOMERS (PATIENTS) 84
TABLE 50 PER CAPITA HEALTH EXPENDITURE BY REGION ($) 85
FIGURE 20 PER CAPITA MEAN HEALTH EXPENDITURE BY REGION ($) 86
PAYERS 86
TABLE 51 PERCENTAGE OF HEALTH EXPENDITURES IN ASIA, BY PAYER TYPE, 2013
(%) 87
TABLE 52 PERCENTAGE OF HEALTH EXPENDITURES IN AFRICA, BY PAYER TYPE,
2013 (%) 87
TABLE 53 PERCENTAGE OF HEALTH EXPENDITURES IN CENTRAL AMERICA, BY
PAYER TYPE, 2013 (%) 88
TABLE 54 PERCENTAGE OF HEALTH EXPENDITURES IN NORTH AMERICA, BY PAYER
TYPE, 2013 (%) 88
TABLE 55 PERCENTAGE OF HEALTH EXPENDITURES IN SOUTH AMERICA, BY PAYER
TYPE, 2013 (%) 88
TABLE 56 PERCENTAGE OF HEALTH EXPENDITURES IN EUROPE, BY PAYER TYPE,
2013 (%) 89
TABLE 57 PERCENTAGE OF HEALTH EXPENDITURES IN THE MIDDLE EAST, BY
PAYER TYPE, 2013 (%) 89
TABLE 58 PERCENTAGE OF HEALTH EXPENDITURES IN OCEANIA, BY PAYER TYPE,
2013 (%) 90
FIGURE 21 SUMMARY CHART OF PROPORTION OF HEALTH EXPENDITURES BY
PAYER TYPE, BY REGION, 2013 (%) 90
FIGURE 22 PAYER TYPE BY COUNTRY INCOME LEVEL, 2013 (%) 91
SUPPLY CHAIN ANALYSIS 92
LABORATORIES 92
TABLE 59 MAJOR INDEPENDENT LABORATORIES BY REVENUE AND NUMBER OF
EMPLOYEES, 2013 93
TABLE 60 COMPARISON OF MARGIN AND COST STRUCTURE OF DIAGNOSTICS LABS
FOR SELECTED COUNTRIES (%) 93
MANUFACTURERS 94
TABLE 61 MAJOR MANUFACTURERS OF AUTOIMMUNE DISEASE DIAGNOSTICS BY
REVENUE* AND NUMBER OF EMPLOYEES, 2013 94
CHAPTER 7 GOVERNMENT REGULATIONS 97
EUROPEAN REGULATIONS 97
REGULATION IN NORTH AMERICAN COUNTRIES 97
U.S. REGULATIONS 97
TABLE 62 DIFFERENCES BETWEEN U.S. AND EUROPEAN GOVERNMENT
REGULATIONS FOR MEDICAL DEVICES 99
CANADIAN REGULATIONS 99
REGULATION IN SOUTH AMERICA 99
REGULATION IN ASIA 100
TABLE 63 REGULATION OF MEDICAL DIAGNOSTICS IN SELECTED ASIAN COUNTRIES 100
REGULATION IN OCEANIA 101
FUTURE REGULATORY TRENDS 101



CHAPTER 8 KEY CHALLENGES IN THE INDUSTRY 103
STANDARDIZATION OF TEST RESULTS 103
LACK OF AWARENESS AMONG PATIENTS OF AUTOIMMUNE COMPLICATIONS 104
SHORTAGE OF SKILLED TECHNICIANS FOR PERFORMING DIAGNOSTIC ASSAYS 104
TABLE 64 CHALLENGES FACED BY IMMUNOASSAY KIT/ INSTRUMENT
MANUFACTURERS 105
TABLE 65 CHALLENGES FACED BY IMMUNOASSAY CLINICAL LABORATORIES 106
TABLE 66 IMMUNOASSAY CHALLENGES FACED BY PHYSICIANS 106
CHAPTER 9 PATENT ANALYSES 108
PATENTS BY DISEASE TYPE 108
TABLE 67 PATENTS RELATED TO TYPE 1 DIABETES, 2007-2013 108
TABLE 68 PATENTS RELATED TO MULTIPLE SCLEROSIS, 2011 108
TABLE 69 PATENTS RELATED TO IRRITABLE BOWEL SYNDROME, 2001-FEB 2014 109
TABLE 70 PATENTS RELATED TO SYSTEMIC LUPUS ERYTHEMATOSUS, 2008-2012 109
TABLE 71 PATENTS RELATED TO RHEUMATOID ARTHRITIS, 1995-2011 110
SELECTED PATENTS BY MANUFACTURER 110
PATENTS BY MULTINATIONAL COMPANIES 110
Abbott 110
TABLE 72 ABBOTT PATENTS RELATED TO AUTOIMMUNE DISEASE DIAGNOSTICS,
2008 AND 2012 110
Bio-rad 111
TABLE 73 BIO-RAD PATENTS RELATED TO AUTOIMMUNE DISEASE DIAGNOSTICS,
2002-2013 111
Biomerieux 111
TABLE 74 BIOMERIEUX PATENTS RELATED TO AUTOIMMUNE DISEASE
DIAGNOSTICS, 2012 AND 2013 111
Hitachi 112
TABLE 75 HITACHI PATENTS RELATED TO AUTOIMMUNE DISEASE DIAGNOSTICS,
2000 112
Life Technologies 112
TABLE 76 LIFE TECHNOLOGIES PATENTS RELATED TO AUTOIMMUNE DISEASE
DIAGNOSTICS, 2012 112
Roche 113
TABLE 77 ROCHE PATENTS RELATED TO AUTOIMMUNE DISEASE DIAGNOSTICS,
2014 113
Siemens Healthcare 113
TABLE 78 SIEMENS HEALTHCARE PATENTS RELATED TO AUTOIMMUNE DISEASE
DIAGNOSTICS, 2013 113
Thermo Fisher (Phadia) 114
TABLE 79 THERMO FISHER PATENTS RELATED TO AUTOIMMUNE DISEASE
DIAGNOSTICS, 2008-2013 114
PATENTS BY AUTOIMMUNE SPECIALIZED COMPANY 114
Aesku 114
TABLE 80 AESKU PATENTS FOR NOVEL BIOMARKERS, 2010 AND 2013 114
TABLE 81 AESKU PATENTS FOR DIAGNOSTIC METHODS, 2013 115
Euroimmun 115
TABLE 82 EUROIMMUN PATENTS FOR NOVEL BIOMARKERS, 2009-2013 115
TABLE 83 EUROIMMUN PATENTS FOR DIAGNOSTIC METHODS, 2013 AND 2014 116



IMMCO 116
TABLE 84 IMMCO PATENTS FOR NOVEL BIOMARKERS, 2004 AND 2008 116
TABLE 85 IMMCO PATENTS FOR DIAGNOSTIC METHODS, 2011 117
Inova 117
TABLE 86 INOVA PATENTS RELATED TO AUTOIMMUNE DIAGNOSTICS, 2008-2013 117
Orgentec Diagnostika 118
TABLE 87 ORGENTEC DIAGNOSTIKA PATENTS RELATED TO AUTOIMMUNE
DIAGNOSTICS, 2011 AND 2013 118
CHAPTER 10 COMPANY PROFILES 120
COMPANY LISTINGS 120
ABBOTT 120
TABLE 88 FINANCIAL DETAILS OF ABBOTT, 2011-2013 ($ MILLIONS/%) 120
BECTON DICKINSON 121
TABLE 89 FINANCIAL DETAILS OF BECTON DICKINSON, 2011-2013 ($ MILLIONS/%) 122
BIOMERIEUX SA 123
TABLE 90 FINANCIAL DETAILS OF BIOMERIEUX, 2010-2012 (MILLIONS/%) 123
BIO-RAD 124
TABLE 91 FINANCIAL DETAILS OF BIO-RAD, 2010-2012 ($ MILLIONS/%) 124
BIO REFERENCE LABS 124
TABLE 92 FINANCIAL DETAILS OF BIO REFERENCE, 2011-2013 ($ MILLIONS/%) 125
DANAHER CORP. 126
TABLE 93 FINANCIAL DETAILS OF DANAHER, 2011-2013 ($ MILLIONS/%) 127
HEMAGEN DIAGNOSTICS 128
TABLE 94 FINANCIAL DETAILS OF HEMAGEN DIAGNOSTICS, 2010-2012 ($
MILLIONS/%) 128
LABCORP 128
TABLE 95 FINANCIAL DETAILS OF LABCORP, 2011-2013 ($ MILLIONS/%) 129
QUEST DIAGNOSTICS 129
TABLE 96 FINANCIAL DETAILS OF QUEST DIAGNOSTICS, 2011-2013 ($ MILLIONS/%) 130
ROCHE HOLDINGS 131
TABLE 97 FINANCIAL DETAILS OF ROCHE, 2011-2013 ($ MILLIONS/%) 131
SIEMENS HEALTHCARE DIAGNOSTICS 132
TABLE 98 FINANCIAL DETAILS OF SIEMENS HEALTHCARE, 2011-2013 (MILLIONS/%) 132
SONIC HEALTHCARE 133
TABLE 99 FINANCIAL DETAILS OF SONIC HEALTHCARE, 2011-2013 (AU$
MILLIONS/%) 133
THERMO FISHER (TMO) 134
TABLE 100 FINANCIAL DETAILS OF THERMO FISHER, 2011-2013 ($ MILLIONS/%) 135
TRINITY BIOTECH GROUP (IMMCO DIAGNOSTICS) 136
TABLE 101 FINANCIAL DETAILS OF TRINITY BIOTECH, 2011-2013 ($ MILLIONS/%) 137
CHAPTER 11 APPENDIX: KEY MERGERS AND ACQUISITIONS 139
TABLE 102 KEY MERGERS AND ACQUISITIONS 139


LIST OF TABLES

SUMMARY TABLE GLOBAL MARKET FOR AUTOIMMUNE DIAGNOSTICS, THROUGH
2019 ($ MILLIONS) 7
TABLE 1 ASSOCIATION OF IMMUNE DYSFUNCTION SYNDROMES ASSOCIATE WITH
AUTOIMMUNE DISEASES 10
TABLE 2 INFECTIOUS ETIOLOGIES OF SELECTED AUTOIMMUNE DISEASES 13
TABLE 3 LIST OF AUTOIMMUNE AND AUTOIMMUNE RELATED DISEASES 14
TABLE 4 AUTOANTIBODIES AND ASSOCIATED DISEASES 20
TABLE 5 COMMON TECHNOLOGIES USED IN AUTOIMMUNE DIAGNOSTICS 22
TABLE 6 ANA PATTERNS AND ASSOCIATED DISEASES 24
TABLE 7 CONDITIONS ASSOCIATED WITH POSITIVE IIF-ANA RESULTS 25
TABLE 8 PERFORMANCE OF LABORATORY METHODS IN DETECTION OF
AUTOIMMUNE ANTIBODIES 37
TABLE 9 AUTOIMMUNE PRODUCTS SOLD BY SELECTED MULTINATIONAL COMPANIES,
BY TECHNOLOGY 38
TABLE 10 PRODUCTS SOLD BY SELECTED AUTOIMMUNE-SPECIALIZED COMPANIES,
BY TECHNOLOGY 39
TABLE 11 MARKET SIZE FOR PRE-TREATMENT PANEL BY DISEASE TYPE, THROUGH
2019 ($ MILLIONS) 48
TABLE 12 MARKET SIZE FOR PRE-TREATMENT AUTOIMMUNE SPECIFIC TESTS BY
DISEASE TYPE, THROUGH 2019 ($ MILLIONS) 48
TABLE 13 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL BY REGION,
THROUGH 2019 ($ MILLIONS) 49
TABLE 14 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL BY GENDER,
THROUGH 2019 ($ MILLIONS) 50
TABLE 15 MARKET SIZE FOR DURING-TREATMENT DIAGNOSTICS BY DISEASE TYPE,
THROUGH 2019 ($ MILLIONS) 51
TABLE 16 MARKET SIZE FOR DURING-TREATMENT DIAGNOSTICS BY REGION,
THROUGH 2019 ($ MILLIONS) 52
TABLE 17 CLASSIFICATION OF RHEUMATOID ARTHRITIS 53
TABLE 18 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR
RHEUMATOID ARTHRITIS BY REGION, THROUGH 2019 ($ MILLIONS) 56
TABLE 19 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR
RHEUMATOID ARTHRITIS BY GENDER, THROUGH 2019 ($ MILLIONS) 57
TABLE 20 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR
RHEUMATOID ARTHRITIS BY TEST TYPE, THROUGH 2019 ($ MILLIONS) 58
TABLE 21 MARKET SIZE FOR DURING-TREATMENT DIAGNOSIS OF RHEUMATOID
ARTHRITIS BY REGION, THROUGH 2019 ($ MILLIONS) 58
TABLE 22 MARKET SIZE FOR DURING-TREATMENT DIAGNOSIS OF RHEUMATOID
ARTHRITIS BY GENDER, THROUGH 2019 ($ MILLIONS) 59
TABLE 23 SELECTED COMPANIES OFFERING DIAGNOSTIC KITS FOR RHEUMATOID
ARTHRITIS 59
TABLE 24 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR IBD BY
REGION, THROUGH 2019 ($ MILLIONS) 61
TABLE 25 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR IBD BY
GENDER, THROUGH 2019 ($ MILLIONS) 62
TABLE 26 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR IBD BY TEST
TYPE, THROUGH 2019 ($ MILLIONS) 63
TABLE 27 MARKET SIZE FOR DURING-TREATMENT DIAGNOSIS OF IBD BY REGION,
THROUGH 2019 ($ MILLIONS) 63
TABLE 28 MARKET SIZE FOR DURING-TREATMENT DIAGNOSIS OF IBD BY GENDER,
THROUGH 2019 ($ MILLIONS) 64



TABLE 29 CURRENT BIOMARKERS FOR IBD DIAGNOSIS AND CLASSIFICATION 64
TABLE 30 COMPANIES WITH TESTS FOR INFLAMMATORY BOWEL DISEASE
DIFFERENTIAL DIAGNOSIS 66
TABLE 31 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL OF TYPE 1
DIABETES BY REGION, THROUGH 2019 ($ MILLIONS) 68
TABLE 32 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR TYPE 1
DIABETES BY GENDER, THROUGH 2019 ($ MILLIONS) 69
TABLE 33 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR TYPE 1
DIABETES BY TEST TYPE, THROUGH 2019 ($ MILLIONS) 70
TABLE 34 MARKET SIZE FOR DIAGNOSTIC DURING-TREATMENT OF TYPE 1 DIABETES
BY REGION, THROUGH 2019 ($ MILLIONS) 70
TABLE 35 MARKET SIZE FOR DIAGNOSTIC DURING-TREATMENT OF TYPE 1 DIABETES
BY GENDER, THROUGH 2019 ($ MILLIONS) 71
TABLE 36 SELECTED COMPANIES WITH TESTS FOR TYPE 1 DIABETES DIFFERENTIAL
DIAGNOSIS 71
TABLE 37 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR MULTIPLE
SCLEROSIS BY REGION, THROUGH 2019 ($ MILLIONS) 74
TABLE 38 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR MULTIPLE
SCLEROSIS BY GENDER, THROUGH 2019 ($ MILLIONS) 75
TABLE 39 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR MULTIPLE
SCLEROSIS BY TEST TYPE, THROUGH 2019 ($ MILLIONS) 76
TABLE 40 MARKET SIZE FOR DURING-TREATMENT DIAGNOSTIC PANEL FOR
MULTIPLE SCLEROSIS BY REGION, THROUGH 2019 ($ MILLIONS) 76
TABLE 41 MARKET SIZE FOR DURING-TREATMENT DIAGNOSTIC PANEL FOR
MULTIPLE SCLEROSIS BY GENDER, THROUGH 2019 ($ MILLIONS) 77
TABLE 42 SELECTED COMPANIES OFFERING DIAGNOSTIC KITS FOR MS 77
TABLE 43 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL OF SLE BY
REGION, THROUGH 2019 ($ MILLIONS) 79
TABLE 44 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR SLE BY
GENDER, THROUGH 2019 ($ MILLIONS) 80
TABLE 45 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL OF SLE BY TEST
TYPE, THROUGH 2019 ($ MILLIONS) 81
TABLE 46 MARKET SIZE FOR DIAGNOSTIC PANEL DURING-TREATMENT OF SLE BY
REGION, THROUGH 2019 ($ MILLIONS) 81
TABLE 47 MARKET SIZE FOR DIAGNOSTIC DURING-TREATMENT OF SLE BY GENDER,
THROUGH 2019 ($ MILLIONS) 82
TABLE 48 COMPANIES WITH DIAGNOSTIC KITS FOR SLE 82
TABLE 49 AUTOIMMUNE DISEASE DIAGNOSTICS INDUSTRY VALUE CHAIN 84
TABLE 50 PER CAPITA HEALTH EXPENDITURE BY REGION ($) 85
TABLE 51 PERCENTAGE OF HEALTH EXPENDITURES IN ASIA, BY PAYER TYPE, 2013
(%) 87
TABLE 52 PERCENTAGE OF HEALTH EXPENDITURES IN AFRICA, BY PAYER TYPE,
2013 (%) 87
TABLE 53 PERCENTAGE OF HEALTH EXPENDITURES IN CENTRAL AMERICA, BY PAYER
TYPE, 2013 (%) 88
TABLE 54 PERCENTAGE OF HEALTH EXPENDITURES IN NORTH AMERICA, BY PAYER
TYPE, 2013 (%) 88
TABLE 55 PERCENTAGE OF HEALTH EXPENDITURES IN SOUTH AMERICA, BY PAYER
TYPE, 2013 (%) 88
TABLE 56 PERCENTAGE OF HEALTH EXPENDITURES IN EUROPE, BY PAYER TYPE,
2013 (%) 89



TABLE 57 PERCENTAGE OF HEALTH EXPENDITURES IN THE MIDDLE EAST, BY PAYER
TYPE, 2013 (%) 89
TABLE 58 PERCENTAGE OF HEALTH EXPENDITURES IN OCEANIA, BY PAYER TYPE,
2013 (%) 90
TABLE 59 MAJOR INDEPENDENT LABORATORIES BY REVENUE AND NUMBER OF
EMPLOYEES, 2013 93
TABLE 60 COMPARISON OF MARGIN AND COST STRUCTURE OF DIAGNOSTICS LABS
FOR SELECTED COUNTRIES (%) 93
TABLE 61 MAJOR MANUFACTURERS OF AUTOIMMUNE DISEASE DIAGNOSTICS BY
REVENUE* AND NUMBER OF EMPLOYEES, 2013 94
TABLE 62 DIFFERENCES BETWEEN U.S. AND EUROPEAN GOVERNMENT
REGULATIONS FOR MEDICAL DEVICES 99
TABLE 63 REGULATION OF MEDICAL DIAGNOSTICS IN SELECTED ASIAN COUNTRIES 100
TABLE 64 CHALLENGES FACED BY IMMUNOASSAY KIT/ INSTRUMENT
MANUFACTURERS 105
TABLE 65 CHALLENGES FACED BY IMMUNOASSAY CLINICAL LABORATORIES 106
TABLE 66 IMMUNOASSAY CHALLENGES FACED BY PHYSICIANS 106
TABLE 67 PATENTS RELATED TO TYPE 1 DIABETES, 2007-2013 108
TABLE 68 PATENTS RELATED TO MULTIPLE SCLEROSIS, 2011 108
TABLE 69 PATENTS RELATED TO IRRITABLE BOWEL SYNDROME, 2001-FEB 2014 109
TABLE 70 PATENTS RELATED TO SYSTEMIC LUPUS ERYTHEMATOSUS, 2008-2012 109
TABLE 71 PATENTS RELATED TO RHEUMATOID ARTHRITIS, 1995-2011 110
TABLE 72 ABBOTT PATENTS RELATED TO AUTOIMMUNE DISEASE DIAGNOSTICS,
2008 AND 2012 110
TABLE 73 BIO-RAD PATENTS RELATED TO AUTOIMMUNE DISEASE DIAGNOSTICS,
2002-2013 111
TABLE 74 BIOMERIEUX PATENTS RELATED TO AUTOIMMUNE DISEASE DIAGNOSTICS,
2012 AND 2013 111
TABLE 75 HITACHI PATENTS RELATED TO AUTOIMMUNE DISEASE DIAGNOSTICS,
2000 112
TABLE 76 LIFE TECHNOLOGIES PATENTS RELATED TO AUTOIMMUNE DISEASE
DIAGNOSTICS, 2012 112
TABLE 77 ROCHE PATENTS RELATED TO AUTOIMMUNE DISEASE DIAGNOSTICS, 2014 113
TABLE 78 SIEMENS HEALTHCARE PATENTS RELATED TO AUTOIMMUNE DISEASE
DIAGNOSTICS, 2013 113
TABLE 79 THERMO FISHER PATENTS RELATED TO AUTOIMMUNE DISEASE
DIAGNOSTICS, 2008-2013 114
TABLE 80 AESKU PATENTS FOR NOVEL BIOMARKERS, 2010 AND 2013 114
TABLE 81 AESKU PATENTS FOR DIAGNOSTIC METHODS, 2013 115
TABLE 82 EUROIMMUN PATENTS FOR NOVEL BIOMARKERS, 2009-2013 115
TABLE 83 EUROIMMUN PATENTS FOR DIAGNOSTIC METHODS, 2013 AND 2014 116
TABLE 84 IMMCO PATENTS FOR NOVEL BIOMARKERS, 2004 AND 2008 116
TABLE 85 IMMCO PATENTS FOR DIAGNOSTIC METHODS, 2011 117
TABLE 86 INOVA PATENTS RELATED TO AUTOIMMUNE DIAGNOSTICS, 2008-2013 117
TABLE 87 ORGENTEC DIAGNOSTIKA PATENTS RELATED TO AUTOIMMUNE
DIAGNOSTICS, 2011 AND 2013 118
TABLE 88 FINANCIAL DETAILS OF ABBOTT, 2011-2013 ($ MILLIONS/%) 120
TABLE 89 FINANCIAL DETAILS OF BECTON DICKINSON, 2011-2013 ($ MILLIONS/%) 122
TABLE 90 FINANCIAL DETAILS OF BIOMERIEUX, 2010-2012 (MILLIONS/%) 123
TABLE 91 FINANCIAL DETAILS OF BIO-RAD, 2010-2012 ($ MILLIONS/%) 124



TABLE 92 FINANCIAL DETAILS OF BIO REFERENCE, 2011-2013 ($ MILLIONS/%) 125
TABLE 93 FINANCIAL DETAILS OF DANAHER, 2011-2013 ($ MILLIONS/%) 127
TABLE 94 FINANCIAL DETAILS OF HEMAGEN DIAGNOSTICS, 2010-2012 ($
MILLIONS/%) 128
TABLE 95 FINANCIAL DETAILS OF LABCORP, 2011-2013 ($ MILLIONS/%) 129
TABLE 96 FINANCIAL DETAILS OF QUEST DIAGNOSTICS, 2011-2013 ($ MILLIONS/%) 130
TABLE 97 FINANCIAL DETAILS OF ROCHE, 2011-2013 ($ MILLIONS/%) 131
TABLE 98 FINANCIAL DETAILS OF SIEMENS HEALTHCARE, 2011-2013 (MILLIONS/%) 132
TABLE 99 FINANCIAL DETAILS OF SONIC HEALTHCARE, 2011-2013 (AU$ MILLIONS/%) 133
TABLE 100 FINANCIAL DETAILS OF THERMO FISHER, 2011-2013 ($ MILLIONS/%) 135
TABLE 101 FINANCIAL DETAILS OF TRINITY BIOTECH, 2011-2013 ($ MILLIONS/%) 137
TABLE 102 KEY MERGERS AND ACQUISITIONS 139


LIST OF FIGURES

SUMMARY FIGURE GLOBAL MARKET FOR AUTOIMMUNE DIAGNOSTICS, 2012-2019 ($
MILLIONS) 7
FIGURE 1 U.S. PREVALENCE OF SELECTED AUTOIMMUNE DISEASES (NUMBER OF
CASES PER 100,000) 17
FIGURE 2 IIF-ANA TEST METHODOLOGY 23
FIGURE 3 ELISA METHODOLOGY 26
FIGURE 4 WESTERN BLOT METHODOLOGY 27
FIGURE 5 DOT BLOT TEST ASSAY METHODOLOGY 29
FIGURE 6 ANA LINE ASSAY METHODOLOGY 30
FIGURE 7 ANA FLOW CYTOMETRY ASSAY METHODOLOGY 32
FIGURE 8 ANA AGGLUTINATION ASSAY METHODOLOGY 33
FIGURE 9 ANA DOUBLE IMMUNE DIFFUSION ASSAY METHODOLOGY 34
FIGURE 10 COUNTERIMMUNOELECTROPHORESIS METHODOLOGY 35
FIGURE 11 GLOBAL PREVALENCE OF THE FIVE MAJOR AUTOIMMUNE DISEASES 46
FIGURE 12 GLOBAL INCIDENCE OF THE FIVE MAJOR AUTOIMMUNE DISEASES 46
FIGURE 13 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR ALL
DISEASES BY REGION, 2019 ($ MILLIONS) 49
FIGURE 14 FREQUENCY OF ORDERING MULTIPLE AUTOANTIBODY TESTS FOR
RHEUMATOID ARTHRITIS DIAGNOSIS (%) 54
FIGURE 15 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR
RHEUMATOID ARTHRITIS BY REGION, 2019 ($ MILLIONS) 56
FIGURE 16 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR IBD BY
REGION, 2019 ($ MILLIONS) 62
FIGURE 17 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL OF TYPE 1
DIABETES BY REGION, 2019 ($ MILLIONS) 69
FIGURE 18 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL FOR MULTIPLE
SCLEROSIS BY REGION, 2019 ($ MILLIONS) 75
FIGURE 19 MARKET SIZE FOR PRE-TREATMENT DIAGNOSTIC PANEL OF SLE BY
REGION, 2019 ($ MILLIONS) 79
FIGURE 20 PER CAPITA MEAN HEALTH EXPENDITURE BY REGION ($) 86
FIGURE 21 SUMMARY CHART OF PROPORTION OF HEALTH EXPENDITURES BY PAYER
TYPE, BY REGION, 2013 (%) 90
FIGURE 22 PAYER TYPE BY COUNTRY INCOME LEVEL, 2013 (%) 91

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