Autoimmune Disease Diagnostics: Global Markets

Table of Contents

Chapter 1 Introduction

Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
What's New in This Report?
Geographic Breakdown
Analyst’s Credentials
BCC Custom Research
Related BCC Research Reports

Chapter 2 Summary and Highlights

Report Highlights

Chapter 3 Market and Technology Background

Autoimmune Disorders and Therapies
Causes of Autoimmune Diseases

• Intrinsic Factors
• Environmental Factors
• Lifestyle Factors

Key Challenges in the Industry

• Standardization of Test Results
• Lack of Awareness Among Patients of Autoimmune Complications
• Shortage of Skilled Technicians for Performing Diagnostic Assays

Emerging Technologies in Autoimmune Diagnostics

• Bioinformatics
• Biomarkers
• Applications for Mobile Phones
• Lab Automation

Chapter 4 Market Dynamics

Market Drivers

• Increasing Epidemiology of Autoimmune Diseases
• Rise in the Geriatric Population
• Rising Awareness of Autoimmune Diseases
• New Diagnostic Pathway for Autoimmune and Inflammatory Disorders

Market Restraints

• Low Availability of Diagnosis Kits in Laboratories
• High Cost of Autoimmune Disease Diagnostics

Market Opportunities

• Launch of New Therapeutics for Autoimmune Diseases
• Growing Rate of Autoimmunity in Population

Chapter 5 Market Breakdown by Gender

Global Market for Autoimmune Disease Diagnostics
Females

• Market Size and Forecast
• Market Analysis

Males

• Market Size and Forecast
• Market Analysis

Chapter 6 Market Breakdown by Technology

Global Market for Autoimmune Disease Diagnostics by Technology
Indirect Immunofluorescence (IIF)

• Indications
• Methodology
• Test Results
• Advantages and Limitations of the IIF-ANA Test
• Market Size and Forecast
• Market Analysis

Enzyme-linked Immunosorbent Assay (ELISA)

• Indication
• Methodology
• Advantages and Limitations of the ELISA Assay for ANA
• Market Size and Forecast
• Market Analysis

ImmunoBlot

• Western Blot
• Dot Blot
• Line Blot
• Market Size and Forecast
• Market Analysis

Multiplex Immunoassays

• Flow Cytometry
• Microarray
• Market Size and Forecast
• Market Analysis

Other Technology

• Agglutination
• Double Immune Diffusion (DID)
• Counter Immuno Electrophoresis (CIEP)
• Market Size and Forecast
• Market Analysis
• Prevalence of ANA in Various Connective Tissue Diseases (CTD)
• Summary of Performance Methods in the Detection of Autoimmune Antibodies

Autoimmune Products Sold by Companies

Chapter 7 Market Breakdown by Indication

Global Market for Autoimmune Disease Diagnostics by Indication

• Type 1 Diabetes
• Rheumatoid Arthritis (RA)
• Psoriasis/Psoriatic Arthritis
• Multiple Sclerosis
• Inflammatory Bowel Disease
• Systemic Lupus Erythematosus
• Other Autoimmune Diseases

Chapter 8 Market Breakdown by Region

Global Market for Autoimmune Disease Diagnostics by Region

• North America
• Europe
• Asia-Pacific
• Rest of World

Chapter 9 Impact of COVID-19 on Autoimmune Disease Diagnostics Market

Autoimmune Disease and COVID-19 Treatment

• Complexities of Diagnosis and Management of COVID-19 in Autoimmune Diseases

Chapter 10 Value Chain Analysis

Demand Chain Analysis

• Customers (Patients)
• Payers

Supply Chain Analysis

• Laboratories

Manufacturers

Chapter 11 Regulatory Scenario

European Regulations
North American Regulations

• U.S. Regulations
• Canadian Regulations

Latin American Regulations
Asia-Pacific Regulations
Future Regulatory Trends

Chapter 12 Competitive Landscape

Global Company Share Analysis
Mergers and Acquisitions
Agreements, Launches, Collaborations and Partnerships
Business SWOT Analysis

Chapter 13 Company Profiles

ABBOTT
BD BIOSCIENCES
BECKMAN COULTER INC.
BIOMERIEUX
BIO-RAD (ABD SEROTEC)
BRISTOL-MYERS SQUIBB
EUROIMMUN (PERKINELMER)
F. HOFFMANN-LA ROCHE AG
SIEMENS HEALTHCARE
THERMO FISHER SCIENTIFIC INC.
TRINITY BIOTECH GROUP (IMMCO DIAGNOSTICS)
Chapter 14 Appendix: Acronyms

List of Tables

Summary Table : Global Market for Autoimmune Disease Diagnostics, by Indication, Through 2026
Table 1 : Association of Immune Dysfunction Syndromes Associate with Autoimmune Diseases
Table 2 : Infectious Etiologies of Selected Autoimmune Diseases
Table 3 : List of Autoimmune and Autoimmune Related Diseases
Table 4 : Autoantibodies and Associated Diseases
Table 5 : Challenges Faced by Immunoassay Kit/Instrument Manufacturers
Table 6 : Challenges Faced by Immunoassay Clinical Laboratories
Table 7 : Immunoassay Challenges Faced by Physicians
Table 8 : Global Market for Autoimmune Disease Diagnostics, by Gender, Through 2026
Table 9 : Global Market for Autoimmune Disease Diagnostics in Female, by Region, Through 2026
Table 10 : Global Market for Autoimmune Disease Diagnostics in Male, by Region, Through 2026
Table 11 : Global Market for Autoimmune Disease Diagnostics, by Technology, Through 2026
Table 12 : ANA Patterns and Associated Diseases
Table 13 : Conditions Associated with Positive IIF-ANA Results
Table 14 : Global Market for Indirect Immunofluorescence (IIF) of Autoimmune Disease Diagnostics, by Region, Through 2026
Table 15 : Global Market for Enzyme-linked Immunosorbent Assay (ELISA) of Autoimmune Disease Diagnostics, by Region, Through 2026
Table 16 : Global Market for ImmunoBlot of Autoimmune Disease Diagnostics, by Region, Through 2026
Table 17 : Global Market for Multiplex Immunoassays of Autoimmune Disease Diagnostics, by Region, Through 2026
Table 18 : Global Market for Other Technologies Segment of Autoimmune Disease Diagnostics, by Region, Through 2026
Table 19 : Prevalence of ANA in Various Connective Tissue Diseases (CTD)
Table 20 : Performance of Laboratory Methods in Detection of Autoimmune Antibodies
Table 21 : Autoimmune Products Sold, by Selected Multinational Companies, by Technology
Table 22 : Global Market for Autoimmune Disease Diagnostics, by Indication, Through 2026
Table 23 : Global Market for Autoimmune Disease Diagnostics for Type 1 Diabetes, by Region, Through 2026
Table 24 : Global Market for Autoimmune Disease Diagnostics for Rheumatoid Arthritis, by Region, Through 2026
Table 25 : Global Market for Autoimmune Disease Diagnostics for Psoriasis/Psoriatic Arthritis, by Region, Through 2026
Table 26 : Drugs in the Pipeline for Psoriatic Disease
Table 27 : Global Market for Autoimmune Disease Diagnostics for Multiple Sclerosis, by Region, Through 2026
Table 28 : Global Market for Autoimmune Disease Diagnostics for Inflammatory Bowel Disease, by Region, Through 2026
Table 29 : Global Market for Autoimmune Disease Diagnostics for Systemic Lupus Erythematosus, by Region, Through 2026
Table 30 : Global Market for Autoimmune Disease Diagnostics for Other Diseases Indication, by Region, Through 2026
Table 31 : Global Market for Autoimmune Disease Diagnostics, by Region, Through 2026
Table 32 : North American Market for Autoimmune Disease Diagnostics, by Gender, Through 2026
Table 33 : North American Market for Autoimmune Disease Diagnostics, by Technology, Through 2026
Table 34 : North American Market for Autoimmune Disease Diagnostics, by Indication, Through 2026
Table 35 : North American Market for Autoimmune Disease Diagnostics, by Country, Through 2026
Table 36 : European Market for Autoimmune Disease Diagnostics, by Gender, Through 2026
Table 37 : European Market for Autoimmune Disease Diagnostics, by Technology, Through 2026
Table 38 : European Market for Autoimmune Disease Diagnostics, by Indication, Through 2026
Table 39 : European Market for Autoimmune Disease Diagnostics, by Country, Through 2026
Table 40 : Asia-Pacific Market for Autoimmune Disease Diagnostics, by Gender, Through 2026
Table 41 : Asia-Pacific Market for Autoimmune Disease Diagnostics, by Technology, Through 2026
Table 42 : Asia-Pacific Market for Autoimmune Disease Diagnostics, by Indication, Through 2026
Table 43 : Asia-Pacific Market for Autoimmune Disease Diagnostics, by Country, Through 2026
Table 44 : Rest of World Market for Autoimmune Disease Diagnostics, by Gender, Through 2026
Table 45 : Rest of World Market for Autoimmune Disease Diagnostics, by Technology, Through 2026
Table 46 : Rest of World Market for Autoimmune Disease Diagnostics, by Indication, Through 2026
Table 47 : Rest of World Market for Autoimmune Disease Diagnostics, by Country, Through 2026
Table 48 : Pharmaceutical Companies Involved in COVID-19 Testing and Research
Table 49 : Companies Offering FDA Emergency Use Authorization Serology Tests with Locations in the United States
Table 50 : Per Capita Health Expenditure in Select Countries, 2016-2018
Table 51 : Out-of-Pocket Health Expenditures, by Major Countries, 2016-2018
Table 52 : Diagnostic Chains Well-positioned to Improve their Operating Parameters Within India
Table 53 : Major Manufacturers of Autoimmune Disease Diagnostics, by Revenue* and Number of Employees, 2020
Table 54 : Differences between U.S. and European Government Regulations for Medical Devices
Table 55 : Regulation of Medical Diagnostics in Selected Asia-Pacific Countries
Table 56 : Major Mergers and Acquisitions in the Global Autoimmune Disease Diagnostics Market, 2021
Table 57 : Agreements, Launches, Collaborations and Partnerships in the Global Autoimmune Disease Diagnostics Market, 2021
Table 58 : Abbott: Product Portfolio
Table 59 : BD Biosciences: Product Portfolio
Table 60 : Beckman Coulter Inc (Danaher).: Product Portfolio
Table 61 : bioMérieux: Product Portfolio
Table 62 : Bio-Rad: Product Portfolio
Table 63 : Bristol-Myers Squibb: Product Portfolio
Table 64 : Euroimmun (PerkinElmer): Product Portfolio
Table 65 : F. Hoffmann-La Roche AG: Product Portfolio
Table 66 : Siemens Healthcare: Product Portfolio
Table 67 : Thermo Fisher Scientific: Product Portfolio
Table 68 : Trinity Biotech: Product Portfolio
Table 69 : Acronyms Used in This Report

List of Figures

Summary Figure : Global Market Shares of Autoimmune Disease Diagnostics, by Indication, 2020
Figure 1 : Prevalence of Selected Autoimmune Diseases in the U.S., 2020
Figure 2 : Prevalence of Diagnosed Autoimmune Conditions in Selected Countries, 2019
Figure 3 : Deaths Due to Diabetes in Adults, by Age Group and Sex, 2019
Figure 4 : Number of Diabetes Patients (Ages 20-79 years), Projection and Trends, 2000-2045
Figure 5 : Technological Development for Some Autoimmune Diseases
Figure 6 : Global Market Shares of Autoimmune Disease Diagnostics, by Gender, 2020
Figure 7 : Global Market for Autoimmune Disease Diagnostics in Female, 2019-2026
Figure 8 : Global Market for Autoimmune Disease Diagnostics in Female, by Region, 2019-2026
Figure 9 : Global Market for Autoimmune Disease Diagnostics in Male, 2019-2026
Figure 10 : Global Market for Autoimmune Disease Diagnostics in Male, by Region, 2019-2026
Figure 11 : Global Market Shares of Autoimmune Disease Diagnostics, by Technology, 2020
Figure 12 : IIF-ANA Test Methodology
Figure 13 : Global Market for Indirect Immunofluorescence (IIF) of Autoimmune Disease Diagnostics, 2019-2026
Figure 14 : Global Market for IIF of Autoimmune Disease Diagnostics, by Region, 2019-2026
Figure 15 : ELISA Testing Methodology
Figure 16 : Global Market for Enzyme-linked Immunosorbent Assay (ELISA) of Autoimmune Disease Diagnostics, 2019-2026
Figure 17 : Global Market for ELISA of Autoimmune Disease Diagnostics, by Region, 2019-2026
Figure 18 : Western Blot Methodology
Figure 19 : Dot Blot Test Assay Methodology
Figure 20 : ANA Line Assay Methodology
Figure 21 : Global Market for ImmunoBlot Test Assay of Autoimmune Disease Diagnostics, 2019-2026
Figure 22 : Global Market for ImmunoBlot of Autoimmune Disease Diagnostics, by Region, 2019-2026
Figure 23 : ANA Flow Cytometry Assay Methodology
Figure 24 : Global Market for Multiplex Immunoassays of Autoimmune Disease Diagnostics, 2019-2026
Figure 25 : Global Market for Multiplex Immunoassays of Autoimmune Disease Diagnostics, by Region, 2019-2026
Figure 26 : ANA Agglutination Assay Methodology
Figure 27 : ANA Double Immune Diffusion Assay Methodology
Figure 28 : Counterimmunoelectrophoresis Methodology
Figure 29 : Global Market for Other Technologies Segment of Autoimmune Disease Diagnostics, 2019-2026
Figure 30 : Global Market for Other Technologies Segment of Autoimmune Disease Diagnostics, by Region, 2019-2026
Figure 31 : Global Market Shares of Autoimmune Disease Diagnostics, by Indication, 2020
Figure 32 : Global Prevalence of Major Autoimmune Diseases, 2016 and 2017
Figure 33 : Global Market for Autoimmune Disease Diagnostics for Type 1 Diabetes, 2019-2026
Figure 34 : Global Market for Autoimmune Disease Diagnostics for Type 1 Diabetes, by Region, 2019-2026
Figure 35 : Global Market for Autoimmune Disease Diagnostics for Rheumatoid Arthritis, 2019-2026
Figure 36 : Global Market for Autoimmune Disease Diagnostics for Rheumatoid Arthritis, by Region, 2019-2026
Figure 37 : Global Market for Autoimmune Disease Diagnostics for Psoriasis/Psoriatic Arthritis, 2019-2026
Figure 38 : Global Market for Autoimmune Disease Diagnostics for Psoriasis/Psoriatic Arthritis, by Region, 2019-2026
Figure 39 : Global Market for Autoimmune Disease Diagnostics for Multiple Sclerosis, 2019-2026
Figure 40 : Global Market for Autoimmune Disease Diagnostics for Multiple Sclerosis, by Region, 2019-2026
Figure 41 : Global Market for Autoimmune Disease Diagnostics for Inflammatory Bowel Disease, 2019-2026
Figure 42 : Global Market for Autoimmune Disease Diagnostics for Inflammatory Bowel Disease, by Region, 2019-2026
Figure 43 : Global Market for Autoimmune Disease Diagnostics for Systemic Lupus Erythematosus, 2019-2026
Figure 44 : Global Market for Autoimmune Disease Diagnostics for Systemic Lupus Erythematosus, by Region, 2019-2026
Figure 45 : Global Market for Autoimmune Disease Diagnostics for Other Diseases Indication, 2019-2026
Figure 46 : Global Market for Autoimmune Disease Diagnostics for Other Diseases Indication, by Region, 2019-2026
Figure 47 : Global Market Shares of Autoimmune Disease Diagnostics, by Region, 2020
Figure 48 : North American Market Shares of Autoimmune Disease Diagnostics, by Gender, 2020
Figure 49 : North American Market Shares of Autoimmune Disease Diagnostics, by Technology, 2020
Figure 50 : North American Market Shares of Autoimmune Disease Diagnostics, by Indication, 2020
Figure 51 : North American Market Shares of Autoimmune Disease Diagnostics, by Country, 2020
Figure 52 : U.S. Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 53 : Canadian Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 54 : Mexican Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 55 : European Market Shares of Autoimmune Disease Diagnostics, by Gender, 2020
Figure 56 : European Market Shares of Autoimmune Disease Diagnostics, by Technology, 2020
Figure 57 : European Market Shares of Autoimmune Disease Diagnostics, by Indication, 2020
Figure 58 : European Market Shares of Autoimmune Disease Diagnostics, by Country, 2020
Figure 59 : German Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 60 : French Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 61 : U.K. Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 62 : Italian Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 63 : Spanish Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 64 : Rest of the European Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 65 : Asia-Pacific Market Shares of Autoimmune Disease Diagnostics, by Gender, 2020
Figure 66 : Asia-Pacific Market Shares of Autoimmune Disease Diagnostics, by Technology, 2020
Figure 67 : Asia-Pacific Market Shares of Autoimmune Disease Diagnostics, by Indication, 2020
Figure 68 : Asia-Pacific Market Shares of Autoimmune Disease Diagnostics, by Country, 2020
Figure 69 : Japanese Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 70 : Chinese Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 71 : Share of Autoimmune Disease Diagnostic Costs* in China, by Type of Therapy, 2020
Figure 72 : Indian Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 73 : Australian and New Zealand Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 74 : Healthcare Expenditure in Australia, 2015 and 2016
Figure 75 : Rest of Asia-Pacific Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 76 : Rest of World Market Shares of Autoimmune Disease Diagnostics, by Gender, 2020
Figure 77 : Rest of World Market Shares of Autoimmune Disease Diagnostics, by Technology, 2020
Figure 78 : Rest of World Market Shares of Autoimmune Disease Diagnostics, by Indication, 2020
Figure 79 : Rest of World Market Shares of Autoimmune Disease Diagnostics, by Country, 2020
Figure 80 : Brazilian Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 81 : GCC Countries Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 82 : South African Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 83 : Other RoW Countries Market for Autoimmune Disease Diagnostics, 2019-2026
Figure 84 : Ups and Down of Diagnostic Field during COVID-19
Figure 85 : Autoimmune Disease Diagnostics Industry Value Chain
Figure 86 : Per Capita Health Expenditure in Select Countries, 2016-2018
Figure 87 : Molecular Tests Approved in the United States, by Therapy Area, 2016
Figure 88 : Global Market Shares of Autoimmune Disease Diagnostics, by Manufacturer, 2020
Figure 89 : SWOT Analysis of the Global Autoimmune Disease Diagnostics Market
Figure 90 : Abbott: Annual Revenue, 2016-2020
Figure 91 : Abbott: Revenue Share, by Country, 2020
Figure 92 : Abbott: Revenue Share, by Business Unit, 2020
Figure 93 : BD Biosciences: Annual Revenue, 2017-2020
Figure 94 : BD Biosciences: Revenue Share, by Business Segment, 2020
Figure 95 : BD Biosciences: Revenue Share, by Medical Segment, 2020
Figure 96 : Beckman Coulter Inc (Danaher): Annual Revenue, 2018-2020
Figure 97 : Beckman Coulter Inc (Danaher): Revenue Share, by Region in Diagnostic Segment, 2020
Figure 98 : Beckman Coulter Inc (Danaher): Revenue Share, by Business Segment, 2020
Figure 99 : bioMérieux: Annual Revenue, 2018-2020
Figure 100 : bioMérieux: Revenue Share, by Region/Country, 2020
Figure 101 : bioMérieux: Revenue Share, by Business Unit, 2019
Figure 102 : Bio-Rad: Annual Revenue, 2017-2020
Figure 103 : Bio-Rad: Revenue Share, by Region, 2020
Figure 104 : Bio-Rad: Revenue Share, by Business Unit, 2020
Figure 105 : Bristol-Myers Squibb: Annual Revenue, 2016-2020
Figure 106 : Bristol-Myers Squibb: Revenue Share, by Region, 2020
Figure 107 : Bristol-Myers Squibb: R&D Market Share, 2019 and 2020
Figure 108 : Euroimmun (PerkinElmer): Annual Revenue, 2017-2020
Figure 109 : Euroimmun (PerkinElmer): Revenue Share, by Region, 2020
Figure 110 : Euroimmun (PerkinElmer): Revenue Share, by Business Unit, 2019
Figure 111 : F. Hoffmann-La Roche AG: Annual Revenue, 2016-2020
Figure 112 : F. Hoffmann-La Roche AG: Revenue Share in Diagnostic Segment, by Region, 2020
Figure 113 : F. Hoffmann-La Roche AG: Revenue Share, by Diagnostic Segment, 2019
Figure 114 : Siemens Healthcare: Annual Revenue, 2019 and 2020
Figure 115 : Siemens Healthcare: Revenue Share, by Region, 2020
Figure 116 : Siemens Healthcare: Revenue Share, by Business Unit, 2020
Figure 117 : Thermo Fisher Scientific: Annual Revenue, 2016-2020
Figure 118 : Thermo Fisher Scientific: Revenue Share, by Region, 2020
Figure 119 : Thermo Fisher Scientific: Revenue Share, by Business Segment, 2020
Figure 120 : Trinity Biotech: Annual Revenue, 2019 and 2020
Figure 121 : Trinity Biotech: Revenue Share, by Region, 2020
Figure 122 : Trinity Biotech: Revenue Share, by Business Segment, 2020

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