Report Description
The US in vitro diagnostics & laboratory developed test for autoimmune disease market size was USD 5.52 Billion in 2022 and is likely to reach USD 8.35 Billion by 2031, expanding at a CAGR of 4.7 % during 2023–2031.
The market growth isattributed to increase in incidence of cancer & autoimmune diseases and advancement of technologies for diagnosis of such diseases. The US remains a highly potential market for substantial growth in the coming years owing to high investment for research and development, increasing awareness among people regarding the early diagnosis of those diseases, and availability of top class healthcare facilities.
As per the estimation by the American Autoimmune Related Diseases Association, Inc. (AARDA), nearly 50 million Americans get diagnosed with autoimmune diseases and it is responsible for most of the deaths occurred to women. Some of the most frequently occurring diseases are type-1 diabetes, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, grave’s disease, and others.
The outbreak of COVID-19 pandemic had a significant impact on the US in vitro diagnostics & laboratory developed tests for autoimmune disease market due to the rising demand for IVD test kits for the detection of SARS-CoV2 virus. The tests are also widely used to diagnose various biological samples at the same time.
Moreover, the fast launch of the diagnostics kit for the diagnosis of COVID-19 is estimated to be a major key driver of the market. For instance, the US Food and Drug Administration (FDA) authorized the emergency use of in vitro diagnostics & laboratory developed test for diagnosis of COVID-19 in February 2020.
Market Trends, Drivers, Restraints, and Opportunities
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Rise in awareness regarding the benefits for using in vitro diagnostics & laboratory developed test for autoimmune disease for the disease treatment is projected to boost the market revenue.
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Various government policies and initiatives encouraging the adoption of the test and expansion of activities in the field of research, education, patient services, and others are expected to act as a driving factor for the market.
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Increase in number of the autoimmune diseases patients globally is a major driving factor of the market.
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Development of advanced technology and automation of laboratories facilities coupled with the presence of specialized medical staff such as doctors, nurses, and technician are major factor expected to fuel the market growth.
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Continuous research in the field of molecular diagnostics for the early diagnosis of such disorders and treatment is driving the market growth.
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Need for various diagnostics test that also result in sluggish turnaround time for results coupled with high cost of the test and certain issues regarding reimbursement are the key restraining factors of the market.
Scope of US In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Report
The report on the US in vitro diagnostics & laboratory developed test for autoimmune disease market includes an assessment of the market, trends, and segments. Overview and dynamics have also been included in the report.
Attributes
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Details
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Report Title
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US In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market - Industry Analysis, Growth, Share, Size, Trends, And Forecast
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Base Year
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2022
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Historic Data
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2016–2021
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Forecast Period
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2023–2031
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Segmentation
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Applications (Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriasis, Alopecia Areata, systemic Sclerosis, Lupus Erythematoses, and Others), Technology (Clinical Chemistry, Coagulation, Immunoassays, Microbiology, Hematology, and Molecular Diagnostics)
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Country
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The US
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Report Coverage
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Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast
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Key Players Covered in the Report
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Abbott, Omega Diagnostics Group PLC; Beckton Dickinson & Co.; Siemens Healthcare GmbH; SQI Diagnostics; Roche Diagnostics; and Bio-Rad Laboratories, Inc.
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US In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Segment Insights
Psoriasis segment is expected to register a fast CAGR
Based on applications, the market is divided into rheumatoid arthritis, ankylosing spondylitis, psoriasis, alopecia areata, systemic sclerosis, lupus erythematoses, and others. The rheumatoid arthritis segment held a major share of the market in 2020 and is projected to account for a key market share during the forecast period. The segment expansion can be attributed to rapid development of laboratory for the testing due to rising cases of rheumatoid arthritis. According to the Arthritis Foundation, nearly 1.5 million of people are affected by the disease alone in the US.
However, the psoriasis segment is expected to register a fast CAGR due to wide prevalence of psoriasis, which results in adding a burden on the healthcare-related economy. In addition, several awareness campaigns are being organized by International Federation of Psoriasis Associations, including World Psoriasis Day, to create public awareness about the disease. This is a key factor propelling the market growth.
Molecular diagnostics segment is anticipated to grow at a rapid pace
On the basis of technology, the US in vitro diagnostics & laboratory developed test for autoimmune disease market is segmented into clinical chemistry, coagulation, immunoassays, microbiology, hematology, and molecular diagnostics. The clinical chemistry segment held a key share of the market in 2020 and is expected to constitute a major share in the coming years.
Urine and blood are the most common samples used for clinical chemistry for the diagnosis of autoimmune disorders and autoantibodies are widely used for the diagnosis. However, the molecular diagnostics segment is anticipated to grow at a rapid pace during the projected period owing to the advancement of technology and the rise in demand for NGS technology. The diagnosis of prognosis is widely conducted using next-generation multiplexing tools.
Segments
The US in vitro diagnostics & laboratory developed test for autoimmune disease market has been segmented on the basis of
Applications
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Psoriasis
- Alopecia Areata
- systemic Sclerosis
- Lupus Erythematoses
- Others
Technology
- Clinical Chemistry
- Coagulation
- Immunoassays
- Microbiology
- Hematology
- Molecular Diagnostics
Country
Key Players
Competitive Landscape
Key players competing in the US in vitro diagnostics & laboratory developed test for autoimmune disease market are Abbott, Omega Diagnostics Group PLC; Beckton, Dickinson & Co.; Siemens Healthcare GmbH; SQI Diagnostics; Roche Diagnostics; and Bio-Rad Laboratories, Inc.
These players have adopted business strategies such as launching new products, introducing new technology, merger, partnership, and production capacity expansion to increase their market position and expand their consumer base globally. Some of these players are primarily focusing on the development of technology that can help in the diagnosis of various diseases and the cure for such rare diseases.

Table Of Content
1. Executive Summary
2. Assumptions and Acronyms Used
3. Research Methodology
4. In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Overview
4.1. Introduction
4.1.1. Market Taxonomy
4.1.2. Market Definition
4.2. Macro-Economic Factors
4.2.1. Industry Outlook
4.3. In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Dynamics
4.3.1. Market Drivers
4.3.2. Market Restraints
4.3.3. Opportunity
4.3.4. Market Trends
4.4. In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market - Supply Chain
4.5. Global In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Forecast
4.5.1. In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size (US$ Mn) and Y-o-Y Growth
4.5.2. In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size (000’ Units) and Y-o-Y Growth
4.5.3. In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Absolute $ Opportunity
5. Global In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Analysis and Forecast by Applications
5.1. Market Trends
5.2. Introduction
5.2.1. Basis Point Share (BPS) Analysis by Applications
5.2.2. Y-o-Y Growth Projections by Applications
5.3. In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size and Volume Forecast by Applications
5.3.1. Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriasis
Alopecia Areata
systemic Sclerosis
Lupus Erythematoses
5.4. Absolute $ Opportunity Assessment by Applications
5.5. Market Attractiveness/Growth Potential Analysis by Applications
6. Global In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Analysis and Forecast by Region
6.1. Market Trends
6.2. Introduction
6.2.1. Basis Point Share (BPS) Analysis by Region
6.2.2. Y-o-Y Growth Projections by Region
6.3. In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size and Volume Forecast by Region
6.3.1. North America
6.3.2. Latin America
6.3.3. Europe
6.3.4. Asia Pacific
6.3.5. Middle East and Africa (MEA)
6.4. Absolute $ Opportunity Assessment by Region
6.5. Market Attractiveness/Growth Potential Analysis by Region
6.6. Global In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Demand Share Forecast, 2019-2026
7. North America In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Analysis and Forecast
7.1. Introduction
7.1.1. Basis Point Share (BPS) Analysis by Country
7.1.2. Y-o-Y Growth Projections by Country
7.2. North America In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size and Volume Forecast by Country
7.2.1. U.S.
7.2.2. Canada
7.3. Absolute $ Opportunity Assessment by Country
7.4. North America In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size and Volume Forecast by Applications
7.4.1. Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriasis
Alopecia Areata
systemic Sclerosis
Lupus Erythematoses
7.5. Basis Point Share (BPS) Analysis by Applications
7.6. Y-o-Y Growth Projections by Applications
7.7. Market Attractiveness/Growth Potential Analysis
7.7.1. By Country
7.7.2. By Product Type
7.7.3. By Application
7.8. North America In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Demand Share Forecast, 2019-2026
8. Latin America In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Analysis and Forecast
8.1. Introduction
8.1.1. Basis Point Share (BPS) Analysis by Country
8.1.2. Y-o-Y Growth Projections by Country
8.1.3. Latin America Average Pricing Analysis
8.2. Latin America In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size and Volume Forecast by Country
8.2.1. Brazil
8.2.2. Mexico
8.2.3. Rest of Latin America
8.3. Absolute $ Opportunity Assessment by Country
8.4. Latin America In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size and Volume Forecast by Applications
8.4.1. Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriasis
Alopecia Areata
systemic Sclerosis
Lupus Erythematoses
8.5. Basis Point Share (BPS) Analysis by Applications
8.6. Y-o-Y Growth Projections by Applications
8.7. Market Attractiveness/Growth Potential Analysis
8.7.1. By Country
8.7.2. By Product Type
8.7.3. By Application
8.8. Latin America In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Demand Share Forecast, 2019-2026
9. Europe In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Analysis and Forecast
9.1. Introduction
9.1.1. Basis Point Share (BPS) Analysis by Country
9.1.2. Y-o-Y Growth Projections by Country
9.1.3. Europe Average Pricing Analysis
9.2. Europe In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size and Volume Forecast by Country
9.2.1. Germany
9.2.2. France
9.2.3. Italy
9.2.4. U.K.
9.2.5. Spain
9.2.6. Russia
9.2.7. Rest of Europe
9.3. Absolute $ Opportunity Assessment by Country
9.4. Europe In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size and Volume Forecast by Applications
9.4.1. Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriasis
Alopecia Areata
systemic Sclerosis
Lupus Erythematoses
9.5. Basis Point Share (BPS) Analysis by Applications
9.6. Y-o-Y Growth Projections by Applications
9.7. Market Attractiveness/Growth Potential Analysis
9.7.1. By Country
9.7.2. By Product Type
9.7.3. By Application
9.8. Europe In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Demand Share Forecast, 2019-2026
10. Asia Pacific In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Analysis and Forecast
10.1. Introduction
10.1.1. Basis Point Share (BPS) Analysis by Country
10.1.2. Y-o-Y Growth Projections by Country
10.1.3. Asia Pacific Average Pricing Analysis
10.2. Asia Pacific In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size and Volume Forecast by Country
10.2.1. China
10.2.2. Japan
10.2.3. South Korea
10.2.4. India
10.2.5. Australia
10.2.6. Rest of Asia Pacific (APAC)
10.3. Absolute $ Opportunity Assessment by Country
10.4. Asia Pacific In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size and Volume Forecast by Applications
10.4.1. Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriasis
Alopecia Areata
systemic Sclerosis
Lupus Erythematoses
10.5. Basis Point Share (BPS) Analysis by Applications
10.6. Y-o-Y Growth Projections by Applications
10.7. Market Attractiveness/Growth Potential Analysis
10.7.1. By Country
10.7.2. By Product Type
10.7.3. By Application
10.8. Asia Pacific In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Demand Share Forecast, 2019-2026
11. Middle East & Africa In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Analysis and Forecast
11.1. Introduction
11.1.1. Basis Point Share (BPS) Analysis by Country
11.1.2. Y-o-Y Growth Projections by Country
11.1.3. Middle East & Africa Average Pricing Analysis
11.2. Middle East & Africa In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size and Volume Forecast by Country
11.2.1. Saudi Arabia
11.2.2. South Africa
11.2.3. UAE
11.2.4. Rest of Middle East & Africa (MEA)
11.3. Absolute $ Opportunity Assessment by Country
11.4. Middle East & Africa In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market Size and Volume Forecast by Applications
11.4.1. Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriasis
Alopecia Areata
systemic Sclerosis
Lupus Erythematoses
11.5. Basis Point Share (BPS) Analysis by Applications
11.6. Y-o-Y Growth Projections by Applications
11.7. Market Attractiveness/Growth Potential Analysis
11.7.1. By Country
11.7.2. By Product Type
11.7.3. By Application
11.8. Middle East & Africa In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Demand Share Forecast, 2019-2026
12. Competition Landscape
12.1. Global In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market: Market Share Analysis
12.2. In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Distributors and Customers
12.3. In Vitro Diagnostics & Laboratory Developed Test for Autoimmune Disease Market: Competitive Dashboard
12.4. Company Profiles (Details: Overview, Financials, Developments, Strategy)
12.4.1. Abbott
Omega Diagnostics Group PLC
Beckton
Dickinson & Co.
Siemens Healthcare GmbH
SQI Diagnostics