Summary

U.S. IVD And LDT For Autoimmune Diseases Market Growth & Trends

The U.S. IVD and LDT for autoimmune diseases market size is expected to reach USD 3.88 billion by 2030, growing at a CAGR of 6.6% from 2025 to 2030, according to a new report by Grand View Research, Inc. The high prevalence of autoimmune disorders, growing awareness about these ailments, growing demand for technologically developed & high performance products, and high investments in research are the driving factors for the expanding growth of the market.

These health problems are second leading cause of chronic illness in the U.S. and are amongst the leading causes of deaths in the U.S. women. They have an adverse impact on the work productivity and the quality of life of patients and form an economic burden greatly affecting the healthcare spending in the U.S. The National Institute of Health estimates the direct healthcare costs associated with these disorders accounted for around USD 100 billion, whereas the cancer costs accounted for USD 57 billion.

A large number of people suffering from these disorders and rising prevalence at an alarming rate resulting in an increase of healthcare spending in the U.S. are all priority concerns, and is thus are expected to drive growth. Furthermore, the complications resulting from such health hazards like damage to internal organs, loss of mobility, and risk of death make it crucial for early diagnosis and intervention of such conditions. The rising awareness about these conditions is expected to lead market growth.

It is believed by number of researchers that the increase in the number of autoimmune diseases globally is due to the genetic predisposition and environmental factors. But there is very little knowledge about what exactly in the environment triggers the occurrence of autoimmune diseases. and mainly focused on commercial kits that are widely used by laboratories.

The FDA regulates IVD as medical devices however in the past it did not use its authority to regulate LDT. The FDA later announced that it would enforce its medical device regulatory authority to regulate the LDTs. Some researchers believe that the FDA regulation on LDTs would lead to an increase in the time and cost required to develop the tests.

U.S. IVD And LDT For Autoimmune Diseases Market Report Highlights

• The IVD segment gained a major market share in 2024 and is expected to grow at a CAGR of 6.26% over the forecast period, attributed to its efficient testing for both systemic & organ-specific autoimmune pathologies and better reimbursement policies.

• Psoriasis held the largest share of 15.21% in 2024 and is expected to maintain a dominant share throughout the forecast period. The rise in psoriasis prevalence and the strategic initiatives undertaken by the NPF to improve diagnostic accuracy are key factors contributing to the segment's growth.

• The clinical chemistry segment held the largest revenue share of 30.32% in 2024. Clinical chemistry tests play a central role in testing and diagnosing various diseases in patients.

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Table of Contents

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation and Scope
1.2. Market Definitions
1.2.1. Type Segment
1.2.2. Technology Segment
1.2.3. Application Segment
1.3. Research Assumptions
1.4. Information Procurement
1.4.1. Primary Research
1.5. Information or Data Analysis
1.6. Market Formulation & Validation
1.7. Market Model
1.8. Global Market: CAGR Calculation
1.9. Objective
1.9.1. Objective 1
1.9.2. Objective2
Chapter 2. Executive Summary
2.1. Market Snapshot
2.2. Type and Technology Segment Snapshot
2.3. Application Segment Snapshot
2.4. Competitive Landscape Snapshot
Chapter 3. Market Variables, Trends, & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Related/Ancillary Market Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Emerging chronic diseases patients
3.2.1.2. Increasing number of new FDA injectable generics drugs approvals
3.2.2. Market Restraint Analysis
3.2.2.1. High cost of injectable
3.3. SWOT Analysis, by Factor
3.4. Industry Analysis- Porter’s
3.5. Consumer Behavior Analysis
3.6. Target Disease Population
3.7. Regulatory Scenario
3.8. Reimbursement Scenario
3.9. Unmet Needs and Opportunity Analysis
Chapter 4. Type Business Analysis
4.1. U.S. IVD & LDT For Autoimmune Diseases Market: Type Movement Analysis
4.2. IVD
4.2.1. IVD Market, 2018 - 2030 (USD Million)
4.2.2. By Technology
4.2.2.1. Immunoassays
4.2.2.1.1. Immunoassays Market, 2018 - 2030 (USD Million)
4.2.2.2. Clinical Chemistry
4.2.2.2.1. Clinical Chemistry Market, 2018 - 2030 (USD Million)
4.2.2.3. Hematology
4.2.2.3.1. Hematology Market, 2018 - 2030 (USD Million)
4.2.2.4. Coagulation
4.2.2.4.1. Coagulation Market, 2018 - 2030 (USD Million)
4.2.2.5. Microbiology
4.2.2.5.1. Microbiology Market, 2018 - 2030 (USD Million)
4.2.2.6. Molecular Diagnostics
4.2.2.6.1. Molecular Diagnostics Market, 2018 - 2030 (USD Million)
4.2.2.7. Others
4.2.2.7.1. Others Market, 2018 - 2030 (USD Million)
4.2.3. By Application
4.2.3.1. Addison’s Disease
4.2.3.1.1. Addison’s Disease Market, 2018 - 2030 (USD Million)
4.2.3.2. Ankylosing Spondylitis
4.2.3.2.1. Ankylosing Spondylitis Market, 2018 - 2030 (USD Million)
4.2.3.3. Alopecia Areata
4.2.3.3.1. Alopecia Areata Market, 2018 - 2030 (USD Million)
4.2.3.4. Rheumatoid Arthritis
4.2.3.4.1. Rheumatoid Arthritis Market, 2018 - 2030 (USD Million)
4.2.3.5. Systemic Lupus Erythematosus
4.2.3.5.1. Systemic Lupus Erythematosus Market, 2018 - 2030 (USD Million)
4.2.3.6. Systemic Sclerosis
4.2.3.6.1. Systemic Sclerosis Market, 2018 - 2030 (USD Million)
4.2.3.7. Psoriasis
4.2.3.7.1. Psoriasis Market, 2018 - 2030 (USD Million)
4.2.3.8. Antiphospholipid Antibody Syndrome
4.2.3.8.1. Antiphospholipid Antibody Syndrome Market, 2018 - 2030 (USD Million)
4.2.3.9. Diabetes Type 1
4.2.3.9.1. Diabetes Type 1 Market, 2018 - 2030 (USD Million)
4.2.3.10. Crohn’s Disease
4.2.3.10.1. Crohn’s Disease Market, 2018 - 2030 (USD Million)
4.2.3.11. Ulcerative Colitis
4.2.3.11.1. Ulcerative Colitis Market, 2018 - 2030 (USD Million)
4.2.3.12. Narcolepsy
4.2.3.12.1. Narcolepsy Market, 2018 - 2030 (USD Million)
4.2.3.13. Multiple Sclerosis
4.2.3.13.1. Multiple Sclerosis Market, 2018 - 2030 (USD Million)
4.2.3.14. Uveitis
4.2.3.14.1. Uveitis Market, 2018 - 2030 (USD Million)
4.2.3.15. Others
4.2.3.15.1. Others Market, 2018 - 2030 (USD Million)
4.3. LDT
4.3.1. LDT Market, 2018 - 2030 (USD Million)
4.3.2. By Technology
4.3.2.1. Immunoassays
4.3.2.1.1. Immunoassays Market, 2018 - 2030 (USD Million)
4.3.2.2. Clinical Chemistry
4.3.2.2.1. Clinical Chemistry Market, 2018 - 2030 (USD Million)
4.3.2.3. Hematology
4.3.2.3.1. Hematology Market, 2018 - 2030 (USD Million)
4.3.2.4. Coagulation
4.3.2.4.1. Coagulation Market, 2018 - 2030 (USD Million)
4.3.2.5. Microbiology
4.3.2.5.1. Microbiology Market, 2018 - 2030 (USD Million)
4.3.2.6. Molecular Diagnostics
4.3.2.6.1. Molecular Diagnostics Market, 2018 - 2030 (USD Million)
4.3.2.7. Others
4.3.2.7.1. Others Market, 2018 - 2030 (USD Million)
4.3.3. By Application
4.3.3.1. Addison’s Disease
4.3.3.1.1. Addison’s Disease Market, 2018 - 2030 (USD Million)
4.3.3.2. Ankylosing Spondylitis
4.3.3.2.1. Ankylosing Spondylitis Market, 2018 - 2030 (USD Million)
4.3.3.3. Alopecia Areata
4.3.3.3.1. Alopecia Areata Market, 2018 - 2030 (USD Million)
4.3.3.4. Rheumatoid Arthritis
4.3.3.4.1. Rheumatoid Arthritis Market, 2018 - 2030 (USD Million)
4.3.3.5. Systemic Lupus Erythematosus
4.3.3.5.1. Systemic Lupus Erythematosus Market, 2018 - 2030 (USD Million)
4.3.3.6. Systemic Sclerosis
4.3.3.6.1. Systemic Sclerosis Market, 2018 - 2030 (USD Million)
4.3.3.7. Psoriasis
4.3.3.7.1. Psoriasis Market, 2018 - 2030 (USD Million)
4.3.3.8. Antiphospholipid Antibody Syndrome
4.3.3.8.1. Antiphospholipid Antibody Syndrome Market, 2018 - 2030 (USD Million)
4.3.3.9. Diabetes Type 1
4.3.3.9.1. Diabetes Type 1 Market, 2018 - 2030 (USD Million)
4.3.3.10. Crohn’s Disease
4.3.3.10.1. Crohn’s Disease Market, 2018 - 2030 (USD Million)
4.3.3.11. Ulcerative Colitis
4.3.3.11.1. Ulcerative Colitis Market, 2018 - 2030 (USD Million)
4.3.3.12. Narcolepsy
4.3.3.12.1. Narcolepsy Market, 2018 - 2030 (USD Million)
4.3.3.13. Multiple Sclerosis
4.3.3.13.1. Multiple Sclerosis Market, 2018 - 2030 (USD Million)
4.3.3.14. Uveitis
4.3.3.14.1. Uveitis Market, 2018 - 2030 (USD Million)
4.3.3.15. Others
4.3.3.15.1. Others Market, 2018 - 2030 (USD Million)
Chapter 5. Technology Business Analysis
5.1. U.S. IVD & LDT For Autoimmune Diseases Market: Technology Movement Analysis
5.2. Immunoassays
5.2.1. Immunoassays Market, 2018 - 2030 (USD Million)
5.3. Clinical Chemistry
5.3.1. Clinical Chemistry Market, 2018 - 2030 (USD Million)
5.4. Hematology
5.4.1. Hematology Market, 2018 - 2030 (USD Million)
5.5. Coagulation
5.5.1. Coagulation Market, 2018 - 2030 (USD Million)
5.6. Microbiology
5.6.1. Microbiology Market, 2018 - 2030 (USD Million)
5.7. Molecular Diagnostics
5.7.1. Molecular Diagnostics Market, 2018 - 2030 (USD Million)
5.8. Others
5.8.1. Others Market, 2018 - 2030 (USD Million)
Chapter 6. Application Business Analysis
6.1. U.S. IVD & LDT For Autoimmune Diseases Market: Application Movement Analysis
6.2. Addison’s Disease
6.2.1. Addison’s Disease Market, 2018 - 2030 (USD Million)
6.3. Ankylosing Spondylitis
6.3.1. Ankylosing Spondylitis Market, 2018 - 2030 (USD Million)
6.4. Alopecia Areata
6.4.1. Alopecia Areata Market, 2018 - 2030 (USD Million)
6.5. Rheumatoid Arthritis
6.5.1. Rheumatoid Arthritis Market, 2018 - 2030 (USD Million)
6.6. Systemic Lupus Erythematosus
6.6.1. Systemic Lupus Erythematosus Market, 2018 - 2030 (USD Million)
6.7. Systemic Sclerosis
6.7.1. Systemic Sclerosis Market, 2018 - 2030 (USD Million)
6.8. Psoriasis
6.8.1. Psoriasis Market, 2018 - 2030 (USD Million)
6.9. Antiphospholipid Antibody Syndrome
6.9.1. Antiphospholipid Antibody Syndrome Market, 2018 - 2030 (USD Million)
6.10. Diabetes Type 1
6.10.1. Diabetes Type 1 Market, 2018 - 2030 (USD Million)
6.11. Crohn’s Disease
6.11.1. Crohn’s Disease Market, 2018 - 2030 (USD Million)
6.12. Ulcerative Colitis
6.12.1. Ulcerative Colitis Market, 2018 - 2030 (USD Million)
6.13. Narcolepsy
6.13.1. Narcolepsy Market, 2018 - 2030 (USD Million)
6.14. Multiple Sclerosis
6.14.1. Multiple Sclerosis Market, 2018 - 2030 (USD Million)
6.15. Uveitis
6.15.1. Uveitis Market, 2018 - 2030 (USD Million)
6.16. Others
6.16.1. Others Market, 2018 - 2030 (USD Million)
Chapter 7. Competitive Landscape
7.1. Company Categorization
7.2. Strategy Mapping
7.2.1. New Product Launch
7.2.2. Partnership & Collaboration
7.2.3. Merger and Acquisition
7.2.4. Others
7.3. Company Market Share Analysis, 2024
7.4. Company Profiles/Listing
7.4.1. Adaptive Biotechnologies Corporation
7.4.1.1. Overview
7.4.1.2. Financial Performance
7.4.1.3. Product Benchmarking
7.4.1.4. Strategic Initiatives
7.4.2. Agilent Technologies, Inc
7.4.2.1. Overview
7.4.2.2. Financial Performance
7.4.2.3. Product Benchmarking
7.4.2.4. Strategic Initiatives
7.4.3. Bio-Rad Laboratories, Inc.
7.4.3.1. Overview
7.4.3.2. Financial Performance
7.4.3.3. Product Benchmarking
7.4.3.4. Strategic Initiatives
7.4.4. bioMerieux, Inc.
7.4.4.1. Overview
7.4.4.2. Financial Performance
7.4.4.3. Product Benchmarking
7.4.4.4. Strategic Initiatives
7.4.5. Corgenix, Inc. (Sebia)
7.4.5.1. Overview
7.4.5.2. Financial Performance
7.4.5.3. Product Benchmarking
7.4.5.4. Strategic Initiatives
7.4.6. F. Hoffmann-La Roche Ltd.
7.4.6.1. Overview
7.4.6.2. Financial Performance
7.4.6.3. Product Benchmarking
7.4.6.4. Strategic Initiatives
7.4.7. Quest Diagnostics, Inc.
7.4.7.1. Overview
7.4.7.2. Financial Performance
7.4.7.3. Product Benchmarking
7.4.7.4. Strategic Initiatives
7.4.8. PerkinElmer, Inc
7.4.8.1. Overview
7.4.8.2. Financial Performance
7.4.8.3. Product Benchmarking
7.4.8.4. Strategic Initiatives
7.4.9. Abbott Laboratories
7.4.9.1. Overview
7.4.9.2. Financial Performance
7.4.9.3. Product Benchmarking
7.4.9.4. Strategic Initiatives
7.4.10. Thermo Fisher Scientific, Inc.
7.4.10.1. Overview
7.4.10.2. Financial Performance
7.4.10.3. Product Benchmarking
7.4.10.4. Strategic Initiatives