U.S. IVD And LDT For Autoimmune Diseases Market To Reach $3.88 Billion By 2030

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.

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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.

U.S. IVD And LDT For Autoimmune Diseases Market Segmentation

Grand View Research has segmented the U.S. IVD and LDT for autoimmune diseases market on the basis of type, technology, and application:

U.S. IVD And LDT For Autoimmune Diseases Type Outlook (Revenue, USD Million, 2018 - 2030)

• IVD

  • IVD by Technology Outlook (Revenue, USD Million, 2018 - 2030)

    • Immunoassays

    • Clinical Chemistry

    • Hematology

    • Coagulation

    • Microbiology

    • Molecular Diagnostics

    • Others

  • IVD by Application Outlook (Revenue, USD Million, 2018 - 2030)

    • Addison’s Disease

    • Ankylosing Spondylitis

    • Alopecia Areata

    • Rheumatoid Arthritis

    • Systemic Lupus Erythematosus

    • Systemic Sclerosis

    • Psoriasis

    • Antiphospholipid Antibody Syndrome

    • Diabetes Type 1

    • Crohn’s Disease

    • Ulcerative Colitis

    • Narcolepsy

    • Multiple Sclerosis

    • Uveitis

    • Others

• LDT

  • LDT by Technology Outlook (Revenue, USD Million, 2018 - 2030)

    • Immunoassays

    • Clinical Chemistry

    • Hematology

    • Coagulation

    • Microbiology

    • Molecular Diagnostics

    • Others

  • LDT by Application Outlook (Revenue, USD Million, 2018 - 2030)

    • Addison’s Disease

    • Ankylosing Spondylitis

    • Alopecia Areata

    • Rheumatoid Arthritis

    • Systemic Lupus Erythematosus

    • Systemic Sclerosis

    • Psoriasis

    • Antiphospholipid Antibody Syndrome

    • Diabetes Type 1

    • Crohn’s Disease

    • Ulcerative Colitis

    • Narcolepsy

    • Multiple Sclerosis

    • Uveitis

    • Others

U.S. IVD And LDT For Autoimmune Diseases Technology Outlook (Revenue, USD Million, 2018 - 2030)

• Immunoassays

• Clinical Chemistry

• Hematology

• Coagulation

• Microbiology

• Molecular Diagnostics

• Others

U.S. IVD And LDT For Autoimmune Diseases Application Outlook (Revenue, USD Million, 2018 - 2030)

• Addison’s Disease

• Ankylosing Spondylitis

• Alopecia Areata

• Rheumatoid Arthritis

• Systemic Lupus Erythematosus

• Systemic Sclerosis

• Psoriasis

• Antiphospholipid Antibody Syndrome

• Diabetes Type 1

• Crohn’s Disease

• Ulcerative Colitis

• Narcolepsy

• Multiple Sclerosis

• Uveitis

• Others

List of Key Players of U.S. IVD And LDT For Autoimmune Diseases Market

• Adaptive Biotechnologies Corporation

• Agilent Technologies, Inc

• Bio-Rad Laboratories, Inc.

• bioMerieux, Inc.

• Corgenix, Inc. (Sebia)

• F. Hoffmann-La Roche Ltd.

• Quest Diagnostics, Inc.

• PerkinElmer, Inc

• Abbott Laboratories

• Thermo Fisher Scientific, Inc.