U.S. IVD And LDT For Autoimmune Diseases Market Size, Share & Trends Analysis Report By Type (IVD, LDT), By Technology (Immunoassays, Clinical Chemistry, Hematology, Coagulation, Microbiology), By Application, By Country, And Segment Forecasts, 2024 - 2030

Market Size & Trends

“2030 U.S. IVD And LDT for Autoimmune Diseases Market value to reach USD 3.70 billion”

The U.S. IVD and LDT for autoimmune diseases market size was valued at USD 2.67 billion in 2023 and is projected to grow at a CAGR of 4.8% from 2024 to 2030. This is attributed to the increase in the number of patients suffering from autoimmune diseases. Around 50 million Americans are affected by autoimmune diseases annually. This increase in cases create demand and need for more diagnostic tools. Furthermore, there is a growing focus on early diagnosis of autoimmune diseases, and IVD and LDT tests help diagnose problems faster and more accurately. In addition, the use of IVD and LDT technology is making tests more precise and efficient.

In order to identify and track autoimmune diseases at an early stage and improve treatment options, doctors currently require dependable and accurate diagnostic testing methods. This group comprises essential tests such as screenings for antinuclear autoantibody and rheumatoid factor (RF), along with others. The growing utilization of advanced diagnostic technologies such as multiplex assays, next-generation sequencing, and other high-throughput screening methods is a significant factor contributing to market growth. These instruments enable doctors to quickly and precisely diagnose autoimmune diseases and monitor the progression of the disease. These tools also help doctors to develop personalized treatment plans by enhancing sensitivity, specificity, and accuracy.

Type Insights & Trends

IVD accounted for the largest market revenue share in 2023. IVD tests usually go through a strict approval process from the FDA to guarantee their precision and dependability. This increased approval from regulators makes them more easily accessible for use in medical facilities.

Additionally, there is a strong existing system for administering and interpreting IVD tests within healthcare systems. This enables a more seamless incorporation of new IVD tests into current processes. Laboratory Developed Tests (LDTs) are projected to witness the fastest compound annual growth rate (CAGR) over the forecast period.

Technology Insights & Trends

Clinical chemistry accounted for the largest market revenue share in 2023. Clinical chemistry provides a recognized range of assays to evaluate markers of inflammation and organ function, important in autoimmune diseases. It is a key revenue generator in the U.S. IVD & LDT for autoimmune diseases market due to its wide-reaching and cost-effective nature. Additionally, these tests can be automated and conducted on high-throughput systems for efficient processing of large sample volumes, crucial for managing high patient numbers.

Molecular diagnostics is expected to register the fastest CAGR during the forecast period due to its abilities to identify distinct genetic changes and examine patterns of gene expression linked to autoimmune disorders. The increased precision can result in more precise diagnoses and distinctions between various autoimmune conditions. Progress in molecular diagnostics is facilitating the identification of new biomarkers, which can assist in earlier and more precise detection of autoimmune diseases.

Application Insights & Trends

Psoriasis dominated the market in 2023. Psoriasis being a common autoimmune condition, it impacts many individuals in the U.S. The significant demand for diagnostic tests is driven by the number of the patient population. Additionally, diagnosing psoriasis may require different tests based on its severity and symptoms. This may involve IVDs for evaluating inflammatory markers, and potentially LDTs for examining specific genetic variations linked to psoriasis susceptibility. Prompt detection of psoriasis enables timely treatment and may help avoid complications.

Crohn’s disease is projected to grow at the fastest CAGR over the forecast period. The incidence of Crohn's disease, a type of inflammatory bowel disease (IBD), is on the rise, particularly in developed nations. Nonetheless, it can be difficult to diagnose Crohn's disease as it shares similar symptoms with other conditions such as ulcerative colitis. This demand for precise and specific diagnosis without a solution creates a lucrative market for new IVD and LDT tests.

Key U.S. IVD And LDT For Autoimmune Diseases Company Insights

Some of the key companies in the U.S. IVD & LDT for autoimmune diseases market include Adaptive Biotechnologies Corporation, Agilent Technologies Inc., Bio-Rad Laboratories, Inc., and others. Vendors in the market are focusing on increasing customer base to gain a competitive edge in the industry. Therefore, key players are taking several strategic initiatives, such as mergers and acquisitions, and partnerships with other major companies. 

Recent Developments

• In September 2023, NeoDx announced the launch of HLA-B27 RT-PCR detection kit for Exon 2 & 3, a real time PCR technology based IVD kit for Ankylosing Spondylitis.

• In October 2022, Sebia announced the acquisition of Zeus Scientific, an IVD organization specialized in autoimmune & infectious diseases technologies. Zeus, with a strong position in the U.S., is anticipated to expand Sebia’s product portfolio in autoimmunity segment.

U.S. IVD & LDT For Autoimmune Diseases Market Report Scope

U.S. IVD & LDT For Autoimmune Diseases Market Report Segmentation

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. IVD and LDT for autoimmune diseases market report based on type, technology, and application.

• Type Outlook (Revenue, USD Billion, 2018 - 2030)

  • IVD

  • LDT

• Technology Outlook (Revenue, USD Billion, 2018 - 2030)

  • Immunoassays

  • Clinical Chemistry

  • Hematology

  • Coagulation

  • Microbiology

  • Molecular Diagnostics

  • Others

• Application Outlook (Revenue, USD Billion, 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