North America Autoimmune Disease Diagnostics Market size exceeded USD 380 million in 2021 and is anticipated to register a CAGR of 6% between 2022 and 2028. A steady rise in the incidence of rare autoimmune conditions across Canada and the U.S. has triggered the market growth.

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Over the last few years, the number of patients suffering from rheumatoid arthritis, multiple sclerosis, type 1 diabetes mellitus, and Graves’ disease has been increasing at a concerning rate. As most of these conditions do not have a cure yet, organizations such as the National Institutes of Health (NIH) and the Autoimmune Association have been working to improve awareness, education, diagnosis, and treatment at every step of patient’s journey. Various programs and policies are aiming for early diagnosis as it can determine a patient’s survival rate. Emphasis on adequate access to autoimmune disease diagnosis is rising, as patients suffering from these conditions experience debilitating symptoms, organ function loss, reducing productivity, and a lifetime of illness.

As these conditions often result in a number of chronic illnesses, healthcare providers as well as government authorities have been dealing with substantial financial burden. With a view to address these concerns, several public and private initiatives will focus in providing early and accurate diagnosis to these patients. There are awareness campaigns conducted by local bodies such as the American Autoimmune related Diseases Association (AARDA). With this, more individuals are growing conscious about autoimmune conditions, their diagnosis, and the available treatment options.

Impact of COVID-19 on North America Autoimmune Disease Diagnostics Market:

During 2020, the large percentage of patients with autoimmune diseases suffered from COVID-19. In fact, some studies conducted over the last couple of years reveals that autoantibodies that were present in a patient’s body even before the SARS-CoV-2 infection was detected, accounted for nearly 20% of high risk COVID-19 cases. Growing evidence suggests a strong link between autoimmune disease and the novel coronavirus, wherein the infection could be a factor triggering the production of autoantibodies amongst other people. Due to these unsettling questions, investments in the development of effective autoimmune disease screening tests have been increasing.

North America Market, By Test Type

The antinuclear antibody (ANA) tests segment will surpass USD 270 million revenue by 2028. More patients have been taking these tests for determining the type of autoimmune condition affecting them. Since these tests provide crucial information such as the amount of ANA in patients’ blood samples, they can reveal an underlying abnormality. Growing incidence of lupus and similar disorders will continue to fuel product uptake. Due to high sensitivity, the antinuclear antibody immunofluorescence assay is often a first-line diagnostic test preferred by physicians for people with suspected autoimmune disorders.

North America Market, By Product

The ankylosing spondylitis (AS) segment is expected to record a steady growth during the forecast period. Since ankylosing spondylitis occurs more frequently in the younger population segment, it is more difficult to diagnose. According to the Centers for Disease Control and Prevention, more than 1.7 million individuals in the U.S. have ankylosing spondylitis, whereas over 3.2 million suffer from some form of axial spondyloarthritis. The need for timely diagnosis for the disorder will generate considerable opportunities for diagnostic solution providers.

North America Market, By Country

U.S. autoimmune disease diagnostics market size is slated to expand at a substantial rate through 2028, driven by the introduction of novel testing technologies across diagnostic centers. More investors have been displaying interest in upgrading laboratory equipment for delivering faster and more comprehensive test results. Presence of well-trained rheumatologists in the nation has enabled smoother diagnosis of conditions affecting ligaments, muscles, tendons, bones, connective tissues, and joints.

Competitive Industry Landscape

Some of the leading players involved in the North America market include Inova Diagnostics, Inc., Hemagen Diagnostics, Abbott Laboratories, Crescendo Bioscience, Inc., Beckman Coulter, Inc., Quest Diagnostics, F. Hoffmann-La Roche Ltd, SQI diagnostics, and Siemens Healthineers.

These companies have been focusing on introducing breakthrough products to address customer pain points. Recently, in June 2022, Thermo Fisher Scientific added the expanded capabilities of its novel Phadia 2500+ product line for scalable and high-performance autoimmune testing, that can perform and deliver over 10,000 test results on a weekly basis.