The U.S. IVD and LDT for autoimmune diseases market size is expected to reach USD 3.70 billion by 2030, growing at a CAGR of 4.8% from 2024 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.

Access the 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

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

·        In 2023, the IVD for rheumatoid arthritis was the leading segment with a revenue share of 12.14% and the LDT for rheumatoid arthritis had a share of 11.47%. The large number of diagnostic tests available for it as well as the high prevalence of the disease contributed to the market share.

·        In 2023, clinical chemistry was the leading segment with a market share of 32.37% in the IVD and 19.98% in the LDT. The diagnosis of autoantibodies in the blood is the most commonly employed diagnosis, thus contributing to the large share.

·        Crohn’s disease is projected to grow at the fastest CAGR over the forecast period

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.

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Key U.S. IVD And LDT For Autoimmune Diseases Companies:         

·        Adaptive Biotechnologies Corporation;

·        Agilent Technologies Inc.

·        Bio-Rad Laboratories, Inc.

·        bioMerieux, Inc.

·        Corgenix, Inc.

·        Johnson & Johnson Services, Inc.

·        Microbix Biosystems Inc.

·        PerkinElmer, Inc.

·        SQI Diagnostics Inc.

·        Thermo Fisher Scientific Inc.

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.

About Grand View Research:

Grand View Research, Inc. is a market research and consulting company that provides off-the-shelf, customized research reports and consulting services. To help clients make informed business decisions, we offer market intelligence studies, ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials, and energy. With a deep-seated understanding of varied business environments, Grand View Research provides strategic objective insights. For more information, visit www.grandviewresearch.com

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