The U.S. IVD for autoimmune diseases market was valued at USD 4.0 billion in 2015 and is expected to reach a value of USD 4.74 billion by 2024 .The U.S. Laboratory Developed Test (LDT) for autoimmune diseases was valued at USD 830.9 million in 2015. 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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Further key findings from the study suggest:

  • In 2015, the IVD for rheumatoid arthritis was the leading segment with a revenue share of 14.05% and the LDT for rheumatoid arthritis had a share of 13.2%. The large number of diagnostic tests available for it as well as the high prevalence of the disease contributed to the market share.
  • In 2015, clinical chemistry was the leading segment with a market share of 35.6% in the IVD and 34.1% in the LDT. The diagnosis of autoantibodies in the blood is the most commonly employed diagnosis, thus contributing to the large share.
  • Some key participants in this field include Becton, Dickinson and Company; Roche Diagnostics; Abbott Laboratories; Bio-Rad Laboratories, Inc.; Danaher Corporation; SQI Diagnostics; Omega Diagnostics Group PLC; ThermoFisher Scientific, Inc.; and some others. The key players focus specially on developing innovative solutions for diagnosis. The laboratories and institutes such as Mayo Medical Laboratories, Oklahoma Medical Research Foundation, and Moleculera Labs also operate in the U.S. in the same domain.

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