The growing awareness regarding diagnostic tests for autoimmune diseases is one of the crucial attributes that can be accounted for the market growth in the coming years. The increasing prevalence of various autoimmune diseases in the U.S., such as Addison’s disease, rheumatoid arthritis, systemic lupus erythematosus, psoriasis, ulcerative colitis, multiple sclerosis, and uveitis is one of the key factors impelling the market growth over the forecast period. Based on the estimates of the National Institutes of Health, autoimmune diseases affect over 23.5 million Americans, whereas heart diseases are estimated to impact over 22 million, and varied cancer types are expected to impact over 9 million. It was also reported that the direct healthcare costs for autoimmune diseases are expected to be nearly USD 100 billion. The Technological advancements in the field of IVD, such as digital PCR, mass spectrometry, fluorescence in situ hybridization, cell signaling pathway testing, next-generation sequencing, and tissue microarrays, are further expected to reinforce the market positively. The growing investments by companies on R&D pertaining to LDT and IVD testing market and increasing cross-licensing and collaborations for Throughput Value Days (TVD) test development are some of the drivers of the market. Some of the companies operating in this market are Illumina, Agilent, and PerkinElmer.
The U.S.IVD lab test for autoimmune disease diagnostics market was valued at USD 4.0 billion in 2015 and is expected to reach USD 4.7 billion by 2024. The local presence of several significant players in the U.S. market, including Roche Diagnostics, J&J, Bio-Rad, Abbott Diagnostics, Hologic, Perkin Elmer, and Alere, is one of the pivotal factors expected to propel the market in the coming few years. The U.S. LDT autoimmune diseases market accounts for nearly 21% of the U.S. IVD autoimmune diseases market. Based on the definition of the U.S.FDA., LDT is a subset of IVDs, which are used for clinical purposes within a single Clinical Laboratory Improvement Amendment (CLIA) certified laboratory. In 1976, the U.S. FDA enacted IVD regulations regarding the development and manufacturing of LDTs. The growing interest of companies regarding LDTs is one of the main attributes of market growth.
In 2015, the U.S. lab test IVD market for rheumatoid arthritis diagnosis held a majority market share of 14.1%, and psoriasis diagnosis is expected to be the fastest growing market with a CAGR of 3.2%. According to the report published by the International Federation of Psoriasis Associations, it is estimated that individuals with psoriasis in the U.S. lose approximately 56 million work hours and spend around USD 2 to 3 billion each year for the treatment of the disease. The growing incidence of psoriasis in the U.S. population and increasing awareness regarding the diagnostic procedures are some of the factors driving the market over the forecast period.
Some of the LDTs developed and marketed by Sequenom Laboratories are MaterniT21 Plus, RetnaGene AMD, HerediT CF, and SensiGene RHD. The U.S. FDA is also proposing several changes in the standards pertaining to the next-generation sequencing based tests and these developments are anticipated to impact the market growth in the near future. The top player in this LDT specialty is Myriad Generics, which had generated a revenue of USD 723.1 million in 2015. Myriad Generics is followed by Genomic Health that reported a revenue of USD 287.4 million. Moreover, growing demand for personalized medication or precision medications is expected to be one of the key attributes of market growth in the coming years.
In-depth report on U.S. IVD and laboratory developed test (LDT) for autoimmune diseases market by Grand View Research: