Autoimmune IVD Testing Market

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Published Oct 11, 2016 | 126 Pages | Pub ID: KLI15126922

Autoimmune IVD Testing Market

Autoimmune disease is a competitive area of clinical testing with numerous competitors and categories of varied revenue potential. The term ―autoimmune disease refers to a varied group of more than 80 chronic illnesses that involve almost every human organ system. In all of these diseases, the underlying problem is similar; the immune system recognizes self as non-self, and the body attacks itself.Some of the more prominent autoimmune diseases include: Rheumatoid arthritis, Crohn’s disease, IBD, celiac disease, lupus erythematosus, Thyroid disease and others.

As part of it's coverage, the report includes information on:

  • Market for Autoimmune IVD Testing (2013, 2016, and 2021) 
  • Prevalence of Selected Autoimmune Diseases 
  • Test Innovations 
  • Autoimmune IVD Diagnostic Market by Type (RA, Thyroid, Type 1 Diabetes, Gastro, SLE, Others) 
  • Autoimmune IVD Diagnostic Market by Region (US, Europe, Japan, Rest of World) 
  • Autoimmune IVD Diagnostic Market by European Country (UK, Germany, France, Italy Spain, Others) Autoimmune IVD Diagnostic Market by Rest of World Country (China, India, Saudi Arabia, Brazil) 
Company profiles are included in this report. The following companies are covered. Revenues, test product, and significant competitive moves are included: 

  • Adaptive Biotechnologies Corporation 
  • Alere, Inc 
  • Human Diagnostics 
  • HYCOR Biomedical 
  • Immunovia AB 
  • Inova DIagnostics 
  • Lophius BioSciences GmbH 
  • Luminex 
  • Protagen 
  • Thermo Fisher 
  • WerfenLife 
  • and other companies... 

The growth of the direct-to-consumer lab testing market is born out of a paradigm shift among consumers who are seeking greater control over their own healthcare. Since the 1980s, consumers have pushed for access to their laboratory tests but it has been slow to evolve due to concerns that consumers may try to diagnose themselves without understanding how diagnoses information all fits together. With the increased use of the Internet for medical information, consumers have become medical consumers not just patients. This has created a change in the doctor/patient relationship as individuals become more knowledgeable about their own health and want more control over their personal information and treatment decisions.

This report provides the reader with an overview of the U.S. direct to consumer laboratory testing industry and the trends driving growth. Included in the report are statistics influencing the industry, incidence of diseases in the U.S. and worldwide, demographics; life expectancy, and company strategies. Information is presented as a U.S market report. A market summary includes a total U.S. market analysis and analysis by test segment. Also included are competitive profiles of leading direct to consumer laboratory testing providers.

What’s driving growth in auto immune?

This will be driven bytype 1 diabetes (HbA1c), gastrointestinal disorders and other diseases.  Also, Because the population is aging andthere will be more women aging, they are going to be affected more often thanmen with autoimmune diseases. This will likely create a large demographic thatwill benefit from novel and sophisticated autoimmune IVD diagnostic testing.

What’s an important trend that the report found?

Automation.  Diagnosticcompanies are continuing to gradually improve these fully automated platforms.In addition, many companies are working to develop innovative new platforms.Demand for healthcare and  diagnostictests in all the major markets is driven by aging populations and increasedincidence of autoimmune conditions. In light of the demand for these tests,they have been reformulated for automated analyzers where the cost per test istraditionally low.

What type of Tests are in this market?

ANA Tests are first-run.The antinuclear antibody (ANA) test - is stillperformed primarily by IFA, although increasingly laboratories have beenshifting to the ELISA method because ELISA automates and standardizes the ANAtest. ANA screening by IFA is labor-intensive and requires visualinterpretation of the stained pattern by microscope.  The test is performed by a specifically trainedtechnician

A next step in automation is multiplex systems for thesimultaneous measurement of autoantibodies based on microspheres (beads) coatedwith specific antigens and flow cytometry detection. These tests have beenavailable since early 2000s.  MultiplexANA tests usually detect the most common autoantibodies including: dsDNA,Chromatin, Ribosomal protein, SS-A (52 and 60), SS-B, Sm, Sm/RNP, RNP (A and68), Scl-70, Jo1 and Centromere B antibodies. With this method, ANA screenreports show the actual levels of individual analytes. Here too, furtherconfirmation can be made using the IFA method.

 Market leader INOVADiagnostics has been leading the way for automation of the ANA test.  INOVA’s FDA cleared NOVA View automated IFAmicroscopy is a technology that fundamentally changes the way IFA is performedin diagnostic testing.

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