PMLS 2018

Editorial, Life Science Network

What are the factors driving change within the Autoimmune Disease IVD market?

Autoimmune diseases affect more people than cancer yet receive just a fraction of the financial investment by comparison. In the US alone, 50 million people are estimated to have been diagnosed with an autoimmune disease. However as autoimmune diseases present with a complex array of symptoms, often overlapping, or mimicking similar diseases, there are many that have yet to receive a diagnosis at all. Due to a previous lack of novel diagnostic technology, clinicians have been forced to rely upon insufficient diagnostic criteria or in vitro diagnostics (IVDs) with limited specificity and/or sensitivity. However, we have reached a stage where the technologies are there to look deeper at the nature of the autoimmune diseases to improve healthcare options and patient outcomes.
So, what are the key factors driving change in this exciting market?

1. Improvements to existing IVDs and better automation: To date autoimmune disease has not been a leading diagnostic market,
nor has it been subject to radical innovation. With much of the instrumentation out there today being variants of instruments
that have been utilised for decades, future changes will likely come from incremental changes and improvements to existing
IVDs, the idenfication of new content for improved assay sensitivity and specificity, or possibly the instruments, to increase
speed and reliability.

Until approximately 2008, the vast majority of the work in diagnostic labs was very manual which was pretty time-inefficient and expensive and required highly skilled laboratory personnel to operate, analyse and troubleshoot each step of the development process. Today, there are companies working to redefine laboratories utilising IVDs for autoimmune disease diagnosis by updating these older laboratory spaces and practices. This can include the installation of fully automated platforms linked to information system software, or closed systems for liquid handling and sample management for more workflow orientated set ups. This has set the standard for IVD R&D, and has enabled research to focus on developing enhanced tests rather than managing processes, while opening up market opportunities in laboratory automation technology.

2. Biomarker discovery, development and commercialization: There are many biomarkers that are, as yet, unknown but would play
a significant role in the correct diagnosis of different autoimmune diseases. As such, it is not an unreaslitic prediction
that the key driving factor for advancement of IVDs for autoimmune diseases will remain tied to the amount invested in new content and the success of new, accurate and predictive biomarkers to compensate for the heterogeneity seen within patients. To avoid the risks associated with novel development, many companies are turning to smaller biotechnology or academic labs that already have a putative IVD or biomarker. Collaborative efforts or licensing agreements like these combine academic research experience, with industry knowledge and experience to effectively bring new tests to the market while reducing the overall costs or risk to any one party. While this is an effective model, the optimisation of this approach and a re-look at the partner/licensing set up could reap greater rewards in the future.

3. Multimodal, multiplex biomarker panels: There is a clear need for IVDs used in combination to form multi-marker panels.
These offer a much higher degree of specificity and sensitivity, can help to achieve an accurate diagnosis as soon as possible
and additionally facilitate patient stratification through the identification of disease subgroups. In addition to
multi-marker panels, other factors driving change in this market involve an evolution in how current technologies are combined
to create multimodal, multiplex biomarker panels capable of integrating data from multiple sources (e.g. DNA sequence,
epigenetic modification, gene expression, protein expression, protein modification etc.) to better understand the full
phenotype of a disease at the molecular level. Using such a combined approach, new IVDs will need to be able to differentiate
between patients with similar symptoms and overcome their inherently transient nature to provide more personalised diagnostic profiles and subsequent treatment regimens.

The IVDs for the autoimmune diseases market are driven by a need for sensitive and specific biomarkers and an understanding
that we need to focus on better diagnosis of these diseases before devising treatment strategies. Now in autoimmmune diseases
we are at the stage where the technologies are there to look deeper at the nature of the diseases and their individual
pathways for progression. We are just at the beginning of redefining autoimmune disease diagnostics and the potential for change and advancement is signficiant.
To find out more about the factors driving change within the autoimmune disease IVD market and its future direction, download
our free market insight report – ‘IN FOCUS: Insights for the In Vitro Diagnostics for Autoimmune Diseases Market’.