Changing Phase of Biomarkers
Article Apr 13, 2015
This featured article was prepared by Frost & Sullivan.
Advancements in multiplexing will lead to the development of biomarker panels with a higher clinical value. The discovery of biomarkers from samples like urine, breath and saliva, as well as the development of non-invasive tests, will find increased application in infectious disease and cancer testing, in which repeat studies are needed to be able monitor the diseases.
The development of multi-biomarker panels that can be used to provide accurate predictive value is important, and companies are working towards discovering and integrating results from different discovery platforms to build such panels.
The adoption of genomics- and proteomics-based biomarkers is currently the highest, with a number of novel lipidomics and immunomics markers also coming to the fore.
Complex diseases with unmet needs are the major potential areas for biomarker development. Traumatic brain injury (TBI), cardiovascular diseases and autoimmune diseases are some of the areas witnessing quality R&D of novel biomarker-based tests.
Various European Governments and health authorities are focussing on investing their funding in biomarker R&D. Various knowledge networks and consortia have been formed to help this cause. The U.K. Biobank, the Biomarkers Consortium and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) E-Register of Studies are some examples.
Changing Business Models:
There is a need for a collaborative model that will enable companies to self-finance the demonstration of clinical utility and bring products to market on time. The diagnostic tests being developed for diagnosis disease management involve complex multiple biomarker analysis.
Existing reimbursement levels and business models find it challenging to reduce expenses, as complex multiple biomarker-based tests are becoming costly for development and validation. To overcome this challenge, many emerging business models are being worked out.
Collaboration with Pharmaceutical Companies:
This will help diagnostic companies in the linkage between companion tests and specific drugs, which may facilitate regulatory approval and uptake in clinical settings.
Incorporation of Single Biomarkers into Simple Molecular and Non-molecular Tests:
The use of existing technology platforms by well-established diagnostic companies may enable the provision of low-cost tests.
Marketing Direct-to-consumer (DTC) Stand-alone Diagnostics:
This type of business model is yet to evolve fully. Companies have begun to market and advertise complex biomarker-based diagnostic tests, health-related products and drugs, and tests (for example, pregnancy tests), among others, in the mainstream media. Companies such as Navigenetics and 23andMe, Inc. continue to market DTC genetic testing.
Integration Model from Research to Commercialisation:
As no specific drug is involved in the development of diagnostic tests, diagnostic companies market these tests to healthcare providers directly. This kind of business model requires multi-parametric predictive values, for companies to self-finance the expensive clinical utility phase.
The first type in this model is companies (for example, Genizon Biosciences) involved in identifying new therapeutic targets. They receive incentives for research and royalties, ranging from 2 to 3% on marketed products.
The second type is a combination of technology licensing and the demonstration of economic benefits. Companies will focus on tests and the underlying techniques for the identification and the development of biomarkers. Commercialisation is completed by another company with adequate resources and well-established marketing capability. One example of such a model is Diagnocure, which carries out proof-of-concept work for licensed technology. The company develops the appropriate cancer prototype and final product completion and commercialisation is done in partnership with another company with a proven robust diagnostic platform. However, Diagnocure is developing itself into a vertically integrated company.
The third type is a fully integrated stand-alone company, such as Genomic Health, Inc. and Myriad Genetics, which carry out all steps with their own sales force - from research to commercialisation.
Advancements in metagenomics are enabling the discovery of novel biomarkers as drug targets. The lowered cost and time of the whole genome shotgun is prompting companies to switch from arrays to sequencing for comprehensive analyses. Biomarkers will facilitate the combination of therapeutics with diagnostics and will thus play an important role in the development of personalised medicine. Increased research on glycans, such as carbohydrate-based biomarkers, as potential for cancer drug development, will provide new opportunities. Collaborations among drug discovery research organisations, academia and pharmaceutical companies, in terms of the sharing of early-stage biomarker data, is quickening the commercialisation process.
Evolving biomarkers will bring a paradigm shift in the way healthcare is provided - from the mere identification of drug targets to the optimisation of therapies. Biomarkers will find extensive demand in patient stratification applications, particularly for cardiac and neurological disorders. Adopting an integrated systems biology approach for information analysis for biomarker discovery will be the key area of focus in future.
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Srinivas Sashidhar is a Senior Research Analyst, Life Sciences, Frost & Sullivan.
Proficient in Healthcare Market Research / Market analysis techniques (with Exposure to Europe and Global Markets). Exposure to global client interactions for primary research, Secondary research, identification of key challenges, drivers & restraints, market trends, competitive analysis, market forecasting and business writing for market research report.
Expertise in the Life Science markets, such as, pharmaceutical and biotechnology, clinical diagnostics and drug discovery tools, particularly in, biosimilars, diabetes and In-Vitro Diagnostics.