A companion diagnostic assay is an in vitro diagnostic device (IVD) that is used to identify whether a patient with certain diseases could be benefitted by a particular drug through the biomarker assessment.
The key factors driving the growth of this market include the increasing lung cancer cases, growing number of genetic testing, rising need for personalized medicines, and regulatory guidelines that support the companion diagnostics market.
The global companion diagnostics market is expected to reach $6.51 billion by 2022 from $2.17 billion in 2016, at a CAGR of 20.1%.
Market Dynamics – Drivers
- Improvements in regulatory guidelines
- Growing need for targeted therapies
- Rising cancer incidence worldwide
- Increasing collaborations and partnerships for companion diagnostics test development
Increasing collaborations and partnerships for companion diagnostics test development
Owing to the advantages of companion diagnostics in drug approval processes, an increasing number of pharmaceutical companies have entered into partnerships and collaborations with different companion diagnostic companies to develop and commercialize companion diagnostics tests for their drugs.
For instance, in 2016, Agilent Technologies, Inc. and Applied Spectral Imaging (ASI) entered into a marketing agreement. ASI’s most advanced GenASIs imaging platforms and Agilent’s fluorescence in situ hybridization (FISH) products and solutions will be marketed by them. Simalarly in 2016, QIAGEN collaborated with Array BioPharma to develop and commercialize a companion diagnostic test. The test will be developed for Array BioPharma’s binimetinib, an MEK inhibitior.
Software and Services
Companion diagnostics software is used to streamline the research and analysis of diagnostic results. Software offers various functions such as the identification of driver vs. passenger mutations, prediction of novel biomarkers, and identification of genes that cause cancer.
Companion diagnostic services include the development and commercialization of companion diagnostic (CDx) kits, biomarker assay development, analytical and clinical validation, regulatory registration/approval, cGMP manufacturing, GCP/CLIA certified laboratory, and project management. There are many companies offering end-to-end companion diagnostic services from development to commercialization.
Reimbursement challenges in different regions could limit market growth to a certain extent. Reimbursements for companion diagnostics vary widely across regions and countries. Currently, in most countries, reimbursement is provided only for treatments that offer better clinical results and evidence of performance.
Assay Kits and Reagents
Companion diagnostic assay kits include test panels that enable the detection of biomarker types. Companion diagnostics assays analyze the efficacy of a particular drug through the detection of disease biomarker activity against that drug.
Companion diagnostic assays are operated on various technology platforms such as polymerase chain reaction (PCR), next-generation sequencing (NGS), immunohistochemistry (IHC), and in situ hybridization (ISH).
Reagents include components such as staining solutions, acids, bases, buffers, detergents, solutions, and substrates required while performing various companion diagnostic tests. Reagents are products paired to the diagnostic test procedures and have a single-use.
The prominent players in the global companion diagnostics market are Thermo Fisher Scientific Inc. (U.S.), F. Hoffmann-La Roche AG (Switzerland), Agilent Technologies, Inc. (U.S.), QIAGEN N.V. (Netherland), Illumina Inc. (U.S.).
Collaborations and partnerships was the key growth strategy adopted by market players between 2014 and 2017. Companies also aim to differentiate themselves in the highly competitive global market by expanding their product portfolios in accordance with industry trends and client needs.
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