Companion diagnostics are diagnostic tests that are used as a companion to a therapeutic drug to evaluate its usefulness to a particular patient. They are co-developed with drugs that help in selecting or excluding specific treatment for individuals.
Companion diagnostics are developed based on biomarkers that help predict probable response or severe toxicity in a prospective way. Companion diagnostic medical devices are generally in-vitro devices, which provide necessary information for the safe and effective use of a drug or biological product. The test helps the healthcare provider to determine whether a particular therapeutic product benefits the patients. On July 31, 2014, the FDA released the ‘Guidance for Industry: In Vitro Companion Diagnostic Devices’ to help the companies understand the need for companion diagnostic at an earlier stage in the drug product development process.
The companion diagnostics market was valued at USD 3,560 million in 2019 and is anticipated to grow with a CAGR of about 15.5%.
The companion diagnostics market is largely driven by the increasing demand for targeted therapy, rising importance of personalized medicine, surging global prevalence of cancer, and burgoening application of companion diagnostics. In addition, increasing cases of adverse drug reactions and lack of efficacy of certain drugs drive market growth.
Currently, the market players are engaging in umpteen collaborations to develop cost-effective and advanced biomarkers and diagnostics. For instance, in January 2020, F. Hoffmann-La Roche Ltd and Illumina, Inc. collaborated to raise patient access to genomic testing. As per the agreement, Roche manufactures and distributes in-vitro diagnostic (IVD) tests for Illumina’s NextSeq 550Dx System as well as its future portfolio of diagnostic sequencing systems.
The market players are actively working and heavily investing in R&D activities to develop novel products in order to address the critical unmet needs of the patients. For instance, in January 2017, Singulex, Inc. collaborated with QIAGEN N.V. to develop companion diagnostics, using Singulex's patented single-molecule counting (SMC) immunodiagnostic platform.
The market is largely driven by rapid product approvals by regulatory authorities. For instance, in January 2018, Myriad Genetics, Inc. obtained the U.S. Food and Drug Administration (FDA) approval for BRAC Analysis CDx, which is used as companion diagnostic to identify patients with HER2-negative metastatic breast cancer with BRCA mutation in geneline, and qualifying for Lynparza (olaparib) therapy. Additionally, in March 2019, F. Hoffmann-La Roche Ltd received the U.S. Food and Drug Administration (FDA) approval of the VENTANA PD-L1 (SP142) Assay, as the first companion diagnostic to help in identifying triple-negative breast cancer (TNBC) patients eligible for Roche immunotherapy treatment Tecentriq (atezolizumab) plus chemotherapy.
Based on technology, the market is divided into immunohistochemistry and molecular diagnostics. Immunohistochemistry technology helps to clarify the tissue distribution of an antigen, which is a crucial application of monoclonal and polyclonal antibodies therapies. It is used to identify enzymes, tumor suppressor genes, antigens, and proliferation of tumor cells. It has gained popularity in the field of companion diagnostics as it is used in the diagnosis of chronic diseases such as cancer, infectious diseases, cardiovascular diseases, and autoimmune diseases. The immunohistochemistry segment is expected to witness significant growth owing to the growing prevalence of chronic diseases and the increasing demand for immunohistochemistry solutions.
The molecular diagnostics segment, on the other hand, holds the highest share in the companion diagnostics market and can be further segmented into In Situ hybridization, real-time PCR, and gene sequencing. The gene sequencing segment holds the largest market share on account of large-scale gene sequencing projects focusing on rare diseases therapeutics and oncology. For instance, in May 2018, QIAGEN partnered with Freenome, a genomics solution provider based on artificial intelligence, to accelerate the development and marketing of gene sequencing-based companion diagnostic test for precision cancer treatment.
Based on indication, the market is segmented into oncology, autoimmune diseases, cardiovascular diseases, central nervous system disorders, and virology diseases. The oncology companion diagnostic segment held the highest market share in 2018 on account of the increasing collaboration activities among key diagnostics manufacturers and pharmaceutical companies for the development of effective solutions. For instance, in January 2016, NanoString Technologies, Inc. signed a collaboration agreement with Astellas and Medivation to upgrade its PAM50-based Prosigna Breast Cancer Assay and use the test as a potential companion diagnostic test with enzalutamide, a drug used to treat triple-negative breast malignancy.
Companion diagnostic testing helps to determine a patient's health status and guide the patient to appropriate treatment, determine potential adverse effects, and predict recovery of patients from umpteen diseases. Researchers also hypothesized that patients and local healthcare settings may benefit from the responses obtained from these diagnostic systems, which can detect virus genetic material and assess whether the treatment given to patients infected with the virus are responding or not, further driving the market growth.
North America dominates the companion diagnostics market as the region is backed by the presence of well-established manufacturers that are offering advanced companion diagnostic. For instance, in June 2018, the U.S. Food and Drug Administration (FDA) approved the Dako PD-L1 IHC 22C3 pharmDx assay developed by Agilent Technologies Inc. For the record, PD-L1 IHC 22C3 pharmDx is the first FDA-approved immunohistochemistry test for determining PD-L1 expression in cervical cancer. As reported by the National Cancer Institute (NCI), in the U.S., around 1,735,350 new cancer cases and 609,640 cancer-related deaths were reported in 2018. Thus, increasing the prevalence of cancer has compelled the manufacturers to develop novel products, further driving the regional market growth.
Asia-Pacific is projected to grow with the highest CAGR in the companion diagnostics market. High incidences of cancer, increasing proteomics and genomics research, rising funding for research and diagnostics, and growing awareness about personalized medicines drive the market growth. For instance, in November 2018, the Pharmaceuticals and Medical Devices Agency of Japan issued perspectives for evaluating comprehensive genomic panels for oncology companion diagnostics. Similarly, Japan has launched a nationwide cancer genome screening project, SCRUM Japan, using companion diagnostics for patients with gastrointestinal cancers and lung cancers.