Companion diagnostic is a medical device used as an in-vitro diagnostic device, which is used to provide essential information of the drug or therapeutic product such as whether the drug is safe and effective towards particular treatment in patients, identify whether the patients are more likely to have benefit from the prescribed drug, and also carries out drug monitoring on the patients.
Companion diagnostics are widely used in diseases such as breast cancer, lung cancer, gastric cancer, and neurological diseases. Moreover, companion diagnostics use a wide range of diagnostic procedures such as polymerase chain reactions, in situ hybridization, next generation sequencing, immunohistochemistry, and multiplex assay and cellular imaging technologies.
Figure 1. Global Companion Diagnostics Market Value (US$ Mn), 2016-2027
The global companion diagnostic market value is estimated to be valued at US$ 3,481.2 million in 2020 and is expected to exhibit a CAGR of 19.5% over the forecast period (2020-2027).
Significant increase in global companion diagnostic testing is mainly due to factors such as increasing prevalence of diseases such as lung cancer and non-small cell lung cancer. For instance, according to the US National Library of Medicine report in 2018, the U.S. estimated around 121,680 cases of lung cancer in men and 234,030 cases in females. Moreover, according to the same source, in 2018, lung carcinoma, prostate cancer, and breast cancer were the most diagnosed cancers in the U.S.
|Base Year:||2019||Market Size in 2019:||US$ 3,481.2 Mn|
|Historical Data for:||2016 to 2019||Forecast Period:||2020 to 2027|
|Forecast Period 2020 to 2027 CAGR:||19.5 %||2027 Value Projection:||US$ 12,114.6 Mn|
F. Hoffmann-La Roche AG, Agilent Technologies, Inc, QIAGEN N.V, Abbott Laboratories, Inc., Almac Group, Danaher Corporation, Illumina, Inc, bioMérieux SA, Myriad Genetics, Inc, Sysmex Corporation, Thermo Fisher Scientific Inc, Abnova Corporation, Guardant Health, Inc., Icon Plc, and Biogenex Laboratories, Inc
|Restraints & Challenges:||
Global Companion Diagnostic Market- Impact of Coronavirus (Covid-19) Pandemic
There is a bidirectional relationship between COVID-19 and companion diagnostic market. For instance in April 2020, according to Diaceutics PLC, a diagnostic company announced results of impact of COVID on the cancer testing and diagnosis in the U.S. from their own COVID-19 oncology tracker. According to Diaceutics COVID-19 tracker, there is approximately 31% drop in companion diagnostic procedures.
Among regions, North America market is expected to grow, as key companies are focusing on product launches to expand the number of testing facilities and development in diagnostic procedures. For instance, in 2018, Roche Molecular Systems, Inc received an approval for cobas EFGR mutation test v2, a polymerase chain reaction (PCR) test used in diagnosis of mutation in epidermal growth factor receptor gene in non-small cell lung cancer.
Figure 2. Global Companion Diagnostic Market Share (%), by Region, 2020
Moreover, in Europe companion diagnostic market, companies are focusing on mergers and acquisitions to strengthen the development in diagnostic procedures, which is expected to drive the market growth in this region. For Instance, in 2019, Myriad Genetics, Inc, a leading company in personalized medicines, announced its merger with AstraZeneca and Merck. The merger will lead to use of BRACAnalysis CDx to identify BRCA mutations in men suffering from metastatic castrate resistant cancer.
Major players operating in global companion diagnostic market include F. Hoffmann-La Roche AG, Agilent Technologies, Inc, QIAGEN N.V, Abbott Laboratories, Inc., Almac Group, Danaher Corporation, Illumina, Inc, bioMérieux SA, Myriad Genetics, Inc, Sysmex Corporation, Thermo Fisher Scientific Inc, Abnova Corporation, Guardant Health, Inc., Icon Plc, and Biogenex Laboratories, Inc.
Companion diagnostic is a diagnostic tool used by healthcare professionals to determine whether a particular therapeutic product is the suitability for the patient to outweigh any potential side effects of the therapeutic product. Companion diagnostic is advancing the course of patient care in the field of oncology sue to proper evaluation of therapeutic product and its efficiency towards the cancer patients. All the patients suffering from cancer are not able to be treated with immunotherapy. In such cases, companion diagnostics play an important role in helping physicians to identify the efficient targeted therapy for such cancer patients.
Robust product pipeline, increasing approval of companion diagnostic procedures, and high outsourcing of funds by companies for the development of companion diagnostic are the factors driving the global companion diagnostic market growth. For instance, in March 2019, F. Hoffmann-La Roche Ltd received the U.S. Food and Drug Administration (FDA) approval for the VENTANA PD-L1 (SP142) Assay, which is the first companion diagnostic to aid in identifying triple-negative breast cancer (TNBC) patient eligible for treatment with the Roche cancer immunotherapy Tecentriq (atezolizumab) plus chemotherapy.
Moreover, increasing incidence of cancer globally is also driving growth of the global companion diagnostic market. For instance, in September 2018, according to the Globocan 2018 report, Europe held the second position in new cancer cases and accounted for 23% and around 3,911,317 new cases of cancer.
Increasing investment in the research and development by pharmaceutical and biotechnological companies targeting major chronic diseases such as cancer, cardiovascular disease, neurological disease, and respiratory disease is expected to drive the companion diagnostic market growth over the forecast period. For instance, in 2018, Abbott Molecular, Inc received approval from the U.S. Food Drug and Administration for Abbott real time IDHI, an in vitro polymerase chain reaction assay for detection of IDHI R123 mutations for identifying acute myeloid leukemia with treatment therapy of TIBSOVO.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.