Published: 2023 March 20

Companion Diagnostics Market Size, Competitive Landscape and Market Forecast - 2030

SKU : CD224
180 pages
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Table of Contents
List of Tables & Figures

Global Companion Diagnostics Market is segmented By Indications (Oncology (Colorectal Cancer, Leukemia, Breast Cancer, Lung Cancer, Others), Neurology, Others), By Technology (In-situ Hybridization, Immunohistochemistry, Polymerase Chain Reaction, Next-Generation Sequencing, Others), By End-User ( Pharmaceutical and Biopharmaceutical Companies, Research Laboratories, Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Size, Share Outlook, and Opportunity Analysis, 2023-2030


Market- Overview

The Global "Companion diagnostics Market"  is expected to grow at a CAGR during the forecast period (2022-2029).     

A companion diagnostic is an in vitro medical device that provides information which is essential for the safe and effective use of a corresponding drug or biological product. This diagnostic test helps a health care professional to determine whether a particular therapeutic product is beneficial to patients and can outweigh any potential serious side effects or risks.


Companion Diagnostics Market Dynamics and Trends

The global companion diagnostics market growth is driven by the surge in R&D of targeted therapies, rise in demand for personalized medicine with increase in awareness in emerging economies, discovery of new biomarkers for various conditions, and higher number of unmet needs for the treatment of cancer are majorly driving the growth of the global companion diagnostics market.  

Growing need for targeted therapy will drive the market growth

With advances in genetic sequencing and genomics, it is now widely believed that drugs can work differently in different individuals. A better understanding of the genetic characteristics or biomarkers of an individual can promote the practice of administering “the right drug, at the right time, at the right dose, for the right person.” Pharmaceutical and biopharmaceutical companies are continuously attempting to implement patient-selection diagnostic frameworks in the earlier stages of drug development to provide targeted therapies to the right candidate. This further supports the growth of the companion diagnostics market.

The rising burden of cancer increases the demand and awareness for personalized medicines among the population. With companies expanding their collaborations for better biomarkers and diagnostics to focus on cost regulations, there has been a significant number of opportunities for its applications in indications like cancer, cardiovascular, and neurological disorders. For instance, in April 2019, Myriad Genetics Inc., AstraZeneca PLC, and Merck Group entered a partnership to identify unmet medical needs in men related to metastatic castration-resistant prostate cancer and expand the company's patient access in the market.

High cost of companion diagnostics tests is likely to hamper the market growth   

However, the high initial cost puts these tests out of reach of a large portion of end users particularly those in developing countries in spite of providing assured returns on investment. This prompts end users such as pharma companies, reference laboratories, hospitals, and CROs, which perceive the usage of such diagnostic tests as a burden on their budgets, to opt for third-party companion diagnostic services. This factor will hamper the market growth in the forecast period.

COVID-19 Impact Analysis on Companion Diagnostics Market

Early diagnosis of COVID-19 is becoming essential in the market, as it can help find the right treatment for patients impacted by the virus. The most commonly used and reliable test for diagnosis of COVID-19 is the polymerase chain reaction (PCR) test performed using nasopharyngeal swabs or other upper respiratory tract specimens, including throat swabs. Thus, the disease diagnosis using polymerase chain reaction (PCR) emerged as a major focus for managing the disease.​​ In November 2020, TScan Therapeutics signed a research license and option agreement with Qiagen to develop a COVID-19 immune response test.

The companion diagnostics market is expected to experience substantial growth due to the development of new biomarkers for various diseases, a rise in R&D of targeted therapies, an increase in demand for customized medicine with increased recognition in developing markets, and a higher number of unmet cancer care needs. For instance, in September 2020, Roche introduced a highly effective SARS-CoV-2 antibody test that provided fast results. The introduction of such highly effective diagnostic tests is expected to boost market growth.   

Companion Diagnostics Market Segment Analysis

The polymerase chain reaction (PCR) segment is expected to grow at the fastest CAGR during the forecast period (2021-2028)     

The polymerase chain reaction segment is expected to dominate the companion diagnostics market in 2020. The large share of this segment can be attributed to the ease of use and widespread availability of PCR kits & reagents in companion diagnostic testing, growing applications of PCR in the high-throughput detection of mutants with a limited or low allele frequency of genes, and high turnaround time of PCR as compared to other technologies. PCR techniques are used in clinical and research laboratories for a broad variety of applications, which include clinical diagnosis, criminal forensics, and biomedical research. PCR-based molecular diagnostic tests are increasingly being used to guide patient management, particularly in the fields of infectious diseases, cancer, and congenital abnormalities. Globally, the prevalence of genetic, infectious, and chronic diseases, coupled with the increased availability of genetic and genomic information, is on the rise, and it has led to the rapid incorporation of PCR techniques in clinical laboratories.

The rising COVID-19 cases and spread of the disease in major countries have increased the demand for the diagnostic tests of the virus in the suspected population. This trend is primarily due to the low or non-availability of rapid or specific diagnostic tests for such diseases. Therefore, pertaining to broad applications of PCR in clinical diagnostics, the segment is likely to register high growth during the forecast period.

The high specificity, sensitivity, and low sample requirement make PCR-based molecular assay a go-to technique for the purpose of clinical diagnosis. PCR-based molecular assays are becoming the primary mode of diagnosis for the detection of pathogens in case of a rapid disease outbreak, such as the recent Zika and coronavirus outbreaks.


Companion Diagnostics Market Geographical Share

North America region holds the largest market share of global companion diagnostics Market

North America has the highest global market share due to the increasing technological advancements aimed at developing companion diagnostic tests for new indications such as neurology and infectious diseases. The use of companion diagnostics is considered an important treatment decision tool for various oncology drugs, which is also reflected in how the FDA classifies these assays concerning risk. Companion diagnostics clinical trials have come to the forefront in the pharmaceutical industry, despite the COVID-19 outbreak, as it helps boost the chances of clinical success. The testing kit has been seeing high demand for identifying those infected with SARS-CoV-2. The novel coronavirus remained the main focus for diagnostic test makers in terms of research and development. In 2020, in the United States, MiraDx set up its lab to provide COVID-19-based test services. The company claims that the lab has been able to analyze more than 9,000 tests accurately.

The increasing burden of cancer in the United States is also expected to drive market growth. According to the data published by American Cancer Society Inc., in 2020, in the United States, there were around 1.8 million new cancer cases diagnosed and 606,520 cancer deaths. The favorable reimbursement scenario for breast cancer diagnostic solutions in the United States is anticipated to facilitate their adoption. In January 2020, the Centers for Medicare & Medicaid Services (CMS) expanded its coverage of next-generation sequencing as a diagnostic tool for patients with germline (inherited) breast cancer. Hence, owing to high healthcare technology adoption rates and the increasing demand for personalized medicine, the North America companion diagnostics market is expected to register a substantial growth rate during the forecast period.


Companion Diagnostics Companies and Competitive Landscape

The Companion diagnostics Market is highly competitive with presence of local as well as global companies.  Some of the key players which are contributing to the growth of the market include Abbott Laboratories Inc., Agilent Technologies Inc., F.Hoffmann-La Roche Ltd, Biomerieux SA, and Qiagen NV, Siemens Healthcare, Thermo Fisher Scientific Inc., Danaher Corporation (Beckman Coulter Inc.), Almac Group, Illumina Inc., among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the Companion diagnostics Market globally. For instance, In May 2020, Bayer AG and ArcherDX Inc. entered a collaboration for the development and commercialization of next-generation sequencing (NGS)-based companion diagnostics (CDx) for Vitrakvi (larotrectinib).

F.Hoffmann-La Roche Ltd.

Overview: F. Hoffmann-La Roche AG provides in-vitro diagnostics and drugs for cancer and transplantation. The Company specializes in medicines for oncology, virology, inflammation, metabolism, CNS, clinical chemistry, immunology, urinalysis, blood screening, genetics, infectious diseases, and microbiology.

Product Portfolio:

cobas 4800 BRAF V600 Mutation Test:  The cobas 4800 BRAF V600 Mutation Test is a real-time polymerase chain reaction (PCR) test for the detection and identification of BRAF V600 mutations in formalin-fixed paraffin-embedded tissue (FFPET) of human melanoma.

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What is the Companion diagnostics Market growth?
The market is growing at a High CAGR
Who are the key players in Companion diagnostics Market?
Some of the key players include Abbott Laboratories Inc., Agilent Technologies Inc., F.Hoffmann-La Roche Ltd, Biomerieux SA, and Qiagen NV, Siemens Healthcare,