Companion Diagnostics Market Size By Product (Instruments, Consumables, Services), By Disease Indication (Breast cancer, Lung cancer, Colorectal Cancer, Skin cancer), By Technology (Immunohistochemistry, In Situ Hybridization, Polymerase Chain Reaction, Genetic Sequencing), By End-use (Hospitals, Diagnostic Laboratories), Industry Analysis Report, Regional Outlook, Application Potential, Competitive Market Share & Forecast, 2019 - 2025

Published Date: Jul 2019  |  Report ID: GMI3972  |  Authors: Sumant Ugalmugle

Report Format: PDF   |   Pages: 110   |   Base Year: 2018

Summary Table of Contents Industry Coverage Methodology

Industry Trends

Companion Diagnostics Market Size was valued at USD 2 billion in 2018 and is expected to witness over 19% CAGR from 2019 to 2025.

Companion Diagnostics Market

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Growing incidences of adverse drug reactions will prove beneficial for companion diagnostics market growth. Adverse reactions worsen the patient’s existing condition and increase the morbidity and mortality rates. Patients on multiple dosages for various diseases at a time are susceptible to adverse drug reactions. Companion diagnostics (CDs) help doctors to identify patients at higher risk of side effects from certain medications and thus enable their prevention. CDx further helps to adjust drug treatment to avoid hazardous repercussions and enhance clinical outcomes. Aforementioned advantages of complementary diagnostics in preventing the adverse effects will escalate its preference over the forecast period rendering significant positive impact on the market growth.

Increasing prevalence of cancer across the globe will propel companion diagnostics industry over the analysis time frame. Cancer patients react differently to variety of drugs and consequently need personalized therapy. Companion diagnostics provide accurate information about the drug’s effectiveness and safety in different patient group. These benefits of companion diagnostics tests in the treatment of cancer will prove beneficial for the market growth. However, high cost of these tests may impede the market to some extent over the forecast period.

Companion Diagnostics Market Report Coverage
Report Coverage Details
Base Year: 2018 Market Size in 2018: 2 Billion (USD)
Historical Data for: 2014 to 2018 Forecast Period: 2019 to 2025
Forecast Period 2019 to 2025 CAGR: 19% 2025 Value Projection: 6.5 Billion (USD)
Pages: 110 Tables, Charts & Figures: 110
Geographies covered (15): U.S., Canada, Germany, UK, France, Italy, Spain, India, China, Japan, Australia, Brazil, Mexico, South Africa, Saudi Arabia
Segments covered: Product, Disease Indication, Technology, End-use and Region
Companies covered (12): Abbott, Agilent Technologies, bioMérieux, Foundation Medicine, Illumina, MolecularMD (ICON), Myriad Genetic Laboratories, Johnson & Johnson, Qiagen, Roche, Thermo Fisher Scientific, Arup Laboratories
Growth Drivers:
  • Increasing drug diagnostic co-development
  • Improving regulatory scenario
  • Growing incidences of adverse drug reaction
  • Increasing prevalence of cancer globally
Pitfalls & Challenges:
  • High cost of companion diagnostics test in developing and underdeveloped regions

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Companion Diagnostics Market, By Product

Consumables segment is anticipated to witness around 19% CAGR over the forecast period. The segment includes reagent and media, that are required for assessment of patient’s reaction to the drug. Unlike instruments, consumables are frequently bought and have high replacement rate. They are consumed in large quantity to cater to increasing demand for companion diagnostics. As a result, consumable segment will offer lucrative growth opportunities with growing companion diagnostics market share.

Service segment was valued over USD 160 million in 2018 and anticipated to show robust growth in forthcoming future. Outsourcing services enables healthcare facilities to emphasize on primary activities. Moreover, companies providing companion diagnostics services have  expertise in the field and thus provides superior quality data. As companion diagnostics services enables healthcare professionals to provide superior quality therapy to patients by using personalized medications, its demand will rise over analysis period.

Companion Diagnostics Industry, By Disease Indication

Lung cancer segment application segment of companion diagnostics market is projected to show more than 18.5% CAGR from 2019 to 2025. Substantial growth is attributed to Increasing prevalence of cancer across the globe. According to Centers for Disease Control and Prevention, 218,229 lung and bronchus cancer incidences were reported in 2016 in the U.S. Selection of effective treatment at early stages plays important role in the treatment of lung cancer. Companion diagnostics enables selection of treatment tailored considering individual needs.  Moreover, it also helps in avoiding adverse reactions throughout the course of treatment. Aforementioned applications of CDx in the field of oncology will augment the segment growth.

Skin cancer segment accounted for over 13% revenue share in 2018. Increasing prevalence of skin cancer due to adverse effects of cosmetics and excess exposure to harmful sun rays will surge demand for companion diagnostics tests. As per CDC, in 2016, 82,476 incidences of melanomas were reported in the U.S. alone. Companion diagnostics is playing pivotal role in assisting doctors to treat skin cancer patients. As a result, demand for companion diagnostics will escalate in near future, thereby fuelling segment growth.

Germany Companion Diagnostics Market By Disease Indication

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Companion Diagnostics Market, By Technology

In situ hybridization technology segment of companion diagnostics market share was valued over USD 400 million in 2018. In situ hybridization uses amplifiable DNA as reporter molecule that produce multiple variants. In situ hybridization enables parallel analysis of multiple protein involved in tissues and cells making it possible to relate protein complex among individual’s cells. In situ hybridization technology is prominently used for fusion in non-small-cell lung cancer or detect amplification in breast cancer. This technology can detect known and novel fusion types and it is simple and easy to use with well designed probes. Aforementioned benefits will augment demand for in situ hybridization, thereby accelerating segment growth.

Genetic sequencing technology segment of companion diagnostics market is anticipated to witness more than 20% CAGR over the forecast period. Next Generation Sequencing (NGS) is used for recognizing unknown genes for microbiome, cancer driver genes, hereditary diseases and also for clinical and research application purposes. Technologically advanced next generation sequencing methods enables in detecting fusions, mutations, microsatellite instability, copy number alterations, tumour mutation burden, etc. These features of genetic testing-based companion diagnostics assist in finding detailed genetic structure of an individual.

Companion Diagnostics Industry, By End-use

Hospitals segment had over 40% revenue share in 2018 and it will expand enormously in the coming years. Increasing patient pool due to high prevalence of chronic disorders will prove beneficial for the segment growth. Hospitals incorporate technologically advanced companion diagnostics that enable physician to provide superior treatment to patient. Availability of developed infrastructure and skilled professionals in hospital increases patient’s preference towards hospitals, thereby fuelling segment growth.

Diagnostic laboratories end use segment of companion diagnostics market share is anticipated to witness around 19.5% growth over the forecast time frame. Increasing awareness pertaining to benefits of early diagnosis have surged the demand for better and accurate diagnostic tests. Additionally, government funding for diagnostic tests to curb the burden of these diseases will benefit the segment growth. Moreover, availability of technological advanced devices for diagnosing specific type of cancer will enable healthcare professionals to provide patient with accurate data. As a result, increasing awareness and prevalence of cancer will fuel segment growth.

Companion Diagnostics Market, By Region

North America companion diagnostics market size is estimated to witness more than 18% CAGR over the forecast timeline. Increasing prevalence of chronic diseases and growing geriatric population susceptible to these diseases will prove beneficial for regional growth. Furthermore, high disposable income and affordability for companion diagnostics tests will render a significant positive impact regional market growth.

Asia Pacific market is anticipated to witness around 20.5% growth in upcoming years. Growing patient pool will increase demand for superior quality diagnostic tests. Additionally, government initiatives for providing effective treatment to cancer patients will prove beneficial for regional growth. Furthermore, companies are taking initiatives and doing necessary alliances to demonstrate usefulness of companion diagnostics for curbing overall healthcare expenditure. Consequent rise in adoption of companion diagnostics in the region will augment its demand thereby, positively stimulating regional market growth.

Asia Pacific Companion Diagnostics Market By Country

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Competitive Market Share

Some of the notable players operating in the companion diagnostics market are Abbott, Agilent Technologies, bioMérieux, Foundation Medicine, Illumina, MolecularMD (ICON), Myriad Genetic Laboratories, Johnson & Johnson, Qiagen, Roche, Thermo Fisher Scientific and Arup Labortaories. Industry players are adopting strategies such as new product launches, collaborations and mergers and acquisitions to grab high revenue share.

Recent industry developments:

  • In April 2018, Bristol Myers Squibb and Illumina announced collaboration to develop and commercialize companion diagnostics for immunotherapy. This strategy aimed at developing new products to cater to demands of unmet needs of patients. This activity will help company to capture high revenue share
  • In May 2015, AstraZeneca and Abbott entered into an agreement to develop companion diagnostic tests to identify patients suffering from severe asthma that can be benefitted with tralokinumab. Objective behind this strategy is to develop innovative product that will aid patients.


Industry Background

Companion diagnostics indsutry can be traced back to late 1990’s. In 1998, 16 oncology drugs were approved by FDA. Companion diagnostics for Herceptin was approved in 1998. Later, with extensive research undertaken by industry players, companion diagnostics industry started gaining momentum. Increasing chronic diseases such as cancer and neurology and adverse reactions has led into development of companion diagnostics technology. Currently the market players are taking initiatives to develop technologically advanced companion tests to aid treatment in improve patient’s life. This market has immense growth opportunities across the globe with large number of healthcare organizations generating huge amount of data annually that would assist researchers in R&D activities. The market is in booming phase and scenario is likely to remain so over the next decade.

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