Companion Diagnostic Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F

The Companion Diagnostic Market was valued at USD 6.17 Billion in 2024, and is expected to reach USD 12.14 Billion by 2030, rising at a CAGR of 11.94%. Companion diagnostics are medical devices used in conjunction with therapeutic drugs to assess the impact and suitability of drugs for specific individuals. These diagnostics are developed alongside drugs to identify patient groups that respond to or are not suitable for the therapy based on their characteristics. Healthcare professionals utilize this device to evaluate the effectiveness of a particular treatment for a patient.

In 2020, Roche obtained FDA approval for the Cobas EGFR Mutation Test v2 companion diagnostic, which assists in determining the appropriate use of EGFR tyrosine kinase inhibitors for lung cancer treatment. Companion Diagnostic (CDx) is a clinical test co-developed with a therapeutic drug to identify patients who will respond or not respond to the drug. It enables the identification of patient groups that can or cannot be treated with the corresponding drug. CDx helps practitioners evaluate the benefits, side effects, and associated risks of therapeutic drugs, ensuring patient safety.

The global Companion Diagnostics Market is driven by factors such as increasing patient demand for tailored therapy, expanded applications of personalized medications, higher prevalence of chronic diseases, and growing incidence of medication-related allergies. These factors contribute to the development of customized CDx, promoting market growth. Additionally, CDx tests offer advantages such as cost-effectiveness, high sensitivity, and rapid and accurate results within shorter time frames, further fueling the growth of the Companion Diagnostics Market.

Key Market Drivers

Increasing Demand for NGS-Based Technology

The growing demand for next-generation sequencing (NGS) technology, with its exceptional capability to identify rare variants, plays a critical role in the continued success and wider distribution of companion diagnostics solutions in the companion diagnostics market. By utilizing NGS panels, a single test has the potential to aid in the treatment of numerous types of cancers, offering a more comprehensive approach to personalized medicine.

For instance, in July 2022, Almac Diagnostic forged a strategic partnership with AstraZeneca, a leading pharmaceutical company, to collaboratively develop and commercialize multiple companion diagnostic (CDx) products. These innovative CDx solutions will be based on cutting-edge NGS (next-generation sequencing) and qPCR-based (quantitative polymerase chain reaction) technologies, further advancing the field of precision medicine and enhancing patient care. Through this collaboration, Almac Diagnostic and AstraZeneca aim to improve the accuracy and effectiveness of diagnostics, enabling targeted therapies and personalized treatment plans for patients. This partnership demonstrates the commitment of both companies to drive innovation in the field of companion diagnostics and contribute to the advancement of precision medicine.

By leveraging the power of NGS and qPCR technologies, Almac Diagnostic and AstraZeneca envision a future where companion diagnostics play a pivotal role in guiding treatment decisions and improving patient outcomes across various therapeutic areas. This collaboration represents a significant step forward in the development of advanced diagnostic solutions that will revolutionize the way diseases are diagnosed and treated. With the combination of cutting-edge technologies and strategic partnerships, the field of precision medicine is poised to make significant strides in improving patient care and transforming healthcare on a global scale.

Key Market Challenges

Lack of Awareness and High Cost of Companion Diagnostics Techniques

While immunotherapy has shown significant promise in the treatment of cancer, its high cost has limited widespread patient access. As a result, physicians may opt to combine treatments, which can extend the duration of treatment from five months to over three years. With longer treatment duration comes a greater financial burden, as the cost of personalized immunotherapies is also substantial. In fact, the cost of cancer immunotherapies can far exceed that of other treatment options such as chemotherapy or radiation therapy. Consequently, the high cost of immuno-oncology treatments is believed to impede the growth of the companion diagnostics market. This financial barrier highlights the need for continued research and innovation to develop more affordable and accessible immunotherapies for cancer patients.

Key Market Trends

Growing Importance of Promotional Activities

The increasing significance of promotional activities represents a key trend in the companion diagnostics market. Companion diagnostics, due to their specificity in being applicable only to particular drugs, are not as extensively marketed as other available test kits and devices in the market. Therefore, it is crucial to give greater attention to improving the distribution network and enhancing the availability of products to end users. In terms of advertising sources, internet channels and search engines are among the most vital, considering their higher visibility and the limited return on investment and visibility of other media.

Furthermore, besides boosting sales, emphasis is placed on product functionality, accuracy, and vendors' after-sales services, while marketing communication takes a back seat. Limited promotion activities pose challenges in reaching the target market and understanding a company's competitive position. To attract customers to a company website, the publication of multiple blogs and newsletters can be beneficial. This approach allows businesses to sustain their marketing campaigns over an extended period and attract repeat visitors. As the market continues to witness product enhancements, vendors are increasingly recognizing the importance of promotional activities, and this trend is expected to gain momentum, thereby supporting the growth of the global companion diagnostics market throughout the forecast period.

Key Market Players

• Abbott Laboratories Inc.
• Agilent Technologies Inc.
• F.Hoffmann-La Roche Ltd
• Biomerieux SA
• Qiagen NV
• Siemens Healthcare
• Thermo Fisher Scientific Inc.
• Danaher Corporation (Beckman Coulter Inc.)
• Myriad Genetics Inc.
• Illumina Inc.

Report Scope:

In this report, the Global Companion Diagnostic Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Companion Diagnostic Market, By Product and Services:

• Kits and Reagents
• Assays
• Software
• Services

Companion Diagnostic Market, By Technology:

• PCR
• NGS
• In-Situ Hybridization
• Immunohistochemistry
• Others

Companion Diagnostic Market, By Disease Indication:

• Oncology
• Neurology
• Cardiology
• Infectious Diseases
• Others

Companion Diagnostic Market, By Application:

• In-Vitro Diagnostics
• Drug Discovery
• Others

Companion Diagnostic Market, By End User:

• Pharmaceutical & Biotechnology Companies
• Research Laboratories
• Contract Research Organization Others

Companion Diagnostic Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia-Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Companion Diagnostic Market.

Available Customizations:

With the given market data, the publisher offers customizations according to a company's specific needs. The following customization options are available for the report.

Company Information

• Detailed analysis and profiling of additional market players (up to five).