Global Companion Diagnostics Market Industry Overview
The global companion diagnostics market was valued at $3,762.0 million in 2023 and is expected to reach $12,498.7 million by 2033, growing at a CAGR of 12.76% between 2023 and 2033. The growth of the companion diagnostics market is driven by the rising prevalence of cancer cases, increasing product approvals in the field of companion diagnostics, and advancing biomedical imaging as the driving force for precision medicine’s companion diagnostics.

Market Introduction
The companion diagnostics market has emerged as a pivotal component in the realm of personalized medicine, transforming the landscape of disease diagnosis and treatment. This innovative sector focuses on developing diagnostic tests that aid in the identification of biomarkers and genetic variations associated with specific diseases. The primary objective of companion diagnostics is to enable healthcare professionals to tailor treatment plans according to the individual characteristics of patients, ensuring a more targeted and effective approach. With the rising prevalence of complex diseases such as cancer, the demand for companion diagnostics has grown significantly.

The market’s evolution has been characterized by a blend of technological advancements, strategic collaborations between pharmaceutical and diagnostic companies, and regulatory efforts to ensure the safety and efficacy of these diagnostic tools. As the healthcare industry continues to embrace precision medicine, the companion diagnostics market stands at the forefront, poised to make substantial contributions to the era of personalized and more effective medical interventions.

Industrial Impact
The advent of the companion diagnostics market has had a profound industrial impact, particularly within the realms of healthcare, diagnostics, and pharmaceuticals. This innovative sector has fundamentally altered the traditional approach to disease diagnosis and treatment by introducing personalized and targeted strategies. Pharmaceutical companies are increasingly integrating companion diagnostics into their drug development pipelines, facilitating the identification of biomarkers and the selection of patient populations that are most likely to respond positively to specific therapies.

Market Segmentation:

Segmentation 1: by Technology

  • Polymerase Chain Reaction (PCR)
  • Immunohistochemistry (IHC)
  • In-Situ Hybridization (ISH)
  • Next-Generation Sequencing (NGS)
  • Others

PCR Segment to Dominate the Companion Diagnostics Market (by Technology)
Based on technology, the global companion diagnostics market was led by PCR in 2022 primarily due to its exceptional accuracy and sensitivity in detecting nucleic acid sequences, making it particularly adept at identifying specific genetic mutations or biomarkers associated with diseases. This precision enables clinicians to make personalized treatment decisions based on reliable diagnostic information. Additionally, PCR’s versatility allows it to detect a wide range of genetic variations, including single nucleotide polymorphisms (SNPs) and gene fusions, facilitating the development of companion diagnostics for diverse diseases and therapeutic targets. Furthermore, PCR techniques, such as real-time PCR (qPCR), offer rapid turnaround times, enabling timely diagnosis and treatment monitoring, which is crucial in companion diagnostics.

Segmentation 2: by Application

  • Lung Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Leukemia
  • Stomach Cancer
  • Melanoma
  • Others

Lung Cancer Segment to Witness the Highest Growth between 2023 and 2033
The lung cancer segment holds the largest share in the companion diagnostics market for several compelling reasons. Firstly, lung cancer is one of the most prevalent and deadliest forms of cancer worldwide, driving the demand for effective diagnostic tools to guide treatment decisions. Companion diagnostics play a crucial role in lung cancer management by identifying specific genetic mutations or biomarkers that can inform targeted therapy selection. For example, mutations in genes such as EGFR, ALK, ROS1, and BRAF are commonly found in non-small cell lung cancer (NSCLC) and are associated with responses to targeted therapies.

Segmentation 3: by End User

  • Pharmaceutical and Biotechnology Companies
  • Reference Laboratories and Hospitals
  • Others

Reference Laboratories and Hospitals Segment to Witness the Highest Growth between 2023 and 2033
Reference laboratories and hospitals hold a significant share of the end user market in the global companion diagnostics market for several reasons. The reference laboratories and hospitals typically have access to advanced diagnostic technologies and expertise, which allows them to perform complex molecular testing required for companion diagnostics. These facilities often have state-of-the-art equipment and trained personnel capable of conducting molecular assays with high accuracy and precision, which is crucial for reliable companion diagnostic testing.

Moreover, reference laboratories and hospitals serve as central hubs for patient care, where individuals seek diagnosis and treatment for various diseases, including those requiring companion diagnostics. As a result, these facilities handle a large volume of diagnostic testing, providing economies of scale and driving demand for companion diagnostics.

Segmentation 5: by Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Rest-of-Europe
  • Asia-Pacific
    • Japan
    • India
    • China
    • South Korea
    • Australia
    • Rest-of-Asia-Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest-of-Latin America
  • Middle East and Africa
    • South Africa
    • U.A.E.
    • Rest-of-Middle East and Africa

The North America region is expected to hold a significant share of the global companion diagnostics market for several reasons. North America, particularly the U.S., boasts advanced healthcare infrastructure and a strong emphasis on precision medicine initiatives. This environment fosters the adoption of companion diagnostics, which play a vital role in guiding targeted therapies and improving patient outcomes.

The region is home to a large number of pharmaceutical and biotechnology companies engaged in the development of targeted therapies. These companies often collaborate with diagnostic companies to co-develop companion diagnostics alongside their therapeutic products. As a result, there has been a rise in demand for companion diagnostics in North America to support the use of these targeted therapies in clinical practices.

Recent Developments in the Companion Diagnostics Market

  • In August 2023, Amoy Diagnostics Co., Ltd entered into a collaboration agreement with AstraZeneca. As per the agreement, AmoyDx’s Essential NGS panel can be utilized as a companion diagnostic for ENHERTU. This diagnostic tool would be used to identify HER2 (ERBB2) mutations, specifically in patients with non-small cell lung cancer (NSCLC).
  • In March 2023, Illumina Inc. and Myriad Genetics Inc. announced an expansion of their strategic partnership to enhance access to and availability of oncology homologous recombination deficiency (HRD) testing in the U.S. As part of the agreement, Illumina TruSight Oncology 500 HRD (TSO 500 HRD), initially a research-use-only test, would now be accessible in the U.S. The expanded collaboration would further establish a unique companion diagnostic (CDx) alliance for the pharmaceutical industry.
  • In November 2023, Abbott Laboratories got approval from the U.S. Food and Drug Administration (FDA) for its HPV screening solution. This new tool can help identify high-risk HPV infections and would now be part of the Alinity m family of diagnostic tests, strengthening its capabilities in cancer screening.
  • In December 2022, the U.S. Food and Drug Administration (FDA) granted approval for Agilent Technologies, Inc.’s Resolution ctDx FIRST to serve as a companion diagnostic (CDx). This approval would allow the use of Resolution ctDx FIRST to identify patients with advanced non-small cell lung cancer (NSCLC) who have KRAS G12C mutations. The purpose would be to identify individuals who could potentially benefit from treatment with KRAZATITM (adagrasib).

Demand – Drivers, Challenges, and Opportunities

Market Demand Drivers:

Increasing Product Approvals in the Field of Companion Diagnostics: As the range of approved companion diagnostic products widens, healthcare providers would gain access to more sophisticated tools that enable precise patient stratification, ultimately contributing to improved therapeutic outcomes and the realization of the promise of personalized medicine.

Market Challenges:
Uncertain Reimbursement Scenario: The companion diagnostics market faces a notable impediment in the form of an uncertain reimbursement scenario, casting a shadow over its potential growth and adoption. This uncertainty introduces financial challenges for healthcare providers, who heavily depend on reimbursements to offset the costs associated with integrating companion diagnostics into their clinical practices.

Market Opportunities:
Continuous Developments and Technological Advancements to Drive Progress in Companion Diagnostics: The landscape of companion diagnostics is continually shaped by ongoing developments and technological evolution. Advancements in genetic and molecular research have paved the way for a deeper understanding of disease mechanisms at the molecular level. This progress has led to the identification and validation of a plethora of biomarkers, allowing for more precise and targeted diagnostic approaches.

How can this report add value to an organization?
Product/Innovation Strategy: The global companion diagnostics market has been segmented based on various categories, such as technology, application, end user, and region.

Growth/Marketing Strategy: Product launches and approvals and synergistic activities together accounted for the maximum number of key developments, accounting for nearly 94.59% of the total developments in the companion diagnostics market between January 2021 and December 2023.

Competitive Strategy: The global companion diagnostics market is a highly fragmented market, with many smaller and private companies constantly entering the market. Key players in the companion diagnostics market analyzed and profiled in the study involve established players that offer various kinds of products and services.


Key Considerations and Assumptions in Market Engineering and Validation

  • The base year considered for the calculation of the market size is 2022. A historical year analysis has been done for the period FY2019-FY2021. The market size has been estimated for FY2022 and projected for the period FY2023-FY2033.
  • The scope of this report has been carefully derived based on interactions with experts in different companies across the world. This report provides a market study of clinical biomarkers.
  • The market contribution of companion diagnostics anticipated to be launched in the future has been calculated based on the historical analysis of the solutions.
  • Revenues of the companies have been referenced from their annual reports for FY2022 and FY2023. For private companies, revenues have been estimated based on factors such as inputs obtained from primary research, funding history, market collaborations, and operational history.
  • The market has been mapped based on the available companion diagnostics solutions. All the key companies with significant offerings in this field have been considered and profiled in this report.

Primary Research:
The primary sources involve industry experts in companion diagnostics, including the market players offering products and services. Resources such as CEOs, vice presidents, marketing directors, and technology and innovation directors have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.

The key data points taken from the primary sources include:

  • validation and triangulation of all the numbers and graphs
  • validation of the report’s segmentation and key qualitative findings
  • understanding the competitive landscape and business model
  • current and proposed production values of a product by market players
  • validation of the numbers of the different segments of the market in focus
  • percentage split of individual markets for regional analysis

Secondary Research

Open Sources

  • Certified publications, articles from recognized authors, white papers, directories, and major databases, among others
  • Annual reports, SEC filings, and investor presentations of the leading market players
  • Company websites and detailed study of their product portfolio
  • Gold standard magazines, journals, white papers, press releases, and news articles
  • Paid databases

The key data points taken from the secondary sources include:

  • segmentations and percentage shares
  • data for market value
  • key industry trends of the top players of the market
  • qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
  • quantitative data for mathematical and statistical calculations

Key Market Players and Competition Synopsis
The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.

The lung cancer application segment players leading the market captured around 37.39% of the market’s presence as of 2022. The breast cancer segment, on the other hand, captured approximately 25.58% of the market presence in 2022.

Some prominent names established in this market are:

  • Agilent Technologies, Inc.
  • Abbott Laboratories
  • Amoy Diagnostics Co., Ltd.
  • bioM?rieux
  • Danaher Corporation
  • DiaCarta
  • F. Hoffmann-La Roche Ltd
  • ICON Plc
  • Illumina, Inc.
  • Invivoscribe Technologies, Inc.
  • Myriad Genetics, Inc.
  • Novogene Co, Ltd.
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.