Companion Diagnostics
Companion Diagnostics Market by Component (Products, Services), Technology (Flow Cytometry, Immunohistochemistry, Mass Spectrometry), Indication, End-User, Application, Biomarker - Global Forecast 2025-2030
SKU
MRR-433AB1DC2871
Region
Global
Publication Date
February 2025
Delivery
Immediate
2024
USD 7.30 billion
2025
USD 8.10 billion
2030
USD 13.51 billion
CAGR
10.79%

The Companion Diagnostics Market size was estimated at USD 7.30 billion in 2024 and expected to reach USD 8.10 billion in 2025, at a CAGR 10.79% to reach USD 13.51 billion by 2030.

Companion Diagnostics Market
To learn more about this report, request a free PDF copy

Companion diagnostics (CDx) refers to medical devices, often in vitro assays, that provide essential information for the safe and effective use of a corresponding drug or biological product. These diagnostics are essential in the field of personalized medicine, as they enable the identification of patients who are most likely to benefit from a particular therapeutic product, thereby optimizing treatment outcomes. The necessity of CDx is driven by the increasing push for precision medicine, facilitating tailored therapeutic approaches that enhance patient care and treatment efficacy. Application sectors primarily include oncology, cardiology, and neurology, with significant end-use across biopharmaceutical companies, research laboratories, and diagnostic laboratories. Market growth is influenced by factors such as increasing prevalence of cancer, rising awareness and adoption of precision medicine, and growing demand for personalized treatment solutions. Technological advancements in genomics and molecular diagnostics further bolster the market. Potential opportunities lie in the integration of next-generation sequencing (NGS) for more precise assays and the expansion into emerging markets where the healthcare infrastructure is improving. However, the market faces challenges like stringent regulatory frameworks, complex reimbursement policies, and high costs associated with CDx development and implementation. Additionally, there exists a limitation in terms of acquiring comprehensive genetic data which requires massive datasets and complex computing capabilities. For innovation, developing robust platforms for integrating artificial intelligence and machine learning could enhance predictive analytics and CDx precision. Market insights indicate a competitive landscape driven by key players investing aggressively in R&D to develop novel assays and expand global footprints. As the market is poised for growth, companies should focus on strategic collaborations with pharmaceutical companies and advancing technological capabilities to seize opportunities. Overall, while companion diagnostics offer substantial growth potential, navigating regulatory complexities remains pivotal for market players.

Ask ResearchAI anything

World's First Innovative Al for Market Research

Ask your question about the Companion Diagnostics market, and ResearchAI will deliver precise answers.
How ResearchAI Enhances the Value of Your Research
ResearchAI-as-a-Service
Gain reliable, real-time access to a responsible AI platform tailored to meet all your research requirements.
24/7/365 Accessibility
Receive quick answers anytime, anywhere, so you’re always informed.
Maximize Research Value
Gain credits to improve your findings, complemented by comprehensive post-sales support.
Multi Language Support
Use the platform in your preferred language for a more comfortable experience.
Stay Competitive
Use AI insights to boost decision-making and join the research revolution at no extra cost.
Time and Effort Savings
Simplify your research process by reducing the waiting time for analyst interactions in traditional methods.

Market Dynamics

The market dynamics represent an ever-changing landscape of the Companion Diagnostics Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.

  • Market Drivers
    • Growing prevalence of chronic diseases necessitating the need for accurate companion diagnostics solutions
    • The rise of targeted therapies in oncology catalyzing the expansion of companion diagnostics utility
    • Regulatory support and streamlined approval processes encouraging innovation in companion diagnostics
  • Market Restraints
    • Obstacles to growth in the companion diagnostics market with emphasis on regulatory challenges
    • Highlighting the technological barriers in the integration of companion diagnostics with newer therapies
    • Analyzing the impact of insufficient data on the adoption of companion diagnostics by healthcare professionals
  • Market Opportunities
    • Advancements in next-generation sequencing technologies accelerate the evolution of companion diagnostics
    • Increased regulatory support for companion diagnostics potentially enhances market accessibility and adoption
    • Strategic partnerships between pharmaceutical companies and diagnostic firms stimulate innovation in the sector
  • Market Challenges
    • Complexities in conducting clinical trials due to varying regulations and patient recruitment hurdles
    • Securing intellectual property rights and navigating patent landscapes within diverse international markets
    • Challenges in regulatory approval processes impact timely market introduction and coverage decisions

Market Segmentation Analysis

  • Technology: Increasing preference of next-generation sequencing in precision medicine

    Immunohistochemistry (IHC) is a technique used to diagnose diseases by detecting proteins in tissue section cells. It is widely employed in cancer diagnostics to identify specific markers that help in determining the type of cancer and its potential responsiveness to treatments. IHC is preferred when the diagnostic focus is on the localization and qualitative assessment of protein expressions in tissue samples. Situ Hybridization (ISH) permits the detection and localization of specific DNA or RNA sequences in tissue sections or cell samples, providing insights into gene expression and chromosomal abnormalities. This technology is particularly valuable in detecting specific gene rearrangements or amplifications associated with certain cancers. Next-generation sequencing (NGS) offers comprehensive insights into the genetic makeup by allowing the sequencing of entire genomes or targeted regions of interest at an unprecedented speed and scale. NGS is the technology of choice for applications requiring a broad understanding of genetic variations, including small mutations, copy number variations, and others that may be relevant for selecting targeted therapies across various diseases. Polymerase Chain Reaction (PCR) is a technique utilized to strengthen small segments of DNA or RNA, making it easier to conduct further analyses. It stands as one of the most widely used technologies due to its simplicity, sensitivity, and specificity. PCR is highly favored for its rapid turnaround times, making it ideal for diseases requiring quick decision-making for therapy selection.

  • End-user: Expansion of pharmaceutical and biopharmaceutical sector driving the significance of companion diagnostics

    Pharmaceutical and biopharmaceutical companies engaged primarily in the discovery, development, and commercialization of therapeutics. The integration of companion diagnostics is crucial in the drug development process, especially for targeted therapies, including those used in cancer treatment. These companies need companion diagnostics to monitor responses to therapy and adjust treatment plans as necessary. Reference laboratories are specialized facilities that perform complex and advanced diagnostic testing, often not available in standard hospital labs. They play a critical role in the implementation of companion diagnostics by providing high-complexity tests that help in the identification of biomarkers associated with specific diseases and treatment responses.

Porter’s Five Forces Analysis

The porter's five forces analysis offers a simple and powerful tool for understanding, identifying, and analyzing the position, situation, and power of the businesses in the Companion Diagnostics Market. This model is helpful for companies to understand the strength of their current competitive position and the position they are considering repositioning into. With a clear understanding of where power lies, businesses can take advantage of a situation of strength, improve weaknesses, and avoid taking wrong steps. The tool identifies whether new products, services, or companies have the potential to be profitable. In addition, it can be very informative when used to understand the balance of power in exceptional use cases.

PESTLE Analysis

The PESTLE analysis offers a comprehensive tool for understanding and analyzing the external macro-environmental factors that impact businesses within the Companion Diagnostics Market. This framework examines Political, Economic, Social, Technological, Legal, and Environmental factors, providing companies with insights into how these elements influence their operations and strategic decisions. By using PESTLE analysis, businesses can identify potential opportunities and threats in the market, adapt to changes in the external environment, and make informed decisions that align with current and future conditions. This analysis helps companies anticipate shifts in regulation, consumer behavior, technology, and economic conditions, allowing them to better navigate risks and capitalize on emerging trends.

Market Share Analysis

The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Companion Diagnostics Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

FPNV Positioning Matrix

The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Companion Diagnostics Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Recent Developments

  • Innovative Partnership Between Thermo Fisher Scientific and Bayer Sets New Standard in Precision Cancer Care

    Thermo Fisher Scientific has announced a groundbreaking collaboration with Bayer aimed at advancing precision oncology treatments through the development of companion diagnostic assays. Utilizing Thermo Fisher's cutting-edge Ion Torrent Genexus Dx System, this partnership is poised to revolutionize cancer care by enabling the rapid analysis of both liquid and tissue samples within 24 hours, thus facilitating quicker access to targeted therapies for patients. [Published On: March 21, 2024]

  • Strategic Partnership between Agilent and Incyte Elevates Companion Diagnostic Development

    Agilent Technologies has announced a strategic collaboration with pharmaceutical company Incyte to advance the development of companion diagnostics. This partnership aims to create diagnostic tests that accurately identify patients who can benefit from targeted treatments, particularly within Incyte’s hematology and oncology portfolio. This collaboration signifies a proactive step towards innovative patient care and a strengthened position in the diagnostics market. [Published On: January 30, 2024]

  • Unlocking New Treatment Horizons: FDA Approves Capivasertib & Fulvestrant Combo for Advanced Breast Cancer, Backed by FoundationOne® CDx Diagnostic Advances

    In a significant move towards enhancing treatment options for individuals with advanced hormone receptor-positive, HER2-negative breast cancer, the FDA greenlit the use of capivasertib in conjunction with fulvestrant. This approval targets patients battling locally advanced & metastatic cancer that exhibits specific genetic alterations (PIK3CA, AKT1, or PTEN), post at least one failed endocrine-based regimen, and recurrence within a year post adjuvant therapy. [Published On: November 21, 2023]

Strategy Analysis & Recommendation

The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Companion Diagnostics Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

Key Company Profiles

The report delves into recent significant developments in the Companion Diagnostics Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, Abnova Corporation, Agendia, Inc., Agilent Technologies, Inc., Almac Group, Amoy Diagnostics Co., Ltd., ARUP Laboratories, Bio-Techne Corporation, Biogenex Laboratories, Inc, bioMérieux SA, Danaher Corporation, Eli Lilly and Company, F. Hoffmann-La Roche AG, Guardant Health, Inc, ICON PLC, Illumina, Inc., Invivoscribe Technologies, Inc., Myriad Genetics, Inc., NG biotech, QIAGEN N.V., R-Biopharm AG, Siemens AG, Sysmex Corporation, and Thermo Fisher Scientific Inc..

Market Segmentation & Coverage

This research report categorizes the Companion Diagnostics Market to forecast the revenues and analyze trends in each of the following sub-markets:

  • Component
    • Products
      • Instrument
      • Reagents
    • Services
      • Consulting
      • Maintenance
      • Training
  • Technology
    • Flow Cytometry
    • Immunohistochemistry
    • Mass Spectrometry
    • Molecular Diagnostics
      • In Situ Hybridization
      • Polymerase Chain Reaction (PCR)
        • Digital PCR
        • Real-Time PCR
    • Next-Generation Sequencing
      • Exome Sequencing
      • RNA Sequencing
      • Whole Genome Sequencing
  • Indication
    • Infectious Diseases
      • Bacterial Infections
      • Viral Infections
    • Oncology
      • Breast Cancer
      • Colorectal Cancer
      • Lung Cancer
  • End-User
    • Clinical Laboratories
    • Hospital and Clinics
    • Pharmaceutical Companies
      • Clinical Trials
      • Research and Development
    • Research Institutes
  • Application
    • Drug Development and Discovery
      • Clinical Trials
      • Preclinical
    • Personalized Medicine
    • Therapeutic Monitoring
  • Biomarker
    • Predictive Biomarkers
      • Genomic Alterations
      • Hormone Receptors
    • Prognostic Biomarkers
      • Oncogenes
      • Tumor Suppressor Genes
  • Region
    • Americas
      • Argentina
      • Brazil
      • Canada
      • Mexico
      • United States
        • California
        • Florida
        • Illinois
        • New York
        • Ohio
        • Pennsylvania
        • Texas
    • Asia-Pacific
      • Australia
      • China
      • India
      • Indonesia
      • Japan
      • Malaysia
      • Philippines
      • Singapore
      • South Korea
      • Taiwan
      • Thailand
      • Vietnam
    • Europe, Middle East & Africa
      • Denmark
      • Egypt
      • Finland
      • France
      • Germany
      • Israel
      • Italy
      • Netherlands
      • Nigeria
      • Norway
      • Poland
      • Qatar
      • Russia
      • Saudi Arabia
      • South Africa
      • Spain
      • Sweden
      • Switzerland
      • Turkey
      • United Arab Emirates
      • United Kingdom

This research report offers invaluable insights into various crucial aspects of the Companion Diagnostics Market:

  1. Market Penetration: This section thoroughly overviews the current market landscape, incorporating detailed data from key industry players.
  2. Market Development: The report examines potential growth prospects in emerging markets and assesses expansion opportunities in mature segments.
  3. Market Diversification: This includes detailed information on recent product launches, untapped geographic regions, recent industry developments, and strategic investments.
  4. Competitive Assessment & Intelligence: An in-depth analysis of the competitive landscape is conducted, covering market share, strategic approaches, product range, certifications, regulatory approvals, patent analysis, technology developments, and advancements in the manufacturing capabilities of leading market players.
  5. Product Development & Innovation: This section offers insights into upcoming technologies, research and development efforts, and notable advancements in product innovation.

Additionally, the report addresses key questions to assist stakeholders in making informed decisions:

  1. What is the current market size and projected growth?
  2. Which products, segments, applications, and regions offer promising investment opportunities?
  3. What are the prevailing technology trends and regulatory frameworks?
  4. What is the market share and positioning of the leading vendors?
  5. What revenue sources and strategic opportunities do vendors in the market consider when deciding to enter or exit?
Table of Contents
  1. Preface
  2. Research Methodology
  3. Executive Summary
  4. Market Overview
  5. Market Insights
  6. Companion Diagnostics Market, by Component
  7. Companion Diagnostics Market, by Technology
  8. Companion Diagnostics Market, by Indication
  9. Companion Diagnostics Market, by End-User
  10. Companion Diagnostics Market, by Application
  11. Companion Diagnostics Market, by Biomarker
  12. Americas Companion Diagnostics Market
  13. Asia-Pacific Companion Diagnostics Market
  14. Europe, Middle East & Africa Companion Diagnostics Market
  15. Competitive Landscape
  16. List of Figures [Total: 29]
  17. List of Tables [Total: 769 ]
  18. List of Companies Mentioned [Total: 24]
360iResearch Analyst Ketan Rohom
Download a Free PDF
Get a sneak peek into the valuable insights and in-depth analysis featured in our comprehensive companion diagnostics market report. Download now to stay ahead in the industry! Need more tailored information? Ketan is here to help you find exactly what you need.
Frequently Asked Questions
  1. How big is the Companion Diagnostics Market?
    Ans. The Global Companion Diagnostics Market size was estimated at USD 7.30 billion in 2024 and expected to reach USD 8.10 billion in 2025.
  2. What is the Companion Diagnostics Market growth?
    Ans. The Global Companion Diagnostics Market to grow USD 13.51 billion by 2030, at a CAGR of 10.79%
  3. When do I get the report?
    Ans. Most reports are fulfilled immediately. In some cases, it could take up to 2 business days.
  4. In what format does this report get delivered to me?
    Ans. We will send you an email with login credentials to access the report. You will also be able to download the pdf and excel.
  5. How long has 360iResearch been around?
    Ans. We are approaching our 7th anniversary in 2024!
  6. What if I have a question about your reports?
    Ans. Call us, email us, or chat with us! We encourage your questions and feedback. We have a research concierge team available and included in every purchase to help our customers find the research they need-when they need it.
  7. Can I share this report with my team?
    Ans. Absolutely yes, with the purchase of additional user licenses.
  8. Can I use your research in my presentation?
    Ans. Absolutely yes, so long as the 360iResearch cited correctly.