Companion Diagnostics Market Size, Share, and Growth Analysis

Global Companion Diagnostics Market

Companion Diagnostics Market By Product (Assays, Kits, And Reagents, Instruments & Systems), By Technology (Polymerase Chain Reaction, In Situ Hybridization), By Indication, By Sample Type, By End User, By Region - Industry Forecast 2025-2032


Report ID: SQMIG35J2130 | Region: Global | Published Date: May, 2025
Pages: 191 |Tables: 160 |Figures: 78

Format - word format excel data power point presentation

Companion Diagnostics Market Insights

Global Companion Diagnostics market size was valued at USD 7.80 Billion in 2023 and is poised to grow from USD 8.72 Billion in 2024 to USD 21.28 Billion by 2032, growing at a CAGR of 11.80% in the forecast period (2025-2032).

The companion diagnostics market is experiencing quite a significant growth, driven by the increase in prevalence of cancer among global populations and technological advancements in genomic and molecular technologies. The market also finds itself in a suitable growing environment due to the rising regulatory support and the growth in demand among the masses for personalized medicine.

Bioinformatics and AI technology are being utilized in the market to accelerate biomarker discovery and improve the accuracy of diagnostics. Companion diagnostics is now not just confined to oncology. The market is witnessing increasing applications in other therapeutic areas such as neurology, cardiology, infectious diseases, and rare genetic conditions. However, the huge upfront costs associated with research, biomarker validation, clinical trials, and regulatory approvals for developing companion diagnostics remains a huge restraint for the market.

How is AI Technology bringing Transformation in the Market?

Artificial Intelligence (AI) technology is transforming companion diagnostics market dynamics. AI helps in advanced data analysis, image recognition, and predictive modeling. AI algorithms can help to analyze complex pathological images and genomic data. By doing this, they can identify biomarkers with more accuracy and speed. This is going to improve the precision of diagnostic and treatment decisions. Roche received FDA Breakthrough Device Designation for the VENTANA TROP2 RxDx Device in March 2025. This is the first AI-driven companion diagnostic for non-small cell lung cancer. This underlines the technology’s potential to bring about transformation in the companion diagnostics market globally.

Market snapshot - 2025-2032

Global Market Size

USD 7.80 Billion

Largest Segment

Fastest Growth

Growth Rate

11.80% CAGR

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Companion Diagnostics Market Segments Analysis

The global companion diagnostics market is segmented into product & service, technology, indication, sample type, end user, and region. By product & service, the market is classified into assays, kits, and reagents, instruments & systems, and software & services. Depending on technology, it is divided into Polymerase Chain Reaction (PCR), In Situ Hybridization (ISH), Next-Generation Sequencing (NGS), Immunohistochemistry (IHC), Mass Spectrometry, Microarrays, and others. According to indication, the market is categorized into cancer (lung cancer, breast cancer, blood cancer, colorectal cancer, others), neurological diseases, cardiovascular diseases, infectious diseases, and others. Depending on the sample type, it is divided into tissue samples, blood samples, bone marrow samples, and others. By end user, the market is classified into academic and research centers, hospitals and physician laboratories, pharmaceutical & biotechnology companies, reference laboratories, contract research organizations, and others. Regionally, the companion diagnostics market is analyzed across North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America.

Which type of Product & Service of Companion Diagnostics is Dominating the Market?

As per the 2024 global companion diagnostics market analysis, the assays, kits, and reagents sub segments led the market by holding the largest share. This is due to the fact that they have very important roles in detecting specific biomarkers that help guide targeted therapies. These are consumables which find use in high volumes across diagnostic workflows. They are widely adopted for oncology and other therapeutic areas. They also find applications in clinical settings. Their huge application is what is making them the most dominant class in the market.

The software & services sub segment is anticipated to grow at the highest CAGR during the forecast period of 2025-2032. This high growth rate can be as a result of the technological advances made recently in the fields of digital pathology, AI, and data analytics. These tools help in better interpretation of diagnostic data. They also help with faster and more accurate decision-making. Other factors such as the growth in demand for integrated diagnostics, remote pathology, and precision medicine are also helping in this market’s growth.

Which Indication is Steering the Future of Companion Diagnostics Market?

The cancer category in the indication segment is the most dominant in the global companion diagnostics market. This sub segment accounts for the majority of the diagnostics applications. Precision oncology is seeing an upward rise. Here, companion diagnostics are essential for identifying patients eligible for targeted therapies. The high prevalence of different types of cancers like lung cancer, breast cancer, and colorectal cancer, along with the continuous R&D activities and regulatory approvals for oncology-focused CDx makes cancer the largest revenue contributors in the market.

During the forecast period, the infectious diseases’ sub-segment is expected to grow with a notable CAGR. The major driving force of this increase is the legacy left behind by the COVID 19 pandemic and the rising cases of antimicrobial resistance. The demand for precision diagnostics to match patients with antivirals or antibiotics which are most effective is recently a key demand. Recent advancements in technologies of molecular testing, next-generation sequencing, and AI-based analysis are also contributing greatly to its fast growth rate.

Global Companion Diagnostics Market Analysis by Product & Service

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Companion Diagnostics Market Regional Insights

Why is North America Leading Companion Diagnostics Market in 2024?

The North America companion diagnostics market share emerges as the most dominant in the world. The region's importance can be attributed to the many established biotechnology, pharmaceutical, and medical device companies in the region. In addition, a strong healthcare infrastructure in the countries of this region, early adoption of precision medicine, and a high prevalence rate of chronic diseases are expected to increase the sector's demand for contract manufacturing independently. The favorable environment provided by the regulatory support of government agencies like the FDA and Canada Drug Agency are also contributing positively towards the growth in companion diagnostics.

U.S. Companion Diagnostics Market

In North America, U.S. leads the companion diagnostics market growth especially due to its well-established and strict regulatory framework, speedy co-development of drug-diagnostic, and strong pharma-biotech partnerships. Many key players in the market such as Agilent Technologies, Thermo Fisher Scientific, Abbott Laboratories, Danaher Corporation, etc. are headquartered here. The FDA’s plays a huge and proactive role in approving CDx with novel therapies which boosts innovation in the country. In November 2024, The FDA approved FoundationOne Liquid CDx. It can be used as a companion diagnostic to identify mNSCLC patients eligible for tepotinib treatment.

Canada Companion Diagnostics Market

Canada in North America is just behind the U.S. The country’s companion diagnostics market growth can also be credited to its strong public healthcare infrastructure, and regulatory pathways which are quite streamlined. In May 2024, Canada’s Drug Agency introduced new improvements to its companion diagnostics reimbursement review process. These amendments include a dedicated Testing Procedure Assessment Report, improved pre-submission templates, and a specialized precision medicine team. This kind of support is highly positive for the market’s growth.

Why is Demand for Companion Diagnostics Fueling Growth in Asia Pacific?

Asia Pacific is predicted to grow at the highest rate in the companion diagnostics market share over the projection period of 2025-2032. The growth in the region is led by the improving healthcare infrastructure and growing burden of cancer in this region. Precision medicine is also seeing higher adoption in the region, especially in countries like China, Japan and India. Governments are actively working on improving access to healthcare to the large pool of patients in the region. The investments on research and development of pharmaceuticals are seeing growth. All these factors contribute to the fast rate at which the companion diagnostics market of Asia Pacific is growing.

China Companion Diagnostics Market

The China companion diagnostics market expansion can be credited to various reasons. This expansion can contribute to a changing market landscape that is seeing advancements in biotechnology and a large patient population. The country’s supporting government initiatives for cancer screening programs also helps the market’s growth. Strategic collaborations between local diagnostic companies and contract research organizations are also accelerating test development. In March 2025, Leica Biosystems and CellCarta partnered with each other to accelerate companion diagnostics development in China. They will utilize Leica’s local R&D and manufacturing capabilities with CellCarta’s advanced biomarker testing services.

Japan Companion Diagnostics Market

Japan’s companion diagnostics market growth is spurred by its adoption of personalized medicine at an early stage and stringent regulatory pathways which has been providing support to drug-diagnostic approvals. In March 2024, Chugai Pharmaceutical received approval in Japan for using the FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for capivasertib in combination with fulvestrant. This is a companion diagnostic for HR-positive, HER2-negative breast cancer with PIK3CA, AKT1, or PTEN alterations. This approval expands the test’s use across 8 cancer types and 27 drugs.

How is Europe Maintaining its Position in the Companion Diagnostics Industry?

Europe held a significant companion diagnostics market share in 2024 and is likely to continue so during the forecast period of 2025-2032. Governments of countries in Europe provide great regulatory backing to targeted therapies. The European Medicines Agency (EMA) extends support to integrated drug-diagnostic development. This encourages collaboration between pharmaceutical and diagnostic companies. Other factors that support growth of companion diagnostics in the region are the widespread cancer screening programs, increasing clinical trials, and a well-developed healthcare system.

Germany Companion Diagnostics Market

Germany has the largest European companion diagnostics market demand. Germany has a strong pharmaceutical industry and a world-class R&D ecosystem. Germany houses many companies focusing on diagnostics. The country has been making precision medicine in oncology a top priority. The accuracy of diagnostics is quite high in the country. These factors enhance the scope of growth of Germany’s companion diagnostics market.

France Companion Diagnostics Market

The France companion diagnostics market demand is also experiencing steady growth. It is supported by the nation’s healthcare reforms and investments in precision medicine. Programs like France Genomic Medicine 2025 supports CDx development and integration into clinical workflows. This strong regulatory oversight along with increasing physician awareness, makes the France companion diagnostics market a highly opportune market in upcoming years.

Global Companion Diagnostics Market By Geography
  • Largest
  • Fastest

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Companion Diagnostics Market Dynamics

Companion Diagnostics Market Drivers

Increase of Cancer Prevalence to Encourage Market Growth

  • The incidence of cancer has noticeably increased in the last several years. According to estimations by the American Cancer Society, in 2024 alone, nearly 2 million new cancer cases and about 611,000 cancer deaths were to occur in the United States alone. Thus, the need for efficient CDx assays is growing as the number of cancer cases increases. This is because genetic testing provides medical professionals with accurate information on treatment plans and a clear picture of their patients' cancers. As a result, there is an increasing need for CDx products due to the rising incidence of cancer.

Regulatory Approval of Innovative Tests for Diverse Indications to Encourage Market Growth

  • There has been an increase in recently approved products in the companion diagnostics industry. For example, in April 2024, FDA has approved Labcorp’s nAbCyte Anti-AAVRh74var HB-FE Assay. This is the first companion diagnostic to identify patients who are eligible for Pfizer's gene therapy for hemophilia B. Thus, the increasing number of newly approved products is driving adoption of several tests and driving market development. Prominent manufacturers also focus on developing novel tests that propel the market for companion diagnostics to grow.

Companion Diagnostics Market Restraints

High Development Costs

  • Companion diagnostics require a substantial cost outlay for regulatory compliance, validation, and clinical trials. Such high costs could create a burden for small companies and thereby make them unable to penetrate the market. In addition, there is another obstruction for the market to expand: the reimbursement policies of companion diagnostics are also very different and sometimes hard to figure.

Technical and Operational Challenges

  • There are several functional and technical issues that could be associated with companion diagnostics in clinical practice. These include advanced techniques for testing, specialized tools to run these tests, and the availability of trained persons who will conduct and interpret these tests. The challenge of achieving homogeneity regarding QC assays between different laboratories could affect the usefulness and reliability of companion diagnostics within a clinical setup.

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Companion Diagnostics Market Competitive Landscape

The global companion diagnostic market is a highly competitive business with many established brands, emerging firms, and niche competitors. It has characteristics of an oligopolistic market. One essential element of competition is innovation. The big companies never cut corners when it comes to R&D expenditures since they want to provide cutting-edge, health-conscious flavors, packaging, and tastes. They usually set the pace initially in the industry. Other tactics that these companies use to stay at the top of their games include acquisitions, alliances, and regulatory approvals. Sysmex, for example, expanded its alliance with QIAGEN in August 2024. This was done with the vision to strengthen collaboration in R&D, clinical trials, and global marketing of genetic testing. This relationship makes use of Sysmex’s global lab network and QIAGEN’s expertise in companion diagnostics.

Top Player’s Company Profiles

  • F. Hoffmann-La Roche Ltd. (Switzerland)
  • Agilent Technologies, Inc. (United States)
  • QIAGEN (Netherlands)
  • Thermo Fisher Scientific Inc. (United States)
  • Abbott Laboratories (United States)
  • Danaher Corporation (United States)
  • Guardant Health, Inc. (United States)
  • Illumina, Inc. (United States)
  • bioMérieux (France)
  • ICON plc (Ireland)
  • Myriad Genetics, Inc. (United States)
  • Sysmex Corporation (Japan)
  • The McClay Foundation (Almac Group) (United Kingdom)
  • ARUP Laboratories (United States)
  • Abnova Corporation (Taiwan)
  • BioGenex (United States)
  • Invivoscribe, Inc. (United States)
  • Laboratory Corporation oof America (ArcherDX, Inc.) (United States)
  • Amoy Diagnostics Co., Ltd. (China)
  • Bio-Techne (Asuragen, Inc.) (United States)

Recent Developments in Companion Diagnostics Market

  • In April 2025, Roche obtained FDA Breakthrough Device Designation for its VENTANA TROP2 (EPR20043) RxDx Device. This device is the first AI-driven companion diagnostic for non-small cell lung cancer (NSCLC). It uses immunohistochemistry with AI-based image analysis. It helps in identifying NSCLC patients who will benefit from DATROWAY, which is an antibody drug conjugate co-developed by Daiichi Sankyo and AstraZeneca.
  • The FDA has approved Illumina’s TruSight Oncology Comprehensive in August 2024. This is a 500+ gene in vitro diagnostic test with pan-cancer companion diagnostic claims. It is the first U.S.-approved distributable comprehensive genomic profiling kit. The test helps in improving access to precision oncology by allowing for broad tumor profiling and detection of actionable biomarkers in solid tumors.
  • In May 2024, Amoy Diagnostics (AmoyDx) collaborated with Boehringer Ingelheim to develop a companion diagnostic (CDx) kit for identifying non-small cell lung cancer (NSCLC) patients in China. This was done as lung cancer remaining a leading cause of death in China. Therefore, the collaboration will improve precision medicine by combining Boehringer's innovation in drugs with AmoyDx's knowledge in tumor molecular diagnostics.

Companion Diagnostics Key Market Trends

Companion Diagnostics Market SkyQuest Analysis

SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected using Primary Exploratory Research backed by robust Secondary Desk research. 

As per SkyQuest analysis, the increasing rate of incidence of chronic diseases such as cancers and cases of death due to it is set to drive the global companion diagnostics market outlook to progress. Consequently, assay kits and reagents emerge as the dominant and fastest growing type of product & service for companion diagnostics. North America secures its position as the most dominant region for the market with Asia Pacific following close behind. The market is seeing advancements in technology for diagnosis in the form of integration of bioinformatics and AI tools. The high costs associated with the development of such diagnostic tools and very limited availability of reimbursement policies for patients utilizing companion diagnostics can stand as massive roadblocks. However, the increase in development and regulatory approval of companion diagnostic tools ensure that the market is observing steady growth.

Report Metric Details
Market size value in 2023 USD 7.80 Billion
Market size value in 2032 USD 21.28 Billion
Growth Rate 11.80%
Base year 2024
Forecast period 2025-2032
Forecast Unit (Value) USD Billion
Segments covered
  • Product & Service
    • Assays
    • Kits
    • And Reagents
    • Instruments & Systems
    • Software & Services
  • Technology
    • Polymerase Chain Reaction (PCR)
    • In Situ Hybridization (ISH)
    • Next-Generation Sequencing (NGS)
    • Immunohistochemistry (IHC)
    • Mass Spectrometry
    • Microarrays
    • Others
  • Indication
    • Cancer (Lung Cancer
    • Breast Cancer
    • Blood Cancer
    • Colorectal Cancer
    • Others)
    • Neurological Diseases
    • Cardiovascular Diseases
    • Infectious Diseases
    • Others
  • Sample Type
    • Tissue Samples
    • Blood Samples
    • Bone Marrow Samples
    • Others
  • End User
    • Academic and Research Centers
    • Hospitals and Physician Laboratories
    • Pharmaceutical & Biotechnology Companies
    • Reference Laboratories
    • Contract Research Organizations
    • Others
Regions covered North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA)
Companies covered
  • F. Hoffmann-La Roche Ltd. (Switzerland)
  • Agilent Technologies, Inc. (United States)
  • QIAGEN (Netherlands)
  • Thermo Fisher Scientific Inc. (United States)
  • Abbott Laboratories (United States)
  • Danaher Corporation (United States)
  • Guardant Health, Inc. (United States)
  • Illumina, Inc. (United States)
  • bioMérieux (France)
  • ICON plc (Ireland)
  • Myriad Genetics, Inc. (United States)
  • Sysmex Corporation (Japan)
  • The McClay Foundation (Almac Group) (United Kingdom)
  • ARUP Laboratories (United States)
  • Abnova Corporation (Taiwan)
  • BioGenex (United States)
  • Invivoscribe, Inc. (United States)
  • Laboratory Corporation oof America (ArcherDX, Inc.) (United States)
  • Amoy Diagnostics Co., Ltd. (China)
  • Bio-Techne (Asuragen, Inc.) (United States)
Customization scope

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Table Of Content

Executive Summary

Market overview

  • Exhibit: Executive Summary – Chart on Market Overview
  • Exhibit: Executive Summary – Data Table on Market Overview
  • Exhibit: Executive Summary – Chart on Companion Diagnostics Market Characteristics
  • Exhibit: Executive Summary – Chart on Market by Geography
  • Exhibit: Executive Summary – Chart on Market Segmentation
  • Exhibit: Executive Summary – Chart on Incremental Growth
  • Exhibit: Executive Summary – Data Table on Incremental Growth
  • Exhibit: Executive Summary – Chart on Vendor Market Positioning

Parent Market Analysis

Market overview

Market size

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • SWOT Analysis

KEY MARKET INSIGHTS

  • Technology Analysis
    • (Exhibit: Data Table: Name of technology and details)
  • Pricing Analysis
    • (Exhibit: Data Table: Name of technology and pricing details)
  • Supply Chain Analysis
    • (Exhibit: Detailed Supply Chain Presentation)
  • Value Chain Analysis
    • (Exhibit: Detailed Value Chain Presentation)
  • Ecosystem Of the Market
    • Exhibit: Parent Market Ecosystem Market Analysis
    • Exhibit: Market Characteristics of Parent Market
  • IP Analysis
    • (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
  • Trade Analysis
    • (Exhibit: Data Table: Import and Export data details)
  • Startup Analysis
    • (Exhibit: Data Table: Emerging startups details)
  • Raw Material Analysis
    • (Exhibit: Data Table: Mapping of key raw materials)
  • Innovation Matrix
    • (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
  • Pipeline product Analysis
    • (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
  • Macroeconomic Indicators

COVID IMPACT

  • Introduction
  • Impact On Economy—scenario Assessment
    • Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
  • Revised Market Size
    • Exhibit: Data Table on Companion Diagnostics Market size and forecast 2021-2027 ($ million)
  • Impact Of COVID On Key Segments
    • Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
  • COVID Strategies By Company
    • Exhibit: Analysis on key strategies adopted by companies

MARKET DYNAMICS & OUTLOOK

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • Regulatory Landscape
    • Exhibit: Data Table on regulation from different region
  • SWOT Analysis
  • Porters Analysis
    • Competitive rivalry
      • Exhibit: Competitive rivalry Impact of key factors, 2021
    • Threat of substitute products
      • Exhibit: Threat of Substitute Products Impact of key factors, 2021
    • Bargaining power of buyers
      • Exhibit: buyers bargaining power Impact of key factors, 2021
    • Threat of new entrants
      • Exhibit: Threat of new entrants Impact of key factors, 2021
    • Bargaining power of suppliers
      • Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
  • Skyquest special insights on future disruptions
    • Political Impact
    • Economic impact
    • Social Impact
    • Technical Impact
    • Environmental Impact
    • Legal Impact

Market Size by Region

  • Chart on Market share by geography 2021-2027 (%)
  • Data Table on Market share by geography 2021-2027(%)
  • North America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • USA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Canada
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Europe
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Germany
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Spain
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • France
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • UK
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Europe
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Asia Pacific
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • China
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • India
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Japan
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Korea
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Asia Pacific
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Latin America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Brazil
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of South America
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Middle East & Africa (MEA)
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • GCC Countries
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Africa
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of MEA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)

KEY COMPANY PROFILES

  • Competitive Landscape
    • Total number of companies covered
      • Exhibit: companies covered in the report, 2021
    • Top companies market positioning
      • Exhibit: company positioning matrix, 2021
    • Top companies market Share
      • Exhibit: Pie chart analysis on company market share, 2021(%)

Methodology

For the Companion Diagnostics Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:

1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.

2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Companion Diagnostics Market.

3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.

4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.

Analyst Support

Customization Options

With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Companion Diagnostics Market:

Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.

Regional Analysis: Further analysis of the Companion Diagnostics Market for additional countries.

Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.

Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.

Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.

Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.

Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.

Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.

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FAQs

Global Companion Diagnostics market size was valued at USD 7.80 Billion in 2023 and is poised to grow from USD 8.72 Billion in 2024 to USD 21.28 Billion by 2032, growing at a CAGR of 11.80% in the forecast period (2025-2032).

F. Hoffmann-La Roche Ltd. (Switzerland), Agilent Technologies, Inc. (United States), QIAGEN (Netherlands), Thermo Fisher Scientific Inc. (United States), Abbott Laboratories (United States), Danaher Corporation (United States), Guardant Health, Inc. (United States), Illumina, Inc. (United States), bioMérieux (France), ICON plc (Ireland), Myriad Genetics, Inc. (United States), Sysmex Corporation (Japan), The McClay Foundation (Almac Group) (United Kingdom, ARUP Laboratories (United States), Abnova Corporation (Taiwan), BioGenex (United States), Invivoscribe, Inc. (United States), Laboratory Corporation oof America (ArcherDX, Inc.) (United States), Amoy Diagnostics Co., Ltd. (China), Bio-Techne (Asuragen, Inc.) (United States)

The incidence of cancer has noticeably increased in the last several years. According to estimations by the American Cancer Society, in 2024 alone, nearly 2 million new cancer cases and about 611,000 cancer deaths were to occur in the United States alone. Thus, the need for efficient CDx assays is growing as the number of cancer cases increases. This is because genetic testing provides medical professionals with accurate information on treatment plans and a clear picture of their patients' cancers. As a result, there is an increasing need for CDx products due to the rising incidence of cancer.

Counting the genes associated with the onset of cancer is accomplished by applying Next-Generation Sequencing (NGS) technology to a surgically removed tumor in a patient. The NGS technology produces large amounts of output within a set time frame, and its technological capabilities are growing. For instance, according to a Centers for Disease Control and Prevention (CDC) report, next-generation sequencing has transitioned from research to clinical usage within the last five years.

The North America companion diagnostics market share emerges as the most dominant in the world. The region's importance can be attributed to the many established biotechnology, pharmaceutical, and medical device companies in the region.

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Global Companion Diagnostics Market
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