Companion Diagnostics Market Size, Share, Growth Analysis, By Product and Services(Assays, Kits, and Reagents, Instruments & Systems), By Technology(Polymerase Chain Reaction, In Situ Hybridization, Next-Generation Sequencing, Immunohistochemistry), By Indication(Cancer (Lung Cancer, Breast Cancer, Blood Cancer, Colorectal Cancer), By Sample Types(Tissue Samples, Blood Samples, and Other Sample Types), By End User(Pharmaceutical & Biotechnology Companies, Reference Laboratories, Healthcare and Pharmaceutical, and Other End Users), By Region - Industry Forecast 2024-2031


Report ID: SQMIG35A2649 | Region: Global | Published Date: June, 2024
Pages: 157 |Tables: 66 |Figures: 75

Companion Diagnostics Market Insights

Global Companion Diagnostic Market size was valued at USD 6.62 Billion in 2022 and is poised to grow from USD 7.37 Billion in 2023 to USD 17.48 Billion by 2031, growing at a CAGR of 11.4% in the forecast period (2024-2031).

Companion diagnostics have a significant role of safe and effective use of particular biological products or drugs especially in cancer diagnostics and therapies. These tests are useful in adjusting the therapeutic strategies depending on the unique biomarker profiles found in each patient. An example is Foundation Medicine’s companion diagnostic known as FOUNDATIONONE CDx, which offers a comprehensive genomic profiling of over 300 genetic markers associated with cancer. 

Analyzing this vast genetic data, the test is informative and helpful in choosing accurate and targeted cancer treatments for solid tumor cancer types. This new approach also helps therapeutic stakeholders make better decisions regarding the efficacy and safety of therapeutic interventions in cancer treatment for patients.

Market Snapshot - 2024-2031

Global Market Size

USD 5.57 billion

Largest Segment

By Product & Service

Fastest Growth

By Technology

Growth Rate

12.5% CAGR

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Companion Diagnostics Market Segmental Analysis

Companion diagnostic market is segmented into Product & Services, Technology, Indication, Sample Types, End User and Region. Based on Product & Services, the market is segmented into Assays, Kits, and Reagents, Instruments & Systems, and Software & Services. Based on Technology, the market is segmented into Polymerase Chain Reaction, In Situ Hybridization, Next-Generation Sequencing, Immunohistochemistry, and Other Technologies. Based on Indication, the market is segmented into Cancer (Lung Cancer, Breast Cancer, Blood Cancer, Colorectal Cancer, Other Cancer), Neurological Diseases, Cardiovascular Diseases, Infectious Diseases, and Other Indications. Based on Sample Types, the market is segmented into Tissue Samples, Blood Samples, and Other Sample Types. Based on End User, the market is segmented into Pharmaceutical & Biotechnology Companies, Reference Laboratories, Healthcare and Pharmaceutical, and Other End Users. Based on region the market is segmented into North America, Asia-Pacific, Europe, Latin America, Middle East and Africa. 

Analysis by Indication 

The largest portion of the market is demanded by assays, kits and reagents due to the large product offerings of this category and increasing use of assays and kits within the context of different therapeutic areas. This selection of assays, kits, and reagents is broad and enabling to support the varied diagnostic requirements in the healthcare environment. Moreover, the flexibility of these products in various therapeutic areas emphasizes the importance they play in clinical and research environments. 

The software & services segment is the key and rather variable element in the companion diagnostic market as it provides incentives and enablers for the harmonization of diagnostic processes. Today, skilled and experienced professionals increasingly rely on technology solutions and services, including in companion diagnostics. This segment comprises products like reference materials, software, and databases for bioinformatics and information management solutions that can be used to decipher complex human genomic and clinical data. 

Analysis by Product & Service 

The market's largest share is attributed to assays, kits, and reagents, a dominance primarily stemming from the extensive array of available products and the escalating utilization of assays and kits across various therapeutic domains. The comprehensive selection of assays, kits, and reagents plays a pivotal role in meeting the diverse diagnostic needs within the healthcare landscape. The adaptability of these products to different therapeutic areas further accentuates their significance in clinical and research settings. 

The software & services segment plays a crucial and dynamic role in the companion diagnostic market, acting as a catalyst for the integration and optimization of diagnostic processes. In an era characterized by rapid technological advancements and data-driven healthcare, the significance of software and services in companion diagnostics cannot be overstated. This segment encompasses a spectrum of offerings, including bioinformatics tools, data analysis platforms, and information management systems tailored to extract meaningful insights from complex genomic and clinical data.

Global Companion Diagnostic Market By Product & Service

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Companion Diagnostics Market Regional Insights

In the year 2023, North America becomes the most influential region and has a great revenue of USD 2. 35 billion. The mentioned regional dominance can be explained via multiple factors, one of which is the increased rate of cancer-related and other chronic disorders among the North American population. The global healthcare scenario has seen the rising trends towards precision medicine that promote the use of the novel Companion Diagnostic (CDx) assays. The implementation of these advanced diagnostic tools has gone a long way in defining the specific patient care intervention approaches in the treatment of patients. 

The Asia-Pacific is expected to be the fastest-growing market over the forecast period. Hence, this specific growth path can be attributed to several interacting factors, as noted below. First and foremost, there has been a demonstrable increase in incidence of cancers in the area and development of CDx assays and superior diagnostic tools.  

Global Companion Diagnostic Market By Region
  • Largest
  • Fastest

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Companion Diagnostics Market Dynamics

Drivers

Personalized Medicine Advancements 

  • One of the primary forces behind the companion diagnostic market is the push towards precision medicine, which involves adjusting treatment based on the characteristics of the patient. Alongside the advancements in knowledge of genetic, proteomic, and metabolomic profiles, the need for companion diagnostics to define appropriate treatments and the likelihood of a positive response rises. This trend is further supported by the introduction of personalized medicine that comes with companion diagnostics as a requirement for implementation. 

Regulatory Support and Approvals 

  • Growing government encouragement and positive recommendations from organizations such as the FDA and EMA are also contributing to the companion diagnostic market. These regulatory bodies are slowly and gradually understanding the value of companion diagnostics in enhancing the efficacy of treatment, and they are working on un-complicating the processes meant for approval. For instance, the FDA’s expedited approval programs of companion diagnostics help in bringing such products to market quickly. 

Restraints 

High Development Costs 

  • Companion diagnostics require a lot of capital commitment to undertake clinical tests, trials, validation and meeting regulatory requirements. These high costs might be a constraint for the small-scale companies and give fewer opportunities for development in the market. Secondly, the nature of reimbursement for companion diagnostics varies and is quite complicated to negotiate which also poses a barrier to market development. 

Technical and Operational Challenges 

  • Companion diagnostics are incorporated in clinical practice and can have several technical and operational issues. Others are the need for specialized equipment, complicated testing techniques, and the need for well-trained personnel to conduct and interpret the tests. However, the standardization of QC assays for different laboratories could be challenging to maintain and affect the reliability and practicability of companion diagnostics in clinical practice.

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Companion Diagnostics Market Competitive Landscape

The global companion diagnostic market is highly competitive and can be considered as an oligopolistic market with a range of dominant brands, emerging players, and niche players. Another important competition factor is that of innovation. The big brands never compromise on investing in research and development to develop new novelty, flavors, packaging and new health-conscious flavors. They are usually ahead in setting pace in the industry.

Top Player’s Company Profile

  • IDEXX Laboratories, Inc. (US) 
  • Zoetis Inc. (US) 
  • Heska Corporation (US) 
  • Thermo Fisher Scientific Inc. (US) 
  • Abaxis, Inc. (US) 
  • Virbac SA (France) 
  • VCA, Inc. (US) 
  • IDVet (France) 
  • NEOGEN Corporation (US) 
  • bioMérieux SA (France) 
  • Randox Laboratories Ltd. (UK) 
  • AniCell Biotech (US) 
  • Bionote Inc. (South Korea) 
  • Bio-Rad Laboratories, Inc. (US) 
  • Neogen Corporation (US) 
  • Antech Diagnostics (US) 
  • Bionote, Inc. (South Korea) 
  • Eurofins Scientific SE (Luxembourg) 
  • Animalytix LLC (US) 
  • Advanced Animal Diagnostics (US)

Recent Developments

  • In August 2023, the Agilent Technologies, Inc based in the US received European IVDR certification for its companion diagnostic assay. In the same month, QIAGEN (Netherlands) gained FDA approval for a companion diagnostic for Blueprint Medicines’ AYVAKIT (avapritinib) for GIST. 

  • In March 2023, F. Hoffmann-La Roche Ltd (Switzerland) received FDA approval on the extension of the label for its VENTANA PD-L1 (SP263) assay for those NSCLC patients who can be treated with Libtayo. 

  • Quantitatively, in April 2024, Labcorp successfully landed on FDA stamp of approval for the first time by developing a companion diagnostic that is intended to be used together with Pfizer’s newly approved gene therapy that targets patients with Hemophilia B.

Companion Diagnostics Key Market Trends

  • The Next-Generation Sequencing (NGS) technique is used by clinicians to examine the plethora of genes that are related to cancer, and they perform this on surgically removed tumor tissue samples of patients. One of the particular strengths of the NGS methodology is the ability to produce a significant amount of genetic data within the specified time limit, which plays a positive role in oncology. It is noteworthy that further technological developments prolong the effectiveness as well as the particularity of this sequencing method. This is evidenced by a publication by the CDC, which indicates that next-generation sequencing’s application has shifted from being a mere research tool to clinical operational use over the last five years. It highlights the increasing relevance of NGS in elucidating the genetic characteristics of cancer, thereby enabling enhanced techniques of treatment and diagnosis in clinical practice.

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 by means of Primary Exploratory Research backed by robust Secondary Desk research. 

The study of Companion Diagnostic market reveals a vibrant marketplace with some of the emergent developments and challenges. The increased rate of cancer across the globe is a major factor that has created higher demand for companion diagnostic tests which has boosted the market's growth. This growth is further driven by the regulatory approval received for these tests across indications. An example is Thermo Fisher Scientific Inc.’s Oncomine Dx Target Test as a companion diagnostic (CDx) which was approved by the U. S. Food and Drug Administration (FDA) in August 2022. Designed especially for NSCLC, this test accurately detects the presence of the HER2 (ERBB2) activating mutations, including SNVs and Exon 20 Insertions.

Report Metric Details
Market size value in 2022 USD 6.62 Billion
Market size value in 2031 USD 17.48 Billion
Growth Rate 11.4%
Base year 2023
Forecast period 2024-2031
Forecast Unit (Value) USD Billion
Segments covered
  • Product and Services
    • Assays, Kits, and Reagents, Instruments & Systems, and Software & Services
  • Technology
    • Polymerase Chain Reaction, In Situ Hybridization, Next-Generation Sequencing, Immunohistochemistry, and Other Technologies
  • Indication
    • Cancer (Lung Cancer, Breast Cancer, Blood Cancer, Colorectal Cancer, Other Cancer), Neurological Diseases, Cardiovascular Diseases, Infectious Diseases, and Other Indications
  • Sample Types
    • Tissue Samples, Blood Samples, and Other Sample Types
  • End User
    • Pharmaceutical & Biotechnology Companies, Reference Laboratories, Healthcare and Pharmaceutical, and Other End Users
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
  • IDEXX Laboratories, Inc. (US) 
  • Zoetis Inc. (US) 
  • Heska Corporation (US) 
  • Thermo Fisher Scientific Inc. (US) 
  • Abaxis, Inc. (US) 
  • Virbac SA (France) 
  • VCA, Inc. (US) 
  • IDVet (France) 
  • NEOGEN Corporation (US) 
  • bioMérieux SA (France) 
  • Randox Laboratories Ltd. (UK) 
  • AniCell Biotech (US) 
  • Bionote Inc. (South Korea) 
  • Bio-Rad Laboratories, Inc. (US) 
  • Neogen Corporation (US) 
  • Antech Diagnostics (US) 
  • Bionote, Inc. (South Korea) 
  • Eurofins Scientific SE (Luxembourg) 
  • Animalytix LLC (US) 
  • Advanced Animal Diagnostics (US)
Customization scope

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  • Market dynamics & outlook
  • Region

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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 Diagnostic Market size was valued at USD 6.62 Billion in 2022 and is poised to grow from USD 7.37 Billion in 2023 to USD 17.48 Billion by 2031, growing at a CAGR of 11.4% in the forecast period (2024-2031).

The global companion diagnostic market is highly competitive and can be considered as an oligopolistic market with a range of dominant brands, emerging players, and niche players. Another important competition factor is that of innovation. The big brands never compromise on investing in research and development to develop new novelty, flavors, packaging and new health-conscious flavors. They are usually ahead in setting pace in the industry. 'IDEXX Laboratories, Inc. (US) ', 'Zoetis Inc. (US) ', 'Heska Corporation (US) ', 'Thermo Fisher Scientific Inc. (US) ', 'Abaxis, Inc. (US) ', 'Virbac SA (France) ', 'VCA, Inc. (US) ', 'IDVet (France) ', 'NEOGEN Corporation (US) ', 'bioMérieux SA (France) ', 'Randox Laboratories Ltd. (UK) ', 'AniCell Biotech (US) ', 'Bionote Inc. (South Korea) ', 'Bio-Rad Laboratories, Inc. (US) ', 'Neogen Corporation (US) ', 'Antech Diagnostics (US) ', 'Bionote, Inc. (South Korea) ', 'Eurofins Scientific SE (Luxembourg) ', 'Animalytix LLC (US) ', 'Advanced Animal Diagnostics (US)'

One of the primary forces behind the companion diagnostic market is the push towards precision medicine, which involves adjusting treatment based on the characteristics of the patient. Alongside the advancements in knowledge of genetic, proteomic, and metabolomic profiles, the need for companion diagnostics to define appropriate treatments and the likelihood of a positive response rises. This trend is further supported by the introduction of personalized medicine that comes with companion diagnostics as a requirement for implementation. 

The Next-Generation Sequencing (NGS) technique is used by clinicians to examine the plethora of genes that are related to cancer, and they perform this on surgically removed tumor tissue samples of patients. One of the particular strengths of the NGS methodology is the ability to produce a significant amount of genetic data within the specified time limit, which plays a positive role in oncology. It is noteworthy that further technological developments prolong the effectiveness as well as the particularity of this sequencing method. This is evidenced by a publication by the CDC, which indicates that next-generation sequencing’s application has shifted from being a mere research tool to clinical operational use over the last five years. It highlights the increasing relevance of NGS in elucidating the genetic characteristics of cancer, thereby enabling enhanced techniques of treatment and diagnosis in clinical practice.

In the year 2023, North America becomes the most influential region and has a great revenue of USD 2. 35 billion. The mentioned regional dominance can be explained via multiple factors, one of which is the increased rate of cancer-related and other chronic disorders among the North American population. The global healthcare scenario has seen the rising trends towards precision medicine that promote the use of the novel Companion Diagnostic (CDx) assays. The implementation of these advanced diagnostic tools has gone a long way in defining the specific patient care intervention approaches in the treatment of patients. 

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