Companion Diagnostics for Oncology Market Size, Share, Growth Analysis, By Component(Products, and Services), By End User(Hospitals, Pathology/Diagnostic Laboratories, and Academic Medical Centers), By Indication(Breast Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Leukemia), By Technology(Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Immunohistochemistry (IHC), In situ hybridization (ISH)/Fluorescence in situ hybridization (FISH)), By Region - Industry Forecast 2024-2031


Report ID: SQMIG35B2205 | Region: Global | Published Date: May, 2024
Pages: 215 |Tables: 122 |Figures: 76

Companion Diagnostics for Oncology Market Insights

Global Companion Diagnostics for Oncology Market size was valued at USD 3.1 billion in 2022 and is poised to grow from USD 3.5 billion in 2023 to USD 9.31 billion by 2031, growing at a CAGR of 13% in the forecast period (2024-2031).

Companion diagnostics refers to the utilization of genetic makeup of a person affected with cancer to design and predict a therapeutic approach. The rise of personalized medicine popularity around the world is a key factor that is slated to bolster the demand for companion diagnostics for oncology over the coming years. High investments in medical research and development are also forecasted to bolster the companion diagnostics for oncology market growth in the future. Use of companion diagnostics can further help enhance the treatment of different types of cancer-affected people. Surging incidence of different types of cancer and growing demand for treatment of the same are also estimated to create new opportunities for companion diagnostics for oncology companies in the long run. Advancements in precision medicine technology are also slated to bolster the demand for companion diagnostics for oncology across the forecast period and beyond. However, complex regulatory framework, high costs of implementation, and complexity of molecular data management are key constraints that could hurt companion diagnostics for oncology market development going forward.

Market snapshot - 2024-2031

Global Market Size

USD 3.1 billion

Largest Segment

Products

Fastest Growth

Services

Growth Rate

13% CAGR

Global Companion Diagnostics for Oncology Market ($ Bn)
Country Share for North America Region (%)

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Companion Diagnostics for Oncology Market Segmental Analysis

The global companion diagnostics for oncology market is segmented based on component, technology, end user, indication, and region. In terms of component, the market is segmented into products and services. In terms of end user, the market is segmented into hospitals, pathology/diagnostic laboratories, and academic medical centers. Based on indication, the market is bifurcated into breast cancer, non-small cell lung cancer, colorectal cancer, leukemia, melanoma, prostate cancer, and others. In terms of technology, the market is segmented into polymerase chain reaction (PCR), next-generation sequencing (NGS), immunohistochemistry (IHC), in situ hybridization (ISH)/fluorescence in situ hybridization (FISH), and other technologies. Based on region, the market is segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa.

Analysis by Component

Products account for a major share of the global companion diagnostics for oncology marketplace. The growing launch of new companion diagnostic equipment for oncology use by leading companies is the key factor allowing this segment to hold sway over others. Development of novel consumables and growing use of different types of reagents in companion diagnostics for oncology are also helping this segment maintain its dominance in the marketplace.

Demand for companion diagnostics for oncology services is slated to increase at a rapid pace across the forecast period and beyond. Increasing the business scope of companion diagnostics for oncology service providers around the world will be a key factor promoting growth of this segment. High adoption of novel companion diagnostics equipment will also foster new demand for companion diagnostics services in the future.

Analysis by End User

Hospitals are estimated to account for a substantial share of the global companion diagnostics for oncology market. High investments in healthcare infrastructure development, growing availability of skilled medical professionals, and most cancer treatments requiring hospital settings all contribute to the dominance of this segment. Rising use of advanced oncology treatment and diagnostics equipment in hospitals will also favor companion diagnostics for oncology demand.

Demand for companion diagnostics for oncology in pathology/diagnostic laboratories is estimated to rise at a robust pace over the coming years. Growing use of laboratories for oncology disease testing is also predicted to contribute to the growing market share of this segment through 2031.

Global Companion Diagnostics for Oncology Market By Component

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Companion Diagnostics for Oncology Market Regional Insights

North America is slated to hold sway over global companion diagnostics for oncology demand outlook across the forecast period. This dominance can be attributed to surging prevalence of different cancers and high investments in oncology research are key factors that allow North America to account for a dominant stance in the global companion diagnostics for oncology marketplace. High availability of grants and subsidies for oncology research are also helping North America to maintain its dominance. The United States and Canada are projected to be the leading markets for companion diagnostics for oncology providers in this region.

High emphasis on healthcare infrastructure development and growing approval of novel oncology treatments and medical devices help Asia Pacific region become the fastest-growing regional market in the world. Supportive government initiatives to promote oncology R&D are also slated to create new opportunities for companion diagnostics providers based in this region going forward. China, India, and Japan are slated to be the top markets for companion diagnostics for oncology companies operating in the Asia Pacific region.

Global Companion Diagnostics for Oncology Market By Region
  • Largest
  • Fastest

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Companion Diagnostics for Oncology Market Dynamics

Drivers

Development of Precision Medicine

  • Precision medicine technologies are being rapidly developed and supplemented by high investments in medical R&D. Growing demand for personalized cancer therapies to minimize side effects will also boost the demand for companion diagnostics for oncology in the future.

High Incidence of Cancer

  • Cancer cases have been increasing rapidly around the world, fostering the demand for novel diagnostics and treatments worldwide. This high prevalence of cancer is slated to benefit companion diagnostics for oncology market growth over the coming years.

Restraints

Regulatory Challenges

  • Governments and regulatory authorities have implemented strict mandates regarding the development of new companion diagnostics for oncology. These strict norms for compliance prove to be a challenge for approvals and could slow down the overall companion diagnostics for oncology market development going forward.

Complex Molecular Data Interpretation

  • Companion diagnostics gives output in terms of complex molecular data that needs to be studied by highly skilled professionals to be interpreted. There is a shortage of such individuals, and this could slow down the overall companion diagnostics for oncology market growth in the long run.

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Companion Diagnostics for Oncology Market Competitive Landscape

Companion diagnostics for oncology market players should solely focus on R&D to foster innovation and stand out from the competition. The requirement of huge amount of capital to enter this market makes it a difficult one for start-ups and new companies looking to innovate. Companion diagnostics for oncology providers can also emphasize improving the reimbursement scenario for companion diagnostics to maximize their revenue generation potential in the long run.

Top Player’s Company Profiles

  • F. Hoffmann-La Roche Ltd.
  • QIAGEN N.V.
  • ARUP Laboratories
  • Biocartis
  • Exact Sciences
  • Myriad Genetics Inc.
  • Sysmex Corporation
  • Abbott
  • Genedrive
  • Genomic Health
  • Archer Dx
  • Agilent Technologies Inc.
  • bioMérieux SA
  • Thermo Fisher Scientific Inc.
  • Invivoscribe Inc.
  • Guardant Health
  • Foundation Medicine
  • Illumina Inc.
  • Amoy Dx

Recent Developments

  • In June 2021, United States Food and Drug Administration (FDA) announced the launch of a pilot program intended to regulate laboratory-developed tests (LDTs) used as companion diagnostics for oncology applications.
  • In October 2022, Roche, a leading name in the medical diagnostics industry, announced that it had received an approval for its companion diagnostic product for HER2 low metastatic breast cancer from the United States Food and Drug Administration (FDA).

Companion Diagnostics for Oncology Key Market Trends

  • Biomarker Discovery: Companion diagnostics for oncology companies should focus on discovering new biomarkers to expand thier business scope and revenue generation potential. Using advanced genomic and proteomic techniques and technologies, companion diagnostics for oncology companies can leverage biomarker discovery to their advantage and boost market growth in the future.

Companion Diagnostics for Oncology Market SkyQuest Analysis

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

As per SkyQuest analysis, growing prevalence of cancer and increasing advancements in precision medicine and personalized medicine are projected to bolster the demand for companion diagnostics for oncology across the forecast period. However, complex molecular data interpretation and stringent regulatory norms are estimated to be key restraints for companion diagnostics for oncology market development in the long run. North America is slated to dominate the global companion diagnostics for oncology market owing to high incidence of different types of cancer and rising adoption of advanced medical devices and technologies. Companion diagnostics for oncology providers should also target new biomarker discovery to create new growth opportunities going forward.

Report Metric Details
Market size value in 2022 USD 3.1 billion
Market size value in 2031 USD 9.31 billion
Growth Rate 13%
Base year 2023
Forecast period 2024-2031
Forecast Unit (Value) USD Billion
Segments covered
  • Component
    • Products, and Services
  • End User
    • Hospitals, Pathology/Diagnostic Laboratories, and Academic Medical Centers
  • Indication
    • Breast Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Leukemia, Melanoma, Prostate Cancer, and Others
  • Technology
    • Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Immunohistochemistry (IHC), In situ hybridization (ISH)/Fluorescence in situ hybridization (FISH), Other Technologies
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.
  • QIAGEN N.V.
  • ARUP Laboratories
  • Biocartis
  • Exact Sciences
  • Myriad Genetics Inc.
  • Sysmex Corporation
  • Abbott
  • Genedrive
  • Genomic Health
  • Archer Dx
  • Agilent Technologies Inc.
  • bioMérieux SA
  • Thermo Fisher Scientific Inc.
  • Invivoscribe Inc.
  • Guardant Health
  • Foundation Medicine
  • Illumina Inc.
  • Amoy Dx
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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 for Oncology 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 for Oncology 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 for Oncology 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 for Oncology 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 for Oncology Market:

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

Regional Analysis: Further analysis of the Companion Diagnostics for Oncology 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

Companion Diagnostics for Oncology Market size was valued at USD 3.1 billion in 2022 and is poised to grow from USD 3.5 billion in 2023 to USD 9.31 billion by 2031, growing at a CAGR of 13% in the forecast period (2024-2031).

Companion diagnostics for oncology market players should solely focus on R&D to foster innovation and stand out from the competition. The requirement of huge amount of capital to enter this market makes it a difficult one for start-ups and new companies looking to innovate. Companion diagnostics for oncology providers can also emphasize improving the reimbursement scenario for companion diagnostics to maximize their revenue generation potential in the long run. 'F. Hoffmann-La Roche Ltd.', 'QIAGEN N.V.', 'ARUP Laboratories', 'Biocartis', 'Exact Sciences', 'Myriad Genetics Inc.', 'Sysmex Corporation', 'Abbott', 'Genedrive', 'Genomic Health', 'Archer Dx', 'Agilent Technologies Inc.', 'bioMérieux SA', 'Thermo Fisher Scientific Inc.', 'Invivoscribe Inc.', 'Guardant Health', 'Foundation Medicine', 'Illumina Inc.', 'Amoy Dx'

Precision medicine technologies are being rapidly developed and supplemented by high investments in medical R&D. Growing demand for personalized cancer therapies to minimize side effects will also boost the demand for companion diagnostics for oncology in the future.

Biomarker Discovery: Companion diagnostics for oncology companies should focus on discovering new biomarkers to expand thier business scope and revenue generation potential. Using advanced genomic and proteomic techniques and technologies, companion diagnostics for oncology companies can leverage biomarker discovery to their advantage and boost market growth in the future.

North America is slated to hold sway over companion diagnostics for oncology demand outlook across the forecast period. This dominance can be attributed to surging prevalence of different cancers and high investments in oncology research are key factors that allow North America to account for a dominant stance in the companion diagnostics for oncology marketplace. High availability of grants and subsidies for oncology research are also helping North America to maintain its dominance. The United States and Canada are projected to be the leading markets for companion diagnostics for oncology providers in this region.

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