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Global Oncology Companion Diagnostic Market to reach USD 8.18 billion by the end of 2030.

Global Oncology Companion Diagnostic Market Size Study & Forecast, by Offerings (Instrument, Consumables, Software, Services), by Technology (Polymerase Chain Reaction, Next-Generation Sequencing, Immunohistochemistry, Other Technologies), By Disease Type (Breast Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Others), By End-Use, and Regional Analysis, 2023-2030

Product Code: HLSMD-57210974
Publish Date: 20-12-2023
Page: 200

Global Oncology Companion Diagnostic Market is valued at approximately USD 3.1 billion in 2022 and is anticipated to grow with a healthy growth rate of more than 12.9% over the forecast period 2023-2030. An oncology Companion Diagnostic (CDx) is a type of medical test or biomarker that is used to identify specific characteristics or molecular alterations in a patient’s tumor. These characteristics are often associated with the patient’s likelihood of responding to a particular targeted therapy or treatment for cancer. The primary purpose of oncology companion diagnostics is to aid healthcare providers in making more personalized and effective treatment decisions for cancer patients. The surge in demand for targeted cancer treatment and tailored drugs, growing investments in the pharmaceutical industry, coupled with the rise in approval rate for companion diagnostics are the most prominent factors that are propelling the market demand across the globe.

Additionally, the incidence of cancer is rising worldwide, due to factors such as an aging population and unhealthy lifestyles. This is creating a greater demand for oncology companion diagnostics. According to the World Health Organization, in 2020, it was estimated that nearly 19.3 million new cases of cancer were recorded globally, which is projected to rise and is likely to reach 30.2 million new cases by 2040. Moreover, the increasing collaborations between diagnostic and pharma entities, as well as the growing investment in research and development activities present various lucrative opportunities over the forecast years. However, the high cost of development and testing and the regulatory challenges are hindering the market growth throughout the forecast period of 2023-2030.

The key regions considered for the Global Oncology Companion Diagnostic Market study include Asia Pacific, North America, Europe, Latin America, and Middle East & Africa. North America dominated the market in 2022 owing to the rising advancements in precision medicine, a growing development of targeted cancer therapies, as well as the growing focus of the pharmaceutical industry on targeted therapies and personalized medicine. Whereas, Asia Pacific is expected to grow at the highest CAGR over the forecast years. The increasing number of government and healthcare industry initiatives promoting precision medicine and genomic research, coupled with ongoing advancements in diagnostic technologies and tools contribute to the development and improvement of companion diagnostics that are significantly propelling the market demand across the region.

Major market players included in this report are:
Agilent Technologies, Inc.
Illumina, Inc.
Thermo Fisher Scientific, Inc.
F. Hoffmann-La Roche Ltd.
ARUP Laboratories
Abbott Laboratories
Myriad Genetics, Inc.
bioMérieux SA
Invivoscribe, Inc.

Recent Developments in the Market:
Ø In July 2020, The Ventana HER2 Dual ISH DNA Probe Cocktail assay received approval from the FDA as a revolutionary fast way to identify the HER2 biomarker for breast cancer and as a complementary diagnosis for Herceptin therapy.
Ø In August 2020, The FDA approved the FoundationOne Liquid CDx, a pan-tumor liquid biopsy test, and the Guardant360 CDx assay, an NGS test that employs circulating cell-free DNA as a CDx. Both tests, Guardant360 CDx and FoundationOne Liquid CDx, serve dual purposes as companion diagnostic tests and for general tumor profiling. A companion diagnostic test provides essential information about the safe and effective use of a corresponding drug, indicating whether a patient’s tumor has a genetic change targeted by a specific drug. Notably, Guardant360 CDx is approved as a companion diagnostic for osimertinib (Tagrisso), a lung cancer therapy, while FoundationOne Liquid CDx holds approval for three lung cancer therapies and a prostate cancer therapy. Ongoing clinical studies aim to support additional companion diagnostic labels for both tests.

Global Oncology Companion Diagnostic Market Report Scope:
ü Historical Data – 2020 – 2021
ü Base Year for Estimation – 2022
ü Forecast period – 2023-2030
ü Report Coverage – Revenue forecast, Company Ranking, Competitive Landscape, Growth factors, and Trends
ü Segments Covered – Offerings, Technology, Disease Type, End-use, Region
ü Regional Scope – North America; Europe; Asia Pacific; Latin America; Middle East & Africa
ü Customization Scope – Free report customization (equivalent up to 8 analyst’s working hours) with purchase. Addition or alteration to country, regional & segment scope*

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within countries involved in the study.

The report also caters detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, it also incorporates potential opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players. The detailed segments and sub-segment of the market are explained below:

By Offerings:

By Technology:
Polymerase Chain Reaction (PCR)
Next-Generation Sequencing (NGS)
Immunohistochemistry (IHC)
In Situ Hybridization (ISH)/Fluorescence In Situ Hybridization (FISH)
Other Technologies

By Disease Type:
Breast Cancer
Non-Small Cell Lung Cancer
Colorectal Cancer
Prostate Cancer

By End-Use:
Pathology/Diagnostic Laboratory
Academic Medical Center

By Region:

North America


Asia Pacific
South Korea

Latin America

Middle East & Africa
Saudi Arabia
South Africa
Rest of Middle East & Africa

Chapter 1. Executive Summary
1.1. Market Snapshot
1.2. Global & Segmental Market Estimates & Forecasts, 2020-2030 (USD Billion)
1.2.1. Oncology Companion Diagnostic Market, by Region, 2020-2030 (USD Billion)
1.2.2. Oncology Companion Diagnostic Market, by Offerings, 2020-2030 (USD Billion)
1.2.3. Oncology Companion Diagnostic Market, by Technology, 2020-2030 (USD Billion)
1.2.4. Oncology Companion Diagnostic Market, by Disease Type, 2020-2030 (USD Billion)
1.2.5. Oncology Companion Diagnostic Market, by End-use, 2020-2030 (USD Billion)
1.3. Key Trends
1.4. Estimation Methodology
1.5. Research Assumption
Chapter 2. Global Oncology Companion Diagnostic Market Definition and Scope
2.1. Objective of the Study
2.2. Market Definition & Scope
2.2.1. Industry Evolution
2.2.2. Scope of the Study
2.3. Years Considered for the Study
2.4. Currency Conversion Rates
Chapter 3. Global Oncology Companion Diagnostic Market Dynamics
3.1. Oncology Companion Diagnostic Market Impact Analysis (2020-2030)
3.1.1. Market Drivers Surge in demand for targeted cancer treatment and tailored drugs Rising incidence of cancer
3.1.2. Market Challenges High cost of development and testing Regulatory challenges
3.1.3. Market Opportunities Increasing collaborations between diagnostic and pharma entities Growing investment in the research and development activities
Chapter 4. Global Oncology Companion Diagnostic Market Industry Analysis
4.1. Porter’s 5 Force Model
4.1.1. Bargaining Power of Suppliers
4.1.2. Bargaining Power of Buyers
4.1.3. Threat of New Entrants
4.1.4. Threat of Substitutes
4.1.5. Competitive Rivalry
4.2. Porter’s 5 Force Impact Analysis
4.3. PEST Analysis
4.3.1. Political
4.3.2. Economical
4.3.3. Social
4.3.4. Technological
4.3.5. Environmental
4.3.6. Legal
4.4. Top investment opportunity
4.5. Top winning strategies
4.6. COVID-19 Impact Analysis
4.7. Disruptive Trends
4.8. Industry Expert Perspective
4.9. Analyst Recommendation & Conclusion
Chapter 5. Global Oncology Companion Diagnostic Market, by Offerings
5.1. Market Snapshot
5.2. Global Oncology Companion Diagnostic Market by Offerings, Performance – Potential Analysis
5.3. Global Oncology Companion Diagnostic Market Estimates & Forecasts by Offerings 2020-2030 (USD Billion)
5.4. Oncology Companion Diagnostic Market, Sub Segment Analysis
5.4.1. Instrument
5.4.2. Consumables
5.4.3. Software
5.4.4. Services
Chapter 6. Global Oncology Companion Diagnostic Market, by Technology
6.1. Market Snapshot
6.2. Global Oncology Companion Diagnostic Market by Technology, Performance – Potential Analysis
6.3. Global Oncology Companion Diagnostic Market Estimates & Forecasts by Technology 2020-2030 (USD Billion)
6.4. Oncology Companion Diagnostic Market, Sub Segment Analysis
6.4.1. Polymerase Chain Reaction (PCR)
6.4.2. Next-Generation Sequencing (NGS)
6.4.3. Immunohistochemistry (IHC)
6.4.4. In Situ Hybridization (ISH)/Fluorescence In Situ Hybridization (FISH)
6.4.5. Other Technologies
Chapter 7. Global Oncology Companion Diagnostic Market, by Disease Type
7.1. Market Snapshot
7.2. Global Oncology Companion Diagnostic Market by Disease Type, Performance – Potential Analysis
7.3. Global Oncology Companion Diagnostic Market Estimates & Forecasts by Disease Type 2020-2030 (USD Billion)
7.4. Oncology Companion Diagnostic Market, Sub Segment Analysis
7.4.1. Breast cancer
7.4.2. Non-small cell lung cancer
7.4.3. Colorectal cancer
7.4.4. Leukemia
7.4.5. Melanoma
7.4.6. Prostate cancer
7.4.7. Others
Chapter 8. Oncology Companion Diagnostic Market, by End-use
8.1. Market Snapshot
8.2. Global Oncology Companion Diagnostic Market by End-use, Performance – Potential Analysis
8.3. Global Oncology Companion Diagnostic Market Estimates & Forecasts by End-use 2020-2030 (USD Billion)
8.4. Oncology Companion Diagnostic Market, Sub Segment Analysis
8.4.1. Hospital
8.4.2. Pathology/Diagnostic laboratory
8.4.3. Academic medical center
Chapter 9. Global Oncology Companion Diagnostic Market, Regional Analysis
9.1. Top Leading Countries
9.2. Top Emerging Countries
9.3. Oncology Companion Diagnostic Market, Regional Market Snapshot
9.4. North America Oncology Companion Diagnostic Market
9.4.1. U.S. Oncology Companion Diagnostic Market Offerings breakdown estimates & forecasts, 2020-2030 Technology breakdown estimates & forecasts, 2020-2030 Disease Type breakdown estimates & forecasts, 2020-2030 End-use breakdown estimates & forecasts, 2020-2030
9.4.2. Canada Oncology Companion Diagnostic Market
9.5. Europe Oncology Companion Diagnostic Market Snapshot
9.5.1. U.K. Oncology Companion Diagnostic Market
9.5.2. Germany Oncology Companion Diagnostic Market
9.5.3. France Oncology Companion Diagnostic Market
9.5.4. Spain Oncology Companion Diagnostic Market
9.5.5. Italy Oncology Companion Diagnostic Market
9.5.6. Rest of Europe Oncology Companion Diagnostic Market
9.6. Asia-Pacific Oncology Companion Diagnostic Market Snapshot
9.6.1. China Oncology Companion Diagnostic Market
9.6.2. India Oncology Companion Diagnostic Market
9.6.3. Japan Oncology Companion Diagnostic Market
9.6.4. Australia Oncology Companion Diagnostic Market
9.6.5. South Korea Oncology Companion Diagnostic Market
9.6.6. Rest of Asia Pacific Oncology Companion Diagnostic Market
9.7. Latin America Oncology Companion Diagnostic Market Snapshot
9.7.1. Brazil Oncology Companion Diagnostic Market
9.7.2. Mexico Oncology Companion Diagnostic Market
9.8. Middle East & Africa Oncology Companion Diagnostic Market
9.8.1. Saudi Arabia Oncology Companion Diagnostic Market
9.8.2. South Africa Oncology Companion Diagnostic Market
9.8.3. Rest of Middle East & Africa Oncology Companion Diagnostic Market

Chapter 10. Competitive Intelligence
10.1. Key Company SWOT Analysis
10.1.1. Company 1
10.1.2. Company 2
10.1.3. Company 3
10.2. Top Market Strategies
10.3. Company Profiles
10.3.1. Agilent Technologies, Inc. Key Information Overview Financial (Subject to Data Availability) Product Summary Recent Developments
10.3.2. Illumina, Inc.
10.3.3. QIAGEN N.V.
10.3.4. Thermo Fisher Scientific, Inc.
10.3.5. F. Hoffmann-La Roche Ltd.
10.3.6. ARUP Laboratories
10.3.7. Abbott Laboratories
10.3.8. Myriad Genetics, Inc.
10.3.9. bioMérieux SA
10.3.10. Invivoscribe, Inc.
Chapter 11. Research Process
11.1. Research Process
11.1.1. Data Mining
11.1.2. Analysis
11.1.3. Market Estimation
11.1.4. Validation
11.1.5. Publishing
11.2. Research Attributes
11.3. Research Assumption

At Bizwit Research and Consultancy, we employ a thorough and iterative research methodology with the goal of minimizing discrepancies, ensuring the provision of highly accurate estimates and predictions over the forecast period. Our approach involves a combination of bottom-up and top-down strategies to effectively segment and estimate quantitative aspects of the market, utilizing our proprietary data & AI tools. Our Proprietary Tools allow us for the creation of customized models specific to the research objectives. This enables us to develop tailored statistical models and forecasting algorithms to estimate market trends, future growth, or consumer behavior. The customization enhances the accuracy and relevance of the research findings.
We are dedicated to clearly communicating the purpose and objectives of each research project in the final deliverables. Our process begins by identifying the specific problem or challenge our client wishes to address, and from there, we establish precise research questions that need to be answered. To gain a comprehensive understanding of the subject matter and identify the most relevant trends and best practices, we conduct an extensive review of existing literature, industry reports, case studies, and pertinent academic research.
Critical elements of methodology employed for all our studies include:
Data Collection:
To determine the appropriate methods of data collection based on the research objectives, we consider both primary and secondary sources. Primary data collection involves gathering information directly from various industry experts in core and related fields, original equipment manufacturers (OEMs), vendors, suppliers, technology developers, alliances, and organizations. These sources encompass all segments of the value chain within the specific industry. Through in-depth interviews, we engage with key industry participants, subject-matter experts, C-level executives of major market players, industry consultants, and other relevant experts. This allows us to obtain and validate critical qualitative and quantitative information while evaluating market prospects. AI and Big Data are instrumental in our primary research, providing us with powerful tools to collect, analyze, and derive insights from data efficiently. These technologies contribute to the advancement of research methodologies, enabling us to make data-driven decisions and uncover valuable findings.
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Data Analysis:
Our team of experts carefully examine the gathered data using suitable statistical techniques and qualitative analysis methods. For quantitative analysis, we employ descriptive statistics, regression analysis, and other advanced statistical methods, depending on the characteristics of the data. This analysis may also incorporate the utilization of AI tools and big data analysis techniques to extract meaningful insights.
To ensure the accuracy and reliability of our findings, we extensively leverage data science techniques, which help us minimize discrepancies and uncertainties in our analysis. We employ Data Science to clean and preprocess the data, ensuring its quality and reliability. This involves handling missing data, removing outliers, standardizing variables, and transforming data into suitable formats for analysis. The application of data science techniques enhances our accuracy, efficiency, and depth of analysis, enabling us to stay competitive in dynamic market environments.
Market Size Estimation:
Our proprietary data tools play a crucial role in deriving our market estimates and forecasts. Each study involves the creation of a unique and customized model. The model incorporates the gathered information on market dynamics, technology landscape, application development, and pricing trends. AI techniques, such as machine learning and deep learning, aid us to analyze patterns within the data to identify correlations, trends, and relationships. By recognizing patterns in consumer behavior, purchasing habits, or market dynamics, our AI algorithms aid us in more precise estimations of market size. These factors are simultaneously analyzed within the model, allowing for a comprehensive assessment. To quantify their impact over the forecast period, correlation, regression, and time series analysis are employed.
To estimate and validate the market size, we employ both top-down and bottom-up approaches. The preference is given to a bottom-up approach, where key regional markets are analyzed as separate entities. This data is then integrated to obtain global estimates. This approach is crucial as it provides a deep understanding of the industry and helps minimize errors.
In our forecasting process, we consider various parameters such as economic tools, technological analysis, industry experience, and domain expertise. By taking all these factors into account, we strive to produce accurate and reliable market forecasts. When forecasting, we take into consideration several parameters, which include:
Market driving trends and favorable economic conditions
Restraints and challenges that are expected to be encountered during the forecast period.
Anticipated opportunities for growth and development
Technological advancements and projected developments in the market
Consumer spending trends and dynamics
Shifts in consumer preferences and behaviors.
The current state of raw materials and trends in supply versus pricing
Regulatory landscape and expected changes or developments.
The existing capacity in the market and any expected additions or expansions up to the end of the forecast period.
To assess the market impact of these parameters, we assign weights to each one and utilize weighted average analysis. This process allows us to quantify their influence on the market and derive an expected growth rate for the forecasted period. By considering these various factors and applying a weighted analysis approach, we strive to provide accurate and reliable market forecasts.
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