USD 5.57 billion
Companion Diagnostics Market Size, Share, Growth Analysis, By Product and Services (Assays, Kits, Reagents, and Software & Services), By Technology (PCR and ISH), By Indication (Cardiovascular and oncology), By Region - Industry Forecast 2025-2032
Report ID:
SQMIG35A2649 |
Region:
Global |
Published Date: August, 2024
Pages:
157
|Tables:
66
|Figures:
75
Companion Diagnostics Market Insights
Companion Diagnostics Market size was valued at USD 7.37 Billion in 2023 and is poised to grow from USD 8.21 Billion in 2024 to USD 19.47 Billion by 2032, growing at a CAGR of 11.4% during the forecast period (2025-2032).
A companion diagnostic is a test intended to safely and effectively administer an analogous biological product or treatment. The most common usage for these tests is in the diagnosis of cancer. The market is growing due to the increased demand for these tests brought on by the global increase in cancer cases. In addition, this companion diagnostic market thrives in an environment promoting precision medicine such as individualization of treatments considering each patient's unique traits.
Genomic, proteomic, and metabolomic profiles unfold, setting a rising need for companion diagnostics to detect relevant treatments and the predictability of a favorable response. This tendency is reinforced by the introduction of personalized medication, which necessitates companion diagnostics for its implementation. Moreover, government initiatives and the positive guidance of organizations, including the FDA and EMA are propelling the companion diagnostics industry. As more regulatory bodies come to understand the value of companion diagnostics in enhancing treatment efficacy, they are working to streamline the approval process. The FDA's companion diagnostics rapid approval procedures, for instance, make it possible for these products to be released onto the market rapidly.
Market snapshot - 2025-2032
Global Market Size
Largest Segment
By Product & Service
Fastest Growth
By Technology
Growth Rate
12.5% CAGR
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Companion Diagnostics Market Segmental Analysis
Global Companion Diagnostics Market is segmented into product & services, technology, indication, and region. By product & services, the companion diagnostics market is classified into assays, kits, reagents, and software & services. Depending on technology, it is categorized into PCR and ISH. According to indication, the market is bifurcated into cardiovascular and oncology. Regionally, it is analyzed across North America, Asia-pacific, Europe, Latin America, and Middle East & Africa.
Companion Diagnostics Market Analysis By Product & Services
With a large selection of products and expanding applications in multiple therapeutic areas, assays, kits, and reagents command the largest market share. The vast numbers of diagnostic demands that arise in the healthcare field can be met with the comprehensive range of assays, kits, and reagents available here. Moreover, product flexibility across many therapeutic areas highlights the importance of these products in clinical and research applications.
The critical and unpredictable part of the companion diagnostic industry is the software and services segment, which provides incentives and helps to harmonize diagnostic processes. Experts in their fields increasingly rely more and more on technological services and solutions, particularly when it comes to companion diagnostics. This market area includes products for bioinformatics and information management solutions, such as software, databases, and reference materials. These products can be used to analyze and make sense of complicated clinical and human genetic data.
Companion Diagnostics Market Analysis By Indication
In the companion diagnostics market, the oncology segment is in a dominant position due to rapid development of customized cancer treatments. It is in this context that companion diagnostics will emerge as the prime focus, with an altered role in targeting patients to the most suitable medication and immunotherapy. So, the rapid development of innovative medicines and the raised incidence of cancer are happening in the face of this being the most crucial market segment that is evolving and in which investments are taking place.
The cardiovascular segment is the fastest growing segment. Companion diagnostics in cardiovascular diseases are oriented toward two main objectives such as optimization of medication choice and risk-factor management. While they are less dynamic compared with oncology, their growth can increase with the progress of personalized medicine and biomarker discovery. Companion diagnostics may become more necessary as cardiovascular treatments advance, indicating a sluggish but continuous expansion in this discipline.
Global Companion Diagnostics Market Size By Indication
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Companion Diagnostics Market Regional Insights
Significantly, the sales are in North America, amounting to USD 2.35 billion in 2023. Some of the factors that give explanations for the mentioned regional dominance include the increased prevalence of chronic diseases such as cancer in North America compared to other regions. The global healthcare landscape's expanding tendencies toward precision medicine are driving the launch of novel Companion Diagnostic (CDx) assays. The definition of the precise patient care intervention techniques employed in patient care has been substantially improved using these advanced diagnostic tools. In the healthcare industry, bioplastics are utilized to produce diagnostic equipment and medical devices. This is because bioplastics can adhere to stringent healthcare regulations and are more environmentally friendly. As precision medicine advances, probability of greater need for advanced diagnostic instruments and the materials required to create them, such as bioplastics, is expected to solidify North America's leading position in the market.
Asia-Pacific is expected to grow at the fastest rate during the forecast period. This specific growth path can be associated with several interconnected factors. First and foremost, there has been a noticeable increase in cancer incidence in the area, along with the development of improved diagnostic instruments and CDx assays. The increased application of bioplastics has resulted from an increase in demand for advanced medical testing. It provides both efficient performance and sustainable growth. Bioplastics are increasingly being adopted in the making of medical instruments and diagnostic equipment. These meet environmental standards and pass health guidelines. Growing investments by the region in medical technology and healthcare infrastructure are further impelling the studies and applications of bioplastics.
Global Companion Diagnostics Market Size 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. 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 is a significant surge in recently approved products in the companion diagnostics industry. 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
Global companion diagnostic market is a highly competitive business with many established brands, emerging firms, and niche competitors. It has the 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.
Top Player’s Company Profiles in Companion Diagnostics Industry
- Abbott
- IDVet
- F. Hoffmann-La Roche Ltd.
- Agilent Technologies, Inc.
- AniCell Biotech
- Illumina, Inc.
- Guardant Health
- Heska Corporation
- Thermo Fisher Scientific Inc.
- BIOMERIEUX
- NEOGEN Corporation
- Zoetis Inc.
- QIAGEN
- Myriad Genetics, Inc.
- Virbac SA
Recent Developments in Companion Diagnostics Industry
- February 2024: PathAI collaborated with F. Hoffmann-La Roche Ltd. for the development of AI-enabled pathology algorithms for companion diagnostics.
- November 2023: Amoy Diagnostics Co., Ltd. and Cell Signaling Technology collaborate on companion diagnostics in the advancement of precision oncology in China.
- October 2022: To assist in identifying patients with metastatic breast cancer who are HER2 low and eligible for ENHERTU (HER2-directed antibody drug conjugate) treatment, the US FDA authorized PATHWAY, a companion diagnostic from F. Hoffmann-La Roche Ltd.
Companion Diagnostics Key Market Trends
Innovations in Next-Generation Sequencing to Promote Market Growth
- 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.
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.
As per SkyQuest Analysis, the increasing global prevalence of cancer has increased the requirement for companion diagnostic tests, which is one of the key drivers propelling the market's expansion. Other drivers of such tests include the regulatory approvals received across all indications. For instance, in August 2022, Thermo Fisher Scientific Inc.'s Oncomine Dx Target Test was approved by the US FDA as a companion diagnostic (CDx) specifically in NSCLC patients. It is highly sensitive for the detection of two activating mutations in HER2 (ERBB2): Exon 20 Insertions and SNVs.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 7.37 Billion |
| Market size value in 2032 | USD 19.47 Billion |
| Growth Rate | 11.4% |
| Base year | 2024 |
| Forecast period | 2025-2032 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| 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 |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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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
- Exhibit: Impact analysis of DROC, 2021
- 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
- Exhibit: Impact analysis of DROC, 2021
- 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
- Competitive rivalry
- 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(%)
- Total number of companies covered
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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