USD 5.57 billion
Report ID:
SQMIG35A2649 |
Region:
Global |
Published Date: June, 2024
Pages:
157
|Tables:
66
|Figures:
75
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.
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 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.
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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.
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Drivers
Personalized Medicine Advancements
Regulatory Support and Approvals
Restraints
High Development Costs
Technical and Operational Challenges
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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
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.
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 |
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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 |
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Customization scope | Free report customization with purchase. Customization includes:-
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Executive Summary
Market overview
Parent Market Analysis
Market overview
Market size
KEY MARKET INSIGHTS
COVID IMPACT
MARKET DYNAMICS & OUTLOOK
Market Size by Region
KEY COMPANY PROFILES
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.
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.
Our industry expert will work with you to provide you with customized data in a short amount of time.
REQUEST FREE CUSTOMIZATIONGlobal 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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Report ID: SQMIG35A2649