Global Companion Diagnostics Market By Overview
- By 2035, the target market is expected to increase at a rate of USD 25.8 Billion.
- In 2024, the companion diagnostics market size accounted for USD 7.7 Billion.
- The market is expanding at a CAGR of 12.9%.
A companion diagnostic is a medical device, known as an in vitro diagnostic, which provide information that is essential for the safe and effective use of corresponding drug and biological product. Companion diagnostics help to identify patients from a particular therapeutic product, identify risk for serious side effects of treatment with a particular therapeutic product, and monitor response to treatment for the purpose of adjusting treatment to improve safety and effectiveness of the therapy. The increasing prevalence of cancer, growing focus on precision medicine, discovery of new biomarkers, and co-development of drugs and corresponding diagnostics help to drive companion diagnostic market growth.
Impact of AI in Companion Diagnostics Market:
Artificial Intelligence (AI) enhances the accuracy and efficiency of identifying specific biomarkers in patient’s tumor. AI can integrate data from various sources, such as imaging, genetic sequencing, and clinical information to provide patient’s condition and AI-powered tools also provide immediate feedback to clinicians during the diagnostic process.
Global Companion Diagnostics Market By Drivers & Restraints
Key Drivers of Target Market:
Increasing Product Approvals in Companion Diagnostics is Expected to Drive Market Growth
The companion diagnostics products provide more sustainable tools that enable precise patient disease identification, ultimately contributing to improve therapeutic results and the personalized medicine. As the number of new products approving, results in increased adoption of several tests and therapy treatments. The key players are focusing on the development of novel tests that lead to growth of the companion diagnostics market.
- For instance, in August 2024, Illumina, a global leader in DNA sequencing and array-based technologies, get the approval from Food and Drug Administration (FDA) for the in vitro diagnostics, a TruSight Oncology Comprehensive test and its first two companion diagnostic indication. FDA approved companion diagnostics to identify over 500 genes of solid tumor, helping to identify an immune-oncology biomarker and clinically actionable biomarker for the targeted therapies of patients.
Restraints:
Lack of Trained Professionals can Impede Target Market Growth
Companion diagnostics testing is a complex and technical process that requires trained professionals for conducting tests. The lack of awareness among clinicians about the latest advancements in companion diagnostic test, results in providers struggle to switch from traditional methods to IT based approaches. Hence, the lack of skilled, well-trained, and technically knowledgeable laboratory technicians to operate advanced companion diagnostics products may lead to restricted companion diagnostics market growth.
- Counterbalance Statements: Use of artificial intelligence and machine learning tools as an alternative for the technicians. AI has the ability to meet the performance of human experts in image-based diagnoses. AI algorithms help to generate patient-specific insights, enabling treatment plans in companion diagnostics.
Opportunities & Market Trends:
Rising Ineffectiveness of Companion Diagnostics is Expected to Boost Market Growth
The importance of companion diagnostics in healthcare providers' treatment decisions for patients is rapidly growing. Companion diagnostics identify specific targeted therapy by detecting the presence of biomarker, allowing for personalized medicine and minimizing unnecessary side effects and optimizing treatment outcomes. Rising demand for the high-priced therapies and safer medication is expected to drive the market growth in upcoming years.
Advancements in the latest technologies are anticipated to market growth.
The next-generation sequencing (NGS) technology used to develop targeted therapies and personalized treatment plans. Next-generation sequencing made possible to screen for multiple biomarkers at once, which improve the accuracy of diagnosis and treatment response monitoring. Next-generation sequencing is applied in cancer genomics to develop targeted therapies. Next-generation sequencing can sequence millions of DNA fragments and identify genetic mutation, resulting to drive companion diagnostics market growth.
- For instance, in November 2024, Thermo Fisher Scientific received the U.S. Food and Drug Administration approval for NGS-based companion diagnostic for the first targeted therapy for patients with Grade 2 IDH-Mutant Glioma. Gliomas are the most common malignant primary brain tumor in adults; thus, the NGS-based companion diagnostics helps to identify IDH mutation and testing for these mutations is essential for accurate treatment decisions.
Global Companion Diagnostics Market By Segmentations & Regional Insights
The companion diagnostics market is segmented into offerings, technology, therapeutic area, end-user, and region.
Offerings:
By offerings, the companion diagnostics market is segmented into product (assays, test kit, and reagent), services (development services, analytical, and clinical validation). The product segment is leading the target market. The products including, assays, test kits & reagents, are used in companion diagnostics to identify patient’s tumor, and biological sample, which possess a specific genetic alteration to give response on targeted therapy and allows for personalized decisions. The wide variety of availability of products and growing utilization of assays and kits in various therapeutic area, resulting to propel the segment’s expansion.
Technology:
Polymerase chain reaction (PCR), next-generation sequencing (NGS), immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and others are the technology segments in the target market. The polymerase chain reaction (PCR) technology segment has largest companion diagnostics market share, as they allow specific detection of genetic mutation and variations associated with a disease. The growing applications in detecting gene mutating with limited allele frequency is expected to drive the companion diagnostics market,
- For instance, in October 2024, Qiagen launched QIAcuityDx a difital PCR system for clinical testing in oncology. QIAcuityDx is aimed for clinical testing by providing highly precise, absolute quantification of target DNA and RNA, supporting applications with less invasive liquid biopsies.
Therapeutic Area:
By therapeutic area, the companion diagnostics market is divided into oncology, immunology, neurology, autoimmune, cardiovascular, infectious disease, and others. The oncology therapeutic area holds the dominant companion diagnostics market share due to the increasing prevalence of cancer diseases in aging population. Companion diagnostics allow to identify patient’s tumor with a specific gene change and biomarker that is targeted by the drug. Companion diagnostic test improve clinical trials more efficient and informative for various cancer therapy treatment. It helps to identify personalized medicine and side effects of drug in individual patients, resulting to drive target market growth in oncology segment.
- For instance, in October 2024, Roche received FDA approval for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer with the new VENTANA CLDN18 RxDx Assay. This assay aimed to fulfill medical need by enabling clinicians to identify patients with gastric and gastroesophageal junction cancer for targeted treatment therapies.
End-User:
Companion diagnostics market by end-user divided into pharmaceutical & biotechnological companies, contract research laboratories, diagnostics laboratories, and others. The diagnostic laboratories segment play dominate role in target market. Diagnostics laboratories provide essential information about a patient’s health through various tests, and companion diagnostics in diagnostic laboratories ensure targeted therapies and optimizes treatment outcomes help to drive target market share in diagnostics laboratories.
Region:
Geographically, the market is studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America: This is dominating region for the companion diagnostics market due to advancement in healthcare infrastructure, strong emphasis on precision medicine initiatives, and presence of pharmaceutical & biotechnology companies in this region, and rapid adoption of new diagnostics technologies help to drive companion diagnostics market in North America region.
- For instance, in November 2024, Foundation Medicine, Inc., received approval from the U.S. Food and Drug administration (FDA) for the FoundationOne Liquid CDx used as companion diagnostic foe TEPMETKO to identify patients with MET Exon 14 skipping alteration in non-small lung cancer. The liquid biopsy first approved companion diagnostic approved in the U.S. foe TEPMETKO, help to identify patients and give targeted treatment.
Asia Pacific: This region is the expected as the fastest growing region in the target market due to the increase in cancer incidence, technological advancements, and focus on precision medicine. Rising investments in healthcare infrastructure, encouraging legal framework and rising funding for the research & development, is expected to drive companion diagnostics market size in upcoming years.
Companion Diagnostics Market Report Scope:
Attribute |
Details |
Market Size 2025 |
USD 8.5 Billion |
Projected Market Size 2035 |
USD 25.8 Billion |
CAGR Growth Rate |
12.9% (2025-2035) |
Base year for estimation |
2024 |
Forecast period |
2025 – 2035 |
Market representation |
Revenue in USD Billion & CAGR from 2025 to 2035 |
Regional scope |
North America - U.S. and Canada Europe – Germany, U.K., France, Russia, Italy, Spain, Netherlands, and Rest of Europe Asia Pacific – China, India, Japan, Australia Indonesia Malaysia, South Korea, and Rest of Asia-Pacific Latin America - Brazil, Mexico, Argentina, and Rest of Latin America Middle East & Africa – GCC, Israel, South Africa, and Rest of Middle East & Africa |
Report coverage |
Revenue forecast, company share, competitive landscape, growth factors, and trends |
Segmentation:
By Offering:
- Product
- Assays
- Test Kits and Reagents
- Services
- Development Services
- Analytical and Clinical Validation
By Technology
- Polymerase Chain Reaction (PCR)
- Next-generation Sequencing (NGS)
- Immunohistochemistry (IHC)
- Fluorescence in Situ Hybridization (FISH)
- Others
By Therapeutic Area:
- Oncology
- Immunology
- Neurology
- Autoimmune
- Cardiovascular
- Infectious Disease
- Others
By End-User:
- Pharmaceutical & Biotechnological Companies
- Contract Research Laboratories
- Diagnostics Laboratories
- Others
By Region:
- North America
- U.S.
- Canada
- Europe
- Germany
- U.K.
- France
- Russia
- Italy
- Spain
- Netherlands
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- Australia
- Indonesia
- Malaysia
- South Korea
- Rest of Asia Pacific
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
Global Companion Diagnostics Market By Competitive Landscape & Key Players
The key players operating in the companion diagnostics market include Promega Corporation, Ajinomoto Bio-Pharma, Crown Bioscience and others. Companion diagnostics is growing in the market and companies are collaborating with drug companies to develop companion diagnostics for drugs, personalized medicine, and therapies is expected to drive companion diagnostics market growth.
List of Key Players in the Market:
- Foundation Medicine, Inc.
- F. Hoffmann-La Roche Ltd
- Agilent Technologies, Inc.
- QIAGEN
- Thermo Fisher Scientific Inc.
- Abbott
- Illumina, Inc
- Myriad Genetics, Inc.
- BIOMÉRIEUX
- BioGenex
- Guardant Health
- Labcorp
- Quest Diagnostics Incorporated
- Sysmex Corporation
Global Companion Diagnostics Market By Recent News
- In July 2024, BD and Quest Diagnostics, announced a global collaboration to develop, manufacture, and commercialize flow cytometry-based companion diagnostics, aimed to help patients with best treatment for cancer and other diseases. This collaboration will offer the pharmaceutical industry with new solutions for companion diagnostics development and exploratory panel development to the manufacturing and distribution of FDA-approved diagnostic kits.
- In December 2024, Guardant health announced collaboration with Boehringer Ingelheim to develop companion diagnostic for detection of specific mutation in advanced lung cancer. This collaboration is aimed to commercialize the Guardant360 CDx liquid biopsy as a companion diagnostic for zongertinib, an investigational covalent tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC).
Analyst View:
Companion diagnostics market is significantly driven by increasing demand for recombinant proteins in biopharmaceutical, neurology, diagnostics, and immunology biotechnology. New technologies help to enhance yield, efficiency, and cost-effectiveness. The companion diagnostics market is driven by the advancements in biologics, vaccines, and Neurology, resulting to the growth of target market.
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Global Companion Diagnostics Market By Company Profile
Company Name |
Foundation Medicine, Inc |
Headquarter |
Cambridge, Massachusetts, U.S. |
CEO |
Dan Malarek |
Employee Count (2024) |
1,700 Employees |
Global Companion Diagnostics Market By Highlights
FAQs
Companion diagnostics market size was valued at USD 8.5 Billion in 2025 and is expected to reach USD 25.8 Billion by 2035 growing at a CAGR of 12.9%.
Offerings, technology, therapeutic area, end-user and region are the segmentation for the target market.
North America, Asia Pacific, Europe, Latin America, and the Middle East & Africa. North America is expected to dominate the market.
The key players operating the companion diagnostics market include Foundation Medicine, Inc., F. Hoffmann-La Roche Ltd, Agilent Technologies, Inc., QIAGEN, Thermo Fisher Scientific Inc., Abbott, Illumina, Inc, Myriad Genetics, Inc., BIOMÉRIEUX, BioGenex, Guardant Health, Labcorp, Quest Diagnostics Incorporated, and Sysmex Corporation.