Companion Diagnostics Market Report and Forecast 2025-2034
Description
The global companion diagnostics market was valued at USD 7.03 Billion in 2024, driven by the rising prevalence of cancer across the globe. The market is anticipated to grow at a CAGR of 12.50% during the forecast period of 2025-2034 to achieve a value of USD 22.83 Billion by 2034.
The global companion diagnostics market is witnessing robust growth due to advancements in precision medicine and increasing demand for targeted therapies. Rising cancer prevalence, the need for biomarker-based diagnostics, and regulatory support for new test approvals drive market expansion. Moreover, the growing adoption of next-generation sequencing (NGS) and polymerase chain reaction (PCR) technologies further enhances diagnostic accuracy, enabling personalised treatment strategies.
Companion Diagnostic Overview
Companion diagnostic tests help in the diagnosis of diseases and determines the most effective drug for a specific patient. These tests are crucial in cancer treatment, identifying biomarkers that indicate a patient’s suitability for individualised treatment. Pharmaceutical companies integrate companion diagnostics into drug development to enhance efficacy, ensuring that only patients most likely to benefit receive targeted therapies.
Market Drivers and Adoption Trends
The companion diagnostic market is expanding due to rising demand for precision cancer treatments. Companies like Foundation Medicine lead innovations with products like FOUNDATIONONE CDx, which analyses cancer-related genes in solid tumors. Increasing regulatory approvals and advancements in companion diagnostic tests further support market growth. The rising prevalence of cancer has prompted greater adoption of companion diagnostics, ensuring effective treatment selection.
Regulatory Approvals and COVID-19 Impact
The U.S. FDA is approving novel companion diagnostic (CDx) tests, such as the Oncomine Dx Target Test by Thermo Fisher Scientific Inc., designed to detect HER2 (ERBB2) activating mutations in non-small cell lung cancer. However, the COVID-19 pandemic initially reduced demand for companion diagnostics products, delaying novel diagnostic tests. Despite this, the global companion diagnostics market is expected to recover and expand significantly during the forecast period.
Global Companion Diagnostics Market Trends
Several trends and developments are being observed in the market to enhance the current situation. Some of the noteworthy trends are as follows:
Expanding Indications
The market is broadening beyond oncology to include neurological, cardiovascular, and infectious diseases. Regulatory approvals for new indications enable the development of biomarker-driven therapies, improving patient outcomes. This trend enhances diagnostic applications, supporting pharmaceutical innovations and expanding the market’s potential across diverse therapeutic areas.
Focus on Precision Medicine
The shift towards precision medicine is driving the demand for companion diagnostics, ensuring targeted drug selection. Advances in genomic profiling allow for personalised treatment plans, reducing adverse reactions and enhancing efficacy. Pharmaceutical companies increasingly integrate biomarker-based diagnostics to develop tailored therapies, improving patient care and optimising treatment strategies.
Rising Healthcare Expenditures
Increasing healthcare investments globally support the growth of companion diagnostics, with governments and private entities funding research and development. The demand for early disease detection and advanced diagnostics drives higher spending, ensuring improved diagnostic capabilities and expanding access to innovative treatments, particularly in emerging economies.
Advancements in Technologies
Cutting-edge technologies like next-generation sequencing (NGS), artificial intelligence (AI), and digital pathology enhance the efficiency of companion diagnostics. Automated platforms enable faster, more accurate biomarker detection, supporting precision medicine. Continuous innovation in diagnostic tools strengthens the market, improving patient outcomes through highly specialised, data-driven diagnostics.
Companion Diagnostics Market Growth Factors
Rising Cancer Incidence to Drive the Demand for Companion Diagnostics
The increasing global burden of cancer is a key factor propelling the growth of the companion diagnostics market. According to the American Cancer Society, cancer cases are projected to reach 35 million by 2050, primarily due to population growth and ageing demographics. This surge in cases necessitates advanced diagnostic solutions for early detection, effective treatment, and improved patient outcomes. Companion diagnostics play a crucial role in guiding targeted therapies, ensuring personalised treatment strategies, and enhancing the efficacy of cancer therapies.
Additionally, technological advancements such as next-generation sequencing (NGS) and liquid biopsy techniques have further bolstered market expansion. These innovations facilitate rapid genetic profiling, helping oncologists identify specific biomarkers associated with different cancer types. The rising adoption of precision medicine by healthcare providers and pharmaceutical companies is also a significant growth driver. As demand for customised cancer treatments increases, the market for companion diagnostics is expected to expand rapidly.
Regulatory Approvals for Novel Diagnostic Tests to Fuel Market Expansion
The approval of new companion diagnostic tests for various indications is another critical factor driving market growth. Regulatory bodies such as the U.S. FDA, European Medicines Agency (EMA), and other global health authorities continue to approve innovative diagnostic solutions for targeted therapies. These approvals validate the clinical efficacy of companion diagnostics, increasing their adoption across healthcare facilities. The expanding pipeline of biomarker-driven therapies further encourages diagnostic companies to develop novel tests, contributing to overall market expansion.
Moreover, regulatory support ensures that new diagnostics meet stringent safety and accuracy standards, enhancing physician confidence in their effectiveness. Recent approvals of companion diagnostic assays for lung, breast, and colorectal cancers have provided patients with access to personalised treatment options. As pharmaceutical firms continue to collaborate with diagnostic developers, the market is poised for sustained growth, driven by innovation and regulatory advancements.
Restraining Factors
Challenges in Reimbursement Policies and Strict Regulatory Requirements Hindering Market Growth
The companion diagnostics market faces significant challenges due to complex reimbursement policies. Many healthcare systems lack well-defined reimbursement frameworks for companion diagnostic tests, making it difficult for patients and healthcare providers to afford these tests. The high cost of developing and validating these diagnostics further complicates accessibility, limiting their widespread adoption. Additionally, variations in reimbursement policies across different countries create inconsistencies in market growth.
Stringent regulatory requirements act as another major barrier, as companion diagnostics must undergo rigorous approval processes to ensure accuracy and efficacy. Regulatory bodies such as the U.S. FDA, EMA, and other global agencies enforce strict guidelines, leading to prolonged approval timelines. Compliance with these complex regulations requires substantial investment and expertise, delaying market entry for new players.
The high cost of companion diagnostics is another critical factor restricting market expansion. Next-generation sequencing (NGS) and polymerase chain reaction (PCR) technologies involve expensive equipment and specialised expertise, making these diagnostics unaffordable for many healthcare institutions. The financial burden on smaller laboratories and emerging markets further limits accessibility, restricting the overall growth of the market.
Furthermore, limited awareness and adoption rates in developing regions pose additional challenges. A lack of trained professionals, inadequate infrastructure, and limited integration of precision medicine hinder the widespread implementation of companion diagnostics. Addressing these barriers requires increased investment in education, regulatory simplifications, and improved reimbursement models to unlock the market’s full potential.
Companion Diagnostics Market Segmentation Analysis
By Technology Analysis
Polymerase Chain Reaction Segment Leads with New Product Launches and Regulatory Approvals
The companion diagnostics market is driven by advancements in key technologies, with polymerase chain reaction (PCR) and next-generation sequencing (NGS) leading the segment. PCR remains a widely used technique due to its high sensitivity and ability to detect specific genetic mutations, making it essential for targeted therapies. Meanwhile, NGS is revolutionising the field by offering comprehensive genomic profiling, allowing for precise identification of mutations across multiple genes in a single test. The growing adoption of NGS-based companion diagnostics is driven by increasing demand for personalised medicine and its ability to enhance treatment selection for cancer and genetic disorders._x000D_
Other technologies such as in-situ hybridisation (ISH) and immunohistochemistry (IHC) play a crucial role in biomarker detection. In-situ hybridisation is particularly valuable for identifying chromosomal abnormalities, while immunohistochemistry is commonly used to detect protein expressions in tissue samples. The expanding role of these technologies, along with emerging innovations, is expected to strengthen the companion diagnostics market.
By Indication Analysis
Rising Cancer Cases and Technological Innovations Drive Segment Dominance
Cancer is expected to lead the market share based on indications. Lung cancer constitutes for a significant share of overall cancer cases, thus, leading to increased adoption of targeted therapies. Biomarker tests for EGFR, ALK, and PD-L1 improve treatment decisions and outcomes. Breast cancer also holds a significant share, driven by HER2, BRCA1/2, and PIK3CA testing, supporting personalised treatments and boosting demand for emerging targeted drugs.
The use of companion diagnostics is on the rise, driven by the rising incidence of colorectal cancer, with KRAS, NRAS, and BRAF mutation tests guiding therapy selection. Additionally, ovarian, prostate, and gastric cancers are adopting biomarker-based diagnostics, broadening market opportunities. Advancements in novel biomarkers continue to enhance precision medicine across oncology.
By End-user Analysis
Strategic Collaborations Boost Market Share of Pharmaceutical and Biopharmaceutical Companies
Pharmaceutical and biopharmaceutical companies are expected to dominate the companion diagnostics market, leveraging strategic collaborations to enhance drug development. They invest in companion diagnostics to improve treatment efficacy and secure regulatory approvals, driving precision medicine adoption.
Reference laboratories and CROs support biomarker testing and diagnostic validation. Academic institutions and specialty diagnostic centres aid clinical trials and biomarker research, accelerating global companion diagnostics adoption.
Regional Insights
North America dominates the companion diagnostics market due to high adoption of precision medicine, strong regulatory support, and major pharmaceutical collaborations. For instance, in January 2025, Foundation Medicine, Inc. secured FDA approval for FoundationOne® CDx as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA. This approval marks a significant advancement in treating pediatric low-grade glioma (pLGG).
Europe holds a significant market share, supported by regulatory advancements and expanding clinical applications. Germany, France, and the UK are investing in molecular diagnostics. For instance, in March 2025, Agilent Technologies Inc. announced that its PD-L1 IHC 28-8 pharmDx kit received two new companion diagnostic indications under EU IVDR, expanding treatment eligibility for non-small cell lung cancer (NSCLC) and advanced melanoma.
The Asia Pacific region is experiencing rapid growth due to increasing cancer prevalence and rising healthcare investments. For instance, in March 2024, Chugai Pharmaceutical Co., Ltd. received approval from Japan's MHLW for FoundationOne® CDx Cancer Genomic Profile as a companion diagnostic for AstraZeneca K.K.'s Truqap (capivasertib) with Faslodex (fulvestrant) in treating HR-positive, HER2-negative breast cancer with specific genetic alterations.
The companion diagnostics market in Latin America, the Middle East, and Africa is gradually expanding due to improving healthcare infrastructure. Brazil, Mexico, and South Africa are key markets, but regulatory challenges and high costs hinder adoption. However, government initiatives and global partnerships aim to improve diagnostic access, supporting market growth.
List of Key Companies in Companion Diagnostics Market
The key features of the market report comprise patent analysis, grants analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
F. Hoffmann-La Roche Ltd
F. Hoffmann-La Roche Ltd is a global leader in pharmaceuticals and diagnostics, pioneering personalised healthcare solutions. Its companion diagnostics portfolio, including tissue-based and molecular assays, enhances targeted therapy selection. Roche collaborates with pharmaceutical firms to develop advanced diagnostic tools, improving precision medicine and patient outcomes in oncology and other therapeutic areas.
Agilent Technologies, Inc.
Agilent Technologies, Inc. specialises in life sciences, diagnostics, and applied chemical markets, offering innovative companion diagnostic solutions. Its high-performance instruments, assays, and genomic technologies support biomarker identification and drug development. Agilent partners with pharmaceutical companies to develop regulatory-approved diagnostic assays, improving targeted therapies and precision medicine in oncology and other critical disease areas.
QIAGEN
QIAGEN is a global provider of molecular diagnostics and sample preparation technologies, advancing companion diagnostics in oncology and genetic diseases. The company develops PCR-based and next-generation sequencing (NGS) assays for biomarker detection. Partnering with pharmaceutical firms, QIAGEN enables personalised treatment strategies, accelerating drug approvals and enhancing patient-specific therapeutic decisions.
Thermo Fisher Scientific Inc.
Thermo Fisher Scientific Inc. is a leader in life sciences and diagnostics, offering advanced solutions for companion diagnostics. Its portfolio includes NGS, PCR, and immunohistochemistry-based assays, aiding targeted therapy selection. Through strategic collaborations, Thermo Fisher supports pharmaceutical innovation, enabling precision medicine advancements in oncology and rare genetic disorders.
Other companies in the market include Abbott, Illumina, Inc., Guardant Health, Myriad Genetics, Inc., and BIOMERIEUX.
Key Industry Developments
Companion Diagnostics Market Report and Forecast 2025-2034 offers a detailed analysis of the market based on the following segments:
Market Breakup by Offerings
The global companion diagnostics market is witnessing robust growth due to advancements in precision medicine and increasing demand for targeted therapies. Rising cancer prevalence, the need for biomarker-based diagnostics, and regulatory support for new test approvals drive market expansion. Moreover, the growing adoption of next-generation sequencing (NGS) and polymerase chain reaction (PCR) technologies further enhances diagnostic accuracy, enabling personalised treatment strategies.
Companion Diagnostic Overview
Companion diagnostic tests help in the diagnosis of diseases and determines the most effective drug for a specific patient. These tests are crucial in cancer treatment, identifying biomarkers that indicate a patient’s suitability for individualised treatment. Pharmaceutical companies integrate companion diagnostics into drug development to enhance efficacy, ensuring that only patients most likely to benefit receive targeted therapies.
Market Drivers and Adoption Trends
The companion diagnostic market is expanding due to rising demand for precision cancer treatments. Companies like Foundation Medicine lead innovations with products like FOUNDATIONONE CDx, which analyses cancer-related genes in solid tumors. Increasing regulatory approvals and advancements in companion diagnostic tests further support market growth. The rising prevalence of cancer has prompted greater adoption of companion diagnostics, ensuring effective treatment selection.
Regulatory Approvals and COVID-19 Impact
The U.S. FDA is approving novel companion diagnostic (CDx) tests, such as the Oncomine Dx Target Test by Thermo Fisher Scientific Inc., designed to detect HER2 (ERBB2) activating mutations in non-small cell lung cancer. However, the COVID-19 pandemic initially reduced demand for companion diagnostics products, delaying novel diagnostic tests. Despite this, the global companion diagnostics market is expected to recover and expand significantly during the forecast period.
Global Companion Diagnostics Market Trends
Several trends and developments are being observed in the market to enhance the current situation. Some of the noteworthy trends are as follows:
Expanding Indications
The market is broadening beyond oncology to include neurological, cardiovascular, and infectious diseases. Regulatory approvals for new indications enable the development of biomarker-driven therapies, improving patient outcomes. This trend enhances diagnostic applications, supporting pharmaceutical innovations and expanding the market’s potential across diverse therapeutic areas.
Focus on Precision Medicine
The shift towards precision medicine is driving the demand for companion diagnostics, ensuring targeted drug selection. Advances in genomic profiling allow for personalised treatment plans, reducing adverse reactions and enhancing efficacy. Pharmaceutical companies increasingly integrate biomarker-based diagnostics to develop tailored therapies, improving patient care and optimising treatment strategies.
Rising Healthcare Expenditures
Increasing healthcare investments globally support the growth of companion diagnostics, with governments and private entities funding research and development. The demand for early disease detection and advanced diagnostics drives higher spending, ensuring improved diagnostic capabilities and expanding access to innovative treatments, particularly in emerging economies.
Advancements in Technologies
Cutting-edge technologies like next-generation sequencing (NGS), artificial intelligence (AI), and digital pathology enhance the efficiency of companion diagnostics. Automated platforms enable faster, more accurate biomarker detection, supporting precision medicine. Continuous innovation in diagnostic tools strengthens the market, improving patient outcomes through highly specialised, data-driven diagnostics.
Companion Diagnostics Market Growth Factors
Rising Cancer Incidence to Drive the Demand for Companion Diagnostics
The increasing global burden of cancer is a key factor propelling the growth of the companion diagnostics market. According to the American Cancer Society, cancer cases are projected to reach 35 million by 2050, primarily due to population growth and ageing demographics. This surge in cases necessitates advanced diagnostic solutions for early detection, effective treatment, and improved patient outcomes. Companion diagnostics play a crucial role in guiding targeted therapies, ensuring personalised treatment strategies, and enhancing the efficacy of cancer therapies.
Additionally, technological advancements such as next-generation sequencing (NGS) and liquid biopsy techniques have further bolstered market expansion. These innovations facilitate rapid genetic profiling, helping oncologists identify specific biomarkers associated with different cancer types. The rising adoption of precision medicine by healthcare providers and pharmaceutical companies is also a significant growth driver. As demand for customised cancer treatments increases, the market for companion diagnostics is expected to expand rapidly.
Regulatory Approvals for Novel Diagnostic Tests to Fuel Market Expansion
The approval of new companion diagnostic tests for various indications is another critical factor driving market growth. Regulatory bodies such as the U.S. FDA, European Medicines Agency (EMA), and other global health authorities continue to approve innovative diagnostic solutions for targeted therapies. These approvals validate the clinical efficacy of companion diagnostics, increasing their adoption across healthcare facilities. The expanding pipeline of biomarker-driven therapies further encourages diagnostic companies to develop novel tests, contributing to overall market expansion.
Moreover, regulatory support ensures that new diagnostics meet stringent safety and accuracy standards, enhancing physician confidence in their effectiveness. Recent approvals of companion diagnostic assays for lung, breast, and colorectal cancers have provided patients with access to personalised treatment options. As pharmaceutical firms continue to collaborate with diagnostic developers, the market is poised for sustained growth, driven by innovation and regulatory advancements.
Restraining Factors
Challenges in Reimbursement Policies and Strict Regulatory Requirements Hindering Market Growth
The companion diagnostics market faces significant challenges due to complex reimbursement policies. Many healthcare systems lack well-defined reimbursement frameworks for companion diagnostic tests, making it difficult for patients and healthcare providers to afford these tests. The high cost of developing and validating these diagnostics further complicates accessibility, limiting their widespread adoption. Additionally, variations in reimbursement policies across different countries create inconsistencies in market growth.
Stringent regulatory requirements act as another major barrier, as companion diagnostics must undergo rigorous approval processes to ensure accuracy and efficacy. Regulatory bodies such as the U.S. FDA, EMA, and other global agencies enforce strict guidelines, leading to prolonged approval timelines. Compliance with these complex regulations requires substantial investment and expertise, delaying market entry for new players.
The high cost of companion diagnostics is another critical factor restricting market expansion. Next-generation sequencing (NGS) and polymerase chain reaction (PCR) technologies involve expensive equipment and specialised expertise, making these diagnostics unaffordable for many healthcare institutions. The financial burden on smaller laboratories and emerging markets further limits accessibility, restricting the overall growth of the market.
Furthermore, limited awareness and adoption rates in developing regions pose additional challenges. A lack of trained professionals, inadequate infrastructure, and limited integration of precision medicine hinder the widespread implementation of companion diagnostics. Addressing these barriers requires increased investment in education, regulatory simplifications, and improved reimbursement models to unlock the market’s full potential.
Companion Diagnostics Market Segmentation Analysis
By Technology Analysis
Polymerase Chain Reaction Segment Leads with New Product Launches and Regulatory Approvals
The companion diagnostics market is driven by advancements in key technologies, with polymerase chain reaction (PCR) and next-generation sequencing (NGS) leading the segment. PCR remains a widely used technique due to its high sensitivity and ability to detect specific genetic mutations, making it essential for targeted therapies. Meanwhile, NGS is revolutionising the field by offering comprehensive genomic profiling, allowing for precise identification of mutations across multiple genes in a single test. The growing adoption of NGS-based companion diagnostics is driven by increasing demand for personalised medicine and its ability to enhance treatment selection for cancer and genetic disorders._x000D_
Other technologies such as in-situ hybridisation (ISH) and immunohistochemistry (IHC) play a crucial role in biomarker detection. In-situ hybridisation is particularly valuable for identifying chromosomal abnormalities, while immunohistochemistry is commonly used to detect protein expressions in tissue samples. The expanding role of these technologies, along with emerging innovations, is expected to strengthen the companion diagnostics market.
By Indication Analysis
Rising Cancer Cases and Technological Innovations Drive Segment Dominance
Cancer is expected to lead the market share based on indications. Lung cancer constitutes for a significant share of overall cancer cases, thus, leading to increased adoption of targeted therapies. Biomarker tests for EGFR, ALK, and PD-L1 improve treatment decisions and outcomes. Breast cancer also holds a significant share, driven by HER2, BRCA1/2, and PIK3CA testing, supporting personalised treatments and boosting demand for emerging targeted drugs.
The use of companion diagnostics is on the rise, driven by the rising incidence of colorectal cancer, with KRAS, NRAS, and BRAF mutation tests guiding therapy selection. Additionally, ovarian, prostate, and gastric cancers are adopting biomarker-based diagnostics, broadening market opportunities. Advancements in novel biomarkers continue to enhance precision medicine across oncology.
By End-user Analysis
Strategic Collaborations Boost Market Share of Pharmaceutical and Biopharmaceutical Companies
Pharmaceutical and biopharmaceutical companies are expected to dominate the companion diagnostics market, leveraging strategic collaborations to enhance drug development. They invest in companion diagnostics to improve treatment efficacy and secure regulatory approvals, driving precision medicine adoption.
Reference laboratories and CROs support biomarker testing and diagnostic validation. Academic institutions and specialty diagnostic centres aid clinical trials and biomarker research, accelerating global companion diagnostics adoption.
Regional Insights
North America dominates the companion diagnostics market due to high adoption of precision medicine, strong regulatory support, and major pharmaceutical collaborations. For instance, in January 2025, Foundation Medicine, Inc. secured FDA approval for FoundationOne® CDx as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA. This approval marks a significant advancement in treating pediatric low-grade glioma (pLGG).
Europe holds a significant market share, supported by regulatory advancements and expanding clinical applications. Germany, France, and the UK are investing in molecular diagnostics. For instance, in March 2025, Agilent Technologies Inc. announced that its PD-L1 IHC 28-8 pharmDx kit received two new companion diagnostic indications under EU IVDR, expanding treatment eligibility for non-small cell lung cancer (NSCLC) and advanced melanoma.
The Asia Pacific region is experiencing rapid growth due to increasing cancer prevalence and rising healthcare investments. For instance, in March 2024, Chugai Pharmaceutical Co., Ltd. received approval from Japan's MHLW for FoundationOne® CDx Cancer Genomic Profile as a companion diagnostic for AstraZeneca K.K.'s Truqap (capivasertib) with Faslodex (fulvestrant) in treating HR-positive, HER2-negative breast cancer with specific genetic alterations.
The companion diagnostics market in Latin America, the Middle East, and Africa is gradually expanding due to improving healthcare infrastructure. Brazil, Mexico, and South Africa are key markets, but regulatory challenges and high costs hinder adoption. However, government initiatives and global partnerships aim to improve diagnostic access, supporting market growth.
List of Key Companies in Companion Diagnostics Market
The key features of the market report comprise patent analysis, grants analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
F. Hoffmann-La Roche Ltd
F. Hoffmann-La Roche Ltd is a global leader in pharmaceuticals and diagnostics, pioneering personalised healthcare solutions. Its companion diagnostics portfolio, including tissue-based and molecular assays, enhances targeted therapy selection. Roche collaborates with pharmaceutical firms to develop advanced diagnostic tools, improving precision medicine and patient outcomes in oncology and other therapeutic areas.
Agilent Technologies, Inc.
Agilent Technologies, Inc. specialises in life sciences, diagnostics, and applied chemical markets, offering innovative companion diagnostic solutions. Its high-performance instruments, assays, and genomic technologies support biomarker identification and drug development. Agilent partners with pharmaceutical companies to develop regulatory-approved diagnostic assays, improving targeted therapies and precision medicine in oncology and other critical disease areas.
QIAGEN
QIAGEN is a global provider of molecular diagnostics and sample preparation technologies, advancing companion diagnostics in oncology and genetic diseases. The company develops PCR-based and next-generation sequencing (NGS) assays for biomarker detection. Partnering with pharmaceutical firms, QIAGEN enables personalised treatment strategies, accelerating drug approvals and enhancing patient-specific therapeutic decisions.
Thermo Fisher Scientific Inc.
Thermo Fisher Scientific Inc. is a leader in life sciences and diagnostics, offering advanced solutions for companion diagnostics. Its portfolio includes NGS, PCR, and immunohistochemistry-based assays, aiding targeted therapy selection. Through strategic collaborations, Thermo Fisher supports pharmaceutical innovation, enabling precision medicine advancements in oncology and rare genetic disorders.
Other companies in the market include Abbott, Illumina, Inc., Guardant Health, Myriad Genetics, Inc., and BIOMERIEUX.
Key Industry Developments
- In October 2024, Roche secured FDA approval for its VENTANA® Claudin 18 (43-14A) RxDx Assay, making it the first immunohistochemistry (IHC) companion diagnostic for CLDN18 protein expression in gastric and gastroesophageal junction adenocarcinoma patients. This breakthrough enabled eligible patients to receive Astellas’ targeted therapy VYLOY® (zolbetuximab), enhancing treatment precision in gastrointestinal cancers.
- In August 2024, Illumina, Inc. announced FDA approval of its TruSight™ Oncology (TSO) Comprehensive test, a single in vitro diagnostic (IVD) that can profile over 500 genes in solid tumors. This test is designed to identify both adult and pediatric patients with solid tumors that have neurotrophic tyrosine receptor kinase (NTRK) gene fusions. If the test detects this, the patient may benefit from Bayer’s VITRAKVI® (larotrectinib). The test is also approved for identifying adult patients with advanced or metastatic non-small-cell lung cancer (NSCLC) that has rearranged during transfection (RET) gene fusions. These patients may benefit from treatment with Lilly’s RETEVMO® (selpercatinib).
- In August 2024, QIAGEN expanded its collaboration with AstraZeneca to develop companion diagnostics (CDx) for chronic diseases. Using QIAGEN’s QIAstat-Dx platform, the partnership aimed at create a genotyping assay that facilitates real-time patient screening, helping healthcare providers determine patient eligibility for AstraZeneca’s genomically targeted medicines, ultimately improving treatment accessibility and clinical decision-making.
- In July 2024, BD and Quest Diagnostics entered a global collaboration to develop flow cytometry-based companion diagnostics (CDx) for cancer and other diseases. This partnership aimed at providing an end-to-end CDx solution pharmaceutical companies. It ranged from exploratory panel development to FDA-approved diagnostic kit distribution, so as to advance precision medicine for better treatment selection.
- In April 2024, Labcorp announced FDA approval for its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic for Pfizer’s gene therapy, BEQVEZ™ (fidanacogene elaparvovec-dzkt). This neutralizing antibody assay ensures patients undergoing hemophilia B treatment are pre-screened for preexisting antibodies, helping optimise treatment safety and efficacy for gene therapy candidates.
- In February 2024, Roche partnered with PathAI to expand digital pathology capabilities for companion diagnostics. This collaboration aimed at integrating AI-powered digital pathology algorithms with Roche Tissue Diagnostics. It also intended to enhance precision medicine in cancer treatment by enabling more accurate biomarker identification and targeted therapy selection.
- In January 2024, Agilent Technologies joined forces with Incyte to advance companion diagnostics in oncology and haematology. The partnership combined Agilent’s expertise in in-vitro diagnostic assays with Incyte’s therapeutic innovations, enhancing targeted treatment options and improving patient outcomes in precision medicine.
- In October 2023, QIAGEN and Myriad Genetics collaborated to develop advanced companion diagnostics for personalised cancer treatments. By leveraging next-generation sequencing and QIAGEN’s digital PCR platform, QIAcuity, the partnership aimed at creating cutting-edge diagnostic assays for multiple cancer types, thus, improving targeted therapy selection and patient outcomes.
Companion Diagnostics Market Report and Forecast 2025-2034 offers a detailed analysis of the market based on the following segments:
Market Breakup by Offerings
- Products
- Assays, Kits and Reagents
- Instruments & Systems
- Software
- Services
- Polymerase Chain Reaction
- Immunohistochemistry
- In Situ Hybridization
- Next-Generation Sequencing
- Others
- Cancer
- Neurological Diseases
- Infectious Diseases
- Others
- Pharmaceutical & Biopharmaceutical Companies
- Reference Laboratories
- Contract Research Organizations
- Others
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa
Table of Contents
400 Pages
- 1 Preface
- 1.1 Objectives of the Study
- 1.2 Key Assumptions
- 1.3 Report Coverage – Key Segmentation and Scope
- 1.4 Research Methodology
- 2 Executive Summary
- 3 Global Companion Diagnostics Market Overview
- 3.1 Global Companion Diagnostics Market Historical Value (2018-2024)
- 3.2 Global Companion Diagnostics Market Forecast Value (2025-2034)
- 4 Vendor Positioning Analysis
- 4.1 Key Vendors
- 4.2 Prospective Leaders
- 4.3 Niche Leaders
- 4.4 Disruptors
- 5 Global Companion Diagnostics Market Landscape*
- 5.1 Global Companion Diagnostics Market: Developers Landscape
- 5.1.1 Analysis by Year of Establishment
- 5.1.2 Analysis by Company Size
- 5.1.3 Analysis by Region
- 5.2 Global Companion Diagnostics Market: Product Landscape
- 5.2.1 Analysis by Offerings
- 5.2.2 Analysis by Indication
- 6 Global Companion Diagnostics Market Dynamics
- 6.1 Market Drivers and Constraints
- 6.2 SWOT Analysis
- 6.2.1 Strengths
- 6.2.2 Weaknesses
- 6.2.3 Opportunities
- 6.2.4 Threats
- 6.3 PESTEL Analysis
- 6.3.1 Political
- 6.3.2 Economic
- 6.3.3 Social
- 6.3.4 Technological
- 6.3.5 Legal
- 6.3.6 Environment
- 6.4 Porter’s Five Forces Model
- 6.4.1 Bargaining Power of Suppliers
- 6.4.2 Bargaining Power of Buyers
- 6.4.3 Threat of New Entrants
- 6.4.4 Threat of Substitutes
- 6.4.5 Degree of Rivalry
- 6.5 Key Demand Indicators
- 6.6 Key Price Indicators
- 6.7 Industry Events, Initiatives, and Trends
- 6.8 Value Chain Analysis
- 7 Global Companion Diagnostics Market Segmentation (218-2034)
- 7.1 Global Companion Diagnostics Market (2018-2034) by Offerings
- 7.1.1 Market Overview
- 7.1.2 Products
- 7.1.2.1 Assays, Kits and Reagents
- 7.1.2.2 Instruments & Systems
- 7.1.3 Software
- 7.1.4 Services
- 7.2 Global Companion Diagnostics Market (2018-2034) by Technology
- 7.2.1 Market Overview
- 7.2.2 Polymerase Chain Reaction
- 7.2.3 Immunohistochemistry
- 7.2.4 In-situ Hybridization
- 7.2.5 Next Generation Gene Sequencing
- 7.2.6 Others
- 7.3 Global Companion Diagnostics Market (2018-2034) by Indication
- 7.3.1 Market Overview
- 7.3.2 Cancer
- 7.3.3 Neurological Diseases
- 7.3.4 Infectious Diseases
- 7.3.5 Others
- 7.4 Global Companion Diagnostics Market (2018-2034) by End User
- 7.4.1 Market Overview
- 7.4.2 Pharmaceutical & Biopharmaceutical Companies
- 7.4.3 Reference Laboratories
- 7.4.4 Contract Research Organizations (CROs)
- 7.4.5 Others
- 7.5 Global Companion Diagnostics Market (2018-2034) by Region
- 7.5.1 Market Overview
- 7.5.2 North America
- 7.5.3 Europe
- 7.5.4 Asia Pacific
- 7.5.5 Latin America
- 7.5.6 Middle East and Africa
- 8 North America Companion Diagnostics Market (218-2034)
- 8.1 North America Companion Diagnostics Market (2018-2034) by Offerings
- 8.1.1 Market Overview
- 8.1.2 Products
- 8.1.2.1 Assays, Kits and Reagents
- 8.1.2.2 Instruments & Systems
- 8.1.3 Software
- 8.1.4 Services
- 8.2 North America Companion Diagnostics Market (2018-2034) by Technology
- 8.2.1 Market Overview
- 8.2.2 Polymerase Chain Reaction
- 8.2.3 Immunohistochemistry
- 8.2.4 In-situ Hybridization
- 8.2.5 Next Generation Gene Sequencing
- 8.2.6 Others
- 8.3 North America Companion Diagnostics Market (2018-2034) by Indication
- 8.3.1 Market Overview
- 8.3.2 Cancer
- 8.3.3 Neurological Diseases
- 8.3.4 Infectious Diseases
- 8.3.5 Others
- 8.4 North America Companion Diagnostics Market (2018-2034) by End User
- 8.4.1 Market Overview
- 8.4.2 Pharmaceutical & Biopharmaceutical Companies
- 8.4.3 Reference Laboratories
- 8.4.4 Contract Research Organizations (CROs)
- 8.4.5 Others
- 8.5 North America Companion Diagnostics Market (2018-2034) by Country
- 8.5.1 United States of America
- 8.5.1.1 United States of America Companion Diagnostics Market (2018-2034) by Offerings
- 8.5.2 Canada
- 8.5.2.1 Canada Companion Diagnostics Market (2018-2034) by Offerings
- 9 Europe Companion Diagnostics Market (218-2034)
- 9.1 Europe Companion Diagnostics Market (2018-2034) by Offerings
- 9.1.1 Market Overview
- 9.1.2 Products
- 9.1.2.1 Assays, Kits and Reagents
- 9.1.2.2 Instruments & Systems
- 9.1.3 Software
- 9.1.4 Services
- 9.2 Europe Companion Diagnostics Market (2018-2034) by Technology
- 9.2.1 Market Overview
- 9.2.2 Polymerase Chain Reaction
- 9.2.3 Immunohistochemistry
- 9.2.4 In-situ Hybridization
- 9.2.5 Next Generation Gene Sequencing
- 9.2.6 Others
- 9.3 Europe Companion Diagnostics Market (2018-2034) by Indication
- 9.3.1 Market Overview
- 9.3.2 Cancer
- 9.3.3 Neurological Diseases
- 9.3.4 Infectious Diseases
- 9.3.5 Others
- 9.4 Europe Companion Diagnostics Market (2018-2034) by End User
- 9.4.1 Market Overview
- 9.4.2 Pharmaceutical & Biopharmaceutical Companies
- 9.4.3 Reference Laboratories
- 9.4.4 Contract Research Organizations (CROs)
- 9.4.5 Others
- 9.5 Europe Companion Diagnostics Market (2018-2034) by Country
- 9.5.1 United Kingdom
- 9.5.1.1 United Kingdom Companion Diagnostics Market (2018-2034) by Offerings
- 9.5.2 Germany
- 9.5.2.1 Germany Companion Diagnostics Market (2018-2034) by Offerings
- 9.5.3 France
- 9.5.3.1 France Companion Diagnostics Market (2018-2034) by Offerings
- 9.5.4 Italy
- 9.5.4.1 Italy Companion Diagnostics Market (2018-2034) by Offerings
- 9.5.5 Others
- 10 Asia Pacific Companion Diagnostics Market (218-2034)
- 10.1 Asia Pacific Companion Diagnostics Market (2018-2034) by Offerings
- 10.1.1 Market Overview
- 10.1.2 Products
- 10.1.2.1 Assays, Kits and Reagents
- 10.1.2.2 Instruments & Systems
- 10.1.3 Software
- 10.1.4 Services
- 10.2 Asia Pacific Companion Diagnostics Market (2018-2034) by Technology
- 10.2.1 Market Overview
- 10.2.2 Polymerase Chain Reaction
- 10.2.3 Immunohistochemistry
- 10.2.4 In-situ Hybridization
- 10.2.5 Next Generation Gene Sequencing
- 10.2.6 Others
- 10.3 Asia Pacific Companion Diagnostics Market (2018-2034) by Indication
- 10.3.1 Market Overview
- 10.3.2 Cancer
- 10.3.3 Neurological Diseases
- 10.3.4 Infectious Diseases
- 10.3.5 Others
- 10.4 Asia Pacific Companion Diagnostics Market (2018-2034) by End User
- 10.4.1 Market Overview
- 10.4.2 Pharmaceutical & Biopharmaceutical Companies
- 10.4.3 Reference Laboratories
- 10.4.4 Contract Research Organizations (CROs)
- 10.4.5 Others
- 10.5 Asia Pacific Companion Diagnostics Market (2018-2034) by Country
- 10.5.1 China
- 10.5.1.1 China Companion Diagnostics Market (2018-2034) by Offerings
- 10.5.2 Japan
- 10.5.2.1 Japan Companion Diagnostics Market (2018-2034) by Offerings
- 10.5.3 India
- 10.5.3.1 India Companion Diagnostics Market (2018-2034) by Offerings
- 10.5.4 ASEAN
- 10.5.4.1 ASEAN Companion Diagnostics Market (2018-2034) by Offerings
- 10.5.5 Australia
- 10.5.5.1 Australia Companion Diagnostics Market (2018-2034) by Offerings
- 10.5.6 Others
- 11 Latin America Companion Diagnostics Market (218-2034)
- 11.1 Latin America Companion Diagnostics Market (2018-2034) by Offerings
- 11.1.1 Market Overview
- 11.1.2 Products
- 11.1.2.1 Assays, Kits and Reagents
- 11.1.2.2 Instruments & Systems
- 11.1.3 Software
- 11.1.4 Services
- 11.2 Latin America Companion Diagnostics Market (2018-2034) by Technology
- 11.2.1 Market Overview
- 11.2.2 Polymerase Chain Reaction
- 11.2.3 Immunohistochemistry
- 11.2.4 In-situ Hybridization
- 11.2.5 Next Generation Gene Sequencing
- 11.2.6 Others
- 11.3 Latin America Companion Diagnostics Market (2018-2034) by Indication
- 11.3.1 Market Overview
- 11.3.2 Cancer
- 11.3.3 Neurological Diseases
- 11.3.4 Infectious Diseases
- 11.3.5 Others
- 11.4 Latin America Companion Diagnostics Market (2018-2034) by End User
- 11.4.1 Market Overview
- 11.4.2 Pharmaceutical & Biopharmaceutical Companies
- 11.4.3 Reference Laboratories
- 11.4.4 Contract Research Organizations (CROs)
- 11.4.5 Others
- 11.5 Latin America Companion Diagnostics Market (2018-2034) by Country
- 11.5.1 Brazil
- 11.5.1.1 Brazil Companion Diagnostics Market (2018-2034) by Offerings
- 11.5.2 Argentina
- 11.5.2.1 Argentina Companion Diagnostics Market (2018-2034) by Offerings
- 11.5.3 Mexico
- 11.5.3.1 Mexico Companion Diagnostics Market (2018-2034) by Offerings
- 11.5.4 Others
- 12 Middle East and Africa Companion Diagnostics Market (218-2034)
- 12.1 Middle East and Africa Companion Diagnostics Market (2018-2034) by Offerings
- 12.1.1 Market Overview
- 12.1.2 Products
- 12.1.2.1 Assays, Kits and Reagents
- 12.1.2.2 Instruments & Systems
- 12.1.3 Software
- 12.1.4 Services
- 12.2 Middle East and Africa Companion Diagnostics Market (2018-2034) by Technology
- 12.2.1 Market Overview
- 12.2.2 Polymerase Chain Reaction
- 12.2.3 Immunohistochemistry
- 12.2.4 In-situ Hybridization
- 12.2.5 Next Generation Gene Sequencing
- 12.2.6 Others
- 12.3 Middle East and Africa Companion Diagnostics Market (2018-2034) by Indication
- 12.3.1 Market Overview
- 12.3.2 Cancer
- 12.3.3 Neurological Diseases
- 12.3.4 Infectious Diseases
- 12.3.5 Others
- 12.4 Middle East and Africa Companion Diagnostics Market (2018-2034) by End User
- 12.4.1 Market Overview
- 12.4.2 Pharmaceutical & Biopharmaceutical Companies
- 12.4.3 Reference Laboratories
- 12.4.4 Contract Research Organizations (CROs)
- 12.4.5 Others
- 12.5 Middle East and Africa Companion Diagnostics Market (2018-2034) by Country
- 12.5.1 Saudi Arabia
- 12.5.1.1 Saudi Arabia Companion Diagnostics Market (2018-2034) by Offerings
- 12.5.2 United Arab Emirates
- 12.5.2.1 United Arab Emirates Companion Diagnostics Market (2018-2034) by Offerings
- 12.5.3 Nigeria
- 12.5.3.1 Nigeria Companion Diagnostics Market (2018-2034) by Offerings
- 12.5.4 South Africa
- 12.5.4.1 South Africa Companion Diagnostics Market (2018-2034) by Offerings
- 12.5.5 Others
- 13 Regulatory Framework
- 13.1 Regulatory Overview
- 13.2 US FDA
- 13.3 EU EMA
- 13.4 INDIA CDSCO
- 13.5 JAPAN PMDA
- 13.6 Others
- 14 Patent Analysis
- 14.1 Analysis by Type of Patent
- 14.2 Analysis by Publication Year
- 14.3 Analysis by Issuing Authority
- 14.4 Analysis by Patent Age
- 14.5 Analysis by CPC Analysis
- 14.6 Analysis by Patent Valuation
- 14.7 Analysis by Key Players
- 15 Funding and Investment Analysis
- 15.1 Analysis by Funding Instances
- 15.2 Analysis by Type of Funding
- 15.3 Analysis by Funding Amount
- 15.4 Analysis by Leading Players
- 15.5 Analysis by Leading Investors
- 15.6 Analysis by Geography
- 16 Strategic Initiatives
- 16.1 Analysis by Partnership Instances
- 16.2 Analysis by Type of Initiatives
- 16.3 Analysis by Joint Ventures
- 16.4 Analysis by Leading Players
- 16.5 Analysis by Geography
- 17 Supplier Landscape
- 17.1 Market Share Analysis, By Region (Top 5 Companies)
- 17.1.1 Market Share Analysis: Global
- 17.1.2 Market Share Analysis: North America
- 17.1.3 Market Share Analysis: Europe
- 17.1.4 Market Share Analysis: Asia Pacific
- 17.1.5 Market Share Analysis: Others
- 17.2 Abbott
- 17.2.1 Financial Analysis
- 17.2.2 Product Portfolio
- 17.2.3 Demographic Reach and Achievements
- 17.2.4 Company News and Development
- 17.2.5 Certifications
- 17.3 F. Hoffmann-La Roche Ltd.
- 17.3.1 Financial Analysis
- 17.3.2 Product Portfolio
- 17.3.3 Demographic Reach and Achievements
- 17.3.4 Company News and Development
- 17.3.5 Certifications
- 17.4 Agilent Technologies, Inc.
- 17.4.1 Financial Analysis
- 17.4.2 Product Portfolio
- 17.4.3 Demographic Reach and Achievements
- 17.4.4 Company News and Development
- 17.4.5 Certifications
- 17.5 Illumina, Inc.
- 17.5.1 Financial Analysis
- 17.5.2 Product Portfolio
- 17.5.3 Demographic Reach and Achievements
- 17.5.4 Company News and Development
- 17.5.5 Certifications
- 17.6 Guardant Health
- 17.6.1 Financial Analysis
- 17.6.2 Product Portfolio
- 17.6.3 Demographic Reach and Achievements
- 17.6.4 Company News and Development
- 17.6.5 Certifications
- 17.7 Thermo Fisher Scientific Inc.
- 17.7.1 Financial Analysis
- 17.7.2 Product Portfolio
- 17.7.3 Demographic Reach and Achievements
- 17.7.4 Company News and Development
- 17.7.5 Certifications
- 17.8 BIOMERIEUX
- 17.8.1 Financial Analysis
- 17.8.2 Product Portfolio
- 17.8.3 Demographic Reach and Achievements
- 17.8.4 Company News and Development
- 17.8.5 Certifications
- 17.9 QIAGEN
- 17.9.1 Financial Analysis
- 17.9.2 Product Portfolio
- 17.9.3 Demographic Reach and Achievements
- 17.9.4 Company News and Development
- 17.9.5 Certifications
- 17.10 Myriad Genetics, Inc.
- 17.10.1 Financial Analysis
- 17.10.2 Product Portfolio
- 17.10.3 Demographic Reach and Achievements
- 17.10.4 Company News and Development
- 17.10.5 Certifications
- 18 Global Companion Diagnostics Market – Distribution Model (Additional Insight)
- 18.1 Overview
- 18.2 Potential Distributors
- 18.3 Key Parameters for Distribution Partner Assessment
- 19 Key Opinion Leaders (KOL) Insights (Additional Insight)
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