Companion Diagnostics Market - By Product, By Disease Indication, By Technology, By End Use - Global Forecast, 2025 - 2034

Companion Diagnostics Market Size

The global companion diagnostics market size was estimated at USD 7.2 billion in 2024. The market is expected to grow from USD 7.9 billion in 2025 to USD 21.1 billion in 2034, growing at a CAGR of 11.5%, according to the latest report published by Global Market Insights Inc. The growth of the global market is largely influenced by the rising prevalence of cancer, growing incidences of adverse drug reactions, and the growth of precision medicine.

The market increased from USD 5.3 billion in 2021 to USD 6.5 billion in 2023. This growth was driven by the rising prevalence of cancer, which is a significant driver of growth in the companion diagnostics market. In 2020, cancer accounted for nearly 10 million deaths globally, with the most commonly diagnosed types being breast (2.26 million cases), lung (2.21 million), colorectal (1.93 million), prostate (1.41 million), non-melanoma skin (1.20 million), and stomach (1.09 million). These figures highlight the urgent need for more precise and effective treatment strategies. Companion diagnostics enable targeted therapy by identifying specific biomarkers, improving treatment outcomes, and minimizing adverse effects. As cancer cases continue to rise, healthcare systems and pharmaceutical companies are increasingly adopting companion diagnostics to personalize care and optimize therapeutic efficacy. The global cancer burden is accelerating demand for companion diagnostics.
 

Pharmaceutical companies are increasingly embedding companion diagnostics into their drug development strategies to improve precision and therapeutic success. This trend is supported by the rapid expansion of the global pharmaceutical R&D ecosystem. For instance, according to Statista, the global pharmaceutical R&D ecosystem grew from around 1,200 active firms in 2001 to over 6,800 by January 2025. The surge in innovation and pipeline activity has increased the need for tools that can identify responsive patient populations early in the development cycle. By integrating diagnostics with therapeutics, companies can reduce clinical trial failures, accelerate regulatory approvals, and enhance treatment outcomes. This rise in pharmaceutical R&D activity is fueling demand for companion diagnostics solutions, making them a strategic driver of innovation, efficiency, and market differentiation in drug development.
 

Companion diagnostics are specialized medical tests developed alongside targeted therapies to identify which patients are most likely to benefit from a specific treatment. They help determine the presence of biomarkers or genetic mutations that influence drug response. By guiding personalized treatment decisions, companion diagnostics improve efficacy, reduce adverse effects, and support precision medicine. These tools are essential in oncology, immunology, and other fields where tailored therapies are critical.
 

Companion Diagnostics Market Trends

• Adverse drug reactions (ADRs) are a growing concern in global healthcare, contributing significantly to patient morbidity, hospitalizations, and healthcare costs. As drug pipelines expand and treatment procedures become more complex, the risk of unintended side effects increases, especially in genetically diverse populations.
   
• For instance, according to the NIH, in 2022 alone, over 1.25 million serious adverse events were reported, including nearly 175,000 deaths. This alarming trend is driving demand for companion diagnostics, which help identify at-risk patients before treatment, enabling safer, more personalized therapies and reducing the likelihood of harmful outcomes.
   
• Companion diagnostics help mitigate this risk by identifying patients who are likely to respond negatively to specific drugs based on their genetic or molecular profiles. This enables clinicians to avoid prescribing ineffective or harmful treatments, improving patient safety and therapeutic outcomes.
   
• The rising awareness among healthcare providers and regulators about ADRs is driving demand for personalized medicine tools. By integrating diagnostics into treatment planning, pharmaceutical companies and hospitals reduce liability, improve drug efficacy, and enhance patient trust in new therapies.
   
• The increasing incidence of adverse drug reactions is accelerating the adoption of companion diagnostics, positioning them as essential tools for safer, more targeted, and cost-effective healthcare delivery.
   

Companion Diagnostics Market Analysis

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The global market was valued at USD 5.3 billion in 2021. The market size reached USD 6.5 billion in 2023, from USD 5.9 billion in 2022.
 

Based on the product, the market is segmented into consumables, instruments, and services. The consumables segment held a significant market share of 65.3% in 2024.
 

• Consumables are single-use materials and reagents such as test kits, assay reagents, cartridges, and sample preparation tools that are essential for running diagnostic tests.
   
• Consumables help the market grow due to their recurring demand in clinical workflows. Unlike instruments, which are one-time investments, consumables are required for each test, making them a consistent revenue stream for manufacturers and suppliers.
   
• Additionally, the growing volume of diagnostic testing, especially in oncology and personalized medicine, is also increasing demand for consumables. As more patients undergo biomarker-based screening, the need for reliable, high-quality consumables increases, driving market growth and innovation in assay development.
   
• Moreover, consumables enable faster turnaround times and standardized testing, which are critical for clinical decision-making. Their scalability and ease of integration into lab systems make them attractive for hospitals, diagnostic labs, and pharma companies.
   

Based on disease indication, the companion diagnostics market is segmented into breast cancer, lung cancer, colorectal cancer, skin cancer, other disease indications. The breast cancer was worth USD 2.3 billion in 2024.  
 

• Breast cancer remains one of the most commonly diagnosed cancers globally. This high prevalence has created a strong demand for early and accurate diagnostic tools that can guide personalized treatment decisions, especially for hormone receptor-positive and HER2-positive subtypes.
   
• For instance, according to WHO, in 2022, an estimated 2.3 million women were diagnosed with breast cancer, and 670,000 deaths occurred worldwide.
   
• As precision medicine becomes more mainstream, breast cancer continues to be a key application area for diagnostic innovation. The consistent testing volume, regulatory support, and pharma-diagnostic partnerships in this space are fueling market expansion and encouraging further investment in biomarker-driven solutions.
   
• The global burden of breast cancer is accelerating the adoption of companion diagnostics, positioning them as essential tools for personalized, effective, and scalable cancer care.
   

Based on technology, the companion diagnostics market is segmented into immunohistochemistry, in situ hybridization, polymerase chain reaction, genetic sequencing, and other technologies. The immunohistochemistry was worth USD 1.8 billion in 2024.  
 

• Immunohistochemistry is a laboratory technique used to detect specific antigens in tissue samples using antibodies. In the market, IHC is widely used to identify biomarkers that guide targeted cancer therapies, especially in breast, lung, and colorectal cancers.
   
• It helps clinicians determine whether a patient is eligible for specific treatments, such as HER2-targeted therapies in breast cancer, improving therapeutic outcomes and reducing unnecessary exposure to ineffective drugs.
   
• Its widespread adoption in pathology labs, ease of integration into clinical workflows, and relatively low cost per test make IHC a preferred technology. The consistent demand for IHC reagents and kits also supports recurring revenue for diagnostic companies.
   
• Immunohistochemistry remains a key technology segment in companion diagnostics, driving growth through its clinical relevance, scalability, and essential role in personalized cancer care.
   

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Based on end use, the companion diagnostics market is categorized into hospitals, diagnostic centers, and other end users. Among these, the hospitals segment dominated the market in 2024, accounting for 40.1% of the total market share. This dominance is projected to continue, with the segment expected to reach USD 8.2 billion by 2034.

• Hospitals are primary centers for administering advanced therapies, especially in oncology and chronic disease management. Their access to large patient populations and integrated clinical infrastructure makes them ideal for implementing biomarker-based diagnostic testing.
   
• They also support high testing volumes and have the capacity to adopt new technologies quickly. This enables faster deployment of companion diagnostics, improving treatment precision and supporting real-time clinical decision-making.
   
• Hospitals often collaborate with pharmaceutical companies and diagnostic providers for clinical trials and co-development of therapies. These partnerships accelerate innovation and expand the reach of companion diagnostics across healthcare systems. As a result, owing to their clinical capacity, patient accessibility, and pivotal role in precision medicine, hospitals significantly contribute to the growth of the market.
   

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North America Companion Diagnostics Market

The North America market dominated the global market with a market share of 40.4% in 2024.
 

The U.S. market was valued at USD 2 billion and USD 2.2 billion in 2021 and 2022, respectively. The market size reached 2.7 billion in 2024, growing from 2.5 billion in 2023.
 

• The U.S. market is witnessing significant growth, driven by the increasing prevalence of cancer and the rising demand for personalized medicine.
   
• For example, according to the NIH, an estimated 2,041,910 new cancer cases are projected to be diagnosed in the U.S. in 2025, with 618,120 deaths attributed to the disease. Among men, prostate, lung, and colorectal cancers are expected to account for 48% of all cancer diagnoses, while among women, breast, lung, and colorectal cancers are anticipated to represent 51% of new cases.
   
• These figures highlight the critical need for advanced companion diagnostic tools that facilitate early detection, enable targeted therapies, and improve patient outcomes. As cancer prevalence continues to rise, the demand for fast, reliable, and technology-driven diagnostic solutions is accelerating, particularly across hospital, outpatient, and home care settings.
   
• The integration of companion diagnostics with precision oncology is becoming a cornerstone of cancer care, allowing clinicians to customize treatments based on individual genetic profiles and tumor characteristics.
   

Europe Companion Diagnostics Market

Europe market accounted for USD 2.1 billion in 2024 and is anticipated to show lucrative growth over the forecast period.
 

• The increasing prevalence of cancer across Europe is driving significant growth in the market. As healthcare systems prioritize personalized medicine, the demand for accurate diagnostic tools to guide targeted therapies is rising.
   
• Cancer remains the second leading cause of death and morbidity in Europe, following cardiovascular diseases. As per the World Health Organization (WHO), annually, over 3.7 million new cancer cases and 1.9 million deaths are reported in the region. This growing burden is accelerating the adoption of companion diagnostics, which play a critical role in early detection, treatment selection, and improving patient outcomes.
   
• With the increasing reliance on biomarker-based testing, companion diagnostics are becoming integral to clinical decision-making. Their incorporation into cancer care pathways is fostering innovation, regulatory advancements, and investments across the European diagnostics market.
   

Germany companion diagnostics market is anticipated to witness considerable growth over the analysis period.
 

• Germany is witnessing a steady rise in cancer cases, which is significantly driving the growth of its market. The increasing demand for personalized and targeted therapies is pushing healthcare providers to adopt advanced diagnostic tools.
   
• As per the Global Cancer Observatory, in 2022, Germany recorded 605,805 new cancer cases and 253,170 deaths, with 1.88 million prevalent cases over a five-year period. These figures reflect the growing burden of cancer and the urgent need for precision diagnostics to support early detection and tailored treatment strategies.
   
• As cancer care becomes more individualized, companion diagnostics are playing a vital role in guiding therapy decisions. Their integration into clinical workflows is enhancing treatment efficacy, reducing trial-and-error approaches, and fostering innovation across Germany’s healthcare and biotech sectors.
   

Asia Pacific Companion Diagnostics Market

• The Asia Pacific region is witnessing rapid growth in the adoption of precision medicine, which is driving the expansion of the market. Countries in the region are heavily investing in genomic research, personalized therapies, and advanced diagnostic technologies to enhance healthcare outcomes.
   
• With the increasing integration of precision medicine into healthcare systems, companion diagnostics play a crucial role in identifying patient-specific biomarkers and enabling targeted treatment strategies. This is particularly significant in oncology, where accurate diagnostics contribute to improved survival rates and cost-effective treatment options.
   
• Governments and healthcare providers across the Asia Pacific region are actively promoting initiatives to incorporate companion diagnostics into clinical practices. This trend is fostering innovation, regulatory harmonization, and collaborations between biotechnology companies and healthcare institutions, thereby strengthening the region's diagnostics landscape.
   

China companion diagnostics market is predicted to grow significantly over the forecast period.
 

• China’s market is rapidly expanding as pharmaceutical companies increasingly integrate companion diagnostics into their drug development pipelines. This strategic alignment enhances treatment precision and supports regulatory approvals for targeted therapies.
   
• China’s rising investment in research and experimental development (R&D), which exceeded USD 510.6 billion (3.6 trillion yuan) in 2024 (as per Chinese government statistics), growing 8.3% year-over-year, supports the expansion of advanced healthcare technologies like companion diagnostics.
   
• As pharmaceutical firms increasingly embed diagnostics into drug development, the surge in basic research funding and a higher R&D intensity (2.68%) create a fertile environment for innovation. This alignment between national R&D priorities and precision medicine is accelerating the growth of China’s market, especially in oncology and genomics-driven therapies.
   
• Additionally, government support for precision medicine, rising cancer prevalence, and increased investment in genomics are further accelerating market adoption. As pharmaceutical companies embed diagnostics into clinical trials and product launches, China is witnessing lucrative growth in personalized healthcare.
   

Latin America Companion Diagnostics Market

Brazil is experiencing significant growth in the Latin America market due to the high burden of cancer.
 

• Brazil’s market is growing, largely due to the rising prevalence of cancer across the country. As cancer cases increase, there’s a growing need for diagnostic tools that can help identify the right treatment for each patient, making companion diagnostics a vital part of modern oncology care.
   
• Pharmaceutical companies in Brazil are also playing a key role by embedding companion diagnostics into their drug development processes. This approach helps ensure that new therapies are matched with the right patients from the start, improving treatment outcomes and speeding up regulatory approvals.
   
• Together, these trends are driving strong growth in Brazil’s companion diagnostics sector. With more targeted therapies entering the market and healthcare providers adopting precision medicine, Brazil is becoming a key region in companion diagnostics solutions.
   

Middle East and Africa Companion Diagnostics Market

Saudi Arabia market is poised to witness substantial growth in the Middle East and Africa market during the forecast period.
 

• Saudi Arabia’s market is set for strong growth, driven by the rising need to manage adverse drug reactions more effectively. As more patients experience unexpected responses to medications, healthcare providers are turning to companion diagnostics to identify which treatments are safest and most effective for each individual.
   
• The country is also embracing precision medicine, which focuses on tailoring healthcare based on a person’s genetic makeup and disease profile. Companion diagnostics are central to this approach, helping doctors choose targeted therapies that improve outcomes and reduce trial-and-error in treatment plans.
   
• With growing investment in healthcare innovation and a push toward personalized care, Saudi Arabia is integrating companion diagnostics across hospitals and clinics. This shift is improving diagnostic accuracy, reducing risks, and positioning the country as a leader in modern medical practices in the Middle East.
   

Companion Diagnostics Market Share

• Leading players such as F. Hoffmann-La Roche, QIAGEN, Thermo Fisher Scientific, and Myriad Genetics are expanding their global footprint through strategic initiatives, including mergers, acquisitions, and co-development partnerships with pharmaceutical companies. These efforts aim to strengthen their competitive edge in the rapidly evolving companion diagnostics landscape, particularly in oncology, infectious diseases, and chronic conditions.
   
• These companies are actively integrating advanced diagnostic technologies such as next-generation sequencing (NGS), multiplex PCR assays, biosensors, and smartphone-enabled platforms into their portfolios. By embedding connectivity features, AI-driven analytics, and cloud-based data sharing, they are enhancing diagnostic speed, accuracy and enabling remote patient monitoring and decentralized testing.
   
• Collaborations with healthcare providers, digital health platforms, and regulatory bodies are central to their strategy. These partnerships ensure that companion diagnostics meet clinical standards, data privacy regulations, and patient safety benchmarks.
   
• Efforts to improve access in underserved and aging populations are gaining momentum. Strategies include mobile testing units, telemedicine integration, community health worker programs, and AI-powered diagnostics tailored for low-resource settings. These initiatives are making companion diagnostics more inclusive and impactful, especially in regions with limited healthcare infrastructure.
   
• Through technology-driven innovation, market leaders are transforming point-of-care diagnostics by enabling faster clinical decisions, reducing hospital visits, and improving patient outcomes. Their focus on patient-centric, evidence-based testing is reshaping care delivery models and contributing to more efficient and sustainable healthcare systems worldwide.
   

Companion Diagnostics Market Companies

Some of the eminent market participants operating in the companion diagnostics solutions industry include:

• Abbott Laboratories
• Amgen
• AstraZeneca
• Becton, Dickinson and Company
• Biogen
• Bristol Myers Squibb
• Eli Lilly and Company
• F. Hoffmann-La Roche
• Foundation Medicine
• Guardant Health
• Johnson & Johnson
• Merck
• Myriad Genetics
• Pfizer
• Thermo Fisher Scientific

• Thermo Fisher Scientific

Thermo Fisher provides robust platforms for companion diagnostics development, including NGS and mass spectrometry technologies. The company supports pharma collaborations to advance personalized therapies, especially in oncology. Its scalable solutions and global reach make it a key contributor to the CDx ecosystem.
 

• Foundation Medicine

Foundation Medicine is a leading innovator in the companion diagnostics space, specializing in comprehensive genomic profiling for cancer. Its FDA-approved tests support treatment decisions across all solid tumors. The company collaborates closely with pharmaceutical partners to accelerate biomarker-driven drug development and commercialization. With a globally established platform and deep expertise in next-generation sequencing, Foundation Medicine plays a critical role in advancing precision oncology and personalized treatment strategies.
 

• Myriad Genetics

Myriad Genetics is a recognized leader in the market, specializing in molecular diagnostic testing and precision medicine. The company offers FDA-approved tests like MyChoice CDx, supporting targeted cancer therapies. Through strategic partnerships with firms like QIAGEN and SOPHiA GENETICS, Myriad is expanding its global reach in both lab-developed and kit-based CDx solutions. Its expertise in assay development, regulatory compliance, and genomic profiling positions it as a key player in advancing personalized healthcare worldwide.
 

Companion Diagnostics Industry News

• In February 2024, F. Hoffmann-La Roche entered into a strategic collaboration with PathAI to enhance its digital pathology capabilities in the companion diagnostics space. Under the agreement, PathAI will work exclusively with Roche Tissue Diagnostics (RTD) to develop AI-powered image analysis algorithms. These algorithms will be integrated into Roche’s navify Digital Pathology platform, enabling seamless deployment across global pathology labs. The partnership aims to advance precision medicine by combining AI interpretation with companion diagnostics, improving access to targeted treatments.
   
• In June 2023, Foundation Medicine announced a strategic collaboration with Merck KGaA, Darmstadt, Germany, to develop FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics in the U.S. market. These tests aim to support selected marketed and pipeline treatments by identifying genomic alterations in patients that may qualify them for targeted therapies.
   

The companion diagnostics market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

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Market, By Product

• Instruments
• Consumables
• Services

Market, By Disease Indication

• Breast cancer
• Lung cancer
• Colorectal cancer
• Skin cancer
• Other diseases indications

Market, By Technology

• Immunohistochemistry
• In situ hybridization
• Polymerase chain reaction
• Genetic sequencing
• Other technologies

Market, By End Use

• Hospitals
• Diagnostic laboratories
• Other End Use

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America 
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa 
  • South Africa
  • Saudi Arabia
  • UAE