Companion Diagnostics Market Size & Share By Product Type (Assays, Kits & Reagents, Instruments & Platforms), By Technology (Polymerase Chain Reaction (PCR), Next-generation Sequencing (NGS), Hybridization, Immunohistochemistry (IHC), and Others)

Companion Diagnostics Market – Global Outlook & Forecast 2024-2029

COMPANION DIAGNOSTICS MARKET SIZE & INSIGHTS

The global companion diagnostics market size was valued at USD 6.49 billion in 2023 and is expected to reach USD 19.95 billion by 2029, growing at a CAGR of 20.58% during the forecast period. This rapid growth is driven by the rising burden of chronic diseases, especially cancer, along with the increasing demand for targeted therapies and personalized medicine.

As healthcare shifts away from a one-size-fits-all approach, companion diagnostics (CDx) have emerged as a cornerstone of modern treatment strategies. These advanced tests help identify the most effective therapies for individual patients by analyzing their genetic and molecular profiles. Once a futuristic concept, companion diagnostics are now at the forefront of precision medicine, guiding decisions that improve treatment outcomes and minimize unnecessary interventions.

While oncology continues to dominate the companion diagnostics market, the technology is quickly expanding into other medical specialties—including cardiovascular, neurological, infectious, autoimmune, and mental health disorders. This broadening scope highlights the increasing reliance on CDx to support accurate diagnoses and personalized treatment across a wide spectrum of diseases. Moreover, advancements in genomics, sequencing technologies, and bioinformatics have made biomarker discovery more efficient and affordable. With mounting evidence supporting the clinical and cost benefits of CDx-guided therapies, adoption is accelerating among healthcare providers, researchers, and pharmaceutical companies alike.

However, the market also faces notable challenges. CDx developers must navigate complex, evolving regulatory environments across different regions. Ensuring affordable access, reliable reimbursement pathways, and education for both clinicians and patients is critical for wider adoption and equitable impact. Looking ahead, the outlook for the companion diagnostics market is promising. Ongoing innovation, strategic partnerships, and global expansion efforts are expected to fuel sustained growth. Integrating CDx earlier in the drug development pipeline will generate robust clinical data, accelerate approvals, and optimize treatment efficacy.

Beyond commercial potential, companion diagnostics represent a transformative shift in healthcare—putting patients at the center of care. By enabling the right treatment at the right time, CDx is not only improving outcomes but also paving the way for a more efficient and cost-effective healthcare system worldwide.

MARKET TRENDS

Expanding Applications of Companion Diagnostics Beyond Oncology

The companion diagnostics market is evolving rapidly, extending far beyond its traditional roots in oncology. As precision medicine becomes more widely adopted, companion diagnostics are increasingly being utilized in the diagnosis and treatment of non-cancer diseases such as cardiovascular, neurological, and infectious disorders.

This expansion marks a significant shift in how healthcare providers approach disease management across specialties. In cardiovascular care, for example, companion diagnostics help identify genetic variations linked to conditions like familial hypercholesterolemia and atrial fibrillation. These insights enable healthcare professionals to personalize treatment strategies, improve medication selection, and enhance patient outcomes. As research continues to explore the broader applications of companion diagnostics, their role in precision medicine will only grow—paving the way for more targeted, effective, and individualized treatment options across a wide range of diseases.

Strategic Collaborations Powering Growth in the Companion Diagnostics Market

One of the key growth drivers in the companion diagnostics (CDx) market is the increasing collaboration between pharmaceutical companies and diagnostic developers. These partnerships are accelerating innovation, aligning drug development with diagnostic testing, and streamlining the path to market for new therapies.

A notable example is the 2023 collaboration between QIAGEN and Servier to develop a companion diagnostic for TIBSOVO, a targeted therapy for acute myeloid leukemia (AML). Collaborations like these are essential in ensuring that diagnostics and therapies are developed in tandem, maximizing treatment efficacy and patient benefit. As more companies recognize the value of integrating diagnostics early in the drug development process, the companion diagnostics market is positioned for sustained, long-term growth.

Evolving Regulatory Frameworks Supporting Innovation in Companion Diagnostics

The regulatory landscape for companion diagnostics is undergoing a meaningful transformation, creating a more favorable environment for innovation and market expansion. Updated guidelines provide clearer definitions, encouraging co-development strategies, and supporting global harmonization—removing previous barriers to entry for both developers and manufacturers.

These evolving regulatory frameworks not only streamline the approval process but also boost stakeholder confidence and facilitate quicker access to global markets. With precision medicine on the rise, regulatory bodies worldwide are recognizing the critical role companion diagnostics play in ensuring safe, effective, and targeted therapies.

COMPANION DIAGNOSTICS MARKET DRIVERS

Rising Global Patient Demographics: Fueling Growth in the Companion Diagnostics Market

As chronic diseases continue to rise worldwide, the demand for personalized and precise healthcare solutions has never been greater. This growing patient population is significantly influencing the companion diagnostics market, creating a surge in the need for tests that guide treatment decisions based on an individual’s unique genetic makeup.

With the global healthcare system shifting toward more proactive and personalized treatment models, companion diagnostics are becoming essential tools. These diagnostics not only enhance treatment accuracy but also improve patient outcomes by ensuring the right therapy reaches the right patient at the right time. As technology advances and global healthcare access improves, the companion diagnostics market is poised for rapid and sustained expansion.

Personalized Medicine: A Driving Force Behind the Companion Diagnostics Market

The shift from generalized healthcare to personalized medicine is reshaping the future of medical treatment—and the companion diagnostics market is at the heart of this transformation. Personalized medicine uses an individual’s genetic, biomarker, and molecular profile to tailor treatment strategies, moving away from the outdated "one-size-fits-all" approach. This has led to a growing reliance on companion diagnostics, which play a crucial role in identifying patients who will benefit most from specific therapies.

Thanks to innovations in genomics, molecular diagnostics, and bioinformatics, healthcare providers can now make more accurate, patient-specific treatment decisions. This not only improves therapeutic effectiveness but also reduces the risk of adverse reactions—creating better outcomes and a more efficient healthcare system overall. As the demand for targeted therapies continues to rise, so does the momentum of the companion diagnostics market.

The Growing Role of Companion Diagnostics in Clinical Research

In the evolving landscape of precision medicine, companion diagnostics (CDx) are proving to be invaluable in the realm of clinical research. Their ability to identify genetic alterations and biomarkers is accelerating drug development and transforming the way treatments are tested and delivered. As clinical research becomes increasingly personalized, the integration of CDx is becoming the norm—not the exception. This trend is one of the key drivers of the companion diagnostics market, signaling a future where research and treatment strategies go hand-in-hand to deliver more precise and effective healthcare solutions.

SEGMENTATION INSIGHTS

INSIGHTS BY PRODUCT TYPE

The global companion diagnostics market by product type is segmented into assay, kits & reagents, and instruments & platforms. In 2023, assay, kits & reagents accounted for the most significant global market share. Assays, kits, and reagents form a critical component of this landscape, facilitating the identification of specific biomarkers and genetic variations that guide the selection of targeted therapies. Companion diagnostics often rely on kits that contain all the necessary components for a specific diagnostic test. These kits streamline the testing process, providing standardized reagents, controls, and protocols for the detection of biomarkers. Kits are designed to be user-friendly, allowing laboratories to perform companion diagnostic tests with consistency and reproducibility.

The global instruments & platform companion diagnostics market is expected to reach USD 4.33 billion by 2029. In the dynamic landscape of personalized medicine, companion diagnostics has emerged as a pivotal tool for tailoring medical treatments to individual patients based on their genetic or molecular profiles. The future of companion diagnostics instruments and platforms promises continued innovation. Miniaturization and portability will bring diagnostic power closer to patients, enabling point-of-care testing.

INSIGHTS BY TECHNOLOGY

The global companion diagnostics market by technology is segmented into polymerase chain reaction (PCR), next-generation sequencing (NGS), hybridization, immunohistochemistry (IHC), and others. The polymerase chain reaction (PCR) technology segment held the most significant share of the global companion diagnostics (CDx) market. PCR technology is highly sensitive and specific, allowing for the detection of low quantities of target DNA with high accuracy. This is crucial in companion diagnostics, where precise identification of genetic or molecular markers is essential. The future of PCR technology in companion diagnostics holds promise with ongoing research and development. Integration with other technologies, such as next-generation sequencing (NGS) and digital PCR, is likely to further enhance the capabilities of companion diagnostics, allowing for more comprehensive and precise patient stratification.

In 2023, the NGS accounted for over 25% share of the global companion diagnostics market. Next-generation sequencing (NGS) technology has revolutionized the field of genomics, providing researchers and clinicians with unprecedented insights into the complexities of the human genome. NGS is also instrumental in predicting drug responses, and prognosis, and monitoring disease progression, fostering a more personalized and effective approach to cancer therapy. Beyond oncology, NGS is increasingly applied in companion diagnostics for various other diseases, such as genetic disorders, infectious diseases, and cardiovascular conditions.

INSIGHTS BY APPLICATION

The cancer application segment accounted for the major share of the global companion diagnostics market in 2023, growing at a CAGR of 20.76% during the forecast period. Companion diagnostics in cancer play a pivotal role in personalized medicine, aiding in identifying specific biomarkers or genetic mutations that can guide treatment decisions. Companion diagnostics help identify specific biomarkers associated with different types of cancer. In oncology, companion diagnostics assist in selecting appropriate targeted therapies. For example, identifying certain mutations may guide the use of specific tyrosine kinase inhibitors or immunotherapies.

The cancer segment market is driven by the increasing prevalence of cancer, advancements in genomics and molecular biology, and the growing trend toward personalized medicine. Furthermore, one of the primary applications of companion diagnostics in cancer is the personalization of treatment strategies. Traditional chemotherapy often involves a one-size-fits-all approach, leading to varying responses and increased side effects among patients. With companion diagnostics, oncologists can identify patients who are most likely to respond positively to a specific targeted therapy based on their unique biomarker profile.

INSIGHTS BY END-USER

The global companion diagnostics market by end-user is segmented into pharma & biotech companies, reference laboratories, CROs & CDMOs, and others. In 2023, the pharma & biotech companies segment accounted for the dominant market share and is growing at a CAGR of over 20% during the forecast period. The pharma & biotech companies are major players in the companion diagnostics (CDx) market. They develop and manufacture targeted therapies and often invest in companion diagnostics to identify patients who will respond optimally to their drugs. These companies collaborate with diagnostic manufacturers or develop in-house companion diagnostics to support their drugs' clinical development and commercialization. Companion diagnostics help in patient stratification and increase the chances of successful clinical trials.

In 2023, the reference laboratories accounted for over 30% share of the global companion diagnostics market. Reference laboratories are pivotal entities in the healthcare ecosystem, providing specialized diagnostic services, particularly in the realm of complex and advanced testing. With the rapid evolution of personalized medicine, reference laboratories have become key end-users of companion diagnostics, contributing significantly to the integration of these innovative tools into routine clinical practice.

COMPANION DIAGNOSTICS (CDx) MARKET’S GEOGRAPHICAL ANALYSIS

North America accounted for the major share of the global companion diagnostics market, accounting for over 50% in 2023. The North American region, particularly the U.S., has significantly contributed to the companion diagnostics market. The presence of key players, a well-established healthcare infrastructure, and a focus on precision medicine contribute to the market's growth. The FDA's supportive regulatory environment for companion diagnostics also plays a crucial role. Further, the region has witnessed a significant surge in the industry, driven by several factors. One of the primary drivers is the increasing prevalence of chronic diseases, such as cancer, cardiovascular disorders, and neurodegenerative conditions. Moreover, the US, a land of innovation and medical prowess, finds itself at the forefront of the burgeoning companion diagnostics market. This dynamic arena, where personalized medicine takes center stage, promises a future where treatments are tailored to individual patients, maximizing effectiveness and minimizing harm.

Europe is another important region for the global companion diagnostics (CDx) market. Germany, France, the UK, Italy, Spain, Russia, and the Netherlands spearhead the companion diagnostics market, driven by factors like well-established healthcare systems, strong pharmaceutical and diagnostics industries, and an early embrace of personalized medicine. Companies like F. Hoffmann-La Roche, Qiagen, and Siemens Healthineers are at the forefront, offering a diverse range of companion diagnostics for various cancers and chronic diseases. Furthermore, Eastern Europe's companion diagnostics market holds immense potential, yet faces challenges like fragmented healthcare systems and lower per capita spending. However, the region is witnessing positive developments. Poland and Hungary are emerging as key players, while initiatives like the "Innovative Medicines Initiative" of the European Union foster regional collaboration and knowledge sharing. Additionally, rising awareness of personalized medicine creates a promising future for market expansion.

The APAC, including countries like China, Japan, and India, is experiencing rapid growth in the companion diagnostics market, growing at a CAGR of 18.46% during the forecast period. Increasing healthcare expenditure, a large patient population, and rising awareness of personalized medicine contribute to industry expansion. One of the primary drivers of the companion diagnostics market in APAC is the increasing incidence of cancer. As cancer remains a leading cause of morbidity and mortality in the region, there is a growing need for precise diagnostic tools to guide targeted therapies. However, the regulatory landscape may vary across countries.

Latin America is showing a growing interest in companion diagnostics, driven by improving healthcare infrastructure and a rising burden of chronic diseases. Brazil and Mexico are among the countries witnessing increased adoption. The Latin American companion diagnostics market has witnessed substantial growth in recent years, driven by factors such as increasing awareness of personalized medicine, rising incidence of chronic diseases, and advancements in genomic research.

The Middle East and Africa region are witnessing gradual growth in adopting companion diagnostics. The regional companion diagnostics market expansion is influenced by improving healthcare facilities, increasing awareness, and focusing on enhancing diagnostic capabilities. The Middle East & Africa region, encompassing diverse countries with varying healthcare infrastructures, is experiencing a paradigm shift in its approach to patient care. Companion diagnostics, which involve the simultaneous development of a diagnostic test alongside a therapeutic drug, have gained prominence in the region.

VENDOR LANDSCAPE

A mix of established pharmaceutical companies, diagnostic laboratories, and emerging biotechnology firms characterizes the competitive landscape of the global companion diagnostics market. One of the primary drivers of competition in the industry is the race to develop innovative and reliable diagnostic tools. The ability to accurately identify biomarkers and genetic variations associated with specific diseases is a critical factor in the success of companion diagnostics. Companies invest heavily in research and development to stay at the forefront of technological advancements and to differentiate their products in a crowded market. Key global companion diagnostics market players include F. Hoffmann-LA Roche, Agilent Technologies, Illumina, QIAGEN, and Thermo Fisher Scientific. The competition is intense, with companies competing for strategic partnerships, regulatory approvals, and industry share.

Agilent Technologies is a prominent player in the global companion diagnostics market, leveraging its expertise in diagnostics and genomics to develop and commercialize assays that guide treatment decisions based on a patient's genetic makeup. The company recently received FDA approval for its pharmDx PD-L1 IHC 22C3 assay as a CDx for Merck & Co.'s KEYTRUDA therapy in esophageal squamous cell carcinoma, marking their entry into this new cancer indication. The acquisition of Dako Omnis in 2012, a leading automated staining and slide preparation platform, strengthened Agilent's presence in the IHC market and enhanced its CDx workflow efficiency.

F. Hoffmann-La Roche, a pharmaceutical and diagnostics company, leads as the world's key provider in the companion diagnostics market. A new collaboration expands Roche's reach in companion diagnostics across various technologies (IHC, digital pathology, sequencing) for targeted therapies. The US FDA approval of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay aids in identifying epithelial ovarian cancer patients eligible for targeted treatment with ELAHERE (mirvetuximab soravtansine-gynx).

Illumina, a leader in next-generation sequencing (NGS) technology, plays a significant role in the global companion diagnostics (CDx) market. TruSight Oncology series, NGS-based tests offer comprehensive tumor profiling, identifying genetic alterations that guide treatment decisions for various cancers. Examples include TruSight Oncology 500 for solid tumors and TruSight Tumor Hotspot.

QIAGEN, a leading player in life sciences, plays a significant role in the global companion diagnostics (CDx) market. They specialize in developing and commercializing CDx tests that link specific genetic variations to drug efficacy and safety, enabling personalized treatment decisions. Furthermore, Thermo Fisher Scientific is a major player in the global companion diagnostics (CDx) market, leveraging its strengths in life sciences and diagnostics to offer comprehensive solutions. The company actively expands its offerings in next-generation sequencing (NGS)-based CDx, a rapidly growing segment fueled by personalized medicine advancements.