Companion Diagnostic Market - Global Industry Analysis and Forecast (2024-2030)

Companion Diagnostic Market Overview:

 

A companion diagnostic is a medical device or test, which provides information that is essential for the safe and effective use of a particular biological product; this would typically be a highly tailored or targeted drug treatment. It helps a healthcare professional to know whether the benefits of a drug or treatment for a patient will outweigh any potential serious side effects or risks. The test takes into consideration the nature of the illness and additional aspects of the patient’s health and the test itself may be developed alongside the drug it is intended to be used with. Generally, these tests are used in the diagnosis of cancer. In this, as per the biomarker identified, a suitable drug is suggested. These tests provide individualized treatment based on the response of a specific patient. Because it gives essential information and is a prerequisite, a companion diagnostic will usually be officially approved for use only as part of the licensing of the drug. The drug must necessarily be used with the test, exactly as per the licensed approval.

 

The rising prevalence of cancer and other chronic diseases necessitates more effective and targeted treatments. Companion Diagnostics helps in identifying patients who are most likely to respond to specific therapies, thereby optimizing treatment strategies and enhancing patient care. According to WHO the number of new cancer patients worldwide has reached 20 Mn in 2022. This has created a huge driver for the companion diagnostic market. Companion diagnostics play a crucial role in personalized medicine by identifying biomarkers or genetic mutations that guide treatment decisions. They enable healthcare providers to match patients with therapies most likely to benefit them, improving treatment outcomes and minimizing adverse effects.

 

PCR technology dominates the companion diagnostic market due to its reliability, cost-effectiveness, and innovative product launches by companies like QIAGEN and Thermo Fisher. NGS is gaining traction for its comprehensive genomic profiling capabilities, aiding personalized medicine. Cancer remains the largest segment, driven by the need for precise molecular profiling and advancements in targeted therapies. Neurology is growing due to rising CNS diseases, while infectious diseases and cardiovascular conditions are significant segments. These diagnostics support precision medicine by enabling accurate treatment selection and improving patient outcomes across various indications.

 

Although the Companion diagnostic market is booming reimbursement policies often lag behind technological advancements. Insurers and healthcare systems may be reluctant to reimburse for new tests without clear evidence of clinical utility and cost-effectiveness. This uncertainty can deter diagnostic developers from investing in new CDx technologies.

 

 

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Companion Diagnostic Market Dynamics

 

Companion Diagnostic Market Drivers: The Rising Prevalence of Cancer and Other Chronic Diseases

 

The prevalence of cancer is on the rise globally, driven by factors such as aging populations and unhealthy lifestyles. In the U.S. alone, approximately 1.9 million new cancer cases were reported in 2022, with breast and lung cancers being prominent worldwide according to the World Health Organization. These trends underscore the increasing need for effective diagnostic tools like Companion Diagnostics, which leverage genomic testing to provide precise insights into tumor profiles. Such tests help doctors tailor treatment plans to individual patients, enhancing therapeutic outcomes.

 

The Companion diagnostic market is expanding rapidly to meet this demand. For example, the FDA's approval of Guardant360 Companion Diagnostics in August 2020 marked a milestone in liquid biopsy diagnostics for identifying EGFR gene mutations in metastatic Non-Small Cell Lung Cancer (NSCLC). Collaborations between industry leaders, such as QIAGEN and Myriad Genetics, further drive innovation in oncology diagnostics. These partnerships aim to develop advanced solutions that cater to the increasing global demand for personalized cancer treatment strategies.

 

Overall, the convergence of rising cancer incidence, technological advancements in genomic testing, and strategic collaborations in the Companion diagnostic market highlight a pivotal era in cancer diagnostics. The focus on precision medicine through Companion Diagnostics not only improves patient care but also positions these diagnostics as crucial tools in the ongoing battle against cancer and other chronic diseases worldwide.

 

 

Preference For Personalized Medicine:

 

Personalized medicine is transforming the Companion diagnostic market, particularly in oncology, where it aims to tailor medical treatments based on the unique genetic mutations, biomarkers, or molecular characteristics of a patient's tumor. By accurately identifying these biomarkers, Companion Diagnostics enables oncologists to select targeted therapies that are more likely to be effective, thereby improving treatment outcomes and reducing adverse effects. This personalized approach not only enhances patient quality of life but also holds promise for extending survival rates. Moreover, Companion Diagnostics plays a crucial role in early detection and prevention strategies by detecting biomarkers associated with early stages of cancer. This capability allows for timely interventions when the disease is most treatable, underscoring their critical role in improving overall patient outcomes through targeted healthcare interventions.

 

 

Technological advancements in genomic sequencing, molecular diagnostics, and bioinformatics have significantly bolstered the capabilities of companion diagnostic market. Next-generation sequencing (NGS) and other high-throughput technologies provide oncologists with precise and actionable information about genetic alterations and molecular profiles, enabling informed treatment decisions. Regulatory agencies like the FDA and EMA recognize the potential of personalized medicine and Companion Diagnostics to enhance patient care. They support the development and commercialization of these tests through established regulatory frameworks and guidelines, ensuring their reliability and clinical utility. Despite initial costs, personalized medicine offers long-term cost savings by optimizing treatment choices and improving healthcare efficiency. By avoiding unnecessary treatments and hospitalizations associated with ineffective therapies, Companion Diagnostics contributes to better healthcare resource allocation and overall economic efficiency. Furthermore, the patient-centered approach of personalized medicine, tailored to individual needs and characteristics, not only enhances clinical outcomes but also increases patient satisfaction and compliance with treatment regimens, demonstrating its comprehensive impact on healthcare delivery and patient care.

 

Challenges: Cost And Reimbursement Issues

 

Cost and reimbursement issues present significant challenges in the companion diagnostic market, despite its pivotal role in advancing personalized medicine and enhancing patient outcomes. Developing Companion Diagnostic tests involves substantial investments in research, technology, and clinical validation, which can be prohibitive for smaller companies. Regulatory hurdles further complicate matters, as Companion Diagnostic tests must undergo rigorous clinical validation and demonstrate clinical utility to gain approval from agencies like the FDA and EMA, adding time and costs to the development process. Once approved, securing reimbursement remains a hurdle due to varying policies and the need to demonstrate cost-effectiveness and improved outcomes compared to traditional diagnostics. Market adoption also faces barriers, with healthcare providers cautious about adopting new tests without clear reimbursement pathways and robust evidence of clinical benefit. Educational efforts are essential to ensure healthcare professionals understand the utility of Companion Diagnostics in personalized medicine. Despite these challenges, addressing cost and reimbursement issues is crucial for maximizing the potential of the companion diagnostic market to guide targeted therapies, optimize healthcare resources, and improve overall patient care in a cost-effective manner.

 

Companion Diagnostic Market Segment Analysis:

 

By Technology: Polymerase chain reaction (PCR) is a well-established and widely adopted technology in diagnostic laboratories globally. Its reliability and robustness make it suitable for routine use in identifying specific genetic markers associated with targeted therapies which makes it a dominant player in the companion diagnostic market. PCR assays are generally more cost-effective compared to some newer technologies, making them accessible for routine testing and widespread adoption.

 

In 2023, PCR technology emerged as the leading player in the global companion diagnostics market, driven by the introduction of innovative PCR kits from major companies such as QIAGEN N.V. and Thermo Fisher Scientific Inc. For instance, QIAGEN N.V. launched the therascreen KRAS RGQ PCR Kit in May 2021, designed to identify non-small cell lung cancer (NSCLC) patients suitable for treatment with LUMAKRAS, a novel therapy by Amgen Inc.

 

Similarly, in March 2021, Thermo Fisher Scientific Inc. introduced the QuantStudio 5 Dx Real-Time PCR System, aimed at improving accuracy and efficiency in laboratory procedures, thereby supporting molecular diagnostic workflow. These product launches and regulatory approvals significantly contributed to PCR's dominance within the companion diagnostic market.

 

NGS (Next-Generation Sequencing) offers a comprehensive genomic profiling capability, enabling the detection of multiple types of genetic alterations simultaneously, such as single nucleotide variants, insertions/deletions, copy number variations, and gene fusions. NGS facilitates personalized medicine by providing detailed insights into tumor biology and patient-specific genetic profiles. This supports precise treatment selection and patient stratification. Regulatory agencies increasingly recognize the value of NGS in companion diagnostics, leading to more approvals and adoption in clinical practice.

 

By Indication

 

The cancer segment holds the largest market share in companion diagnostics, comprising approximately 75-80%. This dominance is attributed to tumors' intricate and heterogeneous nature, necessitating precise molecular profiling for accurate treatment selection. Rapid advancements in oncology therapies, particularly targeted therapies and immunotherapies, have further fueled the demand for the companion diagnostic market. Regulatory agencies increasingly mandate the use of these diagnostics for specific oncology treatments, contributing to market expansion. Clinical utility remains paramount as companion diagnostics in oncology enhance treatment outcomes by identifying patients likely to respond favorably to therapies, thereby optimizing efficacy and minimizing adverse effects.

 

In February 2022, the World Health Organization reported that around 400,000 children are diagnosed with cancer annually worldwide. Additionally, the World Cancer Research Fund International noted 20 Mn cancer cases globally.

 

F. Hoffmann-La Roche Ltd received FDA approval for the VENTANA HER2 Dual ISH DNA Probe Cocktail assay, facilitating HER2 biomarker detection in breast cancer as a companion diagnostic for Herceptin therapy. The neurology segment of Companion diagnostic market is anticipated to experience significant growth due to increasing cases of CNS diseases like Schizophrenia, Parkinson’s, and Alzheimer’s, driving demand for precision medicine and companion diagnostics. In May 2022, Fujirebio launched Lumipulse G β-Amyloid 1-42 and β-Amyloid 1-40 Plasma assays for improved β-amyloid measurement in human plasma using the LUMIPULSE G immunoassay system.

 

Infectious diseases constitute a significant share of the companion diagnostic market. The demand arises from the imperative need for swift and accurate diagnosis of emerging infections, viral and bacterial alike. Concerns over antibiotic resistance have heightened the importance of targeted therapies guided by diagnostic tests to improve treatment effectiveness. Advances in molecular and genetic testing technologies have facilitated faster and more precise detection of infectious agents, enhancing market growth. Events such as pandemics underscore the critical role of companion diagnostics in managing outbreaks and supporting public health responses effectively.

 

In cardiovascular diseases, companion diagnostics command a crucial role. These diagnostics enable precision medicine by identifying genetic variants and biomarkers associated with cardiovascular conditions, thereby facilitating personalized treatment strategies. They also aid in risk assessment and prognosis evaluation, guiding clinicians in selecting the most effective therapies tailored to individual patient profiles. This optimization improves patient outcomes and contributes to cost savings in healthcare delivery.

 

Companion Diagnostic Market Regional Insights:

 

North America is  leading the Companion diagnostic market, with a share of 27.3% in 2023 due to significant technical inventions and the increasing prevalence of chronic diseases like cancer. The companion diagnostics market trends and forecasts are swayed by the expansion of research activities in this field employing companion diagnostic kits and the growing number of healthcare organizations working on genetic databases created to comprehend the human genome. The major drivers in this region include strong regulatory frameworks, high healthcare expenditure, and significant pharmaceutical and biotechnology companies investing in precision medicine.

 

The second-leading market is anticipated to be in Europe, with 21.6 % of companion diagnostic market share in 2023. Countries like Germany, the UK, France, and Switzerland are at the forefront due to robust healthcare systems. A substantial number of businesses are expected to participate as the regional sector expands, and research and development efforts to enhance personalized drug therapy for cancer patients are expected to increase, impacting the regional market. Additionally, rising per capita income increases the desire for individualized care, further promoting consumer development.

 

The Asia-Pacific region is expected to witness the fastest growth in the companion diagnostic market. Countries like China, Japan, India, and South Korea lead the way. Market expansion is aided by the region's increasing healthcare infrastructure and partnerships between pharmaceutical and diagnostic companies. The Asia Pacific companion diagnostics market offers key opportunities for both established players and emerging businesses as they work to improve patient outcomes and contribute to the paradigm shift in modern healthcare as regulatory frameworks change, and healthcare spending rises.

 

Companion Diagnostic Market Scope

Companion Diagnostic Market Scope
Market Size in 2023	USD 6.66 Bn.
Market Size in 2030	USD 15.28 Bn.
CAGR (2024(2030)	12.6%
Historic Data	2018-2022
Base Year	2023
Forecast Period	2024-2030
Segments Analysis	By Technology PCR NGS
	By End-Use Hospitals & Clinics Diagnostic Laboratories Research Institutions Pharmaceutical Companies
	Product & Service Assays, Kits, and Reagents Instruments & Systems Software & Services
	By Indication • Cancer • Infectious Diseases • Cardiovascular Diseases Neurological Diseases Other Indications
Regional Scope	North America (United States, Canada, and Mexico Europe – UK, France, Germany, Italy, Spain, Russia, Austria, and Rest of Europe Asia Pacific – China, India, Japan, South Korea, Australia, ASEAN, Rest of APAC Middle East and Africa (South Africa, GCC, Egypt, Nigeria, Rest of the Middle East and Africa South America – Brazil, Argentina, Rest of South America

 

Companion Diagnostic Key players

North America

1. Abbott (Abbott Park, U.S.)
2. Agilent Technologies, Inc. (Santa Clara, U.S.)
3. Illumina, Inc. (San Diego, U.S.)
4. Guardant Health (Redwood City, U.S.)
5. Thermo Fisher Scientific Inc. (Waltham, U.S.)
6. Myriad Genetics, Inc. (Salt Lake City, U.S.)

Europe

7. BIOMERIEUX (Marcy-l'Étoile, France)
8. QIAGEN (Hilden, Germany)
9. Roche Diagnostics (Basel, Switzerland)

Asia Pacific

10. Sysmex Corporation (Kobe, Japan)
11. SRL Diagnostics (Mumbai, India)