Companion Diagnostic Market 2024 – Market Size & Segments Analysis, Industry Trends, Manufacturers Analysis, Opportunities and Forecast 2032

Companion diagnostics are the most specific type of tests or assays that identify biomarkers or genetic mutations in the patient. Such biomarkers or mutations are interconnected with particular diseases or conditions such as cancer, cardiovascular disorders, and infectious diseases. The main role of companion diagnostics is to provide more accurate information for clinicians to base treatment decisions on by identifying patients who are likely to respond to a particular drug or therapy.

Companion diagnostics pair the most appropriate treatment with patients and therefore increase treatment success rates, decrease side effects, and reduce waste of healthcare resources. Different companion diagnostics technologies like next generation sequencing (NGS), polymerase chain reaction (PCR), in-situ hybridization (ISH) and immunohistochemistry (IHC) are used. They are a central aspect of personalized medicine, through which the most effective treatment for a particular patient can be chosen.

The companion diagnostic global market has been registering a strong growth for the past few years owing to scientific breakthroughs in molecular biology, increasing cases of non-communicable diseases, and an increasing focus on precision medicine. The increasing number of chronic diseases, including cancer, cardiovascular diseases and infectious diseases, has led to a higher demand for companion diagnostics to personalize treatment plans considering individual patient characteristics.

The companion diagnostic market is anticipated to reach USD XXX.X million by 2032 from USD XXX.X million in 2023, at a CAGR of XX.X% during the forecast period.

There is a rising trend of healthcare entities embracing personalized medicine aimed at optimizing care, and improving therapeutic effects with an abundant supply of companion diagnostics. Taken together, the advancement in technology, particularly the genomics and proteomics, has led to the development of the companion diagnostic tests with specific and sensitive nature, which is expected to escalate the companion diagnostic market during the forecast period 2024-2032.

Growth Drivers:

The excessive prevalence of chronic diseases like cancer, cardiovascular disorders, and auto-immune illnesses reminds us of the importance of personalized medicine based on the companion diagnostics principle. The rising global prevalence of the above mentioned diseases has led healthcare providers to resort to companion diagnostics, which ensures that treatment strategies are personalized to match each patient’s characteristic profile.

The personalized medicine trend, which involves tailored patient treatments based on their specific characteristics, is a significant force behind the rapid growth of the companion diagnostics market. The companion diagnostics are indispensable in this paradigm, which enables to identify patients who are potentially suitable for particular therapy. Through the identification of biomarkers and genetic mutations linked to treatment efficacy, companion diagnostics improve patient outcomes, reduce adverse effects, and enhance patient quality of life.

Both the supportive regulatory frameworks and reimbursement policies ensure that the market growth and commercialization prospects are not limited. Regulatory bodies, like the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA), offer guidance and oversight concerning the development and approval of companion diagnostics, making sure that they are safe, effective, and clinically valuable.

The past decade has seen significant advancement of genomic technologies, which have transformed companion diagnostics by allowing the detection of targeted genetic mutations and biomarkers related to disease progression and treatment response. NGS, PCR, and other molecular technologies will help in the pinpointing of genetic alterations, which will in turn guide the making of personalized treatment decisions.

Companion Diagnostic Segmentation:

By Product & Service:

·         Instruments/System

·         Assays, Kits & Reagents

·         Software & Services

By Technology:

·         Next-generation Sequencing (NGS)

·         Polymerase Chain Reaction (PCR)

·         In Situ Hybridization (ISH)

·         Immunohistochemistry (IHC)

·         Others

By Indication:

·         Cancer

o   Lung Cancer

o   Breast Cancer

o   Blood Cancer

o   Colorectal Cancer

o   Other Cancer Types

·         Neurological Disorders

·         Cardiovascular Diseases

·         Infectious Diseases

·         Others

By End-User:

·         Pharmaceuticals & Biopharmaceuticals Companies

·         Contract Research Organizations

·         Reference Laboratories

·         Others

By Region:

·         North America

·         Europe

·         Asia Pacific

·         Latin America

·         Middle East and Africa

Companion Diagnostic Market by Product & Service Review:

Based on the product & service, the companion diagnostic market is segmented into three segments including instruments/system, assays, kits & reagents, and software & services. On the basis of product & service, the assays, kits & reagents segment is expected to dominate the market in terms of market share, while the software & services segment is predicted to grow at the highest rate in terms of CAGR during the forecast period.

Companion Diagnostic Market by Technology Review:

Based on the technology, the market is segmented into next-generation sequencing (NGS), polymerase chain reaction (PCR), in-situ hybridization (ISH), immunohistochemistry (IHC), and others. On the basis of technology, the polymerase chain reaction (PCR) segment is expected to be the largest in terms of market share, while the next-generation sequencing (NGS) segment is predicted to grow at the highest rate in terms of CAGR during the forecast period.

Companion Diagnostic Market by Indication Review:

Based on the indication, the market is segmented into cryosurgery, surgical insufflation, and anesthesia & pain relief. On the basis of application, the anesthesia & pain relief segment is expected to be the largest in terms of market share, while the surgical insufflation segment is predicted to grow at the highest rate in terms of CAGR during the forecast period.

Companion Diagnostic Market by End-User Review:

Based on the end-user, the market is segmented into pharmaceuticals & biopharmaceuticals companies, contract research organizations, reference laboratories, and others. On the basis of end-user, the pharmaceuticals & biopharmaceuticals companies segment is expected to be the largest in terms of market share, while the contract research organizations segment is predicted to grow at the highest rate in terms of CAGR during the forecast period.

Regional Outlook:

The companion diagnostic market research report offers detailed analysis and forecasts for five major regions i.e., North America, Europe, Asia Pacific (APAC), Latin America, and the Middle East & Africa.

The North America region is forecasted to dominate the global companion diagnostic market followed by Asia Pacific, Europe, Latin America, and Middle East & Africa during the forecast period 2023-2030.

The North America region is predicted to retain its leadership position in the global companion diagnostic market by owning around XX.X% market share in 2023. The local companion diagnostic market is propelled by the ethical blend of factors including developed health infrastructure, extensive R&D activities and a supportive regulation. The strategic partnerships between pharmaceutical enterprises, diagnosis manufacturers, and academic institutions in the region, leads to innovation in companion diagnostics. Another important factor is the fact that the region has the largest community of pharmaceutical companies, diagnostic laboratories, research institutions and technology firms, leading to innovations in companion diagnostic tests that is expected to increase the companion diagnostic market in North America over the forecast period 2024-2032.

North America, comprising the United States (U.S.) and Canada, has a considerable portion of the global companion diagnostic market. The influence in the region is due to its long established healthcare infrastructure, technological advancements and a strong emphasis on personalized medicine.

North America exemplifies precision medicine trend with focus on tailoring medical interventions to the personal characteristics of patients. Companion diagnostics play an essential role in precision medicine as it helps to guide treatment choices, predict response and minimize adverse effects, which encourages market growth.

Moreover, partnerships between pharma companies, diagnostic companies, research organization and healthcare providers enable innovation within the companion diagnostic sub-space, which consequently is the driver of companion diagnostic market in North America during the forecast period 2024-2032.

Asia Pacific is the fastest growing segment of the companion diagnostic market in terms of CAGR. The companion diagnostic demand in the Asia-Pacific region will be driven by the rise in economic growth, increasing investment in healthcare research and development and the expansion of healthcare infrastructure. Besides, while China, India, and Japan are leading the market expansion, the cause being growing prevalence of chronic diseases, rising healthcare expenditure, and the switching towards personalized medicine. On the other hand, government policies to promote healthcare accessibility and affordability in the region is anticipated to provide a push to the market growth in the Asia Pacific region during the forecast period 2024-2032.

Key Companies in Companion Diagnostic Market:

The research report offers a competitive analysis of prominent companies operating in the companion diagnostic market. Some of the leading players profiled in the market research report include:

·         F. Hoffmann-La Roche Ltd.

·         Agilent Technologies, Inc.

·         QIAGEN

·         Thermo Fisher Scientific, Inc.

·         Abbott

·         Almac Group

·         Danaher

·         Illumina, Inc.

·         BIOMÉRIEUX

·         Myriad Genetics, Inc.

·         Other Players