The global companion diagnostics market is projected to reach USD 13.6 billion by 2029 from USD 7.5 billion in 2024, at a CAGR of 12.6% during the forecast period. The growth of the companion diagnostics market is primarily driven by several key factors, including a large patient pool undergoing advanced medical testing, high levels of drug development activity, a structured regulatory framework in the region, and policy programs aimed at providing effective care to patients with cancer.
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Based on product & service, the companion diagnostics market is categorized into assays, kits & reagents, instruments/systems and software & services. In 2023, the segment comprising assays, kits, & reagents held the largest share of the companion diagnostics market. This substantial share is due to the wide array of available products, the increasing utilization of assays and kits across various therapeutic fields, and the growing demand for these products in both basic research and commercial applications.
Based on technology, the companion diagnostics market is segmented into into polymerase chain reaction (PCR), in situ hybridization (ISH), next-generation sequencing (NGS), immunohistochemistry (IHC), and other technologies. In 2023, the PCR segment held the predominant market share in the companion diagnostics market. This significant share is attributed to the user-friendly nature and widespread accessibility of PCR kits & reagents in companion diagnostic testing. Additionally, the expanding applications of PCR in the high-throughput detection of gene mutants with limited or low allele frequency, coupled with its quick turnaround time compared to other technologies, contribute to the dominance of the PCR segment.
Based on indication, the companion diagnostics market is categorized into segments including cancer, cardiovascular diseases (CVDs), neurological diseases, infectious diseases, and other indications (inflammatory and inherited diseases, among others). In 2023, the cancer segment held the largest portion of the market. This notable share is driven by several factors, including the rising global incidence of cancer, the expanding role of companion diagnostics in personalized medicine treatments for cancer, the growing importance of biomarkers in cancer diagnosis, advancements in molecular-level cancer diagnostics technology, and the availability of funding for cancer research.
Based on sample type, the companion diagnostics market is segmented into liquid, blood, and other sample types. In 2023, the tissue sample segment accounted for the largest share of the companion diagnostics market. Using tissue samples in companion diagnostics testing offers several advantages, primarily in providing more accurate and reliable results compared to other types of sample.
Categorized by end user, the companion diagnostics market is divided into pharmaceutical & biotechnology companies, reference laboratories, CROs, and other end users (including physician & hospital laboratories, and academic medical centers). In 2023, the pharmaceutical & biotechnology companies segment dominated the companion diagnostics market. This segment’s significant share is linked to the increasing utilization of companion diagnostics in drug development and the rising importance of companion diagnostic biomarkers. Furthermore, the increasing demand for personalized medicine and the necessity for targeted therapies across diverse diseases and disorders are anticipated to fuel the adoption and demand for companion diagnostics among pharmaceutical & biotechnology companies.
The global companion diagnostics market is divided into six primary regions: North America, Europe, Asia Pacific, Latin America, the Middle East & Africa, and GCC countries. Among these regions, North America held the largest regional market share for companion diagnostics. The substantial presence of leading companion diagnostics vendors and national clinical laboratories, coupled with the easy access to technologically advanced devices and instruments, contribute to North America’s significant share in this market. Furthermore, the highly developed healthcare systems in the US and Canada also play a role in this regional dominance.
The major players in this market are F. Hoffmann-La Roche Ltd (Switzerland), Agilent Technologies, Inc. (US), QIAGEN (Netherlands), Thermo Fisher Scientific Inc. (US) and Abbott (US). These players lead the market because of their extensive product portfolios and wide geographic presence. These dominant market players also have numerous advantages, such as more robust marketing and distribution networks, larger budgets for R&D, and better brand recognition.
The companion diagnostics industry is experiencing remarkable growth, projected to soar from $7.5 billion in 2024 to $13.6 billion by 2029, at an impressive compound annual growth rate (CAGR) of 12.6%. This surge can be attributed to the increasing significance of personalized medicine, the rising prevalence of chronic diseases like cancer, and the growing adoption of targeted therapies.
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Personalized Medicine: The Driving Force
The increasing awareness of the advantages of personalized medicine is a key driver propelling the utilization of companion diagnostics and genomics & proteomics technologies. These diagnostic tests analyze specific indications for particular drugs in individual patients, enabling healthcare providers to devise tailored treatment plans and minimize the risk of adverse events. The shift towards personalized medicine is reshaping healthcare practices, with a focus on delivering more precise and effective treatments, further fueling the demand for companion diagnostics products.
Opportunities and Challenges
While the increasing importance of companion diagnostics in drug development presents a significant opportunity for market growth, the industry faces challenges. The shortage of adequately trained professionals in companion diagnostic testing poses a hurdle, as these complex technologies require skilled personnel for accurate testing and interpretation.
Market Landscape
The companion diagnostics market is highly consolidated, with major players like F. Hoffmann-La Roche Ltd., Agilent Technologies, Inc., QIAGEN, Thermo Fisher Scientific, Inc., and Abbott Laboratories, Inc. dominating the scene. These industry giants leverage their extensive product portfolios, robust marketing and distribution networks, and substantial R&D budgets to maintain their market dominance, creating barriers for new entrants.
Product and Technology Landscape
In 2023, the assays, kits & reagents segment held the largest market share, driven by the wide variety of available products and their growing utilization across various therapeutic areas. The polymerase chain reaction (PCR) technology segment also captured a significant portion of the market due to its ease of use and the extensive availability of PCR kits & reagents for companion diagnostic testing.
Cancer: A Significant Market Driver
The cancer segment held the largest share of the companion diagnostics market in 2023, fueled by the increasing role of companion diagnostics in personalized cancer treatments and the growing significance of biomarkers in cancer diagnosis. Additionally, tissue samples dominated the sample type segment, as they enable direct analysis of tumors, providing a comprehensive view of genetic mutations and biomarkers for more accurate and personalized treatment decisions.
Regional Landscape
North America, led by the United States and Canada, emerged as the largest regional market for companion diagnostics in 2023. The region’s technological advancements and a high number of product approvals by regulatory authorities like the FDA have driven market growth.
As the companion diagnostics industry continues to evolve, it plays a pivotal role in shaping the future of personalized medicine, enabling healthcare providers to make informed treatment decisions and ultimately improving patient outcomes.
According to a new report by MarketsandMarkets™ – Companion Diagnostics Market in terms of revenue was estimated to be worth $7.5 billion in 2024 and is poised to reach $13.6 billion by 2029, growing at a CAGR of 12.6% from 2024 to 2029.
The global companion diagnostics market is poised for significant growth in the near future, driven by the increasing incidence of cancers worldwide. This rise in cancer cases is fueling the demand for more accurate and personalized treatment options. Companion diagnostics play a crucial role in this scenario by helping to select appropriate targeted therapies for patients based on their genetic makeup and likely response. This personalized approach is expected to improve treatment outcomes while reducing adverse reactions to unsuited medicines. Additionally, the approvals of many targeted oncology drugs, along with complementary companion diagnostics, by regulatory agencies are expected to further propel the market growth. Emerging economies like China, Japan, and India are presenting attractive opportunities for companies operating in this market.
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Based on product & service, the companion diagnostics market is segmented into assays, kits & reagents, instruments/systems and software & services. The dominance of the assays, kits & reagents segment in 2023 can be attributed primarily to the broad range of available products and the rapidly increasing utilization of assays and kits across various therapeutic areas.
Based on technology, the companion diagnostics market is categorized into polymerase chain reaction (PCR), in situ hybridization (ISH), next-generation sequencing (NGS), immunohistochemistry (IHC), and other technologies. In 2023, the PCR segment held the largest portion of the companion diagnostics market. PCR has become essential in companion diagnostics, especially in the interpretive practice by pharmaceutical companies related to oncology drugs, due to its reliability, sensitivity, and ability to obtain quantitative results. Its extensive range of applications and established market presence give it a significant position in the field.
Based on indication, the companion diagnostics market is segmented into cancer, cardiovascular diseases (CVDs), neurological diseases, infectious diseases, and other indications (inflammatory and inherited diseases, among others). In 2023, the cancer segment held the largest share of the companion diagnostics market. This can be attributed to factors such as the expanding role of companion diagnostics in personalized medicine treatments for cancer, as well as the growing importance of biomarkers in cancer diagnosis.
Based on sample type, the companion diagnostics market is segmented into liquid, blood, and other sample types. In 2023, the tissue sample segment accounted for the largest share of the companion diagnostics market. Tissue samples are often preferred in companion diagnostics for their ability to provide a direct analysis of the tumor, offering a comprehensive view of genetic mutations and biomarkers for more accurate and personalized treatment decisions.
Based on end user, the companion diagnostics market is segmented into pharmaceutical & biotechnology companies, reference laboratories, CROs, and other end users (including physician & hospital laboratories and academic medical centers). The pharmaceutical & biotechnology companies segment held the largest share of the companion diagnostics market in 2023. This is primarily driven by factors such as the rising utilization of companion diagnostics in drug development and the growing significance of companion diagnostic biomarkers.
The global companion diagnostics market is divided into six key regions: North America, Europe, Asia Pacific, Latin America, the Middle East & Africa, and GCC countries. In 2023, North America held the largest portion of the companion diagnostics market. The growth of the North American companion diagnostics market can be credited to several factors, including the significant presence of leading companion diagnostics vendors and national clinical laboratories. Additionally, the easy access to technologically advanced devices and instruments, along with the highly developed healthcare systems in the US and Canada, contributed to the market’s expansion in this region.
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Key Market Players of Companion Diagnostics Industry:
The major players in this market are F. Hoffmann-La Roche Ltd (Switzerland), Agilent Technologies, Inc. (US), QIAGEN (Netherlands), Thermo Fisher Scientific Inc. (US), Abbott (US), Almac Group (UK), Danaher (US), Illumina, Inc. (US), bioMérieux (France), Myriad Genetics, Inc. (US), Sysmex Corporation (Japan), ARUP Laboratories (UK), Abnova Corporation (Taiwan), Guardant Health (US), ICON Plc (Ireland), BioGenex (US), Invivoscribe, Inc. (US), ArcherDX, Inc. (Integrated DNA Technologies, Inc.) (US), NG Biotech (France), Q² Solutions (US), Amoy Diagnostics Co., Ltd. (China), Uniogen (Abacus Diagnostica) (Finland), Asuragen, Inc. (Bio-Techne) (US), NG Biotech (France), Meso Scale Diagnostics, LLC. (US), and Creative Biolabs (US).