Companion Diagnostics Global Market Report 2024

Companion diagnostics refer to in vitro diagnostic medical tests employed to assess the safety and effectiveness of a corresponding drug or biological product. These tests play a crucial role in helping healthcare professionals match patients with specific drugs or therapies.

The primary products and services in the companion diagnostics market include assays, kits, reagents, software, and related services. Assays, kits, and reagents find applications in various life science, environmental, and research laboratories. Assays are procedures used to examine substances for composition or quality, kits are collections of equipment and materials for specific purposes, and reagents are chemicals used in laboratory testing. Technologies such as polymerase chain reaction, next-generation sequencing, in situ hybridization, and immunohistochemistry are employed in companion diagnostics. These diagnostic tools are instrumental in identifying various cancer diseases like lung, breast, colorectal, leukemia, and melanoma. The primary users of companion diagnostics include pharmaceutical and biopharmaceutical companies, reference laboratories, and contract research organizations.

The companion diagnostics market research report is one of a series of new reports that provides companion diagnostics market statistics, including companion diagnostics industry global market size, regional shares, competitors with a companion diagnostics market share, detailed companion diagnostics market segments, market trends and opportunities, and any further data you may need to thrive in the companion diagnostics industry. This companion diagnostics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The companion diagnostics market size has grown exponentially in recent years. It will grow from $6.26 billion in 2023 to $7.52 billion in 2024 at a compound annual growth rate (CAGR) of 20.1%. The growth in the historical period can be attributed to the increased adoption of personalized medicine, the expansion of oncology and cancer therapies, heightened collaboration in pharmaceutical research and development, the implementation of precision medicine initiatives, and advancements in biomarker discovery.

The companion diagnostics market size is expected to see exponential growth in the next few years. It will grow to $15.8 billion in 2028 at a compound annual growth rate (CAGR) of 20.4%. The growth in the forecast period can be attributed to the development of targeted therapies, advancements in infectious disease diagnostics, an increase in rare disease diagnostics, rising trends in biomarker-based drug development, the expansion of point-of-care testing, and the application of liquid biopsy. Major trends in the forecast period include advances in immunotherapy and immunology, the integration of AI and machine learning in diagnostics, product innovations, the adoption of Industry 4.0, and strategic collaborations.

The companion diagnostics market is anticipated to experience growth due to the increasing number of targeted therapies. Targeted therapy, which focuses on specific characteristics of cancer cells to hinder their growth and spread, is gaining prominence in cancer treatment. Companion diagnostics, through biological marker-based testing, play a crucial role in personalized cancer care by identifying eligibility for genome-targeted therapy. As per the European Society for Medical Oncology's April 2021 article, the estimated eligibility for genome-targeted therapy increased from 8.82% in previous years to 13.60% in 2020, reflecting the growing adoption of targeted therapies and driving the companion diagnostics market.

The growth of the companion diagnostics market is further propelled by the rising prevalence of chronic diseases. Companion diagnostics are increasingly used in chronic diseases or non-communicable diseases (NCDs) to tailor treatment plans, monitor disease progression, and predict drug resistance. The World Health Organization reported that 74% of global deaths, equivalent to 41 million, are caused by NCDs annually. Notably, diseases such as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes contribute significantly to this burden. The rising incidence of chronic diseases underscores the essential role of companion diagnostics in enhancing patient outcomes and contributing to the overall growth of the market.

A key trend in the companion diagnostics market is technological advancement, particularly the integration of artificial intelligence (AI). AI is being leveraged to develop more efficient drugs and advance companion diagnostics. The extensive genetic profiling data sets, continuously generated, enable the application of AI to identify insights into disease causes. For example, Toronto-based start-up Deep Genomics is utilizing AI to expedite the discovery of better medications for genetic illnesses. Through deep learning, scientists can explore the human genome, analyze billions of chemical compounds, and identify promising formulations for clinical trials. This application of AI in companion diagnostics aligns with the broader trend of technological innovation, driving advancements in the field.

Prominent companies in the companion diagnostics market are pioneering innovative treatment solutions, exemplified by products like therascreen KRAS PCR Mutation Analysis. This diagnostic test is designed for identifying non-small cell lung cancer (NSCLC) patients and is specifically tailored for Amgen's lung cancer therapy, LUMAKRAS (sotorasib). The test, performed on tumor tissue samples, delivers results promptly, typically within a few days. Laboratory Corporation of America Holdings, a leading US-based healthcare company, launched this companion diagnostic in July 2021. It plays a crucial role in identifying patients with NSCLC whose tumors harbor the specific genetic mutation KRAS G12C. Beyond facilitating targeted therapies, the test prevents patients from undergoing ineffective treatments with potential serious side effects.

In a strategic move, Agilent Technologies Inc., a major player in analytical laboratory solutions, acquired Resolution Bioscience for $695 million in April 2021. This acquisition fortified Agilent's position in next-generation sequencing (NGS)-based cancer diagnostics. Resolution Bioscience, a US-based healthcare research company, specializes in NGS technology, molecular biology, and cancer diagnostics. The acquisition empowered Agilent to meet the escalating demands of the precision medicine sector, reflecting the industry's commitment to advancing technologies and expanding capabilities in the companion diagnostics market.

Major companies operating in the companion diagnostics market include F Hoffmann-La Roche Ltd., Agilent Technologies Inc., Qiagen NV, Thermo Fisher Scientific Inc., Abbott Laboratories Inc., Abnova Corp., Amoy Diagnostics Co. Ltd., ARUP Laboratories, Bayer AG, Biomerieux SA, Danaher Corporation, Guardant Health Inc., Illumina Inc., Myriad Genetics Inc., Siemens Healthcare GmbH, Almac Group, Biogenex Laboratories Inc., Caris Life Sciences, Cepheid Inc., Diaceutics PLC, Epic Sciences Inc., Foundation Medicine Inc., Genomic Health Inc., Grail Inc., Hologic Inc., HTG Molecular Diagnostics Inc., Inivata Ltd., Invivoscribe Inc., MolecularMD Corporation, Natera Inc., NeoGenomics Laboratories Inc., Personal Genome Diagnostics Inc., Precision Therapeutics Inc., Prometheus Laboratories Inc., Sividon Diagnostics GmbH, Sysmex Corporation, Ventana Medical Systems, Vermillion Inc.

North America was the largest region in the companion diagnostics market in 2023. The regions covered in the companion diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the companion diagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK and USA.

The companion diagnostics market includes revenues earned by theranostics and monitoring tests. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


This product will be delivered within 3-5 business days.