Companion Diagnostics Market

Global Companion Diagnostics Market:

The global companion diagnostics market size reached USD 7.6 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 22.3 Billion by 2033, exhibiting a growth rate (CAGR) of 12.11% during 2025-2033. The rising incidences of cancer, the increasing demand for personalized medicine, and continuous technological advancements, including next-generation sequencing (NGS), are some of the primary factors driving the market growth.

Global Companion Diagnostics Market Analysis:

• Major Market Drivers: The growing need for more targeted and effective cancer treatments is positively influencing the companion diagnostics market outlook. Additionally, the increasing usage of personalized medicines tailored to each unique characteristics of patients is also stimulating the companion diagnostics market demand.
• Key Market Trends: One of the emerging trends propelling the companion diagnostics market value is the inflating demand for targeted therapies and drugs to treat various neurological, cardiovascular, and inflammatory conditions. Besides this, continuous advancements in diagnostic technologies, such as the development of next-generation sequencing (NGS), represent growth factors stimulating the companion diagnostics market revenue.
• Geographical Trends: According to the companion diagnostics market research, North America currently dominates the global market. The increasing number of tests receiving approval from governing authorities, including the United States Food and Drug Administration (US FDA), is augmenting the regional market. Furthermore, they are also focusing on clinical trials, thereby stimulating the companion diagnostics market revenue in North America.
• Competitive Landscape: According to the companion diagnostics market overview, some of the prominent companies in the global market include Abbott Laboratories, Agilent Technologies, BioMerieux, Danaher Corporation, Roche Holding AG, Myriad Genetics Inc., Siemens Healthcare, and Thermo Fisher Scientific Inc., among many others.
• Challenges and Opportunities: One of the primary challenges hindering the companion diagnostics market forecast is the extensive drug attrition rate during clinical trials, which, in turn, poses financial constraints for diagnostics providers. However, the co-development of companion diagnostics, along with therapeutic products, is streamlining the commercialization of drug candidates.

Global Companion Diagnostics Market Trends:

 Rising Need for Targeted Therapies

The increasing adoption of companion diagnostic tests (CDXs) in decision-making for treatment related to targeted therapies in lung cancer is augmenting the market growth. Additionally, patients who receive companion diagnostics as part of their initial treatment have more survival benefits than those who are not tested. Besides this, the increasing prevalence of non-small cell lung cancer (NSCLC) is inflating the usage of oncology companion diagnostic tests for the disease. According to the Lung Cancer Research Foundation, an estimated 236,740 individuals were diagnosed with lung cancer in 2022 across the United States, thereby fueling the demand for lung cancer companion diagnostics. The elevating number of tests receiving approval from governing authorities is also bolstering the market. For example, in August 2022, the U.S. FDA granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify individuals whose tumors have a HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small cell lung cancer (NSCLC).

Favorable Regulatory Landscape for Companion Diagnostics

Government bodies and key companies across the countries are focusing on drug approvals to cater to unmet cancer care needs. For instance, in January 2022, PREMIA Holdings (HK) Limited and Amoy Diagnostics Co. Ltd developed the AmoyDx Pan Lung Cancer PCR Panel (the 'PLC Panel') in Japan as a reimbursed companion diagnostic for numerous anti-cancer agents. Similarly, in October 2021, the United States Food and Drug Administration approved Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis), which helped in identifying patients with early breast cancer (EBC) at an elevating risk of disease recurrence. In addition, in August 2023, Agilent Technologies, Inc. received European IVDR certification for companion diagnostic assay. These approvals encourage key players to develop enhanced companion diagnostic tests, which are expected to augment the global market over the forecasted period.

Development of Novel Tests

Key players are focusing on launching advanced tests for companion diagnostics by collaborating with other prominent players, thereby resulting in better patient outcomes. For instance, in February 2022, Genetron Holdings Limited, a major precision oncology platform company in China specializing in early cancer screening products, molecular profiling tests, and companion diagnostics development, entered into an agreement with HUTCHMED (China) Limited to introduce a companion diagnostic (CDx). Furthermore, key market players are also developing enhanced therapeutic options. For example, in July 2021, Labcorp launched Therascreen KRAS PCR Mutation Analysis, which is a companion diagnostic to identify patients suffering from non-small cell lung cancer (NSCLC) who are eligible for therapy with LUMAKRAS (sotorasib).

Companion Diagnostics Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2025-2033. Our report has categorized the market based on product & service, technology, indication, and end user. 

Breakup by Product & Service:

• Assays, Kits and Reagents
• Software and Services
   

Assays, kits and reagents hold the largest market share

The report has provided a detailed breakup and analysis of the companion diagnostics market based on the product & service. This includes assays, kits and reagents, and software and services. According to the report, assays, kits, and reagents represented the largest segment.

Assays, kits, and reagents play important roles in identifying patients who are most likely to benefit from a particular therapeutic product. These diagnostic tools aid in determining the absence or presence of specific biomarkers, protein expressions, genetic mutations, etc., linked to the potential side effects and effectiveness of targeted therapies. This, in turn, is propelling the market growth in this segment.

Breakup by Technology:

• Immunohistochemistry (IHC)
• Polymerase Chain Reaction (PCR)
• In-situ Hybridization (ISH)
• Real-time PCR (RT-PCR)
• Gene Sequencing
• Others
   

Polymerase chain reaction (PCR) exhibits a clear dominance in the market

The report has provided a detailed breakup and analysis of the market based on the technology. This includes immunohistochemistry (IHC), polymerase chain reaction (PCR), in-situ hybridization (ISH), real-time PCR (RT-PCR), gene sequencing, and others. According to the report, polymerase chain reaction (PCR) accounted for the largest market share.

The growth in this segmentation is bolstered by the easy availability of polymerase chain reaction (PCR) kits and reagents used for companion diagnostics. Moreover, their widespread applications in detecting gene mutations with low or limited allele frequencies are contributing to their dominance in the global market.

Breakup by Indication:

• Cancer
  • Lung Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Melanoma
  • Others
• Neurological Diseases
• Infectious Diseases
• Cardiovascular Diseases
• Others
   

Cancer currently accounts for the majority of the total market share

The report has provided a detailed breakup and analysis of the market based on the indication. This includes cancer (lung cancer, breast cancer, colorectal cancer, gastric cancer, melanoma, and others), neurological diseases, infectious diseases, cardiovascular diseases, and others. According to the report, cancer represented the largest segment.

The widespread incidence of cancer is propelling the usage of companion diagnostics, thereby fueling the market growth in this segmentation. According to the American Cancer Society, in January 2022, 1.9 million cancer cases were recorded in the U.S. Consequently, continuous product launches and approvals by government bodies are positively influencing the companion diagnostics market growth in this segmentation. For example, in October 2021, the United States Food and Drug Administration approved Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis), which assisted in identifying patients with early breast cancer (EBC). Besides this, according to the Lung Cancer Research Foundation, in the United States estimated 236,740 individuals were diagnosed with lung cancer in 2022, thereby propelling the need for lung cancer companion diagnostics.

Breakup by End User:

• Pharmaceutical & Biopharmaceutical Companies
• Reference Laboratories
• Contract Research Organizations
• Others
   

Pharmaceutical & biopharmaceutical companies hold the largest market share

The report has provided a detailed breakup and analysis of the market based on the end user. This includes pharmaceutical & biopharmaceutical companies, reference laboratories, contract research organizations, and others. According to the report, pharmaceutical & biopharmaceutical companies accounted for the largest market share. 

The rising adoption of companion diagnostics by pharmaceutical & biopharmaceutical companies in drug development is one of the primary factors propelling the market growth in this segmentation. Moreover, the inflating popularity of companion diagnostics biomarkers is also acting as another significant growth-inducing factor.

Breakup by Region:

• North America
  • United States
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

North America leads the market, accounting for the largest companion diagnostics market share

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share. 

North America currently dominates the global market, with the United States emerging as a major contributor. Strategic collaborations among biopharmaceutical companies and companion diagnostic manufacturers are primarily augmenting the regional market. For example, QIAGEN and Denovo Biopharma partnered to develop a companion diagnostic test for the treatment of diffuse large B-Cell Lymphoma (DLBCL). Furthermore, the increasing drug approvals by governing authorities, such as the United States Food and Drug Administration (US FDA), are projected to bolster the companion diagnostics market in North America over the forecasted period.

Leading Key Players in the Companion Diagnostics Industry:

The market research report has provided a comprehensive analysis of the competitive landscape. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

• Abbott Laboratories
• Agilent Technologies
• BioMerieux
• Danaher Corporation
• Roche Holding AG
• Myriad Genetics Inc.
• Siemens Healthcare
• Thermo Fisher Scientific Inc.
   

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Global Companion Diagnostics Market News:

• March 2024: Thermo Fisher Scientific announced a collaboration with Bayer AG BAYRY to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx).
• February 2024: Roche has partnered with PathAI to leverage artificial intelligence (AI) to introduce algorithms for companion diagnostics.
• December 2023: A German electronics firm, Siemens, contracted to commercialize and develop companion diagnostics by Pfizer.

Companion Diagnostics Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the companion diagnostics market from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the global companion diagnostics market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the companion diagnostics industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.