United States Companion Diagnostics Market 2025 | Growth Drivers, Trends & Market Forecast, Competitive Landscape & Investment Opportunities

Market Size and Growth

The global companion diagnostics market reached US$6.1 billion in 2022 and is projected to witness lucrative growth by reaching up to US$15.0 billion by 2030. The global companion diagnostics market is expected to exhibit a CAGR of 12.2% during the forecast period (2024-2031), according to DataM Intelligence report.

Key Development:

United States: Recent Industry Developments

✅ In September 2025, Illumina announced new partnerships with multiple global pharmaceutical companies to develop companion diagnostics focusing on KRAS alterations. These collaborations aim to advance precision oncology by enabling standardized, globally distributable tests.

✅ In July 2025, Roche received U.S. FDA approval for the VENTANA MET (SP44) RxDx Assay, the first companion diagnostic to identify a form of lung cancer in patients eligible for targeted treatment. Additionally, the company received Breakthrough Device Designation for its AI-driven companion diagnostic for non-small cell lung cancer.

✅ In June 2025, QIAGEN and Incyte unveiled a collaboration to develop a multimodal companion diagnostic for patients with mutant CALR-expressing myeloproliferative neoplasms. The diagnostic leverages next-generation sequencing to facilitate highly accurate testing for several blood cancer genes simultaneously.

Japan: Recent Industry Developments

✅ In September 2025, Japan's Ministry of Health, Labour and Welfare (MHLW) approved the use of a companion diagnostic test for HER2-positive breast cancer patients. This approval facilitates the use of targeted therapies, marking a significant step in personalized medicine within the country.

✅ In August 2025, Labcorp announced its collaboration with pharmaceutical sponsors to bring companion diagnostics therapies to market in Japan. The partnership focuses on securing regulatory approval for corresponding in vitro diagnostics, aligning with therapeutic product development and launch schedules.

✅ In July 2025, a consortium of Japanese pharmaceutical companies initiated a joint venture to develop companion diagnostics for lung cancer. The project aims to enhance the precision of targeted therapies, reflecting Japan's commitment to advancing personalized medicine.

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Companion Diagnostics are medical tests designed to identify patients who are most likely to benefit from a specific therapy or medication. By analyzing genetic, molecular, or biomarker information, they enable personalized treatment, improve drug efficacy, reduce adverse effects, and support precision medicine strategies.

Recent Mergers and Acquisitions:

United States: Recent M&A Activity

✅ In July 2025, Waters Corporation announced a $17.5 billion merger with Becton Dickinson's Biosciences & Diagnostic Solutions division. This strategic move aims to expand Waters' presence in bioseparations, bioanalytical characterization, and multiplex diagnostics, effectively doubling its total addressable market to $40 billion.

✅ In September 2025, Brookfield agreed to acquire Antylia Scientific for $1.4 billion. This acquisition enhances Brookfield's portfolio in laboratory equipment manufacturing, particularly in diagnostics, by integrating Antylia's extensive product offerings and expertise in infectious disease diagnostics and wastewater analysis.

✅ In June 2025, Thermo Fisher Scientific initiated plans to divest its microbiology unit, valued at approximately $4 billion. This strategic decision is part of Thermo Fisher's efforts to streamline its portfolio by shedding low-growth assets, focusing on areas with higher growth potential.

Europe: Recent M&A Activity

✅ In July 2025, Waters Corporation announced a $17.5 billion merger with Becton, Dickinson and Company's Biosciences & Diagnostic Solutions division. This strategic move aims to expand Waters' presence in bioseparations, bioanalytical characterization, and multiplex diagnostics, effectively doubling its total addressable market to $40 billion.

✅ In January 2025, ArchiMed, a European private equity firm, agreed to sell Italian in vitro diagnostics company Diesse Diagnostica Senese to Fremman Capital for approximately €125 million. This transaction resulted in a net return of 4.6 times the original investment for ArchiMed's investors, equating to an internal rate of return between 25% and 30%.

Middle East: Recent M&A Activity

✅ In September 2025, Co-Diagnostics signed a Memorandum of Understanding (MOU) with Saudi Arabia to establish a joint venture for PCR manufacturing and distribution in the Middle East. This collaboration aligns with Saudi Vision 2030 and aims to advance Co-DxTM PCR platform and diagnostic intellectual property, expanding access to molecular testing across the MENA region.

Key Players:

=> F. Hoffmann-La Roche Ltd., Agilent Technologies, Inc., Qiagen N.V., Thermo Fisher Scientific, Inc., Abbott Laboratories, Inc., Biomerieux SA, Siemens Healthcare, Thermo Fisher Scientific Inc., Danaher Corporation (Beckman Coulter Inc.), Guardant Health and Illumina Inc and others.

Growth Forecast Projected:

The Global Companion Diagnostics Market is anticipated to rise at a considerable rate during the forecast period, between 2024 and 2031. In 2023, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Companion Diagnostics Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

➥ By Indications: Oncology (Colorectal Cancer, Leukemia, Breast Cancer, Lung Cancer, Others), Neurology, Others
➥ By Technology: In-situ Hybridization, Immunohistochemistry, Polymerase Chain Reaction, Next-Generation Sequencing, Others
➥ By End-User: Pharmaceutical and Biopharmaceutical Companies, Research Laboratories, Others

Regional Analysis for Companion Diagnostics Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Companion Diagnostics producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Companion Diagnostics revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FAQ

What is the current size of the Companion Diagnostics Market?

A: In 2022, the Companion Diagnostics Market was valued at US$6.1 billion, reflecting its strong industry presence.

Q2: How large is the Companion Diagnostics Market expected to be by 2030?

A: By 2030, industry forecasts suggest the Companion Diagnostics Market will grow to around US$15.0 billion , demonstrating significant expansion.

Q3: What is the growth rate of the Companion Diagnostics Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 12.2% during the forecast period from 2024 to 2031.

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