Companion Diagnostics

Global Companion Diagnostics Market to Reach US$15.4 Billion by 2030

The global market for Companion Diagnostics estimated at US$15.1 Billion in the year 2024, is expected to reach US$15.4 Billion by 2030, growing at a CAGR of 0.3% over the analysis period 2024-2030. Assay kits & Reagents, one of the segments analyzed in the report, is expected to record a -0.4% CAGR and reach US$9.7 Billion by the end of the analysis period. Growth in the Software & Services segment is estimated at 1.7% CAGR over the analysis period.

The U.S. Market is Estimated at US$4.2 Billion While China is Forecast to Grow at -0.3% CAGR

The Companion Diagnostics market in the U.S. is estimated at US$4.2 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$2.4 Billion by the year 2030 trailing a CAGR of -0.3% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of -1.2% and -1.8% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately -3.3% CAGR.

Companion Diagnostics - Key Trends and Drivers

Companion diagnostics are an integral component of precision medicine, designed to identify the suitability of specific treatments for individual patients based on their unique genetic makeup or other biomarkers. These diagnostic tests are critical in the field of oncology, where they help determine the most effective therapies for cancer patients, ensuring treatments are tailored to the molecular profile of a patient`s tumor. By enabling personalized treatment plans, companion diagnostics improve the efficacy and safety of therapies, reduce adverse effects, and ultimately enhance patient outcomes. They work by identifying patients who are most likely to benefit from a particular therapeutic product, ensuring that the right drug is administered to the right patient at the right time. This approach is transforming the landscape of medical treatment, moving away from the one-size-fits-all model to more targeted and individualized care.

The technological advancements in molecular diagnostics and genomics are significantly driving the evolution of companion diagnostics. Next-generation sequencing (NGS) and polymerase chain reaction (PCR) are among the key technologies that have enhanced the precision and speed of companion diagnostics. These technologies enable comprehensive genomic profiling and accurate detection of genetic mutations and alterations associated with various diseases, particularly cancer. Additionally, the integration of artificial intelligence (AI) and machine learning in data analysis has further refined the accuracy of these diagnostics, allowing for more precise and reliable results. The development of multiplex assays, which can detect multiple biomarkers simultaneously, has also expanded the scope and efficiency of companion diagnostics. This technological progress is not only improving diagnostic capabilities but also fostering collaborations between pharmaceutical companies and diagnostic manufacturers to co-develop drugs and companion tests, thereby accelerating the delivery of personalized therapies to patients.

The growth in the companion diagnostics market is driven by several factors. The increasing prevalence of cancer and other chronic diseases necessitates the development of targeted therapies, which in turn boosts the demand for companion diagnostics. Regulatory agencies, such as the FDA, are emphasizing the importance of companion diagnostics in the drug approval process, encouraging pharmaceutical companies to incorporate these tests into their clinical development strategies. The rise of precision medicine and the growing adoption of personalized treatment approaches are also propelling market growth. Furthermore, advancements in molecular diagnostics technologies, such as NGS and digital PCR, are enhancing the accuracy and efficiency of companion diagnostics, making them more accessible and reliable. The expansion of biomarker discovery and the increasing use of biomarkers in drug development are generating new opportunities for the market. Additionally, the collaboration between diagnostic companies and pharmaceutical firms is fostering innovation and accelerating the development of new companion diagnostics. These factors collectively contribute to the robust growth and widespread adoption of companion diagnostics, transforming the landscape of personalized medicine and improving patient care.

SCOPE OF STUDY:

The report analyzes the Companion Diagnostics market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Product & Service (Assay kits & Reagents, Software & Services); Technology (Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next-Generation Sequencing (NGS), Other Technologies); Indication (Oncology, Neurology, Other Indications); End-Use (Pharmaceutical & Biopharmaceutical Companies, Reference Laboratories, CROs, Other End-Uses)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 47 Featured) -

• Abbott Molecular
• Agilent Technologies, Inc.
• bioMérieux SA
• Cepheid
• Danaher Corporation
• F. Hoffmann-La Roche Ltd.
• Foundation Medicine Inc.
• Laboratory Corporation of America® Holdings
• Leica Biosystems Nussloch GmbH
• Merck & Co. Inc.
• Myriad Genetics Inc.
• NeoGenomics Laboratories, Inc.
• QIAGEN N.V.
• Quest Diagnostics Inc.
• Thermo Fischer Scientific Inc.

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

To our valued clients, we say, we have your back. We will present a simplified market reassessment by incorporating these changes!

APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

USA
CHINA
MEXICO
CANADA
EU
JAPAN
INDIA
176 OTHER COUNTRIES.

Leading Economists - Our knowledge base tracks 14,949 economists including a select group of most influential Chief Economists of nations, think tanks, trade and industry bodies, big enterprises, and domain experts who are sharing views on the fallout of this unprecedented paradigm shift in the global econometric landscape. Most of our 16,491+ reports have incorporated this two-stage release schedule based on milestones.

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