Companion Diagnostics (CDx) Development Market Size Worth USD 1,755.79 Million by 2034 | CAGR: 7.6%

The global companion diagnostics (CDx) development market size is expected to reach USD 1,755.79 million by 2034, according to a new study by Polaris Market Research. The report “Companion Diagnostics (Cdx) Development Market Size, Share, Trends, Industry Analysis Report By Type of Service (Feasibility Studies, Assay Development), By Analytical Technique, By Target Therapeutic Area, By End User, By Region – Market Forecast, 2025–2034” gives a detailed insight into current market dynamics and provides analysis on future market growth.

The companion diagnostics (CDx) development market revolves around the creation and production of specialized diagnostic tests that are intricately linked with specific therapeutic drugs. These tests are vital for providing crucial information that guides healthcare professionals in determining which patients are most likely to benefit from a particular treatment. By identifying specific biomarkers or genetic characteristics, CDx ensures that treatments are tailored to individual patients, thereby enhancing both the safety and effectiveness of medications while minimizing the risk of adverse reactions. This co-development approach between a drug and its diagnostic is a cornerstone of precision medicine, moving healthcare toward more personalized and targeted interventions.

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The companion diagnostics development market is experiencing strong growth, driven by a global push toward personalized medicine and the increasing complexity of diseases, especially cancer. As more targeted therapies are developed, the demand for CDx to identify eligible patient populations continues to rise. Advancements in molecular biology, genomics, and analytical techniques such as next-generation sequencing (NGS) are also fueling innovation in this sector, allowing for the discovery of new biomarkers and the development of more sophisticated diagnostic tools. Regulatory agencies play a key role in shaping this market by providing guidelines for the co-development and approval of CDx, further integrating these diagnostics into mainstream medical practice.

Companion Diagnostics Development Market Report Highlights:

• By type of service, the clinical validation segment held the largest share in 2024 due to its essential role in demonstrating a diagnostic's effectiveness in real-world patient settings. Robust clinical validation is critical for regulatory approval, ensuring the test accurately predicts patient response to a specific drug.
• By analytical technique, the polymerase chain reaction (PCR) segment held the largest share in 2024 owing to its proven reliability, cost-effectiveness, and widespread use in clinical labs. Its high sensitivity and specificity in detecting genetic targets make it a fundamental technology for identifying biomarkers that guide targeted therapies.
• By target therapeutic area, the oncological disorders segment held the largest share in 2024, primarily driven by the high global prevalence of various cancers and the increasing adoption of personalized medicine in cancer treatment. Companion diagnostics are vital for selecting patients who will best respond to specific cancer therapies.
• By end user, the industry players segment held a larger share in 2024 due to their significant investments in drug discovery and their inherent need to co-develop CDx alongside new therapeutics. Their extensive resources and global commercial networks enable them to navigate complex regulatory requirements and drive CDx adoption.
• By region, North America held the largest share of the global companion diagnostics market in 2024, benefiting from its advanced healthcare infrastructure, high healthcare spending, and a supportive regulatory environment that encourages the rapid adoption of new diagnostic technologies.
• The companion diagnostics development market includes active players such as F. Hoffmann-La Roche Ltd.; QIAGEN N.V.; Agilent Technologies, Inc.; Abbott Laboratories; Illumina, Inc.; Myriad Genetics, Inc.; Sysmex Corporation; BioMérieux SA; Thermo Fisher Scientific Inc.; Labcorp; Quest Diagnostics; and Guardant Health, Inc.

Polaris Market Research has segmented the CDx development market report on the basis of type of service, analytical technique, target therapeutic area, end user, and region:

By Type of Service Outlook (Revenue – USD Million, 2020–2034)

• Feasibility Studies
• Assay Development
• Analytical Validation
• Clinical Validation
• Manufacturing

By Analytical Technique Outlook (Revenue – USD Million, 2020–2034)

• NGS
• PCR
• IHC
• Flow Cytometry
• Others

By Target Therapeutic Area Outlook (Revenue – USD Million, 2020–2034)

• Oncological Disorders
• Non-oncological Disorders

By End User Outlook (Revenue – USD Million, 2020–2034)

• Industry Players
• Non-Industry Players

By Regional Outlook (Revenue – USD Million, 2020–2034)

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Netherlands
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Malaysia
  • South Korea
  • Indonesia
  • Australia
  • Vietnam
  • Rest of Asia Pacific
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Israel
  • South Africa
  • Rest of Middle East & Africa
• Latin America
  • Mexico
  • Brazil
  • Argentina
  • Rest of Latin America