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
- Published Date:Jul-2025
- Pages: 130
- Format: PDF
- Report ID: PM5955
- Base Year: 2024
- Historical Data: 2020-2023
Overview
The global companion diagnostics (CDx) development market size was valued at USD 845.99 million in 2024 and is anticipated to register a CAGR of 7.6% from 2025 to 2034. The market is primarily driven by the increasing adoption of personalized medicine, which aims to tailor treatments to individual patients.
Key Highlights
- By type of service, the clinical validation segment held the largest share in 2024.
- In terms of analytical technique, the polymerase chain reaction (PCR) segment held the largest share in 2024.
- Based on target therapeutic area, the oncological disorders segment held the largest share in 2024.
- The industry players segment, by end user, held the largest share in 2024 due to their significant investments in drug discovery.
- By region, North America held the largest share of the companion diagnostics development in 2024.
The companion diagnostics development involves creating and producing diagnostic tests that are paired with specific therapeutic drugs. These tests provide vital information to help doctors decide if a particular treatment will be safe and effective for an individual patient. This co-development ensures that the right drug is given to the right patient, enhancing treatment outcomes and minimizing adverse effects.
The evolving and increasingly supportive regulatory landscape is a significant driver for the companion diagnostics development. Regulatory bodies worldwide, such as the U.S. FDA and the European Medicines Agency (EMA), have recognized the critical role of CDx in ensuring the safe and effective use of targeted therapies. They have established clearer guidelines and pathways for the co-development and approval of drugs and their associated diagnostics. This regulatory clarity provides a more predictable environment for pharmaceutical and diagnostic companies, encouraging investments and accelerating the development of new CDx. The streamlined approval processes and emphasis on robust clinical evidence further drive innovation and market entry.
Continuous advancements in diagnostic technology serve as a powerful driver for the companion diagnostics development. Innovations in molecular diagnostics, particularly the evolution of technologies such as Next-Generation Sequencing (NGS), digital PCR, and advanced immunohistochemistry (IHC), are enabling the identification of increasingly complex biomarkers with greater precision and efficiency. These technological leaps allow for more comprehensive genomic profiling, liquid biopsy applications, and the detection of subtle genetic variations that were previously undetectable. The ability to offer more accurate, faster, and less invasive diagnostic solutions expands the potential applications of CDx, making them indispensable for guiding a wider range of targeted therapies and improving patient outcomes.
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Industry Dynamics
- Growing adoption of personalized medicine is driving the growth.
- The rising incidence of cancer is driving the demand for more effective and targeted therapies, which often rely on CDx.
- Advancements in next-generation sequencing (NGS) are projected to create a lucrative opportunity.
Growing Adoption of Personalized Medicine:
The shift toward personalized medicine is a significant driving force of the CDx development. This approach aims to provide the right treatment to the right patient at the right time, minimizing side effects and improving outcomes. Companion diagnostics are essential tools in this process, as they help identify specific biomarkers that indicate whether a patient will respond to a particular therapy.
The Personalized Medicine Coalition (PMC) reported in their "Personalized Medicine at FDA: The Scope & Significance of Progress in 2023" that personalized medicines accounted for over one-third of new U.S. Food and Drug Administration (FDA) drug approvals in 2023, marking the fourth consecutive year this trend has continued. This consistent approval rate highlights the increasing integration of personalized medicine into standard healthcare practices. This ongoing trend in personalized medicine adoption boosts the need for companion diagnostics, thereby driving the growth.
Rising Incidence of Cancer:
The increasing global incidence of cancer propels the demand for CDx development. Cancer is a leading cause of death worldwide, and as the number of new cases continues to rise, there is an urgent need for more precise and effective treatment options. Companion diagnostics play a critical role in oncology by helping to select patients who are most likely to benefit from targeted cancer therapies.
According to the World Health Organization (WHO), an estimated 20 million new cancer cases were reported in 2022, resulting in approximately 9.7 million deaths. They also estimate that about 1 in 5 individuals will develop cancer during their lifetime. This growing global cancer burden directly increases the demand for companion diagnostics, as these tests are crucial for guiding the use of targeted therapies.
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Segmental Insights
Type of Service Analysis
The clinical validation segment held the largest share in 2024. This dominance stems from its critical role in the development process. Once an assay (test) has been designed and proven to work technically through analytical validation, clinical validation is essential to demonstrate that the diagnostic truly identifies patients who will benefit from a specific treatment in a real-world setting. This involves extensive studies on patient samples to confirm the test's clinical utility, sensitivity, and specificity, directly linking the diagnostic's performance to patient outcomes. The rigorous regulatory requirements for CDx, especially from agencies such as the U.S. FDA, heavily emphasize robust clinical validation data. Without this crucial step, a companion diagnostic cannot be approved for clinical use alongside its corresponding drug, making it a leading segment in the overall development services.
The analytical validation segment is anticipated to register the highest growth rate during the forecast period. While clinical validation remains paramount for regulatory approval and entry, the accelerating pace of biomarker discovery and the introduction of novel diagnostic technologies, such as next-generation sequencing (NGS) and digital pathology, are driving significant investments in analytical validation. This stage focuses on confirming the technical performance of a diagnostic assay, including its accuracy, precision, reproducibility, and robustness, before it progresses to expensive and lengthy clinical trials. With the increasing complexity of new biomarkers and the need for highly sensitive and specific tests, ensuring the analytical integrity of these assays upfront is becoming even more critical, leading to substantial growth in this preparatory phase of CDx development.
Analytical Technique Analysis
The polymerase chain reaction (PCR) segment held the largest share in 2024, due to its established reliability, cost-effectiveness, and widespread adoption in clinical laboratories worldwide. PCR-based tests are known for their high sensitivity and specificity in detecting specific DNA or RNA sequences, making them ideal for identifying genetic mutations, gene amplifications, or viral loads that are crucial biomarkers for targeted therapies. The relative simplicity of PCR assays, combined with the availability of numerous validated kits and automated platforms, contributes significantly to its dominant position. Its versatility in diagnosing various conditions, especially in oncology for detecting specific mutations that guide cancer treatment, has solidified its foundational role in the companion diagnostics landscape.
The next-generation sequencing (NGS) segment is anticipated to register the highest growth rate during the forecast period. While PCR excels at detecting known, specific genetic variations, NGS offers a comprehensive approach by sequencing millions of DNA fragments simultaneously. This capability allows for the discovery of novel biomarkers and the simultaneous analysis of multiple genes or even entire genomes, providing a much broader molecular profile of a patient's condition. As personalized medicine evolves to encompass more complex genomic insights, NGS becomes indispensable for identifying intricate genetic signatures that predict treatment response or resistance. The ongoing advancements in sequencing technology, coupled with decreasing costs and increasing computational power to analyze large datasets, are accelerating the adoption of NGS in CDx development.
Target Therapeutic Area Analysis
The oncological disorders segment held the largest share in 2024. This dominance is attributed to several key factors, primarily the high prevalence and increasing incidence of various cancers globally, coupled with a significant shift toward personalized medicine in cancer treatment. Many targeted cancer therapies are effective only in patients who possess specific genetic mutations or biomarkers, making companion diagnostics absolutely essential for patient selection. The complex nature of cancer, with its diverse molecular subtypes, further drives the need for precise diagnostic tools to guide treatment decisions and monitor disease progression.
The non-oncological disorders segment is anticipated to witness the highest growth rate during the forecast period. Although historically a smaller part, there is a growing recognition of the role of personalized medicine in other therapeutic areas, such as neurological disorders, cardiovascular diseases, and infectious diseases. As research uncovers more specific biomarkers and genetic predispositions for these conditions, the demand for CDx tests to identify appropriate patient populations for new targeted therapies is expanding rapidly. The development of therapies for rare genetic diseases and autoimmune conditions also contributes to this segment's accelerated growth, as precision diagnostics are crucial for these specialized treatments.
End User Analysis
The industry players segment held a larger share in 2024. The segment primarily includes pharmaceutical and biotechnology companies, as well as large diagnostics companies. Their leadership stems from their significant financial investments in drug discovery and development, where CDx are often co-developed alongside novel therapeutics. These organizations possess the extensive resources, R&D capabilities, and global commercial networks required to navigate the complex regulatory pathways for both drugs and their companion diagnostics. They also have a vested interest in the success of their targeted therapies, making the development of accurate and reliable CDx a strategic imperative. This integrated approach, from drug research to commercialization, solidifies the industry players' leading position in the CDx development landscape.
The non-industry players segment, which encompasses academic and research institutions, contract research organizations (CROs), and reference laboratories, is anticipated to record the highest growth rate during the forecast period. While industry players drive the initial co-development of CDx, non-industry players are increasingly crucial for specialized services. Academic centers often lead in biomarker discovery outsourcing and early-stage research, laying the groundwork for new CDx. CROs provide essential services such as clinical trial management, analytical and clinical validation, and regulatory support, often offering a more flexible and cost-effective solution for smaller biotech firms or for specific stages of CDx development. Reference laboratories, with their vast infrastructure and expertise in high-volume testing, play a vital role in the widespread adoption and commercialization of approved CDx tests.
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Regional Analysis
The North America compassion diagnostics (CDx) development market accounted for the largest share in 2024. This dominance is driven by its advanced healthcare infrastructure, high healthcare spending, and a robust regulatory system that supports the quick approval of new diagnostic technologies. There is a strong focus on personalized medicine and targeted therapies, particularly for chronic diseases such as cancer, which drives the demand for CDx. Leading research institutions and biotechnology companies in the region are continuously focusing on innovation, further fueling expansion through new diagnostic methods and product launches.
U.S. Companion Diagnostics Development Market Insights
In North America, the U.S. is a leading country in the field of companion diagnostics development. The country benefits from substantial investments in healthcare, a high prevalence of chronic diseases, especially cancer, and a strong regulatory environment that encourages the development and adoption of precision medicine. The U.S. Food and Drug Administration (FDA) has actively supported the co-development of drugs and their companion diagnostics, providing clear guidelines for their approval. This supportive ecosystem, along with a high level of patient awareness and accessibility to advanced medical technologies, contributes to the continuous expansion of the CDx development in the US.
Europe Companion Diagnostics Development Market Trends
Europe represents a substantial and evolving region in the companion diagnostics development landscape, driven by increasing healthcare expenditure, a rising elderly population, and a growing emphasis on personalized medicine. The region's robust research and development activities, particularly in oncology companion diagnostics, contribute significantly to the demand for CDx. European regulatory bodies, such as the European Medicines Agency (EMA), have established frameworks for the approval of companion diagnostics, which helps streamline their entry. The presence of a the strong pharmaceutical and biotechnology sector, coupled with increasing collaborations between diagnostic and drug developers, further supports the growth trajectory across the region.
The Germany companion diagnostics (Cdx) market plays a key role in Europe. The country boasts a highly developed healthcare system, strong research capabilities, and a proactive approach to adopting innovative medical technologies. There is a significant focus on precision medicine in Germany, especially in cancer treatment, which fuels the demand for CDx. The German regulatory landscape, while stringent, is also well-defined, providing a clear path for the approval and reimbursement of companion diagnostics. This combination of advanced healthcare, research excellence, and a supportive regulatory environment makes Germany a leading contributor to the regional growth.
Asia Pacific Companion Diagnostics Development Market Overview
Asia Pacific is rapidly emerging as a dynamic and fast-growing region in the global companion diagnostics development landscape. This growth is propelled by improving healthcare infrastructure, increasing awareness of personalized medicine, and a rising burden of chronic diseases, particularly cancer, across various countries in the region. Governments of several Asia Pacific nations are making significant investments in healthcare and research, and they are increasingly implementing favorable policies to support the development and adoption of advanced diagnostics. The large patient population and the growing middle class, with increasing disposable income, are also contributing to the expanding demand for precision diagnostic tools.
India Companion Diagnostics Market Insights
In Asia Pacific, India is showing significant potential and growth in the companion diagnostics development. The country's large and diverse patient population, coupled with a rising incidence of chronic diseases such as cancer, creates a substantial need for advanced diagnostic solutions. There is a growing awareness among healthcare professionals and patients about the benefits of personalized medicine and targeted therapies. Additionally, increasing government initiatives to improve healthcare access and quality, along with rising investments in research and development, are fostering a more conducive environment for CDx adoption and innovation in India.
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Key Players and Competitive Insights
The companion diagnostics (CDx) development features several major players that significantly influence its direction and growth. A few players include F. Hoffmann-La Roche Ltd., Agilent Technologies, Inc., QIAGEN, Abbott Laboratories, and Illumina, Inc. The competitive landscape is dynamic, marked by a blend of established pharmaceutical and diagnostics companies, as well as specialized biotech firms and contract research organizations. To gain share, companies focus on developing highly accurate, sensitive, and rapid diagnostic platforms, especially for oncology, which remains a key therapeutic area. Innovation in analytical techniques, such as next-generation sequencing (NGS) and advanced PCR methods, is crucial for maintaining a competitive edge. Furthermore, regulatory expertise and a global presence are vital for navigating diverse entry requirements and expanding reach.
Prominent companies in the landscape include 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; Guardant Health, Inc; and others.
Key Players
- Abbott Laboratories
- Agilent Technologies, Inc.
- BioMérieux SA
- F. Hoffmann-La Roche Ltd.
- Guardant Health, Inc.
- Illumina, Inc.
- Labcorp
- Myriad Genetics, Inc.
- QIAGEN N.V.
- Quest Diagnostics
- Sysmex Corporation
- Thermo Fisher Scientific Inc.
Industry Developments
May 2025: Roche received the U.S. Food and Drug Administration (FDA) approval for its VENTANA MET (SP44) RxDx Assay. This is the first companion diagnostic approved to identify non-small cell lung cancer patients who may be eligible for treatment with EMRELIS, a c-MET-targeted therapy.
May 2025: Roche announced a strategic collaboration with Broad Clinical Labs. This partnership aims to develop and pilot new applications using Roche's recently introduced next-generation sequencing (NGS) Sequencing By Expansion (SBX) technology.
Companion Diagnostics Development Market Segmentation
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
- Suth Korea
- Indnesia
- Australia
- Vietnam
- Rest of Asia Pacific
- Middle East & Africa
- Saudi Arabia
- UAE
- Israel
- Suth Africa
- Rest of Middle East & Africa
- Latin America
- Mexic
- Brazil
- Argentina
- Rest of Latin America
Companion Diagnostics Development Market Report Scope
|
Report Attributes |
Details |
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Market Size in 2024 |
USD 845.99 million |
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Market Size in 2025 |
USD 908.17 million |
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Revenue Forecast by 2034 |
USD 1,755.79 million |
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CAGR |
7.6% from 2025 to 2034 |
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Base Year |
2024 |
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Historical Data |
2020–2023 |
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Forecast Period |
2025–2034 |
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Quantitative Units |
Revenue in USD million and CAGR from 2025 to 2034 |
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Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Industry Insights |
|
Segments Covered |
|
|
Regional Scope |
|
|
Competitive Landscape |
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Report Format |
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Customization |
Report customization as per your requirements with respect to countries, regions, and segmentation. |
FAQ's
The global market size was valued at USD 845.99 million in 2024 and is projected to grow to USD 1,755.79 million by 2034.
The global market is projected to register a CAGR of 7.6% during the forecast period.
North America dominated the market share in 2024.
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.
The industry players segment accounted for the largest share of the market in 2024.
The next-generation sequencing (NGS) segment is expected to witness the fastest growth during the forecast period.
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