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Companion Diagnostics Market

The market for Companion Diagnostics was estimated at $8.4 billion in 2024; it is anticipated to increase to $16.8 billion by 2030, with projections indicating growth to around $30.1 billion by 2035.

Report ID:DS1801251
Author:Debadatta Patel - Senior Consultant
Published Date:
Datatree
Life Science
Medical Device
Companion Diagnostics
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Report Summary
Market Data
Methodology
Table of Contents

Global Companion Diagnostics Market Outlook

Revenue, 2024

$8.4B

Forecast, 2034

$26.8B

CAGR, 2025 - 2034

12.3%

The Companion Diagnostics (CDx) industry revenue is expected to be around $9.4 billion in 2025 and expected to showcase growth with 12.3% CAGR between 2025 and 2034. The strategy of companion diagnostics (CDx) is a key element of precision medicine, especially in the treatment of cancer, immunological disorders and rare diseases. It is crucial for the commercial success of targeted therapy products. The importance of biomarkers lies in their capacity to predict how patients will react to certain drugs, in identifying patients most likely to benefit from expensive biologic treatments and in preventing trial and error prescribing. This also supports healthcare delivery models that are based on value and acceptance by payers. The combined impact of regulatory incentives for drug diagnostic pairs, the rising investment in oncology diagnostic development and growing biomarker driven approvals, is reinforcing market penetration and long term prospects.

Current applications of companion diagnostics include the identification of genetic mutations relevant to targeted therapies. For instance, Herceptin, a drug used in the treatment of breast cancer, works effectively only if patients have a particular mutation in their HER2 genes. CDx are thus used to verify the existence of this particular genetic make up. The product has features including validated biomarkers which are tested, tight drug and clinical correlations, its results are integrated into clinical support systems used in healthcare and it is labelled. Theindustry'smain fields of application are in cancer research, where the industry derives 46.6% of its revenue from products used in the treatment of lung cancer and breast cancer. These products are crucial in the selection of a therapy that is specifically targeted and in the management of resistance. Companies are broadening their range of medicines to include hematological malignancies, immuno oncology and inflammatory and rare diseases as more pharmaceutical products are developed using biomarkers. CDx are at present predominantly PCR based technology. By 2025, sales of these technologies are estimated to reach $2.21 billion. The next generation of sequencing technology coupled with liquid biopsy and multiplex panels are being researched extensively. These technologies can assess several biomarkers through minimal sample volumes. The expectation is that there will be continuous innovation and robust demand in the field of CDx, driven by the trends already in place and an increasing need for personalized medicine. Furthermore, reimbursement for high value molecular diagnostics is expected to be more extensive.

Companion Diagnostics market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2024-2034
Companion Diagnostics Market Outlook

Market Key Insights

  • The Companion Diagnostics market is projected to grow from $8.4 billion in 2024 to $26.8 billion in 2034. This represents a CAGR of 12.3%, reflecting rising demand across Lung Cancer, Breast Cancer, and Colorectal Cancer.

  • Among the leading players in this market are Thermo Fisher Scientific Inc., QIAGEN N.V. and F. Hoffmann La Roche. These companies influence the competitive dynamics of this market.

  • The US and China will dominate the Companion Diagnostics market, with both regions forecast to enjoy growth of 11.1 to 14.8 percent per annum from 2024.

  • Markets in Brazil, India and South Korea will be those with the highest growth rates, of 8.6 percent to 12.9 percent per year.

  • The integration of precision therapies is expected to boost the Companion Diagnostics market by $2 billion by the year 2030.

  • The Companion Diagnostics market will grow by $18.4 billion between 2024 and 2034. The market for the treatment of breast cancer and colorectal cancer is expected to increase its share in the Companion Diagnostics market.

  • With

    rising oncology precision medicine pipelines and biomarker-driven drug development accelerating global adoption of companion diagnostics, and

    Expanding regulatory support and payer reimbursement alignment strengthening clinical integration of companion diagnostics worldwide, Companion Diagnostics market to expand 219% between 2024 and 2034.

companion diagnostics market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Companion Diagnostics - Country Share Analysis

Opportunities in the Companion Diagnostics

Despite a rapid growth in immunotherapies in Chinas oncology market, low CDx penetration rates outside of the countrys top hospitals still exist; tests for PD 1/PD L1, EGFR and HER2 are in demand in regional hospitals. Global in flight companion diagnostic systems will be worth $0.84 billion in 2024, and by 2030 will be worth $3.07 billion. The growth rate of this in flight CDx is also 12.57%. The fastest growth will be seen in immunohistochemistry and PCR assays in cities such as Chengdu and Xian.

Growth Opportunities in North America and Asia-Pacific

Companion diagnostics are the most developed in North America in lung cancer. There, precision cancer medicine is being incorporated into standard treatments at an unprecedented rate in both community cancer treatment facilities and university research hospitals. Key opportunities exist in improving the multiple tests used to diagnose lung cancer, introducing these tests to early stage breast and colon cancer treatments and improving non invasive testing methods that enable quicker diagnosis and treatment of cancer. The market for pharmacogenomics testing is extremely competitive. Key participants in this industry include established in vitro diagnostics companies, reference labs and new genetic testing businesses. These firms are competing for inclusion in clinical guidelines and formularies. To gain market share in this field the providers of genetic tests must have genetic test data, be able to easily integrate their systems with electronic medical records and offer reports that can be used in pharmacogenomics. The field is driven by a positive reimbursement environment for companion diagnostics, the strict regulatory requirements which encourage the co development of drugs with these products, the knowledge held by doctors about the biomarkers of cancer and the numerous immuno oncology drugs and targeted agents which require diagnostic partners to reach their full potential.
Due to the high incidence of lung cancer and the concentration of mutations in actionable drivers like EGFR and ALK, in the Asia Pacific region diagnostics for lung cancer is driven. The market has a strong need for next generation sequencing solutions and molecular diagnostics which are cost efficient and can be used in the region according to national treatment guidelines; there is also a large market in developing countries for tests for lung and colorectal cancer in hospitals, in centers of excellence for oncology in South Korea, China and Japan and in modular systems which can be used in single gene tests and can expand to broader panels as the infrastructure and budget improves. The industry is driven by the interplay between the three key groups: multinational companies which offer diagnostic tests, large hospital labs and a growing number of local businesses which specialize in DNA sequencing. The success of any business will depend on how they manufacture, price their products and form partnerships with regional pharmaceutical companies. Government backed precision cancer initiatives in the region are key drivers. Governments have invested in cancer centres of excellence, they have also improved the clinicians understanding of predictive diagnostics and loosened the regulatory process. As a result, new treatments linked to diagnostic tools are being approved faster. This has led to an increased adoption of liquid biopsies and other less invasive testing methods.

Market Dynamics and Supply Chain

01

Driver: Rising oncology precision medicine pipelines and biomarker driven drug development accelerating global adoption of companion diagnostics

Companies in the pharmaceutical and biotechnology sectors are also actively increasing their precision oncology product lines. As a result, the importance of companion diagnostic products is also heightened because they help doctors identify patients who will also benefit most from targeted treatments. This also helps to cut the number of late stage clinical trials which fail. There is also growing demand for companion diagnostic products that can also provide reproducible and robust molecular profiling across diverse geographies and tumors. also advances in the field of next generation sequencing technology allow multiple mutations, fusions and alterations in the number of copies of DNA to be simultaneously analyzed from minimal amounts of tissue. This has also improved the use of modern diagnostic tests used in conjunction with treatments. Liquid biopsy technologies now enable non invasive testing for free floating cancer DNA present in the bloodstream. This approach enables real time monitoring of how a patient is also responding to treatment and help doctors to choose the most appropriate treatment. These trends are also pushing personalized medicine workflows to evolve with pharmaceutical companies and laboratories in diagnostic working together in long term partnerships to jointly develop treatments and tests. The increasing use of dual momentum, however, is also resulting in a substantial increase in the global companion diagnostics market.
As regulators, they are also providing clearer guidelines and more streamlined processes for the joint approval of treatments and tests which work alongside one another. This is also reducing the risks involved in developing treatments defined by biomarkers and speeding up the time it takes for them to reach the market. Encouraging standardised analytical and clinical validation and evidence frameworks promotes hospital systems and clinicians in adopting new tests with greater confidence. Currently insurance companies are also laying down new rules on what treatments they will also pay for, in part because they are also finding that tailored cancer treatments avoid unnecessary therapies and lower the risk of adverse reactions. Healthcare providers are also more likely to integrate CDx tests into standard diagnostic regimes as reimbursement terms for high cost molecular tests become clearer and more consistent across the worlds leading economies. This leads to greater test volumes and underlines the importance of such tests for the introduction of many new treatments.
02

Restraint: Fragmented and evolving regulatory frameworks delay approvals and inflate development costs for companion diagnostics assays

Developers of in vitro diagnostics are facing considerable regulatory differences in various markets and for next generation sequencing based companion diagnostics, leading to a prolongation of the product development phase. The costs associated with clinical trials for these products are increased due to this situation. As a result, there is a delay in the financial returns from these tests. Regulations in the field of precision medicine can sometimes involve several overlapping reviews for drugs and genetic information. As a result clinical trials are often delayed and sponsors have to redesign their studies. The global roll out of companion diagnostics is held back by regulatory hurdles. As a result partnerships which involve the co development of medicines are decreased. Furthermore established diagnostic tests are in greater demand than innovative, personalized medicines. This scenario thus constrains the rate of growth of the market as a whole.
03

Opportunity: Deploying point of care oncology CDx kits in US community clinics treating rural and Medicaid populations and Expanding NGS based rare disease companion diagnostics within pediatric hospitals and reference laboratories across Western Europe

Community oncology clinics serving rural and Medicaid populations in the US often have to wait before making treatment decisions to send out molecular tests. The availability of CDx at the point of patient care enables the turnaround times for tests for mutations such as ALK, KRAS or BRAF from as much as two or three weeks to just two or three days. By partnering, suppliers of medical equipment, healthcare providers who supply a variety of treatments and services and also the insurance companies, value based healthcare payment plans can be put into operation. Decentralised testing through low cost kits which are in cartridge form and analyser systems in US community clinics are due for above average growth.
In European paediatric hospitals, a system to direct targeted therapy by classifying rare diseases based on the patients genome does not only exist for all patients. The use of next generation sequencing in companion diagnostics makes it possible to combine tests for single gene disorders. This reduces the time to receive a diagnosis and patients may qualify for gene therapy and biological treatments. Collaborations between childrens hospitals, orphan drug sponsors and the companies behind NGS technology will be of great importance. In this market, NGS assay kits and bioinformatics systems for centralised reference laboratories in Western Europe are expected to be the most rapidly increasing companion diagnostic technologies.
04

Challenge: Inconsistent reimbursement policies reduce test adoption and discourage investment in innovative CDx platforms

In many areas, payment systems impose stringent testing criteria or charge low fees for high value CDx tools, particularly those which assess the expression of numerous genes. The use of comprehensive genomic profiling and PD L1 testing is limited because the reimbursement for these services is unpredictable. This underutilization results in lower test usage and subsequently a reduced demand for targeted treatments. This uncertainty undermines the viability of investments in the latest CDx and also weakens business cases for the development of new technology platforms. Furthermore, this causes market distortion by prioritizing cost containment above long term benefits. Ultimately it reduces investment into cutting edge diagnostics.

Supply Chain Landscape

1

Biomarker Discovery

F. Hoffmann La Roche Ltd.Thermo Fisher Scientific Inc
2

Companion Diagnostics Development

QIAGEN N.V.Illumina Inc
3

Assay Manufacturing

Agilent Technologies Inc.Thermo Fisher Scientific Inc
4

Clinical End Users

Oncology clinicspharmaceutical companiesreference laboratories
Companion Diagnostics - Supply Chain

Use Cases of Companion Diagnostics in Lung Cancer & Breast Cancer

Lung Cancer : Lung cancer is a major region in which companion diagnostics will have a significant role in the approach known as precision medicine, generating approximately $2.12 billion by 2025. This sum will be increased by a compound rate of 10.4% by 2030. Companion tests become part of the process of treatment in this time. The EGFR, ALK, ROS1, BRAF and PD L1 tumour biomarkers are detected using PCR, sequencing and immunohistochemistry. This testing is generally conducted in hospital and reference laboratories to determine the best therapy. Because of their ability to combine validated reagents with automated systems, routine workflows are dominated by high throughput molecular diagnostic systems which capture approximately 26.3% of the overall demand in terms of kits. The company Roche leads in a wide range of tests and has been given approval to perform these tests by several regulating bodies in the field of EGFR and PD L1 testing. The firms Thermo Fisher Scientific and Illumina are key to the Next Generation Sequencing market. QIAGEN and Agilent are key in PCR tests and IHC/FISH platforms respectively and are fundamental in the biomarker driven treatment programmes and global oncology diagnostic services.
Breast Cancer : At a market worth of approximately $1.8 billion in 2025, breast cancer CDx are likely to experience a compound annual growth rate of 11.3% up to 2030. They are largely driven by the rising use of BRCA, hormone receptor and HER2 testing in targeted and personal medication. The determination of the HER2 and oestrogen receptor/progesterone receptor status is primarily carried out through IHC and in situ hybridization methods. NGS based genetic panels and PCR kits are increasingly being used to assess mutations in the BRCA1 and BRCA2 and PIK3CA genes. This allows for more refined cancer treatment planning. Systems which can automatically interpret results are becoming popular in large cancer treatment clinics where results are frequently checked. These machines have a market share of about 22.7%, automated systems of 20.2%, and are preferred due to consistent interpretation and their ability to interface with computerised systems for examining tissues under a microscope. Companies such as Agilent Technologies Inc. and F. Hoffmann La Roche Ltd. dominate the HER2 field in IHC and ISH, whilst QIAGEN N.V. along with Thermo Fisher Scientific Inc. have developed widely accepted PCR and NGS panels. Many sequencing tests and CDx collaborations with biopharmaceutical firms rely on the platforms of Illumina Inc.
Colorectal Cancer : Colorectal cancers CDx will be worth $1.4 billion by 2025. It is predicted that over the next five years colorectal cancer CDx will experience a compound annual growth rate of 12.9%. This is because standard procedures are being adopted for precision cancer treatments in testing for BRAF, NRAS, KRAS and microsatellite instability. These include kits for PCR based mutation detection and NGS panels which are primarily used for patient stratification with anti EGFR monoclonal antibodies and checkpoint inhibitors. In addition, immunohistochemistry tests are also used to assess the state of mismatch repair proteins. Integrated systems are preferred for the support of centralized high throughput sequencing and also liquid biopsy applications which are emerging in molecular diagnostics. Rapid turnaround and the alignment of reimbursements are on the other hand the factors which make the use of standardized diagnostic kits appealing. Both QIAGEN N.V. and Thermo Fisher Scientific have a strong position in the field of colorectal cancer diagnostics through PCR and next generation sequencing; Roche is able to provide a comprehensive workflow with its in vitro diagnostics and automation equipment; Finally Agilent and Illumina have strong positions in the colorectal cancer diagnostics market through the use of sequencing platforms and genomic and immunohistochemistry solutions respectively.

Recent Developments

Oncology precision medicine and biomarker driven drug development are presently pushing forward rapidly with companion diagnostics, thus, increasing the demand for integrated CDx and drug co development models. Current advancements involve the more widespread use of next generation sequencing, liquid biopsies and multiplexed immunohistochemistry testing. These tools are used to enable the administration of targeted treatments and selection of appropriate treatments on an individual basis. The trend in the market is that of an increase in the number of tests which are co approved by the FDA and the EMA. This trend is being driven by a rise in pharmaceutical diagnostic partnerships and value based healthcare models.

June 2024 : Roche further developed its range of companion diagnostics for precision medicine in cancer therapy by gaining approval for its genetic tests and launching tests which identify genetic mutations associated with particular drugs. Its range of products also comprises NGS and IHC tests. These tests are used alongside targeted cancer treatments in the major markets world wide.
August 2023 : Thermo Fisher Scientifics contributions to companion diagnostics has come about through a strengthening of relationships with pharmaceutical firms across the world. They co develop assays for use in next generation sequencing and liquid biopsy platforms which act as companion diagnostics in the clinic. Through these measures they have sped up the release of drugs which target biomarkers, and they have also sped up the process of precision medicine in clinical settings.
July 2023 : The company strengthened its position in the companion diagnostics business by forming several new agreements to further develop PCR based therascreen and other oncology products. By doing so it ensured the precise detection of certain biomarkers which in turn allow targeted therapies to be tailored to the specific needs of patients undergoing treatment. This agreement helped align drug development with companion diagnostics. Furthermore, it brought about greater personalisation in treatment for patients.

Impact of Industry Transitions on the Companion Diagnostics Market

As a core segment of the Medical Device industry, the Companion Diagnostics market develops in line with broader industry shifts. Over recent years, transitions such as Shift To Precision Therapies and Digital Integration And Real World Data have redefined priorities across the Medical Device sector, influencing how the Companion Diagnostics market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Shift To Precision Therapies

The Companion Diagnostics market is undergoing a transformative shift from single gene testing to comprehensive next generation sequencing, significantly enhancing precision medicine in oncology and rare disease management. This evolution enables drug developers to incorporate diagnostic tools early in clinical trials, improving the prediction of drug responses and mitigating late stage failures. As hospital and reference laboratories invest in high throughput platforms and advanced bioinformatics, the landscape of pharmacogenomics and molecular genetics is being redefined. This strategic integration of precision therapies is projected to drive the Companion Diagnostics market growth by an impressive $2 billion by 2030, underscoring the critical role of personalized medicine in improving patient outcomes and optimizing therapeutic efficacy.
02

Digital Integration And Real World Data

As CDx systems become more sophisticated they incorporate real world evidence, digital pathology and cloud based analytical tools to ensure a continuous assessment of their performance in actual usage conditions after they have come to market. Precision medicines impact is causing regulators, payers and health care providers to rethink how clinical utility, cost effectiveness and reimbursement for treatments is evaluated. Companies in the pharmaceutical industry are now making use of longitudinal data which comes from a variety of places, including electronic health records, laboratory systems and registries. This data is enabling them to improve predictive models of disease and thus expand the possible uses of medicines. Essentially, health technologies assessment, value based pricing models and population health strategies in auto immune diseases and oncology are being rewritten fundamentally.