Oncology Companion Diagnostics Market

Market Overview

The global oncology companion diagnostics market size was valued at USD 893.44 million in 2022. It is estimated to reach USD 2,436.84 million by 2031, growing at a CAGR of 11.8% during the forecast period (2023–2031).

A branch of pharmacogenomics known as companion diagnostics (CDx) studies how to use a person's genetic profile to predict how they will react to a drug or tailor their treatment specifically for them. The FDA defines CDx as a medical device, frequently in vitro, that provides the knowledge required to safely and effectively use a corresponding drug or biological product safely and effectively.

In oncology, companion diagnostics are utilized to better pair a patient with an appropriate treatment. For instance, a companion diagnostic test could determine the presence or absence of a drug-targeted gene alteration or biomarker in a patient's tumor. This is useful information in deciding whether or not to give the drug to the patient.

Market Dynamics

Global Market Drivers

Rising Healthcare Spending Promotes PM Cancer Diagnostic and Treatment Methods

Governments are engaged in capitalizing on DNA sequencing. China invested in a 15-year precision medicine effort to sequence the genomes of 1 million organisms, including people, animals, plants, and microorganisms, in March 2016. Similarly, the United States invested USD 215 million in a project to sequence 1 million human genomes, and the United Kingdom started a program to sequence 100,000 genomes. The United States spends more per person on healthcare than other nations. The success of DNA-sequencing technology will depend heavily on the software and hardware optimization of sequencers, government involvement, and partnerships between biotechnology businesses and medical professionals. Growing cancer-related spending is expected to drive oncology companion diagnostics market growth over the forecast period.

Growing Adoption of Companion Diagnostics

Companion diagnostics can enhance the treatment effects of different diseases by providing doctors with clear clinical grounds for diagnosis and treatment and proper management of patient resources and national insurance policies by reducing unnecessary treatment of costly targeted chemotherapy drugs. The application of companion diagnostics, in combination with therapy, can enable patients to benefit from individualized treatment. This market is estimated to grow tremendously due to the growing demand for targeted agents and the reduced cost of new drug development.

Additionally, patients who are typically knowledgeable about the disease and its states and have access to the internet as a source of health information strongly support extensive testing. Hospitals are working to create tests to meet this demand. Moreover, promotion by advertisements for comprehensive genomic tumor assessment on radio, social media, and television has become a regular practice. In addition, patients considering a clinical trial at a major hospital are beginning to expect molecular characterization of their tumor as quid pro quo for participation in a clinical study. These elements contribute to the year-over-year expansion of the oncology companion diagnostics market.

Global Market Restraint

Possibility of Reduce Due to the Adoption of CDx Laboratory-Developed Tests

The FDA evaluates the analytical validity of a commercial CDx and its clinical validity, which means its ability to predict clinical outcomes from its biomarker measurement. Moreover, commercial companion diagnostics are subject to systematic adverse event reporting, premarket review, and correction or recall process. Such discrepancy in regulatory overseeing between commercial and lab-developed tests grabs substantial attention in using commercially developed pharmacodiagnostic tests in academic organizations and research institutes. Such factors restrain market growth to a certain extent in the coming years.

Global Market Opportunities

Collaborations Between Diagnostic and Pharma Entities

The pathway for developing companion diagnostics can be best achieved through close coordination and interaction among drug companies, regulatory agencies, and diagnostic manufacturers. There is a specific requirement for an alliance between drug companies, regulatory agencies, and diagnostic companies. Co-development of companion diagnostics and drug companies can allow for the proper and effective use of resources to provide cost-effectiveness and therapeutic success. This allows for streamlining research between companies, enabling the selection of a lead compound and corresponding biomarker from pharmaceutical and diagnostic companies, respectively.

Additionally, biopharmaceutical companies are engaged in the incorporation of novel technologies for the commercialization of CDx tests. Most novel technology-based partnerships are focused on CDx test development as commercialization rather than the discovery of the biomarker. These companies usually lack in-house expertise and, therefore, need to collaborate with established players in the field of in vitro diagnostics. Most partnerships are from the oncology sector, creating opportunities for market expansion.

Regional Analysis

North America Dominates the Global Market

Based on region, the global oncology companion diagnostics market share is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

North America is the most significant global oncology companion diagnostics market shareholder and is estimated to exhibit a CAGR of 8.81% during the forecast period. It is believed that funding and grants offered by organizations like the National Cancer Institute (NCI) to speed up the development of precision medicine will favor the region's market. The NCI's Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs promote the creation of cutting-edge tools and products for the early detection, diagnosis, and treatment of cancer. Furthermore, the oncology companion diagnostics market is projected to be driven by the presence of effective rules governing the approval of oncology companion diagnostic tests for cancer along with faster R&D for integrated and personalized medicine in the U.S. several conferences held in Canada to raise awareness of CDx trends and developments also contribute to this expansion.

Europe is estimated to exhibit a CAGR of 9.5% over the forecast period. In Europe, there is a growing demand for new guidance documents that integrate the two treatment aspects of diagnostics and therapeutics to be developed together. The marketing of tests in this region requires CE marking. European companies are engaged in strategic partnerships and alliances with global firms to improve the companion diagnostics market in the region. In June 2016, AstraZeneca from the UK signed a definitive agreement with Foundation Medicine to develop a novel CDx assay for Lynparza (olaparib), an oral PARP inhibitor that kills cancer cells. In December 2018, QIAGEN signed an agreement with NeoGenomics to boost the availability of CDx, allowing precision medicine for cancer patients. This partnership offered Day-One access to CDx for newly approved drugs to cancer patients.

Furthermore, firms are expanding their indication labels of CDx assays. In September 2016, the FDA approved expanded labeling of Roche's Cobas EGFR Mutation Test v2. These factors are expected to enhance Europe's market for pharmacogenomic testing. In Europe, several diagnostics models exist to boost reimbursement rates for diagnostic assays. In addition, the penetration of molecular diagnostic assays in European countries is greatly influenced by the existing reimbursement environment in the region. The reimbursement regime varies from country to country.

The Asia-Pacific market is expected to be driven by improvements in the economy and technological advancements. The growing popularity of CDx assays in Western markets has prompted healthcare entities in Asia-Pacific countries to conduct various conferences and seminars on this subject. These activities aim to increase awareness about the maturing technologies and trends in CDx assays amongst the Asian population. Furthermore, the presence of communities in Asian countries actively monitoring and discovering genetic biomarkers is expected to influence the market positively. For example, Singapore's Surveillance and Pharmacogenomics Initiative for Adverse Drug Reactions (Saphire) program was based on genomic biomarkers discovery to investigate adverse drug reactions.

Additionally, Asia-Pacific laboratories offer several practice-oriented programs focusing on translational aspects of pharmacogenomics research. Publications on next-generation cancer diagnostics by Indian authors are expected to accelerate development in this space, especially in the Indian market.

In the Middle East and Africa, applications of CDx assays and next-generation cancer diagnostics in clinical practice have not significantly impacted. As a result, this region showed the lowest market penetration. The population's limited access to modern medicine, especially CDx assays, is mainly due to a lack of knowledge and awareness. However, international conferences on companion diagnostics advancements aimed at the CDx arena's global growth are expected to influence the market positively. In addition, South Africa's cancer and companion diagnostics market is nascent, holding the lowest share in 2019. However, the presence of the target population and growing chronic disease prevalence is expected to drive the market over the forecast period.

Segmental Analysis

The global oncology companion diagnostics market share is bifurcated into product and service, technology, tumor type, and type.

Based on product and service, the global market is bifurcated into products (equipment, reagents and consumables, software/analysis tools) and services. 

The products segment owns the highest market share and is predicted to boost at a CAGR of 11.2% over the forecast period. The product segment is predicted to expand at a healthy pace over the forecast period due to the advent of extremely sensitive technologies, such as NGS, for cancer diagnostics. In the coming years, it is anticipated that leading companies such as Illumina, Roche, and Thermo Fisher Scientific will experience lucrative growth opportunities due to the increased use of cancer companion diagnostic instruments caused by the global disease burden.

Furthermore, the product segment comprises equipment, reagents and consumables, and software/analysis tools. Due to the surging prevalence of cancer worldwide, the demand for robust cancer diagnostics equipment continues to grow. The equipment segment accounted for the major revenue share among the various product types offered in the market. This can be attributed to end users' increased adoption of new platforms and instruments to improve their testing efficiency and patient outcomes. With the emergence of highly sensitive technologies such as NGS, coupled with highly practiced imaging technologies for cancer diagnosis, the equipment segment has a significant revenue share.

Based on technology, the global market is bifurcated into PCR, ISH, immunohistochemistry, sequencing, microarrays, imaging technologies, and other technologies. 

The sequencing segment dominates the global market and is projected to grow at a CAGR of 10.5% over the forecast period. Sequencing technologies play a crucial role in cancer diagnosis. The advent of NGS has significantly increased the use of sequencing technologies in cancer diagnostics. The segment is estimated to exhibit healthy growth in the coming years due to NGS's technological and clinical benefits over Sanger sequencing. According to a study by the University of Cambridge, UK, in September 2019, Whole Genome Sequencing (WGS) of tumor cells can improve cancer treatments. WGS helps explore all types of genomic alterations in cancer and better understand the landscape of driver mutations. Illumina is also a major company offering whole genome sequencing.

Based on tumor type, the global oncology companion diagnostics market is divided into benign and malignant tumors. 

The malignant tumors segment accounts for the largest market share and is anticipated to grow at a CAGR of 10.8% over the forecast period. Malignant tumors are cancer cells that can spread to other tissues. The malignant tumor segment accounted for the largest market share and is expected to maintain its dominance during the forecast period. In addition, increasing regulatory approvals and launching novel NGS cancer diagnostic solutions are anticipated to support segment growth. Increasing initiatives by various government agencies to facilitate the development of novel NGS solutions are anticipated to support segment growth.

Based on type, the global oncology companion diagnostics market is divided into next-generation cancer diagnostics and oncology companion diagnostics.  

The growing incidence of cancer has led to the rapid adoption of next-generation cancer diagnostic tools that can enable efficient cancer prognosis. Developing Next-generation Sequencing (NGS) technologies has facilitated better accessibility of big genomic and transcriptomic data for researchers to decipher crucial biological insights in cancer management. Additionally, a surging number of product launches is expected to drive the market over the forecast period. Advancements in diagnostic labs and the growing adoption of automated laboratory systems are projected to propel the market.

Recent Developments

• January 2023- Guardant Health, Inc., a renowned precision oncology firm, revealed that the FDA had accepted its Guardant360® CDx liquid biopsy test as a companion diagnostic to diagnose advanced or metastatic breast cancer patients with ESR1 mutations who may benefit from therapy with ORSERDUTM (elacestrant).
• May 2023- The FDA approved FoundationOne® Liquid CDx as a companion diagnostic test for mobocertinib (Exkivity) in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) having EGFR exon 20 insertion mutations.