Companion Diagnostics Market Assessment, By Product [Assay, Kits and Reagents, Software and Services], By Technology [Immunohistochemistry, Molecular Diagnostics, In-situ Hybridization, FISH, CISH, Real-time PCR, Gene Sequencing], By Application [Colorect

Companion Diagnostics Market Assessment, By Product [Assay, Kits and Reagents, Software and Services], By Technology [Immunohistochemistry, Molecular Diagnostics, In-situ Hybridization, FISH, CISH, Real-time PCR, Gene Sequencing], By Application [Colorectal Cancer, Breast Cancer, Lung Cancer, Melanoma, Gastric Cancer, Others], By End-user [Pharmaceutical and Biotechnology Companies, Clinical Research Organizations, Others], By Region, Opportunities and Forecast, 2017-2031F

Global companion diagnostics market is projected to witness a CAGR of 10.23% during the forecast period 2024-2031F, growing from USD 7.1 billion in 2023 to USD 15.48 billion in 2031F. The companion diagnostics market is anticipated to grow under the influence of driving forces such as the growing demand for personalized medicine, the growing prevalence of cancer cases, and technological advances in diagnostics and therapeutics. As the demand for tailored medical facilities and personalized health solutions is rising, the market for companion diagnostics is expected to expand exponentially. The rising incidence of cancer cases boosts the demand for companion diagnostics products in the market to cater to the growing market demand for such products. Manufacturers and innovators are constantly involved in technical advances and utilization of several diagnostic techniques to develop high-quality products. In addition, regulatory agencies such as the United States FDA, CDSCO, and others are actively looking after the approvals of various developed products.

For instance, in December 2023, the United States FDA approved 173 products of companion diagnostic devices (in vitro and imaging tools). These products are mainly approved for the United States market to perform companion diagnostics tests.

Growing Demand for Personalized Medicine

Companion diagnostics methods play a pivotal role in providing personalized medicine. A companion diagnostic test crucially helps to unlock insights for a better understanding of the specific disease-causing genes, biomarkers, and other biomedical factors. Companion diagnostics enable healthcare providers to determine whether the patient responds to treatment or not, further ensuring the safety and efficacy of targeted therapies and simultaneous selection of the finest treatment for that patient without wasting time with trial-and-error method. The key players are also actively involved in driving innovation in companion diagnostics.

For instance, in September 2023, Cell Signaling Technology (CST), partnered with Leica Biosystems, to develop companion diagnostics assays by utilizing the CST’s extensive best-in-class antibodies portfolio. Leica is a global leader in providing the translation of pre-clinical research into companion diagnostics tests, further enabling pharmaceutical partners to develop and commercialize innovative diagnostic solutions. Cell Signaling Technology is a life science technology company and a leading provider of antibodies, kits, and services.

Growing Prevalence of Cancer

The growing prevalence of cancer cases is anticipated to significantly increase the demand for companion diagnostics methods and products. More than 90% of the market products addressing companion diagnostics are mainly indicated for various types of cancers, which further contributes to the larger market share of various types of cancer indications. Non-small Cell Lung Cancer (NSCLC), breast cancer, and colorectal cancer are some of the most common types of cancers for which the companion diagnostics products are FDA-approved and marketed. Manufacturers are actively involved in product development to cater to the market requirement to address the rising demand for such products as the prevalence of cancer is anticipated to increase drastically in the upcoming years.

For instance, in October 2023, Foundation Medicine Inc. announced that it had received United States FDA approval for FoundationOneCDx and FoundationOneLiquidCDx to be used as companion diagnostics with BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib) of Pfizer for the treatment of adult metastatic non-small cell lung cancer (NSCLC) patients having BRAF V600E mutation.

Dominance of Real-time PCR Segment

The real-time PCR segment is anticipated to contribute to the largest market share in the market due to its speed, sensitivity, and accuracy in the detection and quantification of genetic material, which is crucial for detecting the therapeutic efficacy of drugs. Manufacturers are actively involved in product development and collaborative approaches to harness the resources at optimum levels to enhance market growth.

For instance, in October 2023, QIAGEN and Myriad Genetics announced a collaboration agreement for the development of companion diagnostic tests in the field of cancer. The collaboration aims to deliver curative products and services for pharmaceutical companies, further, enabling the development of commercial proprietary cancer diagnostics tests for the United States market, and subsequently providing companion diagnostic test kits for the global market. Through this collaboration, Myriad will leverage its robust commercial infrastructure for clinical sample testing and CLIA-certified, CAP-accredited lab platform, and assay development expertise while QIAGEN will contribute through its Sample to Insight solutions which include its PCR offerings, sample preparation, QIAseq next-generation sequencing technologies, and the QIAGEN Digital Insights portfolio of bioinformatics. The collaboration also focuses on the combined FDA and worldwide regulatory expertise of both organizations.

Hospitals are Chief End-users

The hospital end-user segment is anticipated to secure the largest market share in the global companion diagnostics market because the fundamental of companion diagnostics and therapy administration is mainly done in hospital settings. Most of the companion diagnostics products are consumed in hospital settings during the treatment of cancer patients at these setups. Hospitals are collaborating with manufacturers to facilitate the patients to leverage the potential of companion diagnostics for enhancing revenue.

For instance, in December 2023, ARUP Laboratories and Medicover collaborated to facilitate the market access of a new companion diagnostic, and a new gene therapy in the European Union (EU). ARUP Laboratories, developed AAV5 DetectCDx, a companion diagnostic in collaboration with BioMarin Pharmaceutical Inc. The test helps in the selection of adult patients suffering from severe hemophilia A who can get treatment with BioMarin’s new gene therapy, ROCTAVIAN (valoctocogene roxaparvovec-rvox). Medicover is the provider of diagnostics and hospital services in the EU and thus contributes largely to the market expansion of AAV5 DetectCDx and ROCTAVIAN in European countries.

North America to be the Dominating Region

Cancer incidence and prevalence are notably higher in North American countries like the United States and Canada, driving higher demand and contributing to the lead of the North America region in the global companion diagnostics market. The demand for companion diagnostics products in the region is anticipated to grow exponentially due to the high number of cancer cases diagnosed, advanced healthcare services, wide adoption and awareness about companion diagnostics, and increasing affordability of healthcare through government support. Additionally, the United States FDA’s significant contribution to product development and regulatory approvals also helps in the market expansion.

For instance, in November 2023, Foundation Medicine Inc. announced the receipt of US FDA approval for FoundationOneCDx as a companion diagnostic solution for AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant). Truqap and Faslodex are already approved by US FDA to treat adult patients with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, with identified alterations in PIK3CA/AKT1/PTEN genes, after progression on a prior endocrine-based treatment in the metastatic setting or recurrence within 12 months of completing adjuvant therapy.

Future Market Scenario

The future of the global companion diagnostics market holds the development and commercialization of companion diagnostics products that can be used for indications other than oncology such as infectious diseases. Roche’s launched the first infectious disease companion diagnostics tests and cobas omni utility channel in December 2021. Since then, several high-quality products have been in the pipeline and there is notable traction of market players for the development of such products.

For instance, Advanta Genetics is aiming to develop products for infectious disease companion diagnostics using precision metagenomics. Another example from the clinical trial repository indicates three companion diagnostics products of Prometheus Biosciences, Inc., which is a subsidiary of Merck & Co., Inc. The company holds three companion diagnostics products in the pipeline for indications other than cancer such as diffuse cutaneous systemic sclerosis, interstitial lung disease, Crohn's disease, and ulcerative colitis.

Key Players Landscape and Outlook

The market players are actively involved in the expansion of their market offerings through strategic product development and approvals, mergers and acquisitions, and collaborations with other key players.

In March 2023, QIAGEN N.V. signed up for a strategic partnership with Servier which is a global pharmaceutical organization, to develop a novel companion diagnostic test called TIBSOVO, containing an isocitrate dehydrogenase-1 (IDH1) inhibitor and indicated for the management of the acute myeloid leukemia. Under the Master Collaboration Agreement, QIAGEN is to develop and validate a real-time in-vitro PCR test that can be used for the detection of IDH1 gene mutations in AML patients using their whole blood and bone marrow aspirates. The experienced regulatory teams of QIAGEN will provide support for clinical validation of the companion diagnostic product and its approval in various geographies including the United States, the EU, and Japan.