Global Companion Diagnostics Market - 2023-2030

Market Overview

The global companion diagnostics market reached US$ 6.1 billion in 2022 and is projected to witness lucrative growth by reaching up to US$ 15.0 billion by 2030. The global companion diagnostics market is expected to exhibit a CAGR of 12.2% during the forecast period (2023-2030).

The trends in the global companion diagnostic market include the rising utilization of companion diagnostics, the collaborative efforts between pharmaceutical and diagnostic companies, and the integration of Next-Generation Sequencing (NGS) technology within this market.

Companion diagnostics involve analyzing various types of patient samples, such as tissue biopsies, blood samples, or other bodily fluids. These samples are tested for specific biomarkers, genetic mutations, or other molecular characteristics that can provide insights into a patient's disease or treatment response.

Furthermore, the advancements in genomics and molecular biology, the increased focus on early detection and prevention of chronic diseases, and the growing need for targeted therapies are the factors expected to drive the market over the forecast period.

Market Dynamics

The Increasing FDA approvals for Companion Diagnostic Tests are Expected to Drive the Global Companion Diagnostics Market Growth

In December 2022, the RAS GTPase family inhibitor adagrasib (brand name Krazati) received accelerated approval for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have undergone at least one prior systemic therapy. Alongside the approval of adagrasib, two companion diagnostic tests were also approved, the QIAGEN therascreen KRAS RGQ PCR kit for tissue testing and the Agilent Resolution ctDx FIRST Assay for plasma testing.

The approval of adagrasib was based on data from the KRYSTAL-1 clinical trial, which was a multicenter, single-arm, open-label study involving 116 patients with locally advanced or metastatic NSCLC harboring confirmed KRAS G12C mutations.

In a phase 2 cohort of the trial, the objective response rate (ORR) was 43% among 112 patients with measurable disease at baseline (95% confidence interval [CI]: 33.5, 52.6). The median duration of response (DoR) was 8.5 months (95% CI: 6.2, 13.8), and the median progression-free survival (PFS) was 6.5 months (95% CI: 4.7, 8.4). Among 33 patients with previously treated stable central nervous system metastases, the confirmed intracranial ORR was 33.3%. Thus, owing to the above factors, the market is expected to drive over the forecast period.

Advancing Drug Development and Personalized Treatment through Companion Diagnostics and Predictive Biomarkers are Expected to Drive the Global Companion Diagnostics Market Growth

The high failure rates seen in late-stage clinical trials for promising anti-cancer drugs have prompted the exploration of alternative strategies for drug development and the evaluation of their effectiveness against tumors. Currently, only a few predictive biomarkers are commonly used in clinical practice, often established retrospectively.

However, the emergence of companion diagnostics provides an opportunity to expedite drug development by identifying predictive biomarkers early in the preclinical stages and validating them throughout the drug development process. Companion diagnostics are tests used during preclinical stages to assess the efficacy and safety of new drugs for specific patient populations based on the genetic makeup and biological characteristics of the tumor.

A recent study conducted by Spigel et al. reported the results of a randomized phase II trial investigating the combination of erlotinib and MetMab (a monoclonal antibody targeting MET) versus erlotinib plus placebo in previously treated non-small cell lung cancer patients. The study involved assessing cMET expression in tumor tissue using fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC). The findings demonstrated that adding MetMab to erlotinib significantly improved progression-free and overall survival only in patients with high cMET expression levels.

IHC was found to be the most sensitive predictor of the benefits of MetMab. On the other hand, patients with low cMET expression did not benefit from MetMab and had significantly worse outcomes compared to those treated with erlotinib alone. This study illustrates the prospective assessment of a predictive biomarker and highlights the importance of companion diagnostics in evaluating experimental treatments.

To facilitate drug development with a focus on tumor specificity after early clinical trials, preclinical studies should be conducted to identify biomarkers and develop tests for their evaluation. This approach will pave the way for the development of diagnostic predictive signatures to be clinically evaluated in early trials and prospectively validated in randomized phase II and III studies. Thus, owing to the above factors, the market is expected to drive over the forecast period.

Drawbacks Associated with Companion Diagnostics in Precision Medicine are Expected to Hamper the Global Companion Diagnostics Market Growth

Developing companion diagnostics can be a significant challenge, especially when there is limited information about the disease or drug mechanism. Drug and diagnostics development often follow separate paths, leading to potential delays in aligning them during clinical trials.

Additionally, the reliability of the diagnostic test is crucial, as false positive or negative results can undermine its utility. Another obstacle is the limited reimbursement coverage by healthcare systems, which discourages the widespread use of companion diagnostics. Intellectual property laws for companion diagnostics differ from those for medicinal products, allowing the creation and marketing of cheaper but unvalidated tests.

Despite these challenges, companion diagnostics are considered the future of precision medicine, and it is hoped that changes will be made to provide better support for their development and testing. Hence, owing to the above factors, the market is expected to hamper over the forecast period.

COVID-19 Impact Analysis

Early diagnosis of COVID-19 is becoming essential in the market, as it can help find the right treatment for patients impacted by the virus. The most commonly used and reliable test for diagnosis of COVID-19 is the polymerase chain reaction (PCR) test performed using nasopharyngeal swabs or other upper respiratory tract specimens, including throat swabs. Thus, the disease diagnosis using polymerase chain reaction (PCR) emerged as a major focus for managing the disease.

The companion diagnostics market is expected to experience substantial growth due to the development of new biomarkers for various diseases, a rise in R&D of targeted therapies, an increase in demand for customized medicine with increased recognition in developing markets, and a higher number of unmet cancer care needs. For instance, according to a 2022 article published in Systematic Reviews in Pharmacy, companion diagnostics for SARS-CoV-2 vaccination were being explored to enhance COVID-19 vaccination strategies.

These companion diagnostics involved the use of serological antibody tests. At that stage of research, SARS-CoV-2 vaccine companion diagnostics were found to provide significant advantages. By monitoring the immune response through specific test combinations, these diagnostics aimed to offer durable and reliable protection against COVID-19, thus providing medical reassurance. The article highlighted the potential benefits of companion diagnostics in optimizing vaccination schedules and ensuring effective immune protection against the virus.

Russia-Ukraine Conflict Analysis

The Russian-Ukraine war has had an impact on the companion diagnostics market. The conflict has disrupted healthcare systems and infrastructure in Ukraine, leading to challenges in accessing medical services and supplies, including companion diagnostics.

The war has created an unstable environment for research and development activities in the region, affecting the progress and advancement of companion diagnostics. Limited resources and the diversion of funds towards military efforts have likely hindered investments in healthcare and biomedical research, including the development and implementation of companion diagnostics.

Additionally, the conflict has resulted in population displacement and migration, causing disruptions in patient care and healthcare delivery systems. This disruption can impact the demand for companion diagnostics and limit their accessibility to individuals in need.

Moreover, the geopolitical tensions and economic instability resulting from the war can have broader implications for international collaborations and investments in the companion diagnostics market. Uncertainty and geopolitical risks can deter foreign investors and companies from engaging in the Ukrainian market, potentially impacting the availability and adoption of companion diagnostics in the region.

Segment Analysis

The global companion diagnostics market is segmented based on product & services, technology, indication, end user, and region.

Cancer from the Indication Segment Account for 35.7% of the Market Share Owing to the Increasing Prevalence of Cancer, Growing Product launches, and Increasing Partnership among Market Players

According to World Health Organization Report 2022, cancer remains a leading global cause of death, resulting in nearly 10 million fatalities in 2020. The highest number of new cancer cases in 2020 were observed in breast cancer (2.26 million cases), lung cancer (2.21 million cases), colon and rectal cancer (1.93 million cases), prostate cancer (1.41 million cases), non-melanoma skin cancer (1.20 million cases), and stomach cancer (1.09 million cases). Regarding cancer-related deaths in 2020, lung cancer was the primary cause with 1.80 million deaths, followed by colon and rectal cancer (916,000 deaths), liver cancer (830,000 deaths), stomach cancer (769,000 deaths), and breast cancer (685,000 deaths).

Furthermore, each year approximately 400,000 children are diagnosed with cancer, with the most common types varying across different countries. Notably, cervical cancer was identified as the most prevalent type in 23 countries.

Additionally, on March 9, 2023, QIAGEN N.V. announced a strategic partnership with Servier, a global pharmaceutical group. The partnership aims to develop a companion diagnostic test for TIBSOVO, a medication used in the treatment of acute myeloid leukemia (AML), a type of blood cancer. TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor.

As part of the collaboration, QIAGEN will be responsible for the development and validation of a real-time in vitro PCR test. This test will be designed to detect IDH1 gene mutations in AML patients using whole blood and bone marrow aspirate samples. The companion diagnostic will be compatible with the QIAGEN Rotor-Gene Q MDx device, a widely used platform in laboratories worldwide.

QIAGEN's regulatory teams will provide their expertise to support the clinical validation of the companion diagnostic and seek its approval in the United States, the European Union, and Japan. This partnership aims to advance personalized medicine in the field of AML treatment by enabling the identification of patients who are likely to benefit from TIBSOVO based on their IDH1 gene mutation status.

Geographical Analysis

North America Accounted for Approximately 39.8% of the Market Share Owing to the Increasing FDA Approvals, Presence of Key Players, and Growing Development and Validation of a Therapeutic Drug and Diagnostic Test

On May 4, 2023, Foundation Medicine, Inc., a leader in molecular profiling for cancer, announced that it received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne Liquid CDx to be used as a companion diagnostic for EXKIVITY (mobocertinib), which is currently FDA-approved for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Similarly, On May 31, 2023, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.

Furthermore, Experts from Memorial Sloan Kettering Cancer Center (MSK) shared their recent clinical, translational, and foundational cancer research findings at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, Florida, held from April 14 to 19.

The presentations included significant advancements in clinical research with implications for patients with gastric and gastroesophageal junction cancers, as well as KRAS G12C-mutated cancers. Another notable development was the introduction of a new prognostic risk calculator for patients with myelodysplastic syndromes (MDS).

In addition, MSK researchers showcased their latest work in various cutting-edge areas of translational and foundational cancer research. These included translating predictable patterns in copy number alterations in p53-deficient cancers into clinical applications, gaining insights into the evolution of pancreatic cancer through single-nucleus DNA sequencing, and exploring the use of engineered human leukocyte antigen-independent T cell receptor (HIT) T cells to overcome kidney cancer.

Competitive Landscape

The major global players in the market include: F. Hoffmann-La Roche Ltd., Agilent Technologies, Inc., Qiagen N.V., Thermo Fisher Scientific, Inc., Abbott Laboratories, Inc., Biomerieux SA, Siemens Healthcare, Thermo Fisher Scientific Inc., Danaher Corporation (Beckman Coulter Inc.), Guardant Health, and Illumina Inc. among others.

Why Purchase the Report?

• To visualize the global companion diagnostics market segmentation based on the product & services, technology, indication, end-user, and region, as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of companion diagnostics market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global companion diagnostics market report would provide approximately 69 tables, 71 figures, and 195 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies