Global Oncology Companion Diagnostics Market - 2022-2029

Global Oncology Companion Diagnostics Market - 2022-2029

Market Overview

The global oncology companion diagnostics market size was valued at US$ XX million in 2021 and is estimated to reach US$ XX million by 2029, growing at a CAGR of XX % during the forecast period (2022-2029).

A test that determines whether a patient is a good candidate for a particular drug or therapy. A companion diagnostic test, for instance, could determine whether a patient's tumor has a specific gene change or biomarker that the drug is targeting. This information is used to determine whether the patient should receive the medication.

Market Dynamics

The factors influencing the global oncology companion diagnostics market are the increasing demand for companion diagnostics for cancer and the increasing prevalence.

The increasing demand for companion diagnostics for cancer is expected to drive the market growth in the forecast period

Oncology has several financial advantages. The ability of companion diagnostics (CDx) assays to shorten clinical trial timelines has increased pharmaceutical companies' adoption rate of these assays. Companion diagnostics can improve the treatment outcomes of various diseases by providing clinicians with clear clinical grounds for diagnosis and treatment and proper management of patient resources and national insurance policies by reducing the use of costly targeted chemotherapy drugs that aren't needed. Physicians can use companion diagnostics to identify patients who benefit from FDA-approved treatment options. Companion diagnostics also provide information critical for the safe and effective use of targeted therapies, as the number of targeted oncology therapy indications and approvals in oncology grows rapidly. Due to the increasing demand for companion diagnostics for cancer, FDA approvals are increasing and are expected to boost the market growth. For instance, on 29th July 2020, Roche's VENTANA HER2 Dual ISH DNA Probe Cocktail assay was approved by the US Food and Drug Administration (FDA) to detect the HER2 biomarker in breast cancer as a companion diagnostic for Herceptin (trastuzumab) therapy. Human epidermal growth factor receptor 2 (HER2) is a biomarker that is occasionally found in breast cancers. 2 Its detection and inhibition may aid healthcare providers in better managing this aggressive cancer.

The problems associated with companion diagnostics are expected to hamper the market

Several recent regulatory guidance documents have focused on companion diagnostics, the drug–diagnostic co-development process has become increasingly relevant and necessary. Despite this, the promise of companion diagnostics has yet to be fully realised, and a number of issues remain to be resolved. The road to codeveloping a successful companion diagnostic with its complementary drug is long, winding, and full of obstacles. The logistical, strategic business, regulatory, and financial challenges of drug-companion diagnostic co-development are all the problems associated with companion diagnostics. Companion diagnostic development necessitates specialized knowledge rarely found in a single organisation, posing several challenges. These issues are exacerbated by the lack of an effective companion diagnostics co-development process or rudimentary state.

COVID-19 Impact Analysis

Early detection of COVID-19 is becoming increasingly important in the market, as it can aid in the identification of the best treatment for patients infected with the virus. The polymerase chain reaction (PCR) test, which uses nasopharyngeal swabs or other upper respiratory tract specimens, including throat swabs, is the most used and reliable test for COVID-19 diagnosis. As a result, disease diagnosis using polymerase chain reaction (PCR) has become a major focus for disease management. On 10th November 2020, TScan Therapeutics and Qiagen signed a research license and option agreement to develop a COVID-19 immune response test. The development of new biomarkers for various diseases, an increase in R&D, an increase in demand for customised medicine with increased recognition in developing markets, and a higher number of unmet cancer care needs during covid-19 are all expected to drive the companion diagnostics market.

Segment Analysis

The immunohistochemistry (IHC) segment is expected to dominate the market growth

IHC-based CDx solutions are widely available in the oncology companion diagnostics market, in addition, key players are constantly involved in product approvals and launches in the market space, resulting in segment growth. IHC-based CDx aids in the rapid development of drugs and increases the likelihood of successful approval. IHC-based oncology companion diagnostic assays can help at any point during the development process. Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC), Antibody Drug Conjugates (ADC), immune checkpoint blockade, and signal transduction blockade are just a few of the antibody therapies used IHC technology as a CDx to help speed up clinical trials and marketing procedures.

IHC has primarily been used to provide a wide range of special stains to identify and classify cells and tumors in formalin-fixed paraffin-embedded (FFPE) tissues. IHC is an ideal method to base a CDx on because it demonstrates both a protein target's presence and cellular localization. When IHC is used as the basic technology for a CDx, there is an implied transition from a stain to an assay with elements of quantification. Any changes to an IHC-parameters CDx's and conditions, such as reagents, protocol, and scoring, can affect its clinical sensitivity, resulting in different test results. Moreover, on October 13th, 2021, Agilent Technologies Inc.'s Ki-67 IHC MIB-1 pharmDx (Dako Omnis) received FDA approval as a tool for identifying patients with early breast cancer (EBC) who may benefit from adjuvant treatment with Verzenio (abemaciclib) in combination with endocrine therapy. This is the first IHC assay to measure Ki-67 expression in the context of Verzenio treatment to receive FDA approval, and it was developed in collaboration with Eli Lilly and Company.

Geographical Analysis

North America region is expected to hold the largest market share in the global oncology companion diagnostics market

The growing prevalence of cancer, increasing R&D, and reimbursement policies are all factors expected to drive the market growth in this region. For instance, the rising cancer burden in the United States is expected to fuel market growth. According to the American Cancer Society Inc., around 1.8 million new cancer cases will be diagnosed and 606,520 cancer deaths in the United States in 2020. Moreover, the Centers for Medicare & Medicaid Services (CMS) expanded next-generation sequencing coverage as a diagnostic tool for patients with germline (inherited) breast cancer in January 2020.

The market is expected to grow by the changing role of oncology companion diagnostics in the era of next-generation omics. For instance, on May 21, 2021, the Guardant360 CDx liquid biopsy test was approved by the United States Food and Drug Administration as the first and only companion diagnostic for Janssen Biotech, Inc.'s RYBREVANTTM (amivantamab-vmjw).

Competitive Landscape

The global oncology companion diagnostics market is highly competitive with company mergers, product launches, and acquisitions. Some of the key players in the market are Agilent Technologies, Inc., Illumina, Inc., QIAGEN N.V., Thermo Fisher Scientific, Inc., F. Hoffmann-La Roche Ltd., ARUP Laboratories, Abbott, Myriad Genetics, Inc., bioMérieux SA, Invivoscribe, Inc., Pillar Biosciences, Inc.

F. Hoffmann-La Roche Ltd.

Overview: Roche is a global leader in research-driven healthcare, with strengths in both pharmaceuticals and diagnostics. Roche is one of the largest biotech companies, specialising in oncology, immunology, infectious diseases, ophthalmology, and neuroscience. Its personalised healthcare strategy aims to provide medicines and diagnostics.

Product Portfolio: The VENTANA ALK (D5F3) CDx Assay is used to detect the anaplastic lymphoma kinase (ALK) protein in non-small cell lung carcinoma (NSCLC) tissue that has been formalin-fixed, paraffin-embedded (FFPE), and stained with a BenchMark XT automated staining instrument. It's used to help doctors figure out which patients are candidates for treatment.

Key Development: On August 18th, 2021, Roche's VENTANA MMR RxDx Panel was approved by the US Food and Drug Administration. The VENTANA MMR RxDx Panel is the first companion diagnostic test to aid in identifying patients with deficient DNA mismatch repair (MMR) in solid tumours who may be eligible for GSK's JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD-1 immunotherapy. The test evaluates a panel of MMR proteins in tumours to provide clinicians with crucial treatment information.

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