Over the last decade, cancer treatment and diagnostics has become a major public health concern across the globe. With over 1.5 million instances reported each year, diseases like cancer can have far-reaching implications for individuals as well as a greater influence on the socioeconomic strata. The market for appropriate testing assay kits is expanding rapidly, owing to the increased importance of early diagnosis to minimize further hazards, especially with rates on the rise. The rising global cancer incidence and the growing demand for early detection are expected to drive the growth of the global molecular oncology diagnostics market during the forecast period. 

The global molecular oncology diagnostics market was valued at $3,620.6 million in 2021 and is anticipated to reach $12,130.5 million by 2032, witnessing a CAGR of 11.43% during the forecast period 2022-2032. The growth in the global molecular oncology diagnostics market is expected to be driven by the rising prevalence of cancers and increased transformations in biomarker identification.

Impact

•   The presence of major kit and assay providers of molecular oncology diagnostics has a major impact on the market. For instance, in March 2021, Biocartis NV launched Idylla GeneFusion Assay as a Rapid Lab Workflow Solution for gene fusion testing. This product provides a much faster testing solution for laboratories in comparison to other testing methods, including NGS.
•   Companies such as Bio-Rad Laboratories, Inc., in August 2022, acquired Curiosity Diagnostics. The company acquired all the outstanding shares of the latter from Scope Fluidics, S.A. for its growth in the medical diagnostic and healthcare markets, for a total consideration of up to $170 million. Similarly, in February 2022, Becton and Dickinson Company (BD) acquired Cytogons to gain exclusive access to advanced assays licensed from the EuroFlow Consortium and strengthen BD's leadership position in the molecular oncology diagnostics segment.

Market Segmentation:

Segmentation 1: by Product
•    Kits and Assays
•    Instruments
•    Software

Based on products, the global molecular oncology diagnostics market is expected to be dominated by kit and assay. This is due to the high number of applications performed by kits and their ease of integration with other systems.

Segmentation 2: by Technology
•    Next-Generation Sequencing (NGS)
•    Polymerase Chain Reaction (PCR)
•    Immunohistochemistry (IHC)
•    Fluorescence In-Situ Hybridization (FISH)
•    Flow Cytometry
•    Other Technologies

Based on technology, the global molecular oncology diagnostics market is dominated by polymerase chain reaction (PCR). However, next-generation sequencing (NGS) is expected to be the fastest-growing segment in the market. This is because PCR techniques play an important role in targeted NGS sequencing because they allow for the simultaneous production of several NGS libraries and the sequencing of numerous targeted regions.

Segmentation 3: by Application
•    Clinical Diagnostic
•    Research Use

Based on applications, the global molecular oncology diagnostics market is expected to be dominated by the clinical diagnostic segment. This is due to the high usage of technologies such as companion diagnostics and liquid biopsy emerge.

Segmentation 4: by Cancer Type
•    Solid Tumor
        o    Breast Cancer
        o    Lung Cancer
        o    Colorectal Cancer
        o    Prostate Cancer
        o    Ovarian Cancer
        o    Other Solid Tumors
•    Hematological Malignancy
        o    Lymphoma
        o    Leukemia
        o    Multiple Myeloma
        o    Other Hematological Malignancies

Based on cancer type, the global molecular oncology diagnostics market is dominated by solid tumor cancer type, where breast cancer is expected to be the leading segment. The growth of advanced solid tumor testing has mostly focused on the treatment of distinct cancer kinds, indications, and indication subtypes. The hematological malignancy segment is expected to show a fast growth rate during the forecast period.

Segmentation 5: by End User
•    Hospitals and Diagnostic Centers
•    Reference Laboratories
•    Pharmaceutical and Biotechnology Companies
•    Academic and Research Institutes

Based on end users, global molecular oncology diagnostics was dominated by the hospitals and diagnostic centers segment. The growth of this segment is primarily attributed to the high use of molecular diagnostic tests by hospitals in these fields.

Segmentation 6: by Region
•    North America
•    Europe
•    Asia-Pacific
•    Rest-of-the-World

North America dominated the global market with a revenue of $1,588.6 in 2021. However, the Asia-Pacific region, constituting several emerging economies, is expected to register the highest CAGR of 12.60% during the forecast period 2022-2032.

Recent Developments in the Global Molecular Oncology Diagnostics Market

•    In August 2022, Guardant Health expanded its Guardant Reveal usage, a liquid biopsy test for residual disease detection and recurrence monitoring, to include early-stage breast and lung cancers. It is the only tissue-free test used for colorectal cancer (CRC) and is now available for patients with breast and lung cancer.
•    In December 2021, QIAGEN partnered with Denovo Biopharma to develop a companion diagnostic test for the treatment of diffuse large B-cell lymphoma. This test identified patients expressing Denovo genomic marker 1 (DGM1), which responded to Denovo’s investigational cancer drug DB102.
•    In September 2021, Illumina partnered with Merck to develop and commercialize research tests for use in identifying specific cancer genetic mutations used in the assessment of homologous recombination deficiency (HRD).
•    In August 2021, Agilent Technologies, Inc. expanded its CE-IVD marked PD-L1 IHC 22C3 pharmDx assay usage in Europe. This assay was used as an aid in identifying esophageal cancer patients for treatments with KEYTRUDA using a combined positive score.

Demand - Drivers and Limitations

Following are the demand drivers for the global molecular oncology diagnostics market:

•    Rising Incidence of Cancer Cases
•    Launch of Innovative Products in Molecular Oncology Diagnostics Ecosystem
•    Growth in Biomarker identification and Transformations in Molecular Techniques

The market is expected to face some limitations due to the following challenges:

•    Lack of Qualified Professionals
•    Opaque Regulatory Framework Delaying the Approval of New Molecular Diagnostic Tests
•    High Cost of Equipment Hindering the Adoption Rate

Key Market Players and Competition Synopsis

The companies that are profiled have been selected based on inputs gathered from primary experts, analyzing company coverage, product portfolio, and market penetration.

Some of the prominent names in this market are:

•    Agilent Technologies, Inc.
•    Abbott.
•    Biocartis NV
•    Bio-Rad Laboratories, Inc.
•    F. Hoffmann-La Roche Ltd.
•    QIAGEN N.V.
•    Thermo Fisher Scientific, Inc.
•    Danaher.
•    Guardant Health
•    HTG Molecular Diagnostics, Inc.
•    Illumina, Inc. 
•    Invivoscribe, Inc.
•    Myriad Genetics, Inc.
•    Sysmex Corporation

 The scope of the report exclusively covers manufacturing companies that are actively involved in the development and commercialization of molecular oncology diagnostics products, which predominantly include systems, kits and consumables, and software.

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