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. This expanded usage of kit and assay, instrument, and software has enabled end customers to describe particular system requirements, prompting suppliers to design more appealing and practical products and molecular diagnostics choices.

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 of COVID-19

Cancer screening is crucial for early cancer detection; however, COVID-19 slowed the cancer screening infrastructure greatly. Many cancer organizations have championed the idea of ​​suspending cancer screening services to patients to alter the provision of health care resources. According to the declaration of a national emergency in the US on March 13th, 2020, organizations such as the American Cancer Society advised people to put their cancer screening plans on hold until further notice during the COVID-19 outbreak. Cancer screening services have been severely disrupted because of this proposal, as well as other contextual circumstances (eg, social exclusion measures).

In response to the COVID-19 pandemic and the impact on medical research in the US, the National Institutes of Health (NIH) and the National Cancer Institute (NCI) both extended grant application deadlines, laid back reporting requirements, and offer flexibility in how to grant money is spent. COVID-19 drastically reduced fundraising possibilities for cancer-focused charitable research organizations, which provide up to half of all cancer research funding in the US and frequently fund high-risk, high-reward projects even though the national government supported research work and offered medical researchers the flexibility to implement their skill set and knowledge to studying SARSCoV-2.

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 NV
• Thermo Fisher Scientific, Inc.
• Danaher.
• Guardant Health
• HTG Molecular Diagnostics, Inc.
• Illumina, Inc. 
• Invivoscribe, Inc.
• Myriad Genetics, Inc.
• Sysmex Corporation

Key Questions Answered in the Report

• What are the major market drivers, challenges, and opportunities and their respective impacts in the global molecular oncology diagnostics market?
• What are the underlying structures resulting in the emerging trends within the global molecular oncology diagnostics market?
• What is the current market demand, along with future expected demand for the global molecular oncology diagnostics market?
• What are the key development strategies that have been implemented by the major players in order to sustain the competitive market?
• Which potential entry barriers are expected to be faced by the companies willing to enter the global molecular oncology diagnostics market?
• Who are the leading players with significant offerings to the global molecular oncology diagnostics market, and what is the expected market dominance for each of these leading players?
• Which companies are anticipated to be highly disruptive in the future, and why?
• What are the growth opportunities for the companies in the region of their operation?
• What are the key regulatory implications in developed and developing regions for molecular oncology diagnostics?

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. The study also takes into consideration the various diagnostics application offered by the manufacturers, such as clinical diagnostics (in vitro diagnostics, companion diagnostics (CDx), liquid biopsy) as well as research use only (RUO) products. The global market covers major regions, including North America, Europe, Asia-Pacific, and Rest-of-the-World.

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