Oncology Companion Diagnostics Market Size to Reach USD 6.60 Billion in 2028, Noted Reports and Data

Increasing role of oncology companion diagnostics in omics field, development of new combinational therapies and monotherapies, and increasing unmet medical needs of cancer therapeutics are key factors driving market growth

The global oncology companion diagnostics market size is expected to reach USD 6.60 Billion in 2028 at a CAGR of 13%, according to the latest report by Reports and Data. Increasing demand for personalized medicine, discovery of advanced biomarkers for various conditions, rising unmet medical needs, and rising prevalence of cancer worldwide are key factors driving market revenue growth over the forecast period. Increasing number of research and development activities for cancer, rising number of product approvals from the U.S. FDA, and growing awareness about personalized medicine in developing countries are also key factors expected to drive market growth going ahead.

Companion diagnostics is described as a medical device, generally an in-vitro device, which offers essential information to determine safe and effective use of another drug or biological product. Companion diagnostics is a part of pharmacogenomics, which uses genetic makeup of an individual to predict responsiveness to a drug or tailor customized treatment approaches. Non-small cell lung cancer, colorectal cancer, and breast cancer have the most targeted drug development activities. In oncology, clinical diagnostic also plays a major role in streamlining selection of participants for clinical trials. It can effectively screen and identify patients expected to show positive response to a drug and patients who can have adverse effects to drugs. Companion Diagnostics (CDx) provides insights into personalized treatment options for patients with malignancies by identifying FDA-approved treatment options that suit their individual cancer. Companion diagnostics also offers clinicians clear idea about diagnosis and treatment, thereby enhancing effects of cancer treatment. Emergence of high-throughput and sensitive diagnostic technologies such as NGS, digital pathology, and quantitative histopathology have boosted development of advanced platforms for CDx. This has contributed significantly to revenue growth of the market.

Increasing collaborations and partnerships to co-develop drugs and therapeutic approaches is also expected to drive market growth over the forecast period. However, high costs of companion diagnostics, shortage of skilled professionals, and low awareness about oncological companion diagnostics in developing countries are expected to restrain market growth to a significant extent over the forecast period. 

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Some Key Highlights from the Report:

  • Increasing demand for consumables and reagents, rising burden of cancer globally, and emergence of advanced technologies such as NGS for cancer diagnostics are key factors driving revenue growth of the products segment.
  • Immunohistochemistry segment is expected to register robust revenue growth over the forecast period owing to increasing available of IHC-based cancer diagnostic solutions, rapid progress in drug discovery and development and clinical trials, increasing product approvals, and increasing importance of IHC-based cancer companion diagnostic assays in drug development processes.
  • Breast cancer segment is expected to account for considerable revenue share during the forecast period, attributable to increasing incidence of breast cancer across the globe, launch of companion diagnostic solutions, and favorable reimbursement scenario.
  • Hospitals segment is expected to account for significantly large revenue share in the global market between 2021 and 2028 owing to development of advanced healthcare facilities, availability of skilled professionals, and advancements in diagnosis and treatment of cancer.
  • Asia Pacific market revenue is expected to expand at a robust CAGR over the forecast period owing to rising caseload of cancer, increasing investment and funding in drug research and development, rising demand for personalized medicine, and rise in awareness regarding personalized therapeutics for cancer in countries in the region.
  • Prominent players operating in the market include Agilent Technologies, Inc., Illumina, Inc., QIAGEN N.V., Thermo Fisher Scientific, Inc., F. Hoffmann-La Roche Ltd., ARUP Laboratories, Abbott Laboratories, Myriad Genetics, Inc., bioMérieux SA, and Invivoscribe, Inc.
  • In April 2021, Roche announced approval from the U.S. FDA for its Ventana MMR RxDx panel, which has been particular designed to treat patients with advanced and recurrent endometrial cancer. The companion diagnostic is the first approach to identify patients eligible to undergo treatment with GlaxoSmithKline Plc.’s Jemperli monotherapy.

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For the purpose of this report, Reports and Data has segmented the oncology companion diagnostics market based on product & service, technology, disease type, end-use, and region:  

Product & Service Outlook (Revenue, USD Billion; 2018-2028)

  • Products
    • Consumables
    • Instrument
    • Software
  • Services

Technology Outlook (Revenue, USD Billion; 2018-2028)

  • Polymerase Chain Reaction (PCR)
  • Next-Generation Sequencing (NGS)
  • Immunohistochemistry (IHC)
  • In situ hybridization (ISH)/Fluorescence in situ hybridization (FISH)
  • Others 

Disease Type Outlook (Revenue, USD Billion; 2018-2028)

  • Breast Cancer
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • Leukemia
  • Melanoma
  • Prostate Cancer
  • Others

End-use Outlook (Revenue, USD Billion; 2018-2028)

  • Hospitals
  • Pathology/Diagnostic Laboratory
  • Academic Medical Centers

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Regional Outlook (Revenue, USD Billion; 2018-2028)

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • U.K.
    • Italy
    • France
    • BENELUX
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Rest of APAC
  • Latin America
    • Brazil
    • Rest of LATAM
  • Middle East & Africa
    • Saudi Arabia
    • U.A.E.
    • South Africa
    • Rest of MEA

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