Companion Diagnostics Market by Product & Service (Assays, and Kits & Reagents), Technology (Polymerase Chain Reaction, Next-Generation Sequencing, In Situ Hybridization, Immunohistochemistry, and Other Technologies), Indication (Cancer, Neurological Disorders, Cardiovascular Diseases, and Other Industries): Global Market Size Estimates and Forecast (2022-2030)

The market crossed US$ 4.83 billion mark in 2022 and is expected to hit US$ 11.56 billion by 2030, recording a CAGR of 12% during the forecast period.

Companion diagnostic market has been significantly growing with the high adoption of polymerase chain reaction segment.

Rising demand for targeted medicines and increasing dominance of cancer cases are driving the growth of the companion diagnostics market. With the increasing adoption of early detection and screening of chronic diseases, the market is expected to witness significant growth during the forecast period. The next-generation sequencing segment is expected to pace the growth rate of the campanion diagnostics market as it helps to detect multiple biomarkers for multiple drug therapies in a shorter time frame than other technologies. Further, other segment such as polymerase chain reaction, in-situ hybridization, immunohistochemistry, and other technologies is also expected to gain traction during the forecasted year.

Within the report, the market is segmented into product & service, technology, indication, end-user, and geography. By product & service, the market is further segmented into assays and kits & reagents, software & services. On the basis of technology, the market is segmented into polymerase chain reaction, next-generation sequencing, in-situ hybridization, immunohistochemistry, and other technologies. By indication, the market is categorized into cancer, neurological disorders, cardiovascular diseases, infectious diseases, and other indications. Based on end user, the market is divided into pharmaceutical & biopharmaceutical companies, reference laboratories, contract research organizations, and other end users. Geographically, the market is sub segmented into North America, Europe, Asia Pacific, South & Central America, and Middle East & Africa.

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Increasing burden of Cancer across the globe is expected to drive the market growth.

In 2020, the cancer segment accounted for the largest share of the companion diagnostics market. Additionally, the favorable reimbursement scenario for breast cancer diagnostic solutions in the United States is anticipated to facilitate their adoption. For instance, in January 2020, the centers for Medicare & Medicaid Services expanded its coverage of next-generation sequencing as a diagnostic tool for patients with germline (inherited) breast cancer. Moreover, factors such as the growing role of companion diagnostics in the personalized medicine treatment for cancer, and the rising utility of biomarkers in cancer diagnosis has also resulted in the overall market growth during the forecast period.

Rising adoption in technologies in pharmaceutical & biopharmaceutical companies is one of the major factors accelerating the market growth.

The end user segment of companion diagnostics market is segmented into pharmaceutical & biotechnology companies. In 2020, pharmaceutical & biotechnology companies accounted for a larger share of the companion diagnostic market. The growing use of companion diagnostics owing to their increasing prominence in drug development, and the rising importance of companion diagnostic biomarkers. Other end users are also encouraging the use of next-generation sequencing and polymerase chain reaction technologies, further driving the growth of the companion diagnostic market during the forecast period.

Recent strategic developments in companion diagnostics market

The companion diagnostics market has undergone several significant developments, and a few of these have been mentioned below:

• In March 2021, Qiagen announced the launch of an expanded scope of companion diagnostic, which claims for the therascreen KRAS PCR Kit after it received US regulatory approval as a companion diagnostic to aid in the identification of non-small cell lung cancer (NSCLC) patients that may be eligible for treatment with LUMAKRAS (sotorasib), a newly approved therapy developed and marketed by Amgen Inc.
• In October 2021, the United States Food and Drug Administration approved Agilent’s Ki-67 IHC MIB-1 pharmDx (Dako Omnis), which aids in identifying patients with early breast cancer (EBC) at high risk of disease recurrence.
• In April 2021, Roche Diagnostics acquired TIB Molboil Group (Germany). This acquisition will enhance Roche’s broad portfolio of molecular diagnostics solutions with a wide range of assays for infectious diseases, such as identifying SARS-CoV-2 variants.

The companion diagnostics market is driven by several players by implementing strategic activities such as investments, new launches, mergers & acquisitions, and partnerships. F.Hoffmann-La Roche Ltd., Agilent Technologies, Inc., Almac Group, Danaher Corporation, Illumina Inc., bioMérieux SA, Myriad Genetics, Inc, Sysmex Corporation, are among the prominent players operating in the market.

Target audience for the report:

• Raw material providers
• Kits providers
• Device providers
• Device-related service providers
• Device-related associations, organizations, forums, and alliances
• Government bodies, such as regulating authorities and policy makers
• Venture capitalists, private equity firms, and start-up companies
• Device component suppliers
• Kits and devices distributors and sales firms
• End users of diagnostic devices
• Research institutes, organizations, and consulting companies

Scope of the report:

In this report, the market has been segmented on the basis of:

• Product & Service:
  • Assays and Kits & Reagents
  • Software & Services
• Technology
  • Polymerase Chain Reaction (PCR)
  • Next-Generation Sequencing
  • In Situ Hybridization
  • Immunohistochemistry (IHC)
  • Other Technologies
• Indication:
  • Cancer
    • Lung Cancer
    • Breast Cancer
    • Blood Cancer
    • Colorectal Cancer
    • Other Cancer
  • Infectious Diseases
  • Cardiovascular Diseases
  • Neurological Diseases
  • Other Indications
• End User
  • Pharmaceutical & Biotechnology Companies
  • Reference Laboratories
  • Contract Research Organizations
  • Other End Users
• Region
  • North America
  • Europe
  • Asia Pacific (APAC)
  • South & Central America
  • Middle East & Africa
• Companies profiled
  • F.Hoffmann-La Roche Ltd.
  • Agilent Technologies, Inc.
  • Almac Group
  • Illumina Inc.
  • Danaher Corporation
  • bioMérieux SA
  • Myriad Genetics, Inc,
  • Sysmex Corporation
  • Qiagen N.V.
  • Thermo Fisher Scientific, Inc.