Companion Diagnostics Market to Reach Valuation of USD 10.3 Billion by 2028 – Advances in Next-Generation Sequencing Drives the Market

Vantage Market Research

Feb 28, 2023

In terms of revenue, the Global Companion Diagnostics Market is expected to reach USD 10.3 Billion by 2028, growing at a CAGR (Compound Annual Growth Rate) of 11.90% from 2022 to 2028.

It is now well-accepted that medications can interact differently with different people due to genetic sequencing and genomics advancements. Giving "the correct drug, at the right time, in the right dose, for the right person" might be supported by a better understanding of a person's genetic characteristics or biomarkers. To deliver focused medicines to suitable candidates, pharmaceutical and biopharmaceutical companies continuously work to adopt patient-selection diagnostic frameworks in the early stages of drug development. Therefore, the market for Companion Diagnostics is growing. However, the high initial cost makes these tests unaffordable for many end-users, particularly those in developing nations, despite the assured returns on investment. This causes end users, including pharmaceutical firms, reference labs, hospitals, and CROs, to seek out third-party companion diagnostic services since they view such procedures as expensive.

NGS-based companion diagnostic tests try to gather molecular data from each patient's tumor genome to inform decisions about cancer therapy. Next-generation sequencing discovers several biomarkers for numerous pharmaceutical regimens more quickly than current sequencing methods. Therefore, treatment for multiple cancers may benefit from using NGS panels for biomarker evaluation in a single test.

Key Highlights from the Report

  • Based on Technology, the Polymerase Chain Reaction (PCR) segment dominates the Companion Diagnostics market with the maximum market share. Its dominance will continue in the forecast period due to its sensitivity, specificity, and affordability.
  • Among Indications, the Chemical Processing segment accounted for the highest CAGR in the forecast period. The factors include the growing importance of Companion Diagnostics in customized care and the expanding use of biomarkers in cancer diagnosis.
  • In terms of region, North America holds the significant market share within the Companion Diagnostics market due to the high prevalence of numerous cancer kinds in the American people.

Market Dynamics

The number of cancer-related genes is tested by clinicians using the Next-Generation Sequencing (NGS) method on the tumor of a patient who has had surgery to remove it. The NGS technique produces a lot quickly, and technological breakthroughs are being made. For instance, next-generation sequencing has moved from being used in research to be used in clinical settings during the previous five years, according to a piece written by the Centers for Disease Control and Prevention (CDC). Furthermore, market leaders are developing technologically cutting-edge testing solutions. Therefore, one of the latest Companion Diagnostics market trends is the development of next-generation sequencing to identify genetic anomalies that are useful in treating particular diseases. Recent years have seen a marked growth in the occurrence of cancer. The demand for efficient CDx tests is increased by the rising incidence of cancer cases since genetic testing offers doctors precise information on treatment regimens and presents a clear image of patients' malignancies. As a result, CDx product sales are increasing as cancer incidence rises.

Furthermore, many innovative products have been approved in the Companion Diagnostics sector. As a result, the market is growing faster due to the adoption of many tests as the number of approved goods rises. Additionally, significant producers create innovative tests that fuel the expansion of the Companion Diagnostics industry.

However, the lack of compensation and strict rules may impede potential global adoption and market expansion during the foreseeable period.

The United States emerged as a significant contributor to North America’s dominance of the Companion Diagnostics business. The FDA's risk classification of these assays reflects that using Companion Diagnostics is a key treatment decision tool for various cancer medicines. Despite the COVID-19 pandemic, Companion Diagnostics clinical trials have gained prominence in the pharmaceutical sector since they increase the likelihood of clinical success. The testing kit was in high demand for locating SARS-CoV-2-affected people. In research and development, diagnostic test manufacturers concentrated mainly on COVID-19. MiraDx established its lab in May 2020 to offer COVID-19-based diagnostic services in the United States. According to the business, the lab could accurately assess more than 9,000 tests.

The Global Companion Diagnostics Market is Segmented as follows

  • Product & Service
    • Assays
    • Kits & Reagents
    • Software & Services
  • Technology
    • Next-Generation Sequencing
    • In Situ Hybridization
    • Immunohistochemistry
    • Other Technologies
  • Indication
    • Cancer
    • Neurological Disorders
    • Cardiovascular Disorders
    • Infectious Diseases
    • Other Indication
  • End Users
    • Pharmaceutical & Biopharmaceutical Companies
    • Reference Laboratories
    • Contract Research Organizations
    • Other End Users
  • Region
    • North America
    • Europe
    • Asia Pacific
    • Latin America
    • Middle East & Africa

List of the Key Players of the Global Companion Diagnostics Market is

Abbott Laboratories Molecular Inc. (U.S.), Agilent (Dako Denmark A/S) (U.S.), ARUP Laboratories Inc. (U.S.), BioMerieux (France), Danaher Corporation (Leica Microsystems) (Germany), Foundation Medicine Inc. (U.S.), Myriad Genetics Inc. (U.S.), Roche (Ventana Medical Systems Inc.) (U.S.), Thermo Fisher Scientific (Life Technologies Corporation) (Germany), QIAGEN N.V. (Germany)

The Global Companion Diagnostics Market Scope can be Tabulated as below

Parameter Details
Market Size Provided for Years 2017 - 2030
Base Year 2022
Historic Years 2017 - 2021
Forecast Years 2023 - 2030
Segments Covered
  • Product & Service
    • Assays
    • Kits & Reagents
    • Software & Services
  • Technology
    • Next-Generation Sequencing
    • In Situ Hybridization
    • Immunohistochemistry
    • Other Technologies
  • Indication
    • Cancer
    • Neurological Disorders
    • Cardiovascular Disorders
    • Infectious Diseases
    • Other Indication
  • End Users
    • Pharmaceutical & Biopharmaceutical Companies
    • Reference Laboratories
    • Contract Research Organizations
    • Other End Users
  • Region
    • North America
    • Europe
    • Asia Pacific
    • Latin America
    • Middle East & Africa
Regions & Counties Covered
  • North America
    • U.S.
    • Canada
    • Mexic
  • Eurpe
    • U.K
    • France
    • Germany
    • Italy
    • Spain
    • Rest Of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Suth Korea
    • South East Asia
    • Rest Of Asia Pacific
  • Latin America
    • Brazil
    • Argentina
    • Rest Of Latin America
  • Middle East & Africa
    • GCC Cuntries
    • South Africa
    • Rest Of Middle East & Africa
Companies Covered
  • Abbott Laboratories Molecular Inc. (U.S.)
  • Agilent (Dako Denmark A/S) (U.S.)
  • ARUP Laboratories Inc. (U.S.)
  • BioMerieux (France)
  • Danaher Corporation (Leica Microsystems) (Germany)
  • Foundation Medicine Inc. (U.S.)
  • Myriad Genetics Inc. (U.S.)
  • Roche (Ventana Medical Systems Inc.) (U.S.)
  • Thermo Fisher Scientific (Life Technologies Corporation) (Germany)
  • QIAGEN N.V. (Germany)
Report Coverage Market growth drivers, restraints, opportunities, Porter’s five forces analysis, PEST analysis, value chain analysis, regulatory landscape, technology landscape, patent analysis, market attractiveness analysis by segments and North America, company market share analysis, and COVID-19 impact analysis

Companion Diagnostics Market Size, Share & Trends Analysis Report by Product & Service (Assays, Kits & Reagents, Software & Services), by Technology (Next-Generation Sequencing, In Situ Hybridization, Immunohistochemistry, Other Technologies), by Indication (Cancer, Neurological Disorders, Cardiovascular Disorders, Infectious Diseases), by End Users (Pharmaceutical & Biopharmaceutical Companies, Reference Laboratories, Contract Research Organizations, Other End Users), by Region (North America, Europe, Asia Pacific, Latin America) - Global Industry Assessment (2016 - 2021) & Forecast (2022 - 2028)