Companion Diagnostic Technologies Market By Type (Immunohistochemistry and Molecular Diagnostics), By Application (Oncology, Cardiovascular, Central Nervous System, Auto immune & Inflammation, and Virology), and By Region- Market Trends, Analysis, and Forecast till 2034

Companion Diagnostic Technologies Market was valued at USD 7.9 Billion in 2024 and is projected to grow at a CAGR of 11.60% to reach USD 21.4 Billion by 2034

The Companion Diagnostics Technologies Market focuses on providing various molecular tests that provide essential information for the safe and effective use of drugs. These tests help healthcare professionals to decide whether the specific treatment or therapy is beneficial for the patient, for curing the disease or not. Companion diagnostics play a crucial role in the personalized medicine approach, enabling healthcare professionals to make more informed treatment decisions for patients.

The growing prevalence of cancer and various other infectious diseases is the key factor leading to an increase in the growth of the target market. Cancer remains one of the leading cause of death globally, with a rising number of cases reported annually. Additionally, infectious diseases continue to pose substantial health challenges, especially with the emergence of new strains and the re-emergence of previously controlled infections, eventually leading to an increase in the growth of the Companion Diagnostic Technologies Market.

• For instance, according to The International Agency for Research on Cancer (IARC), it was estimated that 14.1 million new cancer cases were diagnosed globally in 2012. The most frequent kind of these was lung cancer (13%) followed by breast cancer (11.9%) and colorectal cancer (11.9%). Furthermore, in 2023, according to The Hindu, it has been reported that the prospect of climate change is on the verge of leading to an increase in the burden with the spread of diseases like dengue, malaria and chikungunya.

New advancements in Next-Generation Sequencing is one of the major factors leading to the growth of the target market. The number of cancer-related genes are 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 approach produces a lot in a short amount of time, and technical breakthroughs are being made for it, which in turn has been pushing forward the growth of the Companion Diagnostic Technologies Market.

• For instance, in 2021, according to an article published in the Centers for Disease Control and Prevention (CDC), next-generation sequencing has moved from being used in research to being used in clinical settings during the previous five years.

Rising Prevalence of Cancer to boost the target market growth

The rising prevalence of cancer diseases across the globe is one of the key factors leading to the growth of the target market. The demand for efficient CDx (Companion Diagnostic) tests is increased by the rising incidence of cancer cases since genetic testing offers clinician the accurate information on treatment regimens and paints a clear picture of patients' tumor. As a result, CDx (Companion Diagnostic) product sales are growing as cancer incidence rises, which in turn is boosting the growth of the Companion Diagnostic Technologies Market.

• For instance, in 2022, according to a research paper published by the Indian Council of Medical Research, it was estimated that cancer cases in India are likely to rise from 14.6 lakh in the year 2022 to 15.7 lakh in the year 2025.

Restrains:

High cost of installation and maintenance of the equipment is the major factor restraining the growth of the target market, owing to the fact that small-scale companies cannot afford them.

Regional Insights:

On the basis of Region, the Companion Diagnostic Technologies Market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The North America region segment is expected to dominate the target market in the near future, owing to rising prevalence of chronic diseases, advancements in technology, incorporation of advanced devices, improved healthcare facilities as well as growing research and development activities. 

Companion Diagnostic Technologies Market is segmented based on Type, Application, and Region.

Type Insight

On the basis of Type, Companion Diagnostic Technologies Market is segmented into Immunohistochemistry and Molecular Diagnostics.

Application Insights

On the basis of Application, Companion Diagnostic Technologies Market is segmented into Oncology, Cardiovascular, Central Nervous System, Auto immune and Inflammation and Virology. The Oncology Application segment is expected to dominate the growth of the target market, due to the growing role of companion diagnostics in the personalized medicine treatment for cancer as well as the increasing use of biomarkers in the diagnosis and treatment of cancer.

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2022 to 2032. For the purpose of this study, has segmented the Companion Diagnostic Technologies Market report based on Type, Application and Region:

Companion Diagnostic Technologies Market, By Type:

• Immunohistochemistry
• Molecular Diagnostics

• Companion Diagnostic Technologies Market, By Application:

• Oncology
• Cardiovascular
• Central Nervous System
• Auto immune & Inflammation
• Virology

• Companion Diagnostic Technologies Market, By Region:

  • Middle East & Africa
    • GCC
    • Israel
    • South Africa
    • Rest of Middle East & Africa
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Rest of Asia Pacific
  • Europe
    • Germany
    • UK
    • France
    • Russia
    • Italy
    • Rest of Europe
  • North America
    • U.S.
    • Canada

The key players operating the Companion Diagnostic Technologies Market includes, Dako A/S, Qiagen LLC, Roche, Abbott Laboratories Inc., Ventana Medical Systems, bioMerieux, Myriad Genetics Inc., Resonance Health Ltd., Leica Microsystems and Life Technologies.

• In August 2020, the agency Guardant Health, Inc., approved the Guardant360 CDx assay, a next-generation sequencing (NGS) test that uses peripheral whole blood plasma's circulating cell-free DNA to identify EGFR mutations in non-small cell lung cancer patients who are candidates for osimertinib (Tagrisso) therapy. According to the FDA, the test is the first liquid biopsy assay that also incorporates NGS technology.
• In May 2020, U.S FDA (Food and Drug Administration) approved ‘FoundationOne CDx’ as a companion diagnostic for LYNPARZA which is developed by Foundation Medicine Inc. The new approved FoundationOne CDx’ has become the only FDA-approved CGP (comprehensive genomic profiling) test for all types of solid tumors which incorporate various companion diagnostic claims.
• In May 2020, Myriad achieved FDA (Food and Drug Administration) approval for their innovation, “mychoice CDx as a companion diagnostic for Lynparza. It was made, targeting women suffering from ovarian cancer, which could help clinicians identify women with ovarian cancer whose HRD is positive and who will respond to therapy.
• In April 2019, Qiagen launched new product “Therascreen FGFR RGQ RT-PCR Kit” which could work as a companion diagnostic and is known as the first FDA-approved kit to treat Metastatic Urothelial Cancer.

• Dako A/S
• Qiagen LLC
• Roche
• Abbott Laboratories Inc.
• Ventana Medical Systems
• bioMerieux
• Myriad Genetics Inc.
• Resonance Health Ltd.
• Leica Microsystems
• Life Technologies