Global Companion Diagnostics Market Size, Share, Trends, Growth & COVID-19 Impact Analysis Report - Segmented By Indication, Technology and Region - Industry Forecast (2024 to 2029)

Updated On: June, 2024
ID: 588
Pages: 175

Global Companion Diagnostics Market Size (2024 to 2029)

The global companion diagnostics market size is forecasted to grow to USD 19.35 billion by 2029 from USD 6.99 billion in 2024, showcasing a CAGR of 22.56% from 2024 to 2029.


The increasing number of targeted therapies, the shifting trend towards personalized medicine, and the rise in the prevalence of improving treatment procedures by properly analyzing diagnosis results are majorly accelerating the growth of the global companion diagnostics market.

In addition, an increase in the focus on next-generation sequencing technology and diagnostics procedures has an immense role in developing drugs, potentially influencing the growth of the global companion diagnostics market. Furthermore, an increasing number of diagnostic centers with the latest equipment with private and public organizations' help and growing spending on healthcare also fuel the market's growth rate. In addition, companion diagnostics promotes better treatment options suitable for the patient for a particular disease, boosting the global companion diagnostics market.


However, lack of awareness and skilled professionals and the cost of installing and maintaining the equipment require vast amounts that small-scale companies cannot afford, slowly impeding market growth. Furthermore, frequent changes in the software and the time taken to update the existing one are a little more. This attribute is limiting the demand of the market. In addition, the shortage of skilled technicians to resolve the complications in real-time applications has remained challenging for the market.





Market Size Available

2024 to 2029

Base Year


Forecast Period

2024 to 2029

Segments Covered

By Indications, Technology, and Region

Various Analyses Covered

Global, Regional & Country Level Analysis, Segment-Level Analysis, Drivers, Challenges, Restraints, Opportunities; PESTLE Analysis; Porter’s Five Forces Analysis; Competitive Landscape; Analyst Overview of Investment Opportunities

Regions Covered

North America, Europe, Asia Pacific, Latin America, Middle East & Africa

Market Leaders Profiled

Abbott Molecular Inc., Roche Molecular Systems Inc., Leica Biosystems Nussloch GmbH, bioMérieux Inc., Dako Inc., Qiagen Ltd., ARUP Laboratories, Myriad Genetics Inc.


Global Companion Diagnostics Market - By Indications

Oncology is the highest revenue-creating segment based on indications, as most of the companion diagnostics have been developed to detect one or the other cancer biomarkers. Oncology held the most significant market share in 2023 and is likely to continue the same trend during the forecast period. Due to the growing occurrence of cancer worldwide, increasing part of companion diagnostics in raising awareness about the humanizing medicine treatment of cancer helps the oncology segment grow. Growing benefits of biomarkers for cancer diagnosis and advanced technology in cancer diagnostics and treatment.

Within oncology, lung cancer is the most common cancer found in people worldwide and is likely to grow faster in the forthcoming years.

Global Companion Diagnostics Market - By Technology

Based on technology, the molecular diagnostics segment holds the highest share during the forecast period. With this technology, the Real-Time PCR segment is likely to continue its growth during the period. This PCR is used to identify the causes of many diseases, which drives this segment's growth.

The gene Sequencing segment is expected to showcase decent CAGR during the forecast period due to the potentiality of sequencing thousands of genes.


Regionally, North America accounted for the leading share in the global companion diagnostics market in 2023, with revenue rising in developed and developing countries. In addition, the adoption of advanced technologies and the launch of various equipment favoring the end-user are further gearing up the market growth in North America. As a result, the U.S. companion diagnostics market is predicted to grow at a significant CAGR during the forecast period, and Canada is expected to showcase a healthy CAGR. 

The European market accounted for a substantial share of the global market in 2023. The rise in the number of patients with diseases like cancer, cardiovascular, and others fuels the market's growth. Also, increasing knowledge over launching companion diagnostics procedures for various applications prompts the market's demand. As a result, EU Countries such UK, Germany, and France are estimated to register the most significant share of the European market during the forecast period.

Asia Pacific has witnessed a tremendous growth rate in the past decade and is also deemed to hit the highest CAGR in foreseen years. The growing use of biomarkers for various purposes in the medical sector is lavishing the market's growth rate. India is predicted to register a promising CAGR in the APAC region during the forecast period. Other countries such as China, Japan, and Australia are estimated to grow healthy from 2024 to 2029.

The Latin American region is projected to grow at a CAGR of 22.83% during the forecast period.

The Middle East and Africa are to have a positive growth rate shortly with the rising support from the government by introducing reimbursement schemes to allow quality treatment for ordinary people.


Companies playing a vital role in the global companion diagnostics market profiled in this report are Abbott Molecular Inc., Roche Molecular Systems Inc., Leica Biosystems Nussloch GmbH, bioMérieux Inc., Dako Inc., Qiagen Ltd., ARUP Laboratories, Myriad Genetics Inc., Biogenex Laboratories Inc., Ventana Medical Systems Inc., and Thermo Fisher Scientific Inc.


In May 2020, Myriad received FDA clearance for mychoice CDx as a companion diagnostic for Lynparza. It is for women who have ovarian cancer. The acceptance of mychoice helps clinicians identify women with ovarian cancer whose HRD is positive and who responds to the therapy. 

  • In April 2019, Qiagen launched the novel therascreen FGFR RGQ RT-PCR kit that works as a companion diagnostic. It is the first FDA-approved to treat Mestastatc Urothelial Cancer. 
  • In June 2015, the Ventana medical system (a part of Roche Group) received FDA clearance for VENTANA ALK (D5F3). It is a companion diagnostic that helps trigger lung cancer patients for Pfizer's FDA-approved targeted therapy, XALKORI.


This research report on the global companion diagnostics market has been segmented and sub-segmented based on indications, technology, and region.

By Indications

  • Oncology
    • Colorectal Cancer
    • Lung Cancer
    • Breast Cancer
    • Gastric Cancer
    • Melanoma
  • Inflammation and Autoimmune Diseases
  • Cardiovascular Diseases
  • Central Nervous System Disorders
  • Virology Diseases

By Technology

  • Immunohistochemistry
  • Molecular Diagnostics
    • In-Situ Hybridization
    • Real-Time PCR
    • Gene Sequencing

By Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • The Middle East and Africa

Please wait. . . . Your request is being processed

Frequently Asked Questions

What is the current size and growth of the companion diagnostics market?

The companion diagnostics market has been experiencing steady growth due to the increasing adoption of personalized medicine and targeted therapies. Market size and growth rates can vary by region and are influenced by factors such as technological advancements, regulatory policies, and disease prevalence.

What are the challenges facing the companion diagnostics market?

Challenges in the companion diagnostics market include the complexity of biomarker identification and validation, regulatory hurdles, reimbursement issues, and the need for greater collaboration between diagnostic developers and pharmaceutical companies.

What types of diseases are companion diagnostics used for?

Companion diagnostics are used in a wide range of diseases, including cancer, infectious diseases, cardiovascular disorders, and neurological conditions. They are particularly common in oncology, where they can help match patients with targeted therapies based on the genetic characteristics of their tumors.

Related Reports

Access the study in MULTIPLE FORMATS
Purchase options starting from $ 1800

Didn’t find what you’re looking for?

Need something within your budget?


Call us on: +1 888 702 9696 (U.S Toll Free)

Write to us: [email protected]

Click for Request Sample