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Companion Diagnostic Technologies Market Size, Shares and Companies

Companion Diagnostic Technologies Market Business Strategies

A companion diagnostic (CDx) is a test that helps determine the safe and effective use of a drug, identifying patients who would benefit most. CDx uses technologies like sequencing or immunohistochemistry to test samples like blood or tissue, supporting personalized treatments for diseases like cancer.

Companion Diagnostic Technologies Market Companies, Announcements and Updates

The companion diagnostic technologies market was estimated at US$ 2.78 billion in 2023 and is projected to grow to US$ 9.06 billion by 2034, rising at a compound annual growth rate (CAGR) of 11.34% from 2024 to 2034. The increasing demand for personalized medicines, rising incidences of cancer and other chronic disorders, and technological advancements drive the market.

Companion Diagnostic Technologies Market Revenue 2023 - 2034

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Companion Diagnostic Technologies Market: Stimulating Treatment

A companion diagnostic (CDx) is a test that provides information about the safe and effective use of a corresponding drug or biological product. It also gives an idea about the patients most likely to benefit from a particular therapeutic product. CDx involves an in vitro diagnostic (IVD) device or an imaging tool. The test can be performed on different biological samples including a tissue biopsy or blood/plasma or bone marrow samples using different genomic technologies such as next-generation sequencing and qPCR or protein-based technologies such as immunohistochemistry.

The increasing demand for personalized medicines and the development of targeted therapies potentiate the market. CDx tests represent more targeted and personalized medicine for multiple diseases. It gives prior information about the side effects and the desired therapeutic effect of a drug after administration. The growing research and development and the increasing number of clinical drugs for cancer and other chronic disorders increase the likelihood of using CDx.

  • In September 2024, Agilent Technologies, Inc. announced the launch of its Biopharma CDx Services Lab in California to ensure a seamless transition from early assay development and testing to full companion diagnostics commercialization.
  • In August 2024, Becton, Dickinson, and Company announced a strategic collaboration with Quest Diagnostics to develop, manufacture, and commercialize flow cytometry-based companion diagnostics (CDx) for cancer and other diseases.
  • In April 2023, Foundation Medicine announced a collaboration with Bristol Myers Squibb to develop the FoundationOne CDx test as a companion diagnostic to repotrectinib, an investigational tyrosine kinase inhibitor.

Demand for Precision Medicine: Opportunity for the Companion Diagnostic Technologies Market

The demand for precision medicine is becoming more and more prevalent, especially in oncology. It is reported that around 40% of the drug development pipeline is dedicated to rare cancer diseases, where next-generation biotherapeutics such as cell and gene therapy are being used more frequently. CDx are important tools in the practice and application of precision medicine. In 2022, 12 novel personalized medicines were approved by the US FDA. CDx plays a crucial role in optimizing patient outcomes and reducing healthcare costs by ensuring that therapies are tailored to individual patient profiles. A report indicates that CDx-guided drug development can cut the cost of clinical trials by 60%.

Complex Pathway and High Cost Hinder the Companion Diagnostic Technologies Market

The major challenge of the market is the complex pathway for the development of CDx. Strategic business challenges can complicate the path to the development of CDx. This can cost the company time, resources, and revenue. Another major challenge is the high cost of the CDx. The cost can range from several hundred to several thousand dollars, limiting the affordability of many lower- and middle-income groups.

Regional Insights

Favorable Government Policies Dominated North America

North America held the largest share of the companion diagnostic technologies market in 2023. The increasing demand for precision medicines, favorable government policies, increasing investment & collaborations, and the presence of key players drive the market. The increasing cases of cancer also boost the development of CDx. In June 2023, the US FDA issued guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” a pilot program to provide greater transparency regarding performance characteristics that certain tests for oncology biomarkers used to select certain oncology drug treatments should meet. Canada’s Drug Agency also introduced the first phase of process improvements related to companion diagnostics. The market is also driven by technological advancements and innovations in genomic and proteomic testing.

Rising Incidences of Cancer Promote Asia-Pacific

Asia-Pacific is anticipated to grow at the fastest rate in the companion diagnostic technologies market during the forecast period. The growing research and development, rising incidences of cancer and other chronic disorders, and increasing investments & collaborations drive the market. The Chinese government established a regulatory pathway for the development and approval of CDx. The increasing cases of cancer demand the development of precision medicines and CDx. In China, approximately 4.8 million new cancer cases were reported in 2022. The incidence of cancer in India and Japan was found to be 1.4 million and 1 million, respectively, in 2022.

The increasing awareness about genomic and proteomic testing, as well as government policies to support genomics and proteomics, augment the market. In October 2023, the Chinese government launched a multi-billion RMB 30-year proteomics research initiative. Additionally, the Japan Agency for Medical Research and Development (AMED) established a three-year continuing financial support system to spur genomic research on the pathogenesis of diseases and the development of therapeutic drugs.

Segmental Insights

By type, the immunohistochemistry segment held a significant share of the companion diagnostic technologies market in 2023. Immunohistochemistry (IHC) is a technique used to detect the presence of antigens in a tissue sample using antibodies. IHC is widely used in disease diagnosis, biological research, and drug development. It is a simple and cost-effective technique that has applications in biomarker assessment in oncology, diagnosis of infectious diseases, and evaluate neurodegenerative disorders.

By application, the cancer segment held a dominant presence in the companion diagnostic technologies market in 2023. The increasing incidences of cancer, stringent regulatory guidelines, and growing research and development potentiate the segment growth. Currently, there are 51 CDx tests approved by the US FDA, the majority of which are for hematological malignancies and solid tumors. Additionally, out of 170 approved indications for companion diagnostics, only three are for non-oncology drugs.

By application, the central nervous system segment is expected to grow at the fastest rate in the companion diagnostic technologies market during the forecast period. The rising geriatric population, increasing prevalence of neurodegenerative disorders like Alzheimer’s and Parkinson’s disease, and increasing collaborations promote the segment’s growth. CDx using next-generation sequencing technologies are developed for neurodegenerative drugs.

Top Companies in the Companion Diagnostic Technologies Market

  • Agilent Technologies, Inc.
  • Abbott Laboratories
  • Becton, Dickinson and Company
  • BioGenex
  • Bristol Myers Squibb
  • Danaher Corporation
  • Foundation Medicine
  • Myriad Genetics, Inc.
  • Qiagen NV
  • Quest Diagnostics
  • Servier Pharmaceuticals
  • Siemens Healthineers
  • Sysmex Corp
  • Tempus Technologies
  • Thermo Fisher Scientific

Companion Diagnostic Technologies Market Companies

Latest Announcements by Industry Leaders

Randy Evans, Vice President of Medical Affairs at BD Biosciences, commented that several companies should collaborate during the early development stage to achieve strategic harmony among industry players and align with the mandates of external regulatory authorities. He also stated that CDx can provide a competitive advantage for biopharma as the number of therapeutic options increases. Additionally, using a multimodal approach (e.g., genomic and proteomic) could lead to even better outcomes by enabling a more personalized approach.

Recent Developments in the Companion Diagnostic Technologies Market

  • In October 2024, Thermo Fisher Scientific announced that it received US FDA approval for Oncomine, an in vitro diagnostic test, as a companion diagnostic in grade 2 IDH-mutant glioma. It is approved for use along with Servier Pharmaceuticals’ Voranigo (vorasidenib) tablets.
  • In January 2024, ARUP Laboratories announced the first infusion of FDA-approved Roctavian, a gene therapy, with the AAV5 DetectCDx. The CDx kit involves a qualitative in vitro diagnostic test that uses a bridging immunoassay and electrochemiluminescence to determine whether anti-AAV5 antibodies are present in the blood plasma of a person with hemophilia A.

Segments Covered in the Report

By Type

  • Immunohistochemistry
  • Molecular Diagnostics

By Application

  • Oncology
  • Cardiovascular
  • Central Nervous System
  • Autoimmune & Inflammation
  • Virology
  • Others

By Region

  • North America
    • US
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Thailand
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Sweden
    • Denmark
    • Norway
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa (MEA)
    • South Africa
    • UAE
    • Saudi Arabia
    • Kuwait
  • Insight Code: 5330
  • No. of Pages: 150+
  • Format: PDF/PPT/Excel
  • Published: November 2024
  • Report Covered: [Revenue + Volume]
  • Historical Year: 2021-2022
  • Base Year: 2023
  • Estimated Years: 2024-2033

About The Author

Deepa has certified the degree of Master’s in Pharmacy in the Pharmaceutical Quality Assurance department from Dr D.Y. Patil College of Pharmacy. Her research is focused on the healthcare industry. She is the author or co-author of four Review Articles, which include Solid dispersion a strategic method for poorly soluble drugs and solubility improvement techniques for poorly soluble drugs, Herbal Drugs Used In Treatment Of Cataracts, Nano sponges And Their Application in Cancer Prevention and Ayurvedic Remedies of Peptic ulcer. She has also published a Research Article on the Formulation and Evaluation of Mucoadhesive Tablets of Miconazole cocrystal which was published in GIS Science Journal Volume 9 Issue 8. Her passion for secondary research and desire to take on the challenge of solving unresolved issues is making her flourish is the in the research sector.

FAQ's

Companion diagnostic testing refers to a test used to help match a patient to a specific drug or therapy.

Companion Diagnostics (CDx) are assays that are required to be used before a specific therapy can be initiated. They are often co-developed alongside a therapeutic during its clinical development.

Food and Drug Administration, National Cancer Institute, World Health Organization.