Companion Diagnostic Market Analysis

Global Companion Diagnostics Market Overview

The Companion Diagnostics Market Size was valued at USD 23.97 billion in 2022 and is projected to grow from USD 29.70 Billion in 2023 to USD 161.95 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 23.90% during the forecast period (2023 - 2032).

The benefits of companion diagnostics drive the growth of the global companion diagnostics industry; the expanding need for targeted therapy, the importance of personalized medicine, the rising incidence of cancer worldwide, and the ever-expanding companion diagnostics application areas are the key market drivers enhancing the market growth. 

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Labcorp received FDA approval for a companion diagnostic in April 2024 that is designed to be used along with Pfizer’s newly approved gene therapy for Hemophilia B patients.

Tempus said the FDA granted its HLA-LOH assay status as a CDx test with breakthrough device designation on August 2023. The analysis will rely on machine learning models for sequence data.

Agilent Technologies, Inc., based in the USA, secured European IVDR certification for its companion diagnostic assay in August 2023. QIAGEN (Netherlands) also got FDA approval for its companion diagnostics on July 16th, this time for Blueprint Medicines’ AYVAKIT (avapritinib) aimed at GIST or KIT-mutated GIST.

Allarity Therapeutics and DRP® Companion Diagnostics have signed an agreement with FivepHusion to support the clinical development of Deflexifol™, which treats solid tumors.

Tempus has announced a partnership with TScan Therapeutics in July 2023 to create a companion diagnostic (CDx) test for cancer patients.

F. Hoffmann-La Roche Ltd., Switzerland, got FDA approval for an extended label claim of VENTANA PD-L1 (SP263) assay on March 21st, targeting Libtayo eligible NSCLC patients.

PATHWAY, a companion diagnostic by F. Hoffmann-La Roche Ltd., was given the go-ahead in October 2022 to identify patients who qualify under HER2 metastatic breast cancer treatment ENHERTU (an anti-drug conjugate targeted against HER2).

HMNC Brain Health raised US$14.2 million in a funding round in October 2022 to support precision psychiatry programs that combine pharmaceuticals and companion diagnostics capable of identifying patient groups benefiting from such treatments.

OmniSeq Corporation debuted OmniSeq INSTsm in June 2022; this tissue-based test features next-generation sequencing (NGS) technology and aims to enhance precision oncology and patient outcomes.

Illumina Inc. teamed up with Soma Logic Operating Co. Inc. in January 2022 to introduce an assay for proteomics called Soma Scan into Illumina’s high-throughput next-generation sequencing platforms.

Denovo Biopharma LLC partnered with QIAGEN in December 2021 to develop a blood-based companion diagnostic (CDx) test that can identify patients expressing Denovo Genomic Marker 1(DGM1) who may respond to Denovo’s investigational drug DV102, a treatment for lymphoid tumors such as diffuse large B-cell lymphoma.

Qiagen N.V. (Germany) extended the Thera screen KRAS Kit in May 2021.

For instance, the Centers for Medicare and Medicaid Services (CMS), in January 2020, added cutting-edge sequence testing as an asymptotic tool used on germline (acquired) breast cancers.

Companion Diagnostics Market Trends

• Rising preference for personalized medicine market growth

Personalized or targeted medicine is one of the upcoming trends in medical innovation. It is one of the most significant fields that creates the need for companion diagnostics products. The healthcare providers are focusing on using CDx to develop new drugs based on specific genetic biomarkers in major fields such as oncology, cardiac disease, inflammation, infectious diseases, central nervous system disorders, and many more to improve patient outcomes.

Moreover, the companion diagnostic tests are currently used to help identify specific genetic/somatic mutations in patient samples that are specified for targeted therapies for many different types of cancers. For instance, in July 2021, QIAGEN N.V. (Germany) partnered with Sysmex (Japan) to develop and market cancer companion diagnostics (CDx), leveraging the latter’s Plasma-Safe-SeqS technology for next-generation sequencing (NGS); this partnership aims to develop drug treatments for cancer and boost quick clinical use of ultra-sensitive liquid biopsy clinical diagnostics.

Companion Diagnostics Market Segment Insights

Companion Diagnostics Product & Service Insights

The Market segments of Companion Diagnostics, based on product & service, includes assays, kits, & reagents and software & services. The assays, kits, & reagents segment accounted for the largest market share in 2021. Assays, kits, & reagents are required for generating many DNA molecules using primers and preparing libraries from the newly developed DNA molecules. The reagents & test kits unit vary with the number of reactions to be carried out. Camptosar (irinotecan) and Invader UGT1A1 are common examples of molecular assay used in IVD testing.

Companion Diagnostics Technology Insights

The Companion Diagnostics Market data has been segmented, based on technology, by polymerase chain reaction (PCR), next-generation sequencing (NGS), in situ hybridization (ISH), immunohistochemistry (IHC), and others. Polymerase chain reaction (PCR) is a technique used to make multiple copies of a specific genetic material (DNA/RNA) quickly. Polymerase chain reaction (PCR) plays an important role in companion diagnostic tests. This technique helps in screening the suitable treatment for the patient according to its genetic makeup and also helps to reduce the chances of the adverse effects and improves medical outcomes. Polymerase chain reaction (PCR) is the most commonly used technology for the development of companion diagnostics as it provides large quantitative data for analysis.

Companion Diagnostics Indication Insights

The Market data of Companion Diagnostics has been segmented, based on indication, by cancer, neurological diseases, infectious diseases, cardiovascular diseases, and others. The cancer further segmented into lung cancer, breast cancer, colorectal cancer, gastric cancer, and melanoma. The rising prevalence of cancer has accelerated the demand for companion diagnostics products across the globe. Companies such as QIAGEN N.V. (Germany) and F. Hoffmann-La Roche Ltd (Switzerland) are offering various companion diagnostic tools and kits to screen cancer patients. For instance, in May 2021, QIAGEN N.V. (Germany) launched the first US Food Drug and Administration (FDA)-approved tissue companion diagnostic kit to identify the KRAS G12C mutation in NSCLC tumors.

August 2021: QIAGEN N.V. (Germany) and OncXerna (US) entered into a global agreement to advance the development of the Xerna TME panel as a potential next generation sequencing (NGS) companion diagnostic for OncXerna’s Navicixizumab.

Figure 2: Companion Diagnostics Market, by Indication, 2022 & 2032 (USD Billion)Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Companion Diagnostics End User Insights

Based on end user, the market of Companion Diagnostics is segmented into pharmaceutical & biopharmaceutical companies, contract research organizations, laboratories, and others. Pharmaceutical and biotech companies held the largest market size in 2021. This large share can be attributed to the increased adoption of companion diagnostics in drug discovery & development by pharmaceuticals and biotechnology companies. For instance, in August 2020, F. Hoffmann-La Roche Ltd. (Switzerland) launched FoundationOne liquid CDx that has been approved by the FDA for pan-tumor liquid biopsy tests to diagnose the solid tumor.

October 2021: Agilent Technologies, Inc. (US) received FDA companion diagnostic approval for ki-67 ihc mib pharmdx in high-risk early breast cancer.

Companion Diagnostics Regional Insights

By Region, the study segments the market into North America, Europe, Asia-Pacific, and Rest of the World. North America companion diagnostics market accounted for the largest market share in 2021, The increasing number of healthcare organizations working on generated genomic databases to understand the human genome and growing research activities in this region using companion diagnosis kits are also driving the market growth.

Further, the major countries studied are: The US, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 3: COMPANION DIAGNOSTICS MARKET SHARE (%) BY REGIONSource: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe companion diagnostics market accounts for the second-largest market share due to the growing preference for personalized medicine and increasing collaboration among companies, and increasing product approval by major players coupled with the various government initiatives to promote companion diagnostics are some of the prominent factors driving the growth of the market of companion diagnostics. Furthermore, the Germany market of companion diagnostics held the largest market share in 2021, and the France market of companion diagnostics was the fastest growing market in the Europe region.

The rapid growth of the Asia-Pacific regional market is due to the increasing prevalence of infectious diseases, rising of proteomics & genomics, the growing number of cancer patients, cardiovascular and neurological diseases, and growing research funding and rising investments by pharmaceutical biotechnological companies. According to the Alzheimer's Association report, countries such as India have more than four million people with some form of dementia and Alzheimer's, the most common type of dementia. Moreover, China market of companion diagnostics held the largest market share, and the India market of companion diagnostics was the fastest growing market in the Asia-Pacific region.

Companion Diagnostics Key Market Players & Competitive Insights

Major market players are spending a lot of money on R&D to increase their product lines, which will help the market of companion diagnostics grow even more. Market participants are also taking a range of strategic initiatives to grow their worldwide footprint, including new product launches, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations. Competitors in the companion diagnostics industry must offer cost-effective items to expand and survive in an increasingly competitive and rising market environment.

In addition, Thermo Fisher Scientific, Inc. (US) specializes in various biotechnology products such as analytical instruments, laboratory supply chain programs and e-commerce, laboratory equipment, lab services, and specialty diagnostics. The company helps its customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to the market, and increase the productivity of the laboratory. In December 2021, the company received approval for Oncomine Dx Target Test as a companion diagnostic (CDx) by the FDA that aims to assist healthcare experts in identifying non-small cell lung cancer patients whose tumors carry epidermal growth factor receptor (EGFR).

Hoffmann-La Roche Ltd (Switzerland) is one of the leading companies in the field of diagnostics and pharmaceuticals. The company develops and markets products for diagnosis and treatment of anemia, cancer, anticoagulation therapy, cardiovascular diseases, diabetes, central nervous system, chlamydia, dermatology, gonorrhea, gout, hepatitis B and C, hemostasis disorders, HIV/AIDS, HPV, infectious diseases, and autoimmune diseases. In August 2020, the company announced the approval of FoundationOne liquid CDx by the FDA. The product is applicable for pan tumor liquid biopsy tests. This launch aims to strengthen the company’s companion diagnostics product portfolio.

Key Companies in the Companion Diagnostics Market includes.

• Hoffmann-La Roche Ltd (Switzerland)


• Thermo Fisher Scientific Inc. (US)


• Agilent Technologies, Inc. (US)


• QIAGEN N.V. (Germany)


• Abbott Laboratories, Inc. (US)


• BioMérieux SA (France)


• Leica Biosystems Nussloch GmbH (Germany)


• Illumina, Inc. (US)


• Myriad Genetics, Inc. (US)


• ArcherDX, Inc. (US)


• Others

Companion Diagnostics Industry Developments

December 2021: QIAGEN N.V. (Germany) partnered with Denovo Biopharma (US) to develop companion diagnostic tests for the treatment of diffuse large B-cell lymphoma.

October 2021: Agilent Technologies, Inc. (US) PD-L1 IHC 22C3 pharmadx assay got approval in the European Union for use in triple-negative breast cancer.

September 2021: Food Drug and Administration approved tissue based NGS companion diagnostics for Takeda's targeted therapy for NSCLC patients with EGFR Exon 20 insertion mutations.

Companion Diagnostics Market Segmentation

Companion Diagnostics Product & Service Outlook

• Assays, Kits, & Reagents


• Software & Services

Companion Diagnostics Application Outlook

• Polymerase Chain Reaction (PCR)


• Next-Generation Sequencing (NGS)


• In Situ Hybridization (ISH)


• Immunohistochemistry (IHC)


• Others

Companion Diagnostics Indication Outlook

• Cancer
  
  
  
  • Lung Cancer
  
  
  • Breast Cancer
  
  
  • Colorectal Cancer
  
  
  • Gastric Cancer
  
  
  • Melanoma
  
  
  • Others
  
  
  
  


• Neurological Diseases


• Infectious Diseases


• Cardiovascular Diseases


• Others

Companion Diagnostics End User Outlook

• Pharmaceutical & Biopharmaceutical Companies


• Contract Research Organizations


• Laboratories


• Others

Companion Diagnostics Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America