Companion Diagnostics Market

Market Insights

The global companion diagnostics market size was estimated at USD 6.69 billion in 2022 and is expected to grow at a CAGR of 11.99% during 2023-2028 to reach USD 13.55 billion by 2028.

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What is companion diagnostics?

Companion diagnostics is a diagnostic test that helps in determining whether a particular therapeutic drug is beneficial to the patient and can outweigh any potentially serious side effects, providing essential information for ensuring the safety of the patient.

Key Players

Some of the key players in the global market are:- 

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

Recent JVs and Acquisition:

• On January 5, 2023, QIAGEN and Helix established exclusive strategic cooperation for companion diagnostics devices and assays identifying clinically relevant genetic diseases. The partnership will make use of the Helix® Laboratory technology, which recently received the first-ever FDA de novo class II authorization for a full exome sequencing technology.

Market Dynamics

These factors are expected to boost the demand for the global companion diagnostics market in the coming years: 

• Growing demand for personalized medicine: Companion diagnostics help physicians to identify patients who are most likely to benefit from specific treatments, leading to better outcomes and reduced healthcare costs.
• Increase in R&D of targeted therapies: Targeted therapies have become an important area of drug development, and companion diagnostics play a key role in identifying patients who are likely to respond to these therapies.
• Rising prevalence of chronic diseases: The incidence of chronic diseases such as cancer, cardiovascular diseases, and infectious diseases is increasing globally, and companion diagnostics can help to improve diagnosis, treatment, and patient outcomes.
• The increasing number of unmet needs for the treatment of cancer.
• Discovery of new biomarkers for various conditions.

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Opportunities:

• The growth of the personalized medicine market.
• The increasing prevalence of chronic diseases.
• The development of new technologies, such as next-generation sequencing.
• The increasing demand for patient-centric care.

Challenges:

• The high cost of companion diagnostics.
• The complexity of companion diagnostics.
• The regulatory hurdles.
• The lack of awareness of companion diagnostics among healthcare providers and patients.

Segmentation

Segment Analysis

By Technology Type:

The market is segmented as immunohistochemistry, polymerase chain reaction, next-generation sequencing, in situ hybridization, and others. the polymerase chain reaction segment holds a major share of the market and is estimated to dominate the global companion diagnostics market during the forecast period. The growth of the segment is owing to the cost-effectiveness, high sensitivity, and specificity of polymerase chain reaction, as well as the fact that it can be used for simple automated platforms. Furthermore, PCR is used to determine the sequencing of unknown etiologies of many diseases, which fuels its growth over the forecast period.

By Indication Type:

The market is segmented into oncology, neurology, and Others. Oncology is estimated to be the leading segment of the market during 2023-2028 and it holds the major share of the market. Owing to the high prevalence of cancer, the rising number of FDA-approved companion diagnostics, the increasing number of R&D activities for cancer, and growing awareness among patients regarding personalized medicine.

Regional Analysis

Asia-Pacific is estimated to be the fastest-growing as well as the leading region in the global companion diagnostics market during 2023-2028. On account of the rapid growth in population, growing awareness regarding companion diagnostics, increasing demand for advanced therapies, and development in healthcare infrastructures. North America and Europe are also estimated to offer substantial growth opportunities during the forecast period.

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The report provides detailed insights into the market dynamics to enable informed business decision-making and growth strategy formulation based on the opportunities present in the global companion diagnostics market.

The global companion diagnostics market is segmented into the following categories

By Technology Type:

• Immunohistochemistry
• Polymerase Chain Reaction
• Next Generation Sequencing
• In Situ Hybridization
• Others

By Indication Type:

• Oncology
• Neurology
• Others

By Region:

• North America 
• Europe
• Asia-Pacific
• Rest of the World

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Report Features

This report provides market intelligence in the most comprehensive way. The report structure has been kept such that it offers maximum business value. It provides critical insights into the market dynamics and will enable strategic decision-making for the existing market players as well as those willing to enter the global companion diagnostics market. 

What Deliverables Will You Get in this Report?

Research Methodology

This report offers high-quality insights and is the outcome of a detailed research methodology comprising extensive secondary research, rigorous primary interviews with industry stakeholders, and validation and triangulation with Stratview Research’s internal database and statistical tools.

More than 1,000 authenticated secondary sources, such as company annual reports, fact books, press releases, journals, investor presentations, white papers, patents, and articles have been leveraged to gather the data.

We conducted more than 10 detailed primary interviews with the market players across the value chain in all four regions and with industry experts to obtain both qualitative and quantitative insights.

Customization Option

Stratview Research offers one of the following free customization options to our respectable clients:

Company Profiling

• Detailed profiling of additional market players (up to 3 players)
• SWOT analysis of key players (up to 3 players)

Competitive Benchmarking

• Benchmarking of key players on the following parameters: Product portfolio, geographical reach, regional presence, and strategic alliances

Custom Research: Stratview Research offers custom research services across sectors. In case of any custom research requirement related to market assessment, competitive benchmarking, sourcing and procurement, target screening, and others, please send your inquiry to sales@stratviewresearch.com. 

Recent Development

On 9 March 2023, Servier announced a collaboration with QIAGEN to develop a new mIDH1 companion diagnostic test to support Servier's Hemato-Oncology portfolio. QIAGEN will develop and verify a real-time PCR-based in vitro diagnostic test for detecting IDH1 gene alterations in whole blood and bone marrow aspirates in AML under the terms of the Master Collaboration Agreement.

The companion diagnosis will be done using the QIAGEN Rotor-Gene Q MDx equipment, which is extensively used in labs across the world. QIAGEN's skilled regulatory teams will help with clinical validation and approval of the companion diagnostic in the United States, the European Union, and Japan.

On 23 January 2023, Agilent Technologies Inc. announced an agreement with the world’s leading provider of diagnostic information services, Quest Diagnostics. The agreement will enable widespread use of ctDx FIRST, the first liquid biopsy test authorized by the FDA as a companion diagnostic (CDx), to identify advanced non-small cell lung cancer (NSCLC) patients who may benefit from therapy with KRAZATI^TM.

On 15 June 2022, Agilent Technologies Inc. announced that the South Korea Ministry of Food and Drug Safety (MFDS) had approved the company’s PD-L1 IHC 22C3 pharmDx as a companion diagnostic (CDx) to identify individuals with non-small cell lung cancer (NSCLC) who are appropriate for first-line monotherapy with KEYTRUDA (pembrolizumab) on the Dako Omnis platform.