Companion Diagnostics Market Size, Share & Industry Analysis, By Technology (Polymerase Chain Reaction, Immunohistochemistry, In-situ Hybridization, Next Generation Gene Sequencing, and Others), By Indication (Cancer, Neurological Diseases, Infectious Diseases, and Others), By End-user (Pharmaceutical & Biopharmaceutical Companies, Reference Laboratories, Contract Research Organizations, and Others), and Regional Forecast, 2024-2032

The global companion diagnostics market size was valued at USD 8.51 billion in 2023. The market is projected to grow from USD 9.38 billion in 2024 to USD 22.37 billion by 2032, exhibiting a CAGR of 11.5% during the forecast period.

Companion diagnostic is a test used for the safe and effective application of a corresponding biological product or drug. Generally, these tests are used in the diagnosis of cancer. In this, as per the biomarker identified, a suitable drug is suggested. These tests provide individualized treatment based on the response of a specific patient.

• For instance, Foundation Medicine’s companion diagnostic FOUNDATIONONE CDx analyzes more than 300 cancer-related genes to inform the use of precision cancer treatments across all solid tumors.

The rising prevalence of cancer globally is increasing the adoption of these tests, thereby propelling the growth of the market. Combined with this, regulatory approvals of these tests for different indications are estimated to boost the overall market.

• For instance, in August 2022, the U.S. FDA approved the Oncomine Dx Target Test of Thermo Fisher Scientific Inc. as a companion diagnostic (CDx). This test identifies tumors that have HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small cell lung cancer.

The COVID-19 pandemic negatively impacted the global companion diagnostics market, resulting in a decreased demand for companion diagnostics. In 2020, a decrease in the volume of testing other than the COVID test was observed, leading to a decline in revenue. In 2021, with the ease of restrictions, such as the stay-at-home orders in many countries and the launches of novel diagnostics tests for cancer and other chronic disorders, the market saw substantial growth. In 2022, the market stabilized with the increasing sales of companion diagnostics products and is expected to grow significantly during the forecast period.

Companion Diagnostics Market Trends

Advances in Next-Generation Sequencing to Propel Market Progress

Clinicians use the Next-Generation Sequencing (NGS) technique to test the number of genes responsible for cancer development; this test is performed on the surgically removed patient’s tumor. NGS technique provides high output within a specific interval of time and technological advancements are developing for this technique. For example, according to an article published by the Centers for Disease Control and Prevention (CDC), next-generation sequencing has transitioned from research to clinical use during the past five years.

Moreover, key players are introducing technologically advanced testing solutions and focusing on partnerships to advance the NGS systems in the market. Hence, advancements in next-generation sequencing to detect genetic abnormalities, helpful in treating specific diseases, are one of the new companion diagnostics market trends.

• In November 2023, QIAGEN partnered with Element Biosciences with the aim of providing next-generation sequencing (NGS) workflows for the benchtop sequencer AVITI System to escalate the discovery, reduce operational costs, and improve turnaround times for genomic research.


• For instance, in January 2022, Illumina, Inc. collaborated with SomaLogic Operating Co., Inc. to bring SomaScan, a proteomics assay onto Illumina's current and future high throughput next-generation sequencing platforms.

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Companion Diagnostics Market Growth Factors

Increasing Prevalence of Cancer to Augment Market Growth

The prevalence of cancer is increasing significantly in recent years. The growing prevalence of cancer cases increases the need for effective CDx assays as genomic testing provides a clear picture of patients' tumors and offers precise insights to doctors about treatment protocols. Thus, the increasing prevalence of cancer is increasing the sales of products of CDx.

• According to the data published by the American Cancer Society Journal, an estimated 1.9 million new cancer cases were reported in the U.S. in 2022.


• Also, according to the World Health Organization (WHO), in 2022, there were 2.26 million new cases of people diagnosed with breast cancer and 2.21 million issues of people diagnosed with lung cancer worldwide.

Moreover, to fulfill an increasing need, novel tests are being developed to diagnose specific types of mutations.

• In August 2020, the U.S. FDA approved Guardant360 CDx. This first liquid biopsy companion diagnostic uses Next-Generation Sequencing (NGS) technology to identify patients with a specific types of mutations of the Epidermal Growth Factor Receptor (EGFR) gene in metastatic Non-Small Cell Lung Cancer (NSCLC).

Additionally, key players in the market are collaborating to develop advanced companion diagnostics for oncology.

• For instance, in October 2023, QIAGEN collaborated with Myriad Genetics. The partnership aimed to deliver innovative services and products to pharmaceutical companies and advance companion diagnostics solutions for cancer.

This factor has led to global demand for these tests and is responsible for the market’s growth during the forecast duration.

Regulatory Approvals of New Tests for Different Indications to Stimulate Market Growth

The companion diagnostics industry is witnessing a significant number of new product approvals. As the number of new products approved is increasing, it is resulting in the adoption of several tests, thereby augmenting the market growth. Moreover, key manufacturers focus on the development of novel tests that lead to the companion diagnostics market growth. For instance, in May 2022, Illumina received CE approval for its TruSight oncology (TSO) comprehensive test. This kit assesses multiple tumor biomarkers to identify specific molecular profiles of a cancer patient. Also, in May 2022, Agilent Technologies Inc. received approval for its PD-L1 IHC 22C3 pharmDx, a qualitative immunohistochemical assay. This assay is used to identify cervical cancer patients, in which KEYTRUDA (anti-PD-1 therapy) may be an appropriate treatment option.

Furthermore, increasing regulatory approvals by the regulatory bodies for companion diagnostics assays propels the growth of the market.

• For instance, in March 2023, the U.S. Food and Drugs Administration approved a new companion diagnostic assay, VENTANA PD-L1 (SP263), to identify adult patients who may be treated with cemiplimab with stage II to IIIA Non–Small Cell Lung Cancer (NSCLC). Hence, such factors will strongly support the global companion diagnostics market growth.

RESTRAINING FACTORS

Incompetent Reimbursement Scenario and Stringent Regulatory Framework to Restrict Market Growth

Despite increasing acceptance, there is a lack of a standardized method to set the reimbursement rate for a companion diagnostic test. Reimbursement is set on a case-to-case basis.

• For instance, in June 2022, according to an article published by Taylor Wessing LLP in Germany, the reimbursement is different for inpatient and outpatient. For the inpatient care system, diagnostics are covered mainly by diagnosis-related groups. For outpatient treatment, the reimbursement is according to the specific catalog of reimbursable services.

Moreover, there is a lack of a standard regulatory framework for companion diagnostics (CDx). There are a number of challenges involved in the clinical development and regulation of companion diagnostics (CDx), which plays an important role with respect to sensitivity and specificity while making a therapeutic decision.

• The European Union is currently in process of bringing into effect in vitro diagnostic medical devices regulation (IVDR). This new regulation is introducing a wide range of stringent requirements for scientific validity and clinical performance.


• According to an article published in the National Library of Medicine by Biomarker Insights in 2021, the conformity assessment process for the companion diagnostic (CDx) must undergo a conformity procedure between a medical authority and notified body. The timeframe for the consultation is over 60 days, which can extend to another 60 days.

In addition, the U.S. Food and Drug Administration announced the reclassification of the diagnostic devices for infectious disease and companion diagnostic in vitro diagnostics (IVDs), and manufacturers need to seek marketing authorization through the 510(K) clearance pathway.

Generally, suitable reimbursement policies & regulations are the key factors responsible for the adoption of devices. Hence, the lack of reimbursement and stringent regulations hinder the possible global adoption and thereby market’s growth during the forecast duration.

Companion Diagnostics Market Segmentation Analysis

By Technology Analysis

Polymerase Chain Reaction Segment to Dominate Backed by Launch of New Products & Regulatory Approvals

Polymerase chain reaction technology dominated the global companion diagnostics market share in 2023, owing to the introduction of new PCR kits by the key players such as QIAGEN N.V. and Thermo Fisher Scientific Inc. In May 2021, QIAGEN N.V. announced the launch of the therascreen KRAS RGQ PCR Kit. This test kit assists in identifying non-small cell lung cancer (NSCLC) patients eligible for the treatment with LUMAKRAS, a new therapy developed by Amgen Inc.

In March 2021, Thermo Fisher Scientific Inc. announced the launch of QuantStudio 5 Dx Real-Time PCR System which will give enhanced and accurate results to laboratory procedures and will help to maintain the molecular diagnostic workflows. Thus, launches of new products and regulatory approval led to the dominance of the segment in the market.

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By Indication Analysis

Increasing Prevalence of Cancer and the Emphasis of Key Players on Innovative Technology Development Led to the Dominance of the Segment

In terms of indication, the cancer segment is anticipated to exhibit a dominant companion diagnostics market share due to increasing prevalence of cancer and key players' focus on innovative technology to develop advanced tests for cancer drugs. Also, the number of biomarker assays used for targeted cancer drugs is increasing.

• According to statistics published by the World Health Organization (WHO) in February 2022, approximately 400,000 children develop cancer worldwide every year. Also, according to the statistics published by the World Cancer Research Fund International, in 2020, there were 18,094,716 million cases of cancer diagnosed globally. 


• In July 2020, F. Hoffmann-La Roche Ltd received approval from the U.S. FDA for the VENTANA HER2 Dual ISH DNA Probe Cocktail assay. This assay assists in detecting HER2 biomarkers in breast cancer and is a companion diagnostic for Herceptin (trastuzumab) therapy.

The neurology segment is estimated to grow at the highest CAGR due to the progression of Central Nervous System (CNS) disease such as Schizophrenia, Parkinson’s, and Alzheimer’s; this provides the opportunity to use precision medicine and companion diagnostic devices for better diagnostic tools.

• In May 2022, Fujirebio launched two new tests, Lumipulse G β-Amyloid 1-42 Plasma and Lumipulse G β-Amyloid 1-40 Plasma assays for LUMIPULSE G, an immunoassay system. These chemiluminescent enzyme immunoassay (CLEIA) assays are able to measure the β-amyloid1-42 and β-amyloid1-40 in human plasma.

By End-user Analysis

Collaborations with Manufacturers Leading to the Significant Share of the Pharmaceutical & Biopharmaceutical Companies Segment

Pharmaceutical & biopharmaceutical companies generated the highest revenue in the market in 2023. Collaborations with companion diagnostic manufacturers led to the dominance of this segment.

• For instance, in November 2021, Burning Rock Biotech Limited collaborated with Merck KGaA to develop the MET inhibitor tepotinib. This companion diagnostic test is based on the company’s self-developed next-generation sequencing liquid biopsy solution, referred to as the OncoCompass Target panel.


• In August 2021, Burning Rock Biotech Limited entered into a global strategic collaboration with IMPACT Therapeutics. The collaboration aims to develop a companion diagnostic (CDx) test for the pipeline of drugs in the field of synthetic lethality.

Moreover, pharmaceutical & biopharmaceutical companies segment is estimated to grow at the highest CAGR during the forecast period owing to new product launches and technological advancements globally. These companies are continuously involved in the development of companion diagnostics tests for several indications.

• In January 2022, Illumina Inc. collaborated with Boehringer Ingelheim with an aim to develop new tests for various programs of Boehringer Ingelheim's oncology pipeline. This collaboration accelerated the development of precision medicines for patients with advanced cancer.

REGIONAL INSIGHTS

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North America generated a revenue of USD 2.94 billion in 2023. The region's dominance is attributed to a higher prevalence of cancer and other chronic conditions along with rising adoption of advanced CDx assays in the region.

• For instance, according to the National Cancer Institute, in 2020, an estimated 1,806,590 new cases of cancer were diagnosed in the U.S.

On the other hand, Europe is anticipated to be the second-most prominent region in terms of revenue in 2023 globally. The growth in this region is attributed to an increase in collaboration between pharmaceutical companies and companion diagnostic manufacturers in the area.

• For instance, in December 2021, QIAGEN collaborated with Denovo Biopharma LLC, intending to develop a blood-based companion diagnostic (CDx) test to identify patients that are expressing Denovo Genomic Marker 1 (DGM1), who are likely to respond to Denovo's investigational cancer drug DV102, used for the treatment of diffuse large B-cell lymphoma in lymphoid cancers.

Asia Pacific is projected to grow at the highest CAGR during the forecast period. This factor is attributed to the rising prevalence of cancers, improving healthcare infrastructure, and the growing number of medical device companies developing diagnostic products for the treatment.

• According to the Janssen Asia Pacific, Asia Pacific hosts 50% of the world’s new cancer cases each year, and deaths caused by cancer in Asia are expected to increase by 36.0% by 2030.

The market in Latin America and the Middle East & Africa is estimated to grow at a slower pace compared to Asia Pacific. Partnerships between key players and hospitals for the expansion of precision oncology diagnostic labs, providing extensive genetic testing to cancer patients, are estimated to be one of the major market drivers in the region.

• For instance, in July 2022, Geneseeq announced teaming up with Hospital de Base in Sao José do Rio Preto, Brazil, to build an NGS-based precision oncology diagnostic lab to provide advanced clinical research and genetic research testing to cancer patients in Brazil.

List of Key Companies in Companion Diagnostics Market

F. Hoffmann-La Roche Ltd, Agilent Technologies, Inc., and Abbott Account for a Dominant Share in Terms of Revenues

F. Hoffmann-La Roche Ltd, Agilent Technologies, Inc., and Abbott are leading players in the market due to new product launches and the acquisition of competitive players. Furthermore, robust investment in research activities to develop a portfolio of superior treatment solutions has enabled the company to hold a leading position in the market.

• For instance, in April 2021, Agilent Technologies, Inc. acquired Resolution Bioscience, Inc., one of the leading players in next-generation sequencing-based oncology solutions. This acquisition accelerated and expanded the company’s capabilities in NGS-based cancer diagnostics and provided the company with innovative technology that meets the fast-growing personalized medicine market.

Moreover, the market is further characterized by many small manufacturers in emerging nations focusing on developing relatively lower-cost products. Other key players offering a wide range of CDx involve Illumina, Inc., Guardant Health, Thermo Fisher Scientific Inc., BIOMERIEUX, QIAGEN, Myriad Genetics, Inc., and Sysmex Corporation. Illumina, Inc. partnered with leading biotechnology companies to develop companion diagnostics for best-in-class therapeutics. For instance, Illumina, Inc. partnered with Loxo Oncology for the development of next-generation sequencing-based companion diagnostics. Also, bioMérieux created a program to work with pharmaceutical and medical device companies.

LIST OF KEY COMPANIES PROFILED:

• Abbott (U.S.)


• F. Hoffmann-La Roche Ltd. (Switzerland)


• Agilent Technologies, Inc. (U.S.)


• Illumina, Inc. (U.S.)


• Guardant Health (U.S.)


• Thermo Fisher Scientific Inc. (U.S.)


• BIOMERIEUX (France)


• QIAGEN (Germany)


• Myriad Genetics, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• February 2024: F. Hoffmann-La Roche Ltd collaborated with PathAI, and with the collaboration, PathAI developed AI-enabled pathology algorithms for advancing the company's companion diagnostics.


• November 2023: Amoy Diagnostics Co., Ltd. partnered with Cell Signaling Technology with an aim to support precision oncology with the development of companion diagnostics in China.


• October 2022: The U.S. FDA approved F. Hoffmann-La Roche Ltd.’s companion diagnostic- PATHWAY to identify patients with HER2 low metastatic breast cancer eligible for ENHERTU (HER2-directed antibody drug conjugate) treatment.


• October 2022: HMNC Brain Health raised USD 14.2 million in funding series to boost the precision psychiatry programs, in which pharmaceuticals are co-developed with companion diagnostics to identify the patient groups to benefit from these treatments.


• June 2022: Laboratory Corporation of America Holdings collaborated with OmniSeq Corporation and announced the launch of OmniSeq INSIGHTsm, a comprehensive genomic and immune profiling, a tissue-based test incorporating next-generation sequencing (NGS) technology. The test is designed to advance precision oncology and improve patients’ outcomes.


• August 2021: QIAGEN N.V. collaborated with OncXerna Therapeutics, Inc. to develop Next-Generation Sequencing (NGS), a companion diagnostic for OncXernas's product candidate, Navicixizumab, a product candidate for the treatment of patients with ovarian cancer.


• January 2021: Laboratory Corporation of America Holdings collaborated with OmniSeq Corporation and announced the launch of OmniSeq INSIGHTsm, a comprehensive genomic and immune profiling, a tissue-based test incorporating next-generation sequencing (NGS) technology. The test is designed to advance precision oncology and improve patient outcomes.


• July 2020: Laboratory Corporation of America Holdings collaborated with OmniSeq Corporation and announced the launch of OmniSeq INSIGHTsm, a comprehensive genomic and immune profiling, a tissue-based test incorporating NGS technology. The test is designed to advance precision oncology and improve patients’ outcomes.

REPORT COVERAGE

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The research report elaborates on the global market dynamics and competitive landscape. The report presents various key insights, the prevalence of cancer in key countries, new product launches by key players, key mergers, acquisitions, and partnerships, the impact of COVID-19 on the market, the competitive landscape, and company profiles.

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