Companion Diagnostics Market Size, Share | 2032

Report Description

Companion Diagnostics Market Outlook 2032

 The global companion diagnostics market size was USD 7.1 Billion in 2023 and is projected to reach USD 22 Billion by 2032, expanding at a CAGR of 12.2% during 2024–2032. The expansion of the market is fueled by trends such as the increasing importance of companion diagnostics in drug development, the escalating prevalence of cancer, and the rising acceptance of targeted therapies.

Companion diagnostics next-generation sequencing-based tests aim to align treatment decisions for disease medication by unlocking nuclear information from the genomic development of each patient. In contrast to earlier sequencing approaches, the front-end sequencing swiftly identifies multiple biomarkers for various medications. Employing next generation sequencing (NGS) panels for comprehensive biomarker assessment in a single test contributes to the treatment of various ailments. Furthermore, the numerous innovative advancements in NGS confer a competitive edge to the market players, providing alternative pathways.

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Impact of Artificial Intelligence (AI) on the Companion Diagnostic Market

Large-scale data analysis from patient DNA samples is carried out using machine learning algorithms to discover genetic variations that are linked to certain diseases. Treatment programs are customized using this information for every single patient. New techniques for early cancer diagnosis are being developed in the companion diagnostics sector with the use of NGS technology.

Sometimes, doctors identify malignant cells before they even start to cause symptoms by searching for particular alterations in the DNA of healthy cells. Researchers are learning about the progression of various diseases and the suited treatments at different stages of the diseases, due to the use of BIG Data.

Companion Diagnostic Market Dynamics

Major Drivers

A notable surge in the prevalence of cancer cases is expected to drive the market during the forecast period. The funding allocated to research and development (R&D) initiatives associated with companion diagnostics has experienced a significant increase in recent years, due to the contributions from government and non-profit organizations. For instance,

• As of February 2023, data released by the American Society of Clinical Oncology (ASCO) indicated that there were over 3.8 million women in the US living with or beyond breast cancer. In 2023, it is estimated that 297,790 women in the US are going to receive a diagnosis of invasive breast cancer, while 55,720 women to be diagnosed with non-invasive (in situ) breast cancer. Additionally, the projected number of deaths from breast cancer in the US is expected to be 43,700.

Existing Restraints

Inadequate awareness and the high cost associated with companion diagnostics techniques restrain the market. Its high cost has restricted widespread patient access despite the significant potential of treatment in cancer immunotherapy.

Expenses related to immunotherapies for the disease considerably surpass those associated with alternative treatment options such as chemotherapy or radiation therapy. The substantial cost of immuno-oncology treatments is anticipated to impede the expansion of the companion diagnostics market in the coming years.

Emerging Opportunity

Employing NGS panels for comprehensive biomarker assessment in a single test holds promise for treating diverse cancer types, offering growth opportunities for the market players. Next-generation sequencing (NGS) identifies numerous biomarkers for various drug therapies in an efficient timeframe as compared to alternative sequencing methods.

The array of technological advancements in NGS gives a competitive advantage to market players over those utilizing alternative technologies. Consequently, major players are directing their efforts toward the development of companion diagnostic products based on NGS.

Scope of the Companion Diagnostics Market Report

The market report includes an assessment of the market trends, segments, and regional markets. Overview and dynamics are included in the report.

Companion Diagnostic Market Segment Insights

Product Segment Analysis

 On the basis of product, the companion diagnostics market is segmented into assays, kits & reagents, and software & services. The kits & reagents segment constituted a market share in 2023, primarily attributed to the extensive range of available products and the rising utilization of kits & reagents across various therapeutic areas. In laboratory testing, a reagent is a chemical employed to produce or measure other compounds. A kit, on the other hand, is a compilation or set of equipment, materials, or instructions designed for a specific purpose. 

The assays segmented is anticipated to hold a large market share during the forecast period. Assays are utilized to detect and quantify specific biomarkers associated with diseases, helping identify patients who are likely to respond positively to targeted therapies. For example, in oncology, assays detect genetic mutations or protein expression levels indicative of responsiveness to certain cancer treatments.

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Indication Analysis

Based on indication, the companion diagnostics market is segregated into cancer, neurological disorders, cardiovascular disorders, and infectious diseases. The cancer segment is predicted to hold a large share of revenue during the projected period, owing to the increasing utilization of biomarkers in cancer diagnosis and the escalating significance of companion diagnostics in personalized medicine. Noteworthy alterations in gene sequences and expression patterns have been identified in cancer research, forming the basis for targeted therapy. Furthermore, various malignancies exhibit distinct biomarkers, leading to the development of companion diagnostics. Numerous cancer types, such as lung, colorectal, breast, and blood, which are major contributors to mortality, necessitate the use of companion diagnostics.

• In February 2022, the World Health Organization (WHO) released data indicating that approximately 400,000 children receive a cancer diagnosis annually. Global cancer statistics, as reported by the World Cancer Research Fund International in the same month, revealed a total of 18,094,716 million diagnosed cases. In July 2020, F. Hoffmann-La Roche Ltd obtained FDA approval for its VENTANA HER2 dual ISH DNA probe cocktail assay. This assay serves as a companion diagnostic for Herceptin (trastuzumab) therapy, aiding in the detection of HER2 biomarkers. 

The cardiovascular disorder segment is expected to have a substantial market share during the projected timeframe, as companion diagnostics play a crucial role in the field of cardiovascular disorders by aiding in personalized medicine and treatment decision-making. These diagnostics help identify specific biomarkers and genetic variations associated with cardiovascular diseases, enabling targeted and effective therapies. Companion diagnostics contribute to precision medicine approaches for cardiovascular disorders by analyzing genetic and molecular information. This allows healthcare providers to tailor treatment plans based on an individual's unique genetic profile, increasing the likelihood of successful outcomes. 

 Technology Analysis

On the basis of technology, the companion diagnostics market is fragmented into polymerase chain reaction, next generation sequencing, in situ hybridization, immunohistochemistry, and others. The in situ hybridization segment is expanding at a rapid pace, as this technology utilizes amplifiable DNA as a reporter molecule, generating multiple variants. In situ hybridization facilitates the simultaneous analysis of protein complexes in individual cells. This technology is notably applied for detecting fusions in non-small-cell lung cancer or amplifications in breast cancer. It identifies both known and novel fusion types, and its simplicity and user-friendly nature are complemented by well-designed probes.

The next generation sequencing (NGS) segment is anticipated to expand at a 20% CAGR throughout the forecast period. NGS is employed for the identification of unknown genes in microbiomes, cancer driver genes, hereditary diseases, and for both clinical & research applications. 

End-user Analysis

Based on end-user, the market of companion diagnostics is segmented into pharmaceutical & biopharmaceutical companies, reference laboratories, and contract research organizations. The pharmaceutical and biopharmaceutical companies segment are expected to register a high market share during the forecast period, due to the growing utilization of companion diagnostics in the processes of drug discovery and development in the pharmaceutical and biotechnology companies. Pharmaceutical and biopharmaceutical companies often collaborate with diagnostic companies to develop companion diagnostics for their therapeutic products. These collaborations aim to identify biomarkers that predict patient responses to specific treatments.

The reference laboratories segment is projected to expand with a growth rate of approximately 19.5% throughout the forecast period. The increased awareness regarding the advantages of early diagnosis has led to an increasing demand for precise and reliable diagnostic tests. Additionally, government funding directed towards diagnostic tests to alleviate the burden of diseases is expected to contribute to the growth of the reference laboratories segment. The presence of technologically advanced devices, designed for the diagnosis of specific types of cancer, empower healthcare professionals to provide accurate data to patients.

• In August 2020, F.Hoffmann-La Roche Ltd launched FoundationOne Liquid CDx, which received FDA approval for conducting pan-tumor liquid biopsy tests for the diagnosis of solid tumors.

Regional Outlook

In terms of region, the global companion diagnostics market is classified as Asia Pacific, North America, Latin America, Europe, and the Middle East & Africa. North America holds a large market share and is anticipated to experience substantial growth with a projected CAGR of 18% during the forecast period. High occurrences of cancer & chronic diseases, the presence of major market players & advanced healthcare infrastructure, robust support from regulatory authorities & reimbursement policies, and widespread acceptance of personalized medicine & companion diagnostics drive the market in the region. For instance,

• In 2020, the Centers for Disease Control and Prevention (CDC) approximated around 1,603,844 newly identified cancer cases and 602,347 deaths related to cancer in the US. This translated to 403 new cancer cases and 144 cancer-related deaths per 100,000 individuals. As per the American Cancer Society projections, it is anticipated that there are approximately 2,001,140 new cancer cases and 611,720 cancer-related deaths in the US in 2024.

The companion diagnostics market in Europe holds the substantial market share, due to the rising preference for personalized medicine. Increased collaboration among companies, growing product approvals by major players, and various government initiatives aimed at promoting companion diagnostics are key factors contributing significantly to the market growth in the region. 

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