Global Precision Diagnostics Market Size, Share & Trends Analysis Report By End-use, By Type, By Application (Oncology, Respiratory Diseases, CNS Disorders, Immunology, Skin Diseases, Genetic Diseases, and Others), By Regional Outlook and Forecast, 2024 -

Global Precision Diagnostics Market Size, Share & Trends Analysis Report By End-use, By Type, By Application (Oncology, Respiratory Diseases, CNS Disorders, Immunology, Skin Diseases, Genetic Diseases, and Others), By Regional Outlook and Forecast, 2024 - 2031

The Global Precision Diagnostics Market size is expected to reach $55.3 billion by 2031, rising at a market growth of 18% CAGR during the forecast period.

Precision diagnostics play a crucial role in early detection of cancer by identifying genetic predispositions and biomarkers associated with different cancer types. Early diagnosis allows for timely intervention, potentially improving patient outcomes through earlier initiation of treatment and monitoring of disease progression. The rising rates of cancer are increasing the demand for precision diagnostics in oncology. For instance, as per the New York State, each year, nearly 115,000 New Yorkers are diagnosed with cancer. Thus, the oncology segment acquired 23% revenue share in the market 2023.

The major strategies followed by the market participants is Partnership as the key developmental strategy to keep pace with the changing demands of end users. For instance, In February, 2024, F. Hoffmann-La Roche Ltd. and PathAI entered an exclusive agreement to develop AI-enabled digital pathology algorithms for companion diagnostics. This collaboration aims to accelerate innovations in personalized healthcare and enhance digital pathology integration for improved diagnostics and precision therapeutics. Additionally, In May, 2024, bioMérieux partnered with AnaBioTec to enhance Mycoplasma testing in biopharmaceutical and Cell & Gene Therapy industries in Europe. Their collaboration aims to streamline testing with BIOFIRE® Mycoplasma, offering rapid, automated PCR detection to improve manufacturing efficiency and regulatory compliance.

Based on the Analysis presented in the KBV Cardinal matrix; F. Hoffmann-La Roche Ltd. is the forerunners in the Precision Diagnostics Market. Companies such as Thermo Fisher Scientific, Inc., Abbott Laboratories, and Danaher Corporation are some of the key innovators in Precision Diagnostics Market. In March, 2024, Thermo Fisher Scientific and Bayer AG have entered into a partnership to develop next-generation sequencing-based companion diagnostic assays for Bayer’s precision cancer therapies. This partnership aims to improve patient access through decentralized genomic testing, utilizing Thermo Fisher’s Ion Torrent Genexus Dx System with rapid turnaround times.

COVID-19 Impact Analysis

Economic uncertainties caused by the pandemic led to budget constraints in healthcare systems and reduced spending on non-essential healthcare services, including precision diagnostics. Clinical trials for new diagnostic technologies and products were delayed or halted due to restrictions on non-essential research activities and challenges in patient recruitment during the pandemic. Thus, the COVID-19 pandemic had a negative impact on the market.

Driving and Restraining Factors

Drivers

Rising demand for non-invasive diagnostics

• Expansion of healthcare infrastructure
• Rising prevalence of chronic diseases worldwide

Restraints

High initial investment and operational costs

• Limited reimbursement and uncertain payment models

Opportunities

Increasing government initiatives and funding

• Rising patient-centric healthcare trends

Challenges

Insufficient clinical validation and evidence

• Privacy concerns and ethical issues

Market Growth Factors

Non-invasive diagnostics, such as liquid biopsies and advanced imaging techniques, significantly reduce patient discomfort compared to traditional invasive procedures like tissue biopsies or surgical sampling. Additionally, as healthcare infrastructure expands, more facilities are equipped with state-of-the-art diagnostic technologies. This increases the accessibility of precision diagnostics to a larger population, including those in rural and underserved areas.

Market Restraining Factors

Developing precision diagnostic technologies involves substantial R&D expenditures to innovate and refine technologies such as genomic sequencing, digital imaging, and molecular diagnostics. Prototyping and testing phases require specialized equipment and expertise, contributing to high upfront costs. Therefore, high initial investment and operational costs hinder the market's growth.

End Use Outlook

By end-use, the market is categorized into hospitals, clinical laboratories, and others. In 2023, the clinical laboratories segment registered 46% revenue share in the market. Clinical laboratories possess the infrastructure, equipment, and expertise required to perform a wide range of diagnostic tests, including molecular testing, genetic analysis, biochemical assays, and imaging studies.

Type Outlook

Based on type, the market is divided into genetic tests, direct to consumer tests, esoteric tests, and others. In 2023 the DTC segment acquired 12% revenue share in the market 2023. DTC tests offer convenience by allowing consumers to order diagnostic tests online or through retail outlets without needing a healthcare provider's referral.

Application Outlook

On the basis of application, the market is segmented into oncology, respiratory diseases, skin diseases, CNS disorders, immunology, genetic diseases, and others. The skin diseases segment attained 8% revenue share in the market in 2023.

Regional Outlook

Region-wise, the market is analyzed across North America, Europe, Asia Pacific, and LAMEA. In 2023, the Asia Pacific region generated 23% revenue share in the market. Rising incidences of chronic diseases such as diabetes, cardiovascular diseases, and cancer are prevalent in the Asia-Pacific region.

Recent Strategies Deployed in the Market

• May-2024: bioMérieux partnered with AnaBioTec to enhance Mycoplasma testing in biopharmaceutical and Cell & Gene Therapy industries in Europe. Their collaboration aims to streamline testing with BIOFIRE® Mycoplasma, offering rapid, automated PCR detection to improve manufacturing efficiency and regulatory compliance.
• May-2024: QIAGEN N.V announces the launch of the QIAseq Multimodal DNA/RNA Library Kit, facilitating efficient preparation of DNA and RNA libraries for multiomic studies and Comprehensive Genomic Profiling. This advancement enhances precision medicine by providing flexible and sensitive sequencing solutions from a single sample.
• Apr-2024: Agilent Technologies and Transcenta Holding Limited have announced a collaboration to develop Claudin18.2 IHC 14G11 pharmDx, a companion diagnostic for Osemitamab's Phase III trial in gastric/gastroesophageal junction (GEJ) adenocarcinoma. This initiative is intended to optimize patient selection and enhance treatment outcomes, utilizing Agilent's proficiency in precision oncology diagnostics.
• Mar-2024: Thermo Fisher Scientific and Bayer AG have entered a partnership to develop next-generation sequencing-based companion diagnostic assays for Bayer’s precision cancer therapies. This partnership aims to improve patient access through decentralized genomic testing, utilizing Thermo Fisher’s Ion Torrent Genexus Dx System with rapid turnaround times.
• Feb-2024: Roche and PathAI have entered an exclusive agreement to develop AI-enabled digital pathology algorithms for companion diagnostics. This collaboration aims to accelerate innovations in personalized healthcare and enhance digital pathology integration for improved diagnostics and precision therapeutics.

List of Key Companies Profiled

• Abbott Laboratories
• F. Hoffmann-La Roche Ltd.
• Siemens Healthineers AG (Siemens AG)
• Thermo Fisher Scientific, Inc.
• Danaher Corporation
• Agilent Technologies, Inc.
• BioMerieux S.A.
• Becton, Dickinson and Company
• Qiagen N.V
• Hologic, Inc.

Global Precision Diagnostics Market Report Segmentation

By End-use

• Clinical Laboratories
• Hospitals
• Others

By Type

• Genetic Tests
• Esoteric Tests
• Direct to Consumer Tests
• Others

By Application

• Oncology
• Respiratory Diseases
• CNS Disorders
• Immunology
• Skin Diseases
• Genetic Diseases
• Others

By Geography

• North America
• US
• Canada
• Mexico
• Rest of North America
• Europe
• Germany
• UK
• France
• Russia
• Spain
• Italy
• Rest of Europe
• Asia Pacific
• China
• Japan
• India
• South Korea
• Singapore
• Malaysia
• Rest of Asia Pacific
• LAMEA
• Brazil
• Argentina
• UAE
• Saudi Arabia
• South Africa
• Nigeria
• Rest of LAMEA