Immuno-Oncology Diagnostics Market To Reach $11.1B By 2030 As Checkpoint Inhibitor And Cell Therapy Pipelines Drive Demand For Companion Tests

(MENAFN- GlobeNewsWire - Nasdaq) Report Tracks Roche Diagnostics, Thermo Fisher, Illumina, Agilent and Guardant Health Among 132 Companies, With Forecasts by Assay Type, Technology, Customer and Country

Dublin, Oct. 16, 2026 (GLOBE NEWSWIRE) -- "Immuno-Oncology Diagnostics. Market Forecasts for Immuno-Oncology Diagnostics by Assay Type, Technology, Client, and Country with Executive/Consultant Guides 2026 to 2030 (4th Edition)" has been added to ResearchAndMarkets.com's offering.

The report highlights the continued expansion of the global immuno-oncology diagnostics market as immunotherapies become standard treatment options across multiple tumor types. Growing adoption of immune checkpoint inhibitors, CAR-T cell therapies, bispecific antibodies, therapeutic cancer vaccines, and combination regimens is increasing demand for predictive biomarker testing to support patient selection and clinical decision-making.

The global immuno-oncology therapeutics market has exceeded approximately USD 200 billion in recent years and is projected to expand as additional therapies enter clinical practice. This growth is strengthening demand for immuno-oncology diagnostics capable of evaluating complex interactions within the tumor microenvironment and identifying patients most likely to benefit from immune-based treatments.

Biomarkers Supporting Immunotherapy Decisions

PD-L1 expression remains one of the most widely used immuno-oncology biomarkers and is commonly evaluated through immunohistochemistry (IHC) assays. PD-L1 testing supports eligibility decisions for therapies targeting PD-1 or PD-L1 pathways in non-small cell lung cancer, melanoma, bladder cancer, and head and neck cancer.

Other clinically important biomarkers include tumor mutational burden (TMB), microsatellite instability (MSI), mismatch repair deficiency (dMMR), and immune-related gene expression profiles. High TMB and MSI-high status can help identify patients with a greater likelihood of responding to immune checkpoint inhibitors. Emerging approaches include immune gene signatures, tumor-infiltrating lymphocyte (TIL) density measurements, and circulating biomarkers assessed through liquid biopsy platforms. These methods are supporting a shift from single-marker testing toward integrated and multiplex biomarker analysis.

Key Immuno-oncology Diagnostic Technologies

Immunohistochemistry continues to hold a significant market position due to its established role in detecting protein expression within tissue samples. Next-generation sequencing (NGS) is among the fastest-growing technology segments because it enables comprehensive genomic profiling and simultaneous assessment of biomarkers such as TMB, MSI, and gene expression signatures.

Polymerase chain reaction (PCR) remains important for detecting specific genetic alterations and microsatellite instability. Digital pathology and image analysis platforms are gaining adoption for quantifying immune cell infiltration and biomarker expression. Liquid biopsy technologies are also creating new opportunities by analyzing circulating tumor DNA and other blood-based biomarkers for treatment selection, disease monitoring, and response assessment.

Immuno-oncology Diagnostics Market Drivers

Expansion of pharmaceutical immunotherapy pipelines is a primary driver of market growth. Drug developers increasingly require validated biomarker strategies for checkpoint inhibitors, cell therapies, and combination immunotherapies. The broader adoption of precision medicine is further increasing the use of biomarker data to guide treatment decisions based on individual tumor and immune profiles.

Advances in genomic sequencing, bioinformatics, digital pathology, and analytical software are improving biomarker detection and interpretation. At the same time, the growing use of combination therapies is generating demand for testing platforms that can assess multiple immune pathways and biological parameters within a single workflow.

Market Segmentation and Regional Trends

The report segments the immuno-oncology diagnostics market by technology, cancer type, end user, and geography. Immunohistochemistry remains widely adopted, while NGS is expected to record strong growth because of its multiplexing capabilities. Lung cancer represents a major application segment, supported by the extensive use of checkpoint inhibitors in non-small cell lung cancer. Additional applications include melanoma, bladder cancer, breast cancer, colorectal cancer, and head and neck cancer.

Key end users include hospital laboratories, reference laboratories, academic research centers, and pharmaceutical companies conducting clinical trials. North America remains the largest regional market due to advanced healthcare infrastructure, strong clinical adoption of immunotherapies, and established diagnostic testing networks. Europe and Asia-Pacific are also experiencing rising demand as access to immune-based treatments and molecular testing expands.

Competitive Landscape and Future Outlook

The competitive landscape includes major in vitro diagnostics companies, molecular diagnostics providers, and biotechnology firms specializing in biomarker discovery. Partnerships between diagnostic developers and pharmaceutical companies remain central to the co-development, clinical validation, and regulatory approval of companion diagnostics. Market participants are prioritizing multiplex platforms, expanded biomarker portfolios, and advanced bioinformatics capabilities to improve test performance and clinical utility.

Future market development will be influenced by spatial biology, multiplex imaging, artificial intelligence-based biomarker analysis, and liquid biopsy technologies. These innovations may improve predictive accuracy, enable non-invasive monitoring, and support more personalized immunotherapy strategies. The report concludes that immuno-oncology diagnostics will remain integral to precision oncology as immunotherapies expand across additional cancer types and earlier lines of treatment.

Key Attributes:

Report Attribute	Details
No. of Pages	479
Forecast Period	2025 - 2030
Estimated Market Value (USD) in 2025	$6.22 Billion
Forecasted Market Value (USD) by 2030	$11.1 Billion
Compound Annual Growth Rate	12.3%
Regions Covered	Global

Companies Featured

• 10x Genomics, Inc.
• Abbott Laboratories
• AccuraGen Inc.
• Adaptive Biotechnologies
• Aethlon Medical
• Agilent
• Anchor Dx
• ANGLE plc
• ARUP Laboratories
• AVIVA Systems Biology
• Baylor Miraca Genetics Laboratories
• Beckman Coulter Diagnostics (Danaher)
• Becton, Dickinson and Company
• Berkley Lights
• BGI Genomics Co. Ltd
• Bioarray Genetics
• Biocartis
• Biocept, Inc.
• Biodesix Inc.
• BioFluidica
• BioGenex
• BioIVT
• Biolidics Ltd
• bioMerieux Diagnostics
• Bioneer Corporation
• Bio-Rad Laboratories, Inc.
• Bio-Reference Laboratories
• Bio-Techne
• Bioview
• Bristol-Myers Squibb
• Burning Rock
• Cardiff Oncology
• Caris Molecular Diagnostics
• Castle Biosciences, Inc.
• CellCarta
• CellMax Life
• Cepheid (Danaher)
• Charles River Laboratories
• Circulogene
• Cizzle Biotech
• Clearbridge Biomedics
• Clinical Genomics
• Cytolumina Technologies Corp.
• Datar Cancer Genetics Limited
• Diagnologix LLC
• Diasorin S.p.A.
• Dxcover
• Element Biosciences
• Enzo Biochem
• Epic Sciences
• Epigenomics AG
• Eurofins Scientific
• Fabric Genomics
• Fluxion Biosciences (Cell Microsystems)
• Freenome
• FUJIFILM Wako Diagnostics
• Fujirebio
• Fyr Diagnostics
• GeneFirst Ltd.
• Genetron Holdings
• GenomOncology
• GILUPI Nanomedizin
• Guardant Health
• HansaBiomed
• HTG Molecular Diagnostics
• iCellate
• ICON PLC
• Illumina
• Incell Dx
• Inivata
• INOVIQ
• Invitae Corporation
• Invivogen
• Invivoscribe
• J&J Innovative Medicine
• KEW
• Lucence Health
• Lunglife AI Inc
• MDNA Life SCIENCES, Inc.
• MDx Health
• Menarini Silicon Biosystems
• Mesa Laboratories, Inc.
• Millipore Sigma
• Miltenyi Biotec
• miR Scientific
• Myriad Genetics
• Nanostring
• NantHealth, Inc.
• Natera
• NeoGenomics
• NGeneBio
• Novogene
• Oncimmune
• Oncocyte
• OncoDNA
• Oncohost
• Oxford Nanopore Technologies
• PamGene
• Panagene
• Personalis
• PGDx (Labcorp)
• Precipio
• PrecisionMed
• Predicine
• Predictive Oncology
• Prenetics
• Promega
• Qiagen
• QuidelOrtho
• Rarecells SAS
• RareCyte
• Recursion Pharma
• Revvity
• Roche Diagnostics
• Screencell
• Sherlock Biosciences
• Siemens Healthineers
• simfo GmbH
• Singlera Genomics Inc.
• Singular Genomics
• Singulomics
• SkylineDx
• Standard BioTools
• Stilla Technologies
• Sysmex Inostics
• Tempus Labs, Inc.
• Thermo Fisher Scientific
• Todos Medical
• Ultima Genomics
• Veracyte
• VolitionRX
• Vortex Biosciences

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