Immuno-Oncology Diagnostics Markets 2027–2031

Immuno-Oncology Diagnostics Markets: Market Forecast, Competitive Landscape, Technology and Partnering Opportunities, 2027–2031 (5th Edition, October 2026)

Global forecasts by biomarker, therapy class, cancer type, technology and customer, for 14 countries and regions, with 99 company profiles.

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Our Take

Immuno-oncology testing is moving beyond PD-L1. The market grows from $7.54 billion in 2026 to $13.5 billion in 2031, at 12.4% a year. Checkpoint inhibitors still drive most testing, but cell therapies, bispecifics and cancer vaccines take more than half of the new spending, spatial and AI pathology read the tumour in new ways, and blood tests now watch the response over time.

Market Size 2026: USD $7.54B Market Size 2031: USD $13.5B CAGR: 12.4%

Situation Analysis: what is really happening

• Newer therapies drive the growth. Testing for checkpoint inhibitors falls from 67.0% to 56.5% of the market. Bispecifics and T-cell engagers grow 22.2% a year to $2,160 million, cell therapy 17.5% a year to $2,362 million, and cancer vaccines 26.4% a year.
• PD-L1 is still the gatekeeper, but grows slowest. PD-L1 & Checkpoint Expression is the largest biomarker line at $2,262 million in 2026, but grows only 7.0% a year as its share falls from 30.0% to 23.5%. PD-L1 rules tightened in 2026, with Keytruda in oesophageal cancer now limited to CPS ≥1.
• The tumour microenvironment comes into focus. Tumour Microenvironment & Spatial testing grows 20.7% a year to $2,025 million, and Spatial, Digital Pathology & AI is the fastest-growing technology, rising from $566 million to $1,688 million at 24.4% a year.
• Blood tests watch the response. ctDNA Response Monitoring grows 20.5% a year to $1,823 million. Signatera CDx became the first blood-based MRD companion diagnostic in May 2026, and Medicare extended coverage of ctDNA monitoring of immunotherapy.
• MSI and dMMR testing becomes routine. TMB, MSI & dMMR testing grows 10.8% a year to $2,768 million. The October 2026 approval of dostarlimab for dMMR or MSI-H locally advanced rectal cancer makes testing at diagnosis standard.
• China grows fastest. China grows 14.8% a year from $660 million to $1,317 million as domestic PD-1 drugs, bispecifics and cell therapies multiply, and China approved the first CAR-T for a solid tumour in 2026.

Company Analysis: who is positioned, who is exposed

• Agilent: The PD-L1 leader with 22C3 and 28-8 pharmDx, strengthened in 2026 by its acquisition of Biocare Medical and its multiplex IHC.
• Roche (Roche Diagnostics and Foundation Medicine): VENTANA PD-L1 and MMR assays and FoundationOne CDx for TMB and MSI, plus an agreement to acquire the AI pathology company PathAI.
• Natera: Signatera CDx became the first blood-based MRD companion diagnostic, selecting patients for adjuvant Tecentriq in bladder cancer.
• Tempus AI: Its AI-driven Immune Profile Score outperformed PD-L1, TMB and MSI in predicting checkpoint benefit, and it agreed to buy Personalis and its NeXT Personal monitoring test.
• Guardant Health and NeoGenomics: Compete with Natera and Personalis for reimbursed blood-based monitoring of immunotherapy response.
• Waters: Now owns BD's flow cytometry business, central to cell therapy and immune cell monitoring.

Plus 92 more company profiles, each one to two pages with a fact box covering website, headquarters, ownership, revenue, employees and key products.

Questions this report answers

• How fast will testing for cell therapies, bispecifics and cancer vaccines grow compared with checkpoint inhibitors?
• Will spatial and AI-scored tests displace PD-L1 and TMB as the main predictors of immunotherapy benefit?
• How large can blood-based monitoring of immunotherapy response become now that Medicare covers it?
• Which cancers, technologies and customers will add the most new spending?
• Who are the leading companies and partners, and what are immuno-oncology diagnostics companies selling for?
• How large is each country market, and how fast is China growing?

What's inside

• 429 pages, 24 chapters, 63 tables and 61 figures
• Forecasts for 2027–2031 from a 2026 base year, by biomarker, therapy class, cancer type, technology and customer, for 14 countries and regions
• Approved test landscape, clinical evidence and biomarker pipeline, technology landscape, pharma partnerships and business models
• Regulation and reimbursement, intellectual property, litigation and pricing, a China chapter, a deal database and laboratory operations
• 10 market-moving developments from 2025 and 2026, SWOT, Porter's Five Forces and strategic recommendations
• 99 company profiles
• Download the Table of Contents (PDF)

Who buys this report

• Diagnostics executives and business development teams: size immuno-oncology testing opportunities by biomarker and therapy class and find pharma partners and acquisition targets.
• Pharma biomarker and companion diagnostic teams: choose testing partners for checkpoint, cell therapy, bispecific and vaccine programmes.
• Investors and analysts: model the growth of spatial, AI and blood-based testing and benchmark deal values.
• Laboratory and instrument suppliers: judge demand for sequencing, IHC, flow cytometry and immunoassays in hospital, reference and pharma laboratories.

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ABOUT THE LEAD AUTHOR

Mr. Greg Powell, B.Sc., M.B.A., is the President of Howe Sound Research. His education includes:

Finance for Senior Executives - Harvard Business School

Market Research - Burke Institute

M.B.A. (Finance and Policy) - University of British Columbia

B.Sc. (Chemistry) - University of British Columbia

He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years.