Immunoassay Markets 2027–2031

Immunoassay Markets: Market Forecast, Competitive Landscape, Technology and Policy Outlook, 2027–2031

Global forecasts for clinical and research immunoassays by application, technology, sensitivity, setting and product, for 14 countries and regions, with 33 company profiles.

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Our Take

Immunoassay is the largest single technology in in vitro diagnostics, and it is changing faster than it has in decades. Alzheimer's blood tests have moved into routine care, high-sensitivity and digital assays are taking share, and China's price reforms have turned the world's fastest-growing market into a price war that Chinese makers are winning. The market grows from $32,560 million in 2026 to $43,500 million in 2031, at 6.0% a year, adding $10,940 million.

Market Size 2026: USD $32.56B Market Size 2031: USD $43.5B CAGR: 6.0%

Situation Analysis: what is really happening

• Alzheimer's blood tests arrive. Roche and Eli Lilly announced FDA clearance of Elecsys pTau217 on 24 August 2026, the first single-marker blood test to rule Alzheimer's pathology in and out. Neurology grows 18.5% a year, from $651.2 million to $1,522.5 million.
• Sensitivity is the new battleground. Ultra-Sensitive & Digital assays grow 21.7% a year, from $1,302.4 million to $3,480.0 million, and High-Sensitivity assays 9.9% a year.
• China resets prices. Volume-based procurement has cut routine reagent prices by about half, and on 14 August 2026 a national price guide set one price per test whatever the method. China still grows 8.3% a year, from $2,850.9 million to $4,242.4 million, as Chinese makers win at home and sell abroad.
• New owners. Siemens Healthineers confirmed a strategic review of Diagnostics in November 2025, Merck KGaA agreed to buy Bio-Techne on 25 June 2026, and Waters now owns BD's diagnostics business.
• Testing moves closer to the patient. POC & Physician Office grows 8.4% a year, from $6,674.8 million to $10,005.0 million, and Roche won a CE mark for its compact cobas smart e analyser on 27 October 2026.
• Payment pressure. CMS published preliminary 2027 lab fee rates on 21 September 2026, with cuts capped at 15% per test per year through 2029.

Company Analysis: who is positioned, who is exposed

• Roche, Abbott, Siemens Healthineers and Beckman Coulter (Danaher): The core-laboratory leaders, whose installed analysers now carry Alzheimer's and high-sensitivity tests.
• QuidelOrtho, Waters (formerly BD Diagnostic Solutions), bioMérieux and Sysmex: Established suppliers repositioning platforms and partners, including QuidelOrtho's deal to sell Lifotronic analysers outside the US.
• Thermo Fisher, Werfen, Revvity (EUROIMMUN), Bio-Rad and DiaSorin: Specialists in allergy, autoimmune, haemostasis and specialty immunoassays.
• Fujirebio, Quanterix, C2N, ALZpath and Bio-Techne: The neurology and ultra-sensitive testing companies behind the Alzheimer's blood test market.
• Mindray, Snibe, Autobio, Maccura, Lifotronic and Getein: Chinese chemiluminescence makers winning share at home and expanding abroad.
• SD Biosensor, Boditech, Wondfo, Radiometer and SEKISUI: Suppliers of rapid and point-of-care immunoassays.

In all, 33 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 large is the immunoassay market, and which applications and technologies grow fastest?
• How quickly will Alzheimer's blood tests become routine, and who will supply them?
• How far will high-sensitivity and digital assays take share from conventional tests?
• How will China's volume-based procurement and price guide reshape the market, and can Chinese makers win abroad?
• What do the 2027 lab fee schedule, tariffs and the EU IVDR mean for suppliers?
• How large is each country market, and where is growth fastest?

What's inside

• 295 pages, 23 chapters, 70 tables and 59 figures
• Forecasts for 2027–2031 from a 2026 base year, by application, technology, sensitivity, setting and product, for 14 countries and regions
• Core laboratory systems, clinical applications, neurology and ultra-sensitive immunoassays, and point-of-care and rapid tests
• Technology landscape, regulation and reimbursement, operations, and China, Asia-Pacific and emerging markets
• IVD – The Big Picture: healthcare and IVD spending, the four large IVD segments, the road to diagnostics and lab fee trends
• 10 market-moving developments from 2025 and 2026, SWOT, Porter's Five Forces and strategic recommendations
• 33 company profiles
• Download the Table of Contents (PDF)

Who buys this report

• Diagnostic companies and business development teams: plan menus, platforms and sensitivity strategy, including neurology.
• Laboratories and health systems: plan analyser purchases, consolidation and new tests as payment tightens.
• Investors and analysts: model a market reshaped by Alzheimer's testing, China's price reforms and changes of ownership.
• Reagent and component suppliers: size demand for antibodies, antigens and chemistries by technology.

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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.