Five research firms put the 2026 global in vitro diagnostics market somewhere between $81.83 billion and $152.42 billion. Vendor filings for the same year are narrower and colder: Roche Diagnostics grew 3% at constant rates in the first half of 2026, Siemens Healthineers Diagnostics fell 5.5% in the quarter to 30 June. Here are the verified figures behind IVD market research in 2026.
IVD Market Research
What Do IVD Market Research Firms Forecast For 2026?
The 2026 estimates below come from each firm’s own published report, and they do not measure the same thing. Higher figures fold in laboratory services, self-testing and point-of-care products; lower ones treat those as adjacent categories.
| Research firm | 2026 estimate | Forecast endpoint | Stated CAGR |
|---|---|---|---|
| Fortune Business Insights | $81.83B | $135.65B by 2034 | 6.50% |
| Towards Healthcare | $88.88B | $131.52B by 2035 | 4.45% |
| Roots Analysis | $118B | $190B by 2035 | 5.4% |
| Coherent Market Insights | $135.22B | $212.91B by 2033 | 6.7% |
| The Business Research Company | $152.42B | $241.14B by 2030 | 12.2% |
Source: Fortune Business Insights, Towards Healthcare, Roots Analysis, Coherent Market Insights and The Business Research Company, 2026 report editions.
IVD Market Research On Vendor Revenue: The Latest Reported Periods
Each of these vendors publishes two growth rates, and the two rarely match. Currency and acquisitions moved the reported line further than demand did in the first half of 2026.
Abbott’s 24.7% reported jump in Diagnostics is the Exact Sciences acquisition entering the base; on a comparable basis the same business grew 2.4%. Abbott’s medical products portfolio gained a cancer screening franchise that booked $3.247 billion of sales in 2025.
| Business | Period ended | Revenue | Reported change | Underlying change |
|---|---|---|---|---|
| Roche Diagnostics Division | 30 Jun 2026 (6 mths) | CHF 6,735M | −3% in CHF | +3% at CER |
| Abbott Diagnostics | 30 Jun 2026 (6 mths) | $5,272M | +24.7% | +2.4% comparable |
| bioMérieux (group) | 30 Jun 2026 (6 mths) | €1,965M | −3.9% | +0.2% organic |
| Siemens Healthineers Diagnostics | 30 Jun 2026 (3 mths) | not disclosed | — | −5.5% comparable |
| Sysmex (group) | 30 Jun 2026 (3 mths) | ¥130,674M | +23.6% | — |
Source: Roche half-year results 2026; Abbott second-quarter 2026 results; bioMérieux first-half 2026 results; Siemens Healthineers Q3 FY2026 results; Sysmex Q1 FY ending March 2027 results. Periods as stated per row.
bioMérieux split its half in two: organic sales fell 3.9% in the first quarter on a weak respiratory season, then rose 5.0% in the second. The company cut its GO•28 plan target to 3% to 6% organic annual sales growth for 2027 and 2028, down from a 7% CAGR through 2028.
Sysmex went the other way. Group net sales rose 23.6% to ¥130,674 million in the quarter to 30 June 2026 and operating profit rose 39.5% to ¥14,821 million.
Diagnostics Revenue By Segment And Region
Roche splits its Diagnostics Division into four customer areas. Core Lab took 55.8% of division sales in the first half of 2026, and Pathology Lab was the only area to grow in Swiss francs.
Near Patient Care was the weak area at CHF 909 million, down 5% at constant rates and 11% in francs. Roche’s Basel-based group reports the regional split on the same base.
| Region | H1 2026 sales | Share of division | Change at CER | Change in CHF |
|---|---|---|---|---|
| Europe, Middle East, Africa | CHF 2,466M | 36.6% | +3% | −1% |
| North America | CHF 2,211M | 32.8% | +8% | −1% |
| Asia-Pacific | CHF 1,522M | 22.6% | −5% | −12% |
| Latin America | CHF 536M | 8.0% | +10% | +5% |
Source: Roche, Half-Year Results 2026, six months ended 30 June 2026.
Abbott’s Diagnostics segment now has three businesses after the company folded rapid, molecular and point-of-care into one unit and added Exact Sciences as Cancer Diagnostics.
Rapid and Molecular Diagnostics fell 8.0% excluding currency in the quarter on lower respiratory virus test sales. Cancer Diagnostics grew 13.3% on a comparable basis.
How China’s Pricing Reform Shows Up In IVD Market Research
China pricing reform appears in five vendors’ 2026 disclosures, each measured a different way.
| Company | Disclosed China effect | Period |
|---|---|---|
| Roche Diagnostics | Asia-Pacific sales CHF 1,522M, down 5% at CER and 12% in CHF | H1 2026 |
| Roche Diagnostics | Division sales would have grown 6% at CER excluding China price reform, per Roche | H1 2026 |
| Sysmex | Group sales 98.3% of prior year; 105.1% excluding China | FY ended 31 Mar 2026 |
| Siemens Healthineers | FY2026 comparable revenue growth outlook cut to 3.5%–4.0% from 4.5%–5.0%, mainly on Diagnostics | 31 Jul 2026 |
| Abbott | Core Laboratory growth partly offset by China conditions including volume-based procurement | Q4 2025 |
Source: Roche half-year results and H1 2026 earnings call; Sysmex financial highlights, FY ended 31 March 2026; Siemens Healthineers Q3 FY2026 results, 31 July 2026; Abbott fourth-quarter 2025 results.
Sysmex gives the cleanest read on the mechanism. Strip China out of the year to March 2026 and sales were 105.1% of the prior year; leave it in and they were 98.3%.
Ownership is moving too. Siemens plans a shareholder vote in February 2027 on a direct spin-off of Siemens Healthineers shares, which would end the Munich parent’s controlling stake in the imaging and diagnostics business.
Regulatory Data Behind IVD Market Research In 2026
European certification is running behind applications. As of 28 February 2026, notified bodies had received 3,418 IVDR applications and issued 2,318 certificates, with 1,813 written agreements signed and 145 applications refused.
Nineteen notified bodies were designated under the IVDR at 2 March 2026, out of 53 designated under either regulation. Of the twelve that had issued combined quality system and product certificates, 67% reported taking 13 to 18 months.
| IVDR measure | Count | Data status |
|---|---|---|
| Applications lodged | 3,418 | 28 Feb 2026 |
| Certificates issued | 2,318 | 28 Feb 2026 |
| Class D applications | 1,191 | 28 Feb 2026 |
| Class D certificates | 722 | 28 Feb 2026 |
Source: European Commission, 20th Notified Bodies Survey (MDR/IVDR), medium dataset, data status 28 February 2026.
What Changed In US Lab Reimbursement
Section 6226 of the Consolidated Appropriations Act, 2026 passed on 3 February 2026. It removed any Clinical Laboratory Fee Schedule phase-in reduction for 2026 and moved the reporting window to 1 May through 31 July 2026, based on private payor data collected between 1 January and 30 June 2025.
From 1 January 2027 through 2029, CMS may not cut payment for a test by more than 15% per year against the preceding year. The College of American Pathologists counted seven congressional delays to reporting periods and six to the cuts themselves as of February 2026.
Diagnostics M&A: What Closed In 2026
Three transactions announced in late 2025 all completed inside nine weeks of each other.
| Transaction | Completed | Headline value |
|---|---|---|
| BD Biosciences & Diagnostic Solutions into Waters | 9 Feb 2026 | $18.8B per BD, on Waters’ 6 Feb 2026 close; Waters later stated about $16.8B |
| Abbott acquires Exact Sciences | 23 Mar 2026 | $105 per share; about $21B equity, about $23B enterprise value |
| Blackstone and TPG acquire Hologic | 7 Apr 2026 | Up to $79 per share, an enterprise value of up to $18.3B |
Source: BD press release, 9 February 2026 and Waters prospectus supplement; Abbott and Exact Sciences press release, 20 November 2025; Hologic press release, 7 April 2026.
BD received $4 billion of cash and its shareholders took Waters stock representing 39.2% of the combined company. That deal ended the diagnostics chapter of Becton Dickinson’s 1897-founded medical supplies business, while Danaher’s acquisition-assembled diagnostics arm stayed put, booking $9,941 million of segment revenue in 2025 at a 26.7% GAAP operating margin.
FAQ
How big is the IVD market in 2026?
Published 2026 estimates run from $81.83 billion (Fortune Business Insights) to $152.42 billion (The Business Research Company). The gap comes from scope, not arithmetic: higher figures include lab services and point-of-care categories that lower ones exclude.
Why do Reddit threads on IVD market size quote such different numbers?
Because each firm defines the market differently. Reddit posts often cite one figure without its scope, so a $81.83 billion estimate and a $152.42 billion estimate for the same year both circulate as fact.
Which IVD vendor reported the largest revenue growth in mid-2026?
Of the five listed here, Abbott Diagnostics reported 24.7% for the half to 30 June 2026, though only 2.4% on a comparable basis. Sysmex group sales rose 23.6% in the quarter.
How much is China’s pricing reform costing IVD vendors?
Sysmex sales were 98.3% of the prior year for the year to March 2026, or 105.1% excluding China. Roche says its Diagnostics Division would have grown 6% at constant rates in H1 2026 without China price reform.
Do lab professionals on Reddit have the 2027 Medicare cuts right?
The reporting window ran 1 May to 31 July 2026, using data collected January to June 2025. No cut applied in 2026. From 1 January 2027 through 2029, no test may be cut more than 15% a year.
Sources
https://www.roche.com/media/releases/med-cor-2026-07-23
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