Market Research Report · Title & Landscape
In-Vitro Diagnostics (IVD) Market
Executive Outlook 2022–2030
Steady, test-volume-led growth toward a USD 118.6 B diagnostics market AI-enabled labs, at-home testing and localized manufacturing manufacturing reshape where value is created.
3.2%
$91.25 B
$118.57 B
Global market size,
Revenue forecast, 2030
2022 (base year)
2030
Market Size (USD Billion) Base year vs. forecast year
CAGR 3.2% ▲ +$27.3 B
118.57
CAGR over the 2023– 2023–2030 forecast
period
~37–43% North America share — largest region*
Executive Summary IVD market valued at USD 91.25 B in 2022, projected to projected to reach USD 118.57 B by 2030 — ~USD 27.3 B ~USD 27.3 B of incremental value.
Moderate 3.2% CAGR signals a mature, recurringrevenue market where share gains come from innovation and M&A.
91.25
AI-driven lab workflows, at-home testing and government-backed local manufacturing are the key growth catalysts. North America dominates; Asia-Pacific is among the fastest-growing regions on chronic-disease burden.
2022
2030F
Consolidated field led by Roche, Abbott, Siemens Healthineers, Danaher and 11 other key players.
Source: Next Move Strategy Consulting, IVD Market Report. *Regional share range from secondary sources (Fortune Business Insights, MarketDataForecast, Precedence Research).
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Market Landscape · Industry Ecosystem
The IVD Industry Ecosystem 01 ▸
Products & Services
02 ▸
Reagents & Consumables
Software & Services (LIS, Analytics)
Clinical Chemistry
Hematology & Coagulation
03 ▸
Central & Reference Labs
Applications
Molecular (PCR, NAAT, NGS)
Microbiology
Urinalysis
Hospital & Physician Labs
Point-of-Care & Retail
Home & Self-Testing
Infectious Diseases
04 ▸
POC Devices
CRO / Testing Services
Immunoassays
Techniques
Testing Sites / Channels
Instruments & Devices
Nephrology
Cardiovascular
Oncology
Genetic & Prenatal
Drug Monitoring & Toxicology
Endocrinology & Diabetes
Autoimmune
Blood Screening
Ecosystem Insights Reagents & consumables are repeat-purchase items tied to the installed analyzer base — the market's recurring-revenue core. Molecular & immunoassay platforms carry most innovation: NGS, multiplex panels and 20-minute POC assays (e.g., Roche cobas liat STI). Testing is decentralizing — from reference labs to point-ofcare, retail and home self-testing. Software & data (LIS, AI, cloud sharing) is an emerging layer for workflow and decision support. Strict oversight by FDA & Health Canada makes regulatory capability a barrier to entry.
Source: Next Move Strategy Consulting, IVD Market Report — key market segments (product & service, technique, testing site, application).
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02
Growth Drivers & Opportunities
Where IVD Growth Comes From Growth Opportunity Map
Largest market
High-growth
Europe
2 1 3
Asia-Pacific · Fast-growing
2 · Europe
3 · Asia-Pacific
Germany, Italy and France
74 M adults with diabetes
4 · Rest ofpolicies, World Self-reliance
43%)*. Aging
France are the top
diabetes in India (IDF,
population, chronic
regional contributors*;
2021); Healthy China
disease, companion Dx
regulatory harmonization
investment; Siemens
Dx & lab automation.
harmonization aids local
localizing China
automation.
local makers.
production.
North America · Dominant
4
1 · North America Largest share (~37–
RoW · LATAM, ME, Africa
policies, subsidies and and fast-track approvals approvals favour local local kit & reagent production.
Demand Drivers
High-Growth Segments
▲ AI in diagnostics
Home & self-testing — AI-connected devices, devices, subscription testing, diagnostics-as-aas-a-service
Digital pathology & AI cut turnaround times, standardize results and lift throughput.
▲ Local manufacturing push Incentives and streamlined approvals reduce import import dependency.
▼ Restraint: reimbursement Fragmented coverage slows uptake of molecular & molecular & precision assays.
Molecular & companion Dx — personalizedmedicine demand Point-of-care & retail — rapid, decentralized testing Chronic-disease panels — diabetes, cancer, cardiovascular
Source: Next Move Strategy Consulting, IVD Market Report. *Secondary sources: Fortune Business Insights, Precedence Research, iHealthcareAnalyst.
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Competitive Scenario · Positioning
Scale Leaders vs. Diagnostics Specialists Competitive Positioning Matrix X: FY2024 diagnostics revenue (≈USD B) · Y: business model · bubble size ∝ revenue
Hologic $1.8 B
Diversified healthcare / lifescience groups
Danaher $9.8 B Thermo Fisher $4.5 B Roche Dx
Abbott $9.3 B
BD (BDS) $3.4 B
~$16.2 B
QuidelOrtho $2.8 B
Diagnosticsfocused specialists
No specialist exceeds ~$4.3 B — scale Sysmex $3.4 B
advantage sits with diversified majors.
bioMérieux $4.3 B
0
3
6
9
12
15
18
FY2024 diagnostics revenue, USD billion (approx.)
Market Positioning Insights Roche Diagnostics leads with CHF 14.32 B (~USD 16.2 B) in FY2024 — roughly 1.7× the next-largest player. Tier-1 trio: Roche, Danaher (USD 9.8 B) and Abbott (USD 9.34 B) span chemistry, immunoassay, molecular and POC menus. Mid-tier (USD 3–5 B): Thermo Fisher Specialty Dx, bioMérieux, BD Biosciences & Dx Solutions and Sysmex compete on niche depth. Siemens Healthineers is a top-tier player, but its FY2024 diagnostics revenue is not isolated in public releases (off-chart). Challengers in the report's key-player list — Mindray, DiaSorin, QIAGEN, Bio-Rad, Grifols — add regional and specialty pressure. Sources: FY2024 company annual reports / earnings releases (Sysmex: FY ended Mar 2025, ¥508.6 B). USD at approx. 2024 average FX. Key players:
Next Move Strategy Consulting.
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04
Competitive Scenario · Key Strategies
M&A, Innovation & Expansion Moves Company
Roche
Roche
Abbott
Danaher Thermo Fisher bioMérieux
BD Siemens
Strategy
Recent move
Launch
cobas Mass Spec automation; FDA CLIA waiver for 20min cobas liat STI multiplex
M&A
Acquired selected LumiraDx units — point-of-care care platform (USD 0.4 B)
Innovation
15+ new pipeline opportunities incl. Alinity i TBI test, test, AlinIQ Insight cloud
AI / R&D
Beckman Coulter DxI 9000 immunoassay rollout; Chief Data & AI Officer created
M&A
Acquired Olink (proteomics), ~USD 3.1 B
M&A
LUMED (clinical decision-support software); full SpinChip POC acquisition
Portfolio
Separation of Biosciences & Dx Solutions; combination with Waters agreed
Expansion
Healthineers QuidelOrtho
Date
Portfolio
Aim to fully localize production in China for Asia-Pacific Cost-savings program; exit of U.S. donor screening business
Jan 2025
Jul 2024
2024
2024 2024 2024–25
Feb–Jul 2025
Jun 2022
FY2024
What It Means for Each Audience Investors Bolt-on M&A in POC, software and molecular is the the dominant playbook; separations (BD → Waters) Waters) show portfolio valuevalue-unlock potential.
Internal Strategy
B2B Decision-Makers
Prioritize AI-enabled workflows, decentralized testing and localized APAC APAC manufacturing to defend share in a 3.2% CAGR CAGR market.
Assess vendors on menu breadth, LIS / cloud connectivity, POC readiness readiness and reimbursement-aligned assays.
Sources: Next Move Strategy Consulting IVD Market Report; company annual reports and investor releases (2024–2025).
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