In-vitro diagnostic quality control market set to reach $2.2 billion by 2031 driven by automation adoption
Executive summary: Wissen Research released a report forecasting the IVD quality control market to grow to $2.2 billion by 2031. The transition to automated QC workflows represents a significant capital expenditure shift for clinical laboratories seeking to improve diagnostic accuracy and throughput.
Who is involved: Wissen Research (research firm) and the global In-Vitro Diagnostic (IVD) industry.
Likely next: Continued adoption of automated laboratory systems and increased R&D spending by IVD manufacturers to meet automation demands.
The in‑vitro diagnostic quality control market is being reshaped as clinical laboratories increasingly replace manual QC steps with automated workflows. This transition is reflected in a projected compound annual growth rate of 5.3 % that will push the sector’s value to US$2.2 billion by 2031. Laboratories are motivated by the need to reduce turnaround times, minimise human error and satisfy tightening regulatory expectations, all of which are more readily achieved through instrument‑based QC platforms that integrate seamlessly with laboratory information systems. For market participants, the trend signals expanding demand for automation‑focused reagents, software and hardware bundles, encouraging established IVD players and emerging specialists to invest in product development and strategic partnerships. In the near term, we can expect a steady rollout of modular automation solutions that allow mid‑size labs to upgrade incrementally, while larger reference laboratories pursue full‑scale, high‑throughput QC lines. These developments should sustain the market’s upward trajectory without requiring speculative assumptions beyond the reported growth drivers and forecast.
What's next — scenarios
Base: Steady automation transition (60%)
The market follows the projected 5.3% CAGR as labs incrementally upgrade hardware and software.
- Stable laboratory CapEx spending
- Consistent adoption rates of automated workflows
Upside: Accelerated AI-driven automation (25%)
Growth exceeds 5.3% if AI-integrated QC software becomes a standard requirement for diagnostic accuracy.
- Rapid breakthrough in AI diagnostic software
- Regulatory mandates for higher precision standards
Downside: Regulatory or budget constraints (15%)
Growth slows if laboratory budgets are tightened or if new IVD regulations increase the cost of compliance.
- Significant shifts in healthcare reimbursement models
- New, stringent IVD quality standards that increase implementation costs
Timeline
- — IVD Quality Control Market to Reach US$ 2.2 Bn by 2031, Growing at 5.3% CAGR as Labs Shift to Automated QC Workflows: New Report by Wissen Research (PR Newswire)
- — Medical Image Analysis Software Market to Reach US$ 6.3 Bn by 2031, Growing at 8.5% CAGR as AI-Powered Diagnostics Expand: New Report by Wissen Research (PR Newswire)
- — Microfluidics Market to Reach US$ 43 Bn by 2031, Growing at 9.8% CAGR as Point-of-Care and Organ-on-Chip Adoption Expands: New Report by Wissen Research (PR Newswire)
Analysis — what this means
Sectors affected
- In-Vitro Diagnostics
- Laboratory Automation
- Medical Device Manufacturing
- Clinical Laboratory Services
Key entities
Sources
- IVD Quality Control Market to Reach US$ 2.2 Bn by 2031, Growing at 5.3% CAGR as Labs Shift to Automated QC Workflows: New Report by Wissen Research — PR Newswire
- Medical Image Analysis Software Market to Reach US$ 6.3 Bn by 2031, Growing at 8.5% CAGR as AI-Powered Diagnostics Expand: New Report by Wissen Research — PR Newswire
- Microfluidics Market to Reach US$ 43 Bn by 2031, Growing at 9.8% CAGR as Point-of-Care and Organ-on-Chip Adoption Expands: New Report by Wissen Research — PR Newswire
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