North America Life Sciences Quality Management Software Market Size & Outlook

The life sciences quality management software market in North America is expected to reach a projected revenue of US$ 2,687.0 million by 2030. A compound annual growth rate of 13% is expected of North America life sciences quality management software market from 2025 to 2030.
Revenue, 2024 (US$M)
$1,306.2
Forecast, 2030 (US$M)
$2,687.0
CAGR, 2025 - 2030
13%
Report Coverage
North America

North America life sciences quality management software market, 2018-2030 (US$M)

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North America life sciences quality management software market highlights

  • The North America life sciences quality management software market generated a revenue of USD 1,306.2 million in 2024.
  • The market is expected to grow at a CAGR of 10.7% from 2025 to 2030.
  • In terms of segment, data management was the largest revenue generating application in 2024.
  • Regulatory and Compliance Management is the most lucrative application segment registering the fastest growth during the forecast period.
  • Country-wise, U.S. is expected to register the highest CAGR from 2025 to 2030.


North America data book summary

Market revenue in 2024USD 1,306.2 million
Market revenue in 2030USD 2,687.0 million
Growth rate10.7% (CAGR from 2024 to 2030)
Largest segmentData management
Fastest growing segmentRegulatory and Compliance Management
Historical data covered2018 - 2023
Base year for estimation2024
Forecast period covered2025 - 2030
Quantitative unitsRevenue in USD million
Market segmentationData Management, Training management, Supplier management, Regulatory and Compliance Management, Corrective Action Preventive Action (CAPA) Management, Audit Management, Change Management, Non-Conformances Management, Inspection Management, Risk Management
Key market players worldwideAmpleLogic, Qualio, Qualityze Inc, Aura Quality Management, SimplerQMS, Dassault Systemes SE, IQVIA Holdings Inc, MasterControl, QT9 Software, Honeywell International Inc, AssurX, Hexagon AB ADR, Veeva Systems Inc Class A, Ideagen


Other key industry trends

  • In terms of revenue, North America region accounted for 40.0% of the global life sciences quality management software market in 2024.
  • Globally, North America is projected to lead the regional market in terms of revenue in 2030.
  • Asia Pacific is the fastest growing regional market and is projected to reach USD 2,017.3 million by 2030.

Data management was the largest segment with a revenue share of 17.65% in 2024. Horizon Databook has segmented the North America life sciences quality management software market based on data management, training management, supplier management, regulatory and compliance management, corrective action preventive action (capa) management, audit management, change management, non-conformances management, inspection management, risk management covering the revenue growth of each sub-segment from 2018 to 2030.


The life sciences quality management software (QMS) market in North America is evolving rapidly, driven by the need for stringent compliance with regulatory standards and the increasing complexity of product development processes. 

Companies in the life sciences sector, including pharmaceuticals and biotechnology, seek to maintain high-quality standards while navigating regulations. These systems help organizations manage documentation, ensure product safety, and facilitate compliance efforts across various product lifecycle stages.

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Life Sciences Quality Management Software Market Companies

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North America life sciences quality management software market size, by country, 2018-2030 (US$M)

North America Life Sciences Quality Management Software Market Outlook Share, 2024 & 2030 (US$M)

North America life sciences quality management software market size, by country, 2018-2030 (US$M)

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