The pharmaceutical industry is navigating an era of increasing regulatory scrutiny, digital transformation, and global process complexity. A recent Research and Markets report on the Pharmaceutical Quality Management Software (QMS) market shows strong momentum: the global market is expected to grow from USD 1.59 billion in 2025 to USD 2.98 billion by 2030, with a compound annual growth rate (CAGR) of 13.3%.
This growth reflects how pharma companies are investing in digital tools to ensure compliance, streamline quality processes and improve product safety.
One major trend highlighted in the report is how regulatory compliance is driving QMS adoption, especially as organizations strive to meet global standards like FDA, EMA and WHO guidelines.
Solutions that automate audits, documentation and compliance workflows help reduce risk and boost operational visibility, a non-negotiable for any modern pharmaceutical quality team.
The report also points out that CAPA management (Corrective and Preventive Actions) is one of the fastest-growing application areas in the market, as companies focus on proactive quality assurance rather than reactive firefighting. This mirrors a broader push toward data-driven quality practices, with automation and analytics woven into core quality processes.
Regionally, Asia Pacific is expected to experience rapid growth, fueled by expanding manufacturing capacities, outsourced clinical trials and alignment with international quality standards.
Key players in the market: where SoftExpert stands
According to the report, the competitive landscape is diverse, with both large international players and specialized solutions shaping the market.
This recognition places SoftExpert alongside global leaders in quality management solutions that support pharmaceutical quality, compliance and digital transformation.
SoftExpert’s enterprise quality management suite is built to manage quality processes end-to-end, from document control and nonconformance tracking to risk management and corrective actions.
Its modules enable organizations to automate compliance workflows and provide real-time visibility into quality operations, aligning with the market’s shift toward integrated, data-driven quality systems.
Why this matters for Pharma Organizations
The pharmaceutical QMS landscape isn’t growing by accident. Stricter regulatory demands, global supply chains and the need for seamless compliance reporting are pushing life sciences companies to modernize their quality infrastructure. Choosing a solution like SoftExpert that is recognized in such a competitive market underscores a commitment to quality excellence and operational resilience.