REDDING, Calif., July 15, 2024 /PRNewswire/ -- According to a
new market research report titled, 'Pharmaceutical Quality
Management Systems Market Size, Share, Forecast, & Trends
Analysis by Solution Type (Deviation, CAPA, Audit, Risk &
Compliance, Inspection, Change, Training) Deployment Mode (Cloud,
On-premise) End User - Global Forecast to
2031,' published by Meticulous Research®, the
pharmaceutical quality management systems market is projected
to reach $4.59 billion by 2031
at a CAGR of 15.6% from 2024 to 2031.
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Pharmaceutical Quality Management Systems (QMS) are sets of
procedures and practices that contribute to the quality of
pharmaceutical products. Quality management systems facilitate
regulatory requirements relevant to industries and companies. ICH
Q10 and ISO 9001:2015 are some of the most important quality
standards and guidelines for the pharmaceutical industry. Quality
Management systems have positively impacted the global
pharmaceutical market and brought about significant changes in the
pharmaceutical industry.
Rising drug manufacturing costs, stringent regulatory standards
for pharmaceutical production, rapid growth of the pharmaceutical
industry, and the advantages of software-based quality management
systems drive the growth of this market. However, the high costs of
deploying pharmaceutical quality management systems restrain the
growth of this market.
The increasing demand for generic drugs & biopharmaceuticals
and the rising preference for platform-as-a-service solutions among
pharmaceutical companies are expected to create market growth
opportunities. However, security concerns associated with on-cloud
deployments pose a significant challenge to the market's
growth.
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Increasing Inclination Towards Personalized Medicine is
Driving the Demand for Pharmaceutical Quality Management
Systems
Advances in proteomic and genomic sciences have boosted the
development of personalized therapies. Personalized medicine is an
emerging approach in today's healthcare systems. A wave of
personalized medicines has entered mainstream clinical practices,
changing the methods for identifying, classifying, and treating
diseases. Policymakers are increasingly recognizing personalized
medicines, driving innovative approaches to develop and produce
personalized therapies. Personalized therapies are designed
according to patients' unique requirements, which makes it
difficult to manufacture them, maintain quality control, and
guarantee consistency and repeatability. Patient information, such
as genetic and clinical data, is crucial to developing personalized
treatments. Large data volumes can be difficult to handle and
analyze, necessitating powerful data management systems and
analytical tools.
As per a report by the Personalized Medicine Coalition, the
number of personalized medicines on the market is growing rapidly.
In the U.S., the number increased by more than two-fold during
2016–2020. Personalized medicines accounted for 39% of the U.S.
FDA's new drug approvals in 2020, increasing from 5% in 2005.
Further, the use of biomarkers in clinical trials increased from
18% in 2000 to 61% in 2019, generating opportunities to produce
personalized therapies and driving the demand for pharmaceutical
QMS. In June 2020, Infosys Limited
(India) launched a platform for
personalized medicine based on its SCI platform, SAP S/4HANA, SAP
Analytics Cloud solution, and SAP C/4HANA, to address regulatory
compliance, patient management, and supply chain issues.
The key players operating in the global pharmaceutical quality
management systems market are ANTARES VISION SpA (Italy), AssurX Inc. (U.S.), AXSource
Consulting Inc. (U.S.), Körber AG (Germany), ComplianceQuest, Inc. (U.S.),
Dassault Systèmes SE (France), EtQ
Management Consultants Inc.(U.S.), Honeywell International Inc.
(U.S.), Ideagen PLC (U.K.), IQVIA HOLDINGS INC. (U.S), LogicGate
Inc. (U.S.), and MasterControl, Inc. (U.S.).
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The global pharmaceutical quality management systems market
study presents historical market data in terms of values (2022 and
2023), estimated current data (2024), and forecasts for 2031. The
global pharmaceutical quality management systems market is
segmented by solution type, deployment mode, and end user. The
study also evaluates industry competitors and analyzes the market
at the regional and country levels.
Based on solution type, the pharmaceutical quality management
systems market is segmented into non-conformance/deviation
management, CAPA management, audit management, risk &
compliance management, suppliers & materials management,
inspection management, document management, change management,
training management, and other solution types. In 2024, the
non-conformance/deviation management segment is expected to account
for the largest share of 18.1% of the pharmaceutical quality
management systems market. However, the CAPA management segment is
expected to register the highest CAGR during the forecast period.
This segment's growth can be attributed to the increasing demand
for Corrective and Preventive Action (CAPA) management in the
pharmaceutical industry, driven by the need to ensure product
quality, patient safety, and regulatory compliance. CAPA management
is essential for addressing issues and preventing their recurrence,
further contributing to the overall integrity of pharmaceutical
operations.
Based on deployment mode, the pharmaceutical quality management
systems market is segmented into cloud/web-based and on-premise. In
2024, the cloud/web-based segment is expected to account for
the largest share of 79.4% of the pharmaceutical quality
management systems market. The large market share of this segment
can be attributed to the advantages offered by cloud/web-based
deployments over on-premise deployments, such as cost minimization,
easy accessibility, adjustability, and updated cloud systems.
Based on end user, the pharmaceutical quality management systems
market is segmented into pharmaceutical and biotechnology
companies, contract development and manufacturing
organizations/contract research organizations, and research
laboratories. The pharmaceutical and biotechnology companies
segment is expected to register the highest CAGR during the
forecast period. The growth of this segment is attributed to
increasing R&D investments by pharmaceutical &
biotechnology companies, widespread utilization of quality
management systems to ensure product quality, and a growing
emphasis on personalized medicine research.
Geographically, in 2024, North
America is expected to account for the largest share of
38.4% of the pharmaceutical quality management systems
market. North America's large
market share can be attributed to the increasing use of advanced
digital tools approved by regulatory authorities in the region's
pharmaceutical sector to improve overall development &
manufacturing outcomes and the presence of major market players in
the region.
The report also includes an extensive assessment of the key
growth strategies adopted by leading market players over the past
few years (2021–2024). In the last couple of years, the global
pharmaceutical quality management systems market witnessed several
strategic developments.
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Scope of the Report:
Pharmaceutical Quality Management Systems Market
Assessment—by Solution Type
- Non-conformance/Deviation management
- Document Management
- CAPA Management
- Risk & Compliance Management
- Inspection Management
- Audit Management
- Suppliers & Materials Management
- Training Management
- Change Management
- Other Solution Types
(Other solution types include complaint management,
out-of-specification, release management, incidents &
occurrence management, post-market surveillance, design control,
and asset management)
Pharmaceutical Quality Management Systems Market
Assessment—by Deployment Mode
- Cloud/Web-based
- On-Premise
Pharmaceutical Quality Management Systems Market
Assessment—by End User
- Pharmaceutical and Biotechnology Companies
- CDMO/CRO
- Research Laboratories
Pharmaceutical Quality Management Systems Market
Assessment—by Geography
- North America
- Europe
- Germany
- France
- U.K.
- Italy
- Spain
- Ireland
- Belgium
- Netherlands
- Rest of Europe
- Asia-Pacific
- China
- Japan
- India
- Singapore
- Malaysia
- Philippines
- Vietnam
- Rest of Asia-Pacific
- Latin America
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa
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