Medical QMS Software Market Expected to Reach USD 9,061 Million by 2030: Straits Research

In 2020, North America ruled the global medical QMS market with more than 40%. In North America, the Patient Protection and Accountable Care Act (PPACA) of 2010 was authorized to give excellent medical care offices and propel consistency with quality guidelines. In 2010, the Patient Protection and Accountable Care Act (PPACA) was passed in North America to offer quality medical services contributions and commands similar to quality guidelines.


New York, United States, April 18, 2022 (GLOBE NEWSWIRE) -- The global medical QMS software market had a market share of USD 1681.12 million in 2017, according to the new report of Straits Research. It is predicted to increase at a CAGR of 14.4% from 2021 to 2030. Quality Management System (QMS) is a codified framework that documents processes, procedures, and responsibilities for accomplishing quality objectives and safety compliance in pharmaceutical and life science-related activities. These medical care and pharmaceutical ventures must follow strict guidelines as they are concerned with the patient's life and safety. 

The medical QMS software is utilized in primary business operations and processes. QMS helps avoid senseless blunders, make process corrections, and improvise as per the feedback. The medical facilities cannot provide poor quality services as medical errors can cost a fortune. In the US, fatal incidents are often reported due to medical errors. 

Key Insights

  • Based on the solution type, the market is segmented as Complaint handling, Document control, Audit Management, Non-conformances/ corrective and preventive, Supplier quality management, Others. The complaint handling segment acquires almost the largest share of the market, which is above 25%
  • According to the deployment, most of the market is under the on-premises category. It acquires more than 55% of the market. Even though the on-premises category holds the larger piece of the pie cloud-based sector is predicted to grow at a soaring CAGR of 14.5%
  • By End-user, the market is divided into SMEs and large enterprises. Larger enterprises hold the major share of the global medical QMS software market and are expected to grow at a CAGR of 12.8%.
  • America and Europe are the major markets for Medical QMS software. They are expected to grow at a CAGR of 14.2% and 14.34%, respectively.

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The Demand for Medical QMS Software Ascends to Decrease the Medical Errors

The medical QMS market is expected to observe massive development inferable from the rising interest for the effective administration of hierarchical cycles and the requirement for meeting user assumptions in a profoundly aggressive market. Moreover, the quickly expanding innovative headways in the healthcare industries add to the market interest.

Medical errors can lead to fatal outcomes and can further cost a fortune to the medical facilities. An automated system to manage and organize data can help lower these errors considerably and cut down on unnecessary administrative overheads.

QMS programming offers different functionalities, including out-of-detail test results, treatment of non-conformances, adjustment, guaranteeing consistency, and an incorporated framework that ensures association with associations' ERP and CRM frameworks. This large number of functionalities, combined with advantages, such as decreased functional expenses and process advancement, are assessed to move the reception of QMS across a broad scope of healthcare facilities. 

QMS offers expanded adaptability and versatility in applications, for example, report control and the goal of non-conformances. The interest in cloud-based QMS arrangements among end-use ventures due to inferred adaptability and openness is also expected to support market growth. The expanding progressions and functionalities of QMS software, alongside the increasing developments in the field of computerized reasoning and AI, are expected to help the market develop over the forecast period.

For example, in January 2021, Arena Solutions, Inc. collaborated with Rimsys Inc., a Regulatory Information Management (RIM) programming stage supplier, to offer secure cloud-based start to finish quality and item-driven administrative answers for the MedTech industry. QMS is relied upon to improve both the organizations' capacities in observing archive changes and alarming clients during announcing refreshes in light of the report area. Moreover, the FDA's quality metrics initiatives in the pharmaceutical industries are helping transform product quality and positively influence the market.

Effect of COVID-19

In the wake of the COVID-19 pandemic, the healthcare industry experienced huge chaos. The rapid spread of the disease worldwide burdened the hospitals with extreme responsibilities. The world hospitals were not prepared for such a sudden outbreak. There was a need for operational efficiency organization of data as medical errors would have created havoc in the facilities. This created a demand for the QMS software during this period.

Post pandemic, it has become necessary to manage quality systems efficiently, consistently, and in a standardized fashion. Healthcare facilities worldwide have realized the need for an automated system for data and processes. Hence, the demand will keep rising during the forecast period with advancements in technologies in the sector.

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Global Medical QMS Software Market: Segmentation

By Solution Type

  • Complaint Handling
  • Document Control
  • Audit Management
  • Non-Conformances/ Corrective and Preventive
  • Supplier Quality Management
  • Others

By Deployment Type           

  • On-Premises
  • Cloud-Based

By End-User 

  • SMES
  • Large Enterprises

Regions Covered

  • North America
  • Europe
  • Asia-Pacific
  • The Middle East and Africa

List of Key Players

  • Almond, Plex Systems Inc.
  • PTC Inc.
  • Greenlight Guru
  • QAD Inc., Qualio
  • Insilicotrials Technologies
  • QMS Wrapper
  • Sparta Systems
  • Siemens AG
  • Qualys

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Detailed Table of Content

1          Introduction
1.1       Market Definition
1.2       Market Scope
2          Research Methodology
2.1       Primary Research
2.2       Research Methodology
2.3       Assumptions & Exclusions
2.4       Secondary Data Sources
3          Market Overview
3.1       Report Segmentation & Scope
3.2       Value Chain Analysis: Medical QMS Software Market
3.3       Key Market Trends
3.3.1    Drivers
3.3.2    Challenges
3.3.3    Opportunities
3.4       Porter’s Five Forces Analysis
3.4.1    Bargaining Power of Suppliers
3.4.2    Bargaining Power of Buyers
3.4.3    Threat of Substitution
3.4.4    Threat of New Entrants
3.4.5    Competitive Rivalry
3.5       Market Share Analysis
4          Type Overview
4.1       Introduction
4.1.1    Market Size & Forecast
4.2       Cloud Based
4.2.1    Market Size & Forecast
4.3       Web Based
4.3.1    Market Size & Forecast
5          Application Overview
5.1       Introduction
5.1.1    Market Size & Forecast
5.2       SMEs
5.2.1    Market Size & Forecast
5.3       Large Enterprise
5.3.1    Market Size & Forecast
6          Regional Overview
6.1       Introduction
6.1.1    Market Size & Forecast
6.2       North America
6.2.1     Market Size & Forecast
6.2.2      U.S.   By Type   By Application
6.2.3      Canada   By Type   By Application
6.2.4      Mexico   By Type   By Application
6.3       Europe
6.3.1    Market Size & Forecast
6.3.2    Germany      By Type      By Application
6.3.3    France      By Type      By Application
6.3.4    U.K.     By Type     By Application
6.3.5    Italy     By Type     By Application
6.3.6    Spain     By Type     By Application
6.3.7    Rest of Europe      By Type      By Application
6.4       Asia-Pacific
6.4.1    Market Size & Forecast
6.4.2    Japan      By Type      By Application
6.4.3    China      By Type      By Application
6.4.4    Australia      By Type      By Application
6.4.5    India      By Type      By Application
6.4.6    South Korea      By Type      By Application
6.4.7    Rest of Asia-Pacific      By Type      By Application
6.5       LAMEA
6.5.1    Market Size & Forecast
6.5.2    Saudi Arabia      By Type      By Application
6.5.3    South Africa      By Type      By Application
6.5.4    Brazil      By Type      By Application
6.5.5    Rest of LAMEA      By Type       By Application

7          Company Profile
7.1       Greenlight Guru
7.1.1    Company Overview
7.1.2    Financial Performance
7.1.3    Recent Developments
7.1.4    Product Portfolio
7.2       Qualio
7.2.1    Company Overview
7.2.2    Financial Performance
7.2.3    Recent Developments
7.2.4    Product Portfolio
7.3       CEBOS
7.3.1 Company Overview
7.3.2    Financial Performance
7.3.3    Recent Developments
7.3.4    Product Portfolio
7.4       InSilicoTrials
7.4.1    Company Overview
7.4.2    Financial Performance
7.4.3    Recent Developments
7.4.4    Product Portfolio
7.5       QmsWrapper
7.5.1    Company Overview
7.5.2    Financial Performance
7.5.3    Recent Developments
7.5.4    Product Portfolio

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Market News

  • January 2021 – Greenlight Guru announced a strategic partnership with Nelson Labs.
  • January 2021 – PTC Inc. had completed the acquisition of Arena Solutions, a market leader in SaaS and Product lifestyle management (PLM) solutions, thus expanding to the product development market further. The buyout cost USD 715 million.
  • March 2021 – Siemens Digital Industries Software has announced Teamcenter Quality Software, a new suite of solutions that provide a closed-loop approach for quality management from design to manufacturing on the shop floor and back again. 
  • April 2021 – Plex Sytems, the leader in cloud-delivered manufacturing solutions, announced that Quality Management Systems (QMS) is available as a standalone offering. Plex QMS helps manufacturers adhere to industry compliance, regulations, and standards such as FMEA, PPAP, SQF, and BRC to avoid costly product recalls.
  • June 2021– Rockwell Corporation acquired Plex Systems at USD 2.22 billion from Francisco Partners
  • August 2021 – Qualio announced the launch of design controls for medical devices and software as a medical device (SaMD) company.

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