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レポート概要
| 本調査レポートでは医療QMSの世界市場について広く調査・分析し、イントロダクション、調査手法、市場動向、種類別（クラウドベース、ウェブベース）分析、用途別（中小企業、大企業）分析、地域別分析、企業概要などを含め、今後の市場展望をまとめております。 ・イントロダクション ・調査手法 ・市場動向 ・医療QMSの世界市場：種類別（クラウドベース、ウェブベース） ・医療QMSの世界市場：用途別（中小企業、大企業） ・医療QMSの世界市場：地域別 ・企業概要 |
Global Statistics Representing Medical QMS Software Market Scenario
The medical device manufacturing industry is subject to a variety of regulations, which are generally stringent in the U.S. and Europe. Medical QMS software helps in diversifying medical device manufacturing and making it more efficient. Further, the software helps in lowering operational costs while offering quality products, which is spurring the growth of the medical QMS software market. The global medical QMS software market is expected to grow at a CAGR of 8.8% during the forecast period, 2019–2026.
Technological Advancements & Shift in Consumer Expectations
The advancement of technology has been an enabler of growth and innovation for many industries and is poised to do the same for the medical devices industry. In the current scenario, consumer expectations continue to rise in terms of quality and patient care, and, at the same time, resources continue to shrink. As a result, hospitals are shifting from traditional approaches to new and efficient technologies and software that help them enhance quality and performance, which, in turn, is widening the scope for medical QMS software.
The Need to Curtail Healthcare Costs & Medical Errors Drives the Adoption of Medical QMS Software
Performance enhancements are essential to attain safer care as the healthcare industry shifts to a value-based system. The National Institute of Health (NIH) estimates the medical error costs of a preventable nature in the sector at approx. USD 17–29 billion per year. To reduce such avoidable costs and ensure quality, several healthcare institutions are adopting open-source software packages from vendors across the globe. For instance, SunnyBrook Health Sciences Centre, Canada, required a tool that would accurately collect information, track progress, promote the fast turnaround of priority issues, and report data. For years, the company relied on excel spreadsheets; however, the hospital later adopted patient feedback software to monitor its activities. The shift helped in effectively reducing the preventable costs incurred.
Data Security – A Key Concern Associated With Use of Medical QMS Software
Increasing connectivity to existing computer networks has exposed medical devices and software to several cybersecurity vulnerabilities. This is a result of the technological advancements taking place in healthcare delivery, which have the capability and capacity to improve patient care. Regulatory bodies such as the U.S. Department of Health and Human Services & the U.S. Food and Drug Administration take responsibility for assuring the effectiveness, safety, and security of medical devices and thus, monitor data security and other aspects to formulate solutions that mitigate such concerns.
Favorable Regulatory Scenario to Present an Opportunity for the Medical QMS Software Market
The healthcare sector is dynamically driven towards value-based systems and software to ensure quality. Regulatory bodies are also working towards bringing in quality performance in the sector by integrating standards and guidelines and drafting regulations and policies in an attempt to mandate value systems. For instance, the ISO 9001:2015 demands institutions to demonstrate their ability to consistently offer products and services that meet customer and applicable statutory and regulatory requirements. Such initiatives, regulations, and policies that focus on developing medical devices and services keeping in mind the current need for quality among customers, offer an array of opportunities for the medical QMS software market. For instance, the introduction of HL7 QRDA-III STU R2.1 Guidelines and ICD 10 is expected to impart to growth momentum in the U.S. market.
Intended Audience
Distributors and Suppliers
Healthcare Providers
Medical Device Manufacturers
Research Institutes and Academic Centers
Contract Research Organizations (CROs)
Government Associations
Market Research and Consulting
Large Enterprises to Account for a Larger Share of the Pie in Terms of Application
SMEs and large enterprises alike adopt medical QMS software solutions. Medical device manufacturers are multibillion-dollar industries consolidated in large organizations. Siemens Healthcare (Revenue: USD 15.4 billion – 2018) and Medtronic (Revenue: USD 30 billion – 2018) are among the key players in the market. Large medical device manufacturers are scaling up their market share through mergers with and the acquisition of small and medium organizations. For instance, Medtronic acquired HeartWare International Inc., Crospon, Mazor Robotics and Nutrino Health Ltd, and Titan Spine in 2016, 2017, 2018, and 2019, respectively. Overall, growth in the manufacturing of medical devices is providing a fillip to the demand for medical QMS software from large enterprises.
Cloud-Based Technologies to Remain Ahead of Web-Based Technologies in Years to Come
Medical device manufacturers are embracing cloud-based technologies due to the increasing pressure on healthcare providers to lower costs and improve patient care. Cloud-based quality management software solutions are cheaper than on-premise solutions; they are interoperable, quicker to install, and associated with low maintenance costs. Medical devices manufacturers gain substantial profits from adopting cloud platforms as they reduce maintenance costs without compromising quality or service. The Obamacare Act (Patient Protection and Affordable Care Act (PPACA) was enacted in the U.S. in 2010; the act mandates more efficient supply chains in healthcare by reducing reimbursements for large hospitals. Furthermore, various medical QMS software providers are collaborating with cloud platform providers to incorporate quality, security, and data integrity.
North America to Remain the Most Prominent Region in Terms of Value Share
North America holds the largest share of the global medical QMS software market, with the U.S. as a prominent contributor in the regional market. The country, with its large geriatric population, has a long track record of chronic diseases. In 2010, under the Patient Protection and Affordable Care Act, the previously uninsured population gained access to healthcare services. The upsurge in the demand for healthcare services is accelerating the need for cost-effective medical devices, which in turn is bolstering the growth of the medical QMS software market in the country.
Europe to Hold the Second Largest Market Share, With Impetus From a Growing Geriatric Population
Europe holds the second-largest share in the global medical QMS software market. The region constitutes a large geriatric population, which is increasing the demand for healthcare services. According to Johnson & Johnson, “People above the age of 65 years use approximately seven times more healthcare-related products and services than younger people”. The growing demand for healthcare services is accelerating the growth of the medical manufacturing industry, and subsequently, accelerating the demand for medical QMS software solutions.
The number of SMEs in medical devices manufacturing is more in Europe. For instance, according to MedTech Europe, there are approximately 27,000 medical technology companies in Europe, and small and medium-sized companies constitute 95% of the medical technology industry in the region. Germany holds a 28% share in medical device manufacturing and the country has the largest number of SMEs.
Asia-Pacific to Remain a Manufacturing/Sourcing Base for Many Global Medical Device Manufacturers
Asia-Pacific is known for manufacturing low-end medical device products such as drainage bags, surgical tape, and rubber gloves, as well as sophisticated class III medical devices such as drug-eluting stents. Due to relatively low labor costs, low overhead costs, and improving technical capabilities, many international medical device companies prefer to source or manufacture their devices in the Asia-Pacific region. For instance, in 2011, Medtronic opened a new manufacturing facility in Singapore, and in 2018, Siemens Healthineers opened a diagnostics manufacturing facility in Gujarat, India.
While labor cost is increasing in China, it remains relatively low in Vietnam, India, and Indonesia; therefore, the sourcing and manufacturing business in these countries is growing. Additionally, in Asia-Pacific’s medical device industry, innovative domestic companies challenge multinational competitors at the higher end of not just regional, but global markets.
LAMEA Pegged to be a Promising Market With Untapped Opportunities
The Middle Eastern countries are some of the world’s wealthiest economies in the world, offering unique opportunities to multinational companies operating in the medical devices manufacturing sector. These players are surging the demand for medical QMS software solutions in the region. On the other hand, the medical devices market in Africa is price-sensitive, exhibiting opportunities for lower-end devices with low costs.
Key Players
Some of the prominent players in the global medical QMS software market are Greenlight Guru, Qualio, CEBOS, InSilicoTrials, QmsWrapper, Qualsys, Sparta Systems, Almond, Siemens PLM, IQS, Inc., MasterControl, and AssurX.
Medical QMS Software Market Segmentation
By Type
Cloud-based
Web-based
By Application
SMEs
Large enterprise
By Region
North America
U.S.
Canada
Mexico
Europe
U.K.
Germany
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
India
Japan
South Korea
Australia
Rest of Asia-Pacific
LAMEA
Brazil
Saudi Arabia
South Africa
Rest of LAMEA
TABLE OF CONTENTS
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.
6.2.2.1 By Type
6.2.2.2 By Application
6.2.3 Canada
6.2.3.1 By Type
6.2.3.2 By Application
6.2.4 Mexico
6.2.4.1 By Type
6.2.4.2 By Application
6.3 Europe
6.3.1 Market Size & Forecast
6.3.2 Germany
6.3.2.1 By Type
6.3.2.2 By Application
6.3.3 France
6.3.3.1 By Type
6.3.3.2 By Application
6.3.4 U.K.
6.3.4.1 By Type
6.3.4.2 By Application
6.3.5 Italy
6.3.5.1 By Type
6.3.5.2 By Application
6.3.6 Spain
6.3.6.1 By Type
6.3.6.2 By Application
6.3.7 Rest of Europe
6.3.7.1 By Type
6.3.7.2 By Application
6.4 Asia-Pacific
6.4.1 Market Size & Forecast
6.4.2 Japan
6.4.2.1 By Type
6.4.2.1 By Application
6.4.3 China
6.4.3.1 By Type
6.4.3.2 By Application
6.4.4 Australia
6.4.4.1 By Type
6.4.4.2 By Application
6.4.5 India
6.4.5.1 By Type
6.4.5.2 By Application
6.4.6 South Korea
6.4.6.1 By Type
6.4.6.2 By Application
6.4.7 Rest of Asia-Pacific
6.4.7.1 By Type
6.4.7.2 By Application
6.5 LAMEA
6.5.1 Market Size & Forecast
6.5.2 Saudi Arabia
6.5.2.1 By Type
6.5.2.2 By Application
6.5.3 South Africa
6.5.3.1 By Type
6.5.3.2 By Application
6.5.4 Brazil
6.5.4.1 By Type
6.5.4.2 By Application
6.5.5 Rest of LAMEA
6.5.5.1 By Type
6.5.5.2 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
7.6 Qualsys
7.6.1 Company Overview
7.6.2 Financial Performance
7.6.3 Recent Developments
7.6.4 Product Portfolio
7.7 Sparta Systems
7.7.1 Company Overview
7.7.2 Financial Performance
7.7.3 Recent Developments
7.7.4 Product Portfolio
7.8 Almond
7.8.1 Company Overview
7.8.2 Financial Performance
7.8.3 Recent Developments
7.8.4 Product Portfolio
7.9 Siemens PLM
7.9.1 Company Overview
7.9.2 Financial Performance
7.9.3 Recent Developments
7.9.4 Product Portfolio
7.10 IQS, Inc
7.10.1 Company Overview
7.10.2 Financial Performance
7.10.3 Recent Developments
7.10.4 Product Portfolio
LIST OF TABLESTABLE 1 Global Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 2 Cloud Based, Medical QMS Software Market Share by Region, 2016–2026 ($Million)
TABLE 3 Global Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 4 Global Medical QMS Software Market through Type by Region, 2016–2026 ($Million)
TABLE 5 Global Medical QMS Software Market Share Value, 2016–2026 ($Million)
TABLE 6 North America Medical QMS Software Market Share Value by Country, 2016–2026 ($Million)
TABLE 7 North America Medical QMS Software Market Share Value by Type, 2016–2026 ($Million)
TABLE 8 North America Medical QMS Software Market Share Value by Application, 2016–2026 ($Million)
TABLE 9 U.S. Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 10 U.S. Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 11 Canada Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 12 Canada Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 13 Mexico Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 14 Mexico Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 15 Europe Medical QMS Software Market Share Value by Country, 2016–2026 ($Million)
TABLE 16 Europe Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 17 Europe Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 18 Germany Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 19 Germany Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 20 France Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 21 France Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 22 U.K. Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 23 U.K. Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 24 Italy Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 25 Italy Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 26 Spain Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 27 Spain Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 28 Rest of Europe Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 29 Rest of Europe Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 30 Asia-Pacific Medical QMS Software Market Share Value by Country, 2016–2026 ($Million)
TABLE 31 Asia-Pacific Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 32 Asia-Pacific Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 33 Japan Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 34 Japan Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 35 China Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 36 China Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 37 Australia Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 38 Australia Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 39 India Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 40 India Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 41 South Korea Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 42 South Korea Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 43 Rest of Asia-Pacific Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 44 Rest of Asia-Pacific Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 45 LAMEA Medical QMS Software Market Share Value by Country, 2016–2026 ($Million)
TABLE 46 LAMEA Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 47 LAMEA Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 48 Saudi Arabia Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 49 Saudi Arabia Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 50 South Africa Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 51 South Africa Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 52 Brazil Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 53 Brazil Medical QMS Software Market Share by Application, 2016–2026 ($Million)
TABLE 54 Rest of LAMEA Medical QMS Software Market Share by Type, 2016–2026 ($Million)
TABLE 55 Rest of LAMEA Medical QMS Software Market Share by Application, 2016–2026 ($Million)
LIST OF FIGURES
FIGURE 1 Global Medical QMS Software Market Overview
FIGURE 2 Value Chain Analysis
FIGURE 3 Bargaining Power of Suppliers
FIGURE 4 Bargaining Power of Buyers
FIGURE 5 Threat of Substitution
FIGURE 6 Threat of New Entrants
FIGURE 7 Competitive Rivalry
FIGURE 7 Medical QMS Software Market, Market Share Analysis, 2018
FIGURE 9 Global Medical QMS Software Market, 2016–2026
FIGURE 10 U.S. Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 11 Canada Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 12 Mexico Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 13 Germany Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 14 France Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 15 U.K. Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 16 Italy Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 17 Spain Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 17 Rest of Europe Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 19 Japan Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 20 China Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 21 Australia Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 22 India Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 23 South Korea Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 24 Rest of Asia-Pacific Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 25 Saudi Arabia Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 26 South Africa Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 27 Brazil Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 28 Rest of LAMEA Medical QMS Software Market Share, 2016–2026 ($Million)
FIGURE 29 Greenlight Guru: Revenue Analysis ($Million)
FIGURE 30 Greenlight Guru: Segment Revenue 2018 (%)