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レポート概要
| 本市場調査レポートでは、医療機器・IVD薬事申請アウトソーシングの世界市場について調査・分析し、序論、仮定・調査手法、エグゼクティブサマリー、市場概要、市場動向、サービス別（規制作成・提出、規制登録サービス、規制コンサルティング、その他）分析、ソフトウェア別（クラウド、オンプレミス）分析、地域別（北米、ヨーロッパ、アジア太平洋、中南米、中東・アフリカ）分析、競争状況などの項目を掲載しています。 ・序論 ・仮定/調査手法 ・エグゼクティブサマリー ・市場概要 ・市場動向 ・医療機器・IVD薬事申請アウトソーシングの世界市場規模：サービス別（規制作成・提出、規制登録サービス、規制コンサルティング、その他） ・医療機器・IVD薬事申請アウトソーシングの世界市場規模：ソフトウェア別（クラウド、オンプレミス） ・医療機器・IVD薬事申請アウトソーシングの世界市場規模：地域別（北米、ヨーロッパ、アジア太平洋、中南米、中東・アフリカ） ・競争状況 |
Medical Device & IVD Regulatory Affairs Outsourcing Market – Scope of the Report
TMR’s report on the global medical device & IVD regulatory affairs outsourcing market studies past as well as current growth trends and opportunities to gain valuable insights of these indicators for the market during the forecast period from 2020 to 2030. The report provides the revenue of the global medical device & IVD regulatory affairs outsourcing market for the period 2018–2030, considering 2019 as the base year and 2030 as the forecast year. The report also provides the compound annual growth rate (CAGR) of the global medical device & IVD regulatory affairs outsourcing market from 2020 to 2030.
The report has been prepared after extensive research. Primary research involved bulk of research efforts, wherein analysts carried out interviews with key opinion leaders, industry leaders, and opinion makers. Secondary research involved referring to key players’ product literature, annual reports, press releases, and relevant documents to understand the global medical device & IVD regulatory affairs outsourcing market.
Secondary research also included Internet sources, statistical data from government agencies, websites, and trade associations. Analysts have employed a combination of top-down and bottom-up approaches to study various attributes of the global medical device & IVD regulatory affairs outsourcing market.
The report includes an elaborate executive summary, along with a snapshot of the growth behavior of various segments and sub-segments included in the scope of the study. Moreover, the report sheds light on changing competitive dynamics in the global medical device & IVD regulatory affairs outsourcing market. These serve as valuable tools for existing market players as well as entities interested in participating in the global medical device & IVD regulatory affairs outsourcing market.
The report also delves into the competition landscape of the global medical device & IVD regulatory affairs outsourcing market. Key players operating in the global medical device & IVD regulatory affairs outsourcing market have been identified and each one of these has been profiled in terms of various attributes. Company overview, financial standings, recent developments, and SWOT are attributes of players in the global medical device & IVD regulatory affairs outsourcing market that have been profiled in this report.
Key Questions Answered in Medical Device & IVD Regulatory Affairs Outsourcing Report
What is the sales/revenue generated by medical device & IVD regulatory affairs outsourcing service providers across all regions during the forecast period?
What are the opportunities in the global medical device & IVD regulatory affairs outsourcing market?
What are the major drivers, restraints, opportunities, and threats in the global market?
Which region is set to expand at the fastest CAGR during the forecast period?
Which product segment is expected to generate the highest revenue globally in 2030? Which segment is projected to expand at the highest CAGR during the forecast period?
What are the market positions of different companies operating in the global market?
Medical Device & IVD Regulatory Affairs Outsourcing Market – Research Objectives and Research Approach
The comprehensive report on the global medical device & IVD regulatory affairs outsourcing market begins with an overview, followed by the scope and objectives of the study. Following this, the report provides detailed explanation of the objectives behind this study and key vendors and distributors operating in the market and regulatory scenario for approval of products.
For reading comprehensibility, the report has been compiled in a chapter-wise layout, with each section divided into smaller sections. The report comprises an exhaustive collection of graphs and tables that have been appropriately interspersed. Pictorial representation of actual and projected values of key segments is visually appealing to readers. This also allows comparison of market shares of key segments in the past and at the end of the forecast period.
The report analyzes the global medical device & IVD regulatory affairs outsourcing market in terms of service, software, and region. Key segments under each criteria have been studied at length, and the market share for each of these at the end of 2030 has been provided. Such valuable insights enable market stakeholders to make informed business decisions for investment in the global medical device & IVD regulatory affairs outsourcing market.
レポート目次1. Preface
1.1. Market Definition and Scope
1.2. Market Segmentation
1.3. Key Research Objectives
1.4. Research Highlights
2. Assumptions and Research Methodology
3. Executive Summary: Global Medical Device & IVD Regulatory Affairs Outsourcing Market
4. Market Overview
4.1. Introduction & Overview
4.2. Product Overview
4.3. Market Dynamics
4.3.1. Drivers
4.3.2. Restraints
4.3.3. Opportunities
4.4. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast, 2018–2030
5. Market Outlook
5.1. COVID-19 Pandemics Impact on Industry
5.2. Technology/Product Roadmap
5.3. Market Channel Development Trends
5.4. Key Potential Customers
6. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast, by Service
6.1. Introduction & Definition
6.2. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
6.2.1. Regulatory Writing & Submissions
6.2.2. Regulatory Registration Service
6.2.3. Regulatory Consulting
6.2.4. Others
6.3. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Service
7. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast, by Software
7.1. Introduction & Definition
7.2. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
7.2.1. Cloud-based software
7.2.2. On-premises software
7.3. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Software
8. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast, by Region
8.1. Key Findings
8.2. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Region
8.2.1. North America
8.2.2. Europe
8.2.3. Asia Pacific
8.2.4. Latin America
8.2.5. Middle East & Africa
8.3. Global Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Region
9. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
9.1. Introduction
9.2. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
9.2.1. Regulatory Writing & Submissions
9.2.2. Regulatory Registration Service
9.2.3. Regulatory Consulting
9.2.4. Others
9.3. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
9.3.1. Cloud-based software
9.3.2. On-premises software
9.4. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country, 2018–2030
9.4.1. U.S.
9.4.2. Canada
9.5. North America Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
9.5.1. By Service
9.5.2. By Software
9.5.3. By Country
10. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
10.1. Introduction
10.2. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
10.2.1. Regulatory Writing & Submissions
10.2.2. Regulatory Registration Service
10.2.3. Regulatory Consulting
10.2.4. Others
10.3. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
10.3.1. Cloud-based software
10.3.2. On-premises software
10.4. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030
10.4.1. Germany
10.4.2. U.K.
10.4.3. France
10.4.4. Spain
10.4.5. Italy
10.4.6. Rest of Europe
10.5. Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
10.5.1. By Service
10.5.2. By Software
10.5.3. By Country/Sub-region
11. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
11.1. Introduction
11.2. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
11.2.1. Regulatory Writing & Submissions
11.2.2. Regulatory Registration Service
11.2.3. Regulatory Consulting
11.2.4. Others
11.3. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
11.3.1. Cloud-based software
11.3.2. On-premises software
11.4. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030
11.4.1. China
11.4.2. Japan
11.4.3. India
11.4.4. Australia & New Zealand
11.4.5. Rest of Asia Pacific
11.5. Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
11.5.1. By Service
11.5.2. By Software
11.5.3. By Country/Sub-region
12. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
12.1. Introduction
12.2. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
12.2.1. Regulatory Writing & Submissions
12.2.2. Regulatory Registration Service
12.2.3. Regulatory Consulting
12.2.4. Others
12.3. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
12.3.1. Cloud-based software
12.3.2. On-premises software
12.4. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030
12.4.1. Brazil
12.4.2. Mexico
12.4.3. Rest of Latin America
12.5. Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
12.5.1. By Service
12.5.2. By Software
12.5.3. By Country/Sub-region
13. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Analysis and Forecast
13.1. Introduction
13.2. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
13.2.1. Regulatory Writing & Submissions
13.2.2. Regulatory Registration Service
13.2.3. Regulatory Consulting
13.2.4. Others
13.3. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
13.3.1. Cloud-based software
13.3.2. On-premises software
13.4. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030
13.4.1. GCC Countries
13.4.2. South Africa
13.4.3. Rest of Middle East & Africa
13.5. Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Attractiveness Analysis
13.5.1. By Service
13.5.2. By Software
13.5.3. By Country/Sub-region
14. Competition Landscape
14.1. Market Position Analysis, by Company, 2019
14.2. Company Profiles
14.2.1. REGIQ SOLUTIONS
14.2.1.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.1.2. Growth Strategies
14.2.1.3. SWOT Analysis
14.2.2. LORENZ Life Sciences Group
14.2.2.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.2.2. Growth Strategies
14.2.2.3. SWOT Analysis
14.2.3. AxSource Consulting Inc
14.2.3.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.3.2. Growth Strategies
14.2.3.3. SWOT Analysis
14.2.4. Freyr
14.2.4.1. Company Overview (HQ, Business Segments)
14.2.4.2. Growth Strategies
14.2.4.3. SWOT Analysis
14.2.5. Promedica International
14.2.5.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.5.2. Growth Strategies
14.2.5.3. SWOT Analysis
14.2.6. Covance
14.2.6.1. Company Overview (HQ, Business Segments)
14.2.6.2. Growth Strategies
14.2.6.3. SWOT Analysis
14.2.7. Assent Compliance Inc
14.2.7.1. Company Overview (HQ, Business Segments)
14.2.7.2. Growth Strategies
14.2.7.3. SWOT Analysis
14.2.8. MakroCare
14.2.8.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.8.2. Growth Strategies
14.2.8.3. SWOT Analysis
14.2.9. EMERGO
14.2.9.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.9.2. Growth Strategies
14.2.9.3. SWOT Analysis
14.2.10. ICON plc
14.2.10.1. Company Overview (HQ, Business Segments, Employee Strength)
14.2.10.2. Company Financials
14.2.10.3. Growth Strategies
14.2.10.4. SWOT Analysis
List of TablesTable 01: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
Table 02: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
Table 03: Global Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Region, 2018–2030
Table 04: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country, 2018–2030
Table 05: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
Table 06: North America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
Table 07: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-Region, 2018–2030
Table 08: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
Table 09: Europe Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
Table 10: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-Region, 2018–2030
Table 11: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
Table 12: Asia Pacific Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
Table 13: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-Region, 2018–2030
Table 14: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
Table 15: Latin America Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030
Table 16: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Country/Sub-Region, 2018–2030
Table 17: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Service, 2018–2030
Table 18: Middle East & Africa Medical Device & IVD Regulatory Affairs Outsourcing Market Value (US$ Mn) Forecast, by Software, 2018–2030