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レギュラトリーアフェアーズアウトソーシング市場。世界の産業動向、シェア、サイズ、成長、機会、および2021-2026年の予測Regulatory Affairs Outsourcing Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026 The global regulatory affairs outsourcing market grew at a CAGR of around 10% during 2015-2020. Looking forward, IMARC Group expects the market to exhibit strong growth during 2021-2026. Keeping in... もっと見る
サマリーThe global regulatory affairs outsourcing market grew at a CAGR of around 10% during 2015-2020. Looking forward, IMARC Group expects the market to exhibit strong growth during 2021-2026. Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic on different end use sectors. These insights are included in the report as a major market contributor.Regulatory affairs outsourcing refers to the hiring of third-party services by the government bodies and private organizations to ensure public health and safety. The services include managing regulatory requirements for generic drugs, innovator drugs, biologics, biosimilars, etc. The outsourcing organizations control the safety and efficacy of the products and ensure that they are safe for consumption. These services are required for clinical trial and patent application, regulatory writing and publishing, product registration and legal representation. Pharmaceutical organizations also opt for these services to seek speedy government approvals in various regions. Significant growth in the pharmaceutical and biotechnological industries across the globe represents one of the key factors creating a positive outlook for the market. Furthermore, the increasing emphasis of pharmaceutical organizations to expand their operations and supplies in the emerging economies is also driving the market growth. Outsourcing regulatory affairs also aid in minimizing the costs associated with managing in-house resources, such as facilities, training, technology, specialized knowledge and geographic regulations. Additionally, regulatory affairs outsourcing services are also widely used for the development of biosimilar, orphan and generic drugs, which is acting as another major growth-inducing factor. Life science organizations are increasingly outsourcing non-core functions and regulatory services and increase their overall operational efficiencies, which, in turn, is contributing to the market growth. Other factors, including significant improvements in the healthcare infrastructure, along with extensive research and development (R&D) activities, are anticipated to drive the market further. Key Market Segmentation: IMARC Group provides an analysis of the key trends in each sub-segment of the global regulatory affairs outsourcing market, along with forecasts at the global, regional and country level from 2021-2026. Our report has categorized the market based on services, company size, category, indication, stage and end user. Breakup by Services: Regulatory Consulting Legal Representation Regulatory Writing and Publishing Product Registration and Clinical Trial Applications Others Breakup by Company Size: Small Medium Large Breakup by Category: Generic Drugs Innovator Drugs Biologic Drugs Biosimilars Medical Devices Therapeutic Diagnostic Others Breakup by Indication: Oncology Neurology Cardiology Immunology Others Breakup by Stage: Preclinical Clinical PMA (Post Market Authorization) Breakup by End User: Medical Device Companies Pharmaceutical Companies Biotechnology Companies Breakup by Region: North America United States Canada Asia Pacific China Japan India South Korea Australia Indonesia Others Europe Germany France United Kingdom Italy Spain Russia Others Latin America Brazil Mexico Others Middle East and Africa Competitive Landscape: The competitive landscape of the industry has also been examined along with the profiles of the key players being Charles River Laboratories International, Inc., Covance Inc (Laboratory Corporation of America Holdings), Freyr, ICON Plc, Medpace Holdings Inc., Parexel International Corporation, Pharmaceutical Product Development LLC, Promedica International- A California Corporation and Wuxi AppTec Co. Ltd.Key Questions Answered in This Report: How has the global regulatory affairs outsourcing market performed so far and how will it perform in the coming years? What has been the impact of COVID-19 on the global regulatory affairs outsourcing market? What are the key regional markets? What is the breakup of the market based on the services? What is the breakup of the market based on the company size? What is the breakup of the market based on the category? What is the breakup of the market based on the indication? What is the breakup of the market based on the stage? What is the breakup of the market based on the end user? What are the various stages in the value chain of the industry? What are the key driving factors and challenges in the industry? What is the structure of the global regulatory affairs outsourcing market and who are the key players? What is the degree of competition in the industry? 目次1 Preface2 Scope and Methodology 2.1 Objectives of the Study 2.2 Stakeholders 2.3 Data Sources 2.3.1 Primary Sources 2.3.2 Secondary Sources 2.4 Market Estimation 2.4.1 Bottom-Up Approach 2.4.2 Top-Down Approach 2.5 Forecasting Methodology 3 Executive Summary 4 Introduction 4.1 Overview 4.2 Key Industry Trends 5 Global Regulatory Affairs Outsourcing Market 5.1 Market Overview 5.2 Market Performance 5.3 Impact of COVID-19 5.4 Market Forecast 6 Market Breakup by Services 6.1 Regulatory Consulting 6.1.1 Market Trends 6.1.2 Market Forecast 6.2 Legal Representation 6.2.1 Market Trends 6.2.2 Market Forecast 6.3 Regulatory Writing and Publishing 6.3.1 Market Trends 6.3.2 Market Forecast 6.4 Product Registration and Clinical Trial Applications 6.4.1 Market Trends 6.4.2 Market Forecast 6.5 Others 6.5.1 Market Trends 6.5.2 Market Forecast 7 Market Breakup by Company Size 7.1 Small 7.1.1 Market Trends 7.1.2 Market Forecast 7.2 Medium 7.2.1 Market Trends 7.2.2 Market Forecast 7.3 Large 7.3.1 Market Trends 7.3.2 Market Forecast 8 Market Breakup by Category 8.1 Generic Drugs 8.1.1 Market Trends 8.1.2 Market Forecast 8.2 Innovator Drugs 8.2.1 Market Trends 8.2.2 Market Forecast 8.3 Biologic Drugs 8.3.1 Market Trends 8.3.2 Market Forecast 8.4 Biosimilars 8.4.1 Market Trends 8.4.2 Market Forecast 8.5 Medical Devices 8.5.1 Market Trends 8.5.2 Major Types 8.5.2.1 Therapeutic 8.5.2.2 Diagnostic 8.5.3 Market Forecast 8.6 Others 8.6.1 Market Trends 8.6.2 Market Forecast 9 Market Breakup by Indication 9.1 Oncology 9.1.1 Market Trends 9.1.2 Market Forecast 9.2 Neurology 9.2.1 Market Trends 9.2.2 Market Forecast 9.3 Cardiology 9.3.1 Market Trends 9.3.2 Market Forecast 9.4 Immunology 9.4.1 Market Trends 9.4.2 Market Forecast 9.5 Others 9.5.1 Market Trends 9.5.2 Market Forecast 10 Market Breakup by Stage 10.1 Preclinical 10.1.1 Market Trends 10.1.2 Market Forecast 10.2 Clinical 10.2.1 Market Trends 10.2.2 Market Forecast 10.3 PMA (Post Market Authorization) 10.3.1 Market Trends 10.3.2 Market Forecast 11 Market Breakup by End User 11.1 Medical Device Companies 11.1.1 Market Trends 11.1.2 Market Forecast 11.2 Pharmaceutical Companies 11.2.1 Market Trends 11.2.2 Market Forecast 11.3 Biotechnology Companies 11.3.1 Market Trends 11.3.2 Market Forecast 12 Market Breakup by Region 12.1 North America 12.1.1 United States 12.1.1.1 Market Trends 12.1.1.2 Market Forecast 12.1.2 Canada 12.1.2.1 Market Trends 12.1.2.2 Market Forecast 12.2 Asia-Pacific 12.2.1 China 12.2.1.1 Market Trends 12.2.1.2 Market Forecast 12.2.2 Japan 12.2.2.1 Market Trends 12.2.2.2 Market Forecast 12.2.3 India 12.2.3.1 Market Trends 12.2.3.2 Market Forecast 12.2.4 South Korea 12.2.4.1 Market Trends 12.2.4.2 Market Forecast 12.2.5 Australia 12.2.5.1 Market Trends 12.2.5.2 Market Forecast 12.2.6 Indonesia 12.2.6.1 Market Trends 12.2.6.2 Market Forecast 12.2.7 Others 12.2.7.1 Market Trends 12.2.7.2 Market Forecast 12.3 Europe 12.3.1 Germany 12.3.1.1 Market Trends 12.3.1.2 Market Forecast 12.3.2 France 12.3.2.1 Market Trends 12.3.2.2 Market Forecast 12.3.3 United Kingdom 12.3.3.1 Market Trends 12.3.3.2 Market Forecast 12.3.4 Italy 12.3.4.1 Market Trends 12.3.4.2 Market Forecast 12.3.5 Spain 12.3.5.1 Market Trends 12.3.5.2 Market Forecast 12.3.6 Russia 12.3.6.1 Market Trends 12.3.6.2 Market Forecast 12.3.7 Others 12.3.7.1 Market Trends 12.3.7.2 Market Forecast 12.4 Latin America 12.4.1 Brazil 12.4.1.1 Market Trends 12.4.1.2 Market Forecast 12.4.2 Mexico 12.4.2.1 Market Trends 12.4.2.2 Market Forecast 12.4.3 Others 12.4.3.1 Market Trends 12.4.3.2 Market Forecast 12.5 Middle East and Africa 12.5.1 Market Trends 12.5.2 Market Breakup by Country 12.5.3 Market Forecast 13 SWOT Analysis 13.1 Overview 13.2 Strengths 13.3 Weaknesses 13.4 Opportunities 13.5 Threats 14 Value Chain Analysis 15 Porters Five Forces Analysis 15.1 Overview 15.2 Bargaining Power of Buyers 15.3 Bargaining Power of Suppliers 15.4 Degree of Competition 15.5 Threat of New Entrants 15.6 Threat of Substitutes 16 Price Analysis 17 Competitive Landscape 17.1 Market Structure 17.2 Key Players 17.3 Profiles of Key Players 17.3.1 Charles River Laboratories International Inc. 17.3.1.1 Company Overview 17.3.1.2 Product Portfolio 17.3.1.3 Financials 17.3.1.4 SWOT Analysis 17.3.2 Covance Inc (Laboratory Corporation of America Holdings) 17.3.2.1 Company Overview 17.3.2.2 Product Portfolio 17.3.2.3 SWOT Analysis 17.3.3 Freyr 17.3.3.1 Company Overview 17.3.3.2 Product Portfolio 17.3.4 ICON Plc 17.3.4.1 Company Overview 17.3.4.2 Product Portfolio 17.3.4.3 Financials 17.3.4.4 SWOT Analysis 17.3.5 Medpace Holdings Inc 17.3.5.1 Company Overview 17.3.5.2 Product Portfolio 17.3.5.3 Financials 17.3.5.4 SWOT Analysis 17.3.6 Parexel International Corporation 17.3.6.1 Company Overview 17.3.6.2 Product Portfolio 17.3.6.3 SWOT Analysis 17.3.7 Pharmaceutical Product Development LLC 17.3.7.1 Company Overview 17.3.7.2 Product Portfolio 17.3.7.3 Financials 17.3.7.4 SWOT Analysis 17.3.8 Promedica International- A California Corporation 17.3.8.1 Company Overview 17.3.8.2 Product Portfolio 17.3.9 Wuxi AppTec Co. Ltd. 17.3.9.1 Company Overview 17.3.9.2 Product Portfolio
SummaryThe global regulatory affairs outsourcing market grew at a CAGR of around 10% during 2015-2020. Looking forward, IMARC Group expects the market to exhibit strong growth during 2021-2026. Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic on different end use sectors. These insights are included in the report as a major market contributor.Regulatory affairs outsourcing refers to the hiring of third-party services by the government bodies and private organizations to ensure public health and safety. The services include managing regulatory requirements for generic drugs, innovator drugs, biologics, biosimilars, etc. The outsourcing organizations control the safety and efficacy of the products and ensure that they are safe for consumption. These services are required for clinical trial and patent application, regulatory writing and publishing, product registration and legal representation. Pharmaceutical organizations also opt for these services to seek speedy government approvals in various regions. Significant growth in the pharmaceutical and biotechnological industries across the globe represents one of the key factors creating a positive outlook for the market. Furthermore, the increasing emphasis of pharmaceutical organizations to expand their operations and supplies in the emerging economies is also driving the market growth. Outsourcing regulatory affairs also aid in minimizing the costs associated with managing in-house resources, such as facilities, training, technology, specialized knowledge and geographic regulations. Additionally, regulatory affairs outsourcing services are also widely used for the development of biosimilar, orphan and generic drugs, which is acting as another major growth-inducing factor. Life science organizations are increasingly outsourcing non-core functions and regulatory services and increase their overall operational efficiencies, which, in turn, is contributing to the market growth. Other factors, including significant improvements in the healthcare infrastructure, along with extensive research and development (R&D) activities, are anticipated to drive the market further. Key Market Segmentation: IMARC Group provides an analysis of the key trends in each sub-segment of the global regulatory affairs outsourcing market, along with forecasts at the global, regional and country level from 2021-2026. Our report has categorized the market based on services, company size, category, indication, stage and end user. Breakup by Services: Regulatory Consulting Legal Representation Regulatory Writing and Publishing Product Registration and Clinical Trial Applications Others Breakup by Company Size: Small Medium Large Breakup by Category: Generic Drugs Innovator Drugs Biologic Drugs Biosimilars Medical Devices Therapeutic Diagnostic Others Breakup by Indication: Oncology Neurology Cardiology Immunology Others Breakup by Stage: Preclinical Clinical PMA (Post Market Authorization) Breakup by End User: Medical Device Companies Pharmaceutical Companies Biotechnology Companies Breakup by Region: North America United States Canada Asia Pacific China Japan India South Korea Australia Indonesia Others Europe Germany France United Kingdom Italy Spain Russia Others Latin America Brazil Mexico Others Middle East and Africa Competitive Landscape: The competitive landscape of the industry has also been examined along with the profiles of the key players being Charles River Laboratories International, Inc., Covance Inc (Laboratory Corporation of America Holdings), Freyr, ICON Plc, Medpace Holdings Inc., Parexel International Corporation, Pharmaceutical Product Development LLC, Promedica International- A California Corporation and Wuxi AppTec Co. Ltd.Key Questions Answered in This Report: How has the global regulatory affairs outsourcing market performed so far and how will it perform in the coming years? What has been the impact of COVID-19 on the global regulatory affairs outsourcing market? What are the key regional markets? What is the breakup of the market based on the services? What is the breakup of the market based on the company size? What is the breakup of the market based on the category? What is the breakup of the market based on the indication? What is the breakup of the market based on the stage? What is the breakup of the market based on the end user? What are the various stages in the value chain of the industry? What are the key driving factors and challenges in the industry? What is the structure of the global regulatory affairs outsourcing market and who are the key players? What is the degree of competition in the industry? Table of Contents1 Preface2 Scope and Methodology 2.1 Objectives of the Study 2.2 Stakeholders 2.3 Data Sources 2.3.1 Primary Sources 2.3.2 Secondary Sources 2.4 Market Estimation 2.4.1 Bottom-Up Approach 2.4.2 Top-Down Approach 2.5 Forecasting Methodology 3 Executive Summary 4 Introduction 4.1 Overview 4.2 Key Industry Trends 5 Global Regulatory Affairs Outsourcing Market 5.1 Market Overview 5.2 Market Performance 5.3 Impact of COVID-19 5.4 Market Forecast 6 Market Breakup by Services 6.1 Regulatory Consulting 6.1.1 Market Trends 6.1.2 Market Forecast 6.2 Legal Representation 6.2.1 Market Trends 6.2.2 Market Forecast 6.3 Regulatory Writing and Publishing 6.3.1 Market Trends 6.3.2 Market Forecast 6.4 Product Registration and Clinical Trial Applications 6.4.1 Market Trends 6.4.2 Market Forecast 6.5 Others 6.5.1 Market Trends 6.5.2 Market Forecast 7 Market Breakup by Company Size 7.1 Small 7.1.1 Market Trends 7.1.2 Market Forecast 7.2 Medium 7.2.1 Market Trends 7.2.2 Market Forecast 7.3 Large 7.3.1 Market Trends 7.3.2 Market Forecast 8 Market Breakup by Category 8.1 Generic Drugs 8.1.1 Market Trends 8.1.2 Market Forecast 8.2 Innovator Drugs 8.2.1 Market Trends 8.2.2 Market Forecast 8.3 Biologic Drugs 8.3.1 Market Trends 8.3.2 Market Forecast 8.4 Biosimilars 8.4.1 Market Trends 8.4.2 Market Forecast 8.5 Medical Devices 8.5.1 Market Trends 8.5.2 Major Types 8.5.2.1 Therapeutic 8.5.2.2 Diagnostic 8.5.3 Market Forecast 8.6 Others 8.6.1 Market Trends 8.6.2 Market Forecast 9 Market Breakup by Indication 9.1 Oncology 9.1.1 Market Trends 9.1.2 Market Forecast 9.2 Neurology 9.2.1 Market Trends 9.2.2 Market Forecast 9.3 Cardiology 9.3.1 Market Trends 9.3.2 Market Forecast 9.4 Immunology 9.4.1 Market Trends 9.4.2 Market Forecast 9.5 Others 9.5.1 Market Trends 9.5.2 Market Forecast 10 Market Breakup by Stage 10.1 Preclinical 10.1.1 Market Trends 10.1.2 Market Forecast 10.2 Clinical 10.2.1 Market Trends 10.2.2 Market Forecast 10.3 PMA (Post Market Authorization) 10.3.1 Market Trends 10.3.2 Market Forecast 11 Market Breakup by End User 11.1 Medical Device Companies 11.1.1 Market Trends 11.1.2 Market Forecast 11.2 Pharmaceutical Companies 11.2.1 Market Trends 11.2.2 Market Forecast 11.3 Biotechnology Companies 11.3.1 Market Trends 11.3.2 Market Forecast 12 Market Breakup by Region 12.1 North America 12.1.1 United States 12.1.1.1 Market Trends 12.1.1.2 Market Forecast 12.1.2 Canada 12.1.2.1 Market Trends 12.1.2.2 Market Forecast 12.2 Asia-Pacific 12.2.1 China 12.2.1.1 Market Trends 12.2.1.2 Market Forecast 12.2.2 Japan 12.2.2.1 Market Trends 12.2.2.2 Market Forecast 12.2.3 India 12.2.3.1 Market Trends 12.2.3.2 Market Forecast 12.2.4 South Korea 12.2.4.1 Market Trends 12.2.4.2 Market Forecast 12.2.5 Australia 12.2.5.1 Market Trends 12.2.5.2 Market Forecast 12.2.6 Indonesia 12.2.6.1 Market Trends 12.2.6.2 Market Forecast 12.2.7 Others 12.2.7.1 Market Trends 12.2.7.2 Market Forecast 12.3 Europe 12.3.1 Germany 12.3.1.1 Market Trends 12.3.1.2 Market Forecast 12.3.2 France 12.3.2.1 Market Trends 12.3.2.2 Market Forecast 12.3.3 United Kingdom 12.3.3.1 Market Trends 12.3.3.2 Market Forecast 12.3.4 Italy 12.3.4.1 Market Trends 12.3.4.2 Market Forecast 12.3.5 Spain 12.3.5.1 Market Trends 12.3.5.2 Market Forecast 12.3.6 Russia 12.3.6.1 Market Trends 12.3.6.2 Market Forecast 12.3.7 Others 12.3.7.1 Market Trends 12.3.7.2 Market Forecast 12.4 Latin America 12.4.1 Brazil 12.4.1.1 Market Trends 12.4.1.2 Market Forecast 12.4.2 Mexico 12.4.2.1 Market Trends 12.4.2.2 Market Forecast 12.4.3 Others 12.4.3.1 Market Trends 12.4.3.2 Market Forecast 12.5 Middle East and Africa 12.5.1 Market Trends 12.5.2 Market Breakup by Country 12.5.3 Market Forecast 13 SWOT Analysis 13.1 Overview 13.2 Strengths 13.3 Weaknesses 13.4 Opportunities 13.5 Threats 14 Value Chain Analysis 15 Porters Five Forces Analysis 15.1 Overview 15.2 Bargaining Power of Buyers 15.3 Bargaining Power of Suppliers 15.4 Degree of Competition 15.5 Threat of New Entrants 15.6 Threat of Substitutes 16 Price Analysis 17 Competitive Landscape 17.1 Market Structure 17.2 Key Players 17.3 Profiles of Key Players 17.3.1 Charles River Laboratories International Inc. 17.3.1.1 Company Overview 17.3.1.2 Product Portfolio 17.3.1.3 Financials 17.3.1.4 SWOT Analysis 17.3.2 Covance Inc (Laboratory Corporation of America Holdings) 17.3.2.1 Company Overview 17.3.2.2 Product Portfolio 17.3.2.3 SWOT Analysis 17.3.3 Freyr 17.3.3.1 Company Overview 17.3.3.2 Product Portfolio 17.3.4 ICON Plc 17.3.4.1 Company Overview 17.3.4.2 Product Portfolio 17.3.4.3 Financials 17.3.4.4 SWOT Analysis 17.3.5 Medpace Holdings Inc 17.3.5.1 Company Overview 17.3.5.2 Product Portfolio 17.3.5.3 Financials 17.3.5.4 SWOT Analysis 17.3.6 Parexel International Corporation 17.3.6.1 Company Overview 17.3.6.2 Product Portfolio 17.3.6.3 SWOT Analysis 17.3.7 Pharmaceutical Product Development LLC 17.3.7.1 Company Overview 17.3.7.2 Product Portfolio 17.3.7.3 Financials 17.3.7.4 SWOT Analysis 17.3.8 Promedica International- A California Corporation 17.3.8.1 Company Overview 17.3.8.2 Product Portfolio 17.3.9 Wuxi AppTec Co. Ltd. 17.3.9.1 Company Overview 17.3.9.2 Product Portfolio
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