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レポート概要
| 360iResearch社は、2021年に129.1億ドルであった世界の薬事申請（RA）市場規模が、2022年には142.0億ドルに成長し、その後年平均10.21％拡大して2027年には231.5億ドルに達すると予測しています。本調査資料では、薬事申請（RA）の世界市場について総合的に調査・分析し、序論、調査方法、エグゼクティブサマリー、市場概要、市場インサイト、サービス別（法定代理人、製品登録＆臨床試験申請、規制コンサルティング、規制関連執筆＆出版）分析、疾患別（心臓病、免疫疾患、神経内科、腫瘍）分析、段階別（臨床研究、前臨床）分析、最終用途別（バイオテクノロジー会社、医療機器会社、製薬会社）分析、地域別（南北アメリカ、アメリカ、カナダ、ブラジル、アジア太平洋、日本、中国、インド、韓国、台湾、ヨーロッパ/中東/アフリカ、イギリス、ドイツ、フランス、ロシア、その他）分析、競争状況、企業情報などの内容をまとめました。なお、本書内の企業情報には、Accell Clinical Research, LLC、APCER Life Sciences, Inc.、BlueReg Group、Cambridge Regulatory Services、Certara, L.P.、Charles River Laboratories, Inc.、Clinilabs Inc.、Covance, Inc.、Criterium Inc.、Freyr Solutions、Genpact Ltd.、ICON PLC、IQVIA Holdings Inc.などが含まれています。 ・序論 ・調査方法 ・エグゼクティブサマリー ・市場概要 ・市場インサイト ・世界の薬事申請（RA）市場規模：サービス別 - 法定代理人の市場規模 - 製品登録＆臨床試験申請の市場規模 - 規制コンサルティングの市場規模 - 規制関連執筆＆出版の市場規模 ・世界の薬事申請（RA）市場規模：疾患別 - 心臓病における市場規模 - 免疫疾患における市場規模 - 神経内科における市場規模 - 腫瘍における市場規模 ・世界の薬事申請（RA）市場規模：段階別 - 臨床研究の市場規模 - 前臨床の市場規模 ・世界の薬事申請（RA）市場規模：最終用途別 - バイオテクノロジー会社における市場規模 - 医療機器会社における市場規模 - 製薬会社における市場規模 ・世界の薬事申請（RA）市場規模：地域別 - 南北アメリカの薬事申請（RA）市場規模 アメリカの薬事申請（RA）市場規模 カナダの薬事申請（RA）市場規模 ブラジルの薬事申請（RA）市場規模 ... - アジア太平洋の薬事申請（RA）市場規模 日本の薬事申請（RA）市場規模 中国の薬事申請（RA）市場規模 インドの薬事申請（RA）市場規模 韓国の薬事申請（RA）市場規模 台湾の薬事申請（RA）市場規模 ... - ヨーロッパ/中東/アフリカの薬事申請（RA）市場規模 イギリスの薬事申請（RA）市場規模 ドイツの薬事申請（RA）市場規模 フランスの薬事申請（RA）市場規模 ロシアの薬事申請（RA）市場規模 ... - その他地域の薬事申請（RA）市場規模 ・競争状況 ・企業情報 |
The Global Regulatory Affairs Market size was estimated at USD 12.91 billion in 2021 and expected to reach USD 14.20 billion in 2022, and is projected to grow at a CAGR 10.21% to reach USD 23.15 billion by 2027.
Market Statistics:
The report provides market sizing and forecast across 7 major currencies – USD, EUR, JPY, GBP, AUD, CAD, and CHF. It helps organization leaders make better decisions when currency exchange data is readily available. In this report, the years 2018 and 2020 are considered as historical years, 2021 as the base year, 2022 as the estimated year, and years from 2023 to 2027 are considered as the forecast period.
Market Segmentation & Coverage:
This research report categorizes the Regulatory Affairs to forecast the revenues and analyze the trends in each of the following sub-markets:
Based on Services, the market was studied across Legal Representation, Product Registration & Clinical Trial Applications, Regulatory Consulting, and Regulatory Writing & Publishing. The Regulatory Writing & Publishing is further studied across Publishing and Writing.
Based on Indication, the market was studied across Cardiology, Immunology, Neurology, and Oncology.
Based on Stage, the market was studied across Clinical Studies and Preclinical.
Based on Category, the market was studied across Advanced therapy Medicinal Products, Biologics, Drugs, and Medical Devices. The Biologics is further studied across Advanced Therapy Medicinal Products, Biosimilars, and Biotech. The Drugs is further studied across Generics and Innovator. The Medical Devices is further studied across Diagnostics and Therapeutics.
Based on Service Provider, the market was studied across In-house and Outsourced.
Based on Company Size, the market was studied across Large, Medium, and Small.
Based on End-use, the market was studied across Biotechnology Companies, Medical Device Companies, and Pharmaceutical Companies.
Based on Region, the market was studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
Cumulative Impact of COVID-19:
COVID-19 is an incomparable global public health emergency that has affected almost every industry, and the long-term effects are projected to impact the industry growth during the forecast period. Our ongoing research amplifies our research framework to ensure the inclusion of underlying COVID-19 issues and potential paths forward. The report delivers insights on COVID-19 considering the changes in consumer behavior and demand, purchasing patterns, re-routing of the supply chain, dynamics of current market forces, and the significant interventions of governments. The updated study provides insights, analysis, estimations, and forecasts, considering the COVID-19 impact on the market.
Cumulative Impact of 2022 Russia Ukraine Conflict:
We continuously monitor and update reports on political and economic uncertainty due to the Russian invasion of Ukraine. Negative impacts are significantly foreseen globally, especially across Eastern Europe, European Union, Eastern & Central Asia, and the United States. This contention has severely affected lives and livelihoods and represents far-reaching disruptions in trade dynamics. The potential effects of ongoing war and uncertainty in Eastern Europe are expected to have an adverse impact on the world economy, with especially long-term harsh effects on Russia.This report uncovers the impact of demand & supply, pricing variants, strategic uptake of vendors, and recommendations for Regulatory Affairs market considering the current update on the conflict and its global response.
Competitive Strategic Window:
The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period.
FPNV Positioning Matrix:
The FPNV Positioning Matrix evaluates and categorizes the vendors in the Regulatory Affairs Market based on Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.
Market Share Analysis:
The Market Share Analysis offers the analysis of vendors considering their contribution to the overall market. It provides the idea of its revenue generation into the overall market compared to other vendors in the space. It provides insights into how vendors are performing in terms of revenue generation and customer base compared to others. Knowing market share offers an idea of the size and competitiveness of the vendors for the base year. It reveals the market characteristics in terms of accumulation, fragmentation, dominance, and amalgamation traits.
Competitive Scenario:
The Competitive Scenario provides an outlook analysis of the various business growth strategies adopted by the vendors. The news covered in this section deliver valuable thoughts at the different stage while keeping up-to-date with the business and engage stakeholders in the economic debate. The competitive scenario represents press releases or news of the companies categorized into Merger & Acquisition, Agreement, Collaboration, & Partnership, New Product Launch & Enhancement, Investment & Funding, and Award, Recognition, & Expansion. All the news collected help vendor to understand the gaps in the marketplace and competitor’s strength and weakness thereby, providing insights to enhance product and service.
Company Usability Profiles:
The report profoundly explores the recent significant developments by the leading vendors and innovation profiles in the Global Regulatory Affairs Market, including Accell Clinical Research, LLC, APCER Life Sciences, Inc., BlueReg Group, Cambridge Regulatory Services, Certara, L.P., Charles River Laboratories, Inc., Clinilabs Inc., Covance, Inc., Criterium Inc., Freyr Solutions, Genpact Ltd., ICON PLC, IQVIA Holdings Inc., Medpace Inc., NDA Group AB, Parexel International Corporation, Pharmalex GMBH, PRA Health Sciences, Inc., Promedica International, Qvigilance, Voisin Consulting Life Sciences, WuXi AppTec Co. Ltd., and Zeincro Group.
The report provides insights on the following pointers:
1. Market Penetration: Provides comprehensive information on the market offered by the key players
2. Market Development: Provides in-depth information about lucrative emerging markets and analyze penetration across mature segments of the markets
3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments
4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, certification, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players
5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and breakthrough product developments
The report answers questions such as:
1. What is the market size and forecast of the Global Regulatory Affairs Market?
2. What are the inhibiting factors and impact of COVID-19 shaping the Global Regulatory Affairs Market during the forecast period?
3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Regulatory Affairs Market?
4. What is the competitive strategic window for opportunities in the Global Regulatory Affairs Market?
5. What are the technology trends and regulatory frameworks in the Global Regulatory Affairs Market?
6. What is the market share of the leading vendors in the Global Regulatory Affairs Market?
7. What modes and strategic moves are considered suitable for entering the Global Regulatory Affairs Market?
1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Limitations
1.7. Assumptions
1.8. Stakeholders
2. Research Methodology
2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Market Dynamics
5.1.1. Drivers
5.1.1.1. Significant growth in drug discovery and development worldwide
5.1.1.2. Changing governmental regulatory landscapes for healthcare sector
5.1.1.3. Rising prevalence of rare disorders and emergence of novel infectious diseases
5.1.2. Restraints
5.1.2.1. High cost of delivering regulatory services
5.1.3. Opportunities
5.1.3.1. Massive investments by the key market players for development of healthcare equipment
5.1.3.2. Increasing consumer preference for biologics and generic drugs
5.1.4. Challenges
5.1.4.1. Stringent governmental policies and regulations associated with regulatory affairs
5.2. Cumulative Impact of COVID-19
6. Regulatory Affairs Market, by Services
6.1. Introduction
6.2. Legal Representation
6.3. Product Registration & Clinical Trial Applications
6.4. Regulatory Consulting
6.5. Regulatory Writing & Publishing
6.6.1. Publishing
6.6.2. Writing
7. Regulatory Affairs Market, by Indication
7.1. Introduction
7.2. Cardiology
7.3. Immunology
7.4. Neurology
7.5. Oncology
8. Regulatory Affairs Market, by Stage
8.1. Introduction
8.2. Clinical Studies
8.3. Preclinical
9. Regulatory Affairs Market, by Category
9.1. Introduction
9.2. Advanced therapy Medicinal Products
9.3. Biologics
9.4.1. Advanced Therapy Medicinal Products
9.4.2. Biosimilars
9.4.3. Biotech
9.4. Drugs
9.5.1. Generics
9.5.2. Innovator
9.5. Medical Devices
9.6.1. Diagnostics
9.6.2. Therapeutics
10. Regulatory Affairs Market, by Service Provider
10.1. Introduction
10.2. In-house
10.3. Outsourced
11. Regulatory Affairs Market, by Company Size
11.1. Introduction
11.2. Large
11.3. Medium
11.4. Small
12. Regulatory Affairs Market, by End-use
12.1. Introduction
12.2. Biotechnology Companies
12.3. Medical Device Companies
12.4. Pharmaceutical Companies
13. Americas Regulatory Affairs Market
13.1. Introduction
13.2. Argentina
13.3. Brazil
13.4. Canada
13.5. Mexico
13.6. United States
14. Asia-Pacific Regulatory Affairs Market
14.1. Introduction
14.2. Australia
14.3. China
14.4. India
14.5. Indonesia
14.6. Japan
14.7. Malaysia
14.8. Philippines
14.9. Singapore
14.10. South Korea
14.11. Taiwan
14.12. Thailand
14.13. Vietnam
15. Europe, Middle East & Africa Regulatory Affairs Market
15.1. Introduction
15.2. Denmark
15.3. Egypt
15.4. Finland
15.5. France
15.6. Germany
15.7. Israel
15.8. Italy
15.9. Netherlands
15.10. Nigeria
15.11. Norway
15.12. Poland
15.13. Qatar
15.14. Russia
15.15. Saudi Arabia
15.16. South Africa
15.17. Spain
15.18. Sweden
15.19. Switzerland
15.20. Turkey
15.21. United Arab Emirates
15.22. United Kingdom
16. Competitive Landscape
16.1. FPNV Positioning Matrix
16.1.1. Quadrants
16.1.2. Business Strategy
16.1.3. Product Satisfaction
16.2. Market Ranking Analysis, By Key Player
16.3. Market Share Analysis, By Key Player
16.4. Competitive Scenario
16.4.1. Merger & Acquisition
16.4.2. Agreement, Collaboration, & Partnership
16.4.3. New Product Launch & Enhancement
16.4.4. Investment & Funding
16.4.5. Award, Recognition, & Expansion
17. Company Usability Profiles
17.1. Accell Clinical Research, LLC
17.1.1. Business Overview
17.1.2. Key Executives
17.1.3. Product & Services
17.2. APCER Life Sciences, Inc.
17.2.1. Business Overview
17.2.2. Key Executives
17.2.3. Product & Services
17.3. BlueReg Group
17.3.1. Business Overview
17.3.2. Key Executives
17.3.3. Product & Services
17.4. Cambridge Regulatory Services
17.4.1. Business Overview
17.4.2. Key Executives
17.4.3. Product & Services
17.5. Certara, L.P.
17.5.1. Business Overview
17.5.2. Key Executives
17.5.3. Product & Services
17.6. Charles River Laboratories, Inc.
17.6.1. Business Overview
17.6.2. Key Executives
17.6.3. Product & Services
17.7. Clinilabs Inc.
17.7.1. Business Overview
17.7.2. Key Executives
17.7.3. Product & Services
17.8. Covance, Inc.
17.8.1. Business Overview
17.8.2. Key Executives
17.8.3. Product & Services
17.9. Criterium Inc.
17.9.1. Business Overview
17.9.2. Key Executives
17.9.3. Product & Services
17.10. Freyr Solutions
17.10.1. Business Overview
17.10.2. Key Executives
17.10.3. Product & Services
17.11. Genpact Ltd.
17.11.1. Business Overview
17.11.2. Key Executives
17.11.3. Product & Services
17.12. ICON PLC
17.12.1. Business Overview
17.12.2. Key Executives
17.12.3. Product & Services
17.13. IQVIA Holdings Inc.
17.13.1. Business Overview
17.13.2. Key Executives
17.13.3. Product & Services
17.14. Medpace Inc.
17.14.1. Business Overview
17.14.2. Key Executives
17.14.3. Product & Services
17.15. NDA Group AB
17.15.1. Business Overview
17.15.2. Key Executives
17.15.3. Product & Services
17.16. Parexel International Corporation
17.16.1. Business Overview
17.16.2. Key Executives
17.16.3. Product & Services
17.17. Pharmalex GMBH
17.17.1. Business Overview
17.17.2. Key Executives
17.17.3. Product & Services
17.18. PRA Health Sciences, Inc.
17.18.1. Business Overview
17.18.2. Key Executives
17.18.3. Product & Services
17.19. Promedica International
17.19.1. Business Overview
17.19.2. Key Executives
17.19.3. Product & Services
17.20. Qvigilance
17.20.1. Business Overview
17.20.2. Key Executives
17.20.3. Product & Services
17.21. Voisin Consulting Life Sciences
17.21.1. Business Overview
17.21.2. Key Executives
17.21.3. Product & Services
17.22. WuXi AppTec Co. Ltd.
17.22.1. Business Overview
17.22.2. Key Executives
17.22.3. Product & Services
17.23. Zeincro Group
17.23.1. Business Overview
17.23.2. Key Executives
17.23.3. Product & Services
18. Appendix
18.1. Discussion Guide
18.2. License & Pricing