世界の規制関連業務（RA）市場は、2020年には約118億米ドルとなり、2021年から2027年の予測期間には8.4%以上の健全な成長率が見込まれています。規制関連業務は、ガバメントアフェアーズとも呼ばれ、医薬品、エネルギー、医療機器、銀行などの規制産業における専門職です。世界の規制関連業務市場は、画期的な医薬品や機器の迅速な承認プロセスへの要求、個別化医療、バイオシミラー、希少疾病用医薬品などの新興分野の成長によって牽引されています。さらに、ライフサイエンス企業が自社のコアコンピタンスに集中し、経済的・競争的な圧力を受けることで、世界の薬事産業に新たな機会がもたらされるでしょう。例えば、2018年に発表されたSteve Gens Reportによると、調査対象となった製薬企業の約58%が自社のレギュラトリーインテリジェンス（RI）能力の強化を計画していたこと、また別の調査では、参加企業22社のうち約20社がRIデータを活用する処理活動としてAIを検討していたことが明らかになっています。このように、企業によるAIやRIの導入が進むことは、今後の規制関連業務業界の起爆剤になると考えられます。しかし、データのセキュリティやモニタリングの問題に関連するリスクや標準化の欠如が、2021年から2027年の予測期間における市場の成長を妨げる可能性があります。
世界の規制関連業務の地域別分析では、アジア太平洋地域、北アメリカ、ヨーロッパ、ラテンアメリカ、その他の地域が主な対象となっています。アウトソーシングコストの低さ、技術的な専門知識を持つ熟練した人材の存在、税制上の優遇措置、ヘルスケア企業の拡大などにより、アジア太平洋地域は市場シェアで世界の主要地域となっています。また、アジア太平洋地域は、規制面での支援体制が整っていることから、2021年から2027年の予測期間中に最も高い成長率を示すと予想されています。
この調査の目的は、近年のさまざまなセグメントおよび国々の市場規模を定義し、今後8年間の価値を予測することです。本レポートは、調査対象となる各地域・国における産業の質的・量的側面を取り込むように設計されています。さらに、市場の今後の成長を決定づける推進要因や課題などの重要な側面に関する詳細情報も提供しています。さらに、主要企業の競合状況や製品提供の詳細な分析とともに、利害関係者が投資するミクロ市場での機会についても報告します。
目次
Chapter 1. Executive Summary
1.1. Market Snapshot
1.2. Global & Segmental Market Estimates & Forecasts, 2019-2027 (USD Billion)
1.2.1. Regulatory Affairs Market , by Region, 2019-2027 (USD Billion)
1.2.2. Regulatory Affairs Market , by Service, 2019-2027 (USD Billion)
1.2.3. Regulatory Affairs Market , by Category , 2019-2027 (USD Billion)
1.2.4. Regulatory Affairs Market , by Indication, 2019-2027 (USD Billion)
1.2.5. Regulatory Affairs Market , by Product stage, 2019-2027 (USD Billion)
1.2.6. Regulatory Affairs Market , by End Use, 2019-2027 (USD Billion)
1.2.7. Regulatory Affairs Market , by company size, 2019-2027 (USD Billion)
1.2.8.
1.3. Key Trends
1.4. Estimation Methodology
1.5. Research Assumption
Chapter 2. Global Regulatory Affairs Market Definition and Scope
2.1. Objective of the Study
2.2. Market Definition & Scope
2.2.1. Scope of the Study
2.2.2. Industry Evolution
2.3. Years Considered for the Study
2.4. Currency Conversion Rates
Chapter 3. Global Regulatory Affairs Market Dynamics
3.1. Regulatory Affairs Market Impact Analysis (2019-2027)
3.1.1. Market Drivers
3.1.1.1. Demand for faster approval process for breakthrough drugs and devices
3.1.1.2. Growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs
3.1.2. Market Restraint
3.1.2.1. Risk associated with data security
3.1.2.2. Monitoring issues and lack of standardization
3.1.3. Market Opportunities
3.1.3.1. Life science companies focusing on their core competencies
3.1.3.2. Economic and competitive pressures
Chapter 4. Global Regulatory Affairs Market Industry Analysis
4.1. Porter’s 5 Force Model
4.1.1. Bargaining Power of Suppliers
4.1.2. Bargaining Power of Buyers
4.1.3. Threat of New Entrants
4.1.4. Threat of Substitutes
4.1.5. Competitive Rivalry
4.1.6. Futuristic Approach to Porter’s 5 Force Model (2018-2027)
4.2. PEST Analysis
4.2.1. Political
4.2.2. Economical
4.2.3. Social
4.2.4. Technological
4.3. Investment Adoption Model
4.4. Analyst Recommendation & Conclusion
Chapter 5. Global Regulatory Affairs Market , by Service
5.1. Market Snapshot
5.2. Global Regulatory Affairs Market by Service, Performance - Potential Analysis
5.3. Global Regulatory Affairs Market Estimates & Forecasts by Service 2018-2027 (USD Billion)
5.4. Regulatory Affairs Market , Sub Segment Analysis
5.4.1. Regulatory consulting
5.4.2. Legal representation
5.4.3. Regulatory writing & publishing
5.4.4. Product registration & clinical trial applications
5.4.5. Other services
Chapter 6. Global Regulatory Affairs Market , by Category
a. Market Snapshot
6.1. Global Regulatory Affairs Market by Category, Performance - Potential Analysis
6.2. Global Regulatory Affairs Market Estimates & Forecasts by Category 2018-2027 (USD Billion)
6.3. Regulatory Affairs Market , Sub Segment Analysis
6.3.1. Drugs
6.3.2. Biologics
6.3.3. Medical Devices
Chapter 7. Global Regulatory Affairs Market , by Indication
b. Market Snapshot
7.1. Global Regulatory Affairs Market by Indication, Performance - Potential Analysis
7.2. Global Regulatory Affairs Market Estimates & Forecasts by Indication 2018-2027 (USD Billion)
7.3. Regulatory Affairs Market , Sub Segment Analysis
7.3.1. Oncology
7.3.2. Neurology
7.3.3. Cardiology
7.3.4. Immunology
7.3.5. Other Indications
Chapter 8. Global Regulatory Affairs Market , by Product stage
c. Market Snapshot
8.1. Global Regulatory Affairs Market by Product stage, Performance - Potential Analysis
8.2. Global Regulatory Affairs Market Estimates & Forecasts by product stage 2018-2027 (USD Billion)
8.3. Regulatory Affairs Market , Sub Segment Analysis
8.3.1. Preclinical
8.3.2. Clinical
8.3.3. PMA
Chapter 9. Global Regulatory Affairs Market , by End use
d. Market Snapshot
9.1. Global Regulatory Affairs Market by Product stage, Performance - Potential Analysis
9.2. Global Regulatory Affairs Market Estimates & Forecasts by product stage 2018-2027 (USD Billion)
9.3. Regulatory Affairs Market , Sub Segment Analysis
9.3.1. Medical Device Companies
9.3.2. Biotechnology Companies
9.3.3. Pharmaceutical Companies
Chapter 10. Global Regulatory Affairs Market , by Company size
e. Market Snapshot
10.1. Global Regulatory Affairs Market by Product stage, Performance - Potential Analysis
10.2. Global Regulatory Affairs Market Estimates & Forecasts by product stage 2018-2027 (USD Billion)
10.3. Regulatory Affairs Market , Sub Segment Analysis
10.3.1. Small
10.3.2. Medium
10.3.3. Large
Pharmaceutical Companies
Chapter 11. Global Regulatory Affairs Market , Regional Analysis
11.1. Regulatory Affairs Market , Regional Market Snapshot
11.2. North America Regulatory Affairs Market
11.2.1. U.S. Regulatory Affairs Market
11.2.1.1. Service breakdown estimates & forecasts, 2018-2027
11.2.1.2. Category breakdown estimates & forecasts, 2018-2027
11.2.1.3. Indication breakdown estimates & forecasts, 2018-2027
11.2.1.4. Product stage breakdown estimates & forecasts, 2018-2027 (USD Billion)
11.2.1.5. End Use breakdown estimates & forecasts, 2018-2027 (USD Billion)
11.2.1.6. Company Size breakdown estimates & forecasts, 2018-2027 (USD Billion)
11.2.2. Canada Regulatory Affairs Market
11.3. Europe Regulatory Affairs Market Snapshot
11.3.1. U.K. Regulatory Affairs Market
11.3.2. Germany Regulatory Affairs Market
11.3.3. France Regulatory Affairs Market
11.3.4. Spain Regulatory Affairs Market
11.3.5. Italy Regulatory Affairs Market
11.3.6. Rest of Europe Regulatory Affairs Market
11.4. Asia-Pacific Regulatory Affairs Market Snapshot
11.4.1. China Regulatory Affairs Market
11.4.2. India Regulatory Affairs Market
11.4.3. Japan Regulatory Affairs Market
11.4.4. Australia Regulatory Affairs Market
11.4.5. South Korea Regulatory Affairs Market
11.4.6. Rest of Asia Pacific Regulatory Affairs Market
11.5. Latin America Regulatory Affairs Market Snapshot
11.5.1. Brazil Regulatory Affairs Market
11.5.2. Mexico Regulatory Affairs Market
11.6. Rest of The World Regulatory Affairs Market
Chapter 12. Competitive Intelligence
12.1. Top Market Strategies
12.2. Company Profiles
12.2.1. Accell Clinical Research, LLC.
12.2.1.1. Key Information
12.2.1.2. Overview
12.2.1.3. Financial (Subject to Data Availability)
12.2.1.4. Product Summary
12.2.1.5. Recent Developments
12.2.2. GenPact Ltd.
12.2.3. Criterium, Inc.
12.2.4. PRA Health Sciences
12.2.5. Promedica International
12.2.6. WuXi AppTec, Inc.
12.2.7. Medpace
12.2.8. Charles River Laboratories International, Inc.
12.2.9. ICON plc
12.2.10. Covance
Chapter 13. Research Process
13.1. Research Process
13.1.1. Data Mining
13.1.2. Analysis
13.1.3. Market Estimation
13.1.4. Validation
13.1.5. Publishing
13.2. Research Attributes
13.3. Research Assumption
List of Tables
TABLE 2. Global Regulatory Affairs Market , report scope
TABLE 3. Global Regulatory Affairs Market estimates & forecasts by region 2018-2027 (USD Billion)
TABLE 4. Global Regulatory Affairs Market estimates & forecasts by Service 2018-2027 (USD Billion)
TABLE 5. Global Regulatory Affairs Market estimates & forecasts by Catagory 2018-2027 (USD Billion)
TABLE 6. Global Regulatory Affairs Market estimates & forecasts by Indication 2018-2027 (USD Billion)
TABLE 7. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 8. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 9. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 10. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 11. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 12. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 13. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 14. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 15. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 16. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 17. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 18. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 19. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 20. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 21. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 22. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 23. U.S. Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 24. U.S. Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 25. U.S. Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 26. Canada Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 27. Canada Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 28. Canada Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 29. UK Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 30. UK Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 31. UK Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 32. Germany Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 33. Germany Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 34. Germany Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 35. France Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 36. France Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 37. France Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 38. Spain Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 39. Spain Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 40. Spain Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 41. Italy Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 42. Italy Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 43. Italy Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 44. ROE Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 45. ROE Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 46. ROE Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 47. China Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 48. China Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 49. China Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 50. India Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 51. India Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 52. India Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 53. Japan Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 54. Japan Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 55. Japan Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 56. Australia Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 57. Australia Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 58. Australia Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 59. South Korea Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 60. South Korea Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 61. South Korea Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 62. ROPAC Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 63. ROPAC Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 64. ROPAC Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 65. Brazil Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 66. Brazil Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 67. Brazil Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 68. Mexico Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 69. Mexico Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 70. Mexico Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 71. ROLA Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 72. ROLA Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 73. ROLA Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 74. ROW Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 75. ROW Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 76. ROW Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 77. List of secondary sources used in the study of global Regulatory Affairs Market .
TABLE 78. List of primary sources used in the study of global Regulatory Affairs Market .
TABLE 79. Years considered for the study.
TABLE 80. Exchange rates considered.
List of figures
FIG 1. Global Regulatory Affairs Market , research methodology
FIG 2. Global Regulatory Affairs Market , market estimation techniques
FIG 3. Global market size estimates & forecast methods
FIG 4. Global Regulatory Affairs Market , key trends 2020
FIG 5. Global Regulatory Affairs Market , growth prospects 2021-2027
FIG 6. Global Regulatory Affairs Market , porters 5 force model
FIG 7. Global Regulatory Affairs Market , pest analysis
FIG 8. Global Regulatory Affairs Market , value chain analysis
FIG 9. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 10. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 11. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 12. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 13. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 14. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 15. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 16. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 17. Global Regulatory Affairs Market , regional snapshot 2018 & 2027
FIG 18. North America Regulatory Affairs Market 2018 & 2027 (USD Billion)
FIG 19. Europe Regulatory Affairs Market 2018 & 2027 (USD Billion)
FIG 20. Asia-Pacific Regulatory Affairs Market 2018 & 2027 (USD Billion)
FIG 21. Latin America Regulatory Affairs Market 2018 & 2027 (USD Billion)
FIG 22. Global Regulatory Affairs Market , company market share analysis (2020)
