規制情報管理システム市場：機能、展開、用途別-2025～2030年の世界予測

規制情報管理システム市場は、2023年に22億7,000万米ドルと評価され、2024年には25億6,000万米ドルに達すると予測され、CAGR 13.54％で成長し、2030年には55億2,000万米ドルに達すると予測されています。

規制情報管理システム（RIMS）は、医薬品、バイオテクノロジー、医療などの産業向けに、薬事申請やコンプライアンスプロセスの管理を合理化するために設計されたデジタルソリューションです。世界のコンプライアンス基準との整合性を確保するために、規制データの追跡、管理、提出を網羅します。RIMSの必要性は、データ処理に正確性、効率性、適応性を要求する複雑で進化し続ける規制環境の性質から生じています。これらのシステムは、ライフサイエンスや医療機器産業を中心とする様々な最終用途部門に適用され、ワークフローの効率を高め、規制当局への提出におけるエラーを削減しています。市場洞察によると、医療のグローバリゼーションの進展、政府の厳しい規制、包括的な記録を維持するニーズの拡大により、RIMSに対する需要が急増しています。成長に影響を与える主要要因には、データ分析機能の強化、業務の合理化を実現する統合効率性を提供するAIやクラウドコンピューティングなどの技術的進歩が含まれます。新たな機会としては、eCTD（電子共通技術文書）提出の増加や規制枠組みのデジタル変革が挙げられます。こうした機会を活用するための企業への提言としては、堅牢なデータ統合ソリューションへの投資や、新技術に関するスタッフの教育を強化するための教育プログラムの拡充などが挙げられます。しかし、市場は高い導入コスト、システム更新の複雑さ、データセキュリティに関する懸念などの課題に直面しています。また、地域間で標準化されたプラクティスがないため、プロセスが複雑化する可能性もあります。技術革新が必要なセグメントには、コンプライアンス・リスク管理のためのAIを活用した予測分析、安全なデータ取引のためのブロックチェーン、部門横断的なコラボレーションを強化するためのユーザーインターフェース・デザインの強化などがあります。その結果、企業はこのダイナミックに進化する市場情勢の中で競合を維持するために、技術・パートナーシップに注力し、ポリシーシフトに遅れを取らないようにする必要があります。

市場力学：急速に進化する規制情報管理システム市場の主要市場洞察を公開

規制情報管理システム市場は、需要と供給のダイナミックな相互作用によって変貌を遂げています。このような市場力学の進化を理解することで、企業は十分な情報に基づいた投資決定、戦略的決定の精緻化、そして新たなビジネス機会の獲得に備えることができます。これらの動向を包括的に把握することで、企業は政治的、地理的、技術的、社会的、経済的な領域にわたる様々なリスクを軽減することができるとともに、消費者行動とそれが製造コストや購買動向に与える影響をより明確に理解することができます。

• 市場促進要因
  • 規制当局における業務のデジタル化
  • 医薬品、医療機器、食品、化粧品セクターにおける絶え間なく変化する規制環境
  • 迅速な薬事承認に対する消費者の需要
• 市場抑制要因
  • 規制当局の消極的な姿勢
• 市場機会
  • 医薬品、バイオテクノロジー、臨床研究に対する政府投資の増加
  • クラウドベースの規制情報管理システムの採用
• 市場課題
  • サイバー攻撃やデータ盗難に関するリスク

ポーターのファイブフォース：規制情報管理システム市場をナビゲートする戦略ツール

ポーターのファイブフォースフレームワークは、市場情勢の競合情勢を理解するための重要なツールです。ポーターのファイブフォースフレームワークは、企業の競合を評価し、戦略的機会を探るための明確な手法を記載しています。このフレームワークは、企業が市場内の勢力図を評価し、新規事業の収益性を判断するのに役立ちます。これら洞察により、企業は自社の強みを活かし、弱みに対処し、潜在的な課題を回避することができ、より強靭な市場でのポジショニングを確保することができます。

PESTLE分析：規制情報管理システム市場における外部からの影響の把握

外部マクロ環境要因は、規制情報管理システム市場の業績力学を形成する上で極めて重要な役割を果たします。政治的、経済的、社会的、技術的、法的、環境的要因の分析は、これらの影響をナビゲートするために必要な情報を記載しています。PESTLE要因を調査することで、企業は潜在的なリスクと機会をよりよく理解することができます。この分析により、企業は規制、消費者の嗜好、経済動向の変化を予測し、先を見越した積極的な意思決定を行う準備ができます。

市場シェア分析：規制情報管理システム市場における競合情勢の把握

規制情報管理システム市場の詳細な市場シェア分析により、ベンダーの業績を包括的に評価することができます。企業は、収益、顧客ベース、成長率などの主要指標を比較することで、競争上のポジショニングを明らかにすることができます。この分析により、市場の集中、セグメント化、統合の動向が明らかになり、ベンダーは競争が激化する中で自社の地位を高める戦略的意思決定を行うために必要な知見を得ることができます。

FPNVポジショニングマトリックス：規制情報管理システム市場におけるベンダーのパフォーマンス評価

FPNVポジショニングマトリックスは、規制情報管理システム市場においてベンダーを評価するための重要なツールです。このマトリックスにより、ビジネス組織はベンダーのビジネス戦略と製品満足度に基づき評価することで、目標に沿った十分な情報に基づいた意思決定を行うことができます。4つの象限によってベンダーを明確かつ正確にセグメント化し、戦略目標に最適なパートナーやソリューションを特定することができます。

戦略分析と推奨：規制情報管理システム市場における成功への道筋を描く

規制情報管理システム市場の戦略分析は、世界市場でのプレゼンス強化を目指す企業にとって不可欠です。主要なリソース、能力、業績指標を見直すことで、企業は成長機会を特定し、改善に取り組むことができます。このアプローチにより、競合情勢における課題を克服し、新たなビジネス機会を活かして長期的な成功を収めるための体制を整えることができます。

本レポートでは、主要な注目セグメントを網羅した市場の包括的な分析を提供しています。

1.市場の浸透度：現在の市場環境の詳細なレビュー、主要企業による広範なデータ、市場でのリーチと全体的な影響力を評価します。

2.市場の開拓度：新興市場における成長機会を特定し、既存セグメントにおける拡大可能性を評価し、将来の成長に向けた戦略的ロードマップを記載しています。

3.市場の多様化：最近の製品発売、未開拓の地域、産業の主要な進歩、市場を形成する戦略的投資を分析します。

4.競合の評価と情報：競合情勢を徹底的に分析し、市場シェア、事業戦略、製品ポートフォリオ、認証、規制当局の承認、特許動向、主要企業の技術進歩などを検証します。

5.製品開発とイノベーション：将来の市場成長を促進すると期待される最先端技術、研究開発活動、製品イノベーションをハイライトしています。

また、利害関係者が十分な情報を得た上で意思決定できるよう、重要な質問にも答えています。

1.現在の市場規模と今後の成長予測は？

2.最高の投資機会を提供する製品、地域はどこか？

3.市場を形成する主要技術動向と規制の影響とは？

4.主要ベンダーの市場シェアと競合ポジションは？

5.ベンダーの市場参入・撤退戦略の原動力となる収益源と戦略的機会は何か？

目次

第1章 序文

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 市場概要

第5章 市場洞察

• 市場力学
  • 促進要因
    • 規制当局の業務のデジタル化
    • 医薬品、医療機器、食品、化粧品セグメントにおける規制環境は絶えず変化
    • 迅速な規制承認を求める消費者の要望
  • 抑制要因
    • 規制当局の間では消極的な姿勢が強い
  • 機会
    • 医薬品、バイオテクノロジー、臨床研究への政府投資の増加
    • クラウドベースの規制情報管理システムの導入
  • 課題
    • サイバー攻撃やデータ盗難に伴うリスク
• 市場セグメンテーション分析
• ポーターのファイブフォース分析
• PESTEL分析
  • 政治
  • 経済
  • 社会
  • 技術
  • 法律
  • 環境

第6章 規制情報管理システム市場：機能別

• イントロダクション
• ドキュメントと出版管理
• ラベリング管理
• 登録管理
• 規制情報
• 提出計画と追跡管理

第7章 規制情報管理システム市場：展開別

• イントロダクション
• クラウド
• オンプレミス

第8章 規制情報管理システム市場：最終用途別

• イントロダクション
• バイオテクノロジー
• 臨床研究機関
• 製薬

第9章 南北アメリカの規制情報管理システム市場

• イントロダクション
• アルゼンチン
• ブラジル
• カナダ
• メキシコ
• 米国

第10章 アジア太平洋の規制情報管理システム市場

• イントロダクション
• オーストラリア
• 中国
• インド
• インドネシア
• 日本
• マレーシア
• フィリピン
• シンガポール
• 韓国
• 台湾
• タイ
• ベトナム

第11章 欧州・中東・アフリカの規制情報管理システム市場

• イントロダクション
• デンマーク
• エジプト
• フィンランド
• フランス
• ドイツ
• イスラエル
• イタリア
• オランダ
• ナイジェリア
• ノルウェー
• ポーランド
• カタール
• ロシア
• サウジアラビア
• 南アフリカ
• スペイン
• スウェーデン
• スイス
• トルコ
• アラブ首長国連邦
• 英国

第12章 競合情勢

• 市場シェア分析、2023年
• FPNVポジショニングマトリックス、2023年
• 競合シナリオ分析
• 戦略分析と提言

企業一覧

• Accruent, LLC
• Amplelogic
• ArisGlobal LLC
• Calyx
• DDi
• Ennov
• Extedo GmbH
• Freyr Inc.
• Generis Enterprise Technology Limited
• Gimmal, LLC
• Instem PLC
• IQVIA
• MastarControl, Inc.
• Parexel International Corporation
• Rimsys

LIST OF FIGURES

• FIGURE 1. REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET RESEARCH PROCESS
• FIGURE 2. REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, 2023 VS 2030
• FIGURE 3. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, 2018-2030 (USD MILLION)
• FIGURE 4. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY REGION, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 5. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY COUNTRY, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 6. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2023 VS 2030 (%)
• FIGURE 7. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 8. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2023 VS 2030 (%)
• FIGURE 9. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 10. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2023 VS 2030 (%)
• FIGURE 11. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 12. AMERICAS REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY COUNTRY, 2023 VS 2030 (%)
• FIGURE 13. AMERICAS REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY COUNTRY, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 14. UNITED STATES REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY STATE, 2023 VS 2030 (%)
• FIGURE 15. UNITED STATES REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY STATE, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 16. ASIA-PACIFIC REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY COUNTRY, 2023 VS 2030 (%)
• FIGURE 17. ASIA-PACIFIC REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY COUNTRY, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 18. EUROPE, MIDDLE EAST & AFRICA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY COUNTRY, 2023 VS 2030 (%)
• FIGURE 19. EUROPE, MIDDLE EAST & AFRICA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY COUNTRY, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 20. REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SHARE, BY KEY PLAYER, 2023
• FIGURE 21. REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET, FPNV POSITIONING MATRIX, 2023

LIST OF TABLES

• TABLE 1. REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SEGMENTATION & COVERAGE
• TABLE 2. UNITED STATES DOLLAR EXCHANGE RATE, 2018-2023
• TABLE 3. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, 2018-2030 (USD MILLION)
• TABLE 4. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY REGION, 2018-2030 (USD MILLION)
• TABLE 5. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY COUNTRY, 2018-2030 (USD MILLION)
• TABLE 6. REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET DYNAMICS
• TABLE 7. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 8. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DOCUMENT & PUBLISHING MANAGEMENT, BY REGION, 2018-2030 (USD MILLION)
• TABLE 9. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY LABELING MANAGEMENT, BY REGION, 2018-2030 (USD MILLION)
• TABLE 10. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY REGISTRATION MANAGEMENT, BY REGION, 2018-2030 (USD MILLION)
• TABLE 11. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY REGULATORY INTELLIGENCE, BY REGION, 2018-2030 (USD MILLION)
• TABLE 12. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY SUBMISSION PLANNING & TRACKING MANAGEMENT, BY REGION, 2018-2030 (USD MILLION)
• TABLE 13. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 14. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY CLOUD, BY REGION, 2018-2030 (USD MILLION)
• TABLE 15. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY ON-PREMISE, BY REGION, 2018-2030 (USD MILLION)
• TABLE 16. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 17. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY BIOTECHNOLOGY, BY REGION, 2018-2030 (USD MILLION)
• TABLE 18. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY CLINICAL RESEARCH ORGANIZATIONS, BY REGION, 2018-2030 (USD MILLION)
• TABLE 19. GLOBAL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY PHARMACEUTICAL, BY REGION, 2018-2030 (USD MILLION)
• TABLE 20. AMERICAS REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 21. AMERICAS REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 22. AMERICAS REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 23. AMERICAS REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY COUNTRY, 2018-2030 (USD MILLION)
• TABLE 24. ARGENTINA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 25. ARGENTINA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 26. ARGENTINA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 27. BRAZIL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 28. BRAZIL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 29. BRAZIL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 30. CANADA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 31. CANADA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 32. CANADA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 33. MEXICO REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 34. MEXICO REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 35. MEXICO REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 36. UNITED STATES REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 37. UNITED STATES REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 38. UNITED STATES REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 39. UNITED STATES REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY STATE, 2018-2030 (USD MILLION)
• TABLE 40. ASIA-PACIFIC REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 41. ASIA-PACIFIC REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 42. ASIA-PACIFIC REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 43. ASIA-PACIFIC REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY COUNTRY, 2018-2030 (USD MILLION)
• TABLE 44. AUSTRALIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 45. AUSTRALIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 46. AUSTRALIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 47. CHINA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 48. CHINA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 49. CHINA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 50. INDIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 51. INDIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 52. INDIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 53. INDONESIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 54. INDONESIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 55. INDONESIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 56. JAPAN REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 57. JAPAN REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 58. JAPAN REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 59. MALAYSIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 60. MALAYSIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 61. MALAYSIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 62. PHILIPPINES REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 63. PHILIPPINES REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 64. PHILIPPINES REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 65. SINGAPORE REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 66. SINGAPORE REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 67. SINGAPORE REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 68. SOUTH KOREA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 69. SOUTH KOREA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 70. SOUTH KOREA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 71. TAIWAN REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 72. TAIWAN REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 73. TAIWAN REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 74. THAILAND REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 75. THAILAND REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 76. THAILAND REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 77. VIETNAM REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 78. VIETNAM REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 79. VIETNAM REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 80. EUROPE, MIDDLE EAST & AFRICA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 81. EUROPE, MIDDLE EAST & AFRICA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 82. EUROPE, MIDDLE EAST & AFRICA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 83. EUROPE, MIDDLE EAST & AFRICA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY COUNTRY, 2018-2030 (USD MILLION)
• TABLE 84. DENMARK REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 85. DENMARK REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 86. DENMARK REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 87. EGYPT REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 88. EGYPT REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 89. EGYPT REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 90. FINLAND REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 91. FINLAND REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 92. FINLAND REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 93. FRANCE REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 94. FRANCE REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 95. FRANCE REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 96. GERMANY REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 97. GERMANY REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 98. GERMANY REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 99. ISRAEL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 100. ISRAEL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 101. ISRAEL REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 102. ITALY REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 103. ITALY REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 104. ITALY REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 105. NETHERLANDS REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 106. NETHERLANDS REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 107. NETHERLANDS REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 108. NIGERIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 109. NIGERIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 110. NIGERIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 111. NORWAY REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 112. NORWAY REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 113. NORWAY REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 114. POLAND REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 115. POLAND REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 116. POLAND REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 117. QATAR REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 118. QATAR REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 119. QATAR REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 120. RUSSIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 121. RUSSIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 122. RUSSIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 123. SAUDI ARABIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 124. SAUDI ARABIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 125. SAUDI ARABIA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 126. SOUTH AFRICA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 127. SOUTH AFRICA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 128. SOUTH AFRICA REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 129. SPAIN REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 130. SPAIN REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 131. SPAIN REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 132. SWEDEN REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 133. SWEDEN REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 134. SWEDEN REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 135. SWITZERLAND REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 136. SWITZERLAND REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 137. SWITZERLAND REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 138. TURKEY REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 139. TURKEY REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 140. TURKEY REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 141. UNITED ARAB EMIRATES REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 142. UNITED ARAB EMIRATES REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 143. UNITED ARAB EMIRATES REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 144. UNITED KINGDOM REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY FUNCTIONS, 2018-2030 (USD MILLION)
• TABLE 145. UNITED KINGDOM REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY DEPLOYMENT, 2018-2030 (USD MILLION)
• TABLE 146. UNITED KINGDOM REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SIZE, BY END-USE, 2018-2030 (USD MILLION)
• TABLE 147. REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET SHARE, BY KEY PLAYER, 2023
• TABLE 148. REGULATORY INFORMATION MANAGEMENT SYSTEM MARKET, FPNV POSITIONING MATRIX, 2023

The Regulatory Information Management System Market was valued at USD 2.27 billion in 2023, expected to reach USD 2.56 billion in 2024, and is projected to grow at a CAGR of 13.54%, to USD 5.52 billion by 2030.

A Regulatory Information Management System (RIMS) is a digital solution designed to streamline the management of regulatory submissions and compliance processes for industries such as pharmaceuticals, biotech, and healthcare. It encompasses the tracking, management, and submission of regulatory data to ensure alignment with global compliance standards. The necessity of RIMS arises from the complex, ever-evolving nature of regulatory environments, which demand accuracy, efficiency, and adaptability in data handling. These systems are applied across various end-use sectors, predominantly in life sciences and medical device industries, to enhance workflow efficiency and reduce errors in regulatory submissions. Market insights indicate burgeoning demand for RIMS due to increasing globalization of healthcare, stringent government regulations, and the expanding need for maintaining comprehensive records. Key factors influencing growth include technological advancements like AI and cloud computing, which offer enhanced data analytics capabilities, and integration efficiency to streamline operations. Emerging opportunities are noted in the rise of eCTD (Electronic Common Technical Document) submissions and the digital transformation in regulatory frameworks. Recommendations for businesses to capitalize on these opportunities include investing in robust data integration solutions and expanding educational programs to better train staff on new technologies. However, the market faces challenges such as high implementation costs, complexities in system updates, and concerns related to data security. Limitations also arise from the lack of standardized practices across regions, which can complicate processes. Areas ripe for innovation include AI-driven predictive analytics for compliance risk management, blockchain for secure data transactions, and enhanced user-interface design for better cross-functional collaboration. Consequently, companies should focus on technology partnerships and staying abreast of policy shifts to maintain a competitive edge in this dynamically evolving market landscape.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Regulatory Information Management System Market

The Regulatory Information Management System Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Digitalization of operations in regulatory agencies
  • Continuously changing regulatory environment in the pharmaceuticals, medical devices, food, and cosmetics sector
  • Consumer demand for fast-tracked regulatory approvals
• Market Restraints
  • High level of reluctance among regulators
• Market Opportunities
  • Rising government investment in pharmaceuticals, biotechnology, and clinical research
  • Adoption of cloud-based regulatory information management systems
• Market Challenges
  • Risks associated with cyberattacks and data theft

Porter's Five Forces: A Strategic Tool for Navigating the Regulatory Information Management System Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Regulatory Information Management System Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Regulatory Information Management System Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Regulatory Information Management System Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Regulatory Information Management System Market

A detailed market share analysis in the Regulatory Information Management System Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Regulatory Information Management System Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Regulatory Information Management System Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Strategy Analysis & Recommendation: Charting a Path to Success in the Regulatory Information Management System Market

A strategic analysis of the Regulatory Information Management System Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

Key Company Profiles

The report delves into recent significant developments in the Regulatory Information Management System Market, highlighting leading vendors and their innovative profiles. These include Accruent, LLC, Amplelogic, ArisGlobal LLC, Calyx, DDi, Ennov, Extedo GmbH, Freyr Inc., Generis Enterprise Technology Limited, Gimmal, LLC, Instem PLC, IQVIA, MastarControl, Inc., Parexel International Corporation, and Rimsys.

Market Segmentation & Coverage

This research report categorizes the Regulatory Information Management System Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Functions, market is studied across Document & Publishing Management, Labeling Management, Registration Management, Regulatory Intelligence, and Submission Planning & Tracking Management.
• Based on Deployment, market is studied across Cloud and On-Premise.
• Based on End-Use, market is studied across Biotechnology, Clinical Research Organizations, and Pharmaceutical.
• Based on Region, market is 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.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

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. 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. Digitalization of operations in regulatory agencies
    • 5.1.1.2. Continuously changing regulatory environment in the pharmaceuticals, medical devices, food, and cosmetics sector
    • 5.1.1.3. Consumer demand for fast-tracked regulatory approvals
  • 5.1.2. Restraints
    • 5.1.2.1. High level of reluctance among regulators
  • 5.1.3. Opportunities
    • 5.1.3.1. Rising government investment in pharmaceuticals, biotechnology, and clinical research
    • 5.1.3.2. Adoption of cloud-based regulatory information management systems
  • 5.1.4. Challenges
    • 5.1.4.1. Risks associated with cyberattacks and data theft
• 5.2. Market Segmentation Analysis
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Regulatory Information Management System Market, by Functions

• 6.1. Introduction
• 6.2. Document & Publishing Management
• 6.3. Labeling Management
• 6.4. Registration Management
• 6.5. Regulatory Intelligence
• 6.6. Submission Planning & Tracking Management

7. Regulatory Information Management System Market, by Deployment

• 7.1. Introduction
• 7.2. Cloud
• 7.3. On-Premise

8. Regulatory Information Management System Market, by End-Use

• 8.1. Introduction
• 8.2. Biotechnology
• 8.3. Clinical Research Organizations
• 8.4. Pharmaceutical

9. Americas Regulatory Information Management System Market

• 9.1. Introduction
• 9.2. Argentina
• 9.3. Brazil
• 9.4. Canada
• 9.5. Mexico
• 9.6. United States

10. Asia-Pacific Regulatory Information Management System Market

• 10.1. Introduction
• 10.2. Australia
• 10.3. China
• 10.4. India
• 10.5. Indonesia
• 10.6. Japan
• 10.7. Malaysia
• 10.8. Philippines
• 10.9. Singapore
• 10.10. South Korea
• 10.11. Taiwan
• 10.12. Thailand
• 10.13. Vietnam

11. Europe, Middle East & Africa Regulatory Information Management System Market

• 11.1. Introduction
• 11.2. Denmark
• 11.3. Egypt
• 11.4. Finland
• 11.5. France
• 11.6. Germany
• 11.7. Israel
• 11.8. Italy
• 11.9. Netherlands
• 11.10. Nigeria
• 11.11. Norway
• 11.12. Poland
• 11.13. Qatar
• 11.14. Russia
• 11.15. Saudi Arabia
• 11.16. South Africa
• 11.17. Spain
• 11.18. Sweden
• 11.19. Switzerland
• 11.20. Turkey
• 11.21. United Arab Emirates
• 11.22. United Kingdom

12. Competitive Landscape

• 12.1. Market Share Analysis, 2023
• 12.2. FPNV Positioning Matrix, 2023
• 12.3. Competitive Scenario Analysis
• 12.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. Accruent, LLC
• 2. Amplelogic
• 3. ArisGlobal LLC
• 4. Calyx
• 5. DDi
• 6. Ennov
• 7. Extedo GmbH
• 8. Freyr Inc.
• 9. Generis Enterprise Technology Limited
• 10. Gimmal, LLC
• 11. Instem PLC
• 12. IQVIA
• 13. MastarControl, Inc.
• 14. Parexel International Corporation
• 15. Rimsys