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ファーマコビジランス市場レポート：サービスプロバイダー別、製品ライフサイクル別、タイプ別、プロセスフロー別、治療領域別、最終用途別、地域別、2024～2032年

Pharmacovigilance Market Report by Service Provider, Product Life Cycle, Type, Process Flow, Therapeutic Area, End Use, and Region 2024-2032

出版日
発行
IMARC
ページ情報
英文 135 Pages
納期
2～3営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=144.06円
ファーマコビジランス市場レポート：サービスプロバイダー別、製品ライフサイクル別、タイプ別、プロセスフロー別、治療領域別、最終用途別、地域別、2024～2032年
出版日: 2024年08月10日
発行: IMARC
ページ情報: 英文 135 Pages
納期: 2～3営業日
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  • 概要
  • 図表
  • 目次
概要

世界のファーマコビジランス市場規模は2023年に79億米ドルに達しました。今後、IMARC Groupは、2024～2032年にかけて7.8%の成長率（CAGR）を示し、2032年までに159億米ドルに達すると予測しています。医薬品副作用（ADR）の蔓延の増加と、医薬品の適切な使用や臨床試験の実施に関する意識を高めるための政府機関による有利な政策の開始が、主にファーマコビジランス市場の成長を刺激しています。

世界のファーマコビジランス市場分析：

主要市場促進要因：心疾患、高血圧、糖尿病など様々な生活習慣病の増加により、世界中で医薬品の使用量が増加しています。その結果、これまで知られていなかった副作用の検出、頻度や重症度の変化の認識、必要な措置を決定するための薬剤のリスクとベネフィットの評価などを行うファーマコビジランス（PV）の必要性が高まっています。このことが、ファーマコビジランス市場展望に大きな機会をもたらしています。

主要市場動向：ファーマコビジランス市場の主要動向の1つに、副作用（ADR）報告の自動化を確実にする高度なプラットフォームの開発があります。さらに、競合環境のため、主要企業は製造業務の強化や研究開発活動の効率化にも注力しています。このほか、臨床試験件数の増加が予測期間中のファーマコビジランス市場を後押しするとみられています。

競合情勢：著名なファーマコビジランス市場主要企業としては、Accenture plc、ArisGlobal LLC、BioClinica Inc.（Cinven Partners LLP）、Capgemini、Cognizant、International Business Machines Corporation、ICON plc、IQVIA Inc.、ITClinical、Parexel International Corporation、Wipro Limitedなどが挙げられます。

課題と機会：ファーマコビジランス市場分析によると、政府機関による厳しい規制要件、膨大なデータの管理とそこから有意義な知見を引き出すことの複雑化、包括的な医薬品安全性モニタリングとコスト抑制のプレッシャーとのバランスを取る必要性の高まりなどの課題が、ファーマコビジランス業界の成長を世界中で妨げています。しかし、医薬品の安全性を確保し、公衆衛生を守るための戦略的協力関係を促進することが、今後数年間でファーマコビジランス市場のシェアを押し上げると予想されます。

世界のファーマコビジランス市場動向：

絶え間ない技術進歩の発展

機械学習（ML）、自然言語処理（NLP）、人工知能（AI）、ビッグデータ分析などの新しい技術の統合が進み、ファーマコビジランスプロセスが強化されています。これに伴い、これらの技術は有害事象の特定、リスク評価、効率的なシグナル検出などに役立つため、幅広い支持を集めており、予測期間中の市場成長を促進すると期待されています。例えば、サノフィとデロイトは、ファーマコビジランス（PV）プロセスを変革し、業界で最も差し迫った業務上の安全性の問題に対処する次世代の人工知能（AI）を駆使した、Software-as-a-Service型の症例取り込みプラットフォームであるConvergeHEALTH Safetyで協業しました。これに伴い、ArisGlobalはLifeSphere MultiVigilanceを搭載した電子安全性報告プラットフォームであるUSFDA有害事象報告システム（FAERS II）の本稼働を発表し、市場の成長を促進しました。さらに、Saama Technologies Inc.は、新しいActive Safety Analytics for Pharma（ASAP）製品を開発しました。ASAPは、安全性シグナルを検出するためのTreeScan手法と米国食品医薬品局（FDA）のSentinel Common Data Modelを活用した最初の有効なファーマコビジランスソリューションの1つです。

政府機関が実施する厳しい規制

世界中の政府当局は、臨床試験において厳格な規則を実施し、医薬品の適切な使用に関する意識を高めており、これがファーマコビジランスサービスの利用を促進しています。例えば、Frontiers in Drug Safety and Regulationに掲載された研究によると、市販後投薬評価の意義は、実環境における医薬品の安全性プロファイルを特徴付けるために重要です。こうした研究はファーマコビジランスの重要性をさらに高め、市場の成長を刺激しています。さらに、Aurobindo Pharma USAは、N-ニトロソ-キナプリルとニトロソアミン薬剤物質関連不純物（NDSRI）の存在により、キナプリルとヒドロクロロチアジド錠USP 20mg/12.5mgを再製造しました。その結果、規制当局の間で医療情報に対するニーズが高まっており、予測期間中の市場成長に拍車がかかると予想されます。

製薬企業によるファーマコビジランスサービスの採用増加

ファーマコビジランスサービスは、短期間でより良い結果が得られ、社内リソースの柔軟性が高まるなどの利点があるため、世界中の主要製薬企業で広く採用されています。例えば、ワクチン有害事象報告システムによると、報告されたCOVID-19ワクチンの初回投与404万1,396回後に10例のアナフィラキシーが検出されました（100万回投与あたり2.5例）。その結果、ファーマコビジランスサービスに対するニーズの高まりも市場の成長を促しています。これに加えて、主要な業界参入企業は戦略的提携を結んでおり、予測期間中もファーマコビジランス市場を推進すると考えられます。例えば、IQVIAはNRx Pharmaceuticalsと戦略的提携を結び、潜在的な規制措置に備えて医療情報やファーマコビジランスサービスを提供しています。

臨床試験フェーズの高度化

臨床試験の有効性を高めるため、主要な大手企業は先進的な臨床試験を開発しており、これがファーマコビジランスの世界市場を刺激しています。例えば、CognizantはMedable Inc.と提携し、分散型臨床試験向けのMedableのSaaSプラットフォーム別の臨床研究ソリューションを共同で提供しています。また、ファーマコビジランス市場概要によると、ViedocとLINK Medicalは、Viedocが設立したパートナーシップを締結しました。この提携は、LINK Medicalとその顧客の臨床試験の効率を高めることを目的としています。このパートナーシップにより、ニーズ、経験、アイデアなどの交換、新機能のテストが可能になりました。

目次

第1章 序文

第2章 調査範囲と調査手法

  • 調査の目的
  • ステークホルダー
  • データソース
    • 一次情報
    • 二次情報
  • 市場推定
    • ボトムアップアプローチ
    • トップダウンアプローチ
  • 調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

  • 概要
  • 主要業界動向

第5章 世界のファーマコビジランス市場

  • 市場概要
  • 市場実績
  • COVID-19の影響
  • 市場予測

第6章 市場内訳：サービスプロバイダー別

  • 社内
  • 契約アウトソーシング

第7章 市場内訳：製品ライフサイクル別

  • 前臨床
  • フェーズI
  • フェーズII
  • フェーズIII
  • フェーズIV

第8章 市場内訳：タイプ別

  • 自発的報告
  • ADR報告の強化
  • 対象型自発的報告
  • コホートイベントモニタリング
  • EHR鉱業

第9章 市場内訳：プロセスフロー別

  • ケースデータ管理
    • 市場動向
    • 主要タイプ
      • ケースログ
      • ケースデータ分析
      • 医療レビューと報告
    • 市場予測
  • 信号検出
    • 市場動向
    • 主要タイプ
      • 有害事象の記録
      • 有害事象分析
      • 有害事象のレビューと報告
    • 市場予測
  • リスク管理システム
    • 市場動向
    • 主要タイプ
      • リスク評価システム
      • リスク軽減システム
    • 市場予測

第10章 市場内訳：治療領域別

  • 腫瘍学
  • 神経学
  • 心臓病学
  • 呼吸器系
  • その他

第11章 市場内訳：最終用途別

  • 製薬会社
  • バイオテクノロジー企業
  • 医療機器企業
  • その他

第12章 市場内訳：地域別

  • 北米
    • 米国
    • カナダ
  • アジア太平洋
    • 中国
    • 日本
    • インド
    • 韓国
    • オーストラリア
    • インドネシア
    • その他
  • 欧州
    • ドイツ
    • フランス
    • 英国
    • イタリア
    • スペイン
    • ロシア
    • その他
  • ラテンアメリカ
    • ブラジル
    • メキシコ
    • その他
  • 中東・アフリカ
    • 市場動向
    • 市場内訳：国別
    • 市場予測

第13章 SWOT分析

  • 概要
  • 強み
  • 弱み
  • 機会
  • 脅威

第14章 バリューチェーン分析

第15章 ポーターのファイブフォース分析

  • 概要
  • 買い手の交渉力
  • 供給企業の交渉力
  • 競合の程度
  • 新規参入業者の脅威
  • 代替品の脅威

第16章 価格分析

第17章 競合情勢

  • 市場構造
  • 主要企業
  • 主要企業のプロファイル
    • Accenture plc
    • ArisGlobal LLC
    • BioClinica Inc.（Cinven Partners LLP）
    • Capgemini
    • Cognizant
    • International Business Machines Corporation
    • ICON plc.
    • IQVIA Inc.
    • ITClinical
    • Parexel International Corporation
    • Wipro Limited
図表

List of Figures

  • Figure 1: Global: Pharmacovigilance Market: Major Drivers and Challenges
  • Figure 2: Global: Pharmacovigilance Market: Sales Value (in Billion US$), 2018-2023
  • Figure 3: Global: Pharmacovigilance Market Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 4: Global: Pharmacovigilance Market: Breakup by Service Provider (in %), 2023
  • Figure 5: Global: Pharmacovigilance Market: Breakup by Product Life Cycle (in %), 2023
  • Figure 6: Global: Pharmacovigilance Market: Breakup by Type (in %), 2023
  • Figure 7: Global: Pharmacovigilance Market: Breakup by Process Flow (in %), 2023
  • Figure 8: Global: Pharmacovigilance Market: Breakup by Therapeutic Area (in %), 2023
  • Figure 9: Global: Pharmacovigilance Market: Breakup by End Use (in %), 2023
  • Figure 10: Global: Pharmacovigilance Market: Breakup by Region (in %), 2023
  • Figure 11: Global: Pharmacovigilance (In-house) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 12: Global: Pharmacovigilance (In-house) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 13: Global: Pharmacovigilance (Contract Outsourcing) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 14: Global: Pharmacovigilance (Contract Outsourcing) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 15: Global: Pharmacovigilance (Pre-clinical) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 16: Global: Pharmacovigilance (Pre-clinical) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 17: Global: Pharmacovigilance (Phase I) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 18: Global: Pharmacovigilance (Phase I) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 19: Global: Pharmacovigilance (Phase II) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 20: Global: Pharmacovigilance (Phase II) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 21: Global: Pharmacovigilance (Phase III) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 22: Global: Pharmacovigilance (Phase III) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 23: Global: Pharmacovigilance (Phase IV) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 24: Global: Pharmacovigilance (Phase IV) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 25: Global: Pharmacovigilance (Spontaneous Reporting) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 26: Global: Pharmacovigilance (Spontaneous Reporting) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 27: Global: Pharmacovigilance (Intensified ADR Reporting) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 28: Global: Pharmacovigilance (Intensified ADR Reporting) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 29: Global: Pharmacovigilance (Targeted Spontaneous Reporting) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 30: Global: Pharmacovigilance (Targeted Spontaneous Reporting) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 31: Global: Pharmacovigilance (Cohort Event Monitoring) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 32: Global: Pharmacovigilance (Cohort Event Monitoring) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 33: Global: Pharmacovigilance (EHR Mining) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 34: Global: Pharmacovigilance (EHR Mining) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 35: Global: Pharmacovigilance (Case Data Management) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 36: Global: Pharmacovigilance (Case Data Management) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 37: Global: Pharmacovigilance (Signal Detection) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 38: Global: Pharmacovigilance (Signal Detection) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 39: Global: Pharmacovigilance (Risk Management System) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 40: Global: Pharmacovigilance (Risk Management System) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 41: Global: Pharmacovigilance (Oncology) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 42: Global: Pharmacovigilance (Oncology) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 43: Global: Pharmacovigilance (Neurology) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 44: Global: Pharmacovigilance (Neurology) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 45: Global: Pharmacovigilance (Cardiology) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 46: Global: Pharmacovigilance (Cardiology) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 47: Global: Pharmacovigilance (Respiratory Systems) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 48: Global: Pharmacovigilance (Respiratory Systems) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 49: Global: Pharmacovigilance (Other Therapeutic Areas) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 50: Global: Pharmacovigilance (Other Therapeutic Areas) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 51: Global: Pharmacovigilance (Pharmaceuticals Companies) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 52: Global: Pharmacovigilance (Pharmaceuticals Companies) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 53: Global: Pharmacovigilance (Biotechnology Companies) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 54: Global: Pharmacovigilance (Biotechnology Companies) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 55: Global: Pharmacovigilance (Medical Device Companies) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 56: Global: Pharmacovigilance (Medical Device Companies) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 57: Global: Pharmacovigilance (Other End Uses) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 58: Global: Pharmacovigilance (Other End Uses) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 59: North America: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 60: North America: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 61: United States: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 62: United States: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 63: Canada: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 64: Canada: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 65: Asia-Pacific: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 66: Asia-Pacific: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 67: China: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 68: China: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 69: Japan: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 70: Japan: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 71: India: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 72: India: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 73: South Korea: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 74: South Korea: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 75: Australia: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 76: Australia: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 77: Indonesia: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 78: Indonesia: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 79: Others: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 80: Others: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 81: Europe: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 82: Europe: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 83: Germany: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 84: Germany: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 85: France: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 86: France: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 87: United Kingdom: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 88: United Kingdom: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 89: Italy: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 90: Italy: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 91: Spain: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 92: Spain: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 93: Russia: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 94: Russia: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 95: Others: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 96: Others: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 97: Latin America: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 98: Latin America: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 99: Brazil: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 100: Brazil: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 101: Mexico: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 102: Mexico: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 103: Others: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 104: Others: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 105: Middle East and Africa: Pharmacovigilance Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 106: Middle East and Africa: Pharmacovigilance Market: Breakup by Country (in %), 2023
  • Figure 107: Middle East and Africa: Pharmacovigilance Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 108: Global: Pharmacovigilance Industry: SWOT Analysis
  • Figure 109: Global: Pharmacovigilance Industry: Value Chain Analysis
  • Figure 110: Global: Pharmacovigilance Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Pharmacovigilance Market: Key Industry Highlights, 2023 and 2032
  • Table 2: Global: Pharmacovigilance Market Forecast: Breakup by Service Provider (in Million US$), 2024-2032
  • Table 3: Global: Pharmacovigilance Market Forecast: Breakup by Product Life Cycle (in Million US$), 2024-2032
  • Table 4: Global: Pharmacovigilance Market Forecast: Breakup by Type (in Million US$), 2024-2032
  • Table 5: Global: Pharmacovigilance Market Forecast: Breakup by Process Flow (in Million US$), 2024-2032
  • Table 6: Global: Pharmacovigilance Market Forecast: Breakup by Therapeutic Area (in Million US$), 2024-2032
  • Table 7: Global: Pharmacovigilance Market Forecast: Breakup by End Use (in Million US$), 2024-2032
  • Table 8: Global: Pharmacovigilance Market Forecast: Breakup by Region (in Million US$), 2024-2032
  • Table 9: Global: Pharmacovigilance Market: Competitive Structure
  • Table 10: Global: Pharmacovigilance Market: Key Players
目次
Product Code: SR112024A3609

The global pharmacovigilance market size reached US$ 7.9 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 15.9 Billion by 2032, exhibiting a growth rate (CAGR) of 7.8% during 2024-2032. The increasing prevalence of adverse drug reactions (ADRs), coupled with the launch of favorable policies by government bodies to generate awareness about the proper usage of medicines and conduct clinical trials, is primarily stimulating the pharmacovigilance market growth.

Global Pharmacovigilance Market Analysis:

Major Market Drivers: The elevating incidences of various lifestyle diseases, including cardiac disorders, hypertension, diabetes, etc., are augmenting the usage of drugs across the globe. Consequently, there is an elevating need for pharmacovigilance (PV) to detect previously unknown adverse effects, recognize changes in the frequency or severity, assess the risks and benefits of drugs to determine required actions, etc. This, in turn, is providing significant opportunities in the pharmacovigilance market outlook.

Key Market Trends: One of the key pharmacovigilance market trends includes the development of advanced platforms to ensure automated adverse drug reactions (ADR) reporting. Furthermore, key players are also focusing on enhancing manufacturing operations and streamlining R&D activities, owing to the competitive environment. Besides this, the rising number of clinical trials is expected to fuel the pharmacovigilance market in the forecasted period.

Competitive Landscape: Some of the prominent pharmacovigilance market key players are Accenture plc, ArisGlobal LLC, BioClinica Inc. (Cinven Partners LLP), Capgemini, Cognizant, International Business Machines Corporation, ICON plc., IQVIA Inc., ITClinical, Parexel International Corporation, and Wipro Limited, among many others.

Challenges and Opportunities: According to the pharmacovigilance market analysis, some of the challenges, including stringent regulatory requirements by government bodies, the rising complexities in managing and deriving meaningful insights from a vast amount of data, and the increasing need for balancing comprehensive drug safety monitoring with the pressure to control costs, are hindering the growth of the pharmacovigilance industry across the globe. However, fostering strategic collaborations to ensure the safety of drugs and safeguard public health is expected to propel the pharmacovigilance market share in the coming years.

Global Pharmacovigilance Market Trends:

The Development of Continuous Technological Advancements

The increasing integration of novel technologies, such as machine learning (ML), natural language processing (NLP), artificial intelligence (AI), big data analytics, etc., is enhancing the pharmacovigilance processes. In line with this, these technologies are gaining extensive traction, as they help in identifying adverse events, risk assessments, enabling efficient signal detection, etc., which is expected to fuel the market growth over the forecasted period. For instance, Sanofi and Deloitte collaborated on ConvergeHEALTH Safety, a next-generation artificial intelligence (AI) software-as-a-service adverse events case intake platform that transformed pharmacovigilance (PV) processes and addressed some of the industry's most pressing operational safety issues. In line with this, ArisGlobal introduced the go-live of the USFDA Adverse Event Reporting System (FAERS II), an electronic safety reporting platform powered by LifeSphere MultiVigilance, which propelled the market growth. Furthermore, Saama Technologies Inc. developed the new Active Safety Analytics for Pharma (ASAP) products. ASAP is one of the first validated pharmacovigilance solutions to leverage the TreeScan methodology and the United States Food and Drug Administration's (FDA) Sentinel Common Data Model for detecting safety signals.

Stringent Regulations Implemented by Government Bodies

Government authorities across the globe are implementing strict rules in clinical trials and generating awareness regarding the proper utilization of medicines, which is stimulating the usage of pharmacovigilance services. For example, according to a study published in Frontiers in Drug Safety and Regulation, the significance of post-marketing medication evaluation is important for characterizing drug safety profiles in real-world settings. Such studies are further increasing the importance of pharmacovigilance, thereby stimulating the market growth. Moreover, Aurobindo Pharma USA reformulated Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, owing to the presence of N-Nitroso-Quinapril and Nitrosamine Drug Substance Related Impurity (NDSRI). Consequently, the inflating need for medical information among regulatory authorities is expected to fuel the market growth over the forecasted period.

The Rising Adoption of Pharmacovigilance Services by Pharmaceutical Companies

Pharmacovigilance services are extensively adopted by key pharmaceutical companies across the globe, owing to benefits, such as better outcomes over shorter periods and increasing internal resource flexibility. For example, according to the Vaccine Adverse Event Reporting System, 10 cases of anaphylaxis were detected after the administration of a reported 4,041,396 first doses of the Moderna COVID-19 vaccine (2.5 cases per million doses). Consequently, the growing need for pharmacovigilance services is also stimulating the market growth. In addition to this, key industry players are also entering into strategic collaborations, which will continue to propel the pharmacovigilance market over the forecasted period. For example, IQVIA entered into a strategic collaboration with NRx Pharmaceuticals to offer medical information and pharmacovigilance services in preparation for potential regulatory actions.

The Growing Number of Advanced Clinical Trial Phases

To enhance the efficacy of clinical trials, major prominent players are developing advanced clinical trials, which are stimulating the global market for pharmacovigilance. For example, Cognizant entered into a partnership with Medable Inc. to jointly deliver clinical research solutions based on Medable's software-as-a-service platform for decentralized clinical trials. In line with this, according to the pharmacovigilance market overview, Viedoc and LINK Medical entered into a partnership established by Viedoc. The collaboration was designed to enhance trial efficiency for LINK Medical and its clients. The partnership allowed for the exchange of needs, experience, ideas, etc., and the testing of new features.

Pharmacovigilance Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global pharmacovigilance market report, along with forecasts at the global, regional, and country levels from 2024-2032. Our report has categorized the market based on service provider, product life cycle, type, process flow, therapeutic area, and end use.

Breakup by Service Provider:

In-house

Contract Outsourcing

The report has provided a detailed breakup and analysis of the market based on the service provider. This includes in-house and contract outsourcing.

Breakup by Product Life Cycle:

Pre-clinical

Phase I

Phase II

Phase III

Phase IV

A detailed breakup and analysis of the market based on the product life cycle has also been provided in the report. This includes pre-clinical, Phase I, Phase II, Phase III, and Phase IV.

Breakup by Type:

Spontaneous Reporting

Intensified ADR Reporting

Targeted Spontaneous Reporting

Cohort Event Monitoring

EHR Mining

The report has provided a detailed breakup and analysis of the market based on the type. This includes spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, and EHR Mining.

Breakup by Process Flow:

Case Data Management

Case Logging

Case Data Analysis

Medical Reviewing and Reporting

Signal Detection

Adverse Event Logging

Adverse Event Analysis

Adverse Event Review and Reporting

Risk Management System

Risk Evaluation System

Risk Mitigation System

The report has provided a detailed breakup and analysis of the market based on the process flow. This includes case data management (case logging, case data analysis, medical reviewing and reporting), signal detection (adverse event logging, adverse event analysis, and adverse event review and reporting, and risk management system (risk evaluation system and risk mitigation system).

Breakup by Therapeutic Area:

Oncology

Neurology

Cardiology

Respiratory Systems

Others

The report has provided a detailed breakup and analysis of the market based on the therapeutic area. This includes oncology, neurology, cardiology, respiratory systems, and others.

Breakup by End Use:

Pharmaceuticals Companies

Biotechnology Companies

Medical Device Companies

Others

The report has provided a detailed breakup and analysis of the market based on the end-use. This includes pharmaceuticals companies, biotechnology companies, medical device companies, and others.

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

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa.

Competitive Landscape:

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the pharmacovigilance top companies are listed below:

Accenture plc

ArisGlobal LLC

BioClinica Inc. (Cinven Partners LLP)

Capgemini

Cognizant

International Business Machines Corporation

ICON plc.

IQVIA Inc.

ITClinical

Parexel International Corporation

Wipro Limited

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Global Pharmacovigilance Market News:

March 2024: The American Society of Pharmacovigilance (ASP), along with several partners, is focused on advancing drug safety via minimizing ADEs, the fourth leading cause of death in the United States.

February 2024: The Indian Pharmacopoeia Commission (IPC) released the Draft Pharmacovigilance Guidance Document for pharmaceutical products for its latest Version 2.0. The Commission also offered suggestions from Marketing Authorization Holders (MAHs) on the draft document.

February 2024: The US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) launched the standardization of Risk Evaluation and Mitigation Strategies (REMS) data to facilitate its use.

Key Questions Answered in This Report:

  • How has the global pharmacovigilance market performed so far and how will it perform in the coming years?
  • What has been the impact of COVID-19 on the global pharmacovigilance market?
  • What are the key regional markets?
  • What is the breakup of the market based on the service provider?
  • What is the breakup of the market based on the product life cycle?
  • What is the breakup of the market based on the type?
  • What is the breakup of the market based on the process flow?
  • What is the breakup of the market based on the therapeutic area?
  • What is the breakup of the market based on the end use?
  • 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 pharmacovigilance market and who are the key players?
  • What is the degree of competition in the industry?

Table of Contents

1 Preface

2 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 Pharmacovigilance Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Service Provider

  • 6.1 In-house
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Contract Outsourcing
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast

7 Market Breakup by Product Life Cycle

  • 7.1 Pre-clinical
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Phase I
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast
  • 7.3 Phase II
    • 7.3.1 Market Trends
    • 7.3.2 Market Forecast
  • 7.4 Phase III
    • 7.4.1 Market Trends
    • 7.4.2 Market Forecast
  • 7.5 Phase IV
    • 7.5.1 Market Trends
    • 7.5.2 Market Forecast

8 Market Breakup by Type

  • 8.1 Spontaneous Reporting
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Intensified ADR Reporting
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Targeted Spontaneous Reporting
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Cohort Event Monitoring
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast
  • 8.5 EHR Mining
    • 8.5.1 Market Trends
    • 8.5.2 Market Forecast

9 Market Breakup by Process Flow

  • 9.1 Case Data Management
    • 9.1.1 Market Trends
    • 9.1.2 Major Types
      • 9.1.2.1 Case Logging
      • 9.1.2.2 Case Data Analysis
      • 9.1.2.3 Medical Reviewing and Reporting
    • 9.1.3 Market Forecast
  • 9.2 Signal Detection
    • 9.2.1 Market Trends
    • 9.2.2 Major Types
      • 9.2.2.1 Adverse Event Logging
      • 9.2.2.2 Adverse Event Analysis
      • 9.2.2.3 Adverse Event Review and Reporting
    • 9.2.3 Market Forecast
  • 9.3 Risk Management System
    • 9.3.1 Market Trends
    • 9.3.2 Major Types
      • 9.3.2.1 Risk Evaluation System
      • 9.3.2.2 Risk Mitigation System
    • 9.3.3 Market Forecast

10 Market Breakup by Therapeutic Area

  • 10.1 Oncology
    • 10.1.1 Market Trends
    • 10.1.2 Market Forecast
  • 10.2 Neurology
    • 10.2.1 Market Trends
    • 10.2.2 Market Forecast
  • 10.3 Cardiology
    • 10.3.1 Market Trends
    • 10.3.2 Market Forecast
  • 10.4 Respiratory Systems
    • 10.4.1 Market Trends
    • 10.4.2 Market Forecast
  • 10.5 Others
    • 10.5.1 Market Trends
    • 10.5.2 Market Forecast

11 Market Breakup by End Use

  • 11.1 Pharmaceuticals Companies
    • 11.1.1 Market Trends
    • 11.1.2 Market Forecast
  • 11.2 Biotechnology Companies
    • 11.2.1 Market Trends
    • 11.2.2 Market Forecast
  • 11.3 Medical Device Companies
    • 11.3.1 Market Trends
    • 11.3.2 Market Forecast
  • 11.4 Others
    • 11.4.1 Market Trends
    • 11.4.2 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 Accenture plc
      • 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 ArisGlobal LLC
      • 17.3.2.1 Company Overview
      • 17.3.2.2 Product Portfolio
    • 17.3.3 BioClinica Inc. (Cinven Partners LLP)
      • 17.3.3.1 Company Overview
      • 17.3.3.2 Product Portfolio
      • 17.3.3.3 SWOT Analysis
    • 17.3.4 Capgemini
      • 17.3.4.1 Company Overview
      • 17.3.4.2 Product Portfolio
    • 17.3.5 Cognizant
      • 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 International Business Machines Corporation
      • 17.3.6.1 Company Overview
      • 17.3.6.2 Product Portfolio
      • 17.3.6.3 Financials
      • 17.3.6.4 SWOT Analysis
    • 17.3.7 ICON plc.
      • 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 IQVIA Inc.
      • 17.3.8.1 Company Overview
      • 17.3.8.2 Product Portfolio
      • 17.3.8.3 Financials
      • 17.3.8.4 SWOT Analysis
    • 17.3.9 ITClinical
      • 17.3.9.1 Company Overview
      • 17.3.9.2 Product Portfolio
    • 17.3.10 Parexel International Corporation
      • 17.3.10.1 Company Overview
      • 17.3.10.2 Product Portfolio
      • 17.3.10.3 SWOT Analysis
    • 17.3.11 Wipro Limited
      • 17.3.11.1 Company Overview
      • 17.3.11.2 Product Portfolio
      • 17.3.11.3 Financials
      • 17.3.11.4 SWOT Analysis