ファーマコビジランスおよび医薬品安全性ソフトウェア市場の2030年までの予測： 機能別、提供モード別、エンドユーザー別、地域別の世界分析

Stratistics MRCによると、ファーマコビジランスおよび医薬品安全性ソフトウェアの世界市場は、2023年に2億260万米ドルを占め、予測期間中にCAGR 8.8％で成長し、2030年には3億6,580万米ドルに達すると予想されています。

ファーマコビジランスは、市販承認後の医薬品の安全性を監視、評価、確保することを含みます。医薬品安全性ソフトウェアは、医薬品に関連する有害事象データの収集、管理、分析によってこのプロセスを支援する専門技術を指します。これらのソフトウェア・ソリューションは、報告を合理化し、規制要件の遵守を促進し、効率的なシグナル検出を可能にし、医薬品安全性プロファイルの継続的な評価と強化に貢献します。

National Care Instituteによると、米国では2018年に170万件のがんが新たに登録されました。

複雑化する医薬品

生物製剤、個別化医薬品、併用療法など、医薬品の製剤が複雑になるにつれ、有害事象のリスクは高まっています。先進的なファーマコビジランスソフトウェアは、包括的なモニタリング、シグナル検出、合理化された有害事象報告を可能にすることで、この複雑性を管理する上で極めて重要な役割を果たします。膨大で複雑なデータセットを処理するソフトウェアの能力は、その分析能力と相まって、医薬品安全性監視の強化、規制遵守、およびプロアクティブなリスク管理を確実にします。その結果、医薬品の複雑さが増すにつれ、洗練されたファーマコビジランスおよび医薬品安全性ソフトウェア・ソリューションに対する需要が高まっています。

高い導入コスト

ソフトウェアの統合、カスタマイズ、データ移行、スタッフのトレーニングに関連する初期費用は相当なものになります。ライセンス料やインフラ投資を含むこれらのコストは、特に経営資源が限られている小規模な製薬会社やヘルスケア事業体にとっては、予算を圧迫する可能性があります。さらに、継続的なメンテナンスとアップグレードが総所有コストにさらに寄与するため、先進的なファーマコビジランスソフトウェア・ソリューションの採用を思いとどまる組織もあり、これが市場の成長をさらに制限しています。

医薬品承認と臨床試験の増加

製薬業界の拡大と世界の臨床試験の急増に伴い、強固な安全対策と効率的なデータ管理の必要性が高まっています。先進的なソフトウェア・ソリューションは、有害事象報告、シグナル検出、リスク評価を合理化し、迅速な承認取得と厳格な安全性コンプライアンスをサポートします。こうしたソフトウェア・ツールの需要は、医薬品開発の迅速化、患者の安全性の向上、進化する規制への対応に業界が重点を置くことによって推進されており、この市場において技術革新と採用の絶好の機会をもたらしています。

ファーマコビジランスソフトウェアの利点に関する認識不足

ファーマコビジランスソフトウェアの利点に関する認識不足は、同市場にとって大きな脅威となっています。有害事象モニタリングを合理化し、医薬品安全性プロトコルを強化し、規制コンプライアンスを迅速化するソフトウェアの機能について、製薬企業やヘルスケア事業体の理解が限定的であることが、その採用を阻害しています。さらに、認知度が十分でないことが、リスクの低減、患者の安全性の向上、医薬品開発プロセスの最適化におけるソフトウェアの可能性の実現を妨げています。

COVID-19の影響：

COVID-19パンデミックは、ファーマコビジランスおよび医薬品安全性ソフトウェア市場に大きな影響を与えました。ワクチンの迅速な開発と医薬品の承認が世界的に急務となり、規制当局の監視が強化され、ファーマコビジランス活動が活発化しました。堅牢な安全性監視システム、有害事象の追跡、合理化された報告メカニズムに対するこのような需要の急増は、高度なソフトウェア・ソリューションの採用を加速させました。さらに、パンデミック時の遠隔地での作業設定により、クラウドベースで遠隔地からアクセス可能なプラットフォームの必要性が強調され、革新的で拡張性が高く、AIを搭載したファーマコビジランスソフトウェアソリューションへの市場のシフトが加速しました。

予測期間中、製薬・バイオテクノロジー企業セグメントが最大になる見込み

製薬企業およびバイオテクノロジー企業セグメントは、研究開発および医薬品製造への多額の投資により、ファーマコビジランスおよび医薬品安全性ソフトウェア市場を独占すると予測されます。これらの企業は規制遵守と患者の安全を最優先するため、堅牢なファーマコビジランス・システムが必要となります。業界が医薬品安全性監視の強化や厳しい規制要件に対する圧力の高まりに直面する中、これらの企業は先進的なソフトウェア・ソリューションの採用を増やしています。これらの技術は、有害事象報告、シグナル検出、リスク管理を合理化し、医薬品の安全性、コンプライアンス、効率性を確保する上で極めて重要であるため、結果として医薬品・バイオテクノロジー市場を牽引しています。

予測期間中、オンデマンド/クラウドベース（SaaS）分野のCAGRが最も高くなると予想される

ファーマコビジランス・医薬品安全性ソフトウェア市場では、オンデマンド／クラウドベース（SaaS）分野が最も高いCAGRを示すと予測されます。この急成長の背景には、柔軟性、拡張性、コスト効率に優れたソリューションに対する業界の嗜好の高まりがあります。クラウドベースのプラットフォームは、アクセシビリティ、リアルタイムのコラボレーション、インフラコストの削減を提供し、製薬企業の進化するニーズに合致しています。合理化されたデータ管理、迅速な展開、リモートアクセスへの要求が強まる中、SaaSモデルが際立っており、著しい成長を牽引しています。

最大のシェアを占める地域

予測期間中、北米が最大の市場シェアを確保する見通しです。同地域の優位性は、強固なヘルスケアインフラ、テクノロジーへの大規模な投資、厳格な医薬品安全対策を義務付ける厳しい規制枠組みに起因します。著名な製薬企業が存在し、先進的なソフトウェア・ソリューションの導入に積極的であることが、北米の優位性をさらに高めています。患者の安全性、コンプライアンス、効率的な有害事象管理の確保に重点が置かれていることから、この地域はファーマコビジランスソフトウェア・ソリューションの成長と採用を促進する極めて重要な拠点として浮上しています。

CAGRが最も高い地域：

アジア太平洋地域は、予測期間中にファーマコビジランスおよび医薬品安全性ソフトウェア市場で最も高い成長を遂げると予測されています。この急成長の背景には、同地域の製薬・バイオテクノロジー分野の拡大とヘルスケアインフラの急速な進歩があります。さらに、臨床試験のアウトソーシングの増加、研究開発への投資の増加、ヘルスケアのデジタル化への関心の高まりが、堅牢なファーマコビジランス・ソリューションの需要を促進しています。医薬品の安全性強化がますます重視される中、アジア太平洋地域は市場を大きく拡大する極めて重要な地域として浮上しています。

無料のカスタマイズサービス：

本レポートをご購読のお客様には、以下の無料カスタマイズオプションのいずれかをご利用いただけます：

• 企業プロファイル
  • 追加市場プレーヤーの包括的プロファイリング（3社まで）
  • 主要企業のSWOT分析（3社まで）
• 地域セグメンテーション
  • 顧客の関心に応じた主要国の市場推計・予測・CAGR（注：フィージビリティチェックによる）
• 競合ベンチマーキング
  • 製品ポートフォリオ、地理的プレゼンス、戦略的提携に基づく主要企業のベンチマーキング

目次

第1章 エグゼクティブサマリー

第2章 序文

• 概要
• ステークホルダー
• 調査範囲
• 調査手法
  • データマイニング
  • データ分析
  • データ検証
  • 調査アプローチ
• 調査ソース
  • 1次調査ソース
  • 2次調査ソース
  • 前提条件

第3章 市場動向分析

• 促進要因
• 抑制要因
• 機会
• 脅威
• エンドユーザー分析
• 新興市場
• 新型コロナウイルス感染症（COVID-19）の影響

第4章 ポーターのファイブフォース分析

• 供給企業の交渉力
• 買い手の交渉力
• 代替品の脅威
• 新規参入業者の脅威
• 競争企業間の敵対関係

第5章 世界のファーマコビジランスおよび医薬品安全性ソフトウェア市場：機能別

• 有害事象報告ソフトウェア
• 医薬品安全性監査ソフトウェア
• 完全に統合されたソフトウェア
• 問題追跡ソフトウェア
• その他の機能

第6章 世界のファーマコビジランスおよび医薬品安全性ソフトウェア市場：提供モード別

• オンプレミス
• オンデマンド/クラウドベース（SaaS）

第7章 世界のファーマコビジランスおよび医薬品安全性ソフトウェア市場：エンドユーザー別

• 製薬およびバイオテクノロジー企業
• ビジネスプロセスアウトソーシング（BPO）
• 受託調査機関（CRO）
• 調査機関
• その他のエンドユーザー

第8章 世界のファーマコビジランスおよび医薬品安全性ソフトウェア市場：地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • イタリア
  • フランス
  • スペイン
  • その他欧州
• アジア太平洋地域
  • 日本
  • 中国
  • インド
  • オーストラリア
  • ニュージーランド
  • 韓国
  • その他アジア太平洋地域
• 南米
  • アルゼンチン
  • ブラジル
  • チリ
  • その他南米
• 中東とアフリカ
  • サウジアラビア
  • アラブ首長国連邦
  • カタール
  • 南アフリカ
  • その他中東とアフリカ

第9章 主な発展

• 契約、パートナーシップ、コラボレーション、合弁事業
• 買収と合併
• 新製品の発売
• 事業拡大
• その他の主要戦略

第10章 企業プロファイル

• Accelovance
• ArisGlobal LLC
• Cognizant
• DXC Technology
• Ennov
• EXTEDO
• FMD K&L Inc.
• ICON plc
• IQVIA
• Novartis AG
• Oracle Corporation
• Parexel International Corporation
• Sarjen Systems Pvt. Ltd.
• SAS Institute Inc.
• Sparta Systems
• Veeva Systems
• Wingspan Technology, Inc.

List of Tables

• Table 1 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Region (2021-2030) ($MN)
• Table 2 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Functionality (2021-2030) ($MN)
• Table 3 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Adverse Event Reporting Software (2021-2030) ($MN)
• Table 4 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Drug Safety Audits Software (2021-2030) ($MN)
• Table 5 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Fully Integrated Software (2021-2030) ($MN)
• Table 6 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Issue Tracking Software (2021-2030) ($MN)
• Table 7 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Other Functionalities (2021-2030) ($MN)
• Table 8 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Mode of Delivery (2021-2030) ($MN)
• Table 9 Global Pharmacovigilance and Drug Safety Software Market Outlook, By On-Premise (2021-2030) ($MN)
• Table 10 Global Pharmacovigilance and Drug Safety Software Market Outlook, By On-Demand/Cloud-Based (SaaS) (2021-2030) ($MN)
• Table 11 Global Pharmacovigilance and Drug Safety Software Market Outlook, By End User (2021-2030) ($MN)
• Table 12 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Pharmaceuticals & Biotechnology Companies (2021-2030) ($MN)
• Table 13 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Business Process Outsourcing (BPOs) (2021-2030) ($MN)
• Table 14 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Contract Research Organizations (CROs) (2021-2030) ($MN)
• Table 15 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Research Institutions (2021-2030) ($MN)
• Table 16 Global Pharmacovigilance and Drug Safety Software Market Outlook, By Other End Users (2021-2030) ($MN)
• Table 17 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Country (2021-2030) ($MN)
• Table 18 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Functionality (2021-2030) ($MN)
• Table 19 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Adverse Event Reporting Software (2021-2030) ($MN)
• Table 20 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Drug Safety Audits Software (2021-2030) ($MN)
• Table 21 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Fully Integrated Software (2021-2030) ($MN)
• Table 22 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Issue Tracking Software (2021-2030) ($MN)
• Table 23 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Other Functionalities (2021-2030) ($MN)
• Table 24 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Mode of Delivery (2021-2030) ($MN)
• Table 25 North America Pharmacovigilance and Drug Safety Software Market Outlook, By On-Premise (2021-2030) ($MN)
• Table 26 North America Pharmacovigilance and Drug Safety Software Market Outlook, By On-Demand/Cloud-Based (SaaS) (2021-2030) ($MN)
• Table 27 North America Pharmacovigilance and Drug Safety Software Market Outlook, By End User (2021-2030) ($MN)
• Table 28 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Pharmaceuticals & Biotechnology Companies (2021-2030) ($MN)
• Table 29 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Business Process Outsourcing (BPOs) (2021-2030) ($MN)
• Table 30 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Contract Research Organizations (CROs) (2021-2030) ($MN)
• Table 31 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Research Institutions (2021-2030) ($MN)
• Table 32 North America Pharmacovigilance and Drug Safety Software Market Outlook, By Other End Users (2021-2030) ($MN)
• Table 33 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Country (2021-2030) ($MN)
• Table 34 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Functionality (2021-2030) ($MN)
• Table 35 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Adverse Event Reporting Software (2021-2030) ($MN)
• Table 36 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Drug Safety Audits Software (2021-2030) ($MN)
• Table 37 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Fully Integrated Software (2021-2030) ($MN)
• Table 38 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Issue Tracking Software (2021-2030) ($MN)
• Table 39 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Other Functionalities (2021-2030) ($MN)
• Table 40 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Mode of Delivery (2021-2030) ($MN)
• Table 41 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By On-Premise (2021-2030) ($MN)
• Table 42 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By On-Demand/Cloud-Based (SaaS) (2021-2030) ($MN)
• Table 43 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By End User (2021-2030) ($MN)
• Table 44 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Pharmaceuticals & Biotechnology Companies (2021-2030) ($MN)
• Table 45 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Business Process Outsourcing (BPOs) (2021-2030) ($MN)
• Table 46 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Contract Research Organizations (CROs) (2021-2030) ($MN)
• Table 47 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Research Institutions (2021-2030) ($MN)
• Table 48 Europe Pharmacovigilance and Drug Safety Software Market Outlook, By Other End Users (2021-2030) ($MN)
• Table 49 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Country (2021-2030) ($MN)
• Table 50 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Functionality (2021-2030) ($MN)
• Table 51 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Adverse Event Reporting Software (2021-2030) ($MN)
• Table 52 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Drug Safety Audits Software (2021-2030) ($MN)
• Table 53 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Fully Integrated Software (2021-2030) ($MN)
• Table 54 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Issue Tracking Software (2021-2030) ($MN)
• Table 55 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Other Functionalities (2021-2030) ($MN)
• Table 56 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Mode of Delivery (2021-2030) ($MN)
• Table 57 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By On-Premise (2021-2030) ($MN)
• Table 58 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By On-Demand/Cloud-Based (SaaS) (2021-2030) ($MN)
• Table 59 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By End User (2021-2030) ($MN)
• Table 60 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Pharmaceuticals & Biotechnology Companies (2021-2030) ($MN)
• Table 61 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Business Process Outsourcing (BPOs) (2021-2030) ($MN)
• Table 62 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Contract Research Organizations (CROs) (2021-2030) ($MN)
• Table 63 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Research Institutions (2021-2030) ($MN)
• Table 64 Asia Pacific Pharmacovigilance and Drug Safety Software Market Outlook, By Other End Users (2021-2030) ($MN)
• Table 65 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Country (2021-2030) ($MN)
• Table 66 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Functionality (2021-2030) ($MN)
• Table 67 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Adverse Event Reporting Software (2021-2030) ($MN)
• Table 68 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Drug Safety Audits Software (2021-2030) ($MN)
• Table 69 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Fully Integrated Software (2021-2030) ($MN)
• Table 70 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Issue Tracking Software (2021-2030) ($MN)
• Table 71 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Other Functionalities (2021-2030) ($MN)
• Table 72 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Mode of Delivery (2021-2030) ($MN)
• Table 73 South America Pharmacovigilance and Drug Safety Software Market Outlook, By On-Premise (2021-2030) ($MN)
• Table 74 South America Pharmacovigilance and Drug Safety Software Market Outlook, By On-Demand/Cloud-Based (SaaS) (2021-2030) ($MN)
• Table 75 South America Pharmacovigilance and Drug Safety Software Market Outlook, By End User (2021-2030) ($MN)
• Table 76 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Pharmaceuticals & Biotechnology Companies (2021-2030) ($MN)
• Table 77 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Business Process Outsourcing (BPOs) (2021-2030) ($MN)
• Table 78 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Contract Research Organizations (CROs) (2021-2030) ($MN)
• Table 79 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Research Institutions (2021-2030) ($MN)
• Table 80 South America Pharmacovigilance and Drug Safety Software Market Outlook, By Other End Users (2021-2030) ($MN)
• Table 81 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Country (2021-2030) ($MN)
• Table 82 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Functionality (2021-2030) ($MN)
• Table 83 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Adverse Event Reporting Software (2021-2030) ($MN)
• Table 84 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Drug Safety Audits Software (2021-2030) ($MN)
• Table 85 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Fully Integrated Software (2021-2030) ($MN)
• Table 86 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Issue Tracking Software (2021-2030) ($MN)
• Table 87 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Other Functionalities (2021-2030) ($MN)
• Table 88 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Mode of Delivery (2021-2030) ($MN)
• Table 89 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By On-Premise (2021-2030) ($MN)
• Table 90 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By On-Demand/Cloud-Based (SaaS) (2021-2030) ($MN)
• Table 91 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By End User (2021-2030) ($MN)
• Table 92 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Pharmaceuticals & Biotechnology Companies (2021-2030) ($MN)
• Table 93 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Business Process Outsourcing (BPOs) (2021-2030) ($MN)
• Table 94 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Contract Research Organizations (CROs) (2021-2030) ($MN)
• Table 95 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Research Institutions (2021-2030) ($MN)
• Table 96 Middle East & Africa Pharmacovigilance and Drug Safety Software Market Outlook, By Other End Users (2021-2030) ($MN)

According to Stratistics MRC, the Global Pharmacovigilance and Drug Safety Software Market is accounted for $202.6 million in 2023 and is expected to reach $365.8 million by 2030 growing at a CAGR of 8.8% during the forecast period. Pharmacovigilance involves monitoring, assessing, and ensuring the safety of pharmaceutical products post-market approval. Drug Safety Software refers to specialized technology aiding in this process by collecting, managing, and analyzing adverse event data associated with medications. These software solutions streamline reporting, facilitate compliance with regulatory requirements, and enable efficient signal detection, contributing to the continual evaluation and enhancement of drug safety profiles.

According to the National Care Institute 1.7 million new cases of cancer were registered in the U.S. in 2018.

Market Dynamics:

Driver:

Growing complexity of drugs

As drug formulations become more intricate, involving biologics, personalized medicines, and combination therapies, the risk of adverse events intensifies. Advanced pharmacovigilance software plays a pivotal role in managing this complexity by enabling comprehensive monitoring, signal detection, and streamlined adverse event reporting. The software's capacity to handle vast and intricate data sets, coupled with its analytical capabilities, ensures enhanced drug safety surveillance, regulatory compliance, and proactive risk management. Consequently, the growing complexity of drugs propels the demand for sophisticated pharmacovigilance and drug safety software solutions.

Restraint:

High implementation costs

The initial expenses associated with software integration, customization, data migration, and staff training can be substantial. These costs, which include licensing fees and infrastructure investments, can strain budgets, particularly for smaller pharmaceutical companies or healthcare entities with limited resources. Moreover, ongoing maintenance and upgrades further contribute to the total cost of ownership, deterring some organizations from adopting advanced pharmacovigilance software solutions, which further limits the market growth.

Opportunity:

Increasing drug approvals and clinical trials

With an expanding pharmaceutical landscape and a burgeoning number of clinical trials globally, there's a heightened need for robust safety measures and efficient data management. Advanced software solutions offer streamlined adverse event reporting, signal detection, and risk assessment, supporting quicker approvals and ensuring stringent safety compliance. The demand for these software tools is propelled by the industry's focus on accelerating drug development, enhancing patient safety, and complying with evolving regulatory mandates, presenting a ripe opportunity for innovation and adoption within this market.

Threat:

Lack of awareness regarding the benefits of pharmacovigilance software

The lack of awareness regarding the advantages of pharmacovigilance software poses a significant threat to the market. Limited understanding among pharmaceutical companies and healthcare entities about the software's capability to streamline adverse event monitoring, enhance drug safety protocols, and expedite regulatory compliance impedes its adoption. Additionally, insufficient awareness hampers the realization of its potential in reducing risks, improving patient safety and optimizing drug development processes.

COVID-19 Impact:

The COVID-19 pandemic significantly influenced the pharmacovigilance and drug safety software markets. The global urgency for rapid vaccine development and drug approvals prompted heightened regulatory scrutiny and increased pharmacovigilance activities. This surge in demand for robust safety monitoring systems, adverse event tracking, and streamlined reporting mechanisms amplified the adoption of advanced software solutions. Additionally, remote work setups during the pandemic emphasized the need for cloud-based and remote-accessible platforms, accelerating the market's shift towards innovative, scalable, and AI-powered pharmacovigilance software solutions.

The pharmaceuticals & biotechnology companies segment is expected to be the largest during the forecast period

The pharmaceuticals and biotechnology companies segment is anticipated to dominate the pharmacovigilance and drug safety software market due to its substantial investment in research, development, and drug manufacturing. These companies prioritize regulatory compliance and patient safety, necessitating robust pharmacovigilance systems. As the industry faces escalating pressure for enhanced drug safety monitoring and stringent regulatory requirements, these entities increasingly adopt advanced software solutions. These technologies streamline adverse event reporting, signal detection, and risk management, which are crucial in ensuring drug safety, compliance, and efficiency, consequently propelling the pharmaceutical and biotechnology market.

The on-demand/cloud-based (SaaS) segment is expected to have the highest CAGR during the forecast period

The on-demand/cloud-based (SaaS) segment is projected to exhibit the highest CAGR in the pharmacovigilance and drug safety software market. This surge is fueled by the industry's growing preference for flexible, scalable, and cost-effective solutions. Cloud-based platforms offer accessibility, real-time collaboration, and reduced infrastructure costs, aligning well with the evolving needs of pharmaceutical companies. As the demand intensifies for streamlined data management, rapid deployment, and remote accessibility, the SaaS model stands out, driving its remarkable growth.

Region with largest share:

North America is poised to secure the largest market share during the forecast period. This prominence is attributed to the region's robust healthcare infrastructure, substantial investments in technology, and stringent regulatory frameworks mandating stringent drug safety measures. The presence of prominent pharmaceutical companies and a proactive approach toward adopting advanced software solutions further contribute to North America's dominance. With a heightened focus on ensuring patient safety, compliance, and efficient adverse event management, the region emerges as a pivotal hub driving the growth and adoption of pharmacovigilance software solutions.

Region with highest CAGR:

The Asia Pacific region is anticipated to witness the highest growth in the pharmacovigilance and drug safety software market during the forecast period. This upsurge is fueled by the region's expanding pharmaceutical and biotechnology sectors and rapid advancements in healthcare infrastructure. Additionally, increased outsourcing of clinical trials, rising investments in research and development, and a growing focus on healthcare digitization drive the demand for robust pharmacovigilance solutions. With a mounting emphasis on enhancing drug safety, the Asia-Pacific region emerges as a pivotal region for significant market expansion.

Key players in the market:

Some of the key players in Pharmacovigilance And Drug Safety Software Market include Accelovance, ArisGlobal LLC, Cognizant, DXC Technology, Ennov, EXTEDO, FMD K&L Inc., ICON plc, IQVIA, Novartis AG, Oracle Corporation, Parexel International Corporation, Sarjen Systems Pvt. Ltd., SAS Institute Inc., Sparta Systems, Veeva Systems and Wingspan Technology, Inc.

Key Developments:

In October 2023, Ennov is pleased to announce a strategic partnership with ION Pharma. This alliance marks the beginning of a collaborative effort that merges over two decades of expertise in electronic Quality Management Systems (eQMS) with the shared goal of advancing patient outcomes in the Life Sciences sector.

In October 2023, IQVIA, a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry announced a strategic collaboration with argenx to advance treatment to patients with rare autoimmune diseases through innovative and integrated technology-enabled pharmacovigilance (PV) safety services and solutions.

In April 2023, Ennov, a leading provider of regulated content and data management software for the Life Sciences industry, is happy to announce that it has acquired UK-based Samarind from its parent company Instem.

Functionalities Covered:

• Adverse Event Reporting Software
• Drug Safety Audits Software
• Fully Integrated Software
• Issue Tracking Software
• Other Functionalities

Mode of Delivery Covered:

• On-Premise
• On-Demand/Cloud-Based (SaaS)

End Users Covered:

• Pharmaceuticals & Biotechnology Companies
• Business Process Outsourcing (BPOs)
• Contract Research Organizations (CROs)
• Research Institutions
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 End User Analysis
• 3.7 Emerging Markets
• 3.8 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Pharmacovigilance and Drug Safety Software Market, By Functionality

• 5.1 Introduction
• 5.2 Adverse Event Reporting Software
• 5.3 Drug Safety Audits Software
• 5.4 Fully Integrated Software
• 5.5 Issue Tracking Software
• 5.6 Other Functionalities

6 Global Pharmacovigilance and Drug Safety Software Market, By Mode of Delivery

• 6.1 Introduction
• 6.2 On-Premise
• 6.3 On-Demand/Cloud-Based (SaaS)

7 Global Pharmacovigilance and Drug Safety Software Market, By End User

• 7.1 Introduction
• 7.2 Pharmaceuticals & Biotechnology Companies
• 7.3 Business Process Outsourcing (BPOs)
• 7.4 Contract Research Organizations (CROs)
• 7.5 Research Institutions
• 7.6 Other End Users

8 Global Pharmacovigilance and Drug Safety Software Market, By Geography

• 8.1 Introduction
• 8.2 North America
  • 8.2.1 US
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 Italy
  • 8.3.4 France
  • 8.3.5 Spain
  • 8.3.6 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 Japan
  • 8.4.2 China
  • 8.4.3 India
  • 8.4.4 Australia
  • 8.4.5 New Zealand
  • 8.4.6 South Korea
  • 8.4.7 Rest of Asia Pacific
• 8.5 South America
  • 8.5.1 Argentina
  • 8.5.2 Brazil
  • 8.5.3 Chile
  • 8.5.4 Rest of South America
• 8.6 Middle East & Africa
  • 8.6.1 Saudi Arabia
  • 8.6.2 UAE
  • 8.6.3 Qatar
  • 8.6.4 South Africa
  • 8.6.5 Rest of Middle East & Africa

9 Key Developments

• 9.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 9.2 Acquisitions & Mergers
• 9.3 New Product Launch
• 9.4 Expansions
• 9.5 Other Key Strategies

10 Company Profiling

• 10.1 Accelovance
• 10.2 ArisGlobal LLC
• 10.3 Cognizant
• 10.4 DXC Technology
• 10.5 Ennov
• 10.6 EXTEDO
• 10.7 FMD K&L Inc.
• 10.8 ICON plc
• 10.9 IQVIA
• 10.10 Novartis AG
• 10.11 Oracle Corporation
• 10.12 Parexel International Corporation
• 10.13 Sarjen Systems Pvt. Ltd.
• 10.14 SAS Institute Inc.
• 10.15 Sparta Systems
• 10.16 Veeva Systems
• 10.17 Wingspan Technology, Inc.