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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レポート：機能、デリバリーモード、エンドユーザー、地域別、2024年～2032年

Pharmacovigilance and Drug Safety Software Market Report by Functionality, Delivery Mode, End User, and Region 2024-2032

出版日
発行
IMARC
ページ情報
英文 137 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および医薬品安全性ソフトウェア市場レポート：機能、デリバリーモード、エンドユーザー、地域別、2024年～2032年
出版日: 2024年07月01日
発行: IMARC
ページ情報: 英文 137 Pages
納期: 2～3営業日
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  • 全表示
  • 概要
  • 図表
  • 目次
概要

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規模は、2023年に2億230万米ドルに達しました。今後、IMARC Groupは、市場は2032年までに3億4,150万米ドルに達し、2024年から2032年の間に5.9%の成長率（CAGR）を示すと予測しています。大衆の間で慢性疾患が蔓延していること、医薬品の商業化に関する厳格な規制が実施されていること、ソフトウェア機能とユーザーフレンドリーなインターフェースの継続的な進歩が市場を推進している主な要因の一部です。

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は、医薬品副作用（ADR）やその他の医薬品関連の安全性に関する懸念事項のモニタリング、分析、報告を合理化・強化するために設計された専門的なコンピューター・プログラムを指します。これらのソフトウェアシステムは、医薬品の安全かつ効果的な使用を保証するファーマコビジランスの分野で重要な役割を果たしています。これらのソフトウェア・ソリューションにより、製薬会社、規制当局、ヘルスケア専門家は、医薬品の安全性に関する大量のデータを効率的に収集、管理、分析できるようになります。また、潜在的なリスクやパターンの検出を容易にし、タイムリーな介入やリスク軽減戦略を可能にします。

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市場は、臨床研究およびアウトソーシング企業によるこれらのソフトウェアソリューションの採用が増加していることを背景としています。これらの企業は、開発中の医薬品の安全性と有効性を確保し、市販後調査を実施するための強固なファーマコビジランス・システムの重要性を認識しています。さらに、慢性疾患の有病率の増加も市場の成長に寄与しています。長期投薬が必要な患者の増加に伴い、効果的な医薬品安全性監視・管理の必要性も高まっています。これとは別に、世界各国の政府が医薬品の商業化に厳しい規制を課しているため、医薬品安全性規制が複雑化し、需要をさらに押し上げています。その上、最先端技術の利用可能性は、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の容易な採用を促進しています。さらに、ソフトウェア機能とユーザーフレンドリーなインターフェイスの継続的な進歩により、組織はこれらのソリューションを既存のワークフローに導入・統合することが容易になり、市場に好影響をもたらしています。

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市場動向/促進要因：

製薬業界の拡大

製薬業界の開発は、世界のファーマコビジランス（PV）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ています。製薬業界の拡大に伴い、新薬や治療法の開発が増加しています。そのため、有害事象を監視・分析・管理するPV・医薬品安全性ソフトウェアのニーズが高まり、同ソフトウェアの需要増につながっています。さらに、製薬業界の拡大によりデータ量と複雑性が増大し、データを管理・分析するための高度なソフトウェアが必要とされています。このため、このような複雑なデータセットを効果的に処理するために、PVや医薬品安全性ソフトウェアにAIや機械学習の開発・導入が進んでいます。また、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は、これらのリスクを管理するのに役立ち、リスク管理のニーズの高まりがこの市場の需要を促進しています。

医薬品副作用の発生率の増加

医薬品副作用（ADR）の発生率の増加は、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の市場に大きな影響を与えています。ADRの報告件数の増加により、市場における医薬品の安全性と有効性を確保するための強固なファーマコビジランス・システムとソフトウェア・ソリューションに対するニーズが高まっています。副作用は患者の健康や福祉に深刻な影響を及ぼし、入院や追加の医療費、さらには死亡事故につながる可能性があります。そのため、世界中の規制当局は、製薬会社がADRを効果的に監視・報告するための厳しいガイドラインや規制を実施しています。これに伴い、ソフトウェア・ソリューションを提供する企業は、大量の有害事象データを効率的に処理できる高度なツールや機能を提供するために継続的に技術革新を行っているため、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の市場は、ADRの発生率の上昇に直接対応する形で大きな成長を遂げています。

ヘルスケア支出の増加

ヘルスケア支出が世界的に増加し続ける中、患者の安全性を最適化し、ヘルスケア提供の全体的な質を向上させることが重視されるようになっています。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は、医薬品副作用（ADR）やその他の医薬品関連問題の効果的なモニタリング、評価、管理を確実にすることで、これらの目的を達成する上で重要な役割を果たしています。ヘルスケア支出の増加に伴い、患者の安全性への注目が高まっています。ファーマコビジランス・ソフトウェアは、ヘルスケア組織や規制当局にADRを監視・予防するためのツールを提供し、薬害に関連する経済的負担を軽減します。さらに、ヘルスケア支出の増加により、リソースの最適化が必要となっています。さらに、ファーマコビジランス・ソフトウェアは有害事象データの効率的な管理を可能にし、報告および分析プロセスを合理化します。

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および医薬品安全性ソフトウェア市場

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

第6章 市場内訳：機能別

  • 有害事象報告ソフトウェア
    • 市場動向
    • 市場予測
  • 医薬品安全性監査ソフトウェア
    • 市場動向
    • 市場予測
  • 問題追跡ソフトウェア
    • 市場動向
    • 市場予測
  • 完全統合ソフトウェア
    • 市場動向
    • 市場予測

第7章 市場内訳：デリバリーモード別

  • オンプレミス
    • 市場動向
    • 市場予測
  • クラウドベース
    • 市場動向
    • 市場予測

第8章 市場内訳：エンドユーザー別

  • 製薬・バイオテクノロジー企業
    • 市場動向
    • 市場予測
  • 契約調査機関
    • 市場動向
    • 市場予測
  • ビジネスプロセスアウトソーシング企業
    • 市場動向
    • 市場予測
  • その他
    • 市場動向
    • 市場予測

第9章 市場内訳：地域別

  • 北米
    • 米国
    • カナダ
  • アジア太平洋地域
    • 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10章 SWOT分析

  • 概要
  • 強み
  • 弱み
  • 機会
  • 脅威

第11章 バリューチェーン分析

第12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13章 価格分析

第14章 競合情勢

  • 市場構造
  • 主要企業
  • 主要企業のプロファイル
    • Ab Cube
    • Anju Software Inc.
    • ArisGlobal LLC
    • Cognizant
    • Ennov Solutions Inc.
    • Extedo GmbH
    • Max Application
    • Oracle Corporation
    • Sarjen Systems Pvt Ltd
    • Sparta Systems Inc.（Honeywell International Inc.）
    • Tata Consultancy Services Limited
    • United BioSource LLC
    • Wipro Limited
図表

List of Figures

  • Figure 1: Global: Pharmacovigilance and Drug Safety Software Market: Major Drivers and Challenges
  • Figure 2: Global: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018-2023
  • Figure 3: Global: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 4: Global: Pharmacovigilance and Drug Safety Software Market: Breakup by Functionality (in %), 2023
  • Figure 5: Global: Pharmacovigilance and Drug Safety Software Market: Breakup by Delivery Mode (in %), 2023
  • Figure 6: Global: Pharmacovigilance and Drug Safety Software Market: Breakup by End User (in %), 2023
  • Figure 7: Global: Pharmacovigilance and Drug Safety Software Market: Breakup by Region (in %), 2023
  • Figure 8: Global: Pharmacovigilance and Drug Safety Software (Adverse Event Reporting Software) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 9: Global: Pharmacovigilance and Drug Safety Software (Adverse Event Reporting Software) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 10: Global: Pharmacovigilance and Drug Safety Software (Drug Safety Audits Software) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 11: Global: Pharmacovigilance and Drug Safety Software (Drug Safety Audits Software) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 12: Global: Pharmacovigilance and Drug Safety Software (Issue Tracking Software) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 13: Global: Pharmacovigilance and Drug Safety Software (Issue Tracking Software) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 14: Global: Pharmacovigilance and Drug Safety Software (Fully Integrated Software) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 15: Global: Pharmacovigilance and Drug Safety Software (Fully Integrated Software) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 16: Global: Pharmacovigilance and Drug Safety Software (On-premises) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 17: Global: Pharmacovigilance and Drug Safety Software (On-premises) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 18: Global: Pharmacovigilance and Drug Safety Software (Cloud-based) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 19: Global: Pharmacovigilance and Drug Safety Software (Cloud-based) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 20: Global: Pharmacovigilance and Drug Safety Software (Pharmaceutical and Biotechnology Companies) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 21: Global: Pharmacovigilance and Drug Safety Software (Pharmaceutical and Biotechnology Companies) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 22: Global: Pharmacovigilance and Drug Safety Software (Contract Research Organizations) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 23: Global: Pharmacovigilance and Drug Safety Software (Contract Research Organizations) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 24: Global: Pharmacovigilance and Drug Safety Software (Business Process Outsourcing Firms) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 25: Global: Pharmacovigilance and Drug Safety Software (Business Process Outsourcing Firms) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 26: Global: Pharmacovigilance and Drug Safety Software (Other End Users) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 27: Global: Pharmacovigilance and Drug Safety Software (Other End Users) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 28: North America: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 29: North America: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 30: United States: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 31: United States: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 32: Canada: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 33: Canada: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 34: Asia-Pacific: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 35: Asia-Pacific: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 36: China: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 37: China: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 38: Japan: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 39: Japan: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 40: India: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 41: India: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 42: South Korea: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 43: South Korea: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 44: Australia: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 45: Australia: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 46: Indonesia: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 47: Indonesia: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 48: Others: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 49: Others: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 50: Europe: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 51: Europe: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 52: Germany: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 53: Germany: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 54: France: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 55: France: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 56: United Kingdom: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 57: United Kingdom: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 58: Italy: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 59: Italy: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 60: Spain: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 61: Spain: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 62: Russia: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 63: Russia: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 64: Others: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 65: Others: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 66: Latin America: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 67: Latin America: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 68: Brazil: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 69: Brazil: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 70: Mexico: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 71: Mexico: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 72: Others: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 73: Others: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 74: Middle East and Africa: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 75: Middle East and Africa: Pharmacovigilance and Drug Safety Software Market: Breakup by Country (in %), 2023
  • Figure 76: Middle East and Africa: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 77: Global: Pharmacovigilance and Drug Safety Software Industry: SWOT Analysis
  • Figure 78: Global: Pharmacovigilance and Drug Safety Software Industry: Value Chain Analysis
  • Figure 79: Global: Pharmacovigilance and Drug Safety Software Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Pharmacovigilance and Drug Safety Software Market: Key Industry Highlights, 2023 and 2032
  • Table 2: Global: Pharmacovigilance and Drug Safety Software Market Forecast: Breakup by Functionality (in Million US$), 2024-2032
  • Table 3: Global: Pharmacovigilance and Drug Safety Software Market Forecast: Breakup by Delivery Mode (in Million US$), 2024-2032
  • Table 4: Global: Pharmacovigilance and Drug Safety Software Market Forecast: Breakup by End User (in Million US$), 2024-2032
  • Table 5: Global: Pharmacovigilance and Drug Safety Software Market Forecast: Breakup by Region (in Million US$), 2024-2032
  • Table 6: Global: Pharmacovigilance and Drug Safety Software Market: Competitive Structure
  • Table 7: Global: Pharmacovigilance and Drug Safety Software Market: Key Players
目次
Product Code: SR112024A5030

The global pharmacovigilance and drug safety software market size reached US$ 202.3 Million in 2023. Looking forward, IMARC Group expects the market to reach US$ 341.5 Million by 2032, exhibiting a growth rate (CAGR) of 5.9% during 2024-2032. The growing prevalence of chronic diseases among the masses, the implementation of strict regulations on the commercialization of drugs, and continual advancements in software capabilities and user-friendly interfaces are some of the major factors propelling the market.

Pharmacovigilance and drug safety software refers to specialized computer programs designed to streamline and enhance the monitoring, analysis, and reporting of adverse drug reactions (ADRs) and other drug-related safety concerns. These software systems play a crucial role in the field of pharmacovigilance, which is dedicated to ensuring the safe and effective use of medications. These software solutions enable pharmaceutical companies, regulatory authorities, and healthcare professionals to efficiently collect, manage, and analyze large volumes of data pertaining to drug safety. They also facilitate the detection of potential risks and patterns, allowing for timely intervention and risk mitigation strategies.

The pharmacovigilance and drug safety software market is driven by the increasing adoption of these software solutions by clinical research and outsourcing companies. These organizations recognize the importance of robust pharmacovigilance systems to ensure the safety and efficacy of drugs in development and post-marketing surveillance. Moreover, the growing prevalence of chronic diseases is also contributing to the growth of the market. As the number of patients requiring long-term medication increases, so does the need for effective drug safety monitoring and management. Apart from this, governments worldwide are imposing strict regulations on the commercialization of drugs, leading to increased complexity in drug safety regulations, further impelling the demand. Besides, the availability of cutting-edge technology is facilitating the easy adoption of pharmacovigilance and drug safety software. Furthermore, continual advancements in software capabilities and user-friendly interfaces make it easier for organizations to implement and integrate these solutions into their existing workflows, thus impacting the market favorably.

Pharmacovigilance and Drug Safety Software Market Trends/Drivers:

Expansion of the Pharmaceutical Industry

The development of the pharmaceutical industry is having a significant influence on the global pharmacovigilance (PV) and drug safety software market. As the pharmaceutical industry expands, there has been an increase in the development of new drugs and therapies. This leads to a greater need for PV and drug safety software to monitor, analyze, and manage adverse events, leading to an increase in demand for this software. Moreover, the pharmaceutical industry's expansion has led to a rise in data volume and complexity, requiring sophisticated software for managing and analyzing data. This is driving the development and adoption of AI and machine learning within PV and drug safety software to handle, such complex datasets effectively. Also, pharmacovigilance and drug safety software help manage these risks, and the growing need for risk management is driving demand in this market.

Growing Incidence of Adverse Drug Reactions

The increasing incidence of adverse drug reactions (ADRs) is significantly influencing the global pharmacovigilance and drug safety software market. The raising number of reported ADRs has created a greater need for robust pharmacovigilance systems and software solutions to ensure the safety and efficacy of drugs in the market. Adverse drug reactions can have serious consequences on patient health and well-being, leading to hospitalizations, additional medical costs, and even fatalities. Therefore, regulatory authorities worldwide have implemented stringent guidelines and regulations for pharmaceutical companies to monitor and report ADRs effectively. Along with this, the global pharmacovigilance and drug safety software market has experienced significant growth as a direct response to the rising incidence of ADRs since companies offering these software solutions are continuously innovating to provide advanced tools and functionalities that can handle large volumes of adverse event data efficiently.

The Increasing Healthcare Expenditure

As healthcare expenditure continues to rise globally, there is a growing emphasis on optimizing patient safety and improving the overall quality of healthcare delivery. Pharmacovigilance and drug safety software play a crucial role in achieving these objectives by ensuring the effective monitoring, assessment, and management of adverse drug reactions (ADRs) and other drug-related problems. With higher healthcare spending, there has been a growing focus on patient safety. Pharmacovigilance software provides healthcare organizations and regulatory authorities with the tools to monitor and prevent ADRs, thereby reducing the economic burden associated with medication-related harm. Moreover, healthcare expenditure growth necessitates the optimization of resources. Furthermore, pharmacovigilance software enables the efficient management of adverse event data, streamlining the reporting and analysis processes.

Pharmacovigilance and Drug Safety Software Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global pharmacovigilance and drug safety software market report, along with forecasts at the global, regional and country levels from 2024-2032. Our report has categorized the market based on functionality, delivery mode and end user.

Breakup by Functionality:

Adverse Event Reporting Software

Drug Safety Audits Software

Issue Tracking Software

Fully Integrated Software

Adverse event reporting software dominates the market

The report has provided a detailed breakup and analysis of the market based on the functionality. This includes adverse event reporting software, drug safety audits software, issue tracking software, and fully integrated software. According to the report, adverse event reporting software represented the largest segment.

Adverse event reporting software dominates the market as it is a critical aspect of regulatory compliance in the healthcare and pharmaceutical industries. It offers robust data management capabilities, allowing efficient collection, organization, and analysis of adverse event data. It enables the identification of patterns, trends, and potential safety issues associated with specific products or interventions. This data-driven approach helps pharmaceutical companies, healthcare providers, and regulatory agencies make informed decisions regarding product safety and risk mitigation strategies. Additionally, it provides a systematic and standardized approach to capturing and reporting these events, ensuring compliance with regulatory requirements. It provides a centralized platform for healthcare professionals, drug safety experts, and other stakeholders involved in adverse event reporting. Additionally, the software can scale to handle large volumes of adverse event data, ensuring its effectiveness even for organizations with extensive reporting requirements.

Breakup by Delivery Mode:

On-premises

Cloud-based

On- premises delivery holds the largest share in the market

A detailed breakup and analysis of the market based on the delivery mode has also been provided in the report. This includes on-premises and cloud-based. According to the report, on premises accounted for the largest market share.

On-premises deployment holds the largest share of the market as it provides organizations with a higher level of control and security over their data. It offers greater flexibility for customization and integration with existing systems. Organizations can tailor the software to their specific requirements and integrate it seamlessly with other on-premises applications or infrastructure. This level of customization and integration is beneficial for organizations with complex IT environments or unique business processes. The deployment allows organizations to maintain data sovereignty by ensuring that sensitive data remains within the borders of their own country. Moreover, the widespread adoption of on-premises software help eliminate the potential performance issues related to network latency or dependence on internet connectivity. Also, it allows organizations to maintain compliance and meet regulatory standards more easily.

Breakup by End User:

Pharmaceutical and Biotechnology Companies

Contract Research Organizations

Business Process Outsourcing Firms

Others

Contract research organizations hold the largest share in the market

A detailed breakup and analysis of the market based on the end user has also been provided in the report. This includes pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing firms, and others. According to the report, contract research organizations accounted for the largest market share.

CROs hold a significant position and are the leading users of the market's products or services. They specialize in providing comprehensive research services, allowing pharmaceutical and biotech companies to outsource various aspects of their R&D activities. This outsourcing model offers numerous benefits, including access to specialized expertise, reduced operational costs, and increased efficiency in trial execution. They provide in-depth knowledge of industry best practices, regulatory requirements, and emerging trends which makes it an attractive choice for companies seeking reliable partners to navigate complex research processes and achieve successful outcomes. They also have the ability to scale their resources and infrastructure according to project requirements, enabling them to support both small-scale studies and large multinational trials. They can provide expertise in risk management, data integrity, and compliance, helping companies navigate the complex regulatory landscape and mitigate potential pitfalls.

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

North America exhibits a clear dominance, accounting for the largest pharmacovigilance and drug safety software market share

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. According to the report, North America accounted for the largest market share.

North America has a robust and well-established pharmaceutical industry, with numerous companies involved in drug discovery, development, and commercialization. The region is at the forefront of technological innovation, including advancements in healthcare and information technology. The region has a robust IT infrastructure, a favorable investment climate for research and development, and a strong focus on adopting digital solutions. North American pharmaceutical companies and research institutions often collaborate with academic institutions, healthcare providers, and technology companies to drive innovation in pharmacovigilance and drug safety. These collaborations foster the development and adoption of state-of-the-art software solutions, further enhancing North America's dominance in the market. Additionally, the region has stringent regulatory requirements for drug safety and pharmacovigilance is another significant factor responsible for impelling the market across the North America region.

Competitive Landscape:

Top companies in the market are investing in research and development activities to create advanced pharmacovigilance and drug safety software solutions. These software platforms are designed to capture, process, analyze, and report adverse events, safety data, and other relevant information related to pharmaceutical products and medical interventions. Various companies offer flexible and scalable software platforms that can be tailored to meet the unique needs of pharmaceutical companies, CROs, and healthcare institutions. Additionally, companies leverage advanced data analytics techniques, such as artificial intelligence (AI) and machine learning (ML), to analyze large volumes of safety data and identify potential safety signals. These analytics capabilities help in the early detection of adverse events, signal management, risk assessment, and trend analysis.

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 key players in the market include:

Ab Cube

Anju Software Inc.

ArisGlobal LLC

Cognizant

Ennov Solutions Inc.

Extedo GmbH

Max Application

Oracle Corporation

Sarjen Systems Pvt Ltd

Sparta Systems Inc. (Honeywell International Inc.)

Tata Consultancy Services Limited

United BioSource LLC

Wipro Limited.

Recent Developments:

In February 2023, Aris Global launches regulatory information management solution purpose-built for investigational-stage companies. This new product is ideal for emerging life sciences and medical device companies. It is designed to focus on the functionality needed to achieve the next clinical or regulatory milestone.

In June 2022, Tata Consultancy Services has launched the TCS Servitization Engine on Oracle Cloud to help customers create subscription-first business models and provide outcome-based solutions with intelligent service capabilities. The engine offers an industry package with bundled combinations of products, services, support, self-service, and knowledge base that companies can leverage to add value to their core product offerings, along with robust front-end customer-facing solutions.

In October 2022, Cognizant announced its collaboration with Qualcomm to launch a 5G experience centre for digital transformation. The collaboration will assist in generation services, such as autonomous driving, robotic automation, synthetic biology, virtual reality, and smart manufacturing in an ultra-reliable, low-latency, secure, and scalable way.

Key Questions Answered in This Report

  • 1. What was the size of the global pharmacovigilance and drug safety software market in 2023?
  • 2. What is the expected growth rate of the global pharmacovigilance and drug safety software market during 2024-2032?
  • 3. What has been the impact of COVID-19 on the global pharmacovigilance and drug safety software market?
  • 4. What are the key factors driving the global pharmacovigilance and drug safety software market?
  • 5. What is the breakup of the global pharmacovigilance and drug safety software market based on the functionality?
  • 6. What is the breakup of the global pharmacovigilance and drug safety software market based on the delivery mode?
  • 7. What is the breakup of the global pharmacovigilance and drug safety software market based on the end user?
  • 8. What are the key regions in the global pharmacovigilance and drug safety software market?
  • 9. Who are the key players/companies in the global pharmacovigilance and drug safety software market?

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 and Drug Safety Software Market

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

6 Market Breakup by Functionality

  • 6.1 Adverse Event Reporting Software
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Drug Safety Audits Software
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast
  • 6.3 Issue Tracking Software
    • 6.3.1 Market Trends
    • 6.3.2 Market Forecast
  • 6.4 Fully Integrated Software
    • 6.4.1 Market Trends
    • 6.4.2 Market Forecast

7 Market Breakup by Delivery Mode

  • 7.1 On-premises
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Cloud-based
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast

8 Market Breakup by End User

  • 8.1 Pharmaceutical and Biotechnology Companies
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Contract Research Organizations
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Business Process Outsourcing Firms
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Others
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast

9 Market Breakup by Region

  • 9.1 North America
    • 9.1.1 United States
      • 9.1.1.1 Market Trends
      • 9.1.1.2 Market Forecast
    • 9.1.2 Canada
      • 9.1.2.1 Market Trends
      • 9.1.2.2 Market Forecast
  • 9.2 Asia-Pacific
    • 9.2.1 China
      • 9.2.1.1 Market Trends
      • 9.2.1.2 Market Forecast
    • 9.2.2 Japan
      • 9.2.2.1 Market Trends
      • 9.2.2.2 Market Forecast
    • 9.2.3 India
      • 9.2.3.1 Market Trends
      • 9.2.3.2 Market Forecast
    • 9.2.4 South Korea
      • 9.2.4.1 Market Trends
      • 9.2.4.2 Market Forecast
    • 9.2.5 Australia
      • 9.2.5.1 Market Trends
      • 9.2.5.2 Market Forecast
    • 9.2.6 Indonesia
      • 9.2.6.1 Market Trends
      • 9.2.6.2 Market Forecast
    • 9.2.7 Others
      • 9.2.7.1 Market Trends
      • 9.2.7.2 Market Forecast
  • 9.3 Europe
    • 9.3.1 Germany
      • 9.3.1.1 Market Trends
      • 9.3.1.2 Market Forecast
    • 9.3.2 France
      • 9.3.2.1 Market Trends
      • 9.3.2.2 Market Forecast
    • 9.3.3 United Kingdom
      • 9.3.3.1 Market Trends
      • 9.3.3.2 Market Forecast
    • 9.3.4 Italy
      • 9.3.4.1 Market Trends
      • 9.3.4.2 Market Forecast
    • 9.3.5 Spain
      • 9.3.5.1 Market Trends
      • 9.3.5.2 Market Forecast
    • 9.3.6 Russia
      • 9.3.6.1 Market Trends
      • 9.3.6.2 Market Forecast
    • 9.3.7 Others
      • 9.3.7.1 Market Trends
      • 9.3.7.2 Market Forecast
  • 9.4 Latin America
    • 9.4.1 Brazil
      • 9.4.1.1 Market Trends
      • 9.4.1.2 Market Forecast
    • 9.4.2 Mexico
      • 9.4.2.1 Market Trends
      • 9.4.2.2 Market Forecast
    • 9.4.3 Others
      • 9.4.3.1 Market Trends
      • 9.4.3.2 Market Forecast
  • 9.5 Middle East and Africa
    • 9.5.1 Market Trends
    • 9.5.2 Market Breakup by Country
    • 9.5.3 Market Forecast

10 SWOT Analysis

  • 10.1 Overview
  • 10.2 Strengths
  • 10.3 Weaknesses
  • 10.4 Opportunities
  • 10.5 Threats

11 Value Chain Analysis

12 Porters Five Forces Analysis

  • 12.1 Overview
  • 12.2 Bargaining Power of Buyers
  • 12.3 Bargaining Power of Suppliers
  • 12.4 Degree of Competition
  • 12.5 Threat of New Entrants
  • 12.6 Threat of Substitutes

13 Price Analysis

14 Competitive Landscape

  • 14.1 Market Structure
  • 14.2 Key Players
  • 14.3 Profiles of Key Players
    • 14.3.1 Ab Cube
      • 14.3.1.1 Company Overview
      • 14.3.1.2 Product Portfolio
    • 14.3.2 Anju Software Inc.
      • 14.3.2.1 Company Overview
      • 14.3.2.2 Product Portfolio
    • 14.3.3 ArisGlobal LLC
      • 14.3.3.1 Company Overview
      • 14.3.3.2 Product Portfolio
    • 14.3.4 Cognizant
      • 14.3.4.1 Company Overview
      • 14.3.4.2 Product Portfolio
      • 14.3.4.3 Financials
      • 14.3.4.4 SWOT Analysis
    • 14.3.5 Ennov Solutions Inc.
      • 14.3.5.1 Company Overview
      • 14.3.5.2 Product Portfolio
    • 14.3.6 Extedo GmbH
      • 14.3.6.1 Company Overview
      • 14.3.6.2 Product Portfolio
    • 14.3.7 Max Application
      • 14.3.7.1 Company Overview
      • 14.3.7.2 Product Portfolio
    • 14.3.8 Oracle Corporation
      • 14.3.8.1 Company Overview
      • 14.3.8.2 Product Portfolio
      • 14.3.8.3 Financials
      • 14.3.8.4 SWOT Analysis
    • 14.3.9 Sarjen Systems Pvt Ltd
      • 14.3.9.1 Company Overview
      • 14.3.9.2 Product Portfolio
    • 14.3.10 Sparta Systems Inc. (Honeywell International Inc.)
      • 14.3.10.1 Company Overview
      • 14.3.10.2 Product Portfolio
    • 14.3.11 Tata Consultancy Services Limited
      • 14.3.11.1 Company Overview
      • 14.3.11.2 Product Portfolio
      • 14.3.11.3 Financials
      • 14.3.11.4 SWOT Analysis
    • 14.3.12 United BioSource LLC
      • 14.3.12.1 Company Overview
      • 14.3.12.2 Product Portfolio
    • 14.3.13 Wipro Limited
      • 14.3.13.1 Company Overview
      • 14.3.13.2 Product Portfolio
      • 14.3.13.3 Financials
      • 14.3.13.4 SWOT Analysis