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表紙：生物学的同等性試験シミュレーターの世界市場-2023年～2030年
市場調査レポート
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1374853

生物学的同等性試験シミュレーターの世界市場-2023年～2030年

Global Bioequivalence Studies Simulators Market - 2023-2030
出版日: | 発行: DataM Intelligence | ページ情報: 英文 180 Pages | 納期: 約2営業日

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生物学的同等性試験シミュレーターの世界市場-2023年～2030年
出版日: 2023年11月01日
発行: DataM Intelligence
ページ情報: 英文 180 Pages
納期: 約2営業日
ご注意事項 :
本レポートは最新情報反映のため適宜更新し、内容構成変更を行う場合があります。ご検討の際はお問い合わせください。
  • 全表示
  • 概要
  • 目次
概要

概要

仮想生物学的同等性試験（VBE）は、in vitro、in silico、in vivoのトランスレーショナルな関連性に基づいて確立された、試験製剤と参照製剤の間の薬物動態学的および臨床的解釈における類似性および推定される不一致を評価することができます。臨床試験から得られる重要な情報は、仮想生物学的同等性調査の助けを借りて提供され、新規医薬品やジェネリック医薬品の設計を早めることを意図しています。

市場促進要因：市場抑制要因

ジェネリック医薬品需要の増加

世界市場の成長は予測期間中、ジェネリック医薬品の需要増加により後押しされると予想されます。米国国立衛生研究所（NIH）によると、米国の消費者は年間約1,030億米ドルをジェネリック医薬品に費やしています。食品医薬品局（FDA）の認可を受けると、ジェネリック医薬品は高価格のブランド品のほぼ完全な代替品とみなされます。さらに、米国食品医薬品局によれば、米国で処方される医薬品のうち10品目のうち9品目がジェネリック医薬品です。

さらに、感染症や慢性疾患の増加、研究活動の活発化なども、予測期間中の世界市場の成長に寄与すると予想される要因のひとつです。

生物学的同等性試験に伴う問題

生物学的同等性試験に関連する問題点として、高いばらつき、吸収の非常に悪い薬剤、独自のベースラインを持つ内因性物質などがあり、予測期間中の世界市場の成長を妨げると予想されます。さらに、高コストと熟練した専門家の不足も、予測期間中の世界市場の成長を妨げる追加要因の一つです。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

  • 影響要因
    • 促進要因
      • ジェネリック医薬品需要の増加
    • 抑制要因
      • 関連する問題
    • 機会
    • 影響分析

第5章 産業分析

  • ポーターのファイブフォース分析
  • 価格分析
  • 規制分析
  • 特許分析
  • 技術動向
  • アンメットニーズ
  • SWOT分析
  • DMIの見解

第6章 COVID-19分析

第7章 試験タイプ別

  • バイオアベイラビリティ試験
  • 単回投与試験
  • 多回投与試験
  • 比較エンドポイント試験

第8章 用途別

  • 心血管疾患
  • 腫瘍学
  • 中枢神経疾患
  • 感染症
  • その他

第9章 エンドユーザー別

  • 病院
  • 研究機関
  • CRO（医薬品開発業務受託機関）

第10章 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • イタリア
    • スペイン
    • その他欧州
  • 南米
    • ブラジル
    • アルゼンチン
    • その他南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • オーストラリア
    • その他アジア太平洋
  • 中東・アフリカ

第11章 競合情勢

  • 競合シナリオ
  • 市況/シェア分析
  • M&A分析

第12章 企業プロファイル

  • Simulations Plus, Inc.
    • 会社概要
    • 製品ポートフォリオと説明
    • 財務概要
    • 主な動向
  • Certara, Inc.
  • Pumas-AI, Inc., Inc.
  • BioPharma Services Inc.
  • OPEN SYSTEMS PHARMACOLOGY

第13章 付録

目次
Product Code: HCIT7380

Overview

Virtual bioequivalence studies (VBE) can evaluate the resemblance and probable discrepancies in pharmacokinetic and clinical interpretation between test and reference formulations established on the translational association between in vitro, in silico, and in vivo. The essential information from clinical investigations can be provided with the aid of virtual bioequivalence investigation, which intends to hasten up the design of novel and generic medications.

Market Dynamics: Drivers & Restraints

Increasing Demand for Generic Drugs

The global market growth is expected to receive a boost due to the increasing demand for generic drugs during the forecast period. As per the National Institutes of Health (NIH), American consumers spend around $103 billion per year on generic drugs. Upon receiving approval from the Food and Drug Administration (FDA), generic drugs are considered to be almost perfect substitutes for the high-priced branded products they replicate. Furthermore, according to the United States Food and Drug Administration, 9 out of 10 prescriptions filled in the United States are for generic drugs.

Additionally, the rise in infectious and chronic diseases and growing research activities are among other factors that are expected to contribute to the global market growth during the forecast period.

Problems Associated with Bioequivalence Studies

The problems associated with bioequivalence studies such as high variability, very poorly absorbed drugs, and endogenous substances with their own baseline among others are expected to hamper the global market growth during the forecast period. Furthermore, high cost and a deficient number of skilled professionals are among the additional factors hampering the global market growth during the forecast period.

Segment Analysis

The global bioequivalence studies simulators market is segmented based on study type, application, end user and region.

Bioavailability Study Type is Expected to Dominate Market

The bioavailability study type is expected to dominate the global market during the forecast period due to the increase in product introductions. For instance in February 2021, Simulations Plus, Inc., a top provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, released the version 9.8.1 of its flagship physiologically based biopharmaceutics (PBBM)/ pharmacokinetics (PBPK) modeling program, GastroPlus, . Additionally, in October 2021, the company announced the release of version 9.8.2 of the same program.

Geographical Analysis

North America is Expected to Dominate the Global Market

Owing to the increasing grants from the government to validate and define best practices for physiologically based biopharmaceutics/pharmacokinetics (PBBM/PBPK) modeling workflows to simulate virtual bioequivalence (VBE) investigations in support of regulatory biowaivers in North America the region is estimated to dominate the global market during the forecast period.

For instance, in November 2022, Simulations Plus, Inc., a top provider of modeling and simulation software and services for pharmaceutical safety and efficacy, acquired a new sponsored contract from the U.S. Food and Drug Administration (FDA) as a collaborative proposal with the University of Florida's College of Pharmacy to promote in vitro and (patho)physiology-based pharmacokinetics (PBPK) prototypes to comprehend and predict pulmonary absorption and tissue retention of inhaled drugs. Again, in September 2023, Simulations Plus, Inc. obtained a new funded grant from the U.S. Food and Drug Administration (FDA).

COVID-19 Impact Analysis

The COVID-19 pandemic has underscored the importance of speed and safety in drug development. The bioequivalence studies simulators are providing researchers with the ability to evaluate repurposing of existing drugs, predict drug-drug interactions, and perform virtual bioequivalence assessments with an increasing variety of dosing routes. Thus, the pandemic has led to increase in the adoption of the bioequivalence studies simulators, positively impacting the global market.

Market Segmentation

By Study Type

  • Bioavailability Studies
  • Single Dose Studies
  • Multidose Studies
  • Comparative End Point Studies

By Application

  • Cardiovascular Disease
  • Oncology
  • CNS Disorders
  • Infectious Diseases
  • Other

By End User

  • Pharmaceutical Companies
  • Research Institutes
  • Contract Research Organizations

By Region

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Rest of Europe
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa

Key Developments

  • In October 2020, Simulations Plus, Inc., the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, introduced version 9.8 of its flagship platform for physiologically based biopharmaceutics (PBBM) / pharmacokinetic (PBPK) modeling, GastroPlus.
  • In January 2021, Certara, Inc., the global leader in biosimulation, introduced version 20 of its Simcyp Physiologically-based Pharmacokinetic (PBPK) Simulator platform.

Competitive Landscape

The major global players in the market include: Simulations Plus, Inc., Certara, Inc., Pumas-AI, Inc., BioPharma Services Inc., and Open Systems Pharmacology among others.

Why Purchase the Report?

  • To visualize the global bioequivalence studies simulators market segmentation based on study type, application, end user and region as well as understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development.
  • Excel data sheet with numerous data points of bioequivalence studies simulators market-level with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping available as excel consisting of key products of all the major players.

The global bioequivalence studies simulators market report would provide approximately 46 tables, 55 figures and 180 pages.

Target Audience 2023

  • Manufacturers/ Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by Study Type
  • 3.2. Snippet by Application
  • 3.3. Snippet by End User
  • 3.4. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Increasing Demand for Generic Drugs
    • 4.1.2. Restraints
      • 4.1.2.1. Problems Associated
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's Five Force Analysis
  • 5.2. Pricing Analysis
  • 5.3. Regulatory Analysis
  • 5.4. Patent Analysis
  • 5.5. Technology Trend
  • 5.6. Unmet Need
  • 5.7. SWOT Analysis
  • 5.8. DMI Opinion

6. COVID-19 Analysis

  • 6.1. Analysis of COVID-19
    • 6.1.1. Scenario Before COVID
    • 6.1.2. Scenario During COVID
    • 6.1.3. Scenario Post COVID
  • 6.2. Pricing Dynamics Amid COVID-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. By Study Type

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Type
    • 7.1.2. Market Attractiveness Index, By Study Type
  • 7.2. Bioavailability Studies*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Single Dose Studies
  • 7.4. Multidose Studies
  • 7.5. Comparative End Point Studies

8. By Application

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 8.1.2. Market Attractiveness Index, By Application
  • 8.2. Cardiovascular Disease*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Oncology
  • 8.4. CNS Disorders
  • 8.5. Infectious Diseases
  • 8.6. Other

9. By End User

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.1.2. Market Attractiveness Index, By End User
  • 9.2. Hospital*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Research Institutes
  • 9.4. Contract Research Organizations

10. By Region

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 10.1.2. Market Attractiveness Index, By Region
  • 10.2. North America
    • 10.2.1. Introduction
    • 10.2.2. Key Region-Specific Dynamics
    • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Type
    • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.2.6.1. U.S.
      • 10.2.6.2. Canada
      • 10.2.6.3. Mexico
  • 10.3. Europe
    • 10.3.1. Introduction
    • 10.3.2. Key Region-Specific Dynamics
    • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Type
    • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.3.6.1. Germany
      • 10.3.6.2. UK
      • 10.3.6.3. France
      • 10.3.6.4. Italy
      • 10.3.6.5. Spain
      • 10.3.6.6. Rest of Europe
  • 10.4. South America
    • 10.4.1. Introduction
    • 10.4.2. Key Region-Specific Dynamics
    • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Type
    • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.4.6.1. Brazil
      • 10.4.6.2. Argentina
      • 10.4.6.3. Rest of South America
  • 10.5. Asia-Pacific
    • 10.5.1. Introduction
    • 10.5.2. Key Region-Specific Dynamics
    • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Type
    • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.5.6.1. China
      • 10.5.6.2. India
      • 10.5.6.3. Japan
      • 10.5.6.4. Australia
      • 10.5.6.5. Rest of Asia-Pacific
  • 10.6. Middle East and Africa
    • 10.6.1. Introduction
    • 10.6.2. Key Region-Specific Dynamics
    • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Type
    • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

  • 11.1. Competitive Scenario
  • 11.2. Market Positioning/Share Analysis
  • 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

  • 12.1. Simulations Plus, Inc.*
    • 12.1.1. Company Overview
    • 12.1.2. Product Portfolio and Description
    • 12.1.3. Financial Overview
    • 12.1.4. Key Developments
  • 12.2. Certara, Inc.
  • 12.3. Pumas-AI, Inc., Inc.
  • 12.4. BioPharma Services Inc.
  • 12.5. OPEN SYSTEMS PHARMACOLOGY

LIST NOT EXHAUSTIVE

13. Appendix

  • 13.1. About Us and Services
  • 13.2. Contact Us