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市场调查报告书
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1649451

生物等效性测试市场 - 2025 年至 2030 年预测

Bioequivalence Studies Market - Forecasts from 2025 to 2030
出版日期: | 出版商: Knowledge Sourcing Intelligence | 英文 146 Pages | 商品交期: 最快1-2个工作天内

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简介目录

生物等效性测试市场规模预计将从 2025 年的 8,733.52 亿美元扩大到 2030 年的 1,2533.45 亿美元，预测期内的复合年增长率为 7.49%。

生物等效性研究是一种比较含有相同活性成分的两种药物的生物有效性的科学评估。生物有效性是指活性成分从消化道吸收的速率和程度。

生物等效性测试市场驱动因素：

  • 学名药需求不断增长：生物等效性测试市场很大程度上受到对品牌药物可负担的学名药的需求不断增长的推动。这一趋势进一步受到製药业活性化研发的推动，特别是在生物相似药和可扩展配方领域，这导致了对生物等效性研究的需求增加。根据 NIH 的资料，截至 2024 年 6 月，研究和开发一种新药的相关成本从 3.14 亿美元到 44.6 亿美元不等，具体取决于多种因素。开发新药的高成本鼓励了学名药和生物相似药的创造和使用，增加了生物等效性研究的需求。

製药公司正专注于具有大量未满足医疗需求和巨大市场潜力的治疗领域，影响着可负担的学名药和生物相似药的发展。

生物等效性测试市场的地理展望：

  • 欧洲法规环境：欧洲生物等效性测试市场受到严格的监管要求驱动，例如欧洲药品管理局 (EMA)，它确保学名药的安全性和有效性。医疗成本控制措施导致对具有成本效益的学名药的需求不断增加也是推动市场发展的关键因素。此外，分析技术的进步和强大的医药研发生态系统进一步推动了市场的成长。

在英国，学名药被视为品牌药的经济实惠的替代品，需求正在蓬勃发展。由于学名药需要经过审查才能获得市场核准，药品和保健品监管局 (MHRA) 设定的严格法规环境增加了对生物等效性研究的需求。此外，製药业正在加强研发力度，特别是在治疗罕见疾病和开发生物相似药方面，这有助于市场的成长。相较于 GDP，英国在製药业仍是重要的参与者，2022 年製药研发占所有企业研发支出的 18%。此外，分析化学、生物资讯学和临床试验设计的技术进步正在优化生物等效性测试过程，使其更加高效、准确，从而推动整体市场成长。例如，英国在 2022 年启动了 411 项临床试验，高于 2021 年的 394 项。总而言之，由于对学名药的需求不断增加、严格的监管要求、技术进步以及各个地区对研发的大量投资，生物等效性测试市场正在经历强劲增长。

为什么要购买这份报告？

  • 深刻分析：获得涵盖主要和新兴地区的深入市场洞察，重点关注客户细分、政府政策和社会经济因素、消费者偏好、垂直行业和其他子区隔。
  • 竞争格局：了解全球主要企业所采用的策略策略，并了解正确策略带来的潜在市场渗透率。
  • 市场趋势和驱动因素：探索动态因素和关键市场趋势以及它们将如何影响未来的市场发展。
  • 可行的建议：利用洞察力做出策略决策，在动态环境中开闢新的业务流和收益。
  • 适合广泛用户：对于新兴企业、科学研究机构、顾问公司、中小企业和大型企业来说都是有益且具成本效益的。

它有什么用途？

产业与市场考量、商业机会评估、产品需求预测、打入市场策略、地理扩张、资本支出决策、法律规范与影响、新产品开发、竞争影响

研究范围

  • 2022 年至 2030 年的历史资料与预测
  • 成长机会、挑战、供应链前景、法规结构、客户行为和趋势分析
  • 竞争定位、策略和市场占有率分析
  • 细分和区域分析，包括收益成长和预测国家
  • 公司概况（包括主要趋势）

生物等效性测试市场细分如下：

依分子类型

  • 小分子
  • 聚合物

按剂型

  • 口服固态剂型
  • 肠外
  • 外用药物
  • 其他的

按治疗领域

  • 肿瘤学
  • 神经病学
  • 代谢疾病
  • 血液学
  • 免疫学
  • 其他的

按地区

  • 北美洲
  • 美国
  • 加拿大
  • 墨西哥
  • 南美洲
  • 巴西
  • 阿根廷
  • 其他的
  • 欧洲
  • 英国
  • 德国
  • 法国
  • 西班牙
  • 其他中东和非洲地区
  • 沙乌地阿拉伯
  • UAE
  • 以色列
  • 其他的
  • 亚太地区
  • 日本
  • 中国
  • 印度
  • 韩国
  • 印尼
  • 泰国
  • 其他的

目录

第 1 章 简介

  • 市场概况
  • 市场定义
  • 研究范围
  • 市场区隔
  • 货币
  • 先决条件
  • 基准年和预测年时间表
  • 相关人员的主要利益

第二章调查方法

  • 研究设计
  • 研究过程

第三章执行摘要

  • 主要发现
  • 分析师观点

第四章 市场动态

  • 市场驱动因素
  • 市场限制
  • 波特五力分析
  • 产业价值链分析

第五章 生物等效性测试市场（依分子类型划分）

  • 介绍
  • 小分子
  • 聚合物

第六章 生物等效性测试市场（以剂型）

  • 介绍
  • 口服固态剂型
  • 肠外
  • 外用药物
  • 其他的

第七章 生物等值测试市场（依治疗领域）

  • 介绍
  • 肿瘤学
  • 神经病学
  • 代谢疾病
  • 血液学
  • 免疫学
  • 其他的

第 8 章 生物等效性测试市场（按地区）

  • 介绍
  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他的
  • 欧洲
    • 英国
    • 德国
    • 法国
    • 西班牙
    • 其他的
  • 中东和非洲
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 以色列
    • 其他的
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 韩国
    • 印尼
    • 泰国
    • 其他的

第九章竞争格局及分析

  • 主要企业和策略分析
  • 市场占有率分析
  • 合併、收购、协议和合作
  • 竞争仪錶板

第十章 公司简介

  • CliniExperts
  • ProRelix Services LLP
  • IQVIA
  • ICON plc
  • Charles River Laboratories
  • Labcorp Drug Development
  • KYMOS Group
  • Veeda Clinical Research
  • Notrox Research
  • NorthEast BioAnalytical Laboratories LLC
  • Novotech
简介目录
Product Code: KSI061615890

The bioequivalence studies market is projected to grow at a CAGR of 7.49% over the forecast period, increasing from US$873.352 million in 2025 to US$1,253.345 million by 2030.

Bioequivalence studies are scientific evaluations that compare the bioavailability of two pharmaceutical products containing the same active ingredient. Bioavailability refers to the rate and extent to which the active ingredient is absorbed from the gastrointestinal tract.

Drivers of the Bioequivalence Studies Market:

  • Increased Demand for Generic Drugs: The bioequivalence studies market is significantly driven by the rising demand for generic drugs, which serve as affordable alternatives to branded products. This trend is further supported by heightened research and development activities within the pharmaceutical industry, particularly in biosimilars and scalable drug formulations, leading to a greater need for bioequivalence studies. According to NIH data, the costs associated with new drug R&D range from $314 million to $4.46 billion as of June 2024, depending on various factors. This high cost of developing new drugs encourages the creation and use of generic drugs and biosimilars, thereby increasing the demand for bioequivalence studies.

Pharmaceutical companies are focusing on therapeutic areas with significant unmet medical needs and substantial market potential, influencing the development of affordable generic versions or biosimilars.

Geographical Outlook of the Bioequivalence Studies Market:

  • Europe's Regulatory Environment: The European bioequivalence studies market is propelled by stringent regulatory requirements from agencies like the European Medicines Agency (EMA), which ensure the safety and efficacy of generic drugs. The growing demand for cost-effective generics due to healthcare cost containment measures is a significant factor driving this market. Additionally, advancements in analytical technologies and a robust pharmaceutical R&D ecosystem further support market growth.

In the UK, the demand for generic drugs has surged as they are viewed as affordable substitutes for brand-name medications. The stringent regulatory environment established by the Medicines and Healthcare products Regulatory Agency (MHRA) necessitates thorough research to obtain market approval for generic drugs, thereby enhancing demand for bioequivalence studies.Moreover, increased research and development efforts in the pharmaceutical industry, particularly in addressing rare diseases and developing biosimilars, contribute to market growth. The UK remains a significant player in health research funding relative to its GDP, with pharmaceutical R&D accounting for 18% of all business R&D conducted in 2022.Technological advancements in analytical chemistry, bioinformatics, and clinical trial design have also optimized bioequivalence study processes, improving efficiency and accuracy while driving overall market growth. For instance, 411 industry clinical trials were initiated in the UK in 2022, up from 394 in 2021.In summary, the bioequivalence studies market is experiencing robust growth driven by increasing demand for generic drugs, stringent regulatory requirements, advancements in technology, and significant investments in research and development across various regions.

Reasons for buying this report:-

  • Insightful Analysis: Gain detailed market insights covering major as well as emerging geographical regions, focusing on customer segments, government policies and socio-economic factors, consumer preferences, industry verticals, other sub- segments.
  • Competitive Landscape: Understand the strategic maneuvers employed by key players globally to understand possible market penetration with the correct strategy.
  • Market Drivers & Future Trends: Explore the dynamic factors and pivotal market trends and how they will shape up future market developments.
  • Actionable Recommendations: Utilize the insights to exercise strategic decision to uncover new business streams and revenues in a dynamic environment.
  • Caters to a Wide Audience: Beneficial and cost-effective for startups, research institutions, consultants, SMEs, and large enterprises.

What do businesses use our reports for?

Industry and Market Insights, Opportunity Assessment, Product Demand Forecasting, Market Entry Strategy, Geographical Expansion, Capital Investment Decisions, Regulatory Framework & Implications, New Product Development, Competitive Intelligence

Report Coverage:

  • Historical data & forecasts from 2022 to 2030
  • Growth Opportunities, Challenges, Supply Chain Outlook, Regulatory Framework, Customer Behaviour, and Trend Analysis
  • Competitive Positioning, Strategies, and Market Share Analysis
  • Revenue Growth and Forecast Assessment of segments and regions including countries
  • Company Profiling (Strategies, Products, Financial Information, and Key Developments among others)

The Bioequivalence Studies Market has been segmented as following:

By Molecule Type

  • Small Molecule
  • Large Molecule

By Dosage Form

  • Solid Oral Dosage
  • Parenteral Formulations
  • Topical Products
  • Others

By Therapeutic Area

  • Oncology
  • Neurology
  • Metabolic Disorders
  • Hematology
  • Immunology
  • Others

By Geography

  • North America
  • United States
  • Canada
  • Mexico
  • South America
  • Brazil
  • Argentina
  • Others
  • Europe
  • United Kingdom
  • Germany
  • France
  • Spain
  • Others
  • Middle East and Africa
  • Saudi Arabia
  • UAE
  • Israel
  • Others
  • Asia Pacific
  • Japan
  • China
  • India
  • South Korea
  • Indonesia
  • Thailand
  • Others

TABLE OF CONTENTS

1. INTRODUCTION

  • 1.1. Market Overview
  • 1.2. Market Definition
  • 1.3. Scope of the Study
  • 1.4. Market Segmentation
  • 1.5. Currency
  • 1.6. Assumptions
  • 1.7. Base and Forecast Years Timeline
  • 1.8. Key Benefits for the Stakeholders

2. RESEARCH METHODOLOGY

  • 2.1. Research Design
  • 2.2. Research Process

3. EXECUTIVE SUMMARY

  • 3.1. Key Findings
  • 3.2. Analyst View

4. MARKET DYNAMICS

  • 4.1. Market Drivers
  • 4.2. Market Restraints
  • 4.3. Porter's Five Forces Analysis
    • 4.3.1. Bargaining Power of Supplier
    • 4.3.2. Bargaining Power of Buyers
    • 4.3.3. Threat of New Entrants
    • 4.3.4. Threat of Substitutes
    • 4.3.5. Competitive Rivalry in the Industry
  • 4.4. Industry Value Chain Analysis

5. BIOEQUIVALENCE STUDIES MARKET BY MOLECULE TYPE

  • 5.1. Introduction
  • 5.2. Small Molecule
  • 5.3. Large Molecule

6. BIOEQUIVALENCE STUDIES MARKET BY DOSAGE FORM

  • 6.1. Introduction
  • 6.2. Solid Oral Dosage
  • 6.3. Parenteral Formulations
  • 6.4. Topical Products
  • 6.5. Others

7. BIOEQUIVALENCE STUDIES MARKET BY THERAPEUTIC AREA

  • 7.1. Introduction
  • 7.2. Oncology
  • 7.3. Neurology
  • 7.4. Metabolic Disorders
  • 7.5. Hematology
  • 7.6. Immunology
  • 7.7. Others

8. BIOEQUIVALENCE STUDIES MARKET BY GEOGRAPHY

  • 8.1. Introduction
  • 8.2. North America
    • 8.2.1. United States
    • 8.2.2. Canada
    • 8.2.3. Mexico
  • 8.3. South America
    • 8.3.1. Brazil
    • 8.3.2. Argentina
    • 8.3.3. Others
  • 8.4. Europe
    • 8.4.1. United Kingdom
    • 8.4.2. Germany
    • 8.4.3. France
    • 8.4.4. Spain
    • 8.4.5. Others
  • 8.5. Middle East and Africa
    • 8.5.1. Saudi Arabia
    • 8.5.2. UAE
    • 8.5.3. Israel
    • 8.5.4. Others
  • 8.6. Asia Pacific
    • 8.6.1. Japan
    • 8.6.2. China
    • 8.6.3. India
    • 8.6.4. South Korea
    • 8.6.5. Indonesia
    • 8.6.6. Thailand
    • 8.6.7. Others

9. COMPETITIVE ENVIRONMENT AND ANALYSIS

  • 9.1. Major Players and Strategy Analysis
  • 9.2. Market Share Analysis
  • 9.3. Mergers, Acquisitions, Agreements, and Collaborations
  • 9.4. Competitive Dashboard

10. COMPANY PROFILES

  • 10.1. CliniExperts
  • 10.2. ProRelix Services LLP
  • 10.3. IQVIA
  • 10.4. ICON plc
  • 10.5. Charles River Laboratories
  • 10.6. Labcorp Drug Development
  • 10.7. KYMOS Group
  • 10.8. Veeda Clinical Research
  • 10.9. Notrox Research
  • 10.10. NorthEast BioAnalytical Laboratories LLC
  • 10.11. Novotech