생물학적 동등성 시험 시장 예측(2025-2030년)

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