Product Code: GVR-4-68040-084-1
Bioequivalence Studies Market Growth & Trends
The global bioequivalence studies market size is expected to reach USD 1,272.2 million by 2030, expanding at a CAGR of 8.3% from 2023 to 2030, according to a new report by Grand View Research, Inc. The increasing R&D activities pertaining to rare diseases and growing demand for generics are the key factors driving the growth of the market for bioequivalence studies.
Bioequivalence studies are used to analyze the desired in vivo biological equivalence of two formulations of drug products. If two drugs are bioequivalent, then they would be anticipated to reflect equal rates of bioavailability and pharmacokinetic (PK) parameters for all intents and purposes. Some of the major players in the market include ProRelix Services LLP, IQVIA, ICON plc, Charles River Laboratories, and Labcorp Drug Development, among others.
These companies offer a wide range of bioequivalence and bioavailability services to research institutes, pharmaceutical companies, and government agencies involved in drug development. In addition, the increasing pace of clinical research activities with an aim to develop low-cost biosimilars and generics across disease areas such as cancer, neurology, immunology, etc., is anticipated to boost the market growth for bioequivalence studies.
The growing rate of generics launches has helped to create a significant demand for bioequivalence studies over the past few years. For instance, the U.S. Food and Drug Administration (FDA) announced that as of January 2022, there are 33 FDA-approved biosimilars in the U.S., among which 21 are commercially available in the market.
The COVID-19 pandemic negatively impacted the market for bioequivalence studies. However, several players adopted inorganic strategies to mitigate this situation and rebound their sales figures. Additionally, the geopolitical war between Russia and Ukraine has led to a drop in revenue across the bioequivalence industry, as clinical trials outsourced across the war-infected countries have been halted until further notice. This has greatly impacted certain economies, such as the U.S., due to which the overall market witnessed a moderate dip in its revenue during 2022.
Bioequivalence Studies Market Report Highlights
- The small molecule segment accounted for the largest revenue share of 60.6% in 2022.The segment is driven by the steadily growing demand for generics, which constitute a vast portion of small molecules
- Based on the dosage form, the solid oral dosage segment accounted for the largest revenue share of 53.8% in 2022, owing to innovations in the technology involved in manufacturing oral solids at an optimal quality
- The oncology segment is anticipated to register the fastest CAGR of 8.7% during the forecast period. This is due to the growing rate of anti-cancer biosimilars being approved in the market
- Asia Pacific is anticipated to witness the highest CAGR of 8.8% during the forecast timeframe. The expected high growth is primarily since Asian countries such as India and China are major exporters of generic drugs, which also suggests that they have a stronghold in the production of generic drugs, thereby supporting demand for bioequivalence studies
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.1.1. Segment Scope
- 1.1.2. Regional scope
- 1.1.3. Estimates and forecast timeline
- 1.2. Research Methodology
- 1.3. Information Procurement
- 1.3.1. Purchased database
- 1.3.2. GVR's internal database
- 1.3.3. Secondary sources
- 1.3.4. Primary research
- 1.3.5. Details of primary research
- 1.3.5.1. Data for primary interviews in North America
- 1.3.5.2. Data for primary interviews in Europe
- 1.3.5.3. Data for primary interviews in Asia Pacific
- 1.3.5.4. Data for primary interviews in Latin America
- 1.3.5.5. Data for Primary interviews in MEA
- 1.4. Information or Data Analysis
- 1.4.1. Data analysis models
- 1.5. Market Formulation & Validation
- 1.6. Model Details
- 1.6.1. Commodity flow analysis (Model 1)
- 1.6.1.1. Approach 1: Commodity flow approach
- 1.6.2. Volume price analysis (Model 2)
- 1.6.2.1. Approach 2: Volume price analysis
- 1.7. List of Secondary Sources
- 1.8. List of Primary Sources
- 1.9. Objectives
- 1.9.1. Objective 1
- 1.9.2. Objective 2
Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Outlook
- 2.3. Competitive Insights
Chapter 3. Bioequivalence Studies Market Variables, Trends & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent market outlook
- 3.1.2. Related/ancillary market outlook
- 3.2. Market Dynamics
- 3.2.1. Market driver analysis
- 3.2.2. Market restraint analysis
- 3.2.3. Industry challenges
- 3.3. Bioequivalence Studies: Market Analysis Tools
- 3.3.1. Industry Analysis - Porter's
- 3.3.1.1. Supplier power
- 3.3.1.2. Buyer power
- 3.3.1.3. Substitution threat
- 3.3.1.4. Threat of new entrant
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
- 3.3.2.1. Political landscape
- 3.3.2.2. Technological landscape
- 3.3.2.3. Economic landscape
- 3.3.3. Major Deals & Strategic Alliances Analysis
- 3.3.4. Market Entry Strategies
- 3.3.5. COVID-19 Impact Analysis
Chapter 4. Bioequivalence Studies Market: Molecule Type Estimates & Trend Analysis
- 4.1. Bioequivalence Studies Market: Definition & Scope
- 4.2. Bioequivalence Studies Market: Molecule Type Market Share Analysis, 2022 & 2030
- 4.2.1. Small Molecule
- 4.2.1.1. Small Molecule Market estimates and forecast 2018 to 2030 (USD Million)
- 4.2.2. Large Molecule
- 4.2.2.1. Large Molecule Market estimates and forecast 2018 to 2030 (USD Million)
Chapter 5. Bioequivalence Studies Market: Dosage Form Estimates & Trend Analysis
- 5.1. Bioequivalence Studies Market: Definition & Scope
- 5.2. Bioequivalence Studies Market: Dosage Form Market Share Analysis, 2022 & 2030
- 5.2.1. Solid Oral Dosage
- 5.2.1.1. Solid Oral Dosage Market estimates and forecast 2018 to 2030 (USD Million)
- 5.2.2. Parenteral Formulations
- 5.2.2.1. Parenteral Formulations Market estimates and forecast 2018 to 2030 (USD Million)
- 5.2.3. Topical Products
- 5.2.3.1. Topical Products Market estimates and forecast 2018 to 2030 (USD Million)
- 5.2.4. Others
- 5.2.4.1. Others Market estimates and forecast 2018 to 2030 (USD Million)
Chapter 6. Bioequivalence Studies Market: Therapeutic Area Estimates & Trend Analysis
- 6.1. Bioequivalence Studies Market: Definition & Scope
- 6.2. Bioequivalence Studies Market: Therapeutic Area Market Share Analysis, 2022 & 2030
- 6.2.1. Oncology
- 6.2.1.1. Oncology market estimates and forecast 2018 to 2030 (USD Million)
- 6.2.2. Neurology
- 6.2.2.1. Neurology Market estimates and forecast 2018 to 2030 (USD Million)
- 6.2.3. Metabolic Disorders
- 6.2.3.1. Metabolic Disorders Market estimates and forecast 2018 to 2030 (USD Million)
- 6.2.4. Hematology
- 6.2.4.1. Hematology Market estimates and forecast 2018 to 2030 (USD Million)
- 6.2.5. Immunology
- 6.2.5.1. Immunology Market estimates and forecast 2018 to 2030 (USD Million)
- 6.2.6. Orthopedics
- 6.2.6.1. Orthopedics Market estimates and forecast 2018 to 2030 (USD Million)
- 6.2.7. Others
- 6.2.7.1. Others Market estimates and forecast 2018 to 2030 (USD Million)
Chapter 7. Bioequivalence Studies Market: Phase Estimates & Trend Analysis
- 7.1. Bioequivalence Studies Market: Definition & Scope
- 7.2. Bioequivalence Studies Market: Phase Market Share Analysis, 2022 & 2030
- 7.2.1. Drug Discover
- 7.2.1.1. Drug Discover Market estimates and forecast 2018 to 2030 (USD Million)
- 7.2.2. Preclinical Studies
- 7.2.2.1. Preclinical Studies Market estimates and forecast 2018 to 2030 (USD Million)
- 7.2.3. Clinical Studies
- 7.2.3.1. Clinical Studies Market estimates and forecast 2018 to 2030 (USD Million)
Chapter 8. Bioequivalence Studies Market: Regional Estimates & Trend Analysis
- 8.1. Regional market share analysis, 2022 & 2030
- 8.2. Market Size, & Forecasts, Revenue and Trend Analysis, 2018 to 2030:
- 8.3. North America
- 8.3.1. Market estimates and forecast, 2018 - 2030 (Value)
- 8.3.2. U.S.
- 8.3.2.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.3.3. Canada
- 8.3.3.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.4. Europe
- 8.4.1. U.K.
- 8.4.1.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.4.2. Germany
- 8.4.2.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.4.3. France
- 8.4.3.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.4.4. Italy
- 8.4.4.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.4.5. Spain
- 8.4.5.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.4.6. Denmark
- 8.4.6.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.4.7. Sweden
- 8.4.7.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.4.8. Norway
- 8.4.8.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.5. Asia Pacific
- 8.5.1. Japan
- 8.5.1.1. Market estimates and forecast, 2018 - 2030 (USD Billion, Volume, Thousand)
- 8.5.2. China
- 8.5.2.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.5.3. India
- 8.5.3.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.5.4. Australia
- 8.5.4.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.5.5. Thailand
- 8.5.5.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.5.6. South Korea
- 8.5.6.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.6. Latin America
- 8.6.1. Brazil
- 8.6.1.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.6.2. Mexico
- 8.6.2.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.6.3. Argentina
- 8.6.3.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.7. MEA
- 8.7.1. South Africa
- 8.7.1.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.7.2. Saudi Arabia
- 8.7.2.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.7.3. UAE
- 8.7.3.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
- 8.7.4. Kuwait
- 8.7.4.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
Chapter 9. Competitive Landscape
- 9.1. Company Market Share Analysis, 2022
- 9.2. Company Profiles
- 9.2.1. CliniExperts
- 9.2.1.1. Company overview
- 9.2.1.2. Financial Performance
- 9.2.1.3. Product benchmarking
- 9.2.1.4. Strategic initiatives
- 9.2.2. ICBIO Corporation
- 9.2.2.1. Company overview
- 9.2.2.2. Financial performance
- 9.2.2.3. Product benchmarking
- 9.2.2.4. Strategic initiatives
- 9.2.3. ProRelix Services LLP
- 9.2.3.1. Company overview
- 9.2.3.2. Financial performance
- 9.2.3.3. Product benchmarking
- 9.2.3.4. Strategic initiatives
- 9.2.4. PPD, Inc
- 9.2.4.1. Company overview
- 9.2.4.2. Financial performance
- 9.2.4.3. Product benchmarking
- 9.2.4.4. Strategic initiatives
- 9.2.5. Syneos Health
- 9.2.5.1. Company overview
- 9.2.5.2. Financial performance
- 9.2.5.3. Product benchmarking
- 9.2.5.4. Strategic initiatives
- 9.2.6. Labcorp Drug Development
- 9.2.6.1. Company overview
- 9.2.6.2. Financial performance
- 9.2.6.3. Product benchmarking
- 9.2.6.4. Strategic initiatives
- 9.2.7. IQVIA
- 9.2.7.1. Company overview
- 9.2.7.2. Financial performance
- 9.2.7.3. Product benchmarking
- 9.2.7.4. Strategic initiatives
- 9.2.8. Charles River Laboratories Inc.
- 9.2.8.1. Company overview
- 9.2.8.2. Financial performance
- 9.2.8.3. Product benchmarking
- 9.2.8.4. Strategic initiatives
- 9.2.9. Icon PLC
- 9.2.9.1. Company overview
- 9.2.9.2. Financial performance
- 9.2.9.3. Product benchmarking
- 9.2.9.4. Strategic initiatives
- 9.2.10. Intertek Group plc
- 9.2.10.1. Company overview
- 9.2.10.2. Financial performance
- 9.2.10.3. Product benchmarking
- 9.2.10.4. Strategic initiatives