New York, United States , Sept. 05, 2023 (GLOBE NEWSWIRE) -- The Global Bioequivalence Studies Market Size is to grow from USD 661.4 million in 2022 to USD 1451.7 million by 2032, at a Compound Annual Growth Rate (CAGR) of 8.2% during the projected period. Quality assurance is essential in bioequivalence studies to ensure data integrity, regulatory compliance, and adherence to good clinical practices. To maintain high standards, industry players are investing in quality management systems and robust quality assurance processes.
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To assess the pharmacokinetic and pharmacodynamic properties of drugs, bioequivalence studies compare the generic version to the innovator or reference product. They are frequently used in the development of generic pharmaceuticals, biosimilars, and when reforming a drug formulation. According to recent data, both developed and developing economies' demand for generic drugs has increased significantly. Bioequivalence studies compare two drugs or two sets of formulations of the same drug to show that their bioavailability and PK/PD parameters are nearly equal. These studies are frequently conducted for generic drugs or when the formulation of a drug is changed during development. The pharmacokinetic parameters of the generic and reference products, such as absorption, distribution, metabolism, and excretion, are typically compared in these studies. The bioequivalence studies market is an expanding sector of the pharmaceutical industry. These studies are critical in determining whether a generic drug is of comparable quality to its reference product, ensuring patient safety and efficacy. The rising prevalence of chronic diseases, combined with the need for more affordable treatment options, has fueled demand for generic drugs, propelling the bioequivalence studies market forward. The demand for bioequivalence studies is increasing as a result of the rapid growth in the production and consumption of generic products, which is driving the bioequivalence studies market forward. However, infrastructure, analytical equipment, and skilled personnel are all required for bioequivalence studies. Small and medium-sized pharmaceutical companies may be unable to enter the market due to high development costs.
Browse key industry insights spread across 200 pages with 140 market data tables and figures & charts from the report on, "Global Bioequivalence Studies Market Size, Share, and COVID-19 Impact Analysis, By Molecule Type (Small Molecule and Large Molecule), By Dosage Form (Solid Oral Dosage, Parenteral Formulations, Topical Products, and Others), By Therapeutic Area (Oncology, Neurology, Metabolic Disorders, Hematology, Immunology, and Others), and By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2022 – 2032." Get Detailed Report Here:
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The small molecule segment accounted for the largest share of the global bioequivalence studies market in 2022.
The global bioequivalence studies market is divided into two segments based on molecule type: small molecule and large molecule. The small molecule segment held the largest share of the global bioequivalence studies market in 2022. The growing global demand for novel pharmaceuticals and generics that require bioequivalence testing is driving the segment.
The solid oral dosage segment is expected to hold the largest share of the global bioequivalence studies market during the forecast period.
The global bioequivalence studies market is segmented by dosage form into solid oral dosage, parenteral formulations, topical products, and others. The solid oral dosage segment will likely account for the majority share of the global bioequivalence studies market throughout the forecast period. The increased investment by drug developers in bulk production of oral solids, which require bioequivalence research for optimal equivalence in drug compositions, can be attributed to segmental growth.
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North America is anticipated to hold the largest share of the global bioequivalence studies market over the predicted timeframe.
North America is expected to have the majority shares of the global bioequivalence studies market in the coming years. This is primarily due to an increase in clinical trials in the United States, which includes bioequivalence and bioavailability testing. The presence of major players such as IQVIA, Charles River Laboratories, and others in the country has increased the region's revenue share in the bioequivalence studies market.
During the forecast period, Asia Pacific is projected to expand at the highest pace in the global bioequivalence studies market. The presence of multiple pharmaceutical manufacturing hubs, such as India, China, and Japan, has contributed significantly to the region's rapid growth.
Competitive Analysis:
The report offers the appropriate analysis of the key organizations/companies involved within the global market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market. Major vendors in the Global Bioequivalence Studies Market include ProRelix Services LLP, ICON plc, Labcorp Drug Development, Veeda Clinical Research, CliniExperts, IQVIA, Charles River Laboratories, KYMOS Group, Notrox Research, NorthEast BioAnalytical Laboratories LLC, Malvern Panalytical Ltd, Synova Health, and Others.
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Recent Developments
In December 2022, Inhibikase Therapeutics, Inc., a clinical-stage pharmaceutical company, disclosed the first three subjects in its '501' bioequivalence study of IkT-001Pro for the treatment of Chronic Myelogenous Leukemia.
Market Segment
This study forecasts revenue at global, regional, and country levels from 2020 to 2032. Spherical Insights has segmented the Global Bioequivalence Studies Market based on the below-mentioned segments:
Global Bioequivalence Studies Market, By Molecule Type
- Small Molecule
- Large Molecule
Global Bioequivalence Studies Market, By Dosage Form
- Solid Oral Dosage
- Parenteral Formulations
- Topical Products
- Others
Global Bioequivalence Studies Market, By Therapeutic Area
- Oncology
- Neurology
- Metabolic Disorders
- Hematology
- Immunology
- Others
Global Bioequivalence Studies Market, Regional Analysis
- North America
- US
- Canada
- Mexico
- Europe
- Germany
- Uk
- France
- Italy
- Spain
- Russia
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- South Korea
- Australia
- Rest of Asia Pacific
- South America
- Brazil
- Argentina
- Rest of South America
- Middle East & Africa
- UAE
- Saudi Arabia
- Qatar
- South Africa
- Rest of Middle East & Africa
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