Bioequivalence Studies Market To Reach $1,272.2 Million By 2030

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.

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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

Bioequivalence Studies Market Segmentation

Grand View Research has segmented the global bioequivalence studies market based on molecule type, dosage form, therapeutic area, and region:

Bioequivalence Studies Molecule Type Outlook (Revenue, USD Million, 2018 - 2030)

• Small Molecule

• Large Molecule

Bioequivalence Studies Dosage Form Outlook (Revenue, USD Million, 2018 - 2030)

• Solid Oral Dosage

• Parenteral Formulations

• Topical Products

• Others

Bioequivalence Studies Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)

• Oncology

• Neurology

• Metabolic Disorders

• Hematology

• Immunology

• Others

Bioequivalence Studies Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America

  • U.S.                

  • Canada

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Thailand

• Latin America

  • Brazil

  • Mexico

  • Argentina

• Middle East & Africa

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

List of Key Players in the Bioequivalence Studies Market

• CliniExperts

• ProRelix Services LLP

• IQVIA

• ICON plc

• Charles River Laboratories

• Labcorp Drug Development

• KYMOS Group

• Veeda Clinical Research

• Notrox Research

• NorthEast BioAnalytical Laboratories LLC

• Malvern Panalytical Ltd

• Synova Health