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), By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2023 – 2032
Global Bioequivalence Studies Market Size Insights Forecasts to 2032
- The Bioequivalence Studies Market Size was valued at USD 661.4 million in 2022.
- The Market is growing at a CAGR of 8.2% from 2023 to 2032
- The Global Bioequivalence Studies Market Size is expected to reach USD 1451.7 million by 2032
- Asia-Pacific is expected to fastest grow during the forecast period
The Global Bioequivalence Studies Market Size is expected to reach USD 1451.7 million by 2032, at a CAGR of 8.2% during the forecast period 2023 to 2032.
Bioequivalence studies are conducted to compare the pharmacokinetic parameters of two drug formulations to determine if they are interchangeable. These studies are essential for generic drug development and ensure that generic versions of a drug are therapeutically equivalent to the brand-name reference product. The studies involve administering both formulations to healthy volunteers or patients, followed by the measurement of drug concentration in blood or urine over a specific time period. The pharmacokinetic parameters assessed include maximum drug concentration (Cmax) and area under the concentration-time curve (AUC). Statistical analyses are then performed to assess if the generic formulation is bioequivalent to the reference product. Bioequivalence studies play a crucial role in ensuring the safety and efficacy of generic drugs and are an integral part of the regulatory approval process in many countries.
This research report categorizes the market for Bioequivalence Studies Market based on various segments and regions and forecasts revenue growth and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the Bioequivalence Studies Market. Recent market developments and competitive strategies such as expansion, product launch, and development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segments of the Bioequivalence Studies Market.
The bioequivalence studies market is driven by several reasons, such as the growing demand for generic drugs is a major driver. Generic drugs offer cost-effective alternatives to brand-name medications, and bioequivalence studies are necessary to ensure their safety and efficacy. The stringent regulatory requirements by health authorities contribute to market growth. Regulatory agencies mandate bioequivalence studies to establish the therapeutic equivalence of generic drugs, which boosts the demand for these studies. Additionally, the increasing prevalence of chronic diseases and the need for affordable treatment options further propel the market. Moreover, advancements in analytical techniques and bioanalytical methods have streamlined the conduct of bioequivalence studies, making them more efficient and accurate. Furthermore, the rising emphasis on personalized medicine and the development of complex generic drugs, such as biosimilars, drive the demand for bioequivalence studies. Overall, the bioequivalence studies market is expected to witness significant growth due to the increasing demand for generic drugs and the stringent regulatory landscape.
Despite the growth prospects, the bioequivalence studies market faces certain restraints. One major restraint is the high cost associated with conducting these studies. The expenses include clinical trial costs, sample analysis, and regulatory compliance costs, which can be a barrier for smaller pharmaceutical companies or those with limited budgets. Additionally, the time-consuming nature of bioequivalence studies poses a challenge, as it can delay the availability of generic drugs in the market. Furthermore, the complex regulatory landscape and varying requirements across different regions can create barriers to market entry and expansion. These factors collectively restrain the growth of the bioequivalence studies market and pose challenges for companies operating in this sector. However, ongoing advancements in technology and increasing harmonization of regulatory guidelines are expected to address these restraints and foster the growth of the market in the long run.
- In 2022, the small molecule segment accounted for around 57.2% market share
On the basis of the molecule type, the global bioequivalence studies market is segmented into small molecule and large molecule. The small molecule segment has emerged as the dominant player in the bioequivalence studies market. Several factors contribute to the segment's leading position, because small molecules constitute a significant portion of the pharmaceutical market, with a wide range of therapeutic applications. The development of generic versions of small molecule drugs necessitates bioequivalence studies to demonstrate their therapeutic equivalence to the reference product. The regulatory requirements for generic small molecule drugs are well-established and widely implemented across various regions. This regulatory framework mandates rigorous bioequivalence testing for small molecule generics, driving the demand for related studies. Additionally, small molecule drugs often have a simpler molecular structure and are relatively easier to analyze compared to large molecules, such as biologics or biosimilars. This ease of analysis contributes to the preference for small molecule bioequivalence studies. Moreover, the extensive presence of small molecule drug manufacturers and the high demand for affordable generic medications further solidify the dominance of the small molecule segment in the bioequivalence studies market.
- In 2022, the solid oral dosage segment dominated with more than 51.4% market share
Based on the dosage form, the global bioequivalence studies market is segmented into solid oral dosage, parenteral formulations, topical products, and others. The solid oral dosage segment has emerged as the dominant force in the bioequivalence studies industry, commanding a significant revenue share. There are several reasons contributing to the segment's dominance, because solid oral dosage forms, such as tablets and capsules, are the most widely used and preferred dosage forms in pharmaceuticals. They offer convenience, ease of administration, and stable drug delivery, making them popular among patients and healthcare professionals. Consequently, the development of generic versions of solid oral dosage drugs necessitates comprehensive bioequivalence studies to ensure therapeutic equivalence. The regulatory requirements for generic solid oral dosage drugs are well-established and extensively implemented across various regions. Health authorities mandate rigorous bioequivalence testing for solid oral dosage generics, further driving the demand for these studies. Additionally, the availability of advanced analytical methods and well-established bioanalytical techniques for solid oral dosage drugs contributes to the dominance of this segment. Overall, the widespread usage of solid oral dosage forms and the associated regulatory landscape establish it as the leading segment in the bioequivalence studies industry.
Regional Segment Analysis of the Bioequivalence Studies Market
- North America (U.S., Canada, Mexico)
- Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
- Asia-Pacific (China, Japan, India, Rest of APAC)
- South America (Brazil and the Rest of South America)
- The Middle East and Africa (UAE, South Africa, Rest of MEA)
North America dominated the market with more than 39.4% revenue share in 2022.
Based on region, North America has emerged as the dominant market for bioequivalence studies, holding the largest market share. The region has a well-established pharmaceutical industry and a robust regulatory framework, which emphasizes the need for bioequivalence studies for generic drug approvals. The stringent regulations set by the U.S. Food and Drug Administration (FDA) and Health Canada necessitate extensive bioequivalence testing, driving the demand for these studies. North America is home to a large patient population and high healthcare expenditure, creating a substantial market for generic drugs. Moreover, the presence of numerous contract research organizations (CROs) specializing in bioequivalence studies and the availability of advanced research infrastructure further bolster the market in this region. Additionally, the region's emphasis on innovation, strong healthcare infrastructure, and high awareness among healthcare professionals contribute to the market's growth. These factors collectively establish North America as the leading market for bioequivalence studies.
- In September 2022, Vegzelma, a biosimilar to Avastin, was approved by the US Food and Drug Administration for the treatment of six cancer types, including recurrent non-squamous lung cancer, metastatic colorectal cancer, metastatic renal cell carcinoma, recurrent glioblastoma, metastatic cervical cancer, and primary peritoneal cancer.
- In May 2022, Biocon Biologics, a subsidiary of Biocon Ltd., announced the introduction of Abevmy, a biosimilar of Avastin, in Canada in collaboration with Viatris. The collaboration between Biocon Biologics and Viatris demonstrates their shared commitment to advancing healthcare and improving patient outcomes through the availability of biosimilar therapies. This launch reinforces their dedication to making life-saving treatments more accessible and affordable for Canadian patients.
The report offers the appropriate analysis of the key organizations/companies involved within the global bioequivalence studies 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.
List of Companies:
- ProRelix Services LLP
- ICON PLC
- Charles River Laboratories
- Labcorp Drug Development
- KYMOS Group
- Veeda Clinical Research
- Notrox Research
- NorthEast BioAnalytical Laboratories LLC
- Malvern Panalytical Ltd.
- Synova Health
Key Target Audience
- Market Players
- Government Authorities
- Consulting and Research Firm
- Venture Capitalists
- Value-Added Resellers (VARs)
This study forecasts revenue at global, regional, and country levels from 2019 to 2032. Spherical Insights has segmented the global bioequivalence studies market based on the below-mentioned segments:
Bioequivalence Studies Market, By Molecule Type
- Small Molecule
- Large Molecule
Bioequivalence Studies Market, By Dosage Form
- Solid Oral Dosage
- Parenteral Formulations
- Topical Products
Bioequivalence Studies Market, By Therapeutic Area
- Metabolic Disorders