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Bioequivalence Studies Market Size To Reach USD 1,484.5 Million By 2032 CAGR 8%
(MENAFN- EIN Presswire)
Market Analysis
One of the key contributing factors to the growth of the bioequivalence studies market is the increasing focus on generic drug development. With the expiration of patents for several blockbuster drugs, pharmaceutical companies are increasingly focusing on developing generic alternatives, which require bioequivalence studies to gain regulatory approval. Also, in order to ensure efficient and accurate results, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have implemented strict guidelines for bioequivalence testing, contributing to market growth. The rise of sophisticated analytical technologies in bioequivalence analysis is also a noteworthy trend. Techniques including high-performance liquid chromatography (HPLC) and mass spectrometry are now routinely used to guarantee appropriate results. Additionally, the rising trend of Contract Research Organizations (CROs) outsourcing bioequivalence studies further assists pharmaceutical companies in cost containment and speeding up drug development timelines.
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Key Players in Bioequivalence Studies Market
.CliniExperts (Regulatory Consulting Services, Clinical Trial Management)
.ProRelix Services LLP (Clinical Research Services, Bioanalytical Services)
.IQVIA (Clinical Development Services, Real-World Evidence Solutions)
.ICON plc (Clinical Research Services, Laboratory Services)
.Charles River Laboratories (Preclinical Services, Laboratory Testing)
.Labcorp Drug Development (Clinical Trial Management, Bioanalytical Testing)
.KYMOS Group (Bioequivalence Testing, Analytical Development)
.Veeda Clinical Research (Clinical Trial Services, Bioanalytical Services)
.Notrox Research (Clinical Research Services, Bioanalytical Testing)
.NorthEast BioAnalytical Laboratories LLC (Bioanalytical Services, Pharmacokinetic Analysis)
.Malvern Panalytical Ltd (Analytical Instruments, Material Characterization Solutions)
.Synova Health (Clinical Trial Services, Regulatory Consulting)
.Inhibikase Therapeutics, Inc. (IkT-001Pro, IkT-148009)
.Lupin Limited (Ethambutol, Rifampicin)
.Geropharm (Semavic, Insulin Glargine)
.Promomed (Generic Pharmaceuticals, Biosimilars)
.PSK Pharma (Generic Drugs, Active Pharmaceutical Ingredients)
.Zhejiang Peptides Biotech (Active Pharmaceutical Ingredients, Peptide Synthesis Services)
.Gilead Sciences (Remdesivir, Biktarvy)
.Novo Nordisk (Ozempic, Wegovy)
Market Segmentation
By Molecule Type
The small molecule segment dominated the bioequivalence studies market in 2023, accounting for 59% of total revenue share. Small molecules are a common base for generic drug development as their respective chemical structure is easier to replicate. Small molecular drugs have less complex biological equivalence studies, so, they are cheaper and more time-saving. The segment's growth is bolstered by the growing number of small molecule drugs going off-patent presents opportunities for generic drug manufacturers.
By Dosage Form
The solid oral dosage form segment accounted for the largest revenue share, 54%, in 2023. Solid oral dosage forms Tablets and capsules are the most frequently prescribed drug forms owing to their ease of administration, stability and patient compliance. Bioequivalence studies for solid oral dosage forms are essential to ensure that generic versions deliver the same therapeutic effect as the reference drug. The high demand for generic oral medications in the management of chronic diseases, such as diabetes and hyper tension, is also supporting the growth of segment.
By Therapeutic Area
The oncology segment held the largest bioequivalence studies market share in 2023, contributing to 26% of the revenue share. The increasing prevalence of cancer and the high cost of branded oncology drugs have fueled the demand for affordable generic alternatives. Bio-equivalence studies are the key to generic oncology drugs having as much efficacy and safety as the brand. Moreover, increasing emphasis on personalized medicine and targeted therapies in oncology is projected to spur further need for bioequivalence studies in this segment.
Speak with Our Expert Analyst Today to Gain Deeper Insights @
Regional Analysis
In 2023, North America led the bioequivalence studies market, capturing 41% of the total market share. The region is dominated by the establishment of an advanced pharmaceutical industry, stringent regulatory frameworks, and a high demand for generic drugs. Specifically, the U.S. plays an important role in increasing the market driven by the FDA's focus on bioequivalence testing with generic drug approvals. In addition, the region's developed healthcare framework and rising investments in R&D bolster market growth.
The Asia-Pacific market is anticipated to grow at a higher rate throughout the forecast period due to the high adoption of generic drugs, increasing healthcare expenditure, and increasing pharmaceutical manufacturing capabilities. The leading bioequivalence study countries include India and China owing to cost-effective research services pooled by huge patient volumes. India's“Pharma Vision 2020”, which aims to make the country a global leader in drug manufacturing, as well as government initiatives will also contribute to this market growth.
Recent Developments
.In 2023, the FDA introduced new guidelines to streamline the bioequivalence testing process for complex generic drugs, encouraging innovation and reducing development timelines.
.Eurofins Scientific, a leading CRO, expanded its bioequivalence testing capabilities in 2023 by investing in state-of-the-art analytical technologies to meet the growing demand for high-quality studies.
Buy Full Research Report on Bioequivalence Studies Market 2024-2032 @
About Us:
SNS Insider is one of the leading market research and consulting agencies that dominates the market research industry globally. Our company's aim is to give clients the knowledge they require in order to function in changing circumstances. In order to give you current, accurate market data, consumer insights, and opinions so that you can make decisions with confidence, we employ a variety of techniques, including surveys, video talks, and focus groups around the world.
Bioequivalence Studies Market
Rising Demand for Generic Drugs and Regulatory Compliance Drives market Growth
AUSTIN, TX, UNITED STATES, February 28, 2025 /EINPresswire / -- According to Research by SNS Insider, The Bioequivalence Studies Market was valued at USD 742 million in 2023 and is projected to reach USD 1484.5 million by 2032, growing at a CAGR of 8% during the forecast period of 2024-2032. The global Bioequivalence Studies Market is witnessing significant growth, driven by the increasing demand for generic drugs, stringent regulatory requirements, and the need for cost-effective drug development.Market Analysis
One of the key contributing factors to the growth of the bioequivalence studies market is the increasing focus on generic drug development. With the expiration of patents for several blockbuster drugs, pharmaceutical companies are increasingly focusing on developing generic alternatives, which require bioequivalence studies to gain regulatory approval. Also, in order to ensure efficient and accurate results, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have implemented strict guidelines for bioequivalence testing, contributing to market growth. The rise of sophisticated analytical technologies in bioequivalence analysis is also a noteworthy trend. Techniques including high-performance liquid chromatography (HPLC) and mass spectrometry are now routinely used to guarantee appropriate results. Additionally, the rising trend of Contract Research Organizations (CROs) outsourcing bioequivalence studies further assists pharmaceutical companies in cost containment and speeding up drug development timelines.
Get a Free Sample Report@
Key Players in Bioequivalence Studies Market
.CliniExperts (Regulatory Consulting Services, Clinical Trial Management)
.ProRelix Services LLP (Clinical Research Services, Bioanalytical Services)
.IQVIA (Clinical Development Services, Real-World Evidence Solutions)
.ICON plc (Clinical Research Services, Laboratory Services)
.Charles River Laboratories (Preclinical Services, Laboratory Testing)
.Labcorp Drug Development (Clinical Trial Management, Bioanalytical Testing)
.KYMOS Group (Bioequivalence Testing, Analytical Development)
.Veeda Clinical Research (Clinical Trial Services, Bioanalytical Services)
.Notrox Research (Clinical Research Services, Bioanalytical Testing)
.NorthEast BioAnalytical Laboratories LLC (Bioanalytical Services, Pharmacokinetic Analysis)
.Malvern Panalytical Ltd (Analytical Instruments, Material Characterization Solutions)
.Synova Health (Clinical Trial Services, Regulatory Consulting)
.Inhibikase Therapeutics, Inc. (IkT-001Pro, IkT-148009)
.Lupin Limited (Ethambutol, Rifampicin)
.Geropharm (Semavic, Insulin Glargine)
.Promomed (Generic Pharmaceuticals, Biosimilars)
.PSK Pharma (Generic Drugs, Active Pharmaceutical Ingredients)
.Zhejiang Peptides Biotech (Active Pharmaceutical Ingredients, Peptide Synthesis Services)
.Gilead Sciences (Remdesivir, Biktarvy)
.Novo Nordisk (Ozempic, Wegovy)
Market Segmentation
By Molecule Type
The small molecule segment dominated the bioequivalence studies market in 2023, accounting for 59% of total revenue share. Small molecules are a common base for generic drug development as their respective chemical structure is easier to replicate. Small molecular drugs have less complex biological equivalence studies, so, they are cheaper and more time-saving. The segment's growth is bolstered by the growing number of small molecule drugs going off-patent presents opportunities for generic drug manufacturers.
By Dosage Form
The solid oral dosage form segment accounted for the largest revenue share, 54%, in 2023. Solid oral dosage forms Tablets and capsules are the most frequently prescribed drug forms owing to their ease of administration, stability and patient compliance. Bioequivalence studies for solid oral dosage forms are essential to ensure that generic versions deliver the same therapeutic effect as the reference drug. The high demand for generic oral medications in the management of chronic diseases, such as diabetes and hyper tension, is also supporting the growth of segment.
By Therapeutic Area
The oncology segment held the largest bioequivalence studies market share in 2023, contributing to 26% of the revenue share. The increasing prevalence of cancer and the high cost of branded oncology drugs have fueled the demand for affordable generic alternatives. Bio-equivalence studies are the key to generic oncology drugs having as much efficacy and safety as the brand. Moreover, increasing emphasis on personalized medicine and targeted therapies in oncology is projected to spur further need for bioequivalence studies in this segment.
Speak with Our Expert Analyst Today to Gain Deeper Insights @
Regional Analysis
In 2023, North America led the bioequivalence studies market, capturing 41% of the total market share. The region is dominated by the establishment of an advanced pharmaceutical industry, stringent regulatory frameworks, and a high demand for generic drugs. Specifically, the U.S. plays an important role in increasing the market driven by the FDA's focus on bioequivalence testing with generic drug approvals. In addition, the region's developed healthcare framework and rising investments in R&D bolster market growth.
The Asia-Pacific market is anticipated to grow at a higher rate throughout the forecast period due to the high adoption of generic drugs, increasing healthcare expenditure, and increasing pharmaceutical manufacturing capabilities. The leading bioequivalence study countries include India and China owing to cost-effective research services pooled by huge patient volumes. India's“Pharma Vision 2020”, which aims to make the country a global leader in drug manufacturing, as well as government initiatives will also contribute to this market growth.
Recent Developments
.In 2023, the FDA introduced new guidelines to streamline the bioequivalence testing process for complex generic drugs, encouraging innovation and reducing development timelines.
.Eurofins Scientific, a leading CRO, expanded its bioequivalence testing capabilities in 2023 by investing in state-of-the-art analytical technologies to meet the growing demand for high-quality studies.
Buy Full Research Report on Bioequivalence Studies Market 2024-2032 @
About Us:
SNS Insider is one of the leading market research and consulting agencies that dominates the market research industry globally. Our company's aim is to give clients the knowledge they require in order to function in changing circumstances. In order to give you current, accurate market data, consumer insights, and opinions so that you can make decisions with confidence, we employ a variety of techniques, including surveys, video talks, and focus groups around the world.
Jagney Dave
SNS Insider Pvt. Ltd
+1 315 636 4242
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Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.
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