Bioequivalence Studies Market Size, Share & Trends Analysis Report By Molecule Type (Small Molecule, Large Molecule), By Dosage Form, By Therapeutic Area, By Region, And Segment Forecasts, 2023 - 2030

Bioequivalence Studies Market Size & Trends

The global bioequivalence studies market size was valued at USD 679.8 million in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 8.3% from 2023 to 2030. Increasing demand for generics and biosimilars is one of the key factors augmenting the growth of the market for bioequivalence studies. Bioequivalence studies are crucial in the development of pharmaceutical and biopharmaceutical products. These studies involve comparing two sets of formulations of the same drug or two drug products to evaluate if they have equal rates of bioavailability and pharmacokinetic (PK) parameters.

They are often conducted for generic pharmaceuticals, biosimilars, or when a drug formulation is reformed during development. As recent statistics have suggested, the demand for generic drugs has witnessed a significant surge in developed and developing economies. For instance, in March 2023, the Regulatory Affairs Professionals Society (RAPS) stated that the U.S. Food and Drug Administration (FDA) approved 917 Abbreviated New Drug Applications (ANDAs) in 2022, reflecting a rise of 18.0% from 2021, where a total of 776 ANDAs for generic drugs were approved.

Thus, the demand for bioequivalence studies is also increasing due to the strong growth in the production and consumption of generic products, thereby boosting the growth of the market for bioequivalence studies.The COVID-19 pandemic negatively impacted the biopharmaceutical and pharmaceutical sectors, and the bioequivalence research industry was no different. However, companies operating in the market for bioequivalence studies have opted for strategies such as mergers, acquisitions, and partnerships to mitigate the impact of the pandemic and rebound their market presence.

Furthermore, the bioequivalence studies industry has been impacted considerably by the geopolitical war between Russia and Ukraine. Several clinical trials involving bioequivalence research were outsourced to Ukraine from the United States, which were then halted until further notice due to the undesirable situation in the country.

For instance, in October 2022, one of the KOLs of PharmaLex GmbH stated that the impact is anticipated to be more extensive, with the U.S. FDA noting that around 250 devices and drugs-based clinical trials were outsourced to Ukraine, which has been halted for the time being. Thus, the global market for bioequivalence studies has witnessed a moderately negative impact from the geopolitical war between the countries.

In addition, the adoption of bioequivalence studies also helps lower the development cost of a generic or biosimilar, as no clinical trials are mandatory in such cases. Instead, a biosimilar/generic manufacturer is permitted to rely on data from the clinical trials conducted by the original drug sponsor. However, they need to implement or conduct bioequivalence tests for analyzing the equilibrium properties of the specific generic/biosimilar drug to the original pharmaceutical product or biologic.

For instance, the estimated out-of-pocket expenditure in the development of a branded drug is around USD 1.4 to 1.8 billion, while a generic drug product can be placed in the market at the cost of USD 10-15 million, which is much more cost-effective in comparison. Furthermore, generics/biosimilars are only developed for drugs that are commercially and medically successful. Hence, the cost of failed clinical trials can be avoided at the optimum level.  

Molecule Type Insights

The small molecule segment dominated the market for bioequivalence studies and accounted for the largest revenue share of 60.6% in 2022. The segment is driven by the increasing demand for novel pharmaceuticals and generics across the globe, which require bioequivalence testing. The growing pipeline of small molecules is one of the prominent factors supporting the segment’s robust revenue shares during the analysis timeframe.

For instance, in April 2022, Sionna Therapeutics, a developer of small molecule therapies, announced the closing of a USD 111 million Series B financing for the development of a pipeline of first-in-class small molecules to treat cystic fibrosis. The company announced the submission of two IND applications for its first nucleotide-binding domain targeted program, SION-638, and SION-109, by mid-2023. Such investments are anticipated to strongly support the development of novel small molecules, including generics, thereby supporting the segment’s growth in the market for bioequivalence studies.  

The large molecule segment, on the other hand, is anticipated to register a lucrative CAGR of 8.9% in the bioequivalence studies market during the forecast period. The high growth of this segment is attributed to the increasing pipeline of biologics, rising investment by contract manufacturers in the development of large molecule-based therapeutics, and a surge in the number of U.S. FDA approvals for biosimilars.

For example, in 2022, the U.S. FDA approved seven biosimilar medications, including Alymsys, Fylnetra, and Idacio, among others. The U.S. FDA further approved the launch of two interchangeable biosimilars in 2022. Also, the regulatory body is expected to further approve several other biosimilar products by 2023. Thus, the aforementioned factors strongly support the growth of the large molecules segment in the market for bioequivalence studies.   

Dosage Form Insights

The solid oral dosage segment dominated the bioequivalence studies industry with a revenue share of 53.8% in 2022. The high share of this segment is primarily due to the increasing investments by drug developers in the bulk production of oral solids that require bioequivalence research for optimal equivalence in drug compositions. Furthermore, several common medicines and consumer generics are commercialized in oral solid dose (OSD) formats, such as pills, tablets, capsules, etc.

These OSD drugs are witnessing multiple advantages pertaining to formulation concepts, novel technologies, and other manufacturing innovations often targeted at a continual cost reduction.  For instance, in March 2022, Evonik, one of the leading providers of specialty chemicals, announced the launch of EUDRATEC SoluFlow, a new micro-particle technology aimed at improving the solubility of active pharmaceutical ingredients in oral solid drug products. This technology enabled the production of new oral solids in diverse areas such as cardiovascular diseases, cancer, diabetes, and infectious diseases.

Thus, technological innovations in the field of oral solids are anticipated to support the robust demand for solid oral dosage forms in the market for bioequivalence studies. On the other hand, the parenteral formulations category is poised to witness a substantial CAGR of 8.7% from 2023 to 2030. The lucrative growth of this segment is majorly driven by the injectable class of drugs included in the parenteral formulations category. The R&D of injectables is receiving significant global funding, thereby boosting segment growth.

In January 2022, Enable Injections, Inc., developer of the enFuse platform, announced a USD 215 million Series C financing. Enable Injections’ enFuse is a novel injectable drug delivery technique designed to deliver large volumes of up to 50mL drugs subcutaneously for a wide range of diseases and therapies and to provide patients with a convenient, safe, and cost-effective alternative to intravenous administration.

Furthermore, in October 2019, Nevakar Inc., a pharmaceutical company, announced that it had entered into a definitive agreement of product financing with H.I.G. Capital Partners, L.P., for a Series funding of USD 17.5 million in the sustained development of five sterile, differentiated, injectable drugs. Such instances of extensive investments are most likely to stimulate segment growth in the market for bioequivalence studies over the forecast period.

Therapeutic Area Insights

The oncology category dominated the overall market for bioequivalence studies and accounted for the largest revenue share of 27.3% in 2022. This share is attributed to increasing R&D activities pertaining to the discovery of novel anti-cancer therapeutics, rising government initiatives to reduce the cost of treatment for cancer patients, and the growing number of contract developers focusing on the launch of low-cost generics and biosimilars in the treatment of several types of cancer.

In September 2022, Celltrion USA announced that the U.S. FDA had approved Vegzelma, a biosimilar to Avastin, 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 addition, in May 2022, Biocon Biologics, a subsidiary of Biocon Ltd., in partnership with Viatris, announced the launch of Abevmy, a biosimilar to Avastin in Canada, to treat four oncology indications. The increasing number of cancer-based biosimilars is anticipated to strongly support the market growth for bioequivalence studies in the field of oncology, as we know that these studies are mostly conducted for biosimilars and generics.

The neurology category, on the other hand, is anticipated to register a lucrative CAGR of 8.6%, following the oncology segment in terms of growth pace during the forecast period. The segment is poised to witness considerable growth owing to increasing R& D activities in this field. In 2023, the University of Nebraska Medical Center stated that the total neuroscience research funding increased from USD 1.3 million in 2015 to USD 16.2 million in 2022, thus simultaneously supporting the demand for bioequivalence studies in the field of neurology.

Moreover, as of September 2022, the National Institute on Aging is supporting 459 active clinical trials on Alzheimer’s disease and related dementias (AD/ADRD), which are a part of the neurological segment considered in the study. Hence, the increasing clinical research on several neurological conditions has boosted the demand for bioequivalence studies, thereby supporting the segment’s growth.

Regional Insights

North America dominated the market for bioequivalence studies with a revenue share of 42.9% in 2022. This is majorly due to growth in the number of clinical trials across the U.S., which also involves bioequivalence & bioavailability testing. For instance, the U.S. National Library of Medicine stated that as of April 25, 2023, a total of 450,030 studies had been registered, and approximately 31% of the studies are conducted in the U.S. The presence of major players such as IQVIA, Charles River Laboratories, and others in the country has boosted the regional revenue share in the bioequivalence studies market.

Asia Pacific is anticipated to register the fastest CAGR of 8.8% during the forecast period. The region’s significant growth is due to the presence of multiple pharmaceutical manufacturing hubs, including India, China, and Japan. Moreover, the generics market in Asian economies has been flourishing in the past few years. For example, India is one of the largest exporters of generic drugs in the pharmaceutical industry.

This also suggests that the country has a stronghold in the production of generics. For instance, as per the India Brand Equity Foundation, about 8 out of 20 global generic companies are from India, and over 55% of the exports from the country are to highly regulated markets. Hence, the above-stated factors boost the growth of the overall Asia Pacific region in the global market for bioequivalence studies.

Key Companies & Market Share Insights

The major players operating in the market for bioequivalence studies are focused on the adoption of inorganic strategic initiatives such as mergers, partnerships, acquisitions, etc. Furthermore, several players are focusing on the development of novel therapeutics, thereby boosting the demand for bioequivalence testing.

For instance, in December 2022, Inhibikase Therapeutics, Inc., a clinical-stage pharmaceutical company, announced the dosing of the first three subjects in its '501' bioequivalence study of IkT-001Pro for the treatment of Chronic Myelogenous Leukemia. Thus, the increasing pace of clinical research for generic and biosimilar versions of drug products is highly anticipated to boost the market share of prominent players operating across the market for bioequivalence studies. Some of the prominent players in the global bioequivalence studies market include:

• 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

Bioequivalence Studies Market Report Scope

Global Bioequivalence Studies Market Report Segmentation

This report forecasts revenue growth at the global, regional & country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global bioequivalence studies market report based on molecule type, dosage form, therapeutic area, and region.

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

  • Small Molecule

  • Large Molecule

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

  • Solid Oral Dosage

  • Parenteral Formulations

  • Topical Products

  • Others

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

  • Oncology

  • Neurology

  • Metabolic Disorders

  • Hematology

  • Immunology

  • Others

• 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