The bioequivalence studies market is projected to grow at a CAGR of 7.49% over the forecast period, increasing from US$873.352 million in 2025 to US$1,253.345 million by 2030.
Bioequivalence studies are scientific studies that compare the bioavailability of two pharmaceutical products that have the same active ingredient. Bioavailability usually refers to the rate and extent of absorption of an active ingredient from the gastrointestinal tract.
The bioequivalence studies market is nurtured by increased demand for generic drugs as affordable substitutes for brand products, and further the boosting of research and development activities in the pharmaceutical industry, especially in biosimilar and new scalable drug formulations creating the need for an increasing number of bioequivalence studies. According to NIH data, new drug R&D costs range from $314 million to $4.46 billion in June 2024, depending on the therapeutic area, data, and modeling assumptions. This aspect brings out a high R&D cost of new drugs that would, in turn, lead to the development and use of generic drugs, biosimilars, and repurposing strategies, thereby increasing the demand for bioequivalence studies.
This is because pharmaceutical companies are concentrating on the therapeutic area with huge unmet medical needs and large market potential, which will have an impact on the nature of drugs that will have affordable generic versions or those to be developed into biosimilars.
Demand is expected to rise in the bioequivalence studies market with the increasing chronic diseases as the need for generic medicines which usually cost less than brand-name drugs will rise, thereby providing viable and affordable treatment options for most patients.
There is a growing need for generic drugs in the treatment of cardiovascular diseases, diabetes, and cancer. According to WHO data from February 2024, by 2050, there will be 35 million incidences of new cancer cases as compared to 20 million in 2022 which is an increase of 77%.
The rising number of these cases will provide the opportunity for the advancement of bioequivalence studies of generic chronic disease medications, which could lead to further improvement in patients’ access to care and a reduction in the cost of treatment.
Bioequivalence studies in oncology are increasingly driven by the global rise in cancer cases, which amplifies the demand for cost-effective treatments. This surge highlights the growing need for generic drugs, thus fueling the expansion of bioequivalence studies in oncology. Also, the expensive nature of oncology drugs is driving the demand for affordable generics. It is fueled by the rise in investment by the government for the development of generics for reducing healthcare costs.
Oncology is one of the major areas where bioequivalence studies are conducted. The oncology bioequivalence studies market refers to studies done to ensure that generic drugs are as effective and safe as their branded counterparts. In this area, drugs like Imatiniob, Erlotinib, and agents like Irinotecan, Pacitaxel, Cisplatin, etc. are typically studied. The market is driven by the increasingly high prevalence of cancer cases and the need to provide affordable treatment for cancer patients. For example, bioequivalence studies, such as those for irinotecan conducted by Anticancer Research, ensure that generic products are therapeutically equivalent to brand-name drugs while offering lower costs, ultimately making cancer treatment more accessible.
The number of cases of cancer is rapidly growing, increasing the demand for affordable treatment. This increase in the number of cases is evident from the report by the National Cancer Institute which states that in 2024, there were 2 million new cancer cases in the US only. Also, the report estimates that by 2040, there will be 29.9 million new cases, highlighting the increasing number of cancer cases. Thus, the growing cancer cases are increasing the demand for affordable generic drugs and therapies driving the market of bioequivalence studies in oncology.
The European bioequivalence studies market is driven by stringent regulatory requirements from agencies like the EMA, ensuring the safety and efficacy of generic drugs. The rising demand for cost-effective generics due to healthcare cost containment measures is a significant factor. In addition, advancements in analytical technologies and a strong pharmaceutical R&D ecosystem support market growth.
The demand for generic drugs in the United Kingdom bioequivalence studies market has increased because generic drugs are the most affordable substitutes for brand-name medications, and such medicines are finding acceptance in significant proportions. Moreover, the high degree of stringent studies on bioequivalence enhances market demand for bioequivalence studies.
In addition, the UK's regulatory environment is critical. The MHRA has strict guidelines for bioequivalence studies, and hence, careful research is required to gain market approval for generic drugs. This stringent regulatory environment is a significant market driver.
Moreover, escalating research and development work in the pharmaceutical industry, especially in rare diseases and biosimilars, creates an additional factor that is fueling growth in this market. It also calls for stronger bioequivalence studies as new drugs progress toward approval and introduction.
In this regard, the UK remains the second largest comparator country for budget allocation to health research and development as a percentage of gross domestic product (GDP), after only the USA. In 2022, the business enterprise sector spent £9.0 billion on pharmaceutical R&D, which was equivalent to 0.36% of the UK's GDP. Also, pharmaceutical R&D accounted for 18% of all R&D performed by businesses in the UK in 2022, the highest of any product area.
Technological advances in areas including analytical chemistry, bioinformatics, and clinical trial design also help optimize the process involved in bioequivalence studies, thereby enhancing efficiency, and accuracy, and thus, fueling the market as a whole. For instance, as per ABPI, 411 industry clinical trials were initiated in the UK in 2022 (rising from 394 in 2021).
| Report Metric | Details |
|---|---|
| Study Period | 2021 to 2031 |
| Historical Data | 2021 to 2024 |
| Base Year | 2025 |
| Forecast Period | 2026 – 2031 |
| Report Metric | Details |
| Bioequivalence Studies Market Size in 2025 | US$873.352 million |
| Bioequivalence Studies Market Size in 2030 | US$1,253.345 million |
| Growth Rate | CAGR of 7.49% |
| Study Period | 2020 to 2030 |
| Historical Data | 2020 to 2023 |
| Base Year | 2024 |
| Forecast Period | 2025 – 2030 |
| Forecast Unit (Value) | USD Million |
| Segmentation |
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| Geographical Segmentation | North America, South America, Europe, Middle East and Africa, Asia Pacific |
| List of Major Companies in Bioequivalence Studies Market |
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| Customization Scope | Free report customization with purchase |