Bioequivalence Studies Market Size, Share, Opportunities, And Trends By Molecule Type (Small Molecule, Large Molecule), By Dosage Form (Solid Oral Dosage, Parenteral Formulations, Topical Products, Others), By Therapeutic Area (Oncology, Neurology, Metabolic Disorders, Hematology, Immunology, Others), And By Geography - Forecasts From 2023 To 2028

The bioequivalence studies market is estimated to grow at a CAGR of 7.29% during the forecast period.

A specific kind of clinical trial known as a "bioequivalence study" is intended to determine if the bioavailability of two pharmacological drugs with the same active ingredient when delivered to people is equal. The ever-expanding pharmaceutical industry due to the growing demand for generic drugs is a major growth driver of the bioequivalence studies market. Moreover, the rising healthcare costs coupled with government efforts and a rising aging population are further expected to boost the bioequivalence studies market.

Expanding Pharmaceutical Industry

The globalization of pharmaceutical markets and the increasing demand for generic drugs in various countries drive the need for more bioequivalence studies to gain regulatory approvals in different regions. For instance, the total import value of pharmaceuticals product in India increased from 41110 crores in 2018-19 to 42943 crores in 2019-2020 according to the Indian Ministry of Chemicals and Fertilizers. Moreover, in the year 2020, a total of 53 new medications were introduced to the market, and presently, over 9,000 compounds are undergoing various stages of development worldwide according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

Rising Healthcare Costs

Cost-control measures are being taken by governments, healthcare organizations, and insurance. There is a greater demand for bioequivalence studies as a result of the availability of affordable generic versions of pricey branded pharmaceuticals, which promotes their usage. For instance, in 2021, the United States spent 2.7% more on health care, amounting to $4.3 trillion or $12,914 per person. Moreover, out-of-pocket healthcare spending accounted for approximately 10.2% of the total $4255.1 U.S. healthcare expenditure as per the American Medical Association. Additionally, given the predominately private healthcare sector, the Indian State's rollout of insurance systems over the past 15 years has been a realistic step forward. A generic medicine product may be introduced to the market for between US$10 and US$15 million, which is significantly less expensive.

Advancements in Research Methods

Continuous advancements in research methodologies, analytical techniques, and statistical approaches contribute to the accuracy and reliability of bioequivalence studies. This encourages more companies to invest in such studies to develop high-quality generic drugs thereby boosting the bioequivalence studies market. For example, the research-based biopharmaceutical business would have spent USD 198 billion on biopharmaceutical R&D globally in 2020 as per the IFPMA. Moreover, according to the Office for National Statistics (UK), the amount spent by UK companies on research and development (R&D) in 2021 was £46.9 billion, up £5.9 billion from the previous year and £2.9 billion from 2020.

Aging Population

The global aging population increases the demand for pharmaceutical products. Generic drugs, supported by bioequivalence studies, provide accessible and affordable treatment options for the health challenges faced by the elderly. For instance, almost a third of the total Japanese population was aged 65 years or above in 2022 as per the UN Population Division.  According to the CDC, Alzheimer, dementia, diabetes, and cardiovascular diseases are common ailments in older people. Therefore, the rising elderly population is positively impacting the bioequivalence studies market. For instance, the percentage of people over 60 in the globe will increase from 12% to 22% between 2015 and 2050 as per the WHO report.

Prevalence of Chronic Diseases

Bioequivalence studies are essential for the development and approval of generic drugs, which are crucial for the management of chronic diseases. Therefore, the rising cases of chronic illnesses are expected to augment the bioequivalence studies market. According to the World Health Statistics 2023 WHO, about 33.3 million people died from four major non-communicable illnesses in 2019, a 28% increase from 2000. The major causes of these deaths are cardiovascular which contributed around 18 million deaths, and cancer which accounted for 9.3 million deaths. Moreover, throughout the 2000 and 2019 period, diabetes-related deaths grew by approximately 3% as per the WHO report.

Restraints in the Market

The bioequivalence studies market has experienced growth and development however some restraints or challenges can impact its expansion. For example, conducting bioequivalence studies can be expensive due to the need for specialized facilities, skilled personnel, and compliance with regulatory standards. Additionally, the regulatory requirements for bioequivalence studies are rigorous and continuously evolving. The high level of compliance can be a barrier for smaller pharmaceutical companies with limited budgets, potentially limiting their ability to conduct bioequivalence studies and enter the generic drug market. For instance, all bioequivalence studies-related generic drugs shall meet the stringent guidelines regulated by FDA in the US.

North America is Expected to Grow Considerably

North America is expected to hold a significant share of the bioequivalence studies market during the forecast period. The factors attributed to such a share are the growing number of clinical trials, investment in pharmaceutical R&D, the aging population, and advanced healthcare facilities. As of April 25, 2023, the U.S. National Library of Medicine reported that there were 450,030 registered studies, with around 31% of these studies being conducted within the United States. Additionally, the Paycheck Protection Program (PPP) was created to provide substantial support to small businesses, including healthcare organizations like physician practices, during the pandemic. It aimed to help these businesses maintain their workforce by offering loans that were guaranteed by the U.S. Small Business Administration (U.S. Small Business Administration, 2022).

Major Market Players

• CliniExperts is a consulting and regulatory services company based in India that specializes in supporting regulatory affairs in the pharmaceutical, biotechnology, medical device, and food supplement industries.
• Labcorp Drug Development offers a wide range of services across all phases of the drug development process, from preclinical research to post-marketing surveillance. Phoenix® and WinNonlin® measures pharmacokinetic & pharmacodynamic effects on biosimilars.

Key Market Developments

• In December 2022, Inhibikase Therapeutics, Inc., a pharmaceutical company in the clinical development stage, reported that they administered the first doses of IkT-001Pro, their investigational drug for Chronic Myelogenous Leukemia, to the initial three participants in the '501' bioequivalence study.
• In May 2022, Viatris Inc. and Biocon Biologics Ltd. jointly announced the availability of Abevmy® (bevacizumab) in Canada. Health Canada has granted approval for Abevmy which is a biosimilar to Roche's Avastin® (bevacizumab), for use in four oncology indications.

Segmentation:

• By Molecule Type
  • Small Molecule
  • Large Molecule
• By Dosage Form
  • Solid Oral Dosage
  • Parenteral Formulations
  • Topical Products
  • Others
• By Therapeutic Area
  • Oncology
  • Neurology
  • Metabolic Disorders
  • Hematology
  • Immunology
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • South America
    • Brazil
    • Argentina
    • Others
  • Europe
    • United Kingdom
    • Germany
    • France
    • Spain
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • UAE
    • Israel
    • Others
  • Asia Pacific
    • Japan
    • China
    • India
    • South Korea
    • Indonesia
    • Thailand
    • Others