The protein binding assay market is expected to reach US$ 694.63 million by 2028 from US$ 340.14 million in 2021; it is estimated to grow at a CAGR of 10.7% from 2021 to 2028.

Surge in drug discovery activities and growing need to reduce the costs of drug discovery and development are among key factors driving the market growth. However, challenges associated with the existing technologies hinder the market growth. Protein binding assays assist in analyzing the interaction between two types of proteins. These assays are widely used in the new drug development process.

A clinical trial is a crucial and significant step in the determination of the safety and effectiveness of a medical strategy, treatment, and device for commercial usage. These studies also help understand and determine the best medical approaches for a particular therapeutic area. Before the approval of drug molecules or medical devices by the regulatory authorities, a series of clinical studies are conducted. The increasing prevalence of communicable and non-communicable diseases is triggering the demand for the development of new drugs and medical devices, which, in turn, propels the demand for the protein binding assay. As per the data from the US National Library of Medicine, in 2018, there were ~280,801 clinical studies ongoing in 50 states and 204 countries. The following figure shows the rise in the number of studies registered in period of year 2015 to 2020.

Table 1. Number of Registered Studies for Clinical Trials

Year First Posted Studies at Start of Year Studies During Year Studies at End of Year

2015 181,304 24,130 205,434

2016 205,434 27,809 233,243

2017 233,243 29,198 262,441

2018 262,441 17,836 280,277

2019 293,275 32,519 325,794

2020 325,794 36,740 362,534

Source: Clinical Trials.gov and the Insight Partners Analysis

Furthermore, pharmaceutical, medical device, and biotechnology companies focus on research and development (R&D) activities to develop new molecules for therapeutic applications with the greatest medical and commercial potential. The companies invest majorly in the R&Ds intending to deliver high quality and innovative products to the market.

Table 2. Top 10 Pharmaceutical R&D Spenders, 2019

Name of Company (R&D Budget as % of Revenue) Name of Company (R&D Budget as % of Revenue)

1. F. Hoffmann La-Roche Ltd. (19.0%) 2. Johnson & Johnson Services, Inc. (13.8%)

3. Merck KGaA (21.1%) 4. Novartis AG (19.8%)

5. Pfizer, Inc. (16.7%) 6. Sanofi S.A (16.7%)

7. AbbVie, Inc. (19.0%) 8. Bristol Myers Squibb Company Limited (23.6%)

9. AstraZeneca Plc. (24.8%) 10. GlaxoSmithKline Plc (13.8%)

Source: PhRMA, The Insight Partner's Analysis

In the early stages of the drug development process, protein binding assays are being developed. Because unbound circulating drugs have the best access to targets and excretion pathways, drug candidate binding to plasma proteins is crucial for drug distribution, efficacy, and safety margin definition. According to Statista, around 7,493 drugs entered the preclinical stage in 2017, and the number is estimated to reach 8,040 in 2018. As a result, the total number of drug candidates being screened each year is increasing. Protein binding studies, which are conducted early in the drug development process, are an important aspect of the preclinical phase. Hence, the rising drug discovery activities coupled with increasing pharmaceutical R&D expenditure drives the growth of the protein binding assay market.

Technology Insights

Based on technology, the global protein binding assay market is segmented into ultracentrifugation ultrafiltration, equilibrium dialysis, surface plasmon, and others. In 2020, the equilibrium dialysis segment held the largest share of the market. However, the ultrafiltration segment is expected to register the highest CAGR in the market during 2021-2028. Equilibrium dialysis is among the most widely accepted methods for evaluating protein binding, and it can be performed with the help of rapid equilibrium dialysis (RED) devices. Researchers prefer this method as it has fewer binding effects to extraneous and unintended factors affecting research results.

End User Insights

Based on end user, the protein binding assay market is segmented into contract research organization, pharmaceutical and biotechnology companies, and research and diagnostic laboratories. The pharmaceutical and biotechnology companies segment is expected to hold the largest market share in 2021. It is also expected to be the largest shareholder in the market by 2028. These companies are the major adopters of CRO services; they approach CROs for outsourcing drug and molecule research and development. Protein binding is a fundamental biochemical process that is used to study the mechanism of drugs along with their pharmacological effects in subjects. These aspects are propelling the protein binding assay market for the market for the pharmaceutical and biotechnology companies segment.

A few major primary and secondary sources referred to while preparing the report on the global protein binding assay market are European Federation of pharmaceutical Industries and Associations (EFPIA), National Institute for Health Research (NHS), International Trade Administration (ITA), Spanish Council of Ministers established an Ethics Committees for Investigation (CEIm), Spanish Clinical Studies Registry (REec), Spanish Agency of Medicines and Medical Devices (AEMPS), KoNECT Collaboration Center (Korea National Enterprise for Clinical Trials), International Organization for Standardization (ISO), Medical Research Future Fund (MRFF), Ministry of Health (MOH), Health Sciences Authority (HSA), Argentine Ministry of Health (ANMAT), and European Centre for Disease Prevention and Control (ECDC).