Large Molecule Bioanalytical Testing Services Market Size, Share & Trends Analysis Report By Phase (Preclinical, Clinical), By Test Type (PK, PD), By Type, By Therapeutic Area, By End User, And Segment Forecasts, 2021 - 2028

Report Overview

The global large molecule bioanalytical testing services market size was valued at USD 1.4 billion in 2020 and is expected to witness a compound annual growth rate (CAGR) of 9.5% from 2021 to 2028. An increase in demand for advanced and quality large molecule bioanalytical testing services and the rising complexity of product designs and engineering are factors anticipated to boost the market growth. Rapid innovations in healthcare have increased the need for pharmaceutical companies to adopt new technologies in their services, to maintain market demand. Less time to market, increase in regulatory oversight, and high risk of product failure are some factors increasing the need for large molecule bioanalytical testing services.

The nature of COVID-19 transmission has led several laboratory staff to face uncertainties, such as fears of contracting the infection along with other biosafety concerns. Thus, reduced manpower and increasing focus on the development of vaccines & therapies against COVID-19 are anticipated to negatively impact the turnaround time for routine tests. In multiple countries, bioanalytical laboratories are a part of the essential healthcare infrastructure, thus bioanalytical studies were continued with minimal or no initial disruptions. Some of the initial disruptions were increased workload on CROs due to reduced internal lab testing capacities of several biopharmaceutical firms, suspension of courier services, and IT disturbances.

The demand for quality healthcare is increasing due to increasing healthcare costs. With growing innovations pertaining to new pharmaceutical products, the demand for analytical testing is increasing. Many companies are opting for outsourcing services for analytical testing owing to increasing competition in the healthcare industry and growing pricing concerns. Technological advancements and focus on customized care shorten a product’s life cycle, which leads to the rapid development of new products. Increasing R&D activities for new drug development, combination products, and other advanced medicines have increased the demand for analytical testing. Cost is also another factor boosting the demand for analytical testing.

Almost all biopharmaceutical companies outsource some of their services, such as analytical testing, to be able to focus on their core competencies and largely reduce in-house repetitive tasks or complex activities. Outsourcing offers cost savings as companies do not have to establish specialized facilities or hire more staff. Analytical testing is one of the top areas of outsourcing for bio-manufacturers globally, with 90.4% of companies outsourcing this activity. It is outsourced due to the need for highly specialized staff to run assays and maintain equipment.

Phase Insights

The clinical phase segment held the largest revenue share of over 66% in 2020 due to the high incidence of chronic diseases worldwide. Based on the study phase, the market is segmented into preclinical and clinical. The preclinical segment is expected to register the fastest CAGR of 9.7% during the forecast period. Preclinical studies include pharmacokinetic bioanalysis of the plasma or serum samples.

This study includes dosing patients or animals with the drug product and then blood samples are taken at different time points. The plasma or serum is isolated and sent to an analytical laboratory. Two types of preclinical studies (in vivo & in vitro) are carried out at the laboratory. The concentration of the drug product in the plasma or serum is measured using bioanalytical techniques. In the case of large molecules, the concentration is usually measured with ligand binding assays, such as Enzyme-linked Immunosorbent Assay (ELISA), and Meso Scale Discovery (MSD).

The growing prevalence of chronic diseases and increasing demand for clinical trials in developing countries are factors expected to drive segment growth. An increase in the number of biologics, high demand for advanced technologies, and requirement for personalized orphan drugs & medicine are other factors likely to fuel segment growth during the forecast period. In addition, factors, such as technological evolution, globalization of clinical trials, and increased demand for CROs to conduct clinical trials, are further anticipated to boost the market growth.

Test Type Insights

Based on test type, the market is segmented into ADME, PK, PD, bioavailability, bioequivalence, and others. Bioavailability held the largest revenue share of 25% in 2020. The segment growth can be attributed to the high demand for these services in generic drug manufacturing. The bioequivalence is anticipated to register the fastest CAGR over the forecast period.

Bioavailability is the rate at which active drugs or metabolites enter systemic circulation, thereby reaching the site of action. The bioavailability of a drug is determined by the properties of the dosage form, which is dependent partly on its design. It plays a vital role in pharmacokinetics because it is taken into account during the calculation of dosages for non-intravenous administration.

Therapeutic Area Insights

Based on therapeutic areas, the market is segmented into oncology, infectious diseases, cardiology, neurology, and others. The oncology segment dominated the market with the largest revenue share of more than 28.8% in 2020 and is anticipated to maintain its leading position during the forecast period. The segment is also projected to witness the fastest CAGR of 10.1 % over the forecast period. Cancer involves the abnormal growth of cells that result in the formation of a tumor.

These abnormal cells spread to other organs and local tissues through the blood & lymphatic system. An increase in the incidence of cancer, the rapidly rising geriatric population, and unhealthy lifestyles are primary factors expected to drive the segment growth. According to the WHO, around 18.1 million people were suffering from cancer in 2018. An increase in the number of pipeline products and high demand for personalized medicines are factors likely to boost segment growth during the forecast period.

End-user Insights

Based on end users, the market is segmented into Small & Medium Enterprises (SMEs) and large firms. The SMEs segment held the largest revenue share of more than 67% in 2020 due to the increased focus on bioanalytical testing services. The segment is estimated to expand further at the fastest CAGR over the forecast years retaining its dominant position in the market.

The small- and medium-sized biopharmaceutical companies bring a focused approach to innovation. Small pharmaceutical companies are driving innovation, accounting for about 63% of all new prescription drug approvals in the past 5 years. A report by HBM Partners highlighted this trend by tracking NMEs or new molecular entities that were originally developed by small-, midsized, and big pharmaceutical companies.

Type Insights

Based on type, the global market is segmented into pharmacokinetics, Antidrug Antibodies (ADA), and others. The ADA segment held the highest revenue share of more than 44% in 2020. The segment is expected to expand further at the second-fastest CAGR of more than 9% during the forecast period. The ADA assays support the development of large molecule drugs.

Large molecule drugs, such as antibody or protein therapeutics, provoke the immune system to produce antibodies against the drug. Hence, ADAs can be detected with the help of ADA assays. Patients that produce an antibody response will have different responses, from life-threatening reactions to no observable clinical consequences. This also results in adverse reactions, such as anaphylactic shock, allergic reactions, or autoimmunity.

Pharmacokinetic services are strictly carried out in compliance with Good Clinical Practice regulations and as per international regulatory guidelines (FDA, ICH, & EMEA). Furthermore, the concentration of a drug is tested in healthy volunteers as part of the pharmacokinetic investigation for biologics and biosimilars in clinical trials. This service is performed on the ELISA or MSD platform. ELISA is the most frequently performed immunoassay that has a sensitivity for major pharmacokinetic studies. The sensitivity of pharmacokinetic immunoassay requires tweaking, depending on the nature and mechanism of action of drugs.

Regional Insights

North America dominated the global market in 2020 with a revenue share of more than 42.5% as the region is among the top manufacturing hubs for highly reliable, complex, and high-end pharmaceuticals. Rapid technological advancements and growing demand for bioanalytical testing services are factors expected to drive the market. Moreover, biopharmaceutical companies are focusing on the U.S. market due to the booming healthcare industry in the country. Increasing investments by bioanalytical testing services organizations, growing R&D spending in the biopharmaceutical industry, and favorable regulatory reforms are factors contributing to the regional market growth.

Asia Pacific is expected to be the fastest-growing region with a CAGR of 10.3% over the forecast period. This can be attributed to growing healthcare expenditure in the emerging economies of the region, especially in India and China. Moreover, favorable government initiatives are anticipated to improve healthcare R&D, which will drive the market in the coming years. Demographic changes in the region, especially in countries, such as China, India, and Japan, will also propel the demand. Furthermore, advancements in pharmaceuticals and biopharmaceuticals in the region coupled with the rising number of clinical trials will augment the regional market growth over the forecast period.

Key Companies & Market Share Insights

Key companies are focusing more on partnerships, mergers, and acquisitions to strengthen their product portfolio, manufacturing capacities, and provide competitive differentiation. For example, in January 2021, Charles River Laboratories International, Inc. partnered with JADE Biomedical that offers end-to-end quality management services for the biopharma industry. The partnership is anticipated to expand Charles’ biologics testing capabilities around the world. Some prominent players in the global large molecule bioanalytical testing services market are:

• Covance, Inc.

• IQVIA

• Syneos Health

• SGS SA

• Toxikon

• Intertek Group plc

• Pace Analytical Services LLC

Large Molecule Bioanalytical Testing Services Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global large molecule bioanalytical testing services market report on the basis of phase, type, test type, therapeutic area, end user, and region:

• Phase Outlook (Revenue, USD Million, 2016 - 2028)

  • Preclinical

    • With Antibody

    • Without Antibody (ELISA Based Assay)

  • Clinical

• Type Outlook (Revenue, USD Million, 2016 - 2028)

  • Pharmacokinetics

  • ADA

  • Others

• Test Type Outlook (Revenue, USD Million, 2016 - 2028)

  • ADME

  • PK

  • PD

  • Bioavailability

  • Bioequivalence

  • Other Tests

• Therapeutic Area Outlook (Revenue, USD Million, 2016 - 2028)

  • Oncology

  • Infectious Diseases

  • Cardiology

  • Neurology

  • Others

• End-user Outlook (Revenue, USD Million, 2016 - 2028)

  • SMEs

    • CROs & CMOs

    • Sponsor Organizations

    • Others (Academic Institutes, etc.)

  • Large Firms

    • CROs & CMOs

    • Sponsor Organizations

    • Others (Academic Institutes, etc.)

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Spain

    • Italy

  • Asia Pacific

    • India

    • Japan

    • China

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE