Large Molecule Bioanalytical Testing Service Market Size, Share & Trends Analysis Report By Phase (Preclinical, Clinical), By Type, By Test Type, By Therapeutic Area, By End User, By Region, And Segment Forecasts, 2020 - 2027

Report Overview

The global large molecule bioanalytical testing service market size was valued at USD 1.3 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 9.1% from 2020 to 2027. Large molecule bioanalysis falls under the category of analytical chemistry. These large molecule drug products are very effective in combating a variety of chronic disease indications. Increasing the share of large molecules in the biopharmaceutical R&D pipeline has increased the demand for bioanalytical testing services. Due to this reason, various biopharmaceutical companies are adopting outsourcing services on a large scale. Bioanalytical testing of large molecules has always been a challenging task for the biopharmaceutical industry. Hence, various advanced techniques are used such as Maldi-TOF-MS, Ligand Binding Assays (LBA), size exclusion affinity chromatography, and HRMS. With the help of these advanced techniques, bioanalytical testing for large molecules can be easily carried out.

Technological advancement in bioanalytical testing for the large molecule is the vital impact rendering driver for this market. Large molecules are also known as biologics and are based on proteins that have therapeutic effects. As these large molecules are made up of thousands of amino acids it is necessary to carry out bioanalytical testing throughout the drug development process. Bioanalytical testing offers a quantitative measure of the active drugs in the biological system for the purpose of pharmacodynamics or pharmacokinetics study.

It also plays an important role in the drug development process. Bioanalytical testing of large molecules is generally conducted in-house by the biopharmaceutical industries and other Phase II studies and long-term toxicity studies are outsourced. This is mostly because the outsourcing of bioanalytical testing requires fewer method modifications. Hence it helps in reducing the cost of a new method developed by the CRO. Increasing demand for bioanalytical testing services and growing demand for outsourcing of bioanalytical testing are drivers responsible for market growth over the forecast period.

Phase Insights

The clinical segment accounted for the largest revenue share of over 65.0% in 2019. The large share of this segment is attributed to the rising prevalence of chronic diseases and the increasing demand for clinical trials in developing countries. An increase in the number of biologics, high demand for advanced technologies, and the requirement for personalized orphan drugs and 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 market growth over the forecast period.

Test Type Insights

The bioavailability segment accounted for the largest revenue share of 20.9% in 2019 in the market for large molecule bioanalytical testing services. 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.

Based on the test type, the large molecule bioanalytical testing service market is further sub-segmented into ADME, PK, PD, bioequivalence, and other tests. Various biopharmaceutical industries are offering a complete package of bioanalytical testing services, including ADME studies. It includes four parameters absorption, distribution, metabolism, and excretion. These four parameters influence drug performance and its bioavailability. Hence, it is essential to know ADME parameters for every molecule.

Therapeutic Area Insights

The oncology segment holds the largest revenue share of 28.1% in 2019 in the market for large molecule bioanalytical testing services. 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 and lymphatic system. 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.

Other therapeutic areas included in the scope of the study are infectious diseases, cardiology, neurology, and others. According to the WHO, infectious diseases are the second leading cause of death, globally. It is estimated that the global population will reach 9.0 billion by 2050. Proactive government initiatives and an increase in external funding for R&D are among the key factors driving the market for large molecule bioanalytical testing services.

End-user Insights

Based on end-user, the Small and Medium Enterprises (SMEs) segment accounted for the largest revenue share of 32.9% in 2019. SMEs are independent organizations. The development of biopharmaceutical inventions, for example, the introduction of new products, processes, and services in the U.S. has been attributed to increasing demand for SMEs. On the basis of end-user, the market for large molecule bioanalytical testing services is further sub-segmented into CROs and CMOs, sponsor organizations, and others (academic institute, etc.). Increasing investment in the biopharmaceutical industry by prominent players in the market to enhance their productivity and efficiency has driven the bio-manufacturers to increase their focus on outsourcing activities. Various CROs and CMOs provide outsourcing services to SMEs. With the rising demand for outsourcing of bioanalytical testing services, the demand for CROs and CMOs services is expected to significantly increase.

A sponsor is an individual or a group that provides support similar to a benefactor. Increasing focus on bioanalytical testing services and growing R&D spending are major factors responsible for increased demand for sponsor organizations. In addition, the sponsor organization segment is expected to witness growth over the forecast period due to the increasing demand for large molecule bioanalytical testing services. Various sponsor organizations provide sponsorships to SMEs for carrying out outsourcing of bioanalytical testing services.

Type Insights

The Antidrug Antibodies (ADA) segment accounted for the largest revenue share of 45.2% in 2019 and is anticipated to maintain its dominance over the forecast period. ADA assays support the development of large molecule drugs. Large molecule drugs, such as an 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.  

On the basis of type, the market for large molecule bioanalytical testing services is further sub-segmented into pharmacokinetics and others. A pharmacokinetic study helps determine drug exposures in the body over time. Pharmacokinetic parameters are used in the estimation of the Absorption, Distribution, Metabolism, and Excretion (ADME) processes of drugs. Various other large molecule immune assays are used, such as neutralizing antibodies. It plays an important role in the biological activity of drugs. As ADA may affect the safety and efficacy of drug immunogenicity, assays are typically required for clinical studies of large molecules.

Regional Insights

The U.S dominated the market for large molecule bioanalytical testing services and accounted for a revenue share of 47.2%. This is because the U.S. is among the top manufacturing hubs for highly reliable, complex, and high-end pharmaceuticals. The market is expected to grow at a significant rate in the U.S. during the forecast period. This growth can be attributed to the rapid increase in the development of biologics to meet the growing demand for efficient healthcare in the country and strong R&D and promotion of new therapies.

Rapid technological advancements and growing demand for bioanalytical testing services are factors expected to drive the market in the country. Moreover, biomanufacturing companies are focusing on the U.S. 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 growth of the market.

Key Companies & Market Share Insights

Key companies are also engaging in partnerships, mergers, and acquisitions, aiming to strengthen their product portfolio, manufacturing capacities, and provide competitive differentiation. For example, in October 2019, ICON plc acquired Symphony Clinical Research. This acquisition was expected to help ICON provide at-home patient care and site support services. It would also help ICON plc expand its clinical research services in the U.S. and the Middle East, and Africa. Some of the prominent players in the large molecule bioanalytical testing service market include:

• Covance, Inc.

• IQVIA

• Syneos Health

• SGS SA

• Toxikon

• Intertek Group plc

• Pace Analytical Services LLC

Large Molecule Bioanalytical Testing Service 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 2027. For the purpose of this study, Grand View Research has segmented the global large molecule bioanalytical testing service market report on the basis of phase, type, test type, therapeutic area, end-user, and region:

• Phase Outlook (Revenue, USD Million, 2016 - 2027)

  • Preclinical

  • With Antibody

  • Without Antibody (ELISA Based Assay)

  • Clinical

• Type Outlook (Revenue, USD Million, 2016 - 2027)

  • Pharmacokinetics

  • ADA

  • Others

• Test Type Outlook (Revenue, USD Million, 2016 - 2027)

  • ADME

  • PK

  • PD

  • Bioavailability

  • Bioequivalence

  • Other Tests

• Therapeutic Area Outlook (Revenue, USD Million, 2016 - 2027)

  • Oncology

  • Infectious Diseases

  • Cardiology

  • Neurology

  • Others

• End-user Outlook (Revenue, USD Million, 2016 - 2027)

  • SMEs

    • CROs & CMOs

    • Sponsor Organizations

    • Others (Academic institute, etc.)

  • Large Firms

    • CROs & CMOs

    • Sponsor Organizations

    • Others (Academic institute, etc.)

• Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • North America

    • The U.S.

    • Canada

  • Europe

    • The 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