Large Molecule Bioanalytical Testing Services Market Size, Share & Trends Analysis Report By Phase (Preclinical, Clinical), By Test Type (ADME, PD), By End-user, By Type, By Therapeutic Areas, And Segment Forecasts, 2022 - 2030

Report Overview

The global large molecule bioanalytical testing services market size was valued at USD 1.6 billion in 2021 and is anticipated to expand at a compound annual growth rate (CAGR) of 9.1% over the forecast period. The industry is expected to grow as a result of various factors including an increase in demand for high-tech and reliable large molecule bioanalytical testing services. Moreover, the complexity of product designs & engineering has boosted the adoption of analytical testing services. Rapid innovations in healthcare have increased the need for pharmaceutical companies to adopt new technologies in their services, to maintain market demand.

The demand for large molecule bioanalytical testing services is rising as a result of factors, such as less time to market, increased regulatory oversight, and, a high risk of product failure. However, due to the COVID-19 pandemic, several laboratory workers have had to deal with uncertainties including worries about getting the infection and other biosafety concerns. The turnaround time for routine tests is therefore predicted to be negatively impacted by reduced manpower and a growing emphasis on the development of vaccines and treatments against COVID-19. Bioanalytical studies continued with little to no initial disruption even though bioanalytical laboratories are an integral part of the healthcare infrastructure in numerous countries.

Several biopharmaceutical companies' decreased internal lab testing capacities resulted in increased workload for CROs, the suspension of courier services, and IT issues, among other initial disruptions. The industry witnessed a slight positive growth during the year 2020 and is anticipated to execute a stable growth over the forecast period. Post-pandemic, the industry exhibited stable growth owing to factors, such as the increasing rate of R&D for COVID-19 vaccines and a growing number of deals & partnerships among the CROs & biopharmaceutical companies to outsource their bioanalytical testing services. The demand for quality healthcare is increasing due to increasing healthcare costs.

With growing innovations in 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. An increasing number of 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.

Phase Insights

The clinical phase segment dominated the global industry in 2021 and accounted for the largest share of more than 66.50% of the overall revenue. The segment will expand further at a steady CAGR retaining its leading position throughout the forecast period. The growing prevalence of chronic diseases and increasing demand for clinical trials in developing countries are the key factors that are expected to drive the segment growth further. An increase in the number of biologics, high demand for advanced technologies, and the requirement for personalized orphan drugs & medicine are other factors likely to fuel segment growth during the forecast period. The preclinical segment is expected to register the fastest CAGR from 2022 to 2030.

Preclinical studies include pharmacokinetic bioanalysis of the plasma or serum samples. This study involves dosing patients or animals with the drug product and then taking blood samples at various time points. The plasma or serum is separated and sent to a laboratory for analysis. The laboratory conducts two types of preclinical studies (in vivo and in vitro). Bioanalytical techniques are used to determine the concentration of the drug product in the plasma or serum. Large molecules are typically measured using ligand binding assays, such as Enzyme-linked Immunosorbent Assay (ELISA) and Meso Scale Discovery (MSD). Technological evolution, globalization of clinical trials, and high demand for CROs to conduct clinical trials will support the segment’s growth.

Type Insights

Based on types, the global industry has been further categorized into pharmacokinetics, Antidrug Antibodies (ADA), and others. The ADA type segment dominated the global industry in 2021 and accounted for the maximum share of more than 44.45% of the overall revenue. The 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. The pharmacokinetics type segment is expected to register the fastest growth rate during the forecast period.

Pharmacokinetic services are offered in strict accordance with Good Clinical Practice guidelines and international regulatory guidelines (FDA, ICH, and EMEA). Moreover, as part of the pharmacokinetic investigation for biologics and biosimilar in clinical trials, the concentration of a drug is tested in healthy volunteers. The ELISA or MSD platform is used for this service. ELISA is the most commonly used immunoassay with high sensitivity for major pharmacokinetic studies. Depending on the nature and mechanism of action of drugs, the sensitivity of pharmacokinetic immunoassays should be adjusted.

Test Type Insights

Based on test types, the global industry has been further divided into ADME, PD, bioavailability, bioequivalence, and other tests. The segment will expand further at a steady CAGR retaining its leading market position throughout the forecast period. The bioavailability segment dominated the global industry in 2021 and accounted for the largest share of more than 24.95% of the overall revenue. The segment growth can be attributed to the high demand for these services in generic drug manufacturing. 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. The bioequivalence test type segment is anticipated to register the fastest growth rate during the forecast period. It is a biopharmaceutical parameter used to assess biological equivalence using in vivo methods. This parameter becomes critical when drug manufacturers apply it to generic versions of branded pharmaceuticals. Moreover, with the emergence of biosimilars, bioequivalence studies are anticipated to gain popularity during the forecast period.

Therapeutic Areas Insights

Based on therapeutic areas, the global industry has been further divided into oncology, infectious diseases, cardiology, neurology, and others. The oncology segment dominated the global market in 2021 and accounted for the maximum share of more than 28.70% of the overall revenue. The segment is anticipated to retain its leading position, expanding further at the fastest growth rate during the forecast period. An increase in the incidence of cancer, a rapidly rising geriatric population, and an unhealthy lifestyle are some of the key factors that are expected to drive the segment’s growth. For instance, according to the WHO, around 10 million people died from cancer in 2020.

As per the estimates of cancer, 30.2 million people are likely to have cancer by 2040. Infectious diseases were the second-largest therapeutic area segment in 2021 and are expected to grow further at a steady rate during the forecast period. The rising prevalence of infectious diseases, growing initiatives to raise awareness about treatments & diagnosis of these conditions, and increasing clinical test studies for the development of the latest drugs are factors likely to propel segment growth. For instance, according to the WHO, infectious diseases are the second leading cause of death globally. It is estimated that the global population will reach 9 billion by 2050.

End-user Insights

Based on end-users, the global industry has been further segmented into Small- & Medium-size Enterprises (SMEs) and large firms. The SMEs end-user segment dominated the global industry in 2021 and accounted for the maximum share of more than 68.00% of the overall revenue. The segment is also anticipated to expand at the fastest growth rate during the forecast period, maintaining its dominant position in the global market. Small-scale 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-, mid-, and large-scale pharmaceutical companies. Large-scale firms also accounted for a considerable share of the global industry in 2021. Large firms are further divided into CROs & CMOs, sponsor organizations, and others. With increasing changes in the economy, larger companies examine business practices and consider every option & opportunity to manage their workflow. It is very important for large enterprises to control & manage costs as well as maintain their industry position while accelerating their ability to react to changing market and economic conditions.

Regional Insights

North America dominated the global industry in 2021 and accounted for the maximum share of more than 47.85% of the overall revenue. The North America region is among the top manufacturing hubs for highly reliable, complex, and high-end pharmaceuticals. Increasing investments by bioanalytical testing service organizations, growing R&D spending in the biopharmaceutical industry, and favorable regulatory reforms are the factors contributing to the growth of the regional market. Growing investments in pharmaceutical R&D coupled with the rising number of clinical trials will also boost the market growth in the region. For instance, the U.S. conducted 134,516 clinical trials between 1999 and 2019, as registered on WHO’s International Clinical Trials Registry Platform (ICTRP).

The Asia Pacific region is expected to register the fastest CAGR over the forecast period due to the rising healthcare expenditure in emerging economies, particularly India and China. Government initiatives to improve healthcare R&D is expected to drive the industry. However, the Indian government has more than doubled its healthcare spending for the fiscal year 2020-2021 in the union budget, to boost the healthcare sector. Such favorable government initiatives are expected to propel market growth. Changing demographics in the region, particularly in China, India, and Japan, will also drive market demand.

Key Companies & Market Share Insights

Mergers, acquisitions, and partnerships among others were the key strategies adopted by key players to maintain their industry share. For instance, in January 2021, Charles River Laboratories International, Inc. announced that it has partnered with JADE Biomedical, which offers end-to-end quality management services for the biopharma industry. The partnership is anticipated to expand Charles's biologics testing capabilities around the world. Also, Charles River Laboratories acquired Distributed Bio, Inc., which expands Charle’s scientific capabilities with an innovative, large-molecule discovery platform in January 2021. Some of the key players in the global large molecule bioanalytical testing services market include:

• Covance

• IQVIA

• Syneos Health

• SGS SA

• Toxikon

• Intertek Group plc

• Pace Analytical Services LLC

• ICON Plc

• Charles River Laboratories

• Thermo Fisher Scientific

Large Molecule Bioanalytical Testing Services Market Report Scope

Global Large Molecule Bioanalytical Testing Services Market Segmentation

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 2018 to 2030. For this study, Grand View Research has segmented the global large molecule bioanalytical testing services market report based on phase, test type, type, therapeutic areas, end-user, and region:

• Phase Outlook (Revenue, USD Million, 2018 - 2030)

  • Preclinical

    • With Antibody

    • Without Antibody (ELISA Based Assay)

  • Clinical

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmacokinetics

  • ADA

  • Others

• Test Type Outlook (Revenue, USD Million, 2018 - 2030)

  • ADME

  • PD

  • Bioavailability

  • Bioequivalence

  • Other Tests

• Therapeutic Areas Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • Infectious Diseases

  • Cardiology

  • Neurology

  • Others

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • SMEs

    • CROs & CMOs

    • Sponsor Organizations

    • Others (Academic institute, etc.)

  • Large Firms

    • CROs & CMOs

    • Sponsor Organizations

    • Others (Academic institute, etc.)

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE