Large Molecule Bioanalytical Testing Services Market

Market Overview

The global large molecule bioanalytical testing services market size was worth USD 1,5 billion in 2021 and is anticipated to reach ab expected value of USD 3.66 billion by 2030 at a CAGR of 9.7% during the forecast period (2022-2030).

Analytical chemistry includes the field of large molecule bioanalysis. To recognize and examine proteins in living microorganisms, scientists and researchers use a variety of tests, methods, and procedures. The demand for high-tech, high-quality large molecule bioanalytical testing services is expected to increase, and product designs and engineering are expected to become more complicated. To keep up with market demand, pharmaceutical companies now face a more critical requirement than ever to implement innovative technology in their services. Increased regulatory oversight, less time to market, and high risk of product failure are factors boosting the need for large molecule bioanalytical testing services.

Market Dynamics

Market Driving Factors

Increasing Focus on Analytical Testing

Because healthcare expenses are rising, there is a growing need for high-quality care. Analytical testing is becoming increasingly popular as new pharmaceutical items undergo more innovation. Due to rising prices and increased competition in the healthcare sector, many businesses are choosing to outsource their analytical testing needs. A product's life cycle is shortened by technological developments and a focus on personalized care, which spurs the creation of new items quickly. Analytical testing is more in demand as R&D for complex medications, combination products, and novel drug development increases. Another aspect driving up demand for analytical testing is cost.

Growing R&D Expenditure in the Biopharmaceutical Industry

The biopharmaceutical industry has a significant socioeconomic influence on society through R&D investment and manufacturing. R&D acts as a support for various drug discovery programs. Thus, biopharmaceutical R&D spending plays a vital role in drug discovery and development. The worldwide pharmaceutical business now ranks second among all sectors in terms of R&D intensity, which suggests that R&D spending is rising and will likely continue to do so over the projected period. The need for bioanalytical testing has grown due to expanding research on significant compounds. The market for large molecule bioanalytical testing services is thus anticipated to be driven by rising R&D spending during the forecast period.

There has been a significant upsurge in R&D outsourcing expenditure in recent years. Various biopharmaceutical & pharmaceutical companies are increasingly outsourcing R&D activities—such as genetic engineering, assay development, target validation, safety & efficacy tests in animal models, hit exploration & lead optimization, & clinical trials—to private CROs and academic institutes to gain a competitive advantage.

Market Restraining Factors

Monitoring Concerns and Lack of Standardization

Management and control of outsourced bioanalytical testing functions by third-party suppliers is complex. There is a lack of standardization because not all third-party suppliers comply with international regulatory requirements, which may affect the quality of services. Therefore, biopharmaceutical companies outsource only lower-end bioanalytical testing functions and prefer to conduct high-end operations in-house. Standardization and authenticity of documented data is a significant issue, as many small-scale companies do not know about advancements such as digital documentation, which is cost-efficient and reduces workforce requirements. However, these vendors are now attempting to comply with the FDA standards and regulations to combat this challenge.

Key Market Opportunities

Rising Demand for Outsourcing of Analytical Testing

Almost all biopharmaceutical companies outsource some of their services, such as analytical testing, to focus on their core competencies and 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 outsourcing areas for biomanufacturers globally, with 90.4% of companies outsourcing this activity. Analytical testing is outsourced due to the need for highly specialized staff to run assays and maintain equipment. Moreover, the pharmaceutical industry will increasingly use analytical testing processes in drug discovery applications in the coming years. Thus, the market is expected to exhibit lucrative growth due to the rapid adoption of analytical testing.

Segmental Analysis

The global large molecule bioanalytical testing services market is segmented by phase, test type, therapeutic area, end user, and region. 

By Phase, the global large molecule bioanalytical testing services market is segmented into preclinical and clinical. The clinical market segment accounted for the highest market share and registered a CAGR of 9.7% during the forecast period. The clinical study makes use of human subjects in its investigation. The prevalence of chronic diseases is estimated to rise, and there will be greater demand for clinical trials in emerging nations. Other factors anticipated to drive segment growth during the forecast period include the rise in biologics, the rising demand for innovative technologies, and the need for individualized orphan pharmaceuticals & medicines. Additionally, the market is expected to rise due to technological advancement, globalization of clinical trials, and increasing demand for CROs to perform clinical trials.

The preclinical segment is the second largest. Pharmacokinetic bioanalysis of plasma or serum samples is a component of preclinical investigations. In this study, the drug product is administered to humans or animals, and blood samples are subsequently obtained at various intervals. After being separated, the serum or plasma is submitted to a lab for analysis. The laboratory conducts in vivo and in vitro preclinical studies of both types. The amount of the drug product in the plasma or serum is determined using bioanalytical methods. For significant compounds, ligand binding techniques like the Meso Scale Discovery and Enzyme-Linked Immunosorbent Assay (ELISA) and are typically used to quantify the concentration (MSD). In some cases, mass spectrophotometer instruments can also be used for large molecule bioanalysis. Increasing expenditure in R&D and rising outsourcing activities are expected to boost the demand for preclinical trials in the coming years.

By Type, the global large molecule bioanalytical testing services market is segmented into pharmacokinetics, Anti-Drug Antibodies (ADA), and others. The Anti-Drug Antibodies (ADA) segment accounted for the largest market share and is anticipated to grow at a CAGR of 9.8% during the forecast period. Antidrug antibodies (ADA) assays support the development of large-molecule drugs. The immune system produces antibodies against the drug in response to large molecular medications like antibody or protein therapies. As a result, ADA assays can be used to detect ADAs. Patients that develop an antibody response will react differently, displaying everything from potentially fatal reactions to no discernible clinical repercussions. Additionally, this has adverse effects like autoimmunity, allergic responses, or anaphylactic shock. In light of the gravity of side effects and their consequences, the U.S. FDA has published a guideline for assay development and validation for the immunogenicity assessment of therapeutic protein products. ELISA and MSD are some platforms that measure ADA responses. As ADA may affect the drug's safety, immunogenicity assays are essential for clinical studies of large molecules.

By Test Type, the global large molecule bioanalytical testing services market is segmented into ADME, PK, PD, bioavailability, bioequivalence, and others. The bioavailability segment accounted for the highest market share and is anticipated to grow at a CAGR of 10% during the forecast period. Bioavailability is the rate at which active drugs or metabolites enter systemic circulation, reaching the site of action. A drug's bioavailability is influenced by the characteristics of the dosage form, which partly depends on its design. Because it is considered for determining dosages for non-intravenous delivery, it is crucial to pharmacokinetics.

By Therapeutic Area, the global large molecule bioanalytical testing services market is segmented into oncology, infectious diseases, cardiology, neurology, and others. The oncology segment accounted for the largest market share and at a CAGR of 10.3% during the forecast period. Cancer involves abnormal growth of cells that result in tumor formation. These abnormal cells spread to other organs and local tissues through the blood & lymphatic system. An increase in cancer incidence, a rapidly rising geriatric population, and an unhealthy lifestyle are primary factors expected to drive segment growth. According to the WHO, around 18.1 million people had cancer in 2018. Increased pipeline products and high demand for personalized medicines will likely boost segment growth. With the rise in cancer cases, the need for large-molecule bioanalytical testing is increasing, propelling the market growth during the forecast period.

The infectious disease segment is the second largest. The danger of contracting infectious diseases is increased in metropolitan areas. Increased clinical test studies for developing cutting-edge medications, growing attempts to increase knowledge of the treatments and diagnosis of infectious diseases, and rising infectious disease prevalence are all expected to drive segment expansion. Proactive government initiatives and an increase in external funding for R&D are the key factors boosting the market.

By End-User, the global large molecule bioanalytical testing services market is segmented into SMEs and large firms. The SMEs segment accounted for the largest market share at a CAGR of 9.8% during the forecast period. Small and Medium Enterprises (SMEs) biopharmaceutical companies bring a focused approach to innovation. Approximately 63% of all new prescription medicine approvals during the previous five years have come from small pharmaceutical businesses, which are the innovation engine. By tracking NMEs, or new molecular entities, which were initially created by small-, mid-sized-, and large pharmaceutical businesses, HBM Partners' analysis emphasized this tendency.

Regional Analysis

By Region, the global large molecule bioanalytical testing services market is segmented into Asia Pacific, North America, Europe, Latin America, and Middle East & Africa. 

North America accounted for the highest market share and is expected to grow at a CAGR of 9.6% during the forecast period because it is one of the top manufacturing hubs for highly dependable, complicated, and expensive medications. The global market for large molecule bioanalytical testing services is anticipated to be driven by factors including rapid technical development and rising demand for bioanalytical testing services. Moreover, biopharmaceutical companies are concentrating on the U.S. market because of the nation's expanding healthcare sector. The market for large molecule bioanalytical testing services is expanding due to rising investments by companies that provide bioanalytical testing services, rising R&D expenditures in the biopharmaceutical industry, and favorable regulatory reforms.

Europe is the second largest region. It is estimated to reach ab expected value of USD 870 million by 2030 at a CAGR of 10%. European region spearheads microbial manufacturing technology, which represents the R&D effort by this region at the global level. Various developing countries across the globe are seeking partnerships with the Western giants to establish their domestic capability by providing support services to the industry, consisting of clinical research, toxicity testing, drug development, etc. Pharmaceutical and biotechnology industries in Europe have made significant investments in R&D in recent years owing to the rising demand for advanced medicines. This can be attributed to the increasing aging population and growing incidence of chronic & infectious diseases. For instance, more than one-fifth of the European population was 65 or above in 2019.

Asia Pacific is the fastest growing region. This can be attributed to growing healthcare expenditure in the emerging economies of the region, especially India and China. Favorable government initiatives are anticipated to improve healthcare R&D, driving the market for large molecule bioanalytical testing. Demographic changes in the region, especially in countries such as China, India, and Japan, will also propel market 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.

Recent Developments

• September 2022 - The Decentralized Clinical Trial (DCT) program of IQVIA (NYSE: IQV), a top provider of advanced analytics, technological solutions, and contract services to the health sciences sector, has obtained GDPR compliance validation from TRUSTArc. A DCT service has never before received this European data privacy approval.
• September 2022 - Decentralized clinical trials (DCTs) have been shown to provide substantial advantages for patients, sites, and sponsors, according to a new study from IQVIATM (NYSE: IQV), a top global provider of technology solutions, advanced analytics, and clinical research services to the life sciences sector.

Large Molecule Bioanalytical Testing Services Market Segmentation

By Phase

• Preclinical
• Clinical

By Type

• Pharmacokinetics
• Anti-Drug Antibodies (ADA)
• Others

By Test Type

• AADM
• PK
• PD
• Bioavailability
• Bioequivalence
• Others

By Therapeutic Area

• Oncology
• Infectious Diseases
• Cardiology
• Neurology
• Others

By End-user

• SMEs
• Large Firms

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa