According to Nova one advisor, the global Large Molecule Bioanalytical Testing Services market was valued at USD 2.4 billion in 2021 and it is expected to hit around USD 5.0 billion by 2030 with a CAGR of 11.5% during the forecast period 2022 to 2030.
According to Nova one advisor, the global Large Molecule Bioanalytical Testing Services market was valued at USD 2.4 billion in 2021 and it is expected to hit around USD 5.0 billion by 2030 with a CAGR of 11.5% during the forecast period 2022 to 2030.
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Key Takeaways:
- By phase, the U.S. Large Molecule Bioanalytical Testing Services market was valued at USD 450.9 million in 2021 and expected to witness growth at a CAGR of 10.2% from 2022 to 2030.
- By type, the clinical segment held the largest market share in 2021 owing to increasing demand for clinical trials due to the rising prevalence of various infectious diseases
- Bioavailability held the largest market share of 25.9% in 2021 owing to increasing adoption in generic drug manufacturing
- The oncology segment held the largest revenue share due to the increasing prevalence of cancer globally
- The U.S. is expected to witness the fastest growth over the forecast period owing to the growing adoption of advanced therapeutic techniques in the country.
The major factor attributing to market growth is the increased application of bioanalytical testing in clinical trials of biomarkers, large molecules, and others.
Rising prevalence of HIV, infectious disease, and others has led to increasing demand for bioanalytical testing services globally. Moreover, increasing government initiatives to control the outbreak of various infectious diseases such as Corona and Ebola virus is anticipated to offer more opportunities for the market. Hence, the market is expected to grow over the assessment period.
The market is expected to witness lucrative growth during the forecast period due to increased research activities and the presence of a huge pipeline of peptides, biologics, and amino acids based molecules. Additionally, bioanalysis of large molecules requires skilled professionals with innovative analytical instruments and infrastructure. These services are readily offered by bioanalytical testing service providers and are likely to propel the growth of the market during the assessment period.
North America accounted for the highest share in 2019. The U.S. holds the highest market share due to the increasing prevalence of various chronic diseases and the growing adoption of large molecule therapeutics as an alternative for small molecules.
For example, according to International Diabetes Federation Report 2019, around 49.0 million geriatric population in the U.S. has diabetes and this has led to increasing requests for bioanalysis of the novel (large molecule compounds) peptide therapeutics such as glucagon-like peptide 1(GLP-1). Due to this reason, the market is expected to show growth over the forecast period. In addition, the presence of major players in the region contributed to market growth.
Report Scope of the Large Molecule Bioanalytical Testing Services Market
| Report Coverage | Details |
| Market Size | US$ 5.0 Billion by 2030 |
| Growth Rate | CAGR of 11.5% from 2022 to 2030 |
| Largest Market | North America |
| Fastest Growing Market | Asia Pacific |
| Base Year | 2021 |
| Forecast Period | 2022 to 2030 |
| Segments Covered | Phase, type, test type, therapeutic area, end user, and Region, |
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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.
Some of the prominent players in the Large Molecule Bioanalytical Testing Services Market include:
- Covance, Inc.
- IQVIA
- Syneos Health
- SGS SA
- Toxikon
- Intertek Group plc
- Pace Analytical Services LLC
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 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global Large Molecule Bioanalytical Testing Services market
- Phase
- Preclinical
- With Antibody
- Without Antibody (ELISA Based Assay)
- Clinical
- Preclinical
- Type
- Pharmacokinetics
- ADA
- Others
- Test Type
- ADME
- PK
- PD
- Bioavailability
- Bioequivalence
- Other Tests
- Therapeutic Area
- Oncology
- Infectious Diseases
- Cardiology
- Neurology
- Others
- End-user
- SMEs
- CROs & CMOs
- Sponsor Organizations
- Others (Academic Institutes, etc.)
- Large Firms
- CROs & CMOs
- Sponsor Organizations
- Others (Academic Institutes, etc.)
- SMEs
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