Large Molecule Bioanalytical Testing Services Market (By Phase: Preclinical, Clinical; By Type: Pharmacokinetics, ADA, Others; By Test Type: ADME, PK, PD, Bioavailability, Bioequivalence, Other Tests; Therapeutic Area: Oncology, Infectious Diseases, Cardiology, Neurology, Others; By End-user: SMEs, Large Firms) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook 2021 – 2030

Published Date : Aug 2021 | No. of Pages : 150 + Pages | Category : Healthcare

The global Large Molecule Bioanalytical Testing Services market size is expected to be worth around US$ 4.0 billion by 2030, according to a new report by Vision Research Reports.

The global Large Molecule Bioanalytical Testing Services market size was valued at US$ 2.4 billion in 2020 and is anticipated to grow at a CAGR of 10.5% during forecast period 2021 to 2030.

Growth Factors

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 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.

Report Highlights

 The clinical phase segment held the largest revenue share of over 68% 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 10.7% 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).

Based on test type, the market is segmented into ADME, PK, PD, bioavailability, bioequivalence, and others. Bioavailability held the largest revenue share of 35% 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.

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 30.8% 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.

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 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.

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 10% 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.

Report Coverage Details
Market Size US$ 4.0 billion by 2030
Growth Rate CAGR of 10.5% From 2021 to 2030
Base year 2020
Historic Data 2017 to 2020
Forecast Period 2021 to 2030
Segments Covered Phase, Type, Test type, Therapeutic Area, End User
Regional Scope North America, Europe, Asia Pacific, Latin America, Middle East & Africa (MEA)
Companies Mentioned Covance, Inc.; IQVIA; Syneos Health; SGS SA; Toxikon; Intertek Group plc; Pace Analytical Services LLC

Key Players 

  • Covance, Inc.


  • Syneos Health

  • SGS SA

  • Toxikon

  • Intertek Group plc

  • Pace Analytical Services LLC

Market Segmentation

  • Phase Outlook 

    • Preclinical

      • With Antibody

      • Without Antibody (ELISA Based Assay)

    • Clinical

  • Type Outlook 

    • Pharmacokinetics

    • ADA

    • Others

  • Test Type Outlook 

    • ADME

    • PK

    • PD

    • Bioavailability

    • Bioequivalence

    • Other Tests

  • Therapeutic Area Outlook

    • Oncology

    • Infectious Diseases

    • Cardiology

    • Neurology

    • Others

  • End-user Outlook 

    • SMEs

      • CROs & CMOs

      • Sponsor Organizations

      • Others (Academic Institutes, etc.)

    • Large Firms

      • CROs & CMOs

      • Sponsor Organizations

      • Others (Academic Institutes, etc.)

  • Regional Outlook 

    • 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

The Large Molecule Bioanalytical Testing Services market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Large Molecule Bioanalytical Testing Services market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Large Molecule Bioanalytical Testing Services market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Large Molecule Bioanalytical Testing Services market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Large Molecule Bioanalytical Testing Services market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Large Molecule Bioanalytical Testing Services capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Large Molecule Bioanalytical Testing Services by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Large Molecule Bioanalytical Testing Services market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Large Molecule Bioanalytical Testing Services market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Large Molecule Bioanalytical Testing Services market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Large Molecule Bioanalytical Testing Services industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

Large Molecule Bioanalytical Testing Services market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Large Molecule Bioanalytical Testing Services market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Large Molecule Bioanalytical Testing Services market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Large Molecule Bioanalytical Testing Services market. These factors have benefited the growth of the global market for Large Molecule Bioanalytical Testing Services. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Large Molecule Bioanalytical Testing Services. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Large Molecule Bioanalytical Testing Services are as follows:

  • History Year: 2017-2020
  • Base Year: 2021
  • Forecast Year 2021 to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
  • To strategically profile the key players and comprehensively analyze their growth strategies.

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