Large Molecule Bioanalytical Testing Services Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 1.40 Billion |
| Market Size (2029) | USD 2.20 Billion |
| CAGR (2024 - 2029) | 9.20 % |
| Fastest Growing Market | Asia-Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Large Molecule Bioanalytical Testing Services Market Analysis
The Large Molecule Bioanalytical Testing Services Market size is estimated at USD 1.40 billion in 2024, and is expected to reach USD 2.20 billion by 2029, growing at a CAGR of 9.20% during the forecast period (2024-2029).
The market’s growth is largely attributable to the rising focus on analytical testing of biologics and biosimilars, rising research and development expenditure by biotechnology companies, increasing number of large molecule drug candidates in the preclinical trials, and increasing preference for outsourcing bioanalytical testing services.
The increasing research and development expenditure in the biopharmaceutical industry for the development of large molecules such as monoclonal antibodies, gene-based therapies, and hormonal regulators is expected to increase the outsourcing of bioanalytical testing for these large molecules to reduce the overall development cost and drive significant advancements in the treatment of chronic diseases.
For instance, the Indian Ministry of Science and Technology allocated a budget of INR 40 billion (USD 427.20 million) for the Department of Biotechnology (DBT) of India in the Union Budget for the year 2023-2024. An INR 1,100 crore budget has been allocated primarily for biotechnology research and development as well as industrial and entrepreneurship development in the country. Hence, such investments in research and development increase the demand for large molecule outsourcing services to speed up biological drug discovery and reduce the overall cost of development, which is expected to drive the market studied over the forecast period.
Furthermore, the growing bioanalytical service offering for large molecules by the market players across several geographies is likely to contribute to market growth over the forecast period. For instance, in January 2024, Frontage Laboratories completed the acquisition of the Bioanalytical and Drug Metabolism & Pharmacokinetics businesses, which also includes the large molecule bioanalytical testing services of Accelera, marking its entry into continental Europe.
Similarly, in May 2023, Resolian, a new venture resulting from the merger of Alliance Pharma and Drug Development Solutions Ltd, established bioanalytical laboratories and experts across the United States, the United Kingdom, and Australia, underscoring a commitment to meeting the growing global demand for large-molecule bioanalytical and analytical services. Hence, such expansion of bioanalytical testing services is expected to drive the market studied over the forecast period.
Thus, the increasing research and development expenditure in the biopharmaceutical industries and growing bioanalytical service offerings for large molecules by key players are expected to drive the market over the forecast period. However, the complex regulatory framework for maintaining laboratories is expected to restrain the marker studied over the forecast period.
Large Molecule Bioanalytical Testing Services Market Trends
Oncology Segment is Expected Hold Significant Market Share Over the Forecast Period
Bioanalytical testing is important in oncology drug discovery and development. Bioanalytical tests are used to quantify the drugs and their metabolites or relate biomarkers in biological fluids to evaluate pharmacokinetics and toxic kinetic studies. The increasing prevalence of cancer cases across the world and the rising research funding for the development of cancer drugs are expected to increase demand for large molecule bioanalytical testing, driving the market studied over the forecast period.
The increasing prevalence of cancer cases across the globe accelerates the demand for large molecules of biologics and biosimilars, which further increases the demand for large-molecule bioanalytical testing services for early oncology product launches. This is expected to drive the segment’s revenue over the forecasted period. For instance, according to the American Cancer Society, the prevalence of lung cancer is increasing in the United States, and the country reported 238,340 lung cancer cases in 2023 compared to 236,740 in 2022.
Similarly, in February 2023, Cancer Research UK stated that the number of new cancers combined cases on average each year in the United Kingdom is projected to rise from around 420,000 cases during 2023-2025 to around 506,000 cases during 2038-2040. Hence, the increasing prevalence of cancer cases across the globe is expected to drive the market studied over the forecast period.
Furthermore, the increasing research and development funding for the development of new cancer therapies is also expected to increase the outsourcing of large molecule bioanalytical testing services, driving the market over the forecast period. For instance, in the United States, the National Institute of Health (NIH) invested USD 8,078 million in 2023 compared to 7,635 million in 2022 for its research activities associated with cancer. Hence, such investments in cancer research are expected to increase the adoption of outsourcing large molecule bioanalytical testing services, driving the market studied over the forecast period.
Thus, the increasing prevalence of cancer cases and rising research and development investments for the development of novel cancer therapies are expected to increase the demand for large molecule bioanalytical testing services, driving the segment’s growth over the forecast period.
North America is Expected to Hold a Significant Share of the Market Over the Forecast Period
North America is expected to dominate the large molecule bioanalytical testing services market, and this trend is expected to continue over the forecast period. This can be majorly attributed to the growing demand for bioanalytical services with a high volume of ongoing research activities and clinical trials, the increasing expansion of bioanalytical testing services offered by companies, and the increasing prevalence of chronic diseases in the region.
The increasing expansion of bioanalytical service offering companies is expected to increase the accessibility of large molecule bioanalytical testing, driving the market studied over the forecast period. For instance, in November 2022, Altasciences announced the expansion of its facility in Columbia, Missouri, to provide bioanalytical services in support of preclinical and clinical studies conducted in the United States. This new 8,000 sq. ft facility will mirror the existing bioanalytical laboratory of Altasciences in Canada. With the expansion of the laboratory, the company is planning to provide services across the United States and Canada.
Furthermore, in May 2022, an Asia-Pacific biotech specialist contract research organization (CRO)- Novotech, acquired a US-based CRO, NCGS, as part of its service expansion program. Novotech is known for delivering high-quality, expedited preclinical and clinical trials in Asia-Pacific. With this acquisition, the company supported many US-based biotech companies for various preclinical and clinical trial services.
The rising funding activities to accelerate various preclinical studies in the region are expected to drive the demand for large molecule bioanalytical testing services over the forecast period. For instance, in May 2023, the government of Canada invested USD 225 million to support AbCellera in creating a state-of-the-art biotech campus equipped with a new preclinical antibody development facility. Such investments by the government to accelerate preclinical studies in the country increase the demand for preclinical large molecule bioanalytical testing services, which is expected to drive the market studied over the forecast period.
Hence, the increasing expansion of large molecule bioanalytical testing services offering companies and rising investments in preclinical studies to develop new molecules or drug candidates through government support are expected to drive the market over the forecast period in North America.
Large Molecule Bioanalytical Testing Services Industry Overview
The large molecule bioanalytical testing services market is competitive and consists of several major players. In terms of market share, a few of the major players are currently dominating the market, such as Labcorp Drug Development, BioAgilytix Labs, ICON PLC, Syneos Health, and Charles River Laboratories International Inc.
Large Molecule Bioanalytical Testing Services Market Leaders
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BioAgilytix Labs
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ICON Plc
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Syneos Health
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IQVIA, Inc.
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Charles River Laboratories International, Inc.
*Disclaimer: Major Players sorted in no particular order
Large Molecule Bioanalytical Testing Services Market News
- May 2024: Precision for Medicine, a global biomarker-driven clinical research and development supporting life sciences company, reported the expansion of its laboratory campus in Frederick, Maryland. This state-of-the-art facility serves as a center of excellence for Precision for Medicine’s gene therapy companion diagnostic manufacturing, advanced immunological monitoring research, and large molecule bioanalytical testing services.
- April 2024: Smithers, a leading provider of bioanalytical testing, reported the launch of its Generic Pharmacokinetic (PK) Assay. The assay measures the drug concentration of human or humanized mAb kappa IgG molecules with ECL detection.
Large Molecule Bioanalytical Testing Services Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumption and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Clinical Trial Applications of Biologics & Biomarkers
4.2.2 Rising R&D Expenditure by Pharmaceutical Companies
4.2.3 Increased Demand for Outsourcing
4.3 Market Restraints
4.3.1 Complex Regulatory Framework for Maintaining Laboratories
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION
5.1 By Phase
5.1.1 Preclinical
5.1.1.1 With Antibody
5.1.1.2 Without Antibody
5.1.2 Clinical
5.2 By Service
5.2.1 Absorption, Distribution, Metabolism, and Excretion
5.2.2 Pharacokinetics
5.2.3 Pharmacodynamics
5.2.4 Bioavailability
5.2.5 Bioequivalence
5.2.6 Other Tests
5.3 By Therapeutic Area
5.3.1 Oncology
5.3.2 Infectious Diseases
5.3.3 Cardiology
5.3.4 Neurology
5.3.5 Other Therapeutic Areas
5.4 By End User
5.4.1 Small and Medium Enterprises (SMEs)
5.4.2 Large Firms
5.5 By Geography
5.5.1 North America
5.5.1.1 United States
5.5.1.2 Canada
5.5.1.3 Mexico
5.5.2 Europe
5.5.2.1 Germany
5.5.2.2 United Kingdom
5.5.2.3 France
5.5.2.4 Italy
5.5.2.5 Spain
5.5.2.6 Rest of Europe
5.5.3 Asia-Pacific
5.5.3.1 China
5.5.3.2 Japan
5.5.3.3 India
5.5.3.4 Australia
5.5.3.5 South Korea
5.5.3.6 Rest of Asia-Pacific
5.5.4 Middle East and Africa
5.5.4.1 GCC
5.5.4.2 South Africa
5.5.4.3 Rest of Middle East and Africa
5.5.5 South America
5.5.5.1 Brazil
5.5.5.2 Argentina
5.5.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Labcorp Drug Development
6.1.2 Pacific Biolabs Inc.
6.1.3 NorthEast BioAnalytical Laboratories LLC.
6.1.4 BioAgilytix Labs.
6.1.5 SGS SA
6.1.6 ICON Plc
6.1.7 Smithers
6.1.8 Syneos Health
6.1.9 PPD Inc.
6.1.10 IQVIA Inc.
6.1.11 Thermofisher Scientific Inc.
6.1.12 Charles River Laboratories International Inc.
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Large Molecule Bioanalytical Testing Services Industry Segmentation
As per the scope of the report, bioanalysis of large molecules such as proteins or specific biotherapeutics refers to a set of methods and procedures that allow scientists to analyze particular proteins found in living organisms and the biochemical reactions underlying life processes. The large molecule bioanalytical testing services market is segmented by phase, services, therapeutic area, end user, and geography. By phase, the market is segmented into preclinical (with antibody, without antibody) and clinical. By services, the market is segmented into absorption, distribution, metabolism, and excretion (ADME), pharmacokinetics, pharmacodynamics, bioavailability, bioequivalence, and other tests. By therapeutic area, the market is segmented into oncology, infectious diseases, cardiology, neurology, and other therapeutic areas. By end user, the market is segmented into small and medium enterprises (SMEs) and large firms. By geography, the market is segmented into North America, Europe, Asia-Pacific, Middle East and Africa, and South America. The report offers the value (USD) for the above segments.
| By Phase | ||||
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| Clinical |
| By Service | |
| Absorption, Distribution, Metabolism, and Excretion | |
| Pharacokinetics | |
| Pharmacodynamics | |
| Bioavailability | |
| Bioequivalence | |
| Other Tests |
| By Therapeutic Area | |
| Oncology | |
| Infectious Diseases | |
| Cardiology | |
| Neurology | |
| Other Therapeutic Areas |
| By End User | |
| Small and Medium Enterprises (SMEs) | |
| Large Firms |
| By Geography | ||||||||
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Large Molecule Bioanalytical Testing Services Market Research FAQs
How big is the Large Molecule Bioanalytical Testing Services Market?
The Large Molecule Bioanalytical Testing Services Market size is expected to reach USD 1.40 billion in 2024 and grow at a CAGR of 9.20% to reach USD 2.20 billion by 2029.
What is the current Large Molecule Bioanalytical Testing Services Market size?
In 2024, the Large Molecule Bioanalytical Testing Services Market size is expected to reach USD 1.40 billion.
Who are the key players in Large Molecule Bioanalytical Testing Services Market?
BioAgilytix Labs, ICON Plc, Syneos Health, IQVIA, Inc. and Charles River Laboratories International, Inc. are the major companies operating in the Large Molecule Bioanalytical Testing Services Market.
Which is the fastest growing region in Large Molecule Bioanalytical Testing Services Market?
Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Large Molecule Bioanalytical Testing Services Market?
In 2024, the North America accounts for the largest market share in Large Molecule Bioanalytical Testing Services Market.
What years does this Large Molecule Bioanalytical Testing Services Market cover, and what was the market size in 2023?
In 2023, the Large Molecule Bioanalytical Testing Services Market size was estimated at USD 1.27 billion. The report covers the Large Molecule Bioanalytical Testing Services Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Large Molecule Bioanalytical Testing Services Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Large Molecule Bioanalytical Testing Services Industry Report
Statistics for the 2024 Large Molecule Bioanalytical Testing Services market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Large Molecule Bioanalytical Testing Services analysis includes a market forecast outlook for 2024 to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
