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The biopharmaceutical analytical testing services market size is forecast to increase by USD 3.45 billion at a CAGR of 12.61% between 2022 and 2027. The demand for monoclonal antibodies (mAbs) is rising alongside an increase in the number of patent-expired drugs and the prevalence of chronic diseases. However, the industry faces challenges including a shortage of trained professionals, changing formulations in product design, and the emergence of bioterrorism. This market analysis and report includes in-depth information on the key market drivers, trends, and challenges during the forecasted period.
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Biopharmaceutical development and drug discovery, meticulous attention to detail is paramount to ensure the safety and efficacy of pharmaceutical products. This necessitates comprehensive bioanalytical testing encompassing a myriad of aspects such as drug release testing, assessment of drug targets, and evaluation of biological fluids for metabolites and impurities. From the initial stages of biopharmaceutical R&D, where molecular understandings inform the development process, to the final stages of pharmaceutical components and mixtures, every step is crucial in safeguarding patient's health. Contract research organizations (CROs) play a pivotal role in conducting rigorous biotherapeutics testing, ensuring the integrity of proteins, compounds, and other drugs and therapeutics. Amidst concerns about the poor quality of medicines, robust fund systems support the advancement of biopharmaceutical science, facilitating breakthroughs that benefit global healthcare.
In the realm of biopharmaceutical development, biopharmaceutical analytical plays a pivotal role in ensuring the safety, efficacy, and quality of novel therapeutics. Leveraging molecular understandings and advanced techniques, these services encompass a wide range of activities, including drug release testing and characterization of biotherapeutics. From identifying drug targets to assessing therapeutic potential, rigorous biopharmaceutical R&D protocols are followed to bring life-saving treatments to fruition. These services extend to various life sciences services, addressing critical aspects such as drug purity and the analysis of metabolites in biological fluids like blood, plasma, serum, urine, saliva, and tissue extracts. Adherence to regulatory frameworks such as ICH Q9, ICH Q8, and ICH Q10 ensures compliance and fosters trust in the industry's commitment to patient safety and well-being. From rheumatoid arthritis to oncology and infectious diseases, biopharmaceutical analytical testing services contribute to the development of innovative treatments, ultimately improving patient's health and addressing global health challenges.
The increase in demand for mAbs is notably driving the biopharmaceutical analytical testing services market growth. mAbs are proteins developed in pharmaceutical and biotechnology laboratories to bind to the corresponding epitope of the antigen in the body. These antibodies are used as independent treatments or in combination with radiotherapy, drugs, or toxins to exterminate the infected cells.
The global mAbs market is growing, as mAbs are used for immunotherapy to stimulate immune responses to treat diseases. The rise in demand for personalized medicine is a major factor behind this demand. mAbs are subjected to several quality control tests, such as microbial tests, sterility tests, and dissolution tests to ensure their quality. Biopharmaceutical analytical testing services include product-related impurities information, structural characterization, and structural confirmation. Thus, the rise in demand for mAbs will increase the demand for analytical testing services, which, in turn, will fuel the growth of the healthcare analytical testing services market during the forecast period.
The rise in investment in R&D is a key trend influencing the biopharmaceutical analytical testing services market growth. The expenditure on R&D is increasing globally. In developing countries, a large number of laboratories and research facilities are expected to be set up during the forecast period. This will increase the demand for analytical testing services to develop biopharmaceutical drugs.
The trend of increased R&D spending will last throughout the forecast period as countries are focusing on innovation. The increase in R&D leads to the expansion of facilities in fields such as drug discovery and pharmaceutical research, which depend on analytical testing services to develop safe and effective products. Hence, the growth of the pharmaceutical industry will lead to a rise in demand for biopharmaceutical analytical testing services during the forecast period. This, in turn, will support the growth of the global healthcare analytical testing services market.
The shortage of trained professionals may impede the biopharmaceutical analytical testing services market growth. The lack of required skilled professionals leads to a high degree of non-compliance. Improper testing and analysis of analytical tests can lead to product failures, which leads to losses for companies. The dearth of skilled professionals also affects the manufacturing process and, consequently, the quality of biopharmaceuticals.
According to the US Department of Labor, there is a shortage of approximately 12,000-15,000 laboratory professionals. Moreover, professionals currently working in laboratories are quitting their jobs or pursuing different fields in medicine. The attrition of laboratory professionals can be attributed to factors such as dissatisfaction with salaries, inadequate training programs, absence of job satisfaction, and lack of awareness about laboratory professions. The shortage of trained professionals is expected to continue during the forecast period, which, in turn, will impede the growth of the market.
The market research and growth report extensively covers market segmentation by Service (Bioanalytical, Method development and validation, Stability testing, Other), End-User (Pharma, Biotech companies, CROs), and Geography (North America, Europe, Asia, and Rest of World (ROW)). Furthermore, the market growth analysis report includes historic market data from 2017 to 2021. Pharmaceutical analytical testing outsourcing ensures the safety and efficacy of drugs like Cholera, Pertussis, and Influenza vaccines. Compliance with Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) is essential for drug discovery and development. Analytical testing of biologics helps assess their efficacy and safety for the patient population, reducing disease burden. In the realm of healthcare, treatment of diseases such as heart disease, stroke, and chronic conditions remains paramount. This involves the development of custom-made medicine, including monoclonal drugs tailored to individual needs. Ensuring drug's safety and efficacy through rigorous biologics testing and clinical trial expenditures is essential. Additionally, virology testing and biomarker analysis aid in managing infectious diseases like HIV infections and Malaria. Advanced techniques like ICP-MS and physiochemical analysis contribute to understanding drug product quality and biological potency attributes.
The market share growth by the bioanalytical segment will be significant during the forecast period and was valued at USD 0.85 billion in 2017 and continued to grow by 2021. Some of the major applications of techniques include bioavailability, pharmacology, bioequivalence, pharmacokinetic, and toxicology studies on humans and animals. The growth of this segment is expected to be driven by factors such as an increase in the use of biosimilars for a variety of medical indications, especially diabetes and cancer. Most contract research organizations (CROs), pharmaceutical companies, and bioanalytical laboratories are expanding their bioanalytical services and are investing in laboratories. Another driver for the growth of this segment is the outsourcing of R&D activities by pharmaceutical companies so that they can concentrate on their core competencies. New product development and innovation are expected to further increase the demand for services. This, in turn, is expected to expand the market growth and trends during the forecast period.
Market - Revenue Share by Service Segment, 2017 - 2027.
North America Holds a Prominent Position in the Market
North America is estimated to contribute 33% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period. North America has key companies, such as Charles River and Catalent, which are driving the growth of the market. These companies have a diversified portfolio of services, covering aspects of drug discovery, development, and manufacturing. The drugs need to be tested analytically according to the regulations to ensure safety, quality, and efficacy. The US and Canada are the key countries in the region, as stable economies and strong infrastructural support the launch of new drugs or biopharmaceuticals. High investments in R&D are further increasing the demand for high-quality analytical services in these countries. The rising prevalence of several diseases is increasing investments in clinical trials and research studies in the region. These factors are expected to drive the growth of the market in the region during the forecast period.
Market Size, By Region, Global, 2017 - 2027.
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The Biopharmaceutical Analytical Testing Services market is fragmented in nature. Some significant players include Almac Group Ltd.
This market research and growth report also includes detailed analyses of the competitive landscape of the market and information about 15 market companies, including:
Boston Analytical, Catalent Inc., Charles River Laboratories International Inc., Coriolis Pharma Research GmbH, Curia Inc., Element Materials Technology Group Ltd., Eurofins Scientific SE, ICON plc, Intertek Group Plc, Laboratory Corp. of America Holdings, Merck KGaA, Pace Analytical Services LLC, Parexel International Corp., SGS SA, Solvias AG, STERIS Plc, Thermo Fisher Scientific Inc., Vimta Labs Ltd., and West Pharmaceutical Services Inc.
The market plays a pivotal role in drug development and approval processes, addressing the increasing complexity of therapeutics. Outsourcing testing services, particularly for gene therapies and biologics, is prevalent among pharmaceutical and biotechnology companies, involving specialized firms for enhanced efficiency. Technological advancements, including high-throughput screening methods, automation, and advanced analytical techniques, ensure accuracy and speed in bioanalytical testing. The market accommodates combination products and innovative medicines, facilitating the outsourcing of R&D activities for economic efficiency amidst competitive pressure and pricing concerns. Consumer interest in self-care underscores the importance of accessibility to bioanalytical testing services, balancing in-house tests and outsourcing based on testing capabilities.
Stringent regulatory compliance requirements uphold the safety and effectiveness of drugs and therapies, addressing molecules ranging from small to large, fostering medical breakthroughs, and meeting unmet medical needs. Chemical probes, PK, pharmacodynamics, generic and branded drug compounds, and patent expiration contribute to the workflow, encompassing sample analysis, quantitation of impurities, stability of drug molecules, identification of impurities, sample preparation, extraction procedures, and nontraditional extraction technologies. Automation aids in reducing cost use, enabling miniaturization while focusing on Absorption Distribution Metabolism Excretion (ADME), Pharmacokinetics (PK), Pharmacodynamics (PD), and other test types. Moreover, market concentration drives advancements in chromatography, mass spectrometry, and immunoassays, supporting the development of cost-efficient generics or biosimilars such as Ustekinumab Biosimilar (BFI-751).
The market analysis and report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2017 - 2027.
Market Scope |
|
Report Coverage |
Details |
Page number |
171 |
Base year |
2022 |
Historic period |
2017 - 2021 |
Forecast period |
2023-2027 |
Growth momentum & CAGR |
Accelerate at a CAGR of 12.61% |
Market growth 2023-2027 |
USD 3.45 billion |
Market structure |
USD Fragmented |
YoY growth 2022-2023(%) |
11.67 |
Regional analysis |
North America, APAC, Europe, South America, and Middle East and Africa |
Performing market contribution |
North America at 33% |
Key countries |
US, China, Japan, UK, and Germany |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
Almac Group Ltd., Boston Analytical, Catalent Inc., Charles River Laboratories International Inc., Coriolis Pharma Research GmbH, Curia Inc., Element Materials Technology Group Ltd., Eurofins Scientific SE, ICON plc, Intertek Group Plc, Laboratory Corp. of America Holdings, Merck KGaA, Pace Analytical Services LLC, Parexel International Corp., SGS SA, Solvias AG, STERIS Plc, Thermo Fisher Scientific Inc., Vimta Labs Ltd., and West Pharmaceutical Services Inc. |
Market dynamics |
Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, Market growth and Forecasting, COVID 19 impact and recovery analysis and future consumer dynamics, Market condition analysis for forecast period |
Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Service
7 Market Segmentation by End-user
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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