Biopharmaceutical Analytical Testing Services Market Analysis North America, APAC, Europe, South America, Middle East and Africa - US, China, Japan, UK, Germany - Size and Forecast 2024-2028

Biopharmaceutical Analytical Testing Services Market Size 2024-2028

The biopharmaceutical analytical testing services market size is forecast to increase by USD 4.67 billion, at a CAGR of 14.68 between 2023 and 2028. The market is witnessing a surge in demand driven by several factors. The rising demand for monoclonal antibodies (mAbs) is particularly noteworthy, propelled by the expiration of drug patents and the increasing prevalence of chronic diseases. However, the industry confronts various challenges that impact its growth trajectory. These challenges include a shortage of trained professionals with specialized skills in biopharmaceutical analytical testing. Additionally, the landscape is evolving with changing formulations in product design, necessitating advanced analytical capabilities. Furthermore, the emergence of bioterrorism poses new challenges, highlighting the critical importance of rigorous testing protocols and sophisticated analytical services within the biopharmaceutical sector. This market analysis and report includes in-depth information on the key market drivers, trends, and challenges during the forecasted period. 

What will be the size of the Market During the Forecast Period?

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Market Dynamics 

In the realm of biopharmaceutical development, biopharmaceutical analysis 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, other healthcare analytical testing services contribute to the development of innovative treatments, ultimately improving patient's health and addressing global health challenges.

Key Market Drivers

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. 

Additionally, 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.

Significant Market Trends

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.

Further, 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. 

Major Market Challenges

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 bio pharmaceuticals. 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.

Market Segmentation

By Service

The market share growth by the bioanalytical segment will be significant during the forecast period. 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. Custom-made monoclonal drugs targeting specific biomarkers are revolutionizing the treatment of diseases by reducing swelling spots and enhancing immunogenicity, with advanced virology testing aiding in the management of conditions like cardiovascular disorders.

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The bioanalytical segment was valued at USD 965.60 million in 2018.  Furthermore, 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.

By Region

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APAC 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 bio pharmaceuticals components. 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 Companies Overview

The Biopharmaceutical Analytical Testing Services Market is fragmented in nature. Some significant players include 

• Almac Group Ltd. - The company offers biopharmaceutical analytical testing services such as stability testing, raw material testing, and QC release testing.

The research report also includes detailed analyses of the competitive landscape of the market and information about 15 market companies, including:

Almac Group Ltd., Boston Analytical, Catalent Inc., Charles River Laboratories International Inc., Coriolis Pharma Research GmbH, Curia Global 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.

Segment Overview

The market forecasting research report provides comprehensive data (region wise segment analysis), with forecasts and estimates in "USD Billion" for the period 2024 to 2028, as well as historical data from 2018 to 2022 for the following segments

• Service Outlook
  • Bioanalytical 
  • Method development and validation
  • Stability testing
  • Others 
• End-user Outlook
  • Pharma
  •  Biotech companies
  • CROs 
• Region Outlook
  • North America
    • The U.S.
    • Canada
  • Europe
    • The U.K.
    • Germany
    • France
    • Rest of Europe
  • APAC
    • China
    • India
  • Middle East & Africa
    • Saudi Arabia
    • South Africa
    • Rest of the Middle East & Africa
  • South America
    • Argentina
    • Brazil
    • Chile

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Market Analyst Overview

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 as it can be seen in the overall biopharma market. 

Further, 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 for poor quality of medicines. 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).

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What are the Key Data Covered in this Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting of the market between 2024 and 2028
• Precise estimation of the size of the market size and its contribution to the parent market
• Accurate predictions about upcoming market trends and analysis and changes in consumer behavior
• Growth of the market industry across Europe, North America, APAC, South America, and Middle East and Africa
• Thorough market growth analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive market analysis and report on the factors that will challenge the market research and growth of market companies

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