Burlingame, Jan. 24, 2023 (GLOBE NEWSWIRE) -- According to Coherent Market Insights, Global Pharmaceutical Analytical Testing Market is estimated to be valued at US$ 7,695.8 million in 2022 and is expected to exhibit a CAGR of 8.2% during the forecast period (2022-2030).
Analysts’ Views on Global Pharmaceutical Analytical Testing Market:
Pharmaceutical analytical testing is the quantification and identification of constituents in pharmaceutical products. The objective is to ensure that products meet FDA safety, potency, purity, and stability standards. Method development, method transfers, qualification, and validation services are all aspects of analytical development and testing services. Growing demand for analytical testing services/solutions, an increase in number of drug approvals and clinical trials, and technological advancements are the major factors which will propel the global pharmaceutical analytical testing market growth over the forecast period.
Global Pharmaceutical Analytical Testing Market – Driver
Rapid Innovation and Improved Clinical Manufacturing Operations
Rapid innovation and improved clinical manufacturing operations is expected to propel the growth of global pharmaceutical analytical testing market over the forecast period. For instance, in December 2021, Amazon Web Services, Inc. (AWS), a subsidiary of Amazon.com, Inc., announced a collaboration with Pfizer, an American multinational pharmaceutical and biotechnology corporation, to develop novel, cloud-based solutions that have the potential to enhance the way drugs are developed, manufactured, and distributed for clinical trials. These developments are investigated by firms through their recently formed Pfizer Amazon Collaboration Team (PACT) programme, which combines AWS capabilities in analytics, machine learning, computation, storage, security, and cloud data warehousing to Pfizer laboratory, clinical manufacturing, and clinical supply chain initiatives.
Global Pharmaceutical Analytical Testing Market – Restraint
Stringent Regulations Associated with Analytical Testing
The growth of the global pharmaceutical analytical testing market is anticipated to be hampered by the stringent regulations associated with testing of pharmaceutical drugs along with the increasing number of bioanalytical testing service providers, which may impose a threat for the global player operating in the market. For instance, the Center for Drug Evaluation and Research, a division of the U.S. Food and Drug Administration, maintains a comprehensive quality surveillance program to test selected drugs in FDA laboratories. This includes testing active pharmaceutical ingredients (APIs). FDA laboratories generally test drugs as per the standards set by the U.S. Pharmacopeia (USP), a scientific organization that sets minimum standards for the quality of medicines.
Key Trends and Analysis of the Global Pharmaceutical Analytical Testing Market:
Increasing facility expansion by key players in the market for pharmaceutical analytical testing services is expected to drive the market growth over the forecast period. For instance, in December 2022, Catalent, Inc., a provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, announced its plan to open a new biologics analytical center of excellence in Durham, North Carolina, U.S. The facility will provide analytical development and testing for biological drug modalities, including cell and gene therapies. The 80,000-ft2 facility will receive up to US$ 40 million as investment from Catalent Inc. When fully operational, the facility will offer all-inclusive solutions such as bioassays, physico-chemical testing, complete product and process characterization, process validation support, stability testing, in-process manufacturing and formulation analysis, and post-packaging identification.
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Global Pharmaceutical Analytical Testing Market Cross Sectional Analysis:
Bioanalytical testing segment is expected to exhibit the highest CAGR in Asia Pacific region over the forecast period due to the increasing adoption of growth strategies by market players in order to increase the pharmaceutical analytical testing in the region. For instance, in February 2022, SGS Société Générale de Surveillance SA, a Switzerland-based multinational company, which provides inspection, verification, testing and certification services, announced that its new bioanalytical laboratory is ready to operate in Shanghai, China. The new facility will support the local and global pharmaceutical and biopharmaceutical drug testing and development.
Recent Developments:
In October 2022, The U.S. Pharmacopeia (USP), a scientific nonprofit organization, launched a new range of impurity materials to aid pharmaceutical companies' initiative to accelerate and improve analytical R&D and process development. USP Pharmaceutical Analytical Impurities (PAIs) enable the impurity analysis and profiling during drug development and throughout the product lifecycle.
In February 2022, The Center for Breakthrough Medicines (a cell and gene therapy contract development and manufacturing organization) and BioAnalysis LLC (BIA), a biotechnology company, formed a strategic alliance to offer novel analytical testing services including characterization of viral vectors using BIA’s proprietary sedimentation velocity approach to analytical ultracentrification, as well as other advanced biophysical methods and analytics, for cell and gene therapy (CGT) clients.
In June 2019, AptarGroup, Inc. announced that it had acquired Nanopharm Ltd. and Gateway Analytical LLC, two major pharmaceutical services companies, for a total enterprise value of about US$ 50 million. This acquisition will provide differentiated analytical, testing, and development capabilities for drug development and commercialization at all stages.
Key Market Takeaways:
The global pharmaceutical analytical testing market is expected to exhibit a CAGR of 8.2% during the forecast period owing to the increasing investment for pharmaceutical analytical testing services by key players in the market. For instance, in July 2022, Symbiosis Pharmaceutical Services (Symbiosis), a global contract manufacturing organization (CMO) that specializes in providing GMP aseptic fill and finish services for biologic and small molecule pharmaceuticals to biotechnology and pharmaceutical firms throughout the world, announced a US$ 1.3 million investment in its in-house analytical services capabilities.
Among service type, bioanalytical testing segment is expected to hold a dominant position in the global pharmaceutical analytical testing market, owing to increasing adoption of inorganic growth strategies such as acquisitions by key players in the market. For instance, in July 2022, Alliance Pharma, a provider of small and large molecule bioanalytical services in the pharmaceutical and biopharmaceutical industries based in the U.S., acquired Drug Development Solutions (DDS), a U.K.-based bioanalytical and material science testing contract research organization (CRO). This acquisition broadens the bioanalytical, analytical material testing, and laboratory capabilities for biopharma and pharmaceutical industries, including areas of cell and gene therapy, next-generation biologics, material sciences, and protein characterization.
Among region, North America is expected to dominate the global pharmaceutical analytical testing market during the forecast period owing to the presence of well-established players in the region as well increasing investments for analytical testing by major players in the market. For instance, in November 2022, MillporeSigma, the life science business of Merck KGaA, announced that the company is investing more than US$286 million in its biosafety testing capacity. A new, state-of-the-art, 250,000 ft2 facility at the Rockville, Maryland, will facilitate biosafety testing, analytical development, viral clearance suites, and cell bank manufacturing services.
Competitive Landscape:
Key players operating in the global pharmaceutical analytical testing market include Steris PLC, West Pharmaceutical Services Inc., Boston Analytical, Intertek Pharmaceutical Services, Pace Analytical Services, Labcorp (Toxikon Inc.), SGS SA, Eurofins Scientific, and Laboratory Testing Inc., among others
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Market Segmentation:
- Global Pharmaceutical Analytical Testing Market, By Service Type:
- Bioanalytical Testing
- Method Development and Validation
- Stability Testing
- Drug Substances Testing
- Other Service Types
- Global Pharmaceutical Analytical Testing Market, By Geography:
- North America
- By Country
- U.S.
- Canada
- By Country
- Latin America
- By Country
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- By Country
- Europe
- By Country
- Germany
- U.K.
- France
- Italy
- Spain
- Russia
- Rest of Europe
- By Country
- Asia Pacific
- By Country
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
- By Country
- Middle East
- By Country
- GCC
- Israel
- Rest of Middle East
- By Country
- Africa
- By Region/Country
- South Africa
- Central Africa
- North Africa
- By Region/Country
- North America
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