Analytical testing constitutes a key part of pharmaceutical development from the early stages to commercialization of the dug or therapy. The process is a key step in drug manufacturing which includes identification, determination, and purification of a compound or mixture of compounds. The process also entails determining the structure of chemical compounds and helps in the synthesis and characterization of active pharmaceutical ingredients (APIs).
In recent years, pharmaceutical analytical testing outsourcing services, as a part of contract research organizations, have begun playing significant role in substituting a large part of analytical development and testing conducted in-house. The intensify pressure on pharmaceutical and biopharmaceutical organizations in rejuvenating their drug pipelines across R&D cost-cutting measures has propelled the demand for analytical testing outsourcing services. The access to real-time analytical results and first-hand information enable drug manufacturers reduce operating costs and boost their drug pipelines of innovative drugs. This not only helps them in the development of powerful therapies but make them accessible to a wider populations across regions.
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Meanwhile, they are left with ample budget for other strategic ventures such as mergers and consolidations, which furthers their interest in exploring new revenue streams. Major pharmaceutical analytical services offered by these outsourcing organizations include method validation, stability, and quality control testing. In addition, various outsourcing services also include offering regulatory compliance of current good manufacturing practice (CGMP)-good laboratory practice (GLP) guidelines in various regions. This enables pharmaceutical players in adhering to various regional and global regulatory standards related to various routine to complex drug research programs.
The practice wherein a company transfers a portion of its work to an outside supplier to cut costs is referred to as outsourcing. It is said to be a cost-saving strategy observed by several companies. In pharmaceutical industries, in-house laboratory testing might be an expensive affair. Some resources might also be unavailable. Therefore, outsourcing is an excellent way that could be employed to deal with these issues. Analytical testing is an important step in manufacturing which provides first-hand information to the manufacturer, therefore reducing the operating cost. It is also often outsourced.
The global pharmaceutical analytical testing outsourcing market is expected to experience rapid growth during the forecast period due to the swiftly developing pharmaceuticals market, increasing demand for biosimilars & biopharmaceutical products as well as for analytical drugs, and the rising number of products in the pipeline. Furthermore, improved efficiency in testing, reduced cost, quicker & reliable results, and data safety are other factors propelling the global market. However, quality approvals and regulatory audits conducted in outsourcing laboratories could hinder the global pharmaceutical analytical testing outsourcing market during the forecast period.
The global pharmaceutical analytical testing outsourcing market can be divided based on product type into the following segments: raw materials, finished products, and active pharmaceutical ingredients. Active pharmaceutical ingredients are likely to register a significant growth rate in the global market due to the increasing demand for generics drugs and biosimilars. On the basis of application, the global analytical testing outsourcing market is split into the following sections: clinical trials, biological research, drug discovery, and others. The clinical trials segment is anticipated to occupy a major share in the global market during the forecast period due to the rising number of clinical trials and surge in quality requirement to perform the testing with utmost priority and excellence. Based on services, the global pharmaceutical analytical testing outsourcing market can be classified into the following categories: stability testing, method validation testing, quality control testing, and others.
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Geographically, the global pharmaceutical analytical testing outsourcing market is distributed over North America, Asia Pacific, Europe Latin America, and Middle East & Africa. North America occupies a major share in the global analytical testing outsourcing market in terms of value, followed by Europe. The factors attributing to the expansion of the analytical testing outsourcing market in North America by 2025 include the technological advancements, extensive research & development facilities, better quality, and rising demand for drugs & other pharmaceutical products in the region. The global analytical testing outsourcing market in Asia Pacific is anticipated to be develop rapidly during the forecast period owing to the speedy growth in pharmaceutical industries in India & China, high demand for biopharmaceuticals, immense investments by established market players in developing countries, and low-cost proposals in low- and middle-income countries.
To obtain a significant position in the global pharmaceutical analytical testing outsourcing market, players employ various strategies such as geographical expansion, mergers & acquisitions, alliances, and cost-effective & efficient services. Key players operating in the global pharmaceutical analytical testing outsourcing market include Eurofins Scientific, Boston Analytical, Intertek Group plc, Dalton Pharma Services, Charles River Laboratories International, Inc, West Pharmaceutical Services, Inc., Exova, and Halo Pharma.
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