Pharmaceutical Analytical Testing Outsourcing Market by Services (Stability Testing [Stability Indicating Method Validation, Photo-stability Testing, Drug Substance, Accelerated Stability Testing, and Others], Method Development & Validation [Technical Consulting, Impurity Method, Extractable & Leachable, and Others], Bioanalytical Testing [Clinical and Non-Clinical], and Others), and Regions (Asia Pacific, North America, Latin America, Europe, and Middle East & Africa) - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2021 – 2028

The global pharmaceutical analytical testing outsourcing market size was valued at USD 6.46 billion in 2020 and is projected to expand at a CAGR of 8.2% during the forecast period. The growth of the market is attributing to the innovating steps undertaken by pharmaceutical industry, increasing focus on regulatory & safety guidelines, and rising number of consumers in the market.

Pharmaceutical analytical testing outsourcing encompasses all aspects of the pharmaceutical manufacturing, testing, and validation processes. This includes validating pharmaceutical ingredients, compounds, and manufacturing procedures, which are required for medicinal development. These services are offered by expertized manufacturing companies that are completely focused on outsourcing. Several top-selling medicines including Humira, are actively engaged in various studies and methods that would allow wide screening services to ease the use of devices by patients in the coming years. Drug developers are constantly working towards developing several new medicinal products or drugs.

The outbreak of COVID-19 pandemic has affected the market as it forced to shut the production units globally. Moreover, low demand for instruments, and consumables along with the global supply chain interruptions and trade restrictions have harmed the pharmaceutical analytical testing outsourcing market for months.

Market Trends, Drivers, Restraints, and Opportunities

• Huge investments in R&D to develop improved drugs are among the key strategies adopted by pharmaceutical companies. This is expected to boost the market growth in the coming years.
• Increasing demand for product safety & quality along with the dynamic regulations for in vitro and vivo tests are anticipated to fuel the growth of the market.
• Cost-effective pricing benefits of outsourcing by the pharmaceutical companies are key factors driving the market growth.
• Increased efficacy in operations, therapeutic expertise, and on demand service for analytical testing devices are fueling the market expansion.
• Inadequacy of highly skilled personnel for handling the testing devices are major restraining factors expected to hamper the market expansion.
• Ongoing development operational expertise by key pharmaceutical players to enhance the laboratory testing are likely to offer immense opportunities for the market development in the long run.

Scope of the Report

The report on the global pharmaceutical analytical testing outsourcing market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Market Segment Insights

Bioanalytical testing segment is expected to grow at a rapid pace

Based on services, the global pharmaceutical analytical testing outsourcing market is segregated into stability testing, method development & validation, bioanalytical testing, and others. The stability testing is further segmented into stability indicating method validation, photo-stability testing, drug substance, accelerated stability testing, and others. The method development & validation segment is also divided into sub-segment such as technical consulting, impurity method, extractable & leachable, and others. The bioanalytical testing segment is further bifurcated into clinical and non-clinical.

The bioanalytical testing segment is expected to grow at a rapid pace during the forecast period owing to the rising participation of new players and increasing number of clinical trial registrations. Many small-scale firms are unable to procure high-end analytical instruments, which is one of the reasons they provide outsourcing services to deliver expertise performing, documenting, and reacting to the issues occurred during research.

North America is anticipated to constitute a key market share

In terms of regions, the global pharmaceutical analytical testing outsourcing market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is anticipated to constitute a key market share during the forecast period due to the established manufacturing hubs of complex, extensively reliable, & high-end pharmaceuticals in this region. The increasing demand for proactive healthcare infrastructure in the region is also expected to fuel the market growth.

The market of Asia-Pacific, however, is projected to register a high CAGR during the forecast period owing to the increasing development of medical industries in India and China along with rising availability of bulk manufactures and cost-effective drug delivery in these countries. Moreover, increasing in the implementation of favorable rules & regulations from government regulatory bodies pertaining to the standards of the medicinal development and drugs discovery present key drivers for the market growth in this region. On the other hand, expansion of delivery centers in the Philippines, China, and India, which typically support outsourcing services in the region. China is becoming more attractive destination for outsourcing as it is considered to be a delivery hub for Japanese near-shore and onshore clients.

Segments

Segments Covered in the Report
The global pharmaceutical analytical testing outsourcing market has been segmented on the basis of

Services

• Stability Testing
  • Stability Indicating Method Validation
  • Photo-stability Testing
  • Drug Substance
  • Accelerated Stability Testing
  • Others
• Method Development & Validation
  • Technical Consulting
  • Impurity Method
  • Extractable & Leachable
  • Others
• Bioanalytical Testing
  • Clinical
  • Non-clinical
• Others

Regions

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

Key Players

• Eurofins Scientific
• SGS SA
• Toxikon, Inc.
• Intertek Group Plc
• Pace Analytical Services, Inc.
• Charles River
• Pharmaceutical Product Development, LLC
• West Pharmaceutical Services Inc.
• WuXi AppTec, Inc.
• Boston Analytical
• Laboratories International, Inc.

Competitive Landscape

Some of major players competing in the market are Eurofins Scientific; SGS SA; Toxikon, Inc.; Intertek Group Plc; Pace Analytical Services, Inc.; Charles River; Pharmaceutical Product Development, LLC; West Pharmaceutical Services Inc.; WuXi AppTec, Inc.; Boston Analytical; and Laboratories International, Inc.

Most of these big players are implementing various marketing strategies such as partnerships, mergers & acquisitions, collaboration, and extensive service portfolio along with expanding service capacity on various geographies to secure substantial industry position. For example, in 2019, Intertek Group Plc expanded its medical services laboratory in Manchester, the UK to expand its gene therapy and biopharmaceutical development. In December 2018, SGS SA had invested USD 3.84 million to make its project by expanding its laboratory in Poitiers.

Moreover, Boston Analytical opened a new office in Cambridge, in August 2019, thereby expanding its reach of services. Charles River Laboratories was one of the few pharmaceutical companies that remained active and slightly operational during the pandemic. However, the company revised down its 2020 financial revenue by nearly USD 215 million. In another event, as a response to the pandemic, PPD adopted a remote working model and transferred its closed/inaccessible site patients to open sites.