U.S. Pharmaceutical Analytical Testing Outsourcing Market Size 2022-2030

The U.S. pharmaceutical analytical testing outsourcing market was surpassed at USD 3.5 billion in 2021 and is expected to hit around USD 7.2 billion by 2030, growing at a CAGR of 8.34% from 2022 to 2030

Report Highlights

• The bioanalytical testing segment is expected to rise with the fastest CAGR of 8.8% over the forecast period.
• The pharmaceutical companies segment accounted for a revenue share of 47.4% in 2021.
• The biopharmaceutical companies segment is expected to register the fastest CAGR of 8.74% over the forecast period.

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Technological advancements in the healthcare industry and an increase in end-users are the key factors driving the growth of the U.S. market.

Analytical testing services outsourcing allows companies to handle more complex or repetitive tasks while also assisting companies in concentrating on their core competencies. Enabling medical organizations to avoid developing specialized facilities and hiring staff, results in cost savings. The identification and measurement of ingredients in drugs or therapeutic solutions are included in pharmaceutical analytical testing. The market is anticipated to expand during the assessment period as a result of rising R&D investments and rising drug demand.

The outsourcing of pharmaceutical analytical testing has been significantly impacted by the COVID-19 pandemic. Due to various pharmaceutical companies’ internal lab testing capacities being reduced or shut down, the pharmaceutical analytical services-an important component of the healthcare infrastructure-were initially disrupted. The workers initially faced several difficulties, including reduced lab capacity because of concerns about spreading the virus, IT issues, and difficulties sending samples for testing. However, various strategies, including rotating shifts, reducing manpower, and working from home, have been adopted by companies to mitigate or prevent these difficulties.

Various companies supported the government’s efforts to stop the COVID-19 pandemic by producing various cutting-edge tests and solutions. These businesses were able to reduce the effects of COVID-19 on their operations. For example, 40 million COVID-19 tests were successfully manufactured by Eurofins laboratories. Additionally, new test kits are being created for various variants. When WHO classified it as a variant of concern, they released an omicron test kit the same day.

Scope of The Report

Services Insights

The market is divided into bioanalytical testing, method development and validation, stability testing, and other testing services based on the type of service provided. The bioanalytical testing outsourcing services segment is further classified into clinical and non-clinical sub-group, while the method development and validation services were narrowed down to extractable and leachable, impurity method, technical consulting, and other method validation services.

The stability testing services segment has been bifurcated into drug substance, stability indicating method validation, accelerated stability testing, photostability testing, and other stability testing methods. The other testing services segment accounted for the maximum revenue share of the U.S. pharmaceutical analytical testing outsourcing market of 39.93% in 2021. The segment is likely to remain dominant even during the forecast years.

The bioanalytical testing segment is expected to rise with the fastest CAGR of 8.8% over the forecast period due to rising R&D spending by players in the biopharmaceutical industry and a preference for outsourcing analytical testing. The segment for bioanalytical testing has expanded as a result of the rising number of clinical trial registrations and the entry of new players into the market over the past decades.

In bioanalytical testing, drugs, formulations, or active ingredients are analyzed inside of biological systems like blood, urine, serum, and tissue. The sector can be broadly divided into clinical and non-clinical bioanalytical testing and is anticipated to experience profitable growth during the forecast period. Due to strict regulatory frameworks surrounding the process of drug discovery and development and the rising number of clinical trials, clinical bioanalytical testing is anticipated to grow at the fastest rate of any segment.

End-use Insights

The pharmaceutical companies segment accounted for a revenue share of 47.4% in 2021. This growth is anticipated to be fueled by several factors, including an increase in product development activities, rising corporate R&D spending, and the need to create novel therapies. For instance, Pace Analytical Services acquired Drug Delivery Experts, LLC in July 2021. DDE, a CDMO as well, focuses on the development of combined drug-device products and complicated injectable drug formulations.

Due to the acquisition, the company would be able to help an increasing number of clients who need assistance during the drug development process and contribute expertise in extended-release injectable technologies and drug-device combo products. Such U.S. developments would increase the demand in the market.

The biopharmaceutical companies segment is expected to register the fastest CAGR of 8.74% over the forecast period. The International Council for Harmonization (ICH) Q3D elemental impurities guideline and ICH M7 guideline implementation is among the new regulatory requirements. This regulatory guideline’s main goal is to offer a useful framework for categorization, qualification, and identification. Pharma companies would be able to enhance the drug development process to these changes in regulatory requirements.

The primary factors most likely to drive the growth of the segment for biopharmaceutical companies over the forecast period include an increase in clinical trial registrations and new entrants into the market over the past ten years.

Key Players

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

Market Segmentation

• By Services Outlook
  • Bioanalytical Testing
    • Clinical
    • Non-clinical
  • Method Development and Validation
    • Extractable and Leachable
    • Impurity Method
    • Technical Consulting
    • Other Method Validation Services
  • Stability Testing
    • Drug Substance
    • Stability indicating method validation
    • Accelerated stability testing
    • Photostability Testing
    • Other stability testing methods
  • Other Testing Services
• By End-use Outlook
  • Pharmaceutical Companies
  • Biopharmaceutical Companies
  • Contract Research Organizations

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