Pharmaceutical Analytical Testing Outsourcing Market Size, Share & Trends Report

Pharmaceutical Analytical Testing Outsourcing Market Size, Share & Trends Analysis Report By Service (Bioanalytical Testing, Method Development and Validation, Stability Testing), By End Use, By Region, And Segment Forecasts, 2024 - 2030

Report ID: GVR-1-68038-365-2
Number of Pages: 187
Format: Electronic (PDF)

Historical Range: 2018 - 2021
Industry: Healthcare

Market Segmentation

Pharmaceutical Analytical Testing Outsourcing Service Outlook (Revenue, USD Million, 2018 - 2030)
- Bioanalytical Testing
  - Clinical
  - Non-Clinical
- Method Development & Validation
  - Extractable & Leachable
  - Impurity Method
  - Technical Consulting
  - Others
- Stability Testing
  - Drug Substance
  - Stability Indicating Method Validation
  - Accelerated Stability Testing
  - Photostability Testing
  - Others
- Others

Pharmaceutical Analytical Testing Outsourcing End-use Outlook (Revenue, USD Million, 2018 - 2030)
- Pharmaceutical Companies
- Biopharmaceutical Companies
- Contract Research Organizations
Pharmaceutical Analytical Testing Outsourcing Regional Outlook (Revenue, USD Million, 2018 - 2030)
- North America
  - North America Pharmaceutical analytical testing outsourcing market, By Services
    - Bioanalytical Testing
      - Clinical
      - Non-Clinical
    - Method Development & Validation
      - Extractable & Leachable
      - Impurity Method
      - Technical Consulting
      - Others
    - Stability Testing
      - Drug Substance
      - Stability Indicating Method Validation
      - Accelerated Stability Testing
      - Photostability Testing
      - Others
    - Others
  - North America Pharmaceutical analytical testing outsourcing market, By End-use
    - Pharmaceutical Companies
    - Biopharmaceutical Companies
    - Contract Research Organizations
  - U.S.
    - U.S. Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - U.S. Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
  - Canada
    - Canada Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - Canada Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
- Europe
  - Europe Pharmaceutical analytical testing outsourcing market, By Services
    - Bioanalytical Testing
      - Clinical
      - Non-Clinical
    - Method Development & Validation
      - Extractable & Leachable
      - Impurity Method
      - Technical Consulting
      - Others
    - Stability Testing
      - Drug Substance
      - Stability Indicating Method Validation
      - Accelerated Stability Testing
      - Photostability Testing
      - Others
    - Others
  - Europe Pharmaceutical analytical testing outsourcing market, By End-use
    - Pharmaceutical Companies
    - Biopharmaceutical Companies
    - Contract Research Organizations
  - U.K.
    - U.K. Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - U.K. Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
  - Germany
  - France
    - France Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
- Asia Pacific
  - Asia Pacific Pharmaceutical analytical testing outsourcing market, By Services
    - Bioanalytical Testing
      - Clinical
      - Non-Clinical
    - Method Development & Validation
      - Extractable & Leachable
      - Impurity Method
      - Technical Consulting
      - Others
    - Stability Testing
      - Drug Substance
      - Stability Indicating Method Validation
      - Accelerated Stability Testing
      - Photostability Testing
      - Others
    - Others
  - Asia Pacific Pharmaceutical analytical testing outsourcing market, By End-use
    - Pharmaceutical Companies
    - Biopharmaceutical Companies
    - Contract Research Organizations
  - Japan
    - Japan Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - Japan Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
  - China
    - China Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - China Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
  - India
    - India Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - India Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
  - Australia
    - Australia Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - Australia Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
  - South Korea
    - South Korea Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - South Korea Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
  - Thailand
    - Thailand Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - Thailand Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
- Latin America
  - Latin America Pharmaceutical analytical testing outsourcing market, By Services
    - Bioanalytical Testing
      - Clinical
      - Non-Clinical
    - Method Development & Validation
      - Extractable & Leachable
      - Impurity Method
      - Technical Consulting
      - Others
    - Stability Testing
      - Drug Substance
      - Stability Indicating Method Validation
      - Accelerated Stability Testing
      - Photostability Testing
      - Others
    - Others
  - Latin America Pharmaceutical analytical testing outsourcing market, By End-use
    - Pharmaceutical Companies
    - Biopharmaceutical Companies
    - Contract Research Organizations
  - Brazil
    - Brazil Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - Brazil Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
  - Mexico
    - Mexico Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - Mexico Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
  - Argentina
    - Argentina Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - Argentina Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
- MEA
  - MEA Pharmaceutical analytical testing outsourcing market, By Services
    - Bioanalytical Testing
      - Clinical
      - Non-Clinical
    - Method Development & Validation
      - Extractable & Leachable
      - Impurity Method
      - Technical Consulting
      - Others
    - Stability Testing
      - Drug Substance
      - Stability Indicating Method Validation
      - Accelerated Stability Testing
      - Photostability Testing
      - Others
    - Others
  - MEA Pharmaceutical analytical testing outsourcing market, By End-use
    - Pharmaceutical Companies
    - Biopharmaceutical Companies
    - Contract Research Organizations
  - South Africa
    - South Africa Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - South Africa Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
  - Saudi Arabia
    - Saudi Arabia Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - Saudi Arabia Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
  - UAE
    - UAE Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - UAE Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations
  - Kuwait
    - Kuwait Pharmaceutical analytical testing outsourcing market, By Services
      - Bioanalytical Testing
        
        Clinical
        
        Non-Clinical
      - Method Development & Validation
        
        Extractable & Leachable
        
        Impurity Method
        
        Technical Consulting
        
        Others
      - Stability Testing
        
        Drug Substance
        
        Stability Indicating Method Validation
        
        Accelerated Stability Testing
        
        Photostability Testing
        
        Others
      - Others
    - Kuwait Pharmaceutical analytical testing outsourcing market, By End-use
      - Pharmaceutical Companies
      - Biopharmaceutical Companies
      - Contract Research Organizations

Pharmaceutical Analytical Testing Outsourcing Market Dynamics

Driver: Increasing pace of innovations and product development

Innovation and new product development is directly related to the demand for testing services. Due to competitive pressures, pricing concerns, and lead-time to market, companies are preferring outsourcing of testing services. Increasing focus on customized care and technological advancements have reduced the product lifecycle, leading to rapid development of new products. Development of biosimilars, combination products, and other innovative medicines has led to increased demand for specific test types. Moreover, when companies expand their business to a new location, it is mandatory to follow local standards, which may require them to conduct particular types of tests. Outsourcing companies are helping in strategizing systematic approaches to simplify the automation required in analytical instruments. It also increases the speed to market products along with innovative thinking.

Moreover, the use of automation technology has also helped in the development of new drugs by expediting the process without affecting drug quality. In this process, data recording is performed and everything in an experiment is recorded so that the experiment is accurate & repeatable. The use of new technologies has also become fast and they help in organizing & saving data. Increasing R&D investments is a critical sustainability strategy. Not all companies have an infrastructure compatible for all types of analytical testing. Hence, outsourcing these operations is the most suitable option, which also helps save time and costs. In recent years, the R&D expense to total revenue ratio is increasing and expected to continue to rise through 2030.

Driver: Growing safety and quality regulation demand

Increase in complexity and number of standards, which a single product may have to comply with, is driving strong growth in the pharmaceutical analytical testing services outsourcing industry. In addition, companies are required to stay updated with regulatory guidelines and avail expertise & advisory services to be in synchronization with evolving standards. Moreover, organizations such as the International Council for Harmonization (ICH) give harmonized guidelines that are regularly updated. These guidelines are provided so that proper testing, application, and safety of the pharmaceutical product is performed before approving it for human use.

Stringent regulations issued by global regulatory authorities, such as FDA guidelines for clinical trials during the COVID-19 outbreak, Clinical Laboratory Improvement Amendments (CLIA) laboratory regulations, and Good Laboratory Practice (GLP) laboratory regulation, along with increased demand for developing safe & effective therapies and vaccines against SARS-CoV-2, are anticipated to increase the scrutiny on laboratory testing. Testing regulations in Australia are handled by National Measurement Institute (NMI) pertaining to pharmaceutical analysis services, which helps manufacturers in attaining the desired safety level that is appropriate for human use. Increasing awareness about product quality, environmental issues, and safety among consumers is driving companies to outsource tests to ensure that the product complies with aforementioned aspects, thereby building a brand image and enhancing its reputation.

Restraint: Lack of data security

There is always a bilateral information exchange between the client and analytical testing firm involved in the process of analytical testing outsourcing. Several times, clients may have to share confidential information with testing firms, which entails a threat of misuse of this confidential information. If there is no legitimate contract about information security and privacy, it may lead to discrepancies among both parties, hampering mutual trust. For instance, the consultant’s brand image may get affected or the client may have to compromise on security of confidential data.

The attack on data disturbs the process and also delays drug development process. The shared data is very sensitive and can put lives at risk. This data has to be protected effectively, which can be achieved by implementing strong network security. However, this cannot be relied on alone, so there is a need to understand the risks and vulnerabilities within as well as of third-party sources that will help in building resilient data security that would be difficult to breach. Many multinational and small pharmaceutical players are hesitant to opt for consulting services due to the fear of breach of secure information. However, in the future, this situation is expected to change as consulting firms are proactively undertaking initiatives for information protection.

What Does This Report Include?

This section will provide insights into the contents included in this pharmaceutical analytic testing outsourcing market report and help gain clarity on the structure of the report to assist readers in navigating smoothly.

Pharmaceutical analytical testing outsourcing market qualitative analysis

Industry overview
Industry trends
Market drivers and restraints
Market size
Growth prospects
Porter’s analysis
PESTEL analysis
Key market opportunities prioritized
Competitive landscape
- Company overview
- Financial performance
- Product benchmarking
- Latest strategic developments

Pharmaceutical analytical testing outsourcing market quantitative analysis

Market size, estimates, and forecast from 2018 to 2030
Market estimates and forecast for product segments up to 2030
Regional market size and forecast for product segments up to 2030
Market estimates and forecast for application segments up to 2030
Regional market size and forecast for application segments up to 2030
Company financial performance

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