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    Pharmaceutical Analytical Testing Outsourcing Market

    ID: MRFR/HC/5722-CR
    117 Pages
    Kinjoll Dey
    April 2019

    Pharmaceutical Analytical Testing Outsourcing Market Research Report Information By Product (Finished Products and Active Pharmaceutical Ingredients), By Services (Bioanalytical Testing, Stability Testing, Method Development & Validation and others), By End-User (Biopharmaceutical Companies, Biotechnology Industry and Pharmaceutical), and By Region (North America, Europe, Asia-Pacific, And Rest Of The World) – Market Forecast Till 2035

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    Pharmaceutical Analytical Testing Outsourcing Market Summary

    The Global Pharmaceutical Analytical Testing Outsourcing Market is projected to grow significantly from 4.95 USD Billion in 2024 to 12.53 USD Billion by 2035.

    Key Market Trends & Highlights

    Pharmaceutical Analytical Testing Outsourcing Key Trends and Highlights

    • The market is expected to experience a compound annual growth rate (CAGR) of 8.82 percent from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 12.5 USD Billion, indicating robust growth potential.
    • in 2024, the market is valued at 4.95 USD Billion, reflecting a strong foundation for future expansion.
    • Growing adoption of advanced analytical techniques due to increasing regulatory requirements is a major market driver.

    Market Size & Forecast

    2024 Market Size 4.95 (USD Billion)
    2035 Market Size 12.53 (USD Billion)
    CAGR (2025-2035) 8.81%

    Major Players

    Boston Analytical (New Hampshire), West Pharmaceutical Services, Inc. (U.S.), Exova Group PLC (U.K.), Source BioScience (U.K.), Pace Analytical Services, Inc. (U.S.), Merck KGaA (Germany), WuXi AppTec (US), Toxikon (US), Eurofins Scientific (Belgium), Intertek Group Plc (U.K.), Eurofins Scientific (Luxembourg), Charles River Laboratories International, Inc (U.S.), SGS SA (U.K.), Pharmaceutical Product Development, LLC (U.S.)

    Pharmaceutical Analytical Testing Outsourcing Market Trends

    Increasing public awareness of pharmaceutical analytical testing outsourcing will boost market growth

    Additionally, the market will experience significant expansion as a result of the increasing demand for biosimilars and biopharmaceuticals. For instance, it is predicted that the development of new biosimilars will result in consumer savings of up to USD 250 billion and increase access to biological therapies for an additional 1.2 million patients by 2025, according to a study titled "Expected Impact of Biosimilars on the Pharmaceutical Companies" that was published in the Iranian Journal of Medical Sciences in August 2021.

    This makes these items more accessible to patients with chronic diseases and gives them a more inexpensive alternative if they previously had to stop taking their prescriptions or rely on ineffective ones. A rise in the production of biosimilars will enhance the outsourcing of drug testing services, which will accelerate market expansion.

    Furthermore, for businesses in the pharmaceutical and biotechnology industries, research and development is an investment in knowledge and technology. Drug development, research, process improvement, and innovation are areas where pharmaceutical corporations can invest a lot of time and money.

    Many industry players reported record sales, primarily as a result of strong growth in emerging markets like the USA, Japan, China, India, Germany, and the U.K., as well as rising government spending on pharmaceutical R&D in developing countries, advancements in the fields of drug discovery and clinical diagnostics, rising life science R&D expenditure, technological advancements, emerging applications, growing geriatric populations, rising prevalence of chronic diseases, a growing geriatric population, and a growing geriatric market. As a result, high-end research projects call for equipment with high throughput capacity and quality, further boosting the market for outsourcing pharmaceutical analytical testing.

    Thus, it is anticipated that this aspect will accelerate pharmaceutical analytical testing outsourcing market revenue globally.

    The trend towards outsourcing analytical testing in the pharmaceutical sector appears to be driven by the need for enhanced efficiency and compliance with stringent regulatory standards.

    U.S. Food and Drug Administration (FDA)

    Pharmaceutical Analytical Testing Outsourcing Market Drivers

    Market Growth Projections

    The Global Pharmaceutical Analytical Testing Outsourcing Market Industry is poised for substantial growth, with projections indicating an increase from 4.95 USD Billion in 2024 to 12.5 USD Billion by 2035. This trajectory suggests a robust compound annual growth rate (CAGR) of 8.82% from 2025 to 2035. Such growth is indicative of the rising reliance on outsourcing as pharmaceutical companies seek to enhance operational efficiency and maintain compliance with evolving regulatory standards. The market dynamics reflect a broader trend towards specialization and collaboration, positioning outsourcing as a strategic imperative for industry players.

    Regulatory Compliance Requirements

    Regulatory compliance remains a critical driver in the Global Pharmaceutical Analytical Testing Outsourcing Market Industry. The pharmaceutical sector is subject to rigorous regulations imposed by various health authorities worldwide. Outsourcing analytical testing helps companies navigate these complex regulatory landscapes efficiently. By collaborating with specialized testing laboratories, pharmaceutical firms can ensure that their products meet the necessary quality and safety standards. This is particularly relevant as the industry anticipates a significant increase in compliance demands, which may further propel the outsourcing trend, allowing companies to mitigate risks associated with non-compliance.

    Growing Demand for Biopharmaceuticals

    The increasing demand for biopharmaceuticals is a pivotal driver of the Global Pharmaceutical Analytical Testing Outsourcing Market Industry. As biopharmaceuticals become more prevalent, the complexity of their analysis necessitates specialized testing services. This trend is underscored by the projected market growth from 4.95 USD Billion in 2024 to 12.5 USD Billion by 2035, reflecting a compound annual growth rate (CAGR) of 8.82% from 2025 to 2035. The outsourcing of analytical testing allows biopharmaceutical companies to leverage external expertise, ensuring compliance with stringent regulatory standards while focusing on core competencies.

    Cost Efficiency and Resource Optimization

    Cost efficiency is a driving force behind the Global Pharmaceutical Analytical Testing Outsourcing Market Industry. By outsourcing analytical testing, pharmaceutical companies can significantly reduce operational costs associated with maintaining in-house laboratories. This approach allows firms to allocate resources more effectively, focusing on research and development while leveraging the expertise of specialized testing providers. The financial implications are substantial, as outsourcing can lead to lower capital expenditures and operational overhead. As the market evolves, companies are increasingly recognizing the potential for enhanced profitability through strategic outsourcing partnerships.

    Focus on Quality Assurance and Risk Management

    The emphasis on quality assurance and risk management is a significant driver in the Global Pharmaceutical Analytical Testing Outsourcing Market Industry. Pharmaceutical companies are increasingly prioritizing quality control to mitigate risks associated with product recalls and regulatory penalties. Outsourcing analytical testing allows firms to engage with specialized laboratories that adhere to stringent quality standards and best practices. This focus on quality not only enhances product safety but also builds consumer trust, which is essential in a competitive market. As the industry continues to evolve, the importance of robust quality assurance measures will likely sustain the demand for outsourcing.

    Technological Advancements in Analytical Testing

    Technological advancements are reshaping the landscape of the Global Pharmaceutical Analytical Testing Outsourcing Market Industry. Innovations in analytical techniques, such as high-throughput screening and advanced chromatography, enhance the accuracy and efficiency of testing processes. These advancements enable outsourcing partners to deliver faster and more reliable results, which is crucial for pharmaceutical companies aiming to expedite product development timelines. As technology continues to evolve, the demand for sophisticated analytical testing services is likely to increase, further driving the outsourcing trend in the industry.

    Market Segment Insights

    Pharmaceutical Analytical Testing Outsourcing Product Insights

    The Pharmaceutical Analytical Testing Outsourcing Market segmentation, based on product, includes Finished Products and Active Pharmaceutical ingredients. The active pharmaceutical ingredients segment held the majority share in 2022 in the Pharmaceutical Analytical Testing Outsourcing Market data. The essential components of medications are the active pharmaceutical ingredients, which are in charge of the patient's recovery. To eliminate contaminants, quality testing of pharmaceutical active components is required. Active pharmaceutical ingredients (APIs) can now be employed in several drug batches thanks to analytical testing, which has broadened their range of applications.

    Pharmaceutical Analytical Testing Outsourcing Services Insights

    The Pharmaceutical Analytical Testing Outsourcing Market segmentation, based on services, includes Bioanalytical testing, Stability testing, Method development & validation, and others. The stability testing segment dominated the market growth for pharmaceutical analytical testing outsourcing in 2022 and is projected to be the faster-growing segment during the forecast period, 2022-2030. Testing for stability determines whether a medicine can maintain its qualities over the course of its shelf life. One of the most crucial factors in the creation of new medications and formulations is the stability studies of pharmaceutical goods or medications.

    Moreover, the expansion of the industry is being fueled by the strategic actions made by the leading players, such as product launches, approvals, and alliances.

    For instance, LGM Pharma began offering pharmaceutical researchers, manufacturers, and compounding pharmacies analytical testing and stability services in July 2021.

    Pharmaceutical Analytical Testing Outsourcing End-User Insights

    The Pharmaceutical Analytical Testing Outsourcing Market data, based on end-user, includes Biopharmaceutical Companies, Biotechnology Industry and Pharmaceutical. The pharmaceutical segment dominated the pharmaceutical analytical testing outsourcing market revenue for pharmaceutical analytical testing outsourcing in 2022 and is projected to be the faster-growing segment during the forecast period, 2022-2030. Many clinical trials are conducted on pharmaceutical goods with the goal of evaluating various aspects of a medicine. Several medium-sized and smaller pharmaceutical firms do not have the capability of internal testing facilities. These businesses can concentrate on core manufacturing by outsourcing pharmaceutical analytical testing.

    Figure 1: Pharmaceutical Analytical Testing Outsourcing Market, by End-User, 2022 & 2030 (USD Billion)

    Source: Secondary Research, Primary Research, Market Research Future Database and Analyst Review

    Get more detailed insights about Pharmaceutical Analytical Testing Outsourcing Market Research Report - Forecast till 2032

    Regional Insights

    By region, the study provides the market insights for pharmaceutical analytical testing outsourcing into North America, Europe, Asia-Pacific and Rest of the World. North America pharmaceutical analytical testing outsourcing market accounted for USD 1.9 billion in 2022 with a share of around 45.80% and is expected to exhibit a significant CAGR growth during the study period. This is due to the area's dependable, complex, and advanced pharmaceutical production facilities. One of the main factors influencing the market is the quick expansion of pharmaceutical production capacity to fulfill the region's expanding demand for high-quality healthcare services.

    Further, the major countries studied in the market report for pharmaceutical analytical testing outsourcing are: The U.S, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

    News

    The Virginia Biotechnology Research Park's Advanced Pharmaceutical Development Center facilities in Richmond, US, were inaugurated by Phlow Corp. and US Pharmacopeia (USP). To enable them to work together on policies, best practices, and resources to aid in introducing advanced manufacturing techniques, the two partners' labs are "co-located" in one place. To create small molecule active pharmaceutical ingredients (APIs) plus key starting materials (KSMs), the organizations will use their facilities to deliver R&D services to the pharmaceutical sector and the US government. The partners claim they will use cutting-edge manufacturing methods to create high-quality, cost-effective medical products.

    Figure 2: PHARMACEUTICAL ANALYTICAL TESTING OUTSOURCING MARKET SHARE BY REGION 2022 (%)PHARMACEUTICAL ANALYTICAL TESTING OUTSOURCING MARKET SHARE BY REGION 2022

    Source: Secondary Research, Primary Research, Market Research Future Database and Analyst Review

    Europe pharmaceutical analytical testing outsourcing market accounts for the second-largest market share as one of the most cutting-edge manufacturing technologies now on the market, microbial manufacturing technology, has been enthusiastically embraced. In order to strengthen their domestic capabilities, several developing nations around the world are trying to collaborate with Western giants by providing industrial support services including clinical research, medicine development, and others. Further, the UK pharmaceutical analytical testing outsourcing market held the largest market share, and the Germany pharmaceutical analytical testing outsourcing market was the fastest growing market in the region.

    Asia Pacific pharmaceutical analytical testing outsourcing market is expected to grow at the fastest CAGR from 2022 to 2030 due to strong expansion in the pharmaceutical industry, high levels of investment made in the area by major players, and the existence of sizable outsourcing hubs in China, the Philippines, and India. China is gaining favor as a delivery site for Japanese nearshore and onshore clients. Moreover, China pharmaceutical analytical testing outsourcing market held the largest market share, and the India pharmaceutical analytical testing outsourcing market was the fastest growing market in the region.

    Key Players and Competitive Insights

    Major market players are spending a lot of money on R&D to increase their product lines, which will help the pharmaceutical analytical testing outsourcing market grow even more. Market participants are also taking a range of strategic initiatives to grow their worldwide footprint, with key market developments such as new product launches, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations. Competitors in the pharmaceutical analytical testing outsourcing industry must offer cost-effective items to expand and survive in an increasingly competitive and rising market environment.

    One of the primary business strategies adopted by manufacturers in the global pharmaceutical analytical testing outsourcing industry to benefit clients and expand the market sector is to manufacture locally to reduce operating costs. In recent years, pharmaceutical analytical testing outsourcing industry has provided medicine with some of the most significant benefits.

    The pharmaceutical analytical testing outsourcing market major player such as Boston Analytical (New Hampshire), West Pharmaceutical Services, Inc. (U.S.), Exova Group PLC (U.K.), Source BioScience (U.K.), Pace Analytical Services, Inc. (U.S.), Merck KGaA (Germany), WuXi AppTec (US), Toxikon (US), Eurofins Scientific (Belgium), Intertek Group Plc (U.K.), Eurofins Scientific (Luxembourg), West Pharmaceutical Services Inc. (U.S.), Charles River Laboratories International, Inc (U.S.), SGS SA (U.K.), Pharmaceutical Product Development, LLC (U.S.), Source BioScience (U.K.) and WuXi AppTec (U.S.).

    American company Thermo Fisher Scientific Inc. sells scientific equipment, reagents and supplies, and software services. Thermo Fisher was created in 2006 by the union of Thermo Electron and Fisher Scientific and is headquartered in Waltham, Massachusetts. Several reagent, consumable, instrument, and service suppliers have been purchased by Thermo Fisher Scientific. In December 2021, To increase its offering of laboratory services, clinical research, and analytical testing, among other things, Thermo Fisher fully purchased PPD.

    For the CMC (Chemistry, Manufacturing, and Controls) factors involved in medication development and release testing, Boston Analytical specialists in offering high-quality analytical testing services. All necessary testing and related services, including analytical development, storage and stability testing, and microbial testing, can be performed in our cGMP, FDA accredited analytical testing laboratory. In January 2021, Boston Analytical, a Salem, New Hampshire-based cGMP-compliant analytical laboratory, is officially launching its second office in Morrisville, North Carolina. Sampling and testing services will be offered at this location.

    Key Companies in the Pharmaceutical Analytical Testing Outsourcing Market market include

    Industry Developments

    • Q2 2024: Eurofins Scientific Expands U.S. Pharmaceutical Analytical Testing Capacity with New Laboratory Opening in North Carolina Eurofins Scientific announced the opening of a new state-of-the-art analytical testing laboratory in North Carolina, aimed at supporting increased demand for outsourced pharmaceutical testing services and enhancing turnaround times for U.S. clients.
    • Q2 2024: Charles River Laboratories Acquires Bioanalytical Testing Firm in California Charles River Laboratories completed the acquisition of a specialized bioanalytical testing company based in California, strengthening its portfolio of outsourced analytical services for pharmaceutical and biotech clients.
    • Q2 2024: Intertek Launches New Extractables and Leachables Testing Service for Biopharmaceuticals Intertek announced the launch of a new analytical service focused on extractables and leachables testing, addressing regulatory requirements for biopharmaceutical manufacturers outsourcing analytical testing.
    • Q3 2024: SGS Opens Expanded Analytical Testing Facility in New Jersey SGS SA inaugurated an expanded pharmaceutical analytical testing facility in New Jersey, increasing its capacity for outsourced testing and supporting growing demand from U.S. pharmaceutical companies.
    • Q3 2024: Pace Analytical Services Wins Multi-Year Contract with Major U.S. Biopharma for Stability Testing Pace Analytical Services secured a multi-year contract to provide stability testing services for a leading U.S. biopharmaceutical company, further establishing its position in the pharmaceutical analytical testing outsourcing market.
    • Q4 2024: Boston Analytical Announces Expansion of GMP Analytical Testing Capabilities Boston Analytical announced the expansion of its GMP-compliant analytical testing capabilities, including new instrumentation and increased laboratory space to meet rising outsourcing demand.
    • Q4 2024: Eurofins Scientific Acquires Minority Stake in Indian Analytical Testing Firm Eurofins Scientific acquired a minority stake in an Indian pharmaceutical analytical testing company, aiming to expand its global reach and service offerings for outsourced testing.
    • Q1 2025: Intertek Appoints New Head of Pharmaceutical Analytical Services Division Intertek announced the appointment of a new executive to lead its Pharmaceutical Analytical Services division, signaling a strategic focus on expanding its outsourcing business.
    • Q1 2025: Charles River Laboratories Launches Advanced Mass Spectrometry Platform for Outsourced Drug Testing Charles River Laboratories introduced a new mass spectrometry platform designed to enhance the sensitivity and accuracy of outsourced pharmaceutical analytical testing services.
    • Q2 2025: SGS SA Secures FDA Approval for New Analytical Testing Method SGS SA received FDA approval for a novel analytical testing method, enabling the company to offer enhanced outsourced testing services to pharmaceutical clients seeking regulatory compliance.
    • Q2 2025: Pace Analytical Services Announces $30 Million Investment in U.S. Laboratory Expansion Pace Analytical Services announced a $30 million investment to expand its U.S. laboratory network, aiming to meet growing demand for outsourced pharmaceutical analytical testing.
    • Q2 2025: Boston Analytical Wins Contract for Analytical Method Development with European Pharma Boston Analytical secured a contract to provide analytical method development services for a European pharmaceutical company, further expanding its international outsourcing business.

    Future Outlook

    Pharmaceutical Analytical Testing Outsourcing Market Future Outlook

    The Pharmaceutical Analytical Testing Outsourcing Market is poised for growth, driven by technological advancements and regulatory demands, with an 8.81% CAGR from 2025 to 2035.

    New opportunities lie in:

    • Invest in advanced analytical technologies to enhance testing accuracy and efficiency.
    • Develop strategic partnerships with biotech firms to expand service offerings.
    • Leverage data analytics for predictive testing to improve client outcomes.

    By 2035, the market is expected to achieve substantial growth, reflecting evolving industry needs and innovations.

    Market Segmentation

    Pharmaceutical Analytical Testing Outsourcing Product Outlook (USD Billion, 2019-2030)

    • Finished Products
    • Active Pharmaceutical ingredients

    Pharmaceutical Analytical Testing Outsourcing End User Outlook (USD Billion, 2019-2030)

    • Biopharmaceutical Companies
    • Biotechnology Industry
    • Pharmaceutical

    Pharmaceutical Analytical Testing Outsourcing Regional Outlook (USD Billion, 2019-2030)

    • US
    • Canada
    • Germany
    • France
    • UK
    • Italy
    • Spain
    • Rest of Europe
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
    • Middle East
    • Africa
    • Latin America

    Pharmaceutical Analytical Testing Outsourcing Services Outlook (USD Billion, 2019-2030)

    • Bioanalytical Testing
    • Stability Testing
    • Method Development & Validation
    • Others

    Report Scope

    Report Attribute/Metric Details
    Market Size 2024 USD 4.95 billion
    Market Size 2035 12.53 (Value (USD Billion))
    Compound Annual Growth Rate (CAGR) 8.81% (2025 - 2035)
    Base Year 2024
    Market Forecast Period 2025 - 2035
    Historical Data 2019 - 2023
    Market Forecast Units Value (USD Billion)
    Report Coverage Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends
    Segments Covered Type, Product, Application, End User and Region
    Geographies Covered North America, Europe, Asia Pacific, and Rest of the World
    Countries Covered The U.S, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil
    Key Companies Profiled Boston Analytical (New Hampshire), West Pharmaceutical Services, Inc. (U.S.), Exova Group PLC (U.K.), Source BioScience (U.K.), Pace Analytical Services, Inc. (U.S.), Merck KGaA (Germany), WuXi AppTec (US), Toxikon (US), Eurofins Scientific (Belgium)
    Key Market Opportunities Innovation And Launch Of New Tests To Check The Quality Of Products
    Key Market Dynamics Increasing Demand For Analytical Details On Drugs And Process Development By Regulatory Agencies Growing Prevalence Of Cancer And Infectious Diseases
    Market Size 2025 5.39 (Value (USD Billion))

    Market Highlights

    Author
    Kinjoll Dey
    Research Analyst Level I

    He is an extremely curious individual currently working in Healthcare and Medical Devices Domain. Kinjoll is comfortably versed in data centric research backed by healthcare educational background. He leverages extensive data mining and analytics tools such as Primary and Secondary Research, Statistical Analysis, Machine Learning, Data Modelling. His key role also involves Technical Sales Support, Client Interaction and Project management within the Healthcare team. Lastly, he showcases extensive affinity towards learning new skills and remain fascinated in implementing them.

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    FAQs

    How much is the pharmaceutical analytical testing outsourcing market?

    The Pharmaceutical Analytical Testing Outsourcing Market size was valued at USD 4.56 Billion in 2023.

    What is the growth rate of the pharmaceutical analytical testing outsourcing market?

    The Pharmaceutical Analytical Testing Outsourcing Market is projected to grow at a CAGR of 8.81% during the forecast period, 2024-2032.

    Which region held the largest market share in the pharmaceutical analytical testing outsourcing market?

    North America had the largest share in the global market for pharmaceutical analytical testing outsourcing.

    Who are the key players in the pharmaceutical analytical testing outsourcing market?

    The key players in the market for pharmaceutical analytical testing outsourcing are Boston Analytical (New Hampshire), West Pharmaceutical Services, Inc. (U.S.), Exova Group PLC (U.K.), Source BioScience (U.K.), Pace Analytical Services, Inc. (U.S.), Merck KGaA (Germany), WuXi AppTec (US), Toxikon (US), Eurofins Scientific (Belgium).

    Which services led the pharmaceutical analytical testing outsourcing market?

    The stability testing dominated the pharmaceutical analytical testing outsourcing market in 2022.

    Which end-user had the largest market share in the pharmaceutical analytical testing outsourcing market?

    The pharmaceutical had the largest share in the Pharmaceutical Analytical Testing Outsourcing Market.

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