Pharmaceutical Analytical Testing Outsourcing Market
Report ID: SQMIG35C2024
Pharmaceutical Analytical Testing Outsourcing Market Size, Share, Growth Analysis, By Services (Bioanalytical Testing, Method Development & Validation), By End Use (Pharmaceutical Companies, Biopharmaceutical Companies), By Region - Industry Forecast 2025-2032
Report ID:
SQMIG35C2024 |
Region:
Global |
Published Date: October, 2024
Pages:
219
|Tables:
97
|Figures:
76
Pharmaceutical Analytical Testing Outsourcing Market Insights
Pharmaceutical Analytical Testing Outsourcing Market size was valued at USD 8.32 Billion in 2023 and is poised to grow from USD 9.02 Billion in 2024 to USD 17.23 Billion by 2032, growing at a CAGR of 8.42% during the forecast period (2025-2032).
Human health underwent a revolution with the invention of drugs. Only if these medications are delivered in the right dosage and are free of contaminants will they accomplish their intended purpose. medications are estimated using a variety of chemical and technical techniques that were developed periodically to make medications serve their intended purpose. It is, therefore, imperative to detect and quantify the same since these drugs could pose threat in their use. These may, during various stages of production, storage or even distribution, accumulate contaminants. It cannot be done without using analytical instruments and methods.
Analytical evaluation facilities help in optimizing and controlling various processes, in characterizing biosimilars and biologics, in controlling product quality instantly, and in enhancing productivity. One of the important reasons for outsourcing analytical testing services is the availability of expensive analytical instruments, which are not available in house, and skilled personnel. Another key factor enhancing the demand for analytical testing services is the rising biological development. The goal of the Solidarity Trial is to assess the relative efficiency of four treatment options against COVID-19 as compared with the standard of care intervention. The Solidarity Trial aims to rapidly assess whether any of the drugs reduce the disease progression or improve the chances of survival by enrolling patients in multiple countries.
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Pharmaceutical Analytical Testing Outsourcing Market Segmental Analysis
Global Pharmaceutical Analytical Testing Outsourcing Market is segmented by Services, End Use, and region. Based on Services, the market is segmented into 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. Based on End Use, the market is segmented into Pharmaceutical Companies, Biopharmaceutical Companies, Contract Research Organizations. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
Analysis by Type
As per categorization by type, the market is classified as active pharmaceutical ingredient (API), additives, and finished products. Among these, active pharmaceutical ingredients (API) earned the largest share and continues to hold the dominant global pharmaceutical analytical testing outsourcing market share. The global pharmaceutical analytical testing outsourcing market has been on the rise due to the introduction of new products targeting active pharmaceutical ingredients API’s which are necessary for the efficiency and safety of the medication. active pharmaceutical ingredient testing services are gaining ground with improvements in testing facilities like high-resolution mass spectrometry and chromatography for accurate identification and control of the testing standards. There is a great share of the market of the active pharmaceutical ingredients which are used in the formulation of medicinal products and compliance with drug quality norms and the high demand for affordable medications of better standards across countries.
The finished products segment is set to become the fastest-growing segment in the global pharmaceutical analytical testing outsourcing market due to increasing demand for quality assurance and regulatory compliance in the final stages of drug production. Due to the increasing demands of the pharmaceutical industry to adhere to safety and efficacy benchmarks, turning over the testing of finished product provides them the ability to concentrate on core areas, with assurance of satisfying global regulations. In addition, the evolving complexities of various drug forms especially biologics and combination drugs also necessitate cure that enhances the outsourcing services to uphold the quality standards that are competitive in nature.
Analysis by Application
Bioanalytical testing methods are experiencing significant innovation in the global pharmaceutical analytical testing outsourcing market, driven by advancements in technologies like liquid chromatography-mass spectrometry (LC-MS) and enzyme-linked immunosorbent assays (ELISA). These techniques are significant in assessing the absorption, metabolism, and pharmacokinetics of a drug, especially in the early stage of development and in clinical evaluations. The market is largely driven by bioanalytical testing as this method offers superior results that are both highly sensitive and accurate for quality control to guarantee drug safety and efficacy. Since there is a growing insistence for adherence to compliance during operation by the regulatory bodies and because the pharmaceutical industry is shifting towards customized medicine, bioanalytical testing is still relevant in meeting these increasing demands thus fortifying its market leadership.
The Development & Validation segment is poised to become the fastest-growing area in the global pharmaceutical analytical testing outsourcing market due to the increasing complexity of drug development and stringent regulatory requirements. Given the growing demand for and pressure on pharmaceutical companies to shorten time-to-market, it is common for them to outsource development and validation services as this allows them to exploit specialized knowledge of analytical techniques and regulation. Increasing market for personalized medicine, biologics and biosimilars and the desire for accuracy and consistency is the factor fueling the growth of this. The need for cost effective solutions and compliance with standards while easing the process has made outsourcing a major facilitator of growth within the sector.
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Pharmaceutical Analytical Testing Outsourcing Market Regional Insights
Europe dominates the global pharmaceutical analytical testing outsourcing market due to its strong regulatory frameworks, well-established pharmaceutical industry, and extensive infrastructure for drug development and testing. The region has mastered the presence of many pharmaceutical companies and research institutions, which have built a high level of innovation. Ethospa's regional market is further enhanced by Europe's high standards of drug safety and efficacy and the growing appetite for top quality testing services. In addition, lower cost of service delivery through outsourcing, sophisticated bioanalytical methods as well as the concentration of clinical trials in the region make Europe to command the market thus making it the major player in the global pharmaceutical analytical testing outsourcing market.
Asia Pacific is the fastest-growing region in the global pharmaceutical analytical testing outsourcing market due to its rapidly expanding pharmaceutical and biotechnology sectors, cost-effective outsourcing solutions, and a large pool of skilled professionals. The above factors, along with an increase in the number of pharmaceutical companies in the region as evidenced by the rise in competition, enable pharmaceutical companies to cut costs and shorten time-to-market. The growing need for generic drugs, biosimilars, and personalized medicine, the availability of government policies promoting investment in health care in the region, and growth in the region’s technology infrastructure also play a significant role in East Asia’s rapid expansion, making region a major player to the global pharmaceutical analytical testing outsourcing market share.
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Pharmaceutical Analytical Testing Outsourcing Market Dynamics
Pharmaceutical Analytical Testing Outsourcing Market Drivers
Regulatory Compliance and Quality Assurance
- With the global regulatory demands becoming more and more serious, ensuring compliance with drug safety and effectiveness becomes important for pharmaceutical manufacturers. The increasing demand for outsourced analytical testing services is primarily driven by the need among firms to obtain specialized skills, minimize the chances of failing to adhere to regulatory requirements, and ensure the quality of the firm's products.
Cost Efficiency and Speed to Market
- The primary advantage of pharmaceutical analytical testing outsourcing to companies is that such testing can be performed less expensively and without prolonging the development of new drugs. In this way, with the help of additional facilities and prior experience gained from external sources, drug manufacturing firms are able to optimize the processes, increase the speed of work, and release the goods quicker, which makes outsourcing more beneficial as it saves both time and costs.
Pharmaceutical Analytical Testing Outsourcing Market Restraints
Data Security and Confidentiality Concerns
- Outsourcing analytical testing means providing access to sensitive proprietary information, which makes data security and information confidentiality core issues. Most pharmaceutical industries fear the risk of information leaks and the loss of intellectual property, hence the reluctance to outsource its work. Enhancing cyber security as well as inter-partner trust is vital to address such concerns.
Regulatory and Compliance Challenges
- Even though outsourcing has its advantages in terms of cost and time, dealing with the different regulatory requirements across regions can be quite challenging. Any outsourcing of analytical testing services by pharmaceutical organizations would be subject to tight restrictions to ensure local, as well as international, standards are complied with which, in turn, would be a lengthy and complicated process that may even result in delays and/or breaches in compliance.
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Pharmaceutical Analytical Testing Outsourcing Market Competitive Landscape
The global pharmaceutical analytical testing outsourcing industry has a competitive environment that consists of both well-known international corporations and some emerging niche players. Eurofins Scientific, Labcorp Drug Development, Charles River Laboratories and WuXi AppTec are among the companies that provide an array of testing services together with regulatory compliance and the latest technologies. These players endeavor to strengthen their service portfolios and increase their footprint globally in response to the rise in demand for efficient analytical testing services in the pharmaceutical vertical.
Top Player’s Company Profiles
- Eurofins Scientific SE
- Laboratory Corporation of America Holdings
- Charles River Laboratories International, Inc.
- WuXi AppTec
- SGS SA
- PPD, Inc.
- Intertek Group plc
- Almac Group
- Pace Analytical Services, LLC
- Source BioScience plc
- Syneos Health
- BioReliance Corporation
- LGC Limited
- Pharmaceutical Product Development, LLC
- Toxikon Corporation
- Avista Pharma Solutions
- Harlan Laboratories Ltd
- Accutest Laboratories
- Neopharm Labs Inc.
Recent Developments
- In October 2024, Eurofins Scientific expanded its capabilities by acquiring a leading provider of clinical trial testing services, enhancing its service offering for pharmaceutical companies. This acquisition is expected to enhance Eurofins’ capabilities in the global outsourcing pharmaceutical analytical testing services market availed by drug makers for better regulatory compliance and product safety evaluation activities carried out in the course of drug development.
- In September 2024, Labcorp Drug Development launched a new suite of bioanalytical testing services focused on biologics and gene therapies. This development improves the company’s ability to offer high-precision analytical testing for complex biologic drugs, addressing the growing demand for biologic development and accelerating time-to-market for pharmaceutical companies.
- In August 2024, Charles River Laboratories opened a state-of-the-art facility in Singapore, aimed at enhancing its bioanalytical testing capabilities for clients in the Asia-Pacific region. The upgraded center prioritizes enhancing the drug development process via more sophisticated testing services, upholding global standards, and assisting in the overseas growth of the organization.
Pharmaceutical Analytical Testing Outsourcing Key Market Trends
- Rising Demand for Biologic Drug Testing: The increasing focus on biologics and biosimilars is driving demand for specialized pharmaceutical analytical testing outsourcing services. Outsourcing bioanalytical tests is a great benefit for the pharmaceutical companies, as it allows them to take advantage of modern technologies as well as skills, in the development of the biologics, which in turn, safeguards the quality and regulatory requirements of the best complicated drugs.
- Expansion of Outsourcing in Emerging Markets: In recent years, there has been a rapid rise in the foreign outsourcing of pharmaceutical analytical testing services in both the Asia-Pacific region and Latin America. Due to affordable solutions, qualified workforce, and better developing health sector, these companies are looking to these regions for outsourcing testing services, hence these markets are emerging as formidable advancement catalysts for the industry.
Pharmaceutical Analytical Testing Outsourcing Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, in conclusion, the global pharmaceutical analytical testing outsourcing industry is experiencing substantial growth driven by increasing demand for regulatory compliance, cost efficiency, and the rising complexity of drug formulations. Innovations in bioanalytical testing and advancements in Active Pharmaceutical Ingredient (API) testing play crucial roles in ensuring the safety, efficacy, and quality of drugs.
European and Asia-Pacific regions are at the forefront due to the presence of a robust pharmaceutical infrastructure and a qualified workforce. Outsourcing being on the rise leads to more and more pharmaceutical companies resorting to specialized testing services in order to conform to high global standards of product launches of new drugs.
| Report Metric | Details |
|---|---|
| Market size value in 2022 | USD 7.62 billion |
| Market size value in 2031 | USD 15.89 billion |
| Growth Rate | 8.42% |
| Base year | 2023 |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
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| Customization scope | Free report customization with purchase. Customization includes:-
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Pharmaceutical Analytical Testing Outsourcing Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Pharmaceutical Analytical Testing Outsourcing Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Pharmaceutical Analytical Testing Outsourcing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Pharmaceutical Analytical Testing Outsourcing Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Pharmaceutical Analytical Testing Outsourcing Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Pharmaceutical Analytical Testing Outsourcing Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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