Pharmaceutical Analytical Testing Outsourcing Market – By Services (Bioanalytical Testing [Clinical, Non-clinical], Method Development & Validation, Stability Testing) Product Type (API, Additive, Finished Product), End-user & Forecast, 2024 – 2032

Pharmaceutical Analytical Testing Outsourcing Market Size

Pharmaceutical Analytical Testing Outsourcing Market was valued at USD 7.9 billion in 2023 and is expected to register a CAGR of 8% over the analysis period (2024-2032).
 

The market experienced significant growth due to rigorous regulatory requirements from health authorities such as the Food and Drug Administration (FDA), and the European Medicines Agency (EMA), which consistently elevate standards for pharmaceutical quality, safety, and efficacy, necessitating thorough testing throughout development and manufacturing. This has raised the significance of comprehensive analytical testing to ensure compliance, validate product quality, and identify impurities. Hence, as companies strive to adhere to these evolving regulations, there has been a significant surge in demand for analytical testing services, highlighting its crucial role in maintaining pharmaceutical integrity and enhancing public trust in the effectiveness and safety of medications, thereby augmenting the market growth.
 

Pharmaceutical analytical testing outsourcing refers to the practice of delegating the analysis of pharmaceutical products, raw materials, and intermediates to outsourcing service providers. These providers, including contract research organizations (CROs), contract manufacturing organizations (CMOs), or other specialized laboratories, lead various analytical tests to assess the quality, purity, potency, and safety of pharmaceutical compounds.
 

Pharmaceutical Analytical Testing Outsourcing Market Trends

• The pharmaceutical and biopharmaceutical companies confront ongoing pressure to accelerate new product development. Therefore, developing intricate analytical testing tools to ensure and maintain product quality requires a wider spectrum of equipment and expertise, frequently surpassing internal capacities. As a result, many companies increasingly turn to outsourcing pharmaceutical analytical testing services.
   
• Thus, to address the growing trend of outsourcing, CMOs and CROs have expanded their networks to meet the increasing demand, thereby facilitating market expansion. For instance, in December 2023, Sterling Accuris Diagnostics, a prominent network of NABL-accredited pathology laboratories, acquired Vaibhav Analytical Services, a provider of analytical testing services, specializing in pharmaceutical and drug testing. This acquisition broadened the Sterling Accuris service portfolio, particularly in pharmaceutical analytical testing.
   
• Thus, the increasing trend of outsourcing across pharmaceutical sectors along with business initiatives is expected to fuel market expansion.
   

Pharmaceutical Analytical Testing Outsourcing Market Analysis

Based on the services, the global market is categorized into bioanalytical testing, method development & validation, stability testing, and other services. The stability testing segment dominated the market in 2023 and is expected to sustain its leading position, forecasted to yield revenue of USD 6.6 billion by 2032.
 

• Stability testing remains critically important in ensuring the quality, safety, and efficacy of pharmaceutical products. The testing involves subjecting pharmaceutical formulations to various environmental conditions over time to assess their stability and shelf-life.
   
• Furthermore, the bioanalytical testing services sector is projected to experience rapid expansion in the coming years, driven by rise in clinical trial registrations. Also, small-size companies often outsource analytical services to CRO, to expedite their process, thereby fueling the market growth.
   

Based on product type, the pharmaceutical analytical testing outsourcing market is classified into active pharmaceutical ingredients (API), additives, and finished products. API segment held the largest market share of 41.5% in 2023.
 

• API testing involves a wide range of analytical procedures aimed at assessing the quality, purity, potency, and stability testing. Outsourcing API testing is common due to its cost-effectiveness which provides specialized expertise and advanced analytical techniques. This streamline operations pace up the development process and ensures regulatory compliance and product quality.
   
• Additionally, outsourcing testing services ensure adherence to regulatory standards while enabling companies to concentrate on their primary strengths. Thus, the escalating complexity and diversity of APIs, coupled with the rising demand for both generic and specialty drugs, have further bolstered the prominence of API testing within the pharmaceutical analytical testing outsourcing sector.
   

Based on the end-user, the market is classified into pharmaceutical companies, biopharmaceutical companies, and academics & research institutes. The pharmaceutical companies segment is expected to exhibit CAGR of 7.8% during the forecast period.
 

• Several pharmaceutical companies lack internal analytical testing capabilities, prompting collaborations with CROs, and CMOs for outsourcing services. This enables pharmaceutical companies to concentrate on their core strengths while tapping into external resources and capabilities for different aspects of drug development and manufacturing. Such aforementioned factor is expected to spur the segmental growth over the coming years.
   

North America region is expected to maintain its dominance throughout the forecast period, reaching the market revenue of USD 8.3 billion by 2032.
 

• The factors driving this region's dominance include technological advancements, the presence of key market players, increasing chronic disease cases, and rising pharmaceutical research, development, and funding.
   
• In addition, expanding strategic alliances among key players, aimed at broadening service offerings, are fueling market expansion in North America. For instance, in October 2021, Pace Analytical Services, LLC acquired Velesco Pharmaceutical Services, Inc., enhancing its capabilities in developing liquid, semi-solid, and oral solid dose products for pre-clinical and clinical use. This strategic move enables Pace to better serve clients across the drug development continuum. Such initiative is expected to spur the regional market growth.
   

Pharmaceutical Analytical Testing Outsourcing Market Share

The market features a competitive landscape characterized by key players vying for market share through strategic alliances, acquisitions, and service expansions. capitalizing on their extensive expertise, technological innovations, and expanding global reach. While emerging companies are focusing on providing specialized services and targeting niche markets to establish their presence.
 

Pharmaceutical Analytical Testing Outsourcing Market Companies

Prominent players operating in the industry are as mentioned below:

• BA Sciences
• Charles River Laboratories International, Inc.
• Eurofins Scientific
• Immunologix Laboratories
• Indoco Analytical Solutions
• Intertek Group plc
• Labcorp Drug Development
• LGM Pharma
• Pace Analytical Services, LLC
• SGS Societe Generale de Surveillance SA.
• STERIS
• Thermo Fisher Scientific, Inc.
• Triclinic Labs, Inc.
• West Pharmaceutical Services, Inc.
• Wuxi AppTec
   

Pharmaceutical Analytical Testing Outsourcing Industry News:

• In March 2024, LGM Pharma revealed substantial upgrades including a 50% capacity increase and a USD 2 million investment in its Analytical Testing Services (ATS). This expansion complements the introduction of new manufacturing capabilities, enhancing internal resources for growth, and offering customers a streamlined and efficient manufacturing solution.
   
• In August 2023, Eurofins Scientific entered into an outsourcing partnership with Astellas, transferring one of its internal testing facilities, Astellas Analytical Science Laboratories, Inc. The agreement aimed to extend Eurofin's biopharmaceutical testing services in Japan by leveraging Astella's expertise, thereby strengthening its market presence.
   

The pharmaceutical analytical testing outsourcing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 - 2032 for the following segments:

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Market, By Services

• Bioanalytical testing
  • Clinical
  • Non-clinical 
• Method development & validation
  • Extractable & leachable
  • Impurity method
  • Technical consulting
  • Other method development & validation services
• Stability testing
  • Drug substance testing
  • Stability indicating method validation
  • Accelerated stability testing
  • Photostability testing
  • Other stability testing services
• Other services

Market, By Product Type

• Active pharmaceutical ingredient (API)
• Additives
• Finished products

Market, By End-user

• Pharmaceutical companies
• Biopharmaceutical companies
• Academics & research institutes

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada 
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • Rest of Middle East and Africa