Pharmaceutical Analytical Testing Outsourcing Market by Services, Testing Technique, End-use

Description

List of Tables

[195 Pages Report] The Pharmaceutical Analytical Testing Outsourcing Market size was estimated at USD 9.23 billion in 2023 and expected to reach USD 10.07 billion in 2024, at a CAGR 9.38% to reach USD 17.30 billion by 2030.

Pharmaceutical analytical testing outsourcing refers to the professional services provided by external organizations that specialize in performing various analytical testing procedures for pharmaceutical companies. This practice of outsourcing is a strategic approach adopted by pharmaceutical companies to attain cost efficiencies, access specialized expertise, and benefit from advanced technologies that they may not possess in-house. The demand for pharmaceutical analytical testing outsourcing is driven by factors such as increasing regulatory demands for precise drug validation, the rising complexity of drugs, which requires advanced analytical methods, and cost optimization efforts from pharmaceutical companies looking to focus on core competencies. Despite the growth prospects, intellectual property concerns and the need for compliance with stringent regulatory standards, which can lead to an increase in lead time and costs, act as a restraint for market growth. However, advancements in technology, such as AI and high-throughput screening methods, present new avenues for market growth. The trend towards personalized medicine and orphan drugs also opens up a potential for specialized analytical testing services, presenting significant opportunities for the pharmaceutical analytical testing outsourcing market.

KEY MARKET STATISTICS
Base Year [2023]	USD 9.23 billion
Estimated Year [2024]	USD 10.07 billion
Forecast Year [2030]	USD 17.30 billion
CAGR (%)	9.38%

Services: Demand for bioanalytical testing services to determine efficacy and safety of pharmaceutical products

Bioanalytical testing services are essential for both clinical and non-clinical settings. Clinical bioanalytical testing is a critical phase in the drug development process, entailing the quantitative measurement of drugs in biological fluids. This evaluation is paramount for determining the efficacy and safety of pharmaceutical compounds in clinical trials. Non-clinical bioanalytical testing is an essential early-stage component of the drug development cycle. This involves the examination of new drug entities in vivo or in vitro in animal models to establish a preliminary assessment of the safety and biological activity of a substance before it is administered to humans.

In the realm of pharmaceutical analytical testing, method development and validation are critical components that ensure accuracy and reliability in results. Custom development and rigorous validation of methods for extractable and leachable are vital for assessing the compatibility between drug products and their packaging. Similarly, the development of an impurity method is crucial for identifying and quantifying potential impurities that could affect product safety and efficacy. Alongside this, technical consulting provides expert guidance to navigate complex regulatory requirements and optimize analytical procedures for robust outcomes.

Stability testing represents an integral part of pharmaceutical quality control, offering insights into a drug's shelf life and ensuring it remains safe and effective throughout its intended storage period. Accelerated stability testing simulates long-term environmental effects to predict a product's lifespan, while tests on the drug substance evaluate its behavior under varied conditions. Photostability testing assesses how exposure to light affects the stability of pharmaceutical products to ensure drug products do not degrade to an unacceptable degree when exposed to light. Stability indicating method validation is a thorough analytical process that confirms the suitability of analytical procedures for detecting changes in a drug's potency and purity. It involves the validation of specific methods to ensure they can accurately and reliably measure changes in the drug substances and products, which could result from degradation.

Testing Technique: Significant benefits of chromatography owing to its efficiency in separating and quantifying analytes in samples

Chromatography is a versatile separation technique extensively used in the pharmaceutical industry for quantifying and identifying the components of a mixture and purifying pharmaceutical compounds. It is preferred for its high precision, ability to separate complex mixtures, and scalability from analytical to preparative applications. Mass spectrometry offers an analytical technique that identifies compounds by their mass-to-charge ratio. This technique is indispensable for structural elucidation, identification of trace components, and impurity profiling. Its high specificity and sensitivity make it a suitable method for pharmacokinetics, metabolism studies, and proteomics. Spectroscopy encompasses a range of techniques based on the interaction of light with matter. In the pharmaceutical industry, it is used for structural analysis, compound identification, and concentration determination.

End-use: Growing need for a broad range of high-complexity testing services from contract manufacturing organizations

The Biopharmaceuticals & pharmaceuticals segment encompasses companies involved in the development and manufacturing of drugs, both biologically derived products (biopharmaceuticals) and chemically synthesized drugs (pharmaceuticals). Analytical testing services required by these entities include purity assessment, stability testing, bioanalytical testing, and batch-release testing, among others. Contract manufacturing organizations (CMOs) are companies that serve other pharmaceutical businesses on a contract basis to provide a comprehensive suite of services ranging from drug development to drug manufacturing. These organizations commonly outsource analytical testing to maintain regulatory compliance and ensure product quality without needing to invest in expensive laboratory infrastructure.

Regional Insights

The pharmaceutical analytical testing outsourcing market in the Americas is demonstrating robust growth. This growth is fortified by the presence of a pharmaceutical industry, along with well-established outsourcing companies. The stringent regulatory landscape, spearheaded by the U.S. Food and Drug Administration (FDA), and the increasing demand for cost-efficiency, innovation, and faster time-to-market are driving outsourcing activities. Europe remains a major contributor to the pharmaceutical analytical testing outsourcing market within the EMEA region. The market is benefiting from advanced healthcare infrastructure, significant investment in pharmaceutical R&D, and well-defined regulatory frameworks in the region. The Middle East and Africa, while smaller in comparison to Europe, are experiencing gradual expansions fueled by growing investment in healthcare sectors and a rising interest in pharmaceutical outsourcing to reduce costs and leverage regional expertise. The APAC market is experiencing rapid growth in pharmaceutical analytical testing outsourcing, backed by emerging economies such as China and India. These countries are becoming hotspots owing to their cost-competitive labor, growing expertise in pharma analytics, and increasing compliance with international quality standards. The expansion of local pharmaceutical manufacturers, coupled with increased foreign investments in healthcare infrastructure, continues to create new opportunities for pharmaceutical analytical testing outsourcing services in the region.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Pharmaceutical Analytical Testing Outsourcing Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Pharmaceutical Analytical Testing Outsourcing Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Pharmaceutical Analytical Testing Outsourcing Market, highlighting leading vendors and their innovative profiles. These include Ajinomoto Bio-Pharma, Alcami Corporation, AptarGroup, Inc., Ascendia Pharmaceuticals, BioAgilytix, Cambrex Corporation, Catalent, Inc, Charles River Laboratories International, Inc., Element Materials Technology, Eurofins Scientific SE, ICON PLC, Intertek Group PLC, Laboratory Corporation of America Holdings, LGM Pharma, Medpace Holdings, Inc., Merck KGaA, Pace Analytical Services, Inc., SGS SA, Societal CDMO, Source BioScience, Syneos Health, Thermo Fisher Scientific Inc., West Pharmaceutical Services, Inc., and WuXi AppTec.

Market Segmentation & Coverage

This research report categorizes the Pharmaceutical Analytical Testing Outsourcing Market to forecast the revenues and analyze trends in each of the following sub-markets:

Services
- Bioanalytical Testing
  - Clinical
  - Non-Clinical

Method Development & Validation
- Extractable & Leachable
- Impurity Method
- Technical Consulting

Stability Testing
- Accelerated Stability Testing
- Drug Substance
- Photostability Testing
- Stability Indicating Method Validation

Testing Technique
- Chromatography
- Mass Spectrometry
- Spectroscopy

End-use
- Biopharmaceuticals & Pharmaceuticals
- Contract Manufacturing Organizations

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Pharmaceutical Analytical Testing Outsourcing Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Pharmaceutical Analytical Testing Outsourcing Market?

3. What are the technology trends and regulatory frameworks in the Pharmaceutical Analytical Testing Outsourcing Market?

4. What is the market share of the leading vendors in the Pharmaceutical Analytical Testing Outsourcing Market?

5. Which modes and strategic moves are suitable for entering the Pharmaceutical Analytical Testing Outsourcing Market?

Product Code: MRR-A339DAEFAEE4

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Increasing research and development in drug discovery and development
  - 5.1.1.2. Complexity of drug formulations and need for compliance with stringent regulatory standards
  - 5.1.1.3. Growing preferences for pharmaceutical analytical testing outsourcing as a cost optimization strategy
- 5.1.2. Restraints
  - 5.1.2.1. High cost of analytical instruments and maintaining state-of-the-art facilities
- 5.1.3. Opportunities
  - 5.1.3.1. Emerging technological advancements in drug testing procedures
  - 5.1.3.2. Increasing investments in the pharmaceutical industry
- 5.1.4. Challenges
  - 5.1.4.1. Concerns associated with intellectual property rights
5.2. Market Segmentation Analysis
- 5.2.1. Services: Demand for bioanalytical testing services to determine efficacy and safety of pharmaceutical products
- 5.2.2. Testing Technique: Significant benefits of chromatography owing to its efficiency in separating and quantifying analytes in samples
- 5.2.3. End-use: Growing need for a broad range of high-complexity testing services from contract manufacturing organizations
5.3. Market Disruption Analysis
5.4. Porter's Five Forces Analysis
- 5.4.1. Threat of New Entrants
- 5.4.2. Threat of Substitutes
- 5.4.3. Bargaining Power of Customers
- 5.4.4. Bargaining Power of Suppliers
- 5.4.5. Industry Rivalry
5.5. Value Chain & Critical Path Analysis
5.6. Pricing Analysis
5.7. Technology Analysis
5.8. Patent Analysis
5.9. Trade Analysis
5.10. Regulatory Framework Analysis

6. Pharmaceutical Analytical Testing Outsourcing Market, by Services

6.1. Introduction
6.2. Bioanalytical Testing
6.3. Method Development & Validation
6.4. Stability Testing

7. Pharmaceutical Analytical Testing Outsourcing Market, by Testing Technique

7.1. Introduction
7.2. Chromatography
7.3. Mass Spectrometry
7.4. Spectroscopy

8. Pharmaceutical Analytical Testing Outsourcing Market, by End-use

8.1. Introduction
8.2. Biopharmaceuticals & Pharmaceuticals
8.3. Contract Manufacturing Organizations

9. Americas Pharmaceutical Analytical Testing Outsourcing Market

9.1. Introduction
9.2. Argentina
9.3. Brazil
9.4. Canada
9.5. Mexico
9.6. United States

10. Asia-Pacific Pharmaceutical Analytical Testing Outsourcing Market

10.1. Introduction
10.2. Australia
10.3. China
10.4. India
10.5. Indonesia
10.6. Japan
10.7. Malaysia
10.8. Philippines
10.9. Singapore
10.10. South Korea
10.11. Taiwan
10.12. Thailand
10.13. Vietnam

11. Europe, Middle East & Africa Pharmaceutical Analytical Testing Outsourcing Market

11.1. Introduction
11.2. Denmark
11.3. Egypt
11.4. Finland
11.5. France
11.6. Germany
11.7. Israel
11.8. Italy
11.9. Netherlands
11.10. Nigeria
11.11. Norway
11.12. Poland
11.13. Qatar
11.14. Russia
11.15. Saudi Arabia
11.16. South Africa
11.17. Spain
11.18. Sweden
11.19. Switzerland
11.20. Turkey
11.21. United Arab Emirates
11.22. United Kingdom

12. Competitive Landscape

12.1. Market Share Analysis, 2023
12.2. FPNV Positioning Matrix, 2023
12.3. Competitive Scenario Analysis
- 12.3.1. Sterling Accuris expands into pharmaceutical and analytical testing through new acquisition
- 12.3.2. Eurofins expands its biopharmaceutical products testing footprint with an outsourcing agreement with Astellas in Japan
12.4. Strategy Analysis & Recommendation

13. Competitive Portfolio

13.1. Key Company Profiles
13.2. Key Product Portfolio