의약품 불순물 합성 및 분리 서비스 시장 규모, 점유율, 동향 분석 보고서 : 서비스별, 불순물 유형별, 기술별, 용도별, 최종 용도별, 지역별, 부문별 예측(2025-2030년)

Pharmaceutical Impurity Synthesis And Isolation Services Market Growth & Trends:

The global pharmaceutical impurity synthesis and isolation services market size is expected to reach USD 1.94 billion by 2030, growing at a CAGR of 8.10% during the forecast period, according to a new report by Grand View Research, Inc.

Pharmaceutical impurity testing, quantification, and analytical control strategies are important in optimizing safety, purity, and quality control for finished drug products and drug substances. Pharmaceutical impurities can arise from several sources and include reagents, starting materials and their contaminants, catalysts, intermediates, solvents, excipients and their contaminants, and degradation products.

The growing complexity of pharmaceutical formulations is also contributing to market growth. With the increasing development of biologics, complex generics, and novel drug delivery systems, the nature of impurities has become more diverse and challenging to identify. This complexity necessitates advanced analytical techniques and expert services for accurate impurity profiling. Companies seek specialized services to handle these requirements, driving demand for impurity synthesis and isolation services. Thus, the aforementioned factors contribute to market growth.

Moreover, continuous technological advancements in analytical techniques further driving the demand for impurity synthesis and isolation services. The development of more sophisticated methods, such as high-resolution mass spectrometry and advanced chromatographic techniques, enables more precise detection and characterization of impurities. Service providers that adopt and integrate these cutting-edge technologies would easily meet the growing needs of the pharmaceutical industry, further driving growth in the market.

Growing collaboration and outsourcing trends in the pharmaceutical industry play a significant role in the market dynamics. Pharmaceutical companies are increasingly outsourcing impurity synthesis and isolation to specialized service providers to focus on their core competencies and reduce operational costs. This outsourcing trend creates opportunities for service providers to expand their offerings and cater to global clients. Thus, the aforementioned factors are driving the growth of the market.

Pharmaceutical Impurity Synthesis And Isolation Services Market Report Highlights:

• Based on service, the isolation service segment dominated the market with a share of 40.04% in 2024. Isolation of impurities is a fundamental aspect of ensuring the safety and efficacy of pharmaceutical products. Regulatory agencies require comprehensive impurity profiles, which necessitate effectively isolating these substances from drug formulations.
• Based on impurity type, the inorganic impurities segment dominated the market in 2024. Technological advancements have played a significant role in dominating the segment of inorganic impurities. Innovations in analytical techniques, such as Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Atomic Absorption Spectroscopy (AAS), have greatly enhanced the ability to detect and quantify inorganic impurities with high sensitivity and accuracy.
• Based on technique, the chromatography segment accounted for the largest revenue share in 2024. Increasing complexity of pharmaceutical formulations is driving the demand for advanced chromatographic techniques. Modern drugs, including biologics, peptides, and complex generics, often involve intricate mixtures that require proper separation methods.
• Based on application, the commercial manufacturing segment accounted for the largest revenue share in 2024. Growing global pharmaceutical market and expanding pharmaceutical production facilities worldwide are contributing to the segment's growth. As pharmaceutical companies increase their production capacities and enter new markets, the need for reliable impurity analysis services grows significantly.
• Based on end use, the biotech and pharmaceutical companies segment accounted for the largest revenue share in 2024. Biotech and pharmaceutical companies' significant investment in research and development (R&D) is contributing to the segment's growth.
• North America dominated the market with a revenue share of 38.07% in 2024. The regional revenue growth is owing to high R&D activities and government initiatives. Moreover, strong presence of pharmaceutical companies and outsourcing service providers is another major factor expected to propel market growth.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Market Definitions
  • 1.2.1. Service
  • 1.2.2. Impurity Type
  • 1.2.3. Technique
  • 1.2.4. Application
  • 1.2.5. End Use
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased Database
  • 1.4.2. GVR's Internal Database
  • 1.4.3. Secondary Sources
  • 1.4.4. Primary Research
• 1.5. Market Formulation & Validation
• 1.6. Model Details
  • 1.6.1. Commodity Flow Analysis
  • 1.6.2. Bottom-up Approach
• 1.7. List of Secondary Sources
• 1.8. List of Abbreviations
• 1.9. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Pharmaceutical Impurity Synthesis and Isolation Services Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent market outlook
  • 3.1.2. Related/ancillary market outlook.
• 3.2. Market Dynamics
  • 3.2.1. Market driver analysis
    • 3.2.1.1. Stringent Regulatory Landscape
    • 3.2.1.2. Increasing Pharmaceutical R&D Spending
    • 3.2.1.3. Technological Advancement in Analytical Testing
    • 3.2.1.4. Growing Outsourcing Trend in the Market
  • 3.2.2. Market restraint analysis
    • 3.2.2.1. Lack of Skilled workforce
    • 3.2.2.2. Contractual Obligation
• 3.3. Pricing Model Analysis
• 3.4. Technology Landscape
• 3.5. Market Analysis Tools
  • 3.5.1. Porter's Five Forces Analysis
  • 3.5.2. PESTEL Analysis
  • 3.5.3. COVID-19 Impact Analysis

Chapter 4. Pharmaceutical Impurity Synthesis And Isolation Services Market: Service Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Pharmaceutical Impurity Synthesis and Isolation Services Market; Service Movement Analysis
• 4.3. Global Pharmaceutical Impurity Synthesis and Isolation Services Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
• 4.4. Synthesis Services
  • 4.4.1. Synthesis services market estimates and forecasts 2018 to 2030 (USD Million)
• 4.5. Isolation Services
  • 4.5.1. Isolation services market estimates and forecasts 2018 to 2030 (USD Million)
• 4.6. Analytical Services
  • 4.6.1. Analytical services market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 5. Pharmaceutical Impurity Synthesis And Isolation Services Market: Impurity Type Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Pharmaceutical Impurity Synthesis and Isolation Services Market; Impurity Type Movement Analysis
• 5.3. Global Pharmaceutical Impurity Synthesis and Isolation Services Size & Trend Analysis, by Impurity Type, 2018 to 2030 (USD Million)
• 5.4. Inorganic Impurities
  • 5.4.1. Inorganic impurities market estimates and forecasts 2018 to 2030 (USD Million)
• 5.5. Organic impurities
  • 5.5.1. Organic impurities market estimates and forecasts 2018 to 2030 (USD Million)
• 5.6. Residual Solvents
  • 5.6.1. Residual solvents market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 6. Pharmaceutical Impurity Synthesis And Isolation Services Market: Technique Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Global Pharmaceutical Impurity Synthesis and Isolation Services Market; Technique Movement Analysis
• 6.3. Global Pharmaceutical Impurity Synthesis and Isolation Services Size & Trend Analysis, by Technique, 2018 to 2030 (USD Million)
• 6.4. Chromatography
  • 6.4.1. Chromatography market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.4.2. HPLC
    • 6.4.2.1. HPLC market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.4.3. Gas Chromatography
    • 6.4.3.1. Gas chromatography market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.4.4. Preparative Chromatography
    • 6.4.4.1. Preparative chromatography market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.4.5. Others
    • 6.4.5.1. Others market estimates and forecasts 2018 to 2030 (USD Million)
• 6.5. Spectroscopy
  • 6.5.1. Spectroscopy market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.5.2. Mass Spectroscopy
    • 6.5.2.1. Mass spectroscopy market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.5.3. Nuclear Magnetic Resonance (NMR) Spectroscopy
    • 6.5.3.1. Nuclear Magnetic Resonance (NMR) spectroscopy market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.5.4. Others
    • 6.5.4.1. Others market estimates and forecasts 2018 to 2030 (USD Million)
• 6.6. Crystallization
  • 6.6.1. Crystallization market estimates and forecasts 2018 to 2030 (USD Million)
• 6.7. Hyphenated Techniques
  • 6.7.1. Hyphenated techniques market estimates and forecasts 2018 to 2030 (USD Million)
• 6.8. Others
  • 6.8.1. Others market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 7. Pharmaceutical Impurity Synthesis And Isolation Services Market: Application Estimates & Trend Analysis

• 7.1. Segment Dashboard
• 7.2. Global Pharmaceutical Impurity Synthesis and Isolation Services Market; Application Movement Analysis
• 7.3. Global Pharmaceutical Impurity Synthesis and Isolation Services Size & Trend Analysis, by Application, 2018 to 2030 (USD Million)
• 7.4. Commercial Manufacturing
  • 7.4.1. Commercial manufacturing market estimates and forecasts 2018 to 2030 (USD Million)
• 7.5. Drug Development
  • 7.5.1. Drug development market estimates and forecasts 2018 to 2030 (USD Million)
• 7.6. Quality Control
  • 7.6.1. Quality control market estimates and forecasts 2018 to 2030 (USD Million)
• 7.7. Regulatory Compliance
  • 7.7.1. Regulatory compliance market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 8. Pharmaceutical Impurity Synthesis And Isolation Services Market: End Use Estimates & Trend Analysis

• 8.1. Segment Dashboard
• 8.2. Global Pharmaceutical Impurity Synthesis and Isolation Services Market; End Use Movement Analysis
• 8.3. Global Pharmaceutical Impurity Synthesis and Isolation Services Size & Trend Analysis, by End Use, 2018 to 2030 (USD Million)
• 8.4. Biotech & Pharmaceutical Companies
  • 8.4.1. Biotech & pharmaceutical companies market estimates and forecasts 2018 to 2030 (USD Million)
• 8.5. Contract Research Organizations (CRO)
  • 8.5.1. Contract Research Organizations (CRO) market estimates and forecasts 2018 to 2030 (USD Million)
• 8.6. Others
  • 8.6.1. Others market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 9. Pharmaceutical Impurity Synthesis And Isolation Services Market: Regional Estimates & Trend Analysis by Service, Impurity Type, Technique, Application, End Use

• 9.1. Regional Market Share Analysis, 2024 & 2030
• 9.2. Regional Market Dashboard
• 9.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
• 9.4. North America
  • 9.4.1. North America Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 9.4.2. U.S.
    • 9.4.2.1. Key country dynamics
    • 9.4.2.2. Competitive scenario
    • 9.4.2.3. Regulatory framework
    • 9.4.2.4. U.S. market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.4.3. Canada
    • 9.4.3.1. Key country dynamics
    • 9.4.3.2. Competitive scenario
    • 9.4.3.3. Regulatory framework
    • 9.4.3.4. Canada market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.4.4. Mexico
    • 9.4.4.1. Key country dynamics
    • 9.4.4.2. Competitive scenario
    • 9.4.4.3. Regulatory framework
    • 9.4.4.4. Mexico market estimates and forecasts 2018 to 2030 (USD Million)
• 9.5. Europe
  • 9.5.1. Europe Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 9.5.2. UK
    • 9.5.2.1. Key country dynamics
    • 9.5.2.2. Competitive scenario
    • 9.5.2.3. Regulatory framework
    • 9.5.2.4. UK market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.5.3. Germany
    • 9.5.3.1. Key country dynamics
    • 9.5.3.2. Competitive scenario
    • 9.5.3.3. Regulatory framework
    • 9.5.3.4. Germany market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.5.4. France
    • 9.5.4.1. Key country dynamics
    • 9.5.4.2. Competitive scenario
    • 9.5.4.3. Regulatory framework
    • 9.5.4.4. France market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.5.5. Italy
    • 9.5.5.1. Key country dynamics
    • 9.5.5.2. Competitive scenario
    • 9.5.5.3. Regulatory framework
    • 9.5.5.4. Italy market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.5.6. Spain
    • 9.5.6.1. Key country dynamics
    • 9.5.6.2. Competitive scenario
    • 9.5.6.3. Regulatory framework
    • 9.5.6.4. Spain market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.5.7. Denmark
    • 9.5.7.1. Key country dynamics
    • 9.5.7.2. Competitive scenario
    • 9.5.7.3. Regulatory framework
    • 9.5.7.4. Denmark market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.5.8. Sweden
    • 9.5.8.1. Key country dynamics
    • 9.5.8.2. Competitive scenario
    • 9.5.8.3. Regulatory framework
    • 9.5.8.4. Sweden market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.5.9. Norway
    • 9.5.9.1. Key country dynamics
    • 9.5.9.2. Competitive scenario
    • 9.5.9.3. Regulatory framework
    • 9.5.9.4. Norway market estimates and forecasts 2018 to 2030 (USD Million)
• 9.6. Asia Pacific
  • 9.6.1. Asia Pacific Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 9.6.2. Japan
    • 9.6.2.1. Key country dynamics
    • 9.6.2.2. Competitive scenario
    • 9.6.2.3. Regulatory framework
    • 9.6.2.4. Japan market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.6.3. China
    • 9.6.3.1. Key country dynamics
    • 9.6.3.2. Competitive scenario
    • 9.6.3.3. Regulatory framework
    • 9.6.3.4. China market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.6.4. India
    • 9.6.4.1. Key country dynamics
    • 9.6.4.2. Competitive scenario
    • 9.6.4.3. Regulatory framework
    • 9.6.4.4. India market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.6.5. Australia
    • 9.6.5.1. Key country dynamics
    • 9.6.5.2. Competitive scenario
    • 9.6.5.3. Regulatory framework
    • 9.6.5.4. Australia market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.6.6. South Korea
    • 9.6.6.1. Key country dynamics
    • 9.6.6.2. Competitive scenario
    • 9.6.6.3. Regulatory framework
    • 9.6.6.4. South Korea market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.6.7. Thailand
    • 9.6.7.1. Key country dynamics
    • 9.6.7.2. Competitive scenario
    • 9.6.7.3. Regulatory framework
    • 9.6.7.4. Thailand market estimates and forecasts 2018 to 2030 (USD Million)
• 9.7. Latin America
  • 9.7.1. Latin America Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 9.7.2. Brazil
    • 9.7.2.1. Key country dynamics
    • 9.7.2.2. Competitive scenario
    • 9.7.2.3. Regulatory framework
    • 9.7.2.4. Brazil market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.7.3. Argentina
    • 9.7.3.1. Key country dynamics
    • 9.7.3.2. Competitive scenario
    • 9.7.3.3. Regulatory framework
    • 9.7.3.4. Argentina market estimates and forecasts 2018 to 2030 (USD Million)
• 9.8. MEA
  • 9.8.1. MEA Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 9.8.2. South Africa
    • 9.8.2.1. Key country dynamics
    • 9.8.2.2. Competitive scenario
    • 9.8.2.3. Regulatory framework
    • 9.8.2.4. South Africa market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.8.3. Saudi Arabia
    • 9.8.3.1. Key country dynamics
    • 9.8.3.2. Competitive scenario
    • 9.8.3.3. Regulatory framework
    • 9.8.3.4. Saudi Arabia market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.8.4. UAE
    • 9.8.4.1. Key country dynamics
    • 9.8.4.2. Competitive scenario
    • 9.8.4.3. Regulatory framework
    • 9.8.4.4. UAE market estimates and forecasts 2018 to 2030 (USD Million)
  • 9.8.5. Kuwait
    • 9.8.5.1. Key country dynamics
    • 9.8.5.2. Competitive scenario
    • 9.8.5.3. Regulatory framework
    • 9.8.5.4. Kuwait market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 10. Competitive Landscape

• 10.1. Company Categorization
• 10.2. Company Market Position Analysis, 2024
• 10.3. Company Profiles
  • 10.3.1. Eurofins Scientific
    • 10.3.1.1. Company overview
    • 10.3.1.2. Financial performance
    • 10.3.1.3. Service benchmarking
    • 10.3.1.4. Strategic initiatives
  • 10.3.2. Charles River Laboratories
    • 10.3.2.1. Company overview
    • 10.3.2.2. Financial performance
    • 10.3.2.3. Service benchmarking
    • 10.3.2.4. Strategic initiatives
  • 10.3.3. Wuxi AppTec
    • 10.3.3.1. Company overview
    • 10.3.3.2. Financial performance
    • 10.3.3.3. Service benchmarking
    • 10.3.3.4. Strategic initiatives
  • 10.3.4. SGS Societe Generale de Surveillance SA.
    • 10.3.4.1. Company overview
    • 10.3.4.2. Financial performance
    • 10.3.4.3. Service benchmarking
    • 10.3.4.4. Strategic initiatives
  • 10.3.5. Intertek Group Plc
    • 10.3.5.1. Company overview
    • 10.3.5.2. Financial performance
    • 10.3.5.3. Service benchmarking
    • 10.3.5.4. Strategic initiatives
  • 10.3.6. Almac Group
    • 10.3.6.1. Company overview
    • 10.3.6.2. Financial performance
    • 10.3.6.3. Service benchmarking
    • 10.3.6.4. Strategic initiatives
  • 10.3.7. Cambrex Corporation
    • 10.3.7.1. Company overview
    • 10.3.7.2. Financial performance
    • 10.3.7.3. Service benchmarking
    • 10.3.7.4. Strategic initiatives
  • 10.3.8. Pharmaron
    • 10.3.8.1. Company overview
    • 10.3.8.2. Financial performance
    • 10.3.8.3. Service benchmarking
    • 10.3.8.4. Strategic initiatives
  • 10.3.9. Laboratory Corporation of America Holdings
    • 10.3.9.1. Company overview
    • 10.3.9.2. Financial performance
    • 10.3.9.3. Service benchmarking
    • 10.3.9.4. Strategic initiatives
  • 10.3.10. Syngene International Limited
    • 10.3.10.1. Company overview
    • 10.3.10.2. Financial performance
    • 10.3.10.3. Service benchmarking
    • 10.3.10.4. Strategic initiatives
  • 10.3.11. PCI Pharma Services
    • 10.3.11.1. Company overview
    • 10.3.11.2. Financial performance
    • 10.3.11.3. Service benchmarking
    • 10.3.11.4. Strategic initiatives
  • 10.3.12. Catalent Inc
    • 10.3.12.1. Company overview
    • 10.3.12.2. Financial performance
    • 10.3.12.3. Service benchmarking
    • 10.3.12.4. Strategic initiatives
  • 10.3.13. Symeres
    • 10.3.13.1. Company overview
    • 10.3.13.2. Financial performance
    • 10.3.13.3. Service benchmarking
    • 10.3.13.4. Strategic initiatives
  • 10.3.14. Piramal Pharma Solutions
    • 10.3.14.1. Company overview
    • 10.3.14.2. Financial performance
    • 10.3.14.3. Service benchmarking
    • 10.3.14.4. Strategic initiatives
  • 10.3.15. Frontage Labs
    • 10.3.15.1. Company overview
    • 10.3.15.2. Financial performance
    • 10.3.15.3. Service benchmarking
    • 10.3.15.4. Strategic initiatives
  • 10.3.16. Veeda Clinical Research
    • 10.3.16.1. Company overview
    • 10.3.16.2. Financial performance
    • 10.3.16.3. Service benchmarking
    • 10.3.16.4. Strategic initiatives