의약품 TIC 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the pharmaceutical TIC market was valued at USD 6.53 billion in 2025 and is estimated to grow from USD 6.84 billion in 2026 to USD 8.60 billion by 2031, at a CAGR of 4.69% from 2026 to 2031.

This report is Segmented by Service Type (Testing, Inspection, and Certification), Sourcing Type (In-House, and Outsourced), Mode of Service Delivery (On-Site, Off-site/Laboratory, and Remote/Digital), and Geography (North America, Europe, Asia-Pacific, Middle East, Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Pharmaceutical TIC Market Trends and Insights

Stringent Global GMP Enforcement

The FDA, in 2025, issued its highest number of warning letters in two decades, largely for data-integrity lapses and aseptic errors, prompting manufacturers to seek third-party validation of sterile-fill lines and electronic records. The European Medicines Agency's 2022 Annex 1 update imposed prescriptive contamination-control rules that now drive demand for routine clean-room certification across the region. WHO expanded prequalification to 87 sites by end-2025, each requiring biennial audits by approved testing, inspection, and certification (TIC) bodies. Early results from the FDA PreCheck pilot indicate inspection lead times are shrinking to 60 days when accredited TIC assurances are in place. Collectively, these moves embed external testing and certification into baseline pharmaceutical operations.

Accelerating Biologics Pipeline Requiring Complex Testing

The FDA cleared 16 biologics in 2024, with monoclonal antibodies dominating approvals, while the EMA authorized an additional 11 biosimilars the same year. Biologics demand advanced assays such as glycosylation profiling and host-cell protein quantification that few in-house labs possess. The 2024 revision of ICH Q5E pushed many manufacturers to revalidate methods via ISO/IEC 17025-accredited partners. Growing cell-and-gene therapy pipelines add vector potency and replication-competent virus testing to the services mix. As product portfolios fragment into niche and personalized medicines, contract laboratories with deep biologics expertise become indispensable allies.

Scarcity of Skilled Auditors in Emerging Markets

India's CDSCO reported a 40% vacancy rate among inspectors in 2025, and 62% of Asia-Pacific labs cited hiring challenges for advanced biologics analysts. Limited training pipelines and talent migration into higher-paying pharma roles lengthen audit backlogs by 4 to 6 weeks. Leading TIC firms have responded with regional academies and university partnerships, yet tangible workforce growth is several years off, constraining rapid service expansion in high-growth geographies.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Pre-approval Inspection Frequency by US FDA and EMA
2. Shift Toward Continuous Manufacturing in Pharma Plants
3. High Cost of Advanced Analytical Instrumentation

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Testing generated 43.19% of 2025 revenue, marking the largest pharmaceutical TIC market share among service types. Demand stems from complex assays for monoclonal antibodies and cell-and-gene therapies that require costly, specialized instrumentation, which is unavailable in many in-house labs. Certification, though smaller, is rising fastest at a 4.71% CAGR as firms pursue ISO 13485 and WHO prequalification to unlock exports. The pharmaceutical TIC market size linked to certification is expected to widen steadily alongside global mutual recognition agreements.

Margin pressure is sharper in inspection services as remote platforms shorten on-site work, yet specialized audits for continuous manufacturing and data integrity retain pricing power. Bundled multi-year certification contracts that combine ISO 13485, ISO 9001, and GDP audits position TIC providers for recurring revenue. Data-rich testing workflows also generate long-tail opportunities in analytics, enabling laboratories to advise on process optimization alongside compliance.

Geography Analysis

North America accounted for 34.41% of 2025 revenue as biologics clusters in Massachusetts, New Jersey, and North Carolina relied heavily on third-party validations. The region's strict oversight, reinforced by 112 warning letters in 2025, has driven near-universal adoption of accredited testing across sterile-fill lines and electronic records. The 2026 PreCheck pilot further entrenches external audits through digital twins and real-time data streams. Canada and Mexico add incremental volume as both scale production for regional supply, creating new bids for WHO prequalification and export certificates.

Asia-Pacific is the fastest-growing area, advancing at a 5.54% CAGR through 2031, buoyed by India's INR 150 billion (USD 12 million) production-linked incentives and China's 48 biologic approvals in 2024. Indian facilities faced 87 FDA pre-approval inspections in 2025, up sharply from 2020, prompting widespread engagement of TIC firms for readiness checks. China's push into trastuzumab and adalimumab biosimilars further lifts analytical demand, while Japan's risk-based GMP regime prioritizes continuous-manufacturing audits. South Korea and Australia contribute niche volumes through export-oriented biologics and vaccine plants.

Europe maintains a sizable demand on the back of its 2022 EMA Annex 1 contamination-control rules. Germany, France, and the United Kingdom anchor biologics output that necessitates extensive charge-variant and potency testing. Although EU-US mutual recognition eases regulatory duplication, manufacturers still retain local TIC partners for cross-border assurance. The Middle East remains fragmented; Saudi Arabia aligns toward Vision 2030, while the UAE and Turkey operate distinct frameworks, boosting multi-jurisdiction consulting. South America and Africa presently contribute modest revenue but are investing in capacity to cut import reliance, setting the stage for greater TIC penetration after 2028.

1. SGS SA
2. Eurofins Scientific SE
3. Bureau Veritas SA
4. TUV SUD AG
5. Intertek Group plc
6. Applus Services, S.A.
7. UL Solutions Inc.
8. DNV AS
9. TUV Rheinland AG
10. ALS Limited
11. Pace Analytical Services LLC
12. NSF International
13. Charles River Laboratories International, Inc.
14. Element Materials Technology Group Limited
15. Microbac Laboratories, Inc.
16. Labstat International Inc.
17. AmSpec LLC
18. BSI Group (The British Standards Institution)
19. Labcorp Drug Development, Inc.
20. Pharmaron Beijing Co., Ltd.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET LANDSCAPE

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Stringent Global GMP Enforcement
  • 4.2.2 Accelerating Biologics Pipeline Requiring Complex Testing
  • 4.2.3 Shift Toward Continuous Manufacturing in Pharma Plants
  • 4.2.4 Rising Pre-approval Inspection Frequency by US FDA and EMA
  • 4.2.5 Digital Twin Adoption for Remote Inspection
  • 4.2.6 Green Chemistry Validation Mandates
• 4.3 Market Restraints
  • 4.3.1 Scarcity of Skilled Auditors in Emerging Markets
  • 4.3.2 High Cost of Advanced Analytical Instrumentation
  • 4.3.3 Fragmented Regulatory Frameworks Across Middle East
  • 4.3.4 Cybersecurity Risks in Connected Lab Equipment
• 4.4 Industry Value-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Impact of Macroeconomic Factors on the Market
• 4.8 Porter's Five Forces Analysis
  • 4.8.1 Threat of New Entrants
  • 4.8.2 Bargaining Power of Suppliers
  • 4.8.3 Bargaining Power of Buyers
  • 4.8.4 Threat of Substitutes
  • 4.8.5 Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE)

• 5.1 By Service Type
  • 5.1.1 Testing
  • 5.1.2 Inspection
  • 5.1.3 Certification
• 5.2 By Sourcing Type
  • 5.2.1 In-house
  • 5.2.2 Outsourced
• 5.3 By Mode of Service Delivery
  • 5.3.1 On-site
  • 5.3.2 Off-site / Laboratory
  • 5.3.3 Remote / Digital
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 United Kingdom
    • 5.4.2.2 Germany
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 South Korea
    • 5.4.3.5 Rest of Asia-Pacific
  • 5.4.4 Middle East
    • 5.4.4.1 Israel
    • 5.4.4.2 Saudi Arabia
    • 5.4.4.3 United Arab Emirates
    • 5.4.4.4 Turkey
    • 5.4.4.5 Rest of Middle East
  • 5.4.5 Africa
    • 5.4.5.1 South Africa
    • 5.4.5.2 Egypt
    • 5.4.5.3 Rest of Africa
  • 5.4.6 South America
    • 5.4.6.1 Brazil
    • 5.4.6.2 Argentina
    • 5.4.6.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Market Concentration
• 6.2 Strategic Moves
• 6.3 Market Share Analysis
• 6.4 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.4.1 SGS SA
  • 6.4.2 Eurofins Scientific SE
  • 6.4.3 Bureau Veritas SA
  • 6.4.4 TUV SUD AG
  • 6.4.5 Intertek Group plc
  • 6.4.6 Applus Services, S.A.
  • 6.4.7 UL Solutions Inc.
  • 6.4.8 DNV AS
  • 6.4.9 TUV Rheinland AG
  • 6.4.10 ALS Limited
  • 6.4.11 Pace Analytical Services LLC
  • 6.4.12 NSF International
  • 6.4.13 Charles River Laboratories International, Inc.
  • 6.4.14 Element Materials Technology Group Limited
  • 6.4.15 Microbac Laboratories, Inc.
  • 6.4.16 Labstat International Inc.
  • 6.4.17 AmSpec LLC
  • 6.4.18 BSI Group (The British Standards Institution)
  • 6.4.19 Labcorp Drug Development, Inc.
  • 6.4.20 Pharmaron Beijing Co., Ltd.

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment