위조 의약품 탐지 기기 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the counterfeit drug detection device market size is expected to grow from USD 1.53 billion in 2025 to USD 1.63 billion in 2026 and is forecast to reach USD 2.21 billion by 2031 at 6.30% CAGR over 2026-2031.

This report is Segmented by Technology (Infrared & Near-Infrared Spectroscopy, and More), Modality (Handheld Devices, and More), Application (Chemical-Composition Verification, and More), End User (Pharmaceutical Manufacturers, and More), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Counterfeit Drug Detection Device Market Trends and Insights

Emphasis on Advanced Supply-Chain Surveillance

Global regulators now demand end-to-end visibility, transforming detection from sporadic spot checks to continuous traceability. The Drug Supply Chain Security Act in the United States stipulates electronic interoperable exchange of serialized data at the package level, obliging every supply-chain node to validate authenticity before ownership transfer. Parallel efforts in the European Union and Gulf Cooperation Council align serialization formats, allowing multinational companies to streamline compliance workflows. Device vendors therefore embed 2D-data-matrix decode, RFID interrogators, and cloud connectors into spectroscopic platforms. Nigeria's historically high 70% counterfeit prevalence underscores why developing markets also accelerate investment once digital frameworks mature. As low-latency data sharing becomes a license to operate, procurement specifications increasingly list integration readiness alongside analytical performance.

Shift From Packaging to On-Dosage Security

Counterfeiters often recycle authentic secondary packaging, making pack-level markers less reliable. Pharmaceutical firms now embed microscopic identifiers on tablets and capsules, driving demand for optics that can read chemical or photonic signatures resident on the dosage itself. Asia Pacific generics manufacturers champion this shift following India's QR code order for top-selling molecules. SERS micro-substrates bonded to dosage surfaces offer quick confirmatory reads, and portable imagers configured for narrow field-of-view detection ensure in-line process adoption. Drug-regulatory agencies welcome the trend because on-dosage devices travel with the medicine, simplifying border inspection procedures and reducing diversion risk. The design update also shortens investigation cycles because analysts can validate suspect lots without opening primary packs.

Low Awareness in Developing Regions

Misconceptions about authentication technologies persist where primary healthcare budgets remain pressured. Surveys in Ethiopia show only 12% of pharmacists trained on counterfeit recognition techniques, hindering uptake even when external funding subsidizes devices. Manufacturers counter the deficit through donation programs bundled with virtual training modules, yet network connectivity gaps limit remote learning. Regional regulatory agencies often lack forensic labs to validate confiscated samples, suppressing the feedback loop needed to illustrate device value to frontline clinicians. Until governments formalize widespread pharmacovigilance curricula, penetration in these regions will trail global averages.

Other drivers and restraints analyzed in the detailed report include:

1. Supportive Government & Regulatory Mandates
2. AI-Powered SERS Enabling Sub-PPM Field Tests
3. High Upfront Cost of Spectroscopy Devices

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

Segment Analysis

The counterfeit drug detection device market size for raman spectroscopy accounted for 40.92% in 2025. Despite this base, SERS will outpace all rival techniques with a projected 8.94% CAGR to 2031, narrowing the revenue gap rapidly. Raman's dominance stems from its non-destructive nature and minimal sample prep, yet counterfeiters' switch to molecularly similar adulterants pushes traditional Raman to its detection ceiling. SERS employs plasmonic nano-structures that intensify Raman signals, unlocking a detection threshold below 1 ppm, a crucial benchmark for biologics and controlled substances. Instrument builders integrate AI models to autosubtract background fluorescence, enabling frontline staff to interpret outputs accurately. Infrared (IR) and near-infrared (NIR) methods continue as affordable options for excipient verification, while microfluidic lab-on-chip platforms appeal to high-throughput batch release by merging sample dilution and optical interrogation on a single cartridge. RFID-plus-blockchain tagging rises fastest outside optical families, complementing spectroscopic reads by delivering immutable provenance records.

Technological convergence accelerates multi-modal platforms capable of sequential Raman, fluorescence, and hyperspectral imaging in under 60 seconds, maximizing identification certainty. Capital budgets formerly siloed by analytical function are consolidating, encouraging cross-department procurement of unified detection stacks. Start-ups focusing solely on one optical path risk marginalization unless partnering with data-analytics players. Spectral cloud repositories democratize access to reference libraries, but data-sovereignty rules in Europe compel on-premises deployment among some pharmaceutical contract manufacturers, spawning regional variations in cloud uptake.

Handheld units held a 51.05% of counterfeit drug detection device market share in 2025. Portable backpack systems now record an 8.11% CAGR through 2031, benefiting from miniaturized lasers and GPU-equipped micro-controllers that execute onboard chemometrics. End-users evaluate modalities against workflow throughput and sample accessibility: warehouse inspectors favor handhelds that scan blister packs within seconds, whereas field surveillance teams choose backpack rigs to assay drums or IBC totes with deeper penetration optics. The counterfeit drug detection device market size for benchtop instruments remains resilient in QC laboratories where regulated environments justify stationary setups and peak resolution specifications.

Emerging modular designs allow users to dock handheld probes into larger base units for extended spectral range, creating a continuum rather than discrete categories. Hospitals trial cart-mounted hybrids in pharmacy compounding rooms, achieving hospital-grade contamination control without sacrificing portability. Integration of battery management systems offering eight-hour duty cycles resolves earlier adoption hesitations tied to runtime limitations. Modality diversification aligns neatly with supply-chain decentralization smaller batch sizes and direct-to-patient distribution lines stretch authenticity checkpoints beyond plant walls, requiring devices that travel where the product flows.

Complete Report Scope:

• By Technology
  • Infrared & Near-Infrared Spectroscopy
  • Raman Spectroscopy
  • Surface-Enhanced Raman (SERS)
  • Microfluidic Lab-on-Chip
  • Rapid Chemical Testing Kits
  • RFID / Blockchain Tagging
  • Other Emerging Technologies
• By Modality
  • Handheld Devices
  • Benchtop Devices
  • Portable/Back-pack Systems
• By Application
  • Chemical-Composition Verification
  • Packaging & Labelling Authentication
  • Mixed-Dosage Analysis
• By End User
  • Pharmaceutical Manufacturers
  • Drug Testing Laboratories
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America's held market share of 38.22% in the counterfeit drug detection device market in 2025, buoyed by the Drug Supply Chain Security Act deadline that makes electronic verification compulsory. Device penetration in hospital pharmacies and specialty distributors remains among the world's highest, and vendor support ecosystems cover calibration, compliance training, and third-party validation. The European Union maintains steady expansion as the Falsified Medicines Directive demands serialized packs and anti-tamper features. Benelux countries pioneer nation-wide blockchain registries interfacing with spectroscopy scanners, shortening authentication checks to under five seconds.

Asia Pacific now provides the steepest incline, with a 9.33% CAGR through 2031 as China tightens GMP rules and India enforces QR codes on the top 300 prescription brands. Local manufacturers, once reliant on visual inspection, pivot toward portable Raman units to satisfy export-market audits. Regional distributors also deploy mobile SERS devices in rural cold-chain routes where electricity outages mandate quick pass-fail decisions. Southeast Asian customs agencies adopt handheld scanners to intercept ASEAN-wide illicit flows before onward transit to Europe.

Latin America and Middle East-Africa collectively account for less than 10% of global revenue but represent outsized counterfeiting hotspots. Nigeria's high counterfeit incidence drives donor-funded pilots that bundle detection devices with capacity-building workshops. Saudi Arabia's track-and-trace platform Tatmeen aligns with GS1 standards, incentivizing device purchases compatible with 2D-data-matrix scans. Adoption remains sensitive to public-sector procurement schedules and multilateral aid cycles, but steady alignment with international pharmacovigilance norms signals medium-term upside.

1. Thermo Fisher Scientific
2. Rigaku Analytical Devices
3. Agilent Technologies
4. B&W Tek (Part of Metrohm)
5. Bruker
6. HORIBA
7. Renishaw plc
8. Smiths Detection Group Ltd.
9. DetectaChem LLC
10. Spectral Engines Oy
11. Stratio
12. Systech International
13. GAO Group
14. Metrohm AG (Mira devices)
15. ChemImage Corporation
16. TruTag Technologies Inc.
17. Enspectr LLC
18. TSI Incorporated
19. SciAps Inc.
20. Bayer

Additional Benefits:

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

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & 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 Emphasis on Advanced Supply-Chain Surveillance
  • 4.2.2 Shift From Packaging to On-Dosage Security
  • 4.2.3 Supportive Government & Regulatory Mandates
  • 4.2.4 AI-Powered SERS Enabling Sub-Ppm Field Tests
  • 4.2.5 Iot-Integrated Smart Packaging Validation
  • 4.2.6 Demand Surge from Cannabis Edibles & Personalized Meds
• 4.3 Market Restraints
  • 4.3.1 Low Awareness in Developing Regions
  • 4.3.2 High Upfront Cost of Spectroscopy Devices
  • 4.3.3 Laser-Safety Limits on Hospital Use of Handheld Raman
  • 4.3.4 Lack of Spectral Libraries for Novel Drug-Polymer Combos
• 4.4 Regulatory Landscape
• 4.5 Technological Outlook
• 4.6 Porter's Five Forces Analysis
  • 4.6.1 Threat of New Entrants
  • 4.6.2 Bargaining Power of Buyers
  • 4.6.3 Bargaining Power of Suppliers
  • 4.6.4 Threat of Substitutes
  • 4.6.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value in USD)

• 5.1 By Technology
  • 5.1.1 Infrared & Near-Infrared Spectroscopy
  • 5.1.2 Raman Spectroscopy
  • 5.1.3 Surface-Enhanced Raman (SERS)
  • 5.1.4 Microfluidic Lab-on-Chip
  • 5.1.5 Rapid Chemical Testing Kits
  • 5.1.6 RFID / Blockchain Tagging
  • 5.1.7 Other Emerging Technologies
• 5.2 By Modality
  • 5.2.1 Handheld Devices
  • 5.2.2 Benchtop Devices
  • 5.2.3 Portable/Back-pack Systems
• 5.3 By Application
  • 5.3.1 Chemical-Composition Verification
  • 5.3.2 Packaging & Labelling Authentication
  • 5.3.3 Mixed-Dosage Analysis
• 5.4 By End User
  • 5.4.1 Pharmaceutical Manufacturers
  • 5.4.2 Drug Testing Laboratories
  • 5.4.3 Other End Users
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market-level Overview, Core Segments, Financials, Strategic Info, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Thermo Fisher Scientific Inc.
  • 6.3.2 Rigaku Analytical Devices
  • 6.3.3 Agilent Technologies Inc.
  • 6.3.4 B&W Tek (Part of Metrohm)
  • 6.3.5 Bruker Corporation
  • 6.3.6 Horiba Ltd.
  • 6.3.7 Renishaw plc
  • 6.3.8 Smiths Detection Group Ltd.
  • 6.3.9 DetectaChem LLC
  • 6.3.10 Spectral Engines Oy
  • 6.3.11 Stratio Inc.
  • 6.3.12 Systech International
  • 6.3.13 GAO Group
  • 6.3.14 Metrohm AG (Mira devices)
  • 6.3.15 ChemImage Corporation
  • 6.3.16 TruTag Technologies Inc.
  • 6.3.17 Enspectr LLC
  • 6.3.18 TSI Incorporated
  • 6.3.19 SciAps Inc.
  • 6.3.20 Bayer AG

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment