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市场调查报告书
商品编码
1775457
全球假药检测设备市场:2025-2030 年预测Global Counterfeit Drug Detection Device Market - Forecasts from 2025 to 2030 |
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假药检测设备市场预计将从 2025 年的 17.42 亿美元成长到 2030 年的 22.93 亿美元,复合年增长率为 5.65%。
假药带来的公共卫生风险
假药对全球公共卫生构成严重威胁,导致疾病和死亡,尤其是在中低收入国家。世界卫生组织 (WHO) 估计,假药约占全球医药市场的 10%,有些地区的报告比例甚至超过 30%。然而,澳洲、加拿大和许多欧盟国家都拥有严格的监管制度,将假药的普及率控制在 1% 以下。电子商务的兴起加剧了这个问题,约 50% 的假药是透过隐藏地址的非法网站出售的。这种日益严重的威胁,加上弱势群体缺乏意识,正在推动对先进检测设备的需求,以确保药品真实性并保护患者安全。
法规和产业倡议
严格的监管以及政府和医疗机构日益增强的意识正在推动市场成长。美国食品药物管理局)预计在 2023 年查获价值 40 亿美元的假药,凸显了对强大检测解决方案的需求。全球监管机构正在执行更严格的品管标准,并鼓励采用先进技术打击假药贩运。製药公司也因假药面临巨大的财务损失和声誉风险,因此增加了对检测设备的投资,以保护其供应链。
技术进步
光谱学和便携式设备
技术创新是市场成长的前沿,而光谱设备正是其驱动力。 2023年3月,Invita Healthcare Technologies推出了PharmaDefense,这是一款致力于假药检测的开创性解决方案,可增强快速现场检验。赛默飞世尔科技的可携式XRF分析仪、NIR和拉曼光谱仪符合现行良好生产规范(GMP)和21 CFR Part 11标准,可在30秒内现场识别和量化药物成分。这些仪器提供快速、无损的分析,最大限度地减少对耗时的实验室检测的依赖,并确保高品质的检验以打击假药。
人工智慧和高阶成像
人工智慧 (AI) 与先进成像技术的融合正在彻底改变假冒仿冒品的检测方式。 2023 年 12 月,Nynomic AG 收购了 Art Photonics GmbH,以增强其光纤侦测能力。人工智慧解决方案,例如在韩国国家资讯技术产业振兴院的支持下于 2021 年 12 月推出的 Stratio, Inc.影像处理技术,提高了边境检查站的准确性。此外,Spectral Engines 于 2023 年发布的 NIRONE® 扫描仪,将近红外线 (NIR) 技术与云端连接和先进演算法相结合,为材料分析和假药检测提供了承包解决方案。
RFID和区块链
无线射频识别 (RFID) 和区块链技术正日益获得支持,以提升供应链透明度。 2024 年,受要求原料药使用QR码和 RFID 标籤的法规推动,製药业将越来越多地采用 RFID 来追踪假药。由 Hyperledger Fabric 提供支援的云端基础区块链框架能够安全且透明地追踪药品,并透过序列化包装和智慧合约降低假冒风险。
市场区隔分析
The Global Counterfeit Drug Detection Device Market is expected to grow from USD 1.742 billion in 2025 to USD 2.293 billion in 2030, at a CAGR of 5.65%.
Public Health Risks from Counterfeit Drugs
Counterfeit drugs pose a severe threat to global public health, contributing to illnesses and deaths, particularly in low- and middle-income countries. The World Health Organization estimates that counterfeit drugs account for approximately 10% of the global pharmaceutical market, with some regions exceeding 30%. In contrast, stringent regulatory systems in countries like Australia, Canada, and many EU nations limit counterfeit prevalence to less than 1%. The rise of e-commerce, with around 50% of counterfeit drugs sold through illegal websites with hidden addresses, exacerbates the issue. This growing threat, combined with a lack of awareness in vulnerable populations, drives demand for advanced detection devices to ensure drug authenticity and protect patient safety.
Regulatory and Industry Initiatives
Stringent regulations and heightened awareness among governments and healthcare organizations are fueling market growth. In 2023, the U.S. Food and Drug Administration seized over $4 billion worth of counterfeit pharmaceuticals, highlighting the need for robust detection solutions. Globally, regulatory bodies are enforcing stricter quality control standards, encouraging the adoption of advanced technologies to combat counterfeit drug trafficking. Pharmaceutical companies also face significant financial losses and reputational risks from counterfeit drugs, prompting increased investment in detection devices to safeguard supply chains.
Technological Advancements
Spectroscopy and Portable Devices
Technological innovations are at the forefront of market growth, with spectroscopy-based devices leading the charge. In March 2023, InVita Healthcare Technologies launched Pharma Defense, a pioneering solution focused on counterfeit drug detection, enhancing rapid on-site verification. Thermo Fisher Scientific's portable XRF Analyzer, NIR, and Raman Spectrometers enable on-site identification and quantification of pharmaceutical ingredients within 30 seconds, adhering to current good manufacturing practices and 21 CFR Part 11 standards. These devices provide fast, non-destructive analysis, minimizing reliance on time-consuming laboratory tests and ensuring high-quality verification to combat counterfeit drugs.
AI and Advanced Imaging
The integration of artificial intelligence (AI) and advanced imaging techniques is transforming counterfeit detection. In December 2023, Nynomic AG acquired Art Photonics GmbH, enhancing its fiber optic-based detection capabilities. AI-powered solutions, such as Stratio, Inc.'s imaging technology launched in December 2021 with support from South Korea's National IT Industry Promotion Agency, improve accuracy at border checkpoints. Additionally, Spectral Engines' NIRONE(R) Scanner, introduced in 2023, combines NIR technology with cloud connectivity and advanced algorithms, offering a turnkey solution for material analysis and fake drug detection.
RFID and Blockchain
Radio-frequency identification (RFID) and blockchain technologies are gaining traction for supply chain transparency. In 2024, the pharmaceutical industry increasingly adopted RFID to track falsified drugs, driven by regulatory mandates for QR codes and RFID tags on active pharmaceutical ingredients. Cloud-based blockchain frameworks, utilizing Hyperledger Fabric, enable secure, transparent tracking of pharmaceutical products, reducing counterfeit risks through serialized packaging and smart contracts.
Market Segmentation Analysis
Spectroscopy Segment
The spectroscopy segment, including Raman and near-infrared (NIR) technologies, held a significant market share in 2024, valued at USD 0.96 billion. Its non-destructive nature and rapid results make it ideal for on-site verification in pharmacies, border controls, and manufacturing facilities. The segment's growth is driven by demand for portable, user-friendly devices.
Portable Devices
Portable counterfeit detection devices, such as handheld scanners, are gaining popularity due to their flexibility and ease of use in field settings. These devices, including Thermo Fisher's TruScan Raman and microPHAZIR RX NIR analyzers, support rapid screening, enhancing accessibility and adoption across diverse end-users, including regulatory authorities and distributors.
Regional Insights
North America dominates the market, holding a 34.2% revenue share projected by 2037, driven by stringent regulations, advanced healthcare infrastructure, and high counterfeit drug awareness. The region's market was valued at USD 1.0 billion in 2024. The Asia-Pacific region is the fastest-growing, fueled by rising counterfeit drug prevalence, government initiatives, and local manufacturing of detection devices. China, with a 22% increase in fake drugs reported in 2023, is prioritizing advanced detection technologies. Europe follows, with a market size of USD 0.7 billion in 2024, supported by robust regulatory frameworks.
Market Challenges
High costs of advanced detection devices and limited awareness in developing regions pose challenges. Additionally, the sophistication of counterfeit drugs requires continuous technological upgrades, straining R&D budgets. Regulatory gaps in emerging markets further complicate enforcement efforts.
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