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市場調查報告書
商品編碼
1775457
全球假藥檢測設備市場:2025-2030 年預測Global Counterfeit Drug Detection Device Market - Forecasts from 2025 to 2030 |
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假藥檢測設備市場預計將從 2025 年的 17.42 億美元成長到 2030 年的 22.93 億美元,複合年成長率為 5.65%。
假藥帶來的公共衛生風險
假藥對全球公共衛生構成嚴重威脅,導致疾病和死亡,尤其是在中低收入國家。世界衛生組織 (WHO) 估計,假藥約佔全球醫藥市場的 10%,有些地區的報告比例甚至超過 30%。然而,澳洲、加拿大和許多歐盟國家都擁有嚴格的監管制度,將假藥的普及率控制在 1% 以下。電子商務的興起加劇了這個問題,約 50% 的假藥是透過隱藏地址的非法網站出售的。這種日益嚴重的威脅,加上弱勢群體缺乏意識,正在推動對先進檢測設備的需求,以確保藥品真實性並保護患者安全。
法規和產業舉措
嚴格的監管以及政府和醫療機構日益增強的意識正在推動市場成長。美國食品藥物管理局)預計在 2023 年查獲價值 40 億美元的假藥,凸顯了對強大檢測解決方案的需求。全球監管機構正在執行更嚴格的品管標準,並鼓勵採用先進技術打擊假藥販運。製藥公司也因假藥面臨巨大的財務損失和聲譽風險,因此增加了對檢測設備的投資,以保護其供應鏈。
技術進步
光譜學和攜帶式設備
技術創新是市場成長的前沿,而光譜設備正是其驅動力。 2023年3月,Invita Healthcare Technologies推出了PharmaDefense,這是一款致力於假藥檢測的開創性解決方案,可增強快速現場檢驗。賽默飛世爾科技的可攜式XRF分析儀、NIR和拉曼光譜儀符合現行良好生產規範(GMP)和21 CFR Part 11標準,可在30秒內現場識別和量化藥物成分。這些儀器提供快速、無損的分析,最大限度地減少對耗時的實驗室檢測的依賴,並確保高品質的檢驗以打擊假藥。
人工智慧和高階成像
人工智慧 (AI) 與先進成像技術的融合正在徹底改變假冒仿冒品的檢測方式。 2023 年 12 月,Nynomic AG 收購了 Art Photonics GmbH,以增強其光纖偵測能力。人工智慧解決方案,例如在韓國國家資訊技術產業振興院的支持下於 2021 年 12 月推出的 Stratio, Inc.影像處理技術,提高了邊境檢查站的準確性。此外,Spectral Engines 於 2023 年發布的 NIRONE® 掃描儀,將近紅外線 (NIR) 技術與雲端連接和先進演算法相結合,為材料分析和假藥檢測提供了承包解決方案。
RFID和區塊鏈
無線射頻識別 (RFID) 和區塊鏈技術正日益獲得支持,以提升供應鏈透明度。 2024 年,受要求原料藥使用QR碼和 RFID 標籤的法規推動,製藥業將擴大採用 RFID 來追蹤假藥。由 Hyperledger Fabric 提供支援的雲端基礎區塊鏈框架能夠安全且透明地追蹤藥品,並透過序列化包裝和智慧合約降低假冒風險。
市場區隔分析
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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