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市場調査レポート
商品コード
1629905
医薬品コールドチェーン物流の世界市場-2025~2033年Global Pharmaceutical Cold Chain Logistics Market - 2025-2033 |
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カスタマイズ可能
適宜更新あり
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医薬品コールドチェーン物流の世界市場-2025~2033年 |
出版日: 2024年12月30日
発行: DataM Intelligence
ページ情報: 英文 179 Pages
納期: 即日から翌営業日
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医薬品コールドチェーン物流の世界市場は、2024年に186億米ドルに達し、2033年には271億米ドルに達すると予測され、予測期間2025~2033年のCAGRは4.3%で成長する見込みです。
医薬品コールドチェーン物流とは、ワクチン、生物製剤、その他の医薬品など、サプライチェーン全体を通じて有効性と安全性を維持するために厳密な温度管理を必要とする、温度に敏感な医薬品を管理、保管、輸送する専門的なプロセスを指します。医薬品コールドチェーン物流では、製造からエンドユーザーへの最終配送まで、温度に敏感な医薬品のライフサイクル全体を管理します。この物流システムには、温度管理された保管、輸送、包装、リアルタイムのモニタリング、追跡などが含まれます。
過去10年間、医薬品コールドチェーン物流は急速な技術革新と成長を遂げてきました。生物製剤やその他の温度に敏感な医薬品の需要の増加により、信頼性の高い温度管理された物流システムの必要性が高まっています。例えば、米国国立衛生研究所によると、近年、生物製剤が承認された医薬品全体の30%未満を占めています。2000年代初頭には、コールドチェーン物流に特化した取り組みが台頭し、業界の専門家による意識向上とベストプラクティスの標準化のための共同作業が推進されました。
促進要因と阻害要因
コールドチェーン技術の進歩
コールドチェーン技術の進歩の高まりは、医薬品コールドチェーン物流市場の成長を大きく後押ししており、予測期間中も市場を牽引していくと予想されます。IoT対応ソリューションは、輸送や保管中の環境条件をリアルタイムで監視することで、コールドチェーン物流に革命をもたらしています。これらのシステムは、センサーを使用して温度、湿度、その他の条件を継続的に追跡し、逸脱があれば物流プロバイダーに警告を発します。これにより、医薬品、特に温度変化に敏感なワクチンや生物製剤の完全性が保証されます。
例えば、Sensitechは2024年2月、ライフサイエンス業界と物流組織向けに特化した革新的なIoT温度監視ソリューション、TempTale GEO Xを発表しました。この最先端ソリューションは、航空、海上、道路、鉄道など様々な輸送手段で世界的に輸送される、温度に敏感な医薬品やワクチンのリアルタイムモニタリングと分析を提供するように設計されています。TempTale GEO Xは、医薬品サプライチェーンにおけるコールドチェーンのコンプライアンス、サプライチェーンの効率、持続可能性の成果を強化する上で、大きな前進を意味します。
さらに2022年9月、画期的なスマートセンシングソリューションを通じてIoTの未来を加速する新興企業、CubeWorksは、コールドチェーン物流向けの次世代可視化ソリューション、CubiSens XT1を発表しました。XT1は、バイオ医薬品製品のライフサイクル全体の温度コンプライアンスと品質保証のための製品レベルのモニタリングを可能にする、この種のものとしては初の温度トラッカーです。直径わずか16mmのCubiSens XT1は、従来のデータロガーよりも100倍小さく、温度監視が必要な個々の製品に装着できるほど小さいです。
自動化システムは、温度に敏感な医薬品の選別、取り扱い、保管のためのコールドチェーン物流に統合されつつあります。これらの技術は、人為的ミスのリスクを減らし、効率を高め、GDP規制へのコンプライアンスを向上させます。例えば、2024年6月、積極的なサプライチェーンのリスク管理とインテリジェンスの世界的リーダーであるOverhaulは、最先端のコールドチェーン品質ソリューションを発表しました。この革新的なソフトウェアソリューションは、時間や温度に敏感な貨物の比類のないリスクと品質管理を実現し、医薬品、ヘルスケア、高価値食品・飲料セクターのサプライチェーン全体を通じて最適な状態を保証します。
規制上の課題
規制上の課題は、医薬品コールドチェーン物流市場の成長にとって大きな障壁となっています。適正流通規範(GDP)や適正製造規範(GMP)のような厳しい規制は、保管や輸送中の適切な温度管理の維持など、高レベルのコンプライアンスを要求します。これらの基準は、専門的な設備、施設、人員を必要とするため、実施と維持に費用がかかります。
例えば、FDAのGDPガイドラインは、医薬品の温度管理された出荷の厳格な文書化とモニタリングを義務付けています。これらのガイドラインを遵守するには、テクノロジーとインフラに多額の投資が必要であり、中小の物流プロバイダーにとっては障壁となり得ます。
地域によって規制要件は異なります。米国では、主に適正流通規範(GDP)と現行の適正製造規範(cGMP)を通じて、FDAがコールドチェーン管理に関する包括的なガイドラインを提供しています。これらの規制は、医薬品が安全性、有効性、品質を維持するために適切な条件下で保管、取り扱い、輸送されることを保証するものです。欧州医薬品庁(EMA)は、EU域内の医薬品流通に関する厳格なコールドチェーン要件を定めています。この一貫性のなさが、特に世界な事業展開における物流管理を複雑にしています。
規制機関は、医薬品を損傷させるような温度逸脱などのコンプライアンス違反に対して、企業に重い罰金や制裁金を課しています。これらの罰則は、金銭的損失や風評被害につながる厳しいものです。例えば、誤った温度管理が原因で製品が回収された場合、企業は売上損失、訴訟費用、ブランド名へのダメージで数百万米ドルの損失を被る可能性があります。
The global pharmaceutical cold chain logistics market reached US$ 18.6 billion in 2024 and is expected to reach US$ 27.1 billion by 2033, growing at a CAGR of 4.3% during the forecast period 2025-2033.
Pharmaceutical cold chain logistics refers to the specialized process of managing, storing and transporting temperature-sensitive pharmaceutical products such as vaccines, biologics and other medicinal products that require strict temperature controls to maintain their efficacy and safety throughout the supply chain. Pharmaceutical cold chain logistics involves the management of the entire lifecycle of temperature-sensitive pharmaceutical products from manufacturing through to the final delivery to the end-user. This logistics system includes temperature-controlled storage, transportation, packaging, real-time monitoring and tracking.
In the past decade, pharmaceutical cold chain logistics has experienced rapid innovation and growth. The increasing demand for biologics and other temperature-sensitive medicines has heightened the need for reliable, temperature-controlled distribution systems. For instance, according to the National Institute of Health, in recent years, biologics have accounted for less than 30% of the total drugs approved. In the early 2000s, a specialized focus on cold chain logistics emerged, driven by a collaborative effort among industry experts to promote awareness and standardize best practices.
Market Dynamics: Drivers & Restraints
Rising advancements in cold chain technology
The rising advancements in cold chain technology are significantly driving the growth of the Pharmaceutical Cold Chain Logistics market and are expected to drive the market over the forecast period. IoT-enabled solutions have revolutionized cold chain logistics by providing real-time monitoring of environmental conditions during transport and storage. These systems use sensors to continuously track temperature, humidity, and other conditions, alerting logistics providers to any deviations. This ensures the integrity of pharmaceutical products, especially vaccines and biologics, which are sensitive to temperature changes.
For instance, in February 2024, Sensitech introduced TempTale GEO X, an innovative IoT temperature monitoring solution tailored specifically for the life sciences industry and logistics organizations. This cutting-edge solution is designed to deliver real-time monitoring and analytics for temperature-sensitive medicines and vaccines transported globally across various modes of transportation, including air, ocean, road, and rail. TempTale GEO X represents a significant step forward in enhancing cold chain compliance, supply chain efficiency, and sustainability outcomes in the pharmaceutical supply chain.
Additionally, in September 2022, CubeWorks, a startup company accelerating the future of IoT through breakthrough smart sensing solutions, introduced the next-generation visibility solution for cold chain logistics with the CubiSens XT1. The XT1 is the first temperature tracker of its kind that enables product-level monitoring of biopharma products for temperature compliance and quality assurance for the entire lifecycle. Measuring a mere 16 mm in diameter, the CubiSens XT1 is 100x smaller than conventional data loggers, small enough to fit on any individual product that requires temperature monitoring.
Automated systems are being integrated into cold chain logistics for sorting, handling, and storing temperature-sensitive pharmaceuticals. These technologies reduce the risk of human error, enhance efficiency, and improve compliance with GDP regulations. For instance, in June 2024, Overhaul, a global leader in active supply chain risk management and intelligence, launched its cutting-edge Cold Chain Quality Solution. This innovative software solution delivers unparalleled risk and quality management for time and temperature-sensitive cargo, ensuring optimal conditions throughout the supply chain for the pharmaceutical, healthcare and high-value food and beverage sectors.
Regulatory challenges
Regulatory challenges are a significant barrier to the growth of the pharmaceutical cold chain logistics market. Stringent regulations such as Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) require high levels of compliance, which includes maintaining proper temperature controls during storage and transportation. These standards are expensive to implement and maintain due to the need for specialized equipment, facilities, and personnel.
For instance, the FDA's GDP guidelines mandate strict documentation and monitoring of temperature-controlled shipments for pharmaceuticals. Compliance with these guidelines requires significant investments in technology and infrastructure, which can be a barrier for smaller logistics providers.
Different regions have different regulatory requirements. In the United States, the FDA provides comprehensive guidelines for cold chain management, primarily through the Good Distribution Practices (GDP) and current Good Manufacturing Practices (cGMP). These regulations ensure that pharmaceutical products are stored, handled, and transported under appropriate conditions to maintain their safety, efficacy, and quality. The European Medicines Agency (EMA) sets out strict cold chain requirements for pharmaceutical distribution within the European Union. This inconsistency complicates logistics management, especially for global operations.
Regulatory bodies impose heavy fines and sanctions on companies for non-compliance, such as temperature excursions that damage pharmaceutical products. These penalties can be severe, leading to financial losses and reputational damage. For instance, a product recall due to temperature mishandling could cost a company millions in lost sales, legal fees, and damage to its brand reputation.
The global pharmaceutical cold chain logistics market is segmented based on product type, service type, temperature range, mode of delivery, end-user and region.
The cryogenic segment is expected to dominate the pharmaceutical cold chain logistics market share
The demand for Cryogenic conditions (temperatures typically below -150°C) is usually high as these are essential for transporting and storing advanced biopharmaceutical products such as mRNA vaccines, gene therapies and CAR-T cell therapies. These products are highly sensitive to temperature variations, necessitating ultra-low temperature logistics to maintain their stability and efficacy.
For instance, in April 2024, CSafe launched three new technologies building on its portfolio of solutions integrating real-time data tracking to ensure maximum visibility throughout the shipping journey. CSafe's Multi-Use Dewars, the first in the CGT Cryo Series, are designed to serve the growing cell and gene therapy market. These cryogenic, reusable dewars maintain the coldest temperature range of -150°C or colder. This technology uses liquid nitrogen dry vapor units and includes a built-in TracSafe RLT real-time data tracking device.
Technological advancements have made cryogenic logistics more efficient and reliable. The development of advanced cryogenic packaging solutions, including passive cooling technologies like phase change materials and insulated containers, has improved the ability to maintain ultra-low temperatures for longer periods, especially during transit.
North America is expected to hold a significant position in the Pharmaceutical Cold Chain Logistics market share
North America, particularly the United States and Canada, boasts a highly developed healthcare system with a significant demand for biologics, vaccines and temperature-sensitive pharmaceuticals. The region's advanced cold chain infrastructure, including a vast network of refrigerated warehouses and transportation facilities, ensures that products remain stable from manufacturer to patient.
For instance, in six years, NewCold has gone from zero to three of the most advanced temperature-controlled warehouses in the United States, with a fourth set to become operational in mid-2024. January 18, 2024 marks six years since the first pallet was received in 2018. At the time of its founding, NewCold Tacoma was considered one of the most energy-efficient and technologically advanced North American automated warehouses in the United States.
North America leads globally in the demand for biopharmaceuticals such as vaccines, biologics, and advanced therapies. This demand drives the growth of the cold chain logistics market as these products require ultra-low temperatures during transit and storage. For instance, according to the National Institute of Health (NIH), U.S. vaccine sales are estimated to be about $1.5 billion per year.
North America is a hub for cold chain technology innovation. The region is at the forefront of developing advanced logistics technologies such as IoT-enabled real-time temperature monitoring, automated warehouses, and cryogenic packaging solutions. These advancements enhance the efficiency and reliability of cold chain logistics.
For instance, Sensitech introduced TempTale GEO X, an innovative IoT temperature monitoring solution tailored specifically for the life sciences industry and logistics organizations. This cutting-edge solution is designed to deliver real-time monitoring and analytics for temperature-sensitive medicines and vaccines transported globally across various modes of transportation, including air, ocean, road, and rail. TempTale GEO X represents a significant step forward in enhancing cold chain compliance, supply chain efficiency, and sustainability outcomes in the pharmaceutical supply chain.
Asia-Pacific is growing at the fastest pace in the Pharmaceutical Cold Chain Logistics market
The Asia-Pacific region is rapidly improving its cold chain logistics infrastructure, with investments in refrigerated warehouses, transportation networks, and technology upgrades such as real-time monitoring systems. Countries like China and India are particularly active in expanding their cold chain networks to support the growing demand for temperature-sensitive pharmaceuticals.
For instance, in October 2024, UPS launched its specialized healthcare-focused cross-docking facility in Hyderabad. The facility is designed as a pharma-grade facility and comes with global freight forwarding capabilities. Providing an additional layer of security for temperature-controlled pharmaceutical shipments, it can hold or sort 15 pallets at +15°C to +25°C, 7 Pallets at +2 to +8°C and 50 pallets under uncontrolled ambient conditions. This enables pharma companies to distribute their products more efficiently, eliminating the need for prolonged warehouse storage.
The major global players in the pharmaceutical cold chain logistics market include Cardinal Health, AmerisourceBergen Corporation, Envirotainer AB, FedEx, United Parcel Service of America, Inc., Thermo King, Sonoco ThermoSafe, B Medical Systems India Private Limited, DoKaSch TEMPERATURE SOLUTIONS GmbH, Nordic Cold Chain Solutions and among others.
The Growth and Future of Pharmaceutical Cold Chain Logistics
The global pharmaceutical cold chain logistics market report delivers a detailed analysis with 62 key tables, more than 52 visually impactful figures, and 179 pages of expert insights, providing a complete view of the market landscape.
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