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市場調査レポート
商品コード
1519420
臨床試験用品市場レポート:サービス、フェーズ、治療領域、最終用途産業、地域別、2024~2032年Clinical Trial Supplies Market Report by Services, Phase, Therapeutic Area (Oncology, Cardiovascular Diseases, Respiratory Diseases, Central Nervous System And Mental Disorders, and Others), End-Use Industry, and Region 2024-2032 |
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臨床試験用品市場レポート:サービス、フェーズ、治療領域、最終用途産業、地域別、2024~2032年 |
出版日: 2024年07月01日
発行: IMARC
ページ情報: 英文 140 Pages
納期: 2~3営業日
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世界の臨床試験用品市場規模は2023年に25億米ドルに達しました。今後、IMARC Groupは、市場は2032年までに45億米ドルに達し、2024~2032年の間に6.5%の成長率(CAGR)を示すと予測しています。慢性疾患の増加、厳しい規制改革、臨床試験のグローバリゼーション、バイオテクノロジーの進歩、バイオシミラーや希少医薬品の出現、サプライチェーン管理へのブロックチェーンやIoTのような革新的技術の採用などが市場の成長を加速させています。
臨床試験用品は、新薬、治療法、医療機器の安全性と有効性を評価するために、厳密かつ管理された医療実験を実施するために不可欠な幅広い材料とリソースを包含します。これらは臨床試験を円滑に実施する上で極めて重要であり、治療の実施、データの収集、規制基準の遵守を維持するために必要なツールや物質を研究者に記載しています。臨床試験用品は、治験薬、プラセボ、医療機器、生物学的サンプルから構成されます。その用途は、治療効果を評価するための、ヒトを対象とした新規治療や介入の試験にまで及ぶ。臨床試験用品が適切に管理されることの利点には、試験の盲検化を維持する能力、正確なデータ収集の確保、そして最終的には医療知識の進歩が含まれます。
世界の臨床試験用品市場は、慢性疾患の有病率の増加と革新的な治療法に対する需要の高まりの影響を受けています。さらに、医薬品開発プロセスの合理化を目的とした規制改革やガイドラインが製薬企業に臨床試験への投資を促し、市場の成長をさらに後押ししています。これに伴い、多様な患者集団と費用対効果の高い業務の追求を背景とした臨床試験のグローバリゼーションが、試験供給に対するより大きなニーズを生み出し、市場の成長を加速させています。さらに、バイオテクノロジーと個別化医療の進歩が臨床試験の複雑性を高め、市場成長をさらに後押ししています。これとは別に、バイオシミラーや希少疾病用医薬品の出現が臨床試験の範囲を拡大し、市場の成長を後押ししています。
慢性疾患の増加
がん、糖尿病、心血管障害などの慢性疾患の増加は、世界の臨床試験用品市場の重要なドライバーです。人口の高齢化とライフスタイルの変化により、これらの疾患の有病率は世界中で着実に増加しています。その結果、製薬会社は新薬や治療法の開発を余儀なくされ、臨床試験の急増が必要となっています。この動向は、臨床試験用消耗品の需要を煽るだけでなく、こうした健康課題に対処するための効果的かつ効率的な医薬品開発プロセスの緊急性を強調しています。さらに、腫瘍学や神経学のような慢性疾患の特定の治療セグメントに特化した供給が必要であることも、サプライチェーンの複雑さを助長しており、市場関係者にとって重要な重点セグメントとなっています。
規制改革とガイドライン
世界中の保健当局や機関が発表する規制改革やガイドラインは、臨床試験用品市場を推進する上で極めて重要な役割を果たしています。これらの規制は、患者の安全性を確保しつつ、医薬品開発プロセスを標準化・迅速化することを目的としています。製薬・バイオテクノロジーセグメントの企業は、これらのガイドラインを遵守しなければならず、厳格でコンプライアンスに準拠した臨床試験が必要となります。その結果、規制要件を満たす高品質の供給に対する需要が高まっています。このような背景は、厳格な基準を遵守することの重要性を強調するだけでなく、複雑な規制状況をうまく乗り切るための効率的なサプライチェーン管理と文書化の必要性を強調しています。
臨床試験のグローバリゼーション
臨床試験のグローバリゼーションは、臨床試験用品市場のもう一つの重要な促進要因です。製薬企業は、多様な患者集団へのアクセス、被験者募集の迅速化、コスト削減のため、複数の国で臨床試験を実施する傾向が強まっています。この動向は、患者数が多い新興市場で特に顕著です。その結果、臨床試験用品に対する需要は特定の地域に限定されず、世界的に拡大しています。このため、規制要件が異なることが多い様々な地域での臨床試験を効率的にサポートできる強固なロジスティクスとサプライチェーンネットワークの必要性も浮き彫りになっています。さらに、グローバリゼーションにより、言語、文化、現地のインフラなどの面で適応性が必要となり、サプライチェーン管理プロセスが複雑化しています。
The global clinical trial supplies market size reached US$ 2.5 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 4.5 Billion by 2032, exhibiting a growth rate (CAGR) of 6.5% during 2024-2032. Increasing prevalence of chronic diseases, stringent regulatory reforms, the globalization of clinical trials, advancements in biotechnology, the emergence of biosimilars and orphan drugs, and the adoption of innovative technologies like blockchain and IoT for supply chain management are accelerating the market growth.
Clinical trial supplies encompass a wide range of materials and resources essential for conducting rigorous and controlled medical experiments to evaluate the safety and efficacy of new drugs, therapies, or medical devices. They are crucial in ensuring the smooth execution of clinical trials, providing researchers with the necessary tools and substances to administer treatments, collect data, and maintain compliance with regulatory standards. Clinical trial supplies consist of investigational drugs, placebos, medical devices, and biological samples. Their uses extend to the testing of novel treatments and interventions on human subjects to assess their therapeutic effects. Advantages of well-managed clinical trial supplies include the ability to maintain trial blinding, ensuring accurate data collection, and ultimately advancing medical knowledge.
The global clinical trial supplies market is influenced by the increasing prevalence of chronic diseases and the growing demand for innovative therapies. Moreover, regulatory reforms and guidelines aimed at streamlining the drug development process have prompted pharmaceutical companies to invest more in clinical trials, further propelling the market growth. In line with this, the globalization of clinical trials, driven by the pursuit of diverse patient populations and cost-effective operations, has created a greater need for trial supplies, which, in turn, is accelerating the market growth. Additionally, advancements in biotechnology and personalized medicine are increasing the complexity of clinical trials, further boosting the market growth. Apart from this, the emergence of biosimilars and orphan drugs has expanded the scope of clinical trials, which is fueling the market growth.
Increasing prevalence of chronic diseases
The rise in chronic diseases, such as cancer, diabetes, and cardiovascular disorders, is a significant driver of the global clinical trial supplies market. With an aging population and shifting lifestyle patterns, the prevalence of these conditions is steadily increasing worldwide. As a result, pharmaceutical companies are compelled to develop new drugs and therapies, necessitating an upsurge in clinical trials. This trend not only fuels the demand for clinical trial supplies but also underscores the urgency for effective and efficient drug development processes to address these health challenges. Furthermore, the need for specialized supplies for specific therapeutic areas within chronic diseases, like oncology or neurology, contributes to the complexity of the supply chain, making it a critical focus area for market players.
Regulatory reforms and guidelines
Regulatory reforms and guidelines issued by health authorities and agencies worldwide play a pivotal role in driving the clinical trial supplies market. These regulations aim to standardize and expedite the drug development process while ensuring patient safety. Companies operating in the pharmaceutical and biotechnology sectors must adhere to these guidelines, necessitating rigorous and compliant clinical trials. As a result, there is a growing demand for high-quality supplies to meet regulatory requirements. This driver not only underscores the importance of adherence to strict standards but also emphasizes the need for efficient supply chain management and documentation to navigate the complex regulatory landscape successfully.
Globalization of clinical trials
The globalization of clinical trials represents another key driver of the clinical trial supplies market. Pharmaceutical companies are increasingly conducting trials in multiple countries to access diverse patient populations, expedite recruitment, and reduce costs. This trend is especially pronounced in emerging markets with significant patient pools. Consequently, the demand for clinical trial supplies is not limited to a specific region but has expanded globally. This driver also highlights the need for robust logistics and supply chain networks that can efficiently support trials conducted in various geographical locations, often with differing regulatory requirements. Furthermore, globalization necessitates adaptability in terms of language, culture, and local infrastructure, adding complexity to the supply chain management process.
IMARC Group provides an analysis of the key trends in each segment of the global clinical trial supplies market report, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on services, phase, therapeutic area, and end-use industry.
Product Manufacturing
Packaging, Labeling and Storage
Logistics and Distribution
Logistics and distribution dominates the market
A detailed breakup and analysis of the market based on the services has also been provided in the report. This includes product manufacturing, packaging, labeling and storage, and logistics and distribution. According to the report, logistics and distribution represented the largest segment.
The logistics and distribution segment within the clinical trial supplies market is witnessing substantial growth due to the increasing globalization of clinical trials. As pharmaceutical companies expand their trials to diverse geographic locations, the need for efficient and reliable logistics and distribution networks becomes paramount. This includes ensuring timely delivery of supplies to various trial sites worldwide. Moreover, advancements in technology, such as the integration of blockchain and IoT, are revolutionizing supply chain management. These innovations enhance real-time tracking and monitoring of clinical trial supplies, leading to increased efficiency and reduced wastage. In line with this, the COVID-19 pandemic has underscored the importance of resilient and adaptable supply chains. Companies are now investing in robust logistics to ensure the uninterrupted flow of critical supplies, even in times of crisis. Furthermore, the emphasis on patient-centric approaches in clinical trials has led to the need for patient kits and direct-to-patient shipments. This trend requires specialized logistics solutions tailored to individual patient needs.
Phase I
Phase II
Phase III
Others
Phase III dominates the market
The report has provided a detailed breakup and analysis of the market based on the phase. This includes phase I, phase II, phase III, and others. According to the report, phase III represented the largest segment.
The phase III segment dominates the market as it represents the pivotal stage in evaluating a drug's efficacy and safety, making it a critical step in the regulatory approval process. This regulatory focus drives pharmaceutical companies to invest significantly in phase III trials. Moreover, as drugs progress through earlier phases, the sample size required for phase III trials increases substantially, translating into higher demand for clinical trial supplies. Additionally, phase III trials often involve a global patient population, necessitating comprehensive supply chain logistics to ensure the timely delivery of materials to diverse sites. In line with this, the increasing complexity of drug development, particularly in areas like oncology and rare diseases, necessitates larger and more complex phase III trials. This complexity includes the need for specialized supplies, patient-centric approaches, and adaptive trial designs. Furthermore, the demand for phase III trials is influenced by market dynamics, including competition and the need for differentiation in therapeutic areas. Companies seek to demonstrate superior efficacy and safety profiles, making phase III trials a pivotal stage in their product development strategies.
Oncology
Cardiovascular Diseases
Respiratory Diseases
Central Nervous System (CNS) And Mental Disorders
Others
Oncology dominates the market
A detailed breakup and analysis of the market based on the therapeutic area has also been provided in the report. This includes oncology, cardiovascular diseases, respiratory diseases, central nervous system (CNS) and mental disorders, and others. According to the report, oncology represented the largest segment.
The oncology segment is experiencing significant growth within the clinical trial supplies market, primarily driven by the escalating global incidence of cancer. With cancer being one of the leading causes of mortality worldwide, pharmaceutical companies are increasingly investing in oncology-focused clinical trials to develop novel therapies and treatments. Moreover, advances in cancer research and the identification of specific biomarkers have led to the development of targeted therapies. This trend has necessitated the need for specialized clinical trial supplies tailored to the unique requirements of oncology trials, such as precision medicine tools and specialized diagnostics. Furthermore, regulatory agencies are expediting approvals for promising oncology drugs, encouraging pharmaceutical companies to accelerate their research efforts. Consequently, there is a growing demand for clinical trial supplies to support these fast-paced trials. Besides this, collaborations between pharmaceutical firms and academic institutions or research organizations are fostering innovation in oncology research. This partnership-driven approach is increasing the scope and complexity of clinical trials, thereby boosting the demand for clinical trial supplies.
Medical Device Industry
Biopharmaceuticals Industry
Pharmaceuticals Industry
Others
Pharmaceuticals industry hold the largest share in the market
A detailed breakup and analysis of the market based on the end-use industry has also been provided in the report. This includes medical device industry, biopharmaceuticals industry, pharmaceuticals industry, and others. According to the report, pharmaceuticals industry represented the largest segment.
The pharmaceuticals segment is experiencing substantial growth driven by the increasing global burden of chronic diseases, including cancer, cardiovascular ailments, and diabetes, which has led to a heightened demand for innovative drugs and therapies. Moreover, regulatory reforms and evolving healthcare policies are shaping the industry landscape. Stringent regulations and guidelines, particularly in developed markets, necessitate compliance and adherence to safety standards. This environment promotes innovation and the development of high-quality pharmaceutical products. Furthermore, advancements in biotechnology and genomics have ushered in an era of precision medicine. Tailoring treatments to individual patient profiles is becoming more common, driving research and development efforts in the pharmaceutical sector. Apart from this, the emergence of biosimilars and orphan drugs is expanding the pharmaceutical market's scope. Biosimilars offer cost-effective alternatives to biologics, while orphan drugs target rare diseases, presenting lucrative opportunities for pharmaceutical companies.
North America
United States
Canada
Asia Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America exhibits a clear dominance, accounting for the largest clinical trial supplies market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represented the largest segment.
North America's clinical trial supplies market is witnessing substantial growth, fueled by the region's well-established pharmaceutical and biotechnology sector, coupled with a robust healthcare infrastructure, creates a conducive environment for clinical trials. Moreover, regulatory agencies like the FDA in the United States have streamlined approval processes, encouraging pharmaceutical companies to conduct trials in the region. In line with this, North America's diverse patient populations and access to specialized healthcare facilities make it an attractive destination for clinical trials across various therapeutic areas. Furthermore, the increasing prevalence of chronic diseases, such as diabetes and cancer, drives the demand for clinical trials to develop innovative treatments. Additionally, the emergence of cutting-edge technologies like genomics and precision medicine is propelling North America's position as a hub for advanced clinical research. The pandemic's impact has also accelerated the adoption of virtual and decentralized trials in the region, further contributing to market growth.
The competitive landscape of the clinical trial supplies market is characterized by a dynamic interplay of various stakeholders, each contributing to the industry's growth and evolution. Service providers in this sector offer a wide range of solutions, including clinical packaging, labeling, distribution, and logistics services, making it a highly specialized and competitive field. Key players in the market differentiate themselves through their global reach, technological capabilities, regulatory compliance, and ability to cater to diverse therapeutic areas. These companies often form strategic partnerships with pharmaceutical and biotechnology firms to provide end-to-end solutions for clinical trials. In addition to established companies, the market also sees the emergence of niche players focusing on specific areas such as direct-to-patient services, temperature-sensitive logistics, and innovative supply chain technologies. These specialized firms cater to the evolving needs of the industry, offering unique solutions to enhance efficiency and cost-effectiveness. Moreover, the market's competitive landscape is influenced by regulatory changes, as compliance with stringent standards is imperative. This factor underscores the importance of choosing suppliers with a proven track record in maintaining the highest quality and compliance levels.
Almac Group Ltd.
Catalent Pharma Solutions Inc.
DHL
Parexel
Thermo Fisher Scientific Inc.
PCI Services
Sharp Clinical
Biocair
Movianto
In September 2023, Parexel and Partex have inked a deal aiming to leverage artificial intelligence (AI)-powered solutions to accelerate drug discovery and development for biopharmaceutical customers worldwide and de-risk the assets in their portfolios.
In September 2023, DHL Express commenced the full-fledged operation of Incheon Gateway after it invested €131 million to expand the Gateway in 2019. The investment is DHL Express's largest in South Korea to date, making Incheon Gateway the largest gateway in the Asia Pacific.
In June 2021, Catalent announced that it has expanded its integrated development, manufacturing and supply solution, OneBio(R) Suite, across a range of biologic modalities, including antibody and recombinant proteins, cell and gene therapies, and mRNA.