市场调查报告书
商品编码
1465984
药物临床试验供应和物流市场:按阶段、部门、治疗领域划分 - 全球预测 2024-2030Clinical Trial Supply & Logistics for Pharmaceutical Market by Phase, Sector, Therapeutic Area - Global Forecast 2024-2030 |
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预计2023年药品临床试验供应及物流市场规模为227.3亿美元,2024年达244.8亿美元,2030年达383.4亿美元,预估复合年增长率为7.75%。
临床试验供应链是製药业的一个重要方面,因为它涉及临床试验中使用的临床实验药品 (IMP) 的储存、分销和监控。临床试验物流的主要目标是确保在正确的时间、地点和最佳条件下提供必要的资源,以维持整个临床试验过程的品质。临床试验供应和物流直接影响成本控制、风险缓解、效率提高和病人安全,在药物开发专案的整体成功中发挥关键作用。促进该行业成长的主要趋势包括临床试验全球化、采用技术主导的解决方案以及製药公司非核心职能的外包。临床试验供应和物流(CTSL)市场的成长受到製药业不断增加的研发(R&D)支出的显着影响。药物研究和开发对于开发创新药物和治疗方法以改善世界各地的医疗保健结果至关重要。研发投资的持续扩大促进了临床试验流程的进步,并导致临床试验用品和物流行业的强劲成长。由于药物开发成本和临床试验成本上升,製药业面临重大挑战。这些成本增加对产业的许多方面产生了重大影响,导致製药公司对临床试验供应链管理系统的投资减少。近年来,製药业将临床试验活动委託给委外研发机构(CRO)和其他第三方服务供应商的情况显着增加。这一趋势是由多种因素推动的,包括降低成本的需求、获得专业知识以及加快药物开发过程的愿望,大大补充了临床试验供应链和物流服务的成长。
主要市场统计 | |
---|---|
基准年[2023] | 227.3亿美元 |
预测年份 [2024] | 244.8亿美元 |
预测年份 [2030] | 383.4亿美元 |
复合年增长率(%) | 7.75% |
对临床试验用品和物流效用的需求推动了 III 期试验的趋势
BA/BE 测试着重于高效的供应链解决方案,以支持研究药物和参考药物的比较,并强调及时供应材料、合规性和监管合规性的需要。涉及小规模队列评估安全性和药物动力学的 I 期试验需要高度灵活和快速的交付解决方案,以适应早期研究的动态性质。第二阶段评估较大人群中的药物疗效和副作用,需要复杂的预测、库存管理和分销策略,以解决多个临床实验地点的复杂性,同时确保合规性。第三阶段将进一步扩大规模并监测疗效和副作用,需要依靠可扩展、可靠的供应和全球物流知识来有效管理多个地点和国家的试验。第四阶段的重点是核准后监测药物的长期疗效,需要转向更广泛的商业分销管道,同时强调监管合规性和病人安全。
针对不断扩大治疗领域的癌症研究和开发活动,临床实验药物的供应和物流非常效用
药物临床试验供应和物流领域对于推进各个治疗领域的治疗极为重要。贫血、血友病和镰状病等血液疾病强调生物材料的专业处理和低温运输物流,以维持临床实验药物的完整性。胃肠道疾病领域,包括发炎性肠道疾病和消化器官系统癌症,需要严格遵守生技药品和个人化药品的管理监管标准,并且经常需要创新的包装和温控运输解决方案。感染疾病和免疫系统疾病领域涵盖从爱滋病毒/爱滋病到类风湿性关节炎等自体免疫疾病。针对阿兹海默症和忧郁症神经和精神疾病的临床实验需要仔细规划来分发敏感的精神活性化合物,通常需要专门的宅配服务。由于癌症研究的增加,癌症研究领域占据着重要地位,而细胞毒性药物和生技药品的处理需要严格的风险管理和安全通讯协定,以确保符合国际标准的安全可靠的治疗,因此需要输送系统。
区域洞察
由于采用技术先进的产品、完善的监管机构和大型委外研发机构,美洲在医药市场的临床试验供应和物流中占据重要地位。在美国,人们越来越关注学名药和生技药品作为传统药物的成本效益替代品。由于 FDA核准的非专利药处方药在剂量、安全性、强度、品质、性能和预期用途方面与品牌药相当的需求不断增加,市场正在见证业务成长。在亚太地区,中国、韩国和印度等新兴经济体正在扩大其技术领域并加强其製药服务,为供应链管理解决方案创造了多个成长机会。相较之下,澳洲、日本和新加坡等国家代表了该地区先进的医疗保健系统。欧洲、中东和非洲製药市场的临床试验供应和物流专注于重组医疗保健和製药系统,以确保高效的服务交付。欧洲地区代表已开发市场,密切关注已开发市场的技术和医疗保健发展趋势。欧盟(EU)在製药业中发挥重要作用,是药品和药品的重要贸易国。随着製造和分销的全球化,保持临床实验和物流的完整性已成为确保药品和医疗设备。
FPNV定位矩阵
FPNV 定位矩阵对于评估药物临床试验供应和物流市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对药物临床试验供应和物流市场中供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。这种详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4. 竞争评估和情报:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况和製造能力进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1. 药物临床试验供应和物流市场的市场规模和预测是多少?
2.在药物临床试验供应和物流市场的预测期内,有哪些产品、细分市场、应用和领域需要考虑投资?
3.药物临床试验供应和物流市场的技术趋势和法规结构是什么?
4.药物临床试验供应和物流市场主要供应商的市场占有率是多少?
5. 进入药物临床试验供应及物流市场的合适型态与策略手段是什么?
[195 Pages Report] The Clinical Trial Supply & Logistics for Pharmaceutical Market size was estimated at USD 22.73 billion in 2023 and expected to reach USD 24.48 billion in 2024, at a CAGR 7.75% to reach USD 38.34 billion by 2030.
The clinical trial supply chain is a critical aspect of the pharmaceutical industry, as it involves the storage, distribution, and monitoring of investigational medicinal products (IMPs) used in clinical studies. Clinical trial logistics primarily aim to ensure that the essential resources are available at the right time, place, and under optimal conditions to maintain quality throughout the trial process. Clinical trial supply & logistics plays a vital role in the overall success of drug development programs by directly impacting cost management, risk mitigation, efficiency improvement, and patient safety. Some major trends contributing to this industry growth include the globalization of clinical trials, the adoption of technology-driven solutions, and the outsourcing of non-core functions within pharmaceutical companies. The growth of the clinical trial supply & logistics (CTSL) market has been significantly influenced by the increasing Research and Development (R&D) expenditure in the pharmaceutical sector. Pharmaceutical R&D is vital in developing innovative drugs and therapies that improve healthcare outcomes worldwide. The continuous expansion in R&D investments has propelled advancements in clinical trial processes, leading to robust growth in the clinical trial supply & logistics industry. The pharmaceutical industry has faced significant challenges due to the escalating drug development costs and clinical trials. These increased expenses have substantially impacted various aspects of the industry, leading to reduced investment by pharmaceutical companies in their clinical trial supply chain management systems. In recent years, the pharmaceutical industry substantially increased in outsourcing clinical trial activities to contract research organizations (CROs) and other third-party service providers. Multiple factors drive this trend, including the need for cost reduction, access to specialized expertise, and the demand for faster drug development processes, which has significantly supplemented growth in the clinical trial supply chain and logistics services.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 22.73 billion |
Estimated Year [2024] | USD 24.48 billion |
Forecast Year [2030] | USD 38.34 billion |
CAGR (%) | 7.75% |
Phase: Rising inclination toward Phase III trials owing to the need for exponential utility of clinical trial supply & logistics
In BA/BE studies, the focus is on efficient supply chain solutions that support the comparison of a test drug against a reference, highlighting the necessity for timely availability of materials, compliance, and regulatory adherence. Phase I trials, targeting a small cohort for safety and pharmacokinetics evaluations, demand highly flexible and responsive supply solutions to accommodate the dynamic nature of early-stage research. Phase II expands to assess drug efficacy and side effects in larger groups, necessitating advanced forecasting, inventory management, and distribution strategies to address the complexities of multiple trial sites while ensuring compliance. The scale increases further in Phase III, where the efficacy and monitoring of adverse reactions require scalable, reliable supply and global logistics expertise to manage trials across numerous sites and countries efficiently. Phase IV focuses on the post-approval monitoring of a drug's long-term effectiveness, necessitating a shift towards wider commercial distribution channels yet maintaining a focus on regulatory compliance and patient safety.
Therapeutic Area: Exponential utility of clinical trial supply & logistics to cater to the ever-growing oncology R&D activities
The clinical trial supply and logistics sector for pharmaceuticals is crucial in advancing treatments across various therapeutic areas. For blood disorders such as anemia, hemophilia, and sickle cell disease, the focus is on the specialized handling of biological materials, emphasizing cold chain logistics to uphold the integrity of trial supplies. The segment covering digestive system diseases, including inflammatory bowel and gastrointestinal cancers, demands rigorous adherence to regulatory standards for managing biologics and personalized medicines, frequently requiring innovative packaging and temperature-controlled transport solutions. In the realm of infectious and immune system diseases, spanning from HIV/AIDS to autoimmune disorders such as rheumatoid arthritis. Trials targeting neurological and mental disorders, such as Alzheimer's and depression, necessitate detailed planning for the distribution of sensitive psychoactive compounds, often calling for specialized courier services. The oncology segment, significant due to the growing number of cancer research studies, entails strict risk management and safety protocols for handling cytotoxic agents and biologics, underlining the need for secure delivery systems in line with international standards.
Regional Insights
Americas has endured a significant position in the pharmaceutical market's clinical trial supply & logistics due to the adoption of technologically advanced products, well-established regulatory agencies, and considerable contract research organizations. The United States is increasingly focusing on generics and biologics, both cost-effective alternatives to traditional pharmaceuticals. The market has witnessed an increase in business growth with rising demand for generic prescription drugs that the FDA has approved to be the equivalent of a brand-name drug in dosage, safety, strength, quality, performance, and intended use. Asia-Pacific's expanding technology sector and enhancement in the pharmaceutical services in emerging countries such as China, Korea, and India create several growth opportunities for supply chain management solutions. In contrast, countries such as Australia, Japan, and Singapore represent the developed healthcare systems in the region. EMEA clinical trial supply & logistics for the pharmaceutical market has focused on the re-oriented healthcare and pharmaceutical systems to ensure efficient service delivery. The European region represents the developed market, closely following the developed market's technological and healthcare development trends. The European Union (EU) plays a significant role in the pharmaceutical industry and is a substantial trader in pharmaceuticals and medicinal products. Manufacturing and distribution have also become increasingly globalized, with the maintenance of supply & logistics integrity becoming a high priority for ensuring the safety and quality of drugs and devices, increasing demand for next-generation clinical trial supply & logistics.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Clinical Trial Supply & Logistics for Pharmaceutical Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Clinical Trial Supply & Logistics for Pharmaceutical Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Clinical Trial Supply & Logistics for Pharmaceutical Market, highlighting leading vendors and their innovative profiles. These include Almac Group, AmerisourceBergen Corporation, Bilcare Limited, Biocair International Limited, Catalent, Inc., Clinigen Group PLC, DHL International GmbH by Deutsche Post AG, Eurofins Scientific SE, FedEx Corporation, ICON PLC, Infosys Limited, KLIFO A/S, Lonza Group, Marken, Movianto, N-Side, Parexel International Corporation, PCI Pharma Services, Seveillar Clinical Trial Supplies Pvt. Ltd., SIRO Clinpharm Private Limited, and Thermo Fisher Scientific, Inc..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Clinical Trial Supply & Logistics for Pharmaceutical Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Clinical Trial Supply & Logistics for Pharmaceutical Market?
3. What are the technology trends and regulatory frameworks in the Clinical Trial Supply & Logistics for Pharmaceutical Market?
4. What is the market share of the leading vendors in the Clinical Trial Supply & Logistics for Pharmaceutical Market?
5. Which modes and strategic moves are suitable for entering the Clinical Trial Supply & Logistics for Pharmaceutical Market?