市場調查報告書
商品編碼
1465984
藥物臨床試驗供應和物流市場:按階段、部門、治療領域分類 - 全球預測 2024-2030Clinical Trial Supply & Logistics for Pharmaceutical Market by Phase, Sector, Therapeutic Area - Global Forecast 2024-2030 |
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預計2023年藥品臨床試驗供應及物流市場規模為227.3億美元,2024年達244.8億美元,2030年達383.4億美元,預估複合年成長率為7.75%。
臨床試驗供應鏈是製藥業的一個重要方面,因為它涉及臨床試驗中使用的臨床實驗藥品 (IMP) 的儲存、分銷和監控。臨床試驗物流的主要目標是確保在正確的時間、地點和最佳條件下提供必要的資源,以維持整個臨床試驗過程的品質。臨床試驗供應和物流直接影響成本控制、風險緩解、效率提高和病人安全,在藥物開發專案的整體成功中發揮關鍵作用。促進該行業成長的主要趨勢包括臨床試驗全球化、採用技術主導的解決方案以及製藥公司非核心職能的外包。臨床試驗供應和物流(CTSL)市場的成長受到製藥業不斷增加的研發(R&D)支出的顯著影響。藥物研究和開發對於開發創新藥物和治療方法以改善世界各地的醫療保健結果至關重要。研發投資的持續擴大促進了臨床試驗流程的進步,並導致臨床試驗用品和物流行業的強勁成長。由於藥物開發成本和臨床試驗成本上升,製藥業面臨重大挑戰。這些成本增加對產業的許多方面產生了重大影響,導致製藥公司對臨床試驗供應鏈管理系統的投資減少。近年來,製藥業將臨床試驗活動委託給委外研發機構(CRO)和其他第三方服務供應商的情況顯著增加。這一趨勢是由多種因素推動的,包括降低成本的需求、獲得專業知識以及加快藥物開發過程的願望,大大補充了臨床試驗供應鏈和物流服務的成長。
主要市場統計 | |
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基準年[2023] | 227.3億美元 |
預測年份 [2024] | 244.8億美元 |
預測年份 [2030] | 383.4億美元 |
複合年成長率(%) | 7.75% |
對臨床試驗用品和物流效用的需求推動了 III 期試驗的趨勢
BA/BE 測試著重於高效的供應鏈解決方案,以支持研究藥物和參考藥物的比較,並強調及時供應材料、合規性和監管合規性的需要。涉及小規模隊列評估安全性和藥物動力學的 I 期試驗需要高度靈活和快速的交付解決方案,以適應早期研究的動態性質。第二階段評估較大人群中的藥物療效和副作用,需要複雜的預測、庫存管理和分銷策略,以解決多個臨床實驗地點的複雜性,同時確保合規性。第三階段將進一步擴大規模並監測療效和副作用,需要依靠可擴展、可靠的供應和全球物流知識來有效管理多個地點和國家的試驗。第四階段的重點是核准後監測藥物的長期療效,需要轉向更廣泛的商業分銷管道,同時強調監管合規性和病人安全。
針對不斷擴大治療領域的癌症研究和開發活動,臨床實驗藥物的供應和物流非常效用
藥物臨床試驗供應和物流領域對於推進各個治療領域的治療極為重要。貧血、血友病和鐮狀病等血液疾病強調生物材料的專業處理和低溫運輸物流,以維持臨床實驗藥物的完整性。胃腸道疾病領域,包括發炎性腸道疾病和消化器官系統癌症,需要嚴格遵守生技藥品和個人化藥品的管理監管標準,並且經常需要創新的包裝和溫控運輸解決方案。感染疾病和免疫系統疾病領域涵蓋從愛滋病毒/愛滋病到類風濕性關節炎等自體免疫疾病。針對阿茲海默症和憂鬱症神經和精神疾病的臨床實驗需要仔細規劃來分發敏感的精神活性化合物,通常需要專門的宅配服務。由於癌症研究的增加,癌症研究領域佔據著重要地位,而細胞毒性藥物和生技藥品的處理需要嚴格的風險管理和安全通訊協定,以確保符合國際標準的安全可靠的治療,因此需要輸送系統。
區域洞察
由於採用技術先進的產品、完善的監管機構和大型委外研發機構,美洲在醫藥市場的臨床試驗供應和物流中佔據重要地位。在美國,人們越來越關注學名藥和生技藥品作為傳統藥物的成本效益替代品。由於 FDA核准的非專利藥處方藥在劑量、安全性、強度、品質、性能和預期用途方面與品牌藥相當的需求不斷增加,市場正在見證業務成長。在亞太地區,中國、韓國和印度等新興經濟體正在擴大其技術領域並加強其製藥服務,為供應鏈管理解決方案創造了多個成長機會。相較之下,澳洲、日本和新加坡等國家代表了該地區先進的醫療保健系統。歐洲、中東和非洲製藥市場的臨床試驗供應和物流專注於重組醫療保健和製藥系統,以確保高效的服務交付。歐洲地區代表已開發市場,密切關注已開發市場的技術和醫療保健發展趨勢。歐盟(EU)在製藥業中發揮重要作用,是藥品和藥品的重要貿易國。隨著製造和分銷的全球化,保持臨床實驗和物流的完整性已成為確保藥品和醫療設備。
FPNV定位矩陣
FPNV 定位矩陣對於評估藥物臨床試驗供應和物流市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對藥物臨床試驗供應和物流市場中供應商的現狀進行深入而深入的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。這種詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4. 競爭評估和情報:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況和製造能力進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1. 藥物臨床試驗供應和物流市場的市場規模和預測是多少?
2.在藥物臨床試驗供應和物流市場的預測期內,有哪些產品、細分市場、應用和領域需要考慮投資?
3.藥物臨床試驗供應和物流市場的技術趨勢和法規結構是什麼?
4.藥物臨床試驗供應和物流市場主要供應商的市場佔有率是多少?
5. 進入藥物臨床試驗供應及物流市場的合適型態與策略手段是什麼?
[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?