市場調查報告書
商品編碼
1470514
臨床試驗市場:按設計、階段和適應症分類 - 2024-2030 年全球預測Clinical Trials Market by Design (Interventional Study, Observational Study), Phase (Phase I, Phase II, Phase III), Indication - Global Forecast 2024-2030 |
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預計2023年臨床試驗市場規模為383億美元,預計2024年將達417.8億美元,2030年將達到707.8億美元,複合年成長率為9.16%。
臨床試驗是一項研究活動,旨在調查新的測試和治療方法並評估其對健康的影響。它允許人們參與醫療干預措施的測試,包括藥物、細胞和其他生物產品、外科手術、放射治療、設備、行為療法和預防性醫療保健。對慢性病和感染疾病的擔憂使得學名藥和生物製藥的開發和商業化受到重視,從而增加了對臨床試驗的需求。製藥和生物技術行業對藥物開發活動的日益關注以及研發支出的增加正在推動對臨床試驗的需求。然而,與臨床試驗活動相關的高成本和嚴格的政府法規減緩了藥物開發和研究活動。公司專注於降低成本,同時提供創新的調查方法。此外,全球對藥物開發的關注和向以患者為中心的臨床試驗的轉變、臨床試驗全球化的迅速發展以及監管協調性和透明度的提高正在推動創新並改善患者的健康和福祉。
主要市場統計 | |
---|---|
基準年[2023] | 383億美元 |
預測年份 [2024] | 417.8億美元 |
預測年份 [2030] | 707.8億美元 |
複合年成長率(%) | 9.16% |
設計 介入性和觀察性臨床試驗設計對於最佳化治療效果、風險和安全性評估的重要性
介入性研究和觀察性研究是 KEYWORD 的兩種不同的研究方法,它們具有不同的目的來推進醫學知識。在介入研究中,研究人員為參與者分配特定的治療或介入措施,例如適應試驗、非隨機對照試驗或隨機對照試驗,並評估對健康結果的影響。此外,觀察性研究允許研究人員在不干擾受試者護理的情況下觀察受試者,並檢查橫斷面活動、對照和生態學研究等暴露之間的關聯。儘管干預研究由於其受控環境而提供了更高程度的證據,但它們可能昂貴、耗時且在倫理上受到限制。另一方面,觀察性研究反映了現實世界的情況,因此提供了更具普遍性的結果,但由於不受控制的混雜因素而更容易出現偏差。
階段:臨床試驗監測藥物代謝和收集初始資料的階段。
臨床試驗對於新治療方法、藥物和設備的開發和核准至關重要。這些臨床試驗由多個階段組成,並遵循規範的流程,以確保安全性、有效性以及適當的劑量和給藥。 II 期試驗透過確定藥物或治療方法對患有特定疾病的患者是否具有治療效果來評估藥物或治療方法的有效性。 III 期試驗(臨床試驗)是對數百至數千人的不同族群進行的大規模試驗。此階段的目的是在不同環境和地點的更廣泛患者群體中確認治療的安全性和有效性。 IV期試驗(臨床試驗)是在藥物獲得監管機構核准並投放市場後進行的。這些試驗旨在監測更多人群的長期安全性和有效性,同時繼續評估藥物的副作用和潛在的新用途。
適應症:針對慢性病、心血管疾病和其他有害疾病提出適當治療方法和藥物的一些適應症
臨床試驗廣泛描述疾病和狀況,並協助研究人員進行藥物、手術和治療。自體免疫臨床試驗為涉及慢性和有害發炎的疾病提供了參考。本研究旨在確定患者和健康個體自體免疫疾病和發炎疾病的生物標記。心血管疼痛臨床試驗揭示了調節心房-心室(AV)和心室間(VV)時間延遲對運動期間心臟血流動力學的影響。中樞神經系統臨床試驗檢查來自接受過各種手術(包括腦炎和脊髓炎)的受試者的配對血清和腦脊髓液樣本,以調查疑似感染或發炎的具體途徑。此外,人類疾病、糖尿病和腫瘤學方面的臨床試驗有助於研究人員了解患者的免疫系統對疾病的反應,並有助於預防疾病和改善治療方法。
區域洞察
由於癌症診斷和心血管疾病的需求不斷增加,美洲臨床試驗的擴展得到了顯著改善。許多監管機構,例如美國食品藥物管理局(FDA) 和國家衛生管理局 (ANVISA),建立了藥物開發的法規結構並確保所進行的臨床試驗的品質。在墨西哥、阿根廷和巴西等新興國家,政府正在進行大量投資,鼓勵研發和技術進步,以支持醫療保健基礎設施的發展。由於中國、印度、韓國、台灣、印尼和越南等國家製藥業的發展,亞太臨床試驗市場正在快速成長。近年來,澳洲和紐西蘭對生物技術和製藥產業的投資有所增加,並且作為新興經濟體,臨床試驗活動顯著成長。由於擁有大量的製藥和生物技術公司,歐洲長期以來一直被認為是全球臨床試驗的戰場。歐盟 (EU) 制定了在其成員國內進行臨床試驗的既定框架,以確保臨床實驗藥物的安全性、有效性和品質。
FPNV定位矩陣
FPNV定位矩陣對於評估臨床試驗市場至關重要。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,可以對臨床試驗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.臨床試驗市場的市場規模與預測是多少?
2.臨床試驗市場預測期內需要考慮投資的產品、細分市場、應用和領域有哪些?
3.臨床試驗市場的技術趨勢和法規結構是什麼?
4.臨床試驗市場主要廠商的市場佔有率為何?
5. 進入臨床試驗市場的合適型態或策略手段是什麼?
[184 Pages Report] The Clinical Trials Market size was estimated at USD 38.30 billion in 2023 and expected to reach USD 41.78 billion in 2024, at a CAGR 9.16% to reach USD 70.78 billion by 2030.
Clinical trials are research activities that study new tests and treatments and evaluate effects on human health outcomes. It allows people to participate in testing medical interventions, including drugs, cells, other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, and preventive care. The increased focus on developing and commercializing generics and biologics due to concerns related to chronic and infectious diseases increases demand for clinical trials. The growing emphasis on drug development activities and rising research and development expenditure from the pharmaceutical and biotechnology industry enhances the demand for clinical trials. However, the significant cost associated with clinical trial activities and stringent government regulations slow down drug development and research activities. Companies are focusing on cutting a cost alongside providing innovative research methodologies. Moreover, the worldwide focus on drug development and shift towards patient-centric clinical trials alongside rapidly improving globalization of clinical trials and greater regulatory harmonization and transparency promote innovation and better patient health and welfare.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 38.30 billion |
Estimated Year [2024] | USD 41.78 billion |
Forecast Year [2030] | USD 70.78 billion |
CAGR (%) | 9.16% |
Design: Importance of interventional and observational clinical trial design to optimize assessment of treatment efficacy, risk, and safety
Interventional and observational studies are two distinct research approaches in clinical trials, serving different purposes in advancing medical knowledge. Interventional studies involve researchers assigning participants to specific treatments and interventions such as adaptive clinical trials, non-randomized control trials, and randomized control trials to assess their effects on health outcomes. Additionally, observational studies involve researchers observing subjects without interfering in their care to examine associations between exposures, including cross-sectional activities, control, and ecological study. Interventional studies provide higher levels of evidence due to their controlled settings but can be expensive, time-consuming, and ethically limited. On the other hand, observational studies offer more generalizable results since they reflect real-world conditions but are prone to biases from uncontrolled confounding factors.
Phase: clinical trial phases in for monitoring drug metabolism and gathering initial data
Clinical trials are essential in developing and approving new medical treatments, drugs, and devices. These trials follow a structured and regulated process with different phases ensuring safety, efficacy, and appropriate dosage. In Phase II, researchers evaluate effectiveness by determining whether or not the drug or treatment produces therapeutic benefits in patients with specific medical conditions. Phase III clinical trials are large-scale studies conducted on a diverse population ranging from several hundred to several thousand participants. This phase aims to confirm the safety and efficacy of a treatment in a broader patient population under different settings and locations. Phase IV clinical trials occur after a drug has been approved by regulatory authorities and released into the market. These trials aim to monitor long-term safety and effectiveness in a larger population while continuing to evaluate the drug's side effects and potential new uses.
Indication: Several indications suggesting suitable treatments and medications for chronic, cardiovascular, and other harmful diseases
Clinical trials widely indicate a disease or symptom and help researchers with medication, procedure, and treatment. Clinical trials of Autoimmune help learn more about conditions with chronic and harmful inflammation. This study aims to identify biomarkers in people with autoimmune or inflammatory diseases and healthy people. Clinical trial in cardiovascular pain helps to determine the results of adjusting atrial-ventricular (AV) and interventricular (VV) timing delays on cardiac hemodynamics during exercise. Clinical trials in CNS examine paired serum and cerebrospinal fluid samples from subjects with various procedures, including encephalitis and myelitis, to investigate specific pathways of suspected infection and inflammation. In addition, clinical trials involved in the human condition, diabetes, and oncology help researchers understand the patient's immune system response to a disease and work to prevent it and improve its treatment.
Regional Insights
The growing expansion of clinical trials in the Americas significantly improved due to the increasing need for cancer diagnostic and cardiovascular diseases. Many regulatory organizations, such as the United States Food and Drug Administration (FDA) and the National Health Surveillance Agency (ANVISA), establish regulatory frameworks for drug development to ensure the quality of clinical trials conducted. In developing countries such as Mexico, Argentina, and Brazil, governments are making considerable investments to encourage research and technological advancements to boost the development of medical & healthcare infrastructure. The Asia-Pacific region's clinical trial market is growing rapidly due to its evolving pharmaceutical industry in some countries, including China, India, South Korea, Taiwan, Indonesia, and Vietnam. In recent years, the growing investments in biotechnology and pharmaceutical industries in Australia and New Zealand have shown significant growth in clinical trial activities due to their emerging economies. Europe has been considered a rampart place for the global clinical trial due to the presence of numerous pharmaceutical and biotechnology companies. The European Union (EU) has a well-established framework for conducting clinical trials across its member states that ensures the safety, efficacy, and quality of investigational medicinal products.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Clinical Trials 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 Trials 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 Trials Market, highlighting leading vendors and their innovative profiles. These include Accell Clinical Research, LLC, Atlant Clinical Ltd., Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., Bristol-Myers Squibb Company, Charles River Laboratories International, Inc., Clinipace, Congenix LLP, Eli Lilly and Company, Icon PLC, Illumina, Inc, IQVIA Holdings, Inc., Labcorp, Merck KGaA, Novo Nordisk A/S, Parexel International Corporation, Pfizer Inc., ProPharma Group Holdings, LLC, Qiagen NV, Sartorius AG, SGS S.A., SIRO Clinpharm Private Limited, Syneos Health, Inc., Thermo Fisher Scientific Inc., and Wuxi AppTec 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 Trials Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Clinical Trials Market?
3. What are the technology trends and regulatory frameworks in the Clinical Trials Market?
4. What is the market share of the leading vendors in the Clinical Trials Market?
5. Which modes and strategic moves are suitable for entering the Clinical Trials Market?