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市場調查報告書
商品編碼
1949529
全球藥品採購市場比較分析-按服務類型、治療領域、最終用戶、地區和競爭格局分類的行業規模、佔有率、趨勢、機會和預測(2021-2031年)Comparator Drug Sourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service Type, By Therapeutic Area, By End User, By Region & Competition, 2021-2031F |
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全球比價採購市場預計將從 2025 年的 15.6 億美元成長到 2031 年的 22.1 億美元,複合年成長率達到 5.98%。
該領域涉及對已上市藥物進行策略性採購,這些藥物可作為臨床試驗的參考標準,從而能夠將臨床實驗藥物的安全性和有效性與現有治療方法進行比較。推動該領域成長的主要因素是臨床研究的增加以及嚴格的監管要求(這些要求強制要求進行比較療效研究才能獲得上市核准),而這些又是由行業的大量投資所驅動的。例如,歐洲製藥工業協會聯合會 (EFPIA) 估計,到 2024 年,以研發為基礎的製藥業將在歐洲的研發領域投資 550 億歐元,這凸顯了需要對照產品的龐大臨床活動規模。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 15.6億美元 |
| 市場規模:2031年 | 22.1億美元 |
| 複合年成長率:2026-2031年 | 5.98% |
| 成長最快的細分市場 | 腫瘤學 |
| 最大的市場 | 北美洲 |
儘管市場呈現上升趨勢,但仍面臨與供應鏈安全和假冒風險相關的重大挑戰。檢驗來自分散的全球供應鏈網路中的對照藥品的真偽和來源極為困難,因為假藥的引入會嚴重損害試驗資料的完整性和病患安全。因此,供應鏈受損的持續威脅對市場的有效擴張構成重大障礙,要求相關人員實施嚴格的保障措施,以保護臨床結果的有效性。
全球臨床試驗的興起是對照藥物採購市場的主要驅動力,因為這些藥物對於評估藥物相對於現有標準療法的安全性和有效性至關重要。製藥公司和受託研究機構(CRO) 不得不採購大量市售藥物,作為隨機試驗的對照組。這種做法在腫瘤學和免疫學領域尤其重要,因為在這些領域,安慰劑對照試驗通常被認為是不道德的。大量活躍的研究也印證了這種後勤上的必要性。根據美國國立衛生研究院 (NIH) 的數據,截至 2024 年 12 月,ClinicalTrials.gov 註冊庫中全球累計收錄了 563,278 項研究,證實了對採購對照藥物以支持正在進行的研究的巨大需求。
此外,生物相似藥和學名藥產業的快速成長進一步加劇了這些採購需求,因為研發人員需要參考藥品(RMP)用於臨床等效性研究以及早期研發階段的詳細分析特性。向監管機構證明生物類似性需要從不同地區採購多個批次的原廠藥,這需要複雜的籌資策略。市場滲透率的提高和監管活動的增加也推動了這一趨勢。根據三星生物製劑公司(Samsung Bioepis)預測,到2024年8月,Adalimumab生物相似藥的市場佔有率將達到22%;生物類似藥中心(Center for Biosimilars)報告稱,美國FDA在2024年核准了19種生物相似藥。這一成長與對對照藥品採購服務需求的增加直接相關。
供應鏈安全漏洞及其導致的假冒風險嚴重阻礙了全球對照藥品採購市場的擴張。隨著臨床試驗日益跨越國際司法管轄區,從不同地區採購對照藥品使供應鏈面臨假冒偽劣藥品的威脅。對照藥品安全受損不僅嚴重威脅病人安全,還會損害臨床數據的完整性,可能導致多年研究和資金投入付諸東流。因此,這種風險迫使採購專業人員優先考慮通訊協定而非成本效益和速度,導致籌資策略高度受限,從而抑制了市場成長。
產業內持續且普遍存在的非法活動進一步加劇了這些營運限制的嚴峻性。根據藥品安全研究所統計,2024年全球共記錄了6,424起藥品犯罪案件,顯示供應鏈的完整性面臨持續壓力。為了應對這些威脅,製藥公司被迫完全依賴既有的、高成本的網路,並實施詳盡的檢驗措施。雖然這些防禦性通訊協定必不可少,但它們增加了前置作業時間和採購成本,並限制了可行的採購管道,從而降低了市場的整體規模和靈活性。
受大分子治療藥物和生物製藥(需要溫度控制)需求變化的推動,專業低溫運輸能力的擴展正在重塑市場格局。臨床試驗申辦方現在要求對照藥物,特別是細胞和基因治療藥物,必須具備嚴格的端到端物流完整性,才能在全球分銷過程中保持其效力。這項變更迫使採購供應商在其網路中整合先進的溫控基礎設施,以防止溫度波動。作為這項產業變革的象徵,UPS醫療保健於2024年7月宣布投資超過2,160萬美元,在其歐洲車隊中新增200多輛溫控車輛,從而保障高價值生物製劑的價值鏈。
同時,採用人工智慧驅動的需求預測和風險管理正成為應對採購複雜性的關鍵差異化因素。採購專業人員正在利用機器學習演算法預測對照品的供應情況並最佳化庫存水平,從而有效降低短缺風險,減少成本高成本的臨床試驗中的廢棄物。這種數位轉型使得採購模式從被動回應轉向主動供應鏈協調,確保在需要時能夠獲得參考標準品。這一趨勢也體現在更廣泛的研發領域。根據皮斯托亞聯盟於2024年9月發布的《2024年未來實驗室全球調查》,生命科學領域68%的受訪者表示正在使用人工智慧(AI)和機器學習(ML),這證實了計算工具正迅速融入製藥營運。
The Global Comparator Drug Sourcing Market is projected to expand from USD 1.56 Billion in 2025 to USD 2.21 Billion by 2031, achieving a compound annual growth rate (CAGR) of 5.98%. This sector involves the strategic procurement of marketed medicinal products to serve as reference standards in clinical trials, enabling the comparison of an investigational drug's safety and efficacy against established treatments. Growth is primarily driven by the rising volume of clinical research and strict regulatory mandates requiring comparative effectiveness studies for market approval, a demand fueled by significant industry investment. For instance, the European Federation of Pharmaceutical Industries and Associations (EFPIA) estimated that the research-based pharmaceutical industry invested €55,000 million in R&D across Europe in 2024, emphasizing the vast scale of clinical activities necessitating comparator products.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 1.56 Billion |
| Market Size 2031 | USD 2.21 Billion |
| CAGR 2026-2031 | 5.98% |
| Fastest Growing Segment | Oncology |
| Largest Market | North America |
Despite this upward trajectory, the market faces significant hurdles related to supply chain security and the risk of counterfeiting. Verifying the authenticity and pedigree of sourced comparators across fragmented global supply networks poses a considerable difficulty, as the intrusion of falsified medicines can severely compromise trial data integrity and patient safety. Consequently, the constant threat of compromised supply lines creates a substantial barrier to efficient market expansion, requiring stakeholders to implement rigorous safeguards to protect the validity of clinical outcomes.
Market Driver
The escalating volume of global clinical trials serves as a fundamental catalyst for the comparator drug sourcing market, as these agents are indispensable for benchmarking safety and efficacy against current standards of care. Pharmaceutical companies and contract research organizations (CROs) are compelled to acquire significant quantities of commercial medicines for use as reference arms in randomized studies, a practice that is particularly critical in oncology and immunology where placebo-controlled trials are frequently deemed unethical. This logistical necessity is highlighted by the sheer scale of active research; according to the National Institutes of Health, the ClinicalTrials.gov registry listed a cumulative total of 563,278 studies globally as of December 2024, underscoring the massive requirement for sourced comparators to support these ongoing investigations.
Furthermore, the rapid growth of the biosimilars and generics sector intensifies these sourcing requirements, as developers need reference medicinal products (RMPs) for both clinical equivalence testing and extensive analytical characterization during early development. Securing multiple lots of originator products from diverse regions is essential for demonstrating biosimilarity to regulators, which drives complex procurement strategies. This trend is evidenced by rising market penetration and regulatory activity; according to Samsung Bioepis, the market share of adalimumab biosimilars reached 22% by August 2024, while the Center for Biosimilars reported that the U.S. FDA approved 19 biosimilars in 2024, a surge that directly correlates with an increased demand for comparator sourcing services.
Market Challenge
Supply chain security vulnerabilities and the associated risks of counterfeiting represent a major obstacle hindering the expansion of the global comparator drug sourcing market. As clinical trials increasingly span international jurisdictions, sourcing comparator drugs from diverse regions exposes the supply chain to the threat of unauthorized and falsified medicines. The compromise of a comparator product not only poses a severe threat to patient safety but also undermines clinical data integrity, potentially invalidating years of research and financial investment. Consequently, this risk limits market growth by forcing sourcing specialists to prioritize security protocols over cost efficiency or speed, leading to highly restrictive procurement strategies.
The severity of this operational constraint is reinforced by the persistent prevalence of illicit activity within the sector. According to the Pharmaceutical Security Institute, 6,424 pharmaceutical crime incidents were recorded globally in 2024, illustrating the sustained pressure on supply chain integrity. In response to these threats, pharmaceutical companies are compelled to rely exclusively on established, high-cost networks and implement exhaustive verification measures. While necessary, these defensive protocols increase lead times and procurement costs and limit the diversity of viable sourcing channels, thereby reducing the market's overall volume and agility.
Market Trends
The market is being reshaped by the expansion of specialized cold chain capabilities, driven by the shifting requirements of temperature-sensitive large molecule therapies and biologics. Clinical trial sponsors now demand rigorous end-to-end logistical integrity for comparator drugs, particularly for cell and gene therapies that necessitate cryogenic storage to preserve potency during global distribution. This shift compels sourcing providers to embed sophisticated thermal regulation infrastructure into their networks to prevent temperature excursions. Highlighting this industry-wide pivot, UPS Healthcare announced in July 2024 an investment of over $21.6 million to add more than 200 temperature-controlled vehicles to its European fleet, securing the supply chain for high-value biologics.
Simultaneously, the adoption of AI-driven demand forecasting and risk management is emerging as a critical differentiator for navigating the complexities of procurement. Sourcing specialists are increasingly utilizing machine learning algorithms to predict comparator drug availability and optimize inventory levels, effectively mitigating shortage risks and reducing waste within costly clinical trials. This digital evolution enables a transition from reactive procurement to proactive supply chain orchestration, ensuring reference standards are available precisely when required. The momentum of this trend is reflected in the broader R&D sector; according to the Pistoia Alliance's 'Lab of the Future 2024 Global Survey' from September 2024, 68% of life sciences respondents reported using Artificial Intelligence and Machine Learning, underscoring the rapid integration of computational tools into pharmaceutical operations.
Report Scope
In this report, the Global Comparator Drug Sourcing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Comparator Drug Sourcing Market.
Global Comparator Drug Sourcing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: