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市场调查报告书
商品编码
1949529
全球药品采购市场比较分析-按服务类型、治疗领域、最终用户、地区和竞争格局分類的行业规模、份额、趋势、机会和预测(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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全球比价采购市场预计将从 2025 年的 15.6 亿美元成长到 2031 年的 22.1 亿美元,复合年增长率达到 5.98%。
该领域涉及对已上市药物进行策略性采购,这些药物可作为临床试验的参考标准,从而能够将临床实验药物的安全性和有效性与现有治疗方法进行比较。推动该领域成长的主要因素是临床研究的增加以及严格的监管要求(这些要求强制要求进行比较疗效研究才能获得上市核准),而这些又是由行业的大量投资所驱动的。例如,欧洲製药工业协会联合会 (EFPIA) 估计,到 2024 年,以研发为基础的製药业将在欧洲的研发领域投资 550 亿欧元,这凸显了需要对照产品的庞大临床活动规模。
| 市场概览 | |
|---|---|
| 预测期 | 2027-2031 |
| 市场规模:2025年 | 15.6亿美元 |
| 市场规模:2031年 | 22.1亿美元 |
| 复合年增长率:2026-2031年 | 5.98% |
| 成长最快的细分市场 | 肿瘤学 |
| 最大的市场 | 北美洲 |
儘管市场呈现上升趋势,但仍面临与供应链安全和假冒风险相关的重大挑战。检验来自分散的全球供应链网路中的对照药品的真伪和来源极为困难,因为假药的引入会严重损害试验资料的完整性和病患安全。因此,供应链受损的持续威胁对市场的有效扩张构成重大障碍,要求相关人员实施严格的保障措施,以保护临床结果的有效性。
全球临床试验的兴起是对照药物采购市场的主要驱动力,因为这些药物对于评估药物相对于现有标准疗法的安全性和有效性至关重要。製药公司和受託研究机构(CRO) 不得不采购大量市售药物,作为随机试验的对照组。这种做法在肿瘤学和免疫学领域尤其重要,因为在这些领域,安慰剂对照试验通常被认为是不道德的。大量活跃的研究也印证了这种后勤上的必要性。根据美国国立卫生研究院 (NIH) 的数据,截至 2024 年 12 月,ClinicalTrials.gov 註册库中全球累计收录了 563,278 项研究,证实了对采购对照药物以支持正在进行的研究的巨大需求。
此外,生物相似药和学名药产业的快速成长进一步加剧了这些采购需求,因为研发人员需要参考药品(RMP)用于临床等效性研究以及早期研发阶段的详细分析特性。向监管机构证明生物类似性需要从不同地区采购多个批次的原厂药,这需要复杂的筹资策略。市场渗透率的提高和监管活动的增加也推动了这一趋势。根据三星生物製剂公司(Samsung Bioepis)预测,到2024年8月,Adalimumab生物相似药的市场份额将达到22%;生物类似药中心(Center for Biosimilars)报告称,美国FDA在2024年核准了19种生物相似药。这一增长与对对照药品采购服务需求的增加直接相关。
供应链安全漏洞及其导致的假冒风险严重阻碍了全球对照药品采购市场的扩张。随着临床试验日益跨越国际司法管辖区,从不同地区采购对照药品使供应链面临假冒伪劣药品的威胁。对照药品安全受损不仅严重威胁病人安全,还会损害临床数据的完整性,可能导致多年研究和资金投入付诸东流。因此,这种风险迫使采购专业人员优先考虑通讯协定而非成本效益和速度,导致筹资策略高度受限,从而抑制了市场成长。
产业内持续且普遍存在的非法活动进一步加剧了这些营运限制的严峻性。根据药品安全研究所统计,2024年全球共记录了6,424起药品犯罪案件,显示供应链的完整性面临持续压力。为了应对这些威胁,製药公司被迫完全依赖既有的、高成本的网络,并实施详尽的检验措施。虽然这些防御性通讯协定必不可少,但它们增加了前置作业时间和采购成本,并限制了可行的采购管道,从而降低了市场的整体规模和灵活性。
受大分子治疗药物和生物製药(需要温度控制)需求变化的推动,专业低温运输能力的扩展正在重塑市场格局。临床试验申办方现在要求对照药物,特别是细胞和基因治疗药物,必须具备严格的端到端物流完整性,才能在全球分销过程中保持其效力。这项变更迫使采购供应商在其网路中整合先进的温控基础设施,以防止温度波动。作为这项产业变革的象征,UPS医疗保健于2024年7月宣布投资超过2,160万美元,在其欧洲车队中新增200多辆温控车辆,从而保障高价值生物製剂的价值链。
同时,采用人工智慧驱动的需求预测和风险管理正成为应对采购复杂性的关键差异化因素。采购专业人员正在利用机器学习演算法预测对照品的供应情况并优化库存水平,从而有效降低短缺风险,减少成本高成本的临床试验中的废弃物。这种数位转型使得采购模式从被动回应转向主动供应链协调,确保在需要时能够获得参考标准品。这一趋势也体现在更广泛的研发领域。根据皮斯托亚联盟于2024年9月发布的《2024年未来实验室全球调查》,生命科学领域68%的受访者表示正在使用人工智慧(AI)和机器学习(ML),这证实了计算工具正迅速融入製药营运。
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: