![]() |
市场调查报告书
商品编码
1871415
2021-2031年北美临床试验市场报告:范围、细分、动态和竞争分析North America Clinical Trials Market Report 2021-2031 by Scope, Segmentation, Dynamics, and Competitive Analysis |
||||||
预计北美临床试验市场将大幅成长,到 2031 年将达到约 324.4582 亿美元,高于 2023 年的 190.4218 亿美元,在此期间的年复合成长率(CAGR) 为 6.9%。
执行摘要和市场分析
北美临床试验市场以其先进的基础设施、雄厚的研究经费和庞大的患者群体为特征。技术创新和个人化医疗的兴起推动了该行业的发展,提升了试验的设计和执行效率。製药公司与合约研究组织(CRO)之间的合作提高了营运效率。然而,该市场也面临着许多挑战,例如严格的监管要求和不断上涨的成本,因此需要持续调整以维持成长并优化药物研发流程。
市场区隔分析
北美临床试验市场可根据研究设计、适应症和阶段类型进行细分:
市场展望
研究在製药、生物製药和医疗器材领域发挥着至关重要的作用,它能够开发出具有巨大医疗和商业潜力的新型治疗方案。製药业尤其註重研发投入,致力于提高药物的疗效和效率,以满足患者的需求。药品成本的不断上涨仍然是主要问题,促使企业利用研发来实现成本目标。过去十年,新药的年度核准率持续成长,光是2022年,美国食品药物管理局(FDA)就批准了37种新药。美国在全球研发投入方面处于领先地位,过去十年中,其新药分子数量占全球总数的50%以上。根据欧洲製药工业协会联合会(EFPIA)的数据,2021年北美占全球药品销售额的49.1%,而美国在2016年至2021年期间的新药销售额占全球新药销售额的64.4%。
主要製药公司的研发投资
下表列出了主要製药公司的研发支出:
| 公司 | 2022年(十亿美元) | 2023(十亿美元) |
| - - - - - - - - - - - - - - - - | - - - - - - - - - - | - - - - - - - - - - |
| 武田药品工业株式会社 | 4.2 | 5.08 |
| 辉瑞公司 | 11.4 | 10.6 |
|格里福斯公司 | 427.05 | 427.05 432.71 | 432.71
註:货币显示采用当前汇率。 *
资料来源:年度报告与The Insight Partners分析
研发投入对于企业发现、开发和生产新产品、改进现有产品以及确保合规至关重要。临床试验的相关成本包括材料、耗材、员工薪资和品质控制开发。根据美国药品研究与製造商协会(PhRMA)2021年会员公司报告,前15名的製药公司在研发方面共投入1,330亿美元,其中约44%用于临床试验。与医院的合作也在不断增加,以开发治疗包括免疫系统疾病在内的各种疾病的方法。例如,武田製药于2021年6月宣布启动ADVANCE-1试验,以评估HYQVIA治疗慢性发炎性脱髓鞘性多发性神经根神经病变(CIDP)的疗效。
国家概况
北美临床试验市场涵盖美国、加拿大和墨西哥,其中美国在2023年占据最大的市场份额。美国是临床研究的首选目的地,几乎一半的临床试验都在美国进行。製药公司青睐美国,是因为其完善的医疗基础设施、快速的批准流程和良好的监管环境。世界卫生组织的报告显示,美国拥有最多的临床试验,2021年总计达157,618项。美国临床试验市场的成长得益于创新产品和服务,例如Medical Metrics公司的“Assessa”,该工具可辅助神经系统疾病的药物研发。
公司简介
临床试验市场的主要参与者包括QVIA Holdings Inc、Parexel International Corp、IXICO Plc、Charles River Laboratories International Inc、ICON Plc、药明康德股份有限公司、SGS SA、Syneos Health Inc、Thermo Fisher Scientific Inc、Laboratory Corp of America Holdings、CliniRx Research Private Limited、Caidyaal.这些公司正在推行扩张、产品创新以及併购等策略,以增强其市场份额并提供创新解决方案。
The North American clinical trials market is projected to grow significantly, reaching approximately USD 32,445.82 million by 2031, up from USD 19,042.18 million in 2023, reflecting a compound annual growth rate (CAGR) of 6.9% during this period.
Executive Summary and Market Analysis
The clinical trials market in North America is characterized by its advanced infrastructure, substantial research funding, and a large patient population. The sector is driven by technological innovations and the rise of personalized medicine, which enhance trial design and execution. Collaborations between pharmaceutical companies and contract research organizations (CROs) are improving operational efficiency. However, the market faces challenges such as stringent regulatory requirements and increasing costs, necessitating ongoing adjustments to sustain growth and optimize drug development processes.
Market Segmentation Analysis
The North American clinical trials market can be segmented based on study design, indications, and phase type:
Market Outlook
Research plays a crucial role in the pharmaceutical, biopharmaceutical, and medical device sectors, enabling the development of new therapeutic solutions with significant medical and commercial potential. The pharmaceutical industry is notably R&D-intensive, focusing on enhancing effectiveness and efficiency to meet patient needs. The rising costs of medications remain a primary concern, prompting companies to leverage R&D to achieve cost targets. Over the past decade, the annual approval rate of new drugs has increased, with the FDA approving 37 new drugs in 2022 alone. The United States leads globally in R&D investments, contributing over 50% of new drug molecules in the last decade. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), North America accounted for 49.1% of global pharmaceutical sales in 2021, with the US responsible for 64.4% of new medicine sales from 2016 to 2021.
R&D Investments by Major Pharmaceutical Companies
The following table outlines R&D expenditures by major pharmaceutical companies:
| Company | 2022 (USD Billion) | 2023 (USD Billion) |
|----------------------------------|--------------------|--------------------|
| Takeda Pharmaceutical Co Ltd | 4.2 | 5.08 |
| Pfizer Inc | 11.4 | 10.6 |
| Grifols SA | 427.05 | 432.71 |
Note: Current conversion rates are applied for currency presentation.*
Source: Annual Reports and The Insight Partners Analysis
R&D spending is vital for companies to discover, develop, and produce new products, improve existing outcomes, and ensure regulatory compliance. The costs associated with clinical trials include materials, supplies, employee salaries, and quality control development. According to the PhRMA Member Companies 2021 report, the top 15 pharmaceutical companies invested a total of USD 133 billion in R&D, with approximately 44% allocated to clinical trials. Collaborations with hospitals are also increasing to develop treatments for various diseases, including immunological disorders. For instance, in June 2021, Takeda announced the ADVANCE-1 trial to evaluate HYQVIA for treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Country Insights
The North American clinical trials market includes the US, Canada, and Mexico, with the US holding the largest market share in 2023. The US is a premier destination for clinical research, hosting nearly half of all clinical trials. Pharmaceutical companies favor the US for its established medical infrastructure, rapid approval processes, and favorable regulatory environment. A WHO report indicated that the US had the highest number of clinical trials, totaling 157,618 in 2021. The growth of the clinical trials market in the US is driven by innovative products and services, such as Medical Metrics' "Assessa," which aids in drug discovery for neurological disorders.
Company Profiles
Key players in the clinical trials market include QVIA Holdings Inc, Parexel International Corp, IXICO Plc, Charles River Laboratories International Inc, ICON Plc, WuXi AppTec Co Ltd, SGS SA, Syneos Health Inc, Thermo Fisher Scientific Inc, Laboratory Corp of America Holdings, CliniRx Research Private Limited, Caidya, Oracle Corp, Medpace Holdings Inc, and SIRO Clinpharm Pvt Ltd. These companies are pursuing strategies such as expansion, product innovation, and mergers and acquisitions to enhance their market presence and offer innovative solutions.