![]() |
市场调查报告书
商品编码
1889211
体外诊断(IVD)契约製造市场预测至2032年:按服务类型、产品类型、技术、合约类型、产能、最终用户和地区分類的全球分析IVD Contract Manufacturing Market Forecasts To 2032 - Global Analysis By Service Type, Product Type, Technology, Contract Type, Capacity, End User And By Geography |
||||||
根据 Stratistics MRC 的一项研究,预计到 2025 年,全球 IVD契约製造市场价值将达到 237.1 亿美元,到 2032 年将达到 537.5 亿美元,在预测期内的复合年增长率为 12.4%。
体外诊断(IVD)契约製造是指将体外诊断设备、试剂和检测套组的生产外包给专业的第三方製造商。这些公司协助完成所有生产流程,包括设计、工程、测试、大量生产和法规遵循。这种方式使体外诊断公司能够降低成本、提高效率并加快产品推出速度,使其能够专注于研发和市场策略,同时保持产品品质和法规遵循。
根据国际贸易局 (ITA) 的数据,加拿大医疗设备市场预计在 2022 年将达到 65 亿美元,并在 2026 年之前以每年 2.1% 的速度成长。
内部体外诊断试剂生产高成本
企业在专用设备、无尘室基础设施和熟练劳动力方面需要大量资金投入。持续的品质保证、合规性和验证成本进一步加重了营运负担。小型企业和Start-Ups公司往往难以维持这些投资,从而限制了其扩大生产规模的能力。契约製造製造商透过将基础设施和专业知识分配给多个客户,提供了一种经济高效的替代方案。因此,外包正日益被视为降低营运成本和加速市场准入的策略解决方案。
复杂且不断变化的全球监管格局
符合FDA、CE-IVD和ISO 13485等标准需要大量的文件记录和持续的监控。製造商必须迅速适应因地区和产品类型而异的不断变化的法规。这种复杂性常常导致产品上市延迟,并增加认证成本。中小企业如果没有外部专业知识的帮助,很难满足这些要求。因此,监管方面的挑战会造成障碍,减缓技术应用,并限制创新步伐。
采用先进技术
人工智慧驱动的分析、机器人技术和云端基础平台等技术正在简化生产流程。这些创新提高了诊断应用的准确性、加快了处理速度并增强了扩充性。契约製造正在加大对智慧製造系统的投资,以赢得全球客户。尖端材料和微流体技术的整合正在推动下一代诊断试剂盒的开发,随着医疗保健系统进行数位转型,这些技术的应用预计将显着促进体外诊断(IVD)合约製造业务的成长。
网路安全和资料互通性挑战
如果系统安全措施不到位,敏感的患者资料和专有研究成果将面临外洩风险。不同软体和资料标准之间的互通性挑战进一步加剧了安全协作的复杂性。契约製造製造商必须大力投资网路安全基础设施,以维护客户信任。未能解决这些风险可能导致声誉受损和监管处罚。随着数位整合的不断加深,网路安全和互通性的差距仍然是该行业面临的重大威胁。
新冠疫情扰乱了全球供应链,导致原料和试剂短缺。然而,疫情也凸显了快速诊断解决方案的重要性,并推动了体外诊断(IVD)产品的需求成长。契约製造製造商在扩大生产规模以满足紧急检测需求方面发挥了关键作用。远端协作工具和数位化平台成为维持生产连续性的关键。后疫情时代的策略强调在整个体外诊断生态系统中增强韧性、分散式生产和数位敏捷性。
预计在预测期内,试剂和试剂盒细分市场将占据最大的市场份额。
由于试剂和试剂盒在医院、实验室和临床机构的常规诊断检测中至关重要,预计在预测期内,试剂和试剂盒细分市场将占据最大的市场份额。对耗材的高需求确保了製造商的持续收入来源。将试剂和试剂盒的生产外包,使企业能够有效率地满足全球需求。契约製造製造商是该领域的首选合作伙伴,因为他们能够提供扩充性和品质保证。
预计在预测期内,研究机构/学术实验室领域的复合年增长率将最高。
预计在预测期内,研究机构/学术实验室领域将实现最高成长率。这主要归功于转化研究和个人化医疗的日益普及,从而推动了对专业诊断解决方案的需求。这些机构通常缺乏大规模生产能力,因此外包成为可行的选择。契约製造製造商能够为实验性诊断提供快速原型製作和小批量生产服务。产学合作正在促进创新并加速商业化进程。
由于北美拥有先进的医疗保健基础设施和强劲的诊断测试需求,预计该地区在预测期内将占据最大的市场份额。 FDA 等法规结构为核准提供了信誉和进入全球市场的管道。主要的契约製造总部设在美国,拥有丰富的专业知识和强大的生产能力。创新诊断技术的广泛应用进一步巩固了该地区的地位。
预计亚太地区在预测期内将实现最高的复合年增长率,这主要得益于医疗基础设施的不断改进和诊断意识的提高,这些因素正在推动全部区域的需求成长。中国、印度和韩国等国正大力投资本地製造能力。政府主导的措施和公私合营正在促进外包和技术转移。该地区的成本优势和不断增长的患者群体对全球製造商而言极具吸引力。
According to Stratistics MRC, the Global IVD Contract Manufacturing Market is accounted for $23.71 billion in 2025 and is expected to reach $53.75 billion by 2032 growing at a CAGR of 12.4% during the forecast period. IVD contract manufacturing involves delegating the creation of in vitro diagnostic instruments, reagents, and test kits to expert external manufacturers. These firms support every stage of production, including design, engineering, testing, mass manufacturing, and adherence to regulatory standards. This approach helps IVD companies lower expenses, improve efficiency, and speed product launches, allowing them to concentrate on research and market strategies while maintaining consistent quality and regulatory compliance.
According to the International Trade Agency (ITA), the medical device market in Canada accounted for USD 6.5 billion in 2022, which is expected to grow at a rate of 2.1 % by 2026.
High cost of in-house IVD manufacturing
Companies face heavy capital requirements for specialized equipment, cleanroom infrastructure, and skilled labor. Ongoing costs related to quality assurance, compliance, and validation further increase operational burdens. Smaller firms and startups often struggle to sustain these investments, limiting their ability to scale production. Contract manufacturers provide a cost-effective alternative by spreading infrastructure and expertise across multiple clients. As a result, outsourcing is increasingly viewed as a strategic solution to reduce overhead and accelerate market entry.
Complex and evolving global regulatory landscape
Compliance with standards such as FDA, CE-IVD, and ISO 13485 requires extensive documentation and continuous monitoring. Manufacturers must adapt quickly to evolving rules, which vary across regions and product categories. This complexity often delays product launches and increases the cost of certification. Smaller players may find it difficult to navigate these requirements without external expertise. Consequently, regulatory challenges act as a restraint, slowing adoption and limiting the pace of innovation.
Adoption of advanced technologies
Technologies such as AI-driven analytics, robotics, and cloud-based platforms are streamlining production workflows. These innovations improve accuracy, reduce turnaround times, and enhance scalability for diverse diagnostic applications. Contract manufacturers are increasingly investing in smart manufacturing systems to attract global clients. Integration of advanced materials and microfluidics is enabling next-generation diagnostic kits. As healthcare systems embrace digital transformation, adoption of these technologies is expected to drive significant growth in outsourced IVD production.
Cybersecurity and data interoperability gaps
Sensitive patient data and proprietary research are vulnerable to breaches if systems are not adequately protected. Interoperability challenges between different software and data standards further complicate secure collaboration. Contract manufacturers must invest heavily in cybersecurity infrastructure to maintain trust with clients. Failure to address these risks could result in reputational damage and regulatory penalties. As digital integration expands, cybersecurity and interoperability gaps remain a critical threat to the industry.
The COVID-19 pandemic disrupted global supply chains and created shortages in raw materials and reagents. However, it also highlighted the importance of rapid diagnostic solutions, boosting demand for IVD products. Contract manufacturers played a vital role in scaling up production to meet urgent testing needs. Remote collaboration tools and digital platforms became essential for maintaining continuity in manufacturing. Post-pandemic strategies now emphasize resilience, distributed production, and digital agility across the IVD ecosystem.
The reagents & kits segment is expected to be the largest during the forecast period
The reagents & kits segment is expected to account for the largest market share during the forecast period, due to these products are essential for routine diagnostic testing across hospitals, laboratories, and point-of-care settings. High demand for consumables ensures recurring revenue streams for manufacturers. Outsourcing production of reagents and kits allows companies to meet global demand efficiently. Contract manufacturers provide scalability and quality assurance, making them preferred partners for this segment.
The research institutes / academic labs segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the research institutes / academic labs segment is predicted to witness the highest growth rate, due to increasing focus on translational research and personalized medicine is driving demand for specialized diagnostic solutions. These institutions often lack large-scale manufacturing capabilities, making outsourcing a practical choice. Contract manufacturers support rapid prototyping and small-batch production for experimental diagnostics. Collaborations between academia and industry are fostering innovation and accelerating commercialization.
During the forecast period, the North America region is expected to hold the largest market share, due to the region benefits from advanced healthcare infrastructure and strong demand for diagnostic testing. Regulatory frameworks such as FDA approvals provide credibility and global market access. Leading contract manufacturers are headquartered in the U.S., offering extensive expertise and capacity. High adoption of innovative diagnostic technologies further strengthens regional dominance.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR, owing to expanding healthcare infrastructure and rising awareness of diagnostics are fueling demand across the region. Countries such as China, India, and South Korea are investing heavily in local manufacturing capabilities. Government initiatives and public-private partnerships are encouraging outsourcing and technology transfer. The region's cost advantages and growing patient population make it attractive for global manufacturers.
Key players in the market
Some of the key players in IVD Contract Manufacturing Market include Thermo Fi, Fujirebio, Merck KGa, Meridian B, Bio-Techno, KMC Syste, Argonaut, Cone Biop, Invetech, Kimball El, Randox La, Phillips-M, TE Connec, Viant Med, and Celestica.
In November 2025, Thermo Fisher Scientific Inc. announced the grand opening of its East Coast flagship Advanced Therapies Collaboration Center (ATxCC) in Philadelphia, marking the company's second ATxCC in the United States following the opening of its Carlsbad, California, site. Together, these centers expand the company's nationwide network supporting cell and gene therapy (CGT) innovation, providing critical resources to biotech, biopharma and translational researchers developing next-generation cell-based immunotherapies.
In June 2025, Fujirebio Holdings, Inc. announced that Fujirebio Diagnostics, Inc., a subsidiary of Fujirebio, has acquired all shares of Plasma Services Group, Inc. (hereinafter "Plasma Services Group"). The transaction value has not been disclosed. The company is particularly well positioned in the field of rare diseases. From its state-of-the-art FDA registered, ISO certified facility in Moorestown, NJ, USA, Plasma Services Group provides sera and other samples for materials of control reagents and calibrators for a wide range of diseases and offers sample collection services globally.
List Of Tables
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.