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市場調查報告書
商品編碼
1889211
體外診斷(IVD)契約製造市場預測至2032年:按服務類型、產品類型、技術、合約類型、產能、最終用戶和地區分類的全球分析IVD Contract Manufacturing Market Forecasts To 2032 - Global Analysis By Service Type, Product Type, Technology, Contract Type, Capacity, End User And By Geography |
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根據 Stratistics MRC 的一項研究,預計到 2025 年,全球 IVD契約製造市場價值將達到 237.1 億美元,到 2032 年將達到 537.5 億美元,在預測期內的複合年成長率為 12.4%。
體外診斷(IVD)契約製造是指將體外診斷設備、試劑和檢測套組的生產外包給專業的第三方製造商。這些公司協助完成所有生產流程,包括設計、工程、測試、大量生產和法規遵循。這種方式使體外診斷公司能夠降低成本、提高效率並加快產品推出速度,使其能夠專注於研發和市場策略,同時保持產品品質和法規遵循。
根據國際貿易局 (ITA) 的數據,加拿大醫療設備市場預計在 2022 年將達到 65 億美元,並在 2026 年之前以每年 2.1% 的速度成長。
內部體外診斷試劑生產高成本
企業在專用設備、無塵室基礎設施和熟練勞動力方面需要大量資金投入。持續的品質保證、合規性和驗證成本進一步加重了營運負擔。小型企業和Start-Ups公司往往難以維持這些投資,從而限制了其擴大生產規模的能力。契約製造製造商透過將基礎設施和專業知識分配給多個客戶,提供了一種經濟高效的替代方案。因此,外包正日益被視為降低營運成本和加速市場准入的策略解決方案。
複雜且不斷變化的全球監管格局
符合FDA、CE-IVD和ISO 13485等標準需要大量的文件記錄和持續的監控。製造商必須迅速適應因地區和產品類型而異的不斷變化的法規。這種複雜性常常導致產品上市延遲,並增加認證成本。中小企業如果沒有外部專業知識的幫助,很難滿足這些要求。因此,監管方面的挑戰會造成障礙,減緩技術應用,並限制創新步伐。
採用先進技術
人工智慧驅動的分析、機器人技術和雲端基礎平台等技術正在簡化生產流程。這些創新提高了診斷應用的準確性、加快了處理速度並增強了擴充性。契約製造正在加大對智慧製造系統的投資,以贏得全球客戶。尖端材料和微流體技術的整合正在推動下一代診斷試劑盒的開發,隨著醫療保健系統進行數位轉型,這些技術的應用預計將顯著促進體外診斷(IVD)合約製造業務的成長。
網路安全和資料互通性挑戰
如果系統安全措施不到位,敏感的患者資料和專有研究成果將面臨外洩風險。不同軟體和資料標準之間的互通性挑戰進一步加劇了安全協作的複雜性。契約製造製造商必須大力投資網路安全基礎設施,以維護客戶信任。未能解決這些風險可能導致聲譽受損和監管處罰。隨著數位整合的不斷加深,網路安全和互通性的差距仍然是該行業面臨的重大威脅。
新冠疫情擾亂了全球供應鏈,導致原料和試劑短缺。然而,疫情也凸顯了快速診斷解決方案的重要性,並推動了體外診斷(IVD)產品的需求成長。契約製造製造商在擴大生產規模以滿足緊急檢測需求方面發揮了關鍵作用。遠端協作工具和數位化平台成為維持生產連續性的關鍵。後疫情時代的策略強調在整個體外診斷生態系統中增強韌性、分散式生產和數位敏捷性。
預計在預測期內,試劑和試劑盒細分市場將佔據最大的市場佔有率。
由於試劑和試劑盒在醫院、實驗室和臨床機構的常規診斷檢測中至關重要,預計在預測期內,試劑和試劑盒細分市場將佔據最大的市場佔有率。對耗材的高需求確保了製造商的持續收入來源。將試劑和試劑盒的生產外包,使企業能夠有效率地滿足全球需求。契約製造製造商是該領域的首選合作夥伴,因為他們能夠提供擴充性和品質保證。
預計在預測期內,研究機構/學術實驗室領域的複合年成長率將最高。
預計在預測期內,研究機構/學術實驗室領域將實現最高成長率。這主要歸功於轉化研究和個人化醫療的日益普及,從而推動了對專業診斷解決方案的需求。這些機構通常缺乏大規模生產能力,因此外包成為可行的選擇。契約製造製造商能夠為實驗性診斷提供快速原型製作和小批量生產服務。產學合作正在促進創新並加速商業化進程。
由於北美擁有先進的醫療保健基礎設施和強勁的診斷測試需求,預計該地區在預測期內將佔據最大的市場佔有率。 FDA 等法規結構為核准提供了信譽和進入全球市場的管道。主要的契約製造總部設在美國,擁有豐富的專業知識和強大的生產能力。創新診斷技術的廣泛應用進一步鞏固了該地區的地位。
預計亞太地區在預測期內將實現最高的複合年成長率,這主要得益於醫療基礎設施的不斷改進和診斷意識的提高,這些因素正在推動全部區域的需求成長。中國、印度和韓國等國正大力投資本地製造能力。政府主導的措施和公私合營正在促進外包和技術轉移。該地區的成本優勢和不斷成長的患者群體對全球製造商而言極具吸引力。
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.