IVD Contract Manufacturing Market Growth Report | Share, Size & Forecasts 2030
【研究报告】IVD代工市场规模预计将从2022年的1480,001万美元增长到2030年的2992562万美元;预计 2022 年至 2030 年复合年增长率为 9.20%。
分析师观点
体外诊断 (IVD) 合同制造涉及将诊断测试的生产外包给第三方制造商。这可能包括制造组件、组装最终产品,有时甚至包括包装。简化运营并利用专业制造商的专业知识是诊断行业公司的常见做法。 IVD 合同制造有几个好处。这使得诊断公司能够专注于其核心技能,如营销、开发和研究,并依靠专业制造商进行高效且负担得起的生产。这一策略可以缩短新诊断产品上市的时间,节省生产成本,并提高整体运营效率。合同制造商遍布全球,使公司能够进入国际市场,而无需大量基础设施投资。临床实验室使用的体外诊断产品的需求快速增长,导致制造商需要帮助以跟上生产节奏。这反过来又推动了 IVD 合同制造的需求。因此,Invetech、Zentech、Merck KGaA 等主要参与者都提供 IVD 合同制造服务。
体外诊断领域的扩张和创新有多种前景( IVD)合同制造部门。流行病和传染病等新出现和持续存在的全球健康问题为 IVD 合同制造商提供了加快诊断测试的创建和开发的机会。对此类障碍的快速反应会增加市场潜力。 IVD 合同制造可以通过针对每个患者的情况进行诊断,从个性化医疗的趋势中受益。需要定制解决方案,例如遗传和分子诊断。
此外,发展中国家对更好的医疗基础设施的需求不断增长,因此存在大量机会。 IVD 合同制造商可以在这些地区设立商店,以解决地区医疗保健问题并支持市场扩张。 IVD 合同制造商可以将自己打造成先进诊断技术的重要合作者,并通过抓住这些机遇来满足医疗保健行业不断变化的需求。
战略见解
市场洞察
传染病患病率上升   ;
IVD 合同制造对于生产对抗传染病的诊断测试至关重要。合同制造商可以更快地开发传染病快速诊断测试,这将有助于早期发现和遏制工作。合同制造商可以快速提高产量,以应对传染病的爆发,满足诊断测试不断增长的需求,并促进及时识别和管理。合同制造商可以生产的各种诊断测试,例如抗原测试、血清学测定和核酸测试,可以帮助诊断传染病的综合方法。使用拥有尖端技术的合同制造商可以帮助开发更复杂、更精确的诊断测试,提高识别不同传染源的能力。因此,预计传染病患病率的增加将推动市场的增长。例如,根据美国疾病控制与预防中心的数据,2022 年,美国报告了大约 8,331 例结核病 (TB) 病例。据加拿大政府称,2021年加拿大报告了1,829例活动性结核病病例。相比之下,每10万人中有4.8例活动性结核病病例,每10万人中有4.3例活动性结核病病例,每10万人中有4.3例活动性结核病病例,每10万人中有5.3例活动性结核病病例。 span>
此外,IVD公司和合同制造商可以共同努力促进诊断技术的持续创新,最终提高传染病诊断的速度和精度。 IVD 公司可以通过合同制造合作伙伴关系战略性地规划和优化生产能力,这使他们能够更有效地应对新出现的传染病挑战。
IVD 合同制造市场往往受到限制严格的法规、维持质量控制的困难以及遵循全球标准的要求。此外,由于技术的复杂性和对专业设施的需求,可能会出现新制造商的进入壁垒。经济变量和医疗保健支出的变化也可能影响市场扩张,给行业的长期增长带来困难。
未来趋势
IVD 合同制造的技术进步
多项技术进步正在塑造体外诊断 (IVD) 的格局) 合同起草(名词。自动化和机器人技术的进步提高了制造过程的精度和效率。这包括自动化装配、质量控制和包装,有助于提高生产能力并降低错误率。数字技术和物联网(IoT)的诊断设备集成正在变得流行。通过实现实时数据收集、连接和远程监控,提高了 IVD 产品的整体功能和可用性。分子诊断技术的进步,包括聚合酶链反应 (PCR) 和其他核酸检测方法,导致诊断分析方法更加灵敏和特异。合同制造商在生产用于这些复杂测试的组件方面发挥着重要作用。技术进步也延伸到可持续制造实践。合同制造商正在采用节能工艺和可回收材料等环保技术,以适应行业对可持续发展的日益重视。这些技术进步共同为 IVD 合同制造领域带来了更先进、更高效、更准确的诊断设备。
报告细分和范围
基于产品的见解
基于在产品方面,全球IVD合同制造市场分为设备和服务。到 2022 年,设备细分市场将占据更大的市场份额。由于人口老龄化、慢性病患病率上升以及对诊断的持续需求等因素的推动,全球范围内对诊断测试的需求不断增长,IVD 合同制造正在增长。传染性疾病。诊断技术(例如现场检测、分子诊断和先进成像方法)的不断进步,为 IVD 合同制造商提供了分享开发最先进设备知识的机会。< /p>
基于技术的见解
根据技术,全球IVD合同制造市场分为免疫分析、分子诊断、临床化学、血液学、微生物学、尿液分析等。到 2022 年,免疫分析领域将占据更大的市场份额。免疫分析可以通过多种方式检测分析物,而合同制造服务对于满足这些诊断测试的需求至关重要。糖尿病、自身免疫性疾病和心血管疾病等慢性病患病率的上升推动了免疫测定在诊断和监测方面的需求。因此,对合同制造服务的需求更大。由于分散测试(包括即时免疫测定)的趋势,对这些测试的需求正在增加。合同制造商在创建用于护理点的快速便携式免疫测定仪器时至关重要。
IVD 合同制造市场(按产品) - 2022年和2030年
区域分析
北美 IVD 合同制造市场分为美国、加拿大和墨西哥。随着人们越来越意识到神经监测在外科手术中的好处,北美的 IVD 合同制造市场一直在稳步增长。北美有一个明显的分散测试趋势,特别是在护理点诊断方面。
由于对诊断测试的需求不断增长、技术进步以及对具有成本效益的制造解决方案的需求,美国的 IVD 合同制造市场一直在稳定增长。在美国,糖尿病、心血管疾病和癌症等慢性病的患病率不断上升,增加了对诊断测试的需求,促进了 IVD 合同制造行业的增长。政府计划和公共卫生运动可能会影响对特定诊断测试的需求。例如,旨在疾病预防或筛查的举措可能是特定 IVD 产品需求背后的驱动力。
同样,亚太地区的 IVD 复合年增长率将最高2020-2030 年预测期内的合同制造市场。由于疾病流行率、医疗保健成本的上升以及诊断测试意识的增强,IVD 合同制造行业在亚太地区显着增长。由于人口老龄化和医疗保健成本上升,亚太国家对诊断服务的需求不断增加,这推动了 IVD 市场和合同制造的发展。韩国、中国和印度等国家已成为 IVD 市场的主要参与者。这些国家对合同制造服务的需求特别高,因为他们在医疗保健基础设施方面投入巨资。
该报告介绍了在全球 IVD 合同制造市场上运营的领先企业。其中包括 Invetech、Zentech、Veracyte、Merck KGaA、Avioq, Inc、TCS Biosciences Ltd、Bio-Techne、SCIENION、Hochuen Medical 和 SeaskyMedical。
2023 年 5 月,Reagent IVD 资源列兵。 Ltd. (RIVDR) 是一家总部位于斋浦尔的生物技术初创公司,专注于诊断,而 TechInvention Lifecare Pvt. Ltd. (RIVDR) 是一家专注于诊断的生物技术初创公司。 Ltd. 是一家总部位于孟买的生物技术初创公司,通过战略合作开发和生产广泛的诊断产品。 RIVDR 是一家生产生命科学试剂和体外诊断 (IVD) 的合同制造商,为诊断行业的颠覆性转变提供创意制造解决方案。
2023 年 5 月, ;Biofortuna 扩大了其 IVD 服务组合,重点关注免疫分析设计、开发和制造。该公司对其制造能力进行了大量投资,包括板包被、清洗、干燥和质量控制,从而打造出了卓越的免疫测定试剂盒制造套件。
2018 年 3 月合同制造、定制自动化和新产品开发领域的领先公司 Invetech 宣布,其位于马萨诸塞州 Boxborough 的体外诊断 (IVD) 制造工厂已获得正式的 ISO 13485 认证。这一成就增强了公司在澳大利亚墨尔本工厂的既定制造能力,并将其全球 IVD 合同制造足迹扩展到美国。
公司简介
- Invetech
- Zentech
- Veracyte
- Merck KGaA
- Avioq, Inc
- TCS Biosciences Ltd
- Bio-Techne
- SCIENION
- 合川医疗
- SeaskyMedical
![Report Coverage](https://www.theinsightpartners.com/assets/rdimages/report_coverage.png)
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
![Segment Covered](https://www.theinsightpartners.com/assets/rdimages/segment_covered.png)
Segment Covered
This text is related
to segments covered.
![Regional Scope](https://www.theinsightpartners.com/assets/rdimages/regional_scope.png)
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
![Country Scope](https://www.theinsightpartners.com/assets/rdimages/country_scope.png)
Country Scope
This text is related
to country scope.
- Invetech
- Zentech
- Veracyte
- Merck KGaA
- Avioq, Inc
- TCS Biosciences Ltd
- Bio-Techne
- SCIENION
- Hochuen Medical
- SeaskyMedical
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.