分析师观点：
一种流行的分子生物学技术，称为聚合酶链式反应 (PCR)，可放大 DNA 和 RNA 序列，从而在研究、诊断等领域。市场上既有传统的 PCR 技术，也有最先进的技术，例如实时 PCR (qPCR) 和数字 PCR (dPCR)。 PCR 技术市场竞争非常激烈，少数大型制造商控制着该行业。这些公司不断在研发上投入资金，将新产品推向市场并改进现有产品。由于测试需求的增加，PCR 机器的销量急剧增加，并且快速和多重 PCR 测试是专门针对 COVID-19 定制的。
技术进步提高了 PCR 仪器、试剂的性能、灵敏度和易用性和软件。通过自动化和集成简化了工作流程，实现高吞吐量测试并加快周转速度。对分子诊断、基因检测和个性化治疗的需求不断增长是市场增长的主要原因之一。此外，随着慢性病患病率的增加、基因组研究的发展以及对疾病早期检测的需求，技术的发展显着影响市场增长。
市场概述：
PCR 在临床环境中至关重要，因为它能够快速、精确地检测遗传变异、传染病和生物标志物。此外，由于慢性病患病率的增加和基因组研究的发展，对基于 PCR 的诊断的需求也不断增加。此外，PCR 仪器、化学品和软件的自动化、集成和持续改进提高了工作流程的性能、灵敏度和效率，从而推动了市场的扩张。
COVID-19 大流行进一步增加了对PCR 技术，特别是 COVID-19 检测。 PCR 技术的采用主要是由于对分子诊断、基因检测和个性化医疗的需求不断增长而推动的。一个主要障碍是 PCR 设备和用品的成本高昂，这使得它们在资源有限的环境中难以获得。随着人们对精准医学的兴趣日益浓厚以及对伴随诊断的需求，PCR 技术成为可能。此外，将 PCR 与微流控和下一代测序 (NGS) 等其他技术相结合，可以开辟新的研究机会并提高诊断能力。此外，开发针对新发传染病的创新 PCR 检测方法以及增加在法医学、农业和环境监测方面的应用，提供了巨大的市场扩张和多样化前景。
战略见解
市场驱动力和限制：
根据国家组织的报告关于遗传性疾病或先天性残疾的信息，遗传性疾病是罕见疾病，但每年总共有超过 15,500 例阳性诊断。美国 MJH 生命科学公司 2022 年发布的一份报告估计，全球每年约有 30 万新生儿出生时患有镰状细胞病 (SCD)，约占全球人口的 5%。在美国，SCD 是最普遍的遗传病之一。根据美国疾病控制与预防中心 (CDC) 的数据，每 500 名非裔美国人中就有 1 人患有 SCD，其中约 12 人中就有 1 人患有常染色体隐性突变。根据诺华公司（瑞士）2020 年 6 月的报告，每年约有 15,000 人和 270 名新生儿被诊断患有 SCD。这种疾病在印度等新兴国家最为流行。在印度的部落社区中，约 1800 万人表现出镰状细胞特征 (SCT)，140 万人患有 SCD。由于 SCD 发病率不断上升，病理中心越来越多地采用数字聚合酶链式反应 (dPCR)，其中该技术被用于靶向各种 DNA 特异性序列，以确认诊断并设计各种临床测试。 dPCR 可以仅针对一个 DNA 分子中的特定 DNA 序列。该工具使研究人员能够检测使用实时 PCR 难以识别的罕见基因突变。世界各地的政府和联邦机构都认识到定量聚合酶链式反应 (qPCR) 和 dPCR 产品在基因组研究中的作用。 2021年，为生物技术和制药领域提供基因的合成生物学初创公司Camena Bioscience完成了由Mercia领投的1000万美元A轮融资。利用额外资金，该公司扩大了业务，并继续开发其突破性的 DNA 合成平台 — gSynth。因此，针对特定疾病基因组学研究和开发的财政支持不断增加，以及遗传性疾病和传染病患病率的上升，推动了对 PCR 技术的需求。
根据 SafePath Laboratories, LLC 的说法，进入的最低成本-水平 PCR 机约为 10,000 美元。由于 dPCR 是一种现代 PCR 技术，大多数制造商通常为其最先进的 dPCR 仪器设定近 120,000 美元的溢价；然而，qPCR 机器的成本约为 90,000 美元。手动 dPCR 的价格从 65,000 美元到 70,000 美元不等，自动 dPCR 的价格可能升至 100,000 美元。在美国，截至 2022 年 7 月，根据仪器设计和预期用途/应用，dPCR 仪器的平均价格估计为 55,000-120,000 美元。一台实时 PCR 机的成本从 20,000 美元到 30,000 美元不等。此外，进行PCR检测所需的消耗品、试剂和配件价格昂贵。如此高的价格限制了喜欢更便宜的基因组技术的最终用户对 PCR 仪器和试剂的需求，特别是机构研究人员、小型 CRO 以及制药和生物技术公司。 RT-PCR 检测广泛用于诊断呼吸道传染病。 2020 年 9 月，F. Hoffmann-La Roche AG 在欧洲推出了 SARS-CoV-2 快速抗原检测。测试套件在 15 分钟内即可得出结果。同样，2021 年 3 月，XPhyto Therapeutics Corp. 的快速 COVID-19 测试系统在欧洲获得批准，该系统只需 25 分钟即可提供结果，比快速 PCR 测试快得多。因此，PCR技术的高成本和替代方案的可用性限制了PCR技术市场的增长。
细分分析：
PCR根据技术分为实时PCR、常规PCR、逆转录、数字 PCR (dPCR)、多重 RT-PCR、热启动 PCR 等。实时 PCR 细分市场在 2022 年占据最大市场份额，预计 2022 年至 2030 年复合年增长率最高，为 8.8%。实时 PCR 是一种基于核的方法，用于识别任何疾病（包括病毒）中的特定遗传物质。实时PCR已成为最广泛使用的基因定量方法之一。由于其动态范围、卓越的灵敏度、具有高度序列特异性的能力、无需扩增后处理以及提高样品通量的能力。
根据产品，PCR 分为试剂和耗材、仪器和软件和服务。试剂和耗材领域在 2022 年占据最大的市场份额，据说在 2022 年至 2030 年期间复合年增长率最高。
根据应用，PCR 技术市场分为基因表达分析、基因测序、基因分型、核酸合成、标准验证、护理点诊断应用、环境应用等。基因表达分析细分市场将在 2022 年占据更大的市场份额。此外，预计该细分市场在 2022 年至 2030 年期间将实现更高的复合年增长率。
根据最终用户，PCR 技术市场分为医院和诊断中心、制药和生物技术公司、研究实验室和学术机构等。医院和诊断中心细分市场在 2022 年占据最大的市场份额。此外，预计该细分市场在 2022 年至 2030 年期间复合年增长率最高。
区域分析：
北美是 PCR 的主导区域。 2022年北美PCR价值为50.7581亿美元，预计到2030年将达到96.3486亿美元；预计2022-2030年复合年增长率为8.30%。北美 PCR 分为美国、加拿大和墨西哥。生物分析仪器制造商和 PCR 公司对创新产品的需求不断增加、主要市场参与者的存在以及各个学术和研究机构进行的广泛研发是导致该地区市场增长的因素。美国正在寻求公共和私人组织的大量资金，以鼓励对先进研究方法的投资。例如，国际基因工程和生物技术中心旨在促进成员国之间的合作研究。美国食品和药物管理局（USFDA）致力于确保生物技术产品的安全。美国积极参与各种研究团体和组织举办的科学会议、研讨会和活动，帮助交流不同地区内基于 PCR 的趋势和最新研究成果。
欧洲在 PCR 技术市场中占有第二大份额。该地区的市场增长主要归功于政府和私人组织为高级研究提供的资金、人工 DNA 合成创新技术的推出以及基于新技术的应用的各种研究的增加。
亚太地区 PCR 技术市场复合年增长率最高。促进该地区市场进步的因素包括外国直接投资的增加、高技能、高效劳动力的大量供应以及政府政策的精简，从而导致生物技术领域的高投资。此外，传染病和慢性病病例的增加以及政府和非政府举措推动了亚太地区 PCR 技术市场的增长。
主要参与者分析：
Atila Biosystems、Thermo Fisher Scientific, Inc.；宝生物公司；标准生物工具公司； F.Hoffmann-La Roche AG、Bio-Rad Laboratories, Inc；安捷伦科技、BIOMERIEUX、QIAGEN、Promega 公司；贝克顿·迪金森公司；维斯比医疗有限公司；和 Ellume Limited 是市场研究期间分析的关键 PCR 技术参与者。由于其多样化的产品组合，F. Hoffman-La Roche AG 和 Thermo Fisher Scientific, Inc. 是 PCR 技术市场的两大参与者。
最新动态：
PCR 技术市场上的公司高度采用无机和有机技术并购等战略。下面列出了最近的一些关键市场发展：
2023 年 3 月，Stilla Technologies 和 Atila Biosystems 宣布，他们将合作创建用于与癌症相关的液体活检应用的数字 PCR 试剂盒。两家公司将共同努力将 Atila 的数字 PCR 试剂盒和检测方法商业化，这些试剂盒和检测方法可与 Stilla 的六色 Naica 系统一起使用。这些试剂盒仅用于研究目的，旨在从患有乳腺癌、肺癌、黑色素瘤、前列腺癌、结直肠癌等恶性肿瘤的个体的液体活检样本中识别循环肿瘤 DNA。2023 年 7 月，QIAGEN 宣布扩大其数字 PCR (dPCR) 产品用于在生物制药行业开发细胞和基因疗法。该公司与 Niba Labs 合作，为生物制药客户提供定制的数字 PCR 检测设计服务。此外，它还推出了新的 CGT 病毒载体裂解试剂盒，该试剂盒实现了从细胞裂解物到多种血清型病毒滴度的绝对和精确定量的标准化工作流程。2023 年 10 月，QIAGEN 和 Myriad Genetics 宣布了一项新的主合作协议，以开发伴随诊断测试在癌症领域。该合作伙伴关系旨在为制药公司提供创新服务和产品，促进美国临床市场专有癌症检测的开发和商业化，并为全球市场提供可分发的伴随诊断检测试剂盒。2023 年 11 月，Qiagen 推出了用于其 QIAcuity 系统和重大新软件更新旨在扩展数字 PCR 技术在细胞和基因治疗、DNA 和 RNA 定量以及食品和药品安全等领域的应用组合。
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
This text is related
to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
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to country scope.
Frequently Asked Questions
Global PCR technologies market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. The North America regional market is expected to grow with a CAGR of 8.3% during 2022–2030. Market growth in this region is attributed to the increased demand for innovative products from bioanalytical instrument manufacturers and PCR companies, the presence of key market players, and extensive R&D conducted across various academic and research institutes. In addition, the well-known practice of adopting medical devices in healthcare operations to improve quality and reduce costs also benefits the PCR technologies market in the US and other North American countries.
Hoffmann-La Roche Ltd and Thermo Fisher Scientific, Inc. are the top two companies that hold huge market shares in the PCR technologies market.
The PCR technologies market majorly consists of the players such Thermo Fisher Scientific Inc, Promega Corp, QIAGEN NV, bioMerieux SA, Hoffmann-La Roche Ltd, Bio-Rad Laboratories Inc, Becton Dickinson and Co, Atila Biosystems Inc, Takara Bio Inc, Standard BioTools Inc, Agilent Technologies Inc, Visby Medical Inc, and Ellume Ltd.
The gene expression analysis segment dominated the global PCR technologies market and held the largest market share of 23.25% in 2022.
The real time PCR segment held the largest share of the market in the global PCR technologies market and held the largest market share of 38.45% in 2022.
The CAGR value of the PCR technologies market during the forecasted period of 2022-2030 is 8.2%.
PCR is a sensitive technique that allows rapid amplification of a specific section of DNA. PCR creates billions of copies of a specific DNA fragment or gene, allowing detection and identification of gene sequences using visual techniques based on size and charge. PCR amplification produces the significant amounts of DNA required for molecular and genetic analysis. Technology variations are available to support PCR testing, including thermal cyclers, gradient PCR devices, PCR workstations and cabinets, and qPCR devices. Uses of PCR include genetic testing and tissue typing, detection of bacteria or viruses such as AIDS, DNA fingerprinting, and mapping.
Key factors that are driving the growth of this market are the rising prevalence of genetic and infectious diseases and surging investments and funds availability for PCR technologies.
The List of Companies - PCR Technology Market
- Thermo Fisher Scientific Inc
- Promega Corp
- QIAGEN NV
- bioMerieux SA
- Hoffmann-La Roche Ltd
- Bio-Rad Laboratories Inc
- Becton Dickinson and Co
- Atila Biosystems Inc
- Takara Bio Inc
- Standard BioTools Inc
- Agilent Technologies Inc
- Visby Medical Inc
- Ellume Ltd
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.
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