Apheresis Market Developments by 2031
【研究报告】2022年全球单采市场规模为31.3305亿美元,预计到2030年单采市场规模将达到52.35亿美元,预计复合年增长率预测期内增长 8.29%。
市场洞察和分析师观点:
单采血液成分术是一种医疗程序,涉及从捐赠者或患者身上分离和提取特定的血液成分。这种治疗干预使用一种称为单采机的专用机器,它可以选择性地收集特定的血液成分,同时将剩余的血液返回给个体。根据目标医疗适应症,该过程通常涉及去除、分离和返回特定的血液成分,例如血浆、血小板、红细胞或白细胞。单采术对于治疗各种疾病至关重要,包括自身免疫性疾病、血液恶性肿瘤和某些神经系统疾病。该程序使医疗保健从业者能够对个人的血液成分进行治疗,解决某些疾病状态或采集特定的血液成分用于其他人的治疗用途。
增长驱动因素和机遇:
单采血液成分市场增长的主要驱动力是开发新技术的持续技术进步,这显着扩大了范围和这种治疗过程的复杂性,提供了更高的精确度和治疗潜力。现代创新导致了更有针对性和更高效的单采方法的发展,促进了特定血液成分的选择性提取、调制和回输,提高了准确性并减少了侵入性。这些进步为血浆分离术程序的定制化铺平了道路,从而能够针对不同的医疗适应症提供量身定制的治疗方案。此外,技术进步促进了自动化单采系统的集成,配备了先进的软件、实时监测功能和改进的生物相容性,从而提高了安全性、程序效率和患者舒适度。新型单采技术的发展,包括选择性免疫调节和细胞工程策略,体现了技术进步对扩大单采治疗范围的变革性影响,为个性化医疗和有针对性的疾病干预提供了有希望的途径。因此,这些技术进步有望提高单采术在广泛医学专业领域的临床实用性和影响力,强调其在解决复杂疾病状态和推进治疗性单采术前沿方面的关键作用。
另一方面,熟练专业人员的短缺是阻碍单采市场增长的重大挑战。单采手术需要操作单采机的专业知识、细致的患者监测以及对每个手术的治疗目标的全面了解。缺乏熟练执行单采技术的训练有素的专业人员可能会导致这些关键程序的可及性受到限制,可能会阻碍基于单采的疗法的及时和最佳实施。解决这一限制需要对培训计划、教育举措和专业发展努力进行战略投资,以培养一支能够满足单采服务不断增长的需求的熟练劳动力队伍。通过缓解单采领域熟练专业人员的短缺,医疗保健行业可以有效增强提供高质量、专业治疗的能力,从而促进单采市场的持续发展和扩张。
< p>战略见解报告细分和范围:
“全球单采市场”正在蓬勃发展。根据产品、单采程序、技术、应用和地区进行细分。单采市场大致分为设备和一次性用品。单采市场根据程序进行分类,例如白细胞去除术、血浆去除术、血小板去除术、红细胞去除术等。单采市场的技术部分大致分为离心和膜分离。根据应用,市场分为肾脏疾病、血液疾病、神经系统疾病、自身免疫性疾病和其他应用。基于地理位置的单采市场分为北美(美国、加拿大和墨西哥)、欧洲(德国、法国、意大利、英国和欧洲其他地区)、亚太地区(澳大利亚、中国、日本、印度、韩国、和亚太地区其他地区)、中东和非洲(南非、沙特阿拉伯、阿联酋以及中东和非洲其他地区)以及南美和非洲中美洲(巴西、阿根廷以及南美洲和中美洲其他地区)
细分分析:
根据应用,单采血液成分市场细分为肾脏疾病、血液疾病、神经系统疾病、自身免疫性疾病等应用程序。 2022年,单采市场收入主要归因于血液疾病,占比最大。血液系统疾病是指影响血液和造血器官的疾病,例如血小板、白细胞、红细胞、骨髓、淋巴结和脾脏的问题。在世界范围内,血液疾病对人们的发病率和死亡率有重大影响。根据 CDC 2022 年 5 月的更新,大约有 10 万美国人患有镰状细胞病 (SCD)。大约每 365 名出生的黑人或非裔美国人中就有 1 人经历过这种情况。如果患者患有血细胞问题,早期发现和治疗是挽救患者生命的最佳策略。因此,由于血液学事件负担的增加以及单采术作为血液疾病治疗策略的应用不断扩大,预计在整个预测期内,所研究的部分将会增加。
单采术根据产品细分市场分为一次性单采试剂盒和设备。由于血袋、一次性试剂盒和导管生产的显着进步,一次性单采试剂盒类别预计将继续保持其在市场上的主导地位,到 2022 年占据约 73% 的份额,并在整个预测中继续保持这一趋势时期。由于对自动化成分分离过程的需求不断增长,尤其是在发达经济体,该领域正在不断增长。
根据程序,单采血液成分市场分为白细胞去除术、血浆去除术、血小板去除术、红细胞去除术血浆分离术和其他血浆分离术程序。免疫系统受损的患者可以服用血浆药物来增强其对感染和疾病的抵抗力。随着血液相关疾病的增长以及对血浆治疗的需求不断增加,预计该市场将会扩大。使用血浆置换术从体内排出的血液中提取白细胞 (WBC)。移植物抗宿主病 (GvHD) 和 T 细胞淋巴瘤 (CTCL) 的治疗需要此类手术,预计这将增加对血浆置换的需求。
基于在技术领域,单采市场分为离心和膜分离。离心比膜过滤更快速、更容易、更精确地产生结果;它的使用更频繁。由于对自动血浆分离系统的需求不断增长,预计该市场也会增长。为了提高产品效率,企业正在开发自动化和高度现代化的技术小工具。制造商正在开发自动化接口系统、定制抗凝输注系统以及具有连续流离心功能的自动单采设备。
< span>区域分析:
根据地理位置,全球单采市场分为五个关键区域: 北美、 欧洲、亚太地区、南美和非洲中美洲、中东和非洲非洲。
由于肾脏疾病、代谢疾病、癌症和神经系统疾病等血液相关疾病的患病率不断上升,以及该地区完善的医疗保健系统,高患者意识,预计北美在整个预测期内将会增加。据白血病和癌症中心称,在美国,大约每三分钟就有一个人被诊断出患有血癌。淋巴瘤协会 (LLS) 2021。2021 年美国诊断出的 1,898,160 例新癌症病例中,白血病、淋巴瘤和骨髓瘤病例占 9.8%。由于目标疾病患病率不断上升,正在研究的市场正在扩大。
由于国家对操作和设备的报销规定不断扩大,对单采术的需求正在上升。联合医疗保健集团于 2022 年 1 月发布的联合医疗保健商业医疗政策为各种适应症的单采手术提供了医疗政策,但干细胞收获或收集用于骨髓/干细胞移植除外。该国的单采术市场最终是由现行的单采手术政策推动的,这些政策提高了目标人群对治疗的需求。
此外,单采术意识日美国血液分离学会 (ASFA) 于 2021 年 9 月 21 日宣布,随后将于每年 9 月的第三个星期二庆祝。使用循证实践来推进单采医学并提高认识,旨在向许多献身于拯救他人的捐献者、患者和单采从业者致敬。因此,在预测期内,前面提到的这些变量预计将极大提升北美单采市场。
行业发展及未来机遇:
全球单采血液成分市场主要参与者采取的各种举措如下:
- 2023 年 9 月,FDA 批准了 APHEXDA(motixafortide) )和 BioLineRx Ltd. 生产的非格司亭 (G-CSF) 用于动员多发性骨髓瘤患者外周血中的造血干细胞。干细胞将被收集,然后进行自体移植。 APHEXDA 的皮下使用是通过注射给药实现的。
- 2022 年 7 月,Eliaz Therapeutics 与 Terumo Blood and Cell Technologies 合作开发和销售一种独特的治疗性单采疗法,用于治疗急性肾损伤 (AKI) .
- 2022 年 6 月,英国 NHS 选择使用该公司的 Spectra Optia 血浆分离系统,自动红细胞交换 (RBCX) 程序来治疗镰状细胞病。 Terumo Blood and Cell Technologies 是一家医疗技术公司,专注于血液成分采集、治疗性单采和细胞技术的产品、软件和服务。这一决定将导致 Spectra Optia 在英格兰各地的医院得到更广泛的实施。镰状细胞病患者现在可以更好地获得这种改变游戏规则的药物。
- 2021 年 10 月,美国 FDA 为其支持 Persona 的 NexSys PCS 系统授予了 Haemonetics 510(k) 认证。
竞争格局和主要公司:
一些全球单采术市场的主要参与者包括旭化成公司、贝朗公司、费森尤斯公司和Co. KGAA (Fresenius Kabi AG)、Haemonetics Corporation、Terumo Corporation (Terumo BCT Inc.)、Kaneka Corporation、Sumitomo Bakelite Company Limited (Kawasumi Laboratories Inc.)、Medica SPA、Baxter International、Cerus Corporation、Macopharma SA、Otsuka Holdings Co . Ltd(JIMRO Co. Ltd)等。这些单采血液成分市场专注于新产品发布和地域扩张,以满足全球不断增长的消费者需求并增加其专业产品组合的产品范围。他们在全球范围内拥有广泛的影响力,能够为许多客户提供服务,从而增加他们的市场份额。该报告提供了单采市场趋势分析,强调了各种参数,例如技术进步、市场动态以及全球领先市场参与者的竞争格局分析。
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
This text is related
to country scope.
The List of Companies
1. Terumo BCT, Inc.
2. Fresenius SE & Co. KGaA
3. Haemonetics Corporation
4. Asahi Kasei Medical Co. Ltd.
5. B. Braun Melsungen AG
6. Baxter International Inc.
7. Cerus Corporation
8. Kaneka Corporation
9. Kawasumi Laboratories, Inc.
10. Nikkiso Co., 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.