市场调查报告书
商品编码
1219674
全球蛋白A树脂市场规模、份额、行业趋势分析报告,按产品类型(琼脂糖基、玻璃/二氧化硅基、有机聚合物基)、用途、类型、应用、区域展望和预测2022-2028Global Protein A Resin Market Size, Share & Industry Trends Analysis Report By Product Type (Agarose-based, Glass/Silica-based and Organic Polymer-based), By End Use, By Type, By Application, By Regional Outlook and Forecast, 2022 - 2028 |
蛋白 A 树脂的全球市场规模预计到 2028 年将达到 19 亿美元,预测期内復合年增长率为 6.1%。
天然蛋白 A 由 5 个 IgG 结合位点和一些作用未知的位点组成。 重组蛋白 A 由五个高亲和力 IgG 结合部分和可切割结构域组成,以减少非特异性结合。 它有五个免疫球蛋白结合位点,每个位点都是 Fc 区内的重结合位点,能够结合多种哺乳动物物种的蛋白质,包括 IgG(免疫球蛋白 G)。
这些是生物製造中最常用的亲和树脂。 製药和生物技术公司对药物进化的关注以及对合成生物学行业投资的增加预计将推动市场的增长。 生物製药业务在其研究活动中广泛使用蛋白质工程产品,以开发范围广泛的蛋白质药物。
COVID-19 影响分析
正确理解和分析蛋白质树脂在 SARS-CoV-2 病毒对策中的作用和结构对于药物发现和治疗方法的进步是必要的。 感染 SARS-CoV-2 病毒已导致研究实验室关闭并阻碍研究分析。 此外,主要参与者已经采取了一些有意的步骤来开发单克隆抗体来治疗 COVID-19 患者。 因此,生物技术和生物製药企业也参与合併和合作,以开髮用于治疗 COVID-19 患者的疫苗。 由于抗体纯化需要蛋白A树脂,因此作为抗击疫情的对策,单克隆抗体产量正在增加,预计这将对疫情期间的市场产生积极影响。
市场增长因素
对药物抗体的需求不断增长
色谱法是纯化 mAb(单克隆抗体)的重要工具。 因此,肿瘤学和其他製药领域(包括自身免疫性疾病、炎症和神经系统疾病)对单克隆抗体的需求巨大。 正因如此,几乎所有的大型製药公司都将重点放在药物抗体的研发上。 对药物抗体的需求不断增长正在显着加速蛋白 A 树脂市场的增长。
增加 CMOS 和 CROS
越来越多的 CMO 和 CRO 为世界各地的製药公司提供设施。 预计这将为预测期内的蛋白 A 树脂生产商提供潜在的发展机会。 製药公司在多个研究领域越来越依赖合同製造商来满足成本节约和专业能力等基本需求。 近年来,医药 CMO 经历了强劲的发展,预计这一趋势将在未来几年继续下去。 此外,政府要求削减医疗成本和简化研发的压力越来越大,迫使大型製药公司依赖 CMO。 这已成为蛋白 A 树脂市场增长的重要因素。
市场约束
树脂成本高
Protein A 树脂的成本是其他树脂的 5 到 10 倍。 儘管没有一种方法能达到与蛋白 A 树脂一样高的纯化程度,但由于成本高昂,客户正在寻找替代品。 因此,已经提出了几种同时使用非色谱法和色谱法的纯化方法。 PEG(聚乙二醇)沉淀和 mAb 结晶是已经研究过的蛋白质 A 层析的其他方法。 这种抑制因素的影响在拉丁美洲和亚太地区等新兴市场更为明显。 因此,蛋白 A 树脂市场在预测期内可能会增长。
按类型划分的前景
根据类型,蛋白 A 树脂市场分为天然树脂和重组树脂。 2021 年,天然部分在蛋白 A 树脂市场中占据了很大的收入份额。 为了纯化 mAb,衍生并获得了金黄色葡萄球菌的细菌细胞。 此外,天然蛋白 A 树脂在亲和层析、疫苗和治疗剂生产以及抗体纯化等生物医学研究中具有多种应用。 此外,预计该领域的扩展,因为它可以减轻传统天然蛋白 A 树脂的配体消除程序和稳定性问题。
按产品类型划分的展望
根据产品类型,蛋白 A 树脂市场分为基于琼脂糖的蛋白 A、基于玻璃/硅胶的蛋白 A 和基于有机聚合物的蛋白 A。 到 2021 年,基于有机聚合物的蛋白 A 细分市场将在蛋白 A 树脂市场中占据相当大的收入份额。 这是由于大而快的分子剥离效应。 此外,它具有高生物降解性和生物相容性,广泛应用于生物传感器、成像、生物分离和药物输送等领域。
应用展望
蛋白 A 树脂市场按应用类型分为抗体纯化和免疫沉淀。 2021年,抗体纯化领域在蛋白A树脂市场的收入份额最高。 研究、工业用途和治疗生产对 mAb 的需求一直存在。 抗体纯化涉及从腹水、mAb 细胞培养上清液和多克隆抗体中富集和分离抗体。
结束使用 Outlook
蛋白 A 树脂市场根据最终用途类型分为製药和生物製药公司、学术研究机构和其他。 2021 年,製药和生物製药领域将占蛋白 A 树脂市场的最高收入份额。 蛋白 A 树脂在 mAb、药物发现、治疗学和生物製药生产中的疫苗生产过程中的增加使用以及一致的製造程序的使用是蛋白 A 树脂的促成因素。
区域展望
按地区分析,分析了北美、欧洲、亚太地区和 LAMEA 的蛋白 A 树脂市场。 2021 年,北美地区将占据最大的收入份额,推动蛋白 A 树脂市场。 这是由于该地区对以蛋白质为基础的疗法治疗传染病的需求不断增长,以及 FDA 批准的生物技术和製药企业数量不断增加。 此外,推动市场增长的主要公司之间的合併、收购和合作的数量也在增加。
The Global Protein A Resin Market size is expected to reach $1.9 billion by 2028, rising at a market growth of 6.1% CAGR during the forecast period.
Protein A Resin is an affinity chromatography medium developed for one-step purification of classes, easy, fragments, and sub-classes of immunoglobulin from cell culture media and biological fluids. It could be utilized for protein complexes, antigens, or immunoprecipitation of proteins. The recombinant protein A ligand is combined with agarose.
The combining is maximized to provide a high tying ability for immunoglobulin. The static tying ability of Protein A Resin is more than 20 mg human IgG/ml fixed resin. The dynamic tying ability varies depending on specific factors like target antibody, flow rate, etc. Protein A is a bacterial cell wall protein distant from Staphylococcus aureus that merges with mammals primarily via the Fc region.
Native protein A has five IgG binding sections and several sections with undetermined roles. Recombinant protein A comprises five high-affinity IgG binding sections with other unnecessary domains detached to decrease nonspecific binding. It includes five immunoglobulin-tying sections, each of which can tie the proteins from several mammal species, most significantly IgG (Immunoglobulin G) by the heavy tie inside the Fc region.
These are the most often utilized affinity resins in biomanufacturing. Increasing emphasis on drug evolution by pharmaceutical & biotechnology and growing investment in synthetic biology industries would drive the market's growth. The biopharmaceutical businesses are widely utilizing protein-engineered products in its research activities to expand a wide variety of protein-based drugs.
COVID-19 Impact Analysis
Progress of drug discovery & therapeutics needs proper understanding and analysis of the role and structure of protein resins in combating SARS-CoV-2 virus. Altough, the enforced lockdown, the closing of the research institutions became an obstruction to the research analysis. Moreover, several planned measures have been enforced by leading players to develop mAbs to treat COVID-19 patients. Thus, biotechnology & biopharmaceutical businesses are also involved in mergers & collaboration for the growth of vaccines used in treating COVID-19 patients. As protein A resin is needed for purification of antibodies, the increasing production of mAb as a measure to tackle pandemic is predicted to positively affect the market in the pandemic period.
Market Growth Factors
Increasing demand for medicinal antibodies
Chromatography is a crucial measure in the purification of mAbs (monoclonal antibodies). Consequently, there has been an immense demand for monoclonal antibodies in oncology and other medicinal sectors, comprising autoimmune, inflammatory and neurological diseases. Due to this, nearly all significant pharmaceutical businesses are concentrating on the research & development of medicinal antibodies. The increasing demand for medicinal antibodies has significantly accelerated the growth of the protein A resin market.
Growing number of CMOS & CROS
A growing number of CMOs & CROs are providing their facilities to pharmaceutical industries worldwide. This is anticipated to offer potential development chances to protein A resin producers throughout the predicted period. Pharmaceutical businesses are progressively depending on contract producers in several research fields to attain essential needs, like cost reduction and specialized competencies. The pharmaceutical CMOs have accomplished robust development in recent years, and this tendency is anticipated to pursue in the upcoming years. Furthermore, the growing pressure from various governments to decrease healthcare rates and decrease R&D efficiency has forced the main pharmaceutical manufacturers to depend on CMOs. This serves as an important factor for the growth of the protein A resins market.
Market Restraining Factors
High cost associated with resins
Protein A resin's cost is about 5 to 10 times higher than any other resin. Although no other method could attain a purification degree as high as protein A resins, their high cost makes customers seek alternatives. A few methods offer an acceptable degree of purification that comprises both non-chromatography and chromatography techniques. PEG (polyethylene glycol) precipitation & mAb crystallization are being researched as other methods for protein A chromatography. The influence of this preventing factor is more apparent in developing markets like Latin America and the Asia Pacific. This may result in the growth of protein A resin market over the course of projection period.
Type Outlook
Based on the type, the protein A resin market is divided into natural and recombinant. In 2021, the natural segment garnered a significant revenue share in the protein A resin market. For the purification of mAbs, the bacterial cell of the staphylococcus aureus species is derived and acquired. Besides, natural protein A resins have various uses in biomedical research for affinity chromatography, vaccine & therapeutics production and antibody purification. Furthermore, the sector is predicted to expand because of its capability to reduce the ligand draining procedure and stability issues with traditional natural protein A resins.
Product Type Outlook
On the basis of product type, the protein A resin market is classified into agarose-based protein A, glass/silica-based protein A and organic polymer-based protein A. In 2021, the organic polymer-based protein A segment registered a substantial revenue share in the protein A resin market. This is credited to its large and fast molecule detachment effects. In addition, they have high biodegradability & biocompatibility, comprising a wide variety of usages in biosensors, imaging, bio-separation and drug delivery.
Application Outlook
By application type, the protein A resin market is bifurcated into antibody purification and immunoprecipitation. In 2021, the antibody purification segment witnessed the highest revenue share in the protein A resin market. There has been a consistent demand for mAbs for research, industrial purpose, and therapeutic production. Antibody purification involves the enrichment and isolation of antibodies from ascites fluids, cell culture supernatant of mAbs and polyclonal Abs.
End-Use Outlook
Based on the end-use type, the protein A resin market is classified into pharmaceutical & biopharmaceutical companies, academic research institutes and others. In 2021, the pharmaceutical & biopharmaceutical companies segment held the highest revenue share in the protein A resin market. The growing usage of protein A resins in mAbs, drug discovery, therapeutics and vaccine production processes in biopharmaceutical production, and the increasing utilization of constant production procedures are factors responsible for protein A resin.
Regional Outlook
Region-wise, the protein A resin market is analysed across North America, Europe, Asia Pacific and LAMEA. In 2021, the North America region led the protein A resin market by generating the largest revenue share. This is because of the growing demand for protein-based remedies for curing contagious diseases and the increasing amount of FDA-approved biotechnology and pharmaceutical businesses in this region. Furthermore, there is a growth in the number of mergers, acquisitions and collaborations between the main players that drive the market's growth.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include General Electric (GE) Co. (GE Healthcare), Repligen Corporation, PerkinElmer, Inc, Thermo Fisher Scientific, Inc., Merck Millipore (Merck Group), Genscript Biotech Corporation, Agilent Technologies, Inc., Abcam plc, and Novasep Holdings SAS (Azulis Capital).
Strategies Deployed in Protein A Resin Market
Nov-2022: Repligen Corporation extended its partnership with Purolite, an Ecolab Company, for the development and manufacturing of affinity ligands. Through this partnership extension, Repligen Corporation would expand its product line which goes well with the Proteins strategy and helps the acceleration in market adoption of the Praesto affinity resin portfolio.
Jun-2022: Bio-Rad Laboratories, Inc. launched EconoFit Low-Pressure Prepacked Chromatography Column Packs. This new product would help resin screening experiments in the development of protein purification workflows. Additionally, Bio-Rad's range of EconoFit Columns delivers a broad selection of resins in a pre-packed format, allowing customers to simply screen resins and choose the optimal chemistry for different target molecules. Columns are available in 1 ml and 5 ml sizes.
Oct-2021: Thermo Fisher Scientific, Inc unveiled the Thermo Scientific HyPeak chromatography system. It is the first single-use chromatography system for bioprocessing proposed by the company, with key applications in vaccine development and therapeutic protein. Other features include zero dead-leg and a ring flush valve manifold.
Sep-2021: Repligen Corporation took over Avitide Inc., a company that discovers, and supplies custom and catalog biopharmaceutical affinity purification solutions to the biopharmaceutical industry. Through this acquisition, Repligen Corporation would be able to strengthen and extends its ligand discovery and development capabilities.
Sep-2021: PerkinElmer, Inc., acquired BioLegend, a global developer, and manufacturer of antibodies and reagents used in biomedical research. Through this acquisition, PerkinElmer, Inc would improve its leading reagents suit and this would enable PerkinElmer to innovate and develop science for its customers.
Jun-2021: Repligen Corporation acquired Polymem S.A., a leading industry expert in the development and manufacture of hollow fiber membranes and modules. Under this acquisition, Repligen Corporation would be able to extend its module production capabilities and hollow fibre membrane which further adds core R&D, production expertise, and engineering in hollow fibre technology for both bioprocessing and industrial markets.
Aug-2018: Bio-Rad Laboratories, Inc., unveiled the CHT Ceramic Hydroxyapatite XT Media and Nuvia HP-Q Resin, which are the two new chromatography media for process protein purification. CHT XT delivers high-resolution and efficient single-step clearance of aggregates and other impurities such as dsDNA, HCP, and leached Protein A. On the other hand, Nuvia HP-Q Anion Exchange Resin can be used for downstream purification of large molecules such as high molecular weight (HMW) plasma proteins viruses, IgA and IgM, PEGylated proteins, and VLPs.
Market Segments covered in the Report:
By Product Type
By End Use
By Type
By Application
By Geography
Companies Profiled
Unique Offerings from KBV Research
List of Figures