市場調查報告書
商品編碼
1219674
全球蛋白A樹脂市場規模、份額、行業趨勢分析報告,按產品類型(瓊脂糖基、玻璃/二氧化矽基、有機聚合物基)、用途、類型、應用、區域展望和預測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 樹脂的全球市場規模預計到 2028 年將達到 19 億美元,預測期內復合年增長率為 6.1%。
天然蛋白 A 由 5 個 IgG 結合位點和一些作用未知的位點組成。 重組蛋白 A 由五個高親和力 IgG 結合部分和可切割結構域組成,以減少非特異性結合。 它有五個免疫球蛋白結合位點,每個位點都是 Fc 區內的重結合位點,能夠結合多種哺乳動物物種的蛋白質,包括 IgG(免疫球蛋白 G)。
這些是生物製造中最常用的親和樹脂。 製藥和生物技術公司對藥物進化的關注以及對合成生物學行業投資的增加預計將推動市場的增長。 生物製藥業務在其研究活動中廣泛使用蛋白質工程產品,以開發範圍廣泛的蛋白質藥物。
COVID-19 影響分析
正確理解和分析蛋白質樹脂在 SARS-CoV-2 病毒對策中的作用和結構對於藥物發現和治療方法的進步是必要的。 感染 SARS-CoV-2 病毒已導致研究實驗室關閉並阻礙研究分析。 此外,主要參與者已經採取了一些有意的步驟來開發單克隆抗體來治療 COVID-19 患者。 因此,生物技術和生物製藥企業也參與合併和合作,以開髮用於治療 COVID-19 患者的疫苗。 由於抗體純化需要蛋白A樹脂,因此作為抗擊疫情的對策,單克隆抗體產量正在增加,預計這將對疫情期間的市場產生積極影響。
市場增長因素
對藥物抗體的需求不斷增長
色譜法是純化 mAb(單克隆抗體)的重要工具。 因此,腫瘤學和其他製藥領域(包括自身免疫性疾病、炎症和神經系統疾病)對單克隆抗體的需求巨大。 正因如此,幾乎所有的大型製藥公司都將重點放在藥物抗體的研發上。 對藥物抗體的需求不斷增長正在顯著加速蛋白 A 樹脂市場的增長。
增加 CMOS 和 CROS
越來越多的 CMO 和 CRO 為世界各地的製藥公司提供設施。 預計這將為預測期內的蛋白 A 樹脂生產商提供潛在的發展機會。 製藥公司在多個研究領域越來越依賴合同製造商來滿足成本節約和專業能力等基本需求。 近年來,醫藥 CMO 經歷了強勁的發展,預計這一趨勢將在未來幾年繼續下去。 此外,政府要求削減醫療成本和簡化研發的壓力越來越大,迫使大型製藥公司依賴 CMO。 這已成為蛋白 A 樹脂市場增長的重要因素。
市場約束
樹脂成本高
Protein A 樹脂的成本是其他樹脂的 5 到 10 倍。 儘管沒有一種方法能達到與蛋白 A 樹脂一樣高的純化程度,但由於成本高昂,客戶正在尋找替代品。 因此,已經提出了幾種同時使用非色譜法和色譜法的純化方法。 PEG(聚乙二醇)沉澱和 mAb 結晶是已經研究過的蛋白質 A 層析的其他方法。 這種抑制因素的影響在拉丁美洲和亞太地區等新興市場更為明顯。 因此,蛋白 A 樹脂市場在預測期內可能會增長。
按類型劃分的前景
根據類型,蛋白 A 樹脂市場分為天然樹脂和重組樹脂。 2021 年,天然部分在蛋白 A 樹脂市場中佔據了很大的收入份額。 為了純化 mAb,衍生並獲得了金黃色葡萄球菌的細菌細胞。 此外,天然蛋白 A 樹脂在親和層析、疫苗和治療劑生產以及抗體純化等生物醫學研究中具有多種應用。 此外,預計該領域的擴展,因為它可以減輕傳統天然蛋白 A 樹脂的配體消除程序和穩定性問題。
按產品類型劃分的展望
根據產品類型,蛋白 A 樹脂市場分為基於瓊脂糖的蛋白 A、基於玻璃/矽膠的蛋白 A 和基於有機聚合物的蛋白 A。 到 2021 年,基於有機聚合物的蛋白 A 細分市場將在蛋白 A 樹脂市場中佔據相當大的收入份額。 這是由於大而快的分子剝離效應。 此外,它具有高生物降解性和生物相容性,廣泛應用於生物傳感器、成像、生物分離和藥物輸送等領域。
應用展望
蛋白 A 樹脂市場按應用類型分為抗體純化和免疫沉澱。 2021年,抗體純化領域在蛋白A樹脂市場的收入份額最高。 研究、工業用途和治療生產對 mAb 的需求一直存在。 抗體純化涉及從腹水、mAb 細胞培養上清液和多克隆抗體中富集和分離抗體。
結束使用 Outlook
蛋白 A 樹脂市場根據最終用途類型分為製藥和生物製藥公司、學術研究機構和其他。 2021 年,製藥和生物製藥領域將佔蛋白 A 樹脂市場的最高收入份額。 蛋白 A 樹脂在 mAb、藥物發現、治療學和生物製藥生產中的疫苗生產過程中的增加使用以及一致的製造程序的使用是蛋白 A 樹脂的促成因素。
區域展望
按地區分析,分析了北美、歐洲、亞太地區和 LAMEA 的蛋白 A 樹脂市場。 2021 年,北美地區將佔據最大的收入份額,推動蛋白 A 樹脂市場。 這是由於該地區對以蛋白質為基礎的療法治療傳染病的需求不斷增長,以及 FDA 批准的生物技術和製藥企業數量不斷增加。 此外,推動市場增長的主要公司之間的合併、收購和合作的數量也在增加。
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