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市场调查报告书
商品编码
1374855
全球蛋白 A 树脂市场 - 2023-2030Global Protein A Resin Market - 2023-2030 |
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Protein A 树脂是一种层析介质,特别用于生物製药和生物技术工艺,主要用于纯化抗体,特别是单株抗体 (mAb)。这种树脂是生物製造下游加工的关键成分。此树脂固定有蛋白 A,使其能够从细胞培养上清液或生物製程液等混合物中捕获抗体。
此外,纯化过程包括将混合物加载到装有 Protein A 树脂的柱上,抗体与树脂结合。将树脂结合的抗体进行洗脱和处理以获得高纯度的抗体。该技术对于生产治疗性抗体和确保生物製药产品的安全性和有效性至关重要。
预计对抗体的需求不断增长将在预测期内推动市场发展。抗体所提供的优势不仅限于单一疾病,它们主要用于治疗多种疾病,包括各种类型的癌症、自体免疫疾病和传染病。因此,许多研究中心和市场参与者都在关注 Protein A 树脂市场的成长。
例如,2023 年 9 月 14 日,利默里克大学的爱尔兰科学基金会 (SFI) 製药研究中心 SPC 启动了与领先产业合作伙伴的第二阶段合作伙伴关係,以应对 Protein A 树脂市场的成长。该合作计画正在利用最先进的研究仪器来探索重复使用树脂的可能性和可行性,使抗体药物的生产更具成本效益和环境友好。
此外,单株抗体专门设计用于靶向参与疾病途径的特定分子,使其能够高效治疗各种严重疾病。这种特异性最大限度地减少了与其相关的副作用,并使单株抗体成为许多医疗状况的首选。甚至,许多关键参与者都专注于用于纯化和製造 mAb 的 Protein A 树脂。
例如,2020 年 3 月 18 日,全球领先的生命科学、先进技术和应用材料行业客户关键型产品和服务提供商 Avantor, Inc. 推出了一种新型重组 Protein A 亲和层析树脂,用于在mAb 生产过程中纯化抗体。 Protein A 层析是 mAb 生产中经过验证的下游纯化步骤。然而,仍需要降低总纯化成本,同时提高纯度和产率。众所周知,新型 Avantor 重组蛋白 A 树脂可以解决这些挑战。
此外,癌症和慢性病的盛行率不断增加、FDA 对 Protein A 树脂的批准不断增加、透过 Protein A 树脂纯化抗体的临床试验不断增加、人们对 Protein A 树脂优势的认识不断提高以及蛋白质开发的进步色谱树脂是预计在预测期内推动市场的因素。
与蛋白 A 树脂相关的复杂性、蛋白 A 浸出和毒性、低 pH 洗脱以及与蛋白 A 树脂相关的高成本等因素预计会阻碍市场发展。
Protein A resin is a chromatography medium that is especially used in biopharmaceutical and biotechnology processes mainly for the purification of antibodies, particularly monoclonal antibodies (mAbs). This resin is a key component of downstream processing in biomanufacturing. The resin is immobilized with protein A, allowing it to capture antibodies from a mixture like cell culture supernatant or bioprocess fluid.
Moreover, the purification process involves loading the mixture onto a column packed with protein A resin, where the antibodies bind to the resin. The resin-bound antibodies are eluted and processed to obtain highly pure antibodies. This technology is crucial for producing therapeutic antibodies and ensuring the safety and efficacy of biopharmaceutical products.
The increasing demand for antibodies is expected to drive the market over the forecast period. The advantages offered by antibodies are not only limited to a single disease, mainly they are employed in the treatment of a wide range of illnesses including various types of cancers, autoimmune disorders and infectious diseases. Thus many research centers and market players are focusing on the growth of the protein A resin market.
For instance, on September 14, 2023, SPC, the Science Foundation Ireland (SFI) Research Centre for Pharmaceuticals, at the University of Limerick launched phase two of a partnership with leading industry partners to address the growth in the protein A resin market. This collaborative project is using state of the art research instrumentation to explore the possibility and feasibility of reusing resins, making the production of antibody medicines, more cost-effective and environmentally friendly.
Moreover, mAbs especially designed to target the specific molecules involved in disease pathways, by making them highly effective in treating various serious diseases. This specificity minimizes the side effects associated with them and making mAbs a preferred choice for many medical conditions. Even, many key players are focussing on protein A resins for the purification and manufacturing of mAbs.
For instance, on March 18, 2020, Avantor, Inc., a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies and applied materials industries, launched a new recombinant Protein A affinity chromatography resin used to purify antibodies during mAbs production. Protein A chromatography is a proven downstream purification step in manufacturing mAbs. Yet, there remains a need to reduce the total purification costs while improving purity and yield. The new Avantor recombinant protein A resin is known to address these challenges.
Further, the increasing prevalence of cancers and chronic diseases, rising FDA approvals for the protein A resins, increasing clinical trials for the purification of antibodies by protein A resins, increasing awareness about the advantages of the protein A resins and advancements in the development of protein A chromatography resins are the factors expected to drive the market over the forecast period.
Factors such as complications associated with the protein A resins, protein A leaching and toxicity, low pH elution and the high cost associated with protein A resins are the factors expected to hamper the market.
The global protein A resin market is segmented based on product type, application, end-user and region.
The agarose-based protein A resins segment is expected to hold the largest market share over the forecast period. Agarose-based protein A resins are widely utilized in biopharmaceutical and biotechnology industries for the purification of monoclonal antibodies (mAbs) due to their high binding capacity and ability to efficiently capture and purify a large number of antibodies. They are also designed to address the purification of pH-sensitive antibodies.
For instance, on September 30, 2021, Purolite launched the novel next-generation chromatography resins, Praesto Jetted A50 HipH and Praesto Jetted (dT)18-DVB. Praesto Jetted A50 HipH is the world's first protein A alkaline stable resin based on a 50μm uniform agarose bead, designed to address the purification of pH-sensitive antibodies or other Fc-containing proteins. With 40 years of resin bead expertise, Purolite has combined 'Jetting' technology, an innovative process that produces uniform-size agarose beads with a very narrow particle size distribution together with a new, Protein A ligand, NGL-Impact A Hi pH, from Repligen Corporation.
Furthermore, agarose resins have excellent flow properties, that are essential for efficient chromatographic separation. Good flow properties allow for faster processing and better resolution. Agarose resins are chemically stable under a wide range of pH and salt conditions commonly used in protein purification processes. Agarose-based resins are compatible with various chromatography techniques including affinity chromatography, which is most commonly used for antibody purification.
North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and increasing adoption of protein A resins. North America especially the United States is known for its strong presence of major players such as biopharmaceutical and biotechnology companies. These companies are actively involved in the research, development and production of therapeutic monoclonal antibodies (mAbs) and other biologics by using protein A resins.
For instance, on January 27, 2021, Cytiva launched HiScreen Fibro PrismA, the newest product available for early monoclonal antibody (mAb) purification process development. The product complements HiTrap Fibro PrismA, the company's new fiber-based Protein A platform launched for research applications. The Fibro technology features an open porous adsorbent material comprising cellulose fibers designed for rapid mass transfer. Fibro PrismA uses the same chromatography systems, infrastructure and ligands as resin chromatography, which allows for a simple transition into existing biomanufacturing facilities.
Furthermore, increasing adoption of protein A resins in various biotechnology and biopharmaceutical industries is also expected to drive the market in the region. The demand for biologic therapies including antibodies and mAbs has been steadily increasing in the region, this further increases the adoption of the protein A resins for its purification.
The major global players in the protein A resin market include: GE Healthcare, Bio-Rad Laboratories, Inc., Merck KGaA, Thermo Fisher Scientific Inc., Tosoh Bioscience LLC, Cytiva, IPSUM LIFESCIENCES LLP, Repligen Corporation, Purolite Corporation and Avantor Inc among others.
The COVID-19 pandemic significantly impacted the global protein A resin market. During the pandemic, there is an increased demand for therapeutic antibodies and diagnostic tests for COVID-19. This resulted in an increased adoption and need for the purification of antibodies, where protein A resins play a crucial role. As a result, some manufacturers of protein A resins experienced increased demand for their products.
For instance, on February 08, 2021, Repligen Corporation, a life sciences company focused on bioprocessing technology leadership and Navigo Proteins GmbH, a premier protein engineering company specializing in novel affinity ligand development, released that they had completed the development and initiated the commercial launch of NGL COVID-19 Spike Protein Affinity Resin, a novel affinity resin to be utilized in the purification of COVID-19 vaccines.
The global protein A resin market report would provide approximately 61 tables, 62 figures, and 187 Pages.
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