全球蛋白 A 树脂市场 - 2023-2030
市场调查报告书
商品编码
1374855

全球蛋白 A 树脂市场 - 2023-2030

Global Protein A Resin Market - 2023-2030

出版日期: | 出版商: DataM Intelligence | 英文 187 Pages | 商品交期: 约2个工作天内

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简介目录

概述

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。

市场动态:驱动因素

对抗体的需求不断增加

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。

限制

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。

目录

第 1 章:方法与范围

  • 研究方法论
  • 报告的研究目的和范围

第 2 章:定义与概述

第 3 章:执行摘要

  • 按产品类型分類的片段
  • 按应用程式片段
  • 最终使用者的片段
  • 按地区分類的片段

第 4 章:动力学

  • 影响因素
    • 司机
      • 对抗体的需求不断增加
    • 限制
      • 低pH值洗脱
    • 机会
    • 影响分析

第 5 章:产业分析

  • 波特五力分析
  • 供应链分析
  • 定价分析
  • 监管分析
  • 管道分析
  • 未满足的需求
  • DMI 意见

第 6 章:COVID-19 分析

  • COVID-19 分析
    • 新冠疫情爆发前的情景
    • 新冠疫情期间的情景
    • 新冠疫情后的情景
  • COVID-19 期间的定价动态
  • 供需谱
  • 疫情期间政府与市场相关的倡议
  • 製造商策略倡议
  • 结论

第 7 章:按产品类型

  • 以琼脂糖为基底的 Protein A 树脂
  • 二氧化硅基蛋白 A 树脂
  • 磁性蛋白A树脂
  • 有机聚合物蛋白A树脂
  • 其他的

第 8 章:按应用

  • 单株抗体生产
  • 抗体纯化
  • 免疫沉淀
  • 其他的

第 9 章:最终用户

  • 生技公司
  • 製药公司
  • 生物製药公司
  • 学术及研究机构
  • 其他的

第 10 章:按地区

  • 北美洲
    • 我们
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 法国
    • 义大利
    • 西班牙
    • 欧洲其他地区
  • 南美洲
    • 巴西
    • 阿根廷
    • 南美洲其他地区
  • 亚太
    • 中国
    • 印度
    • 日本
    • 澳洲
    • 亚太其他地区
  • 中东和非洲

第 11 章:竞争格局

  • 竞争场景
  • 市场定位/份额分析
  • 併购分析

第 12 章:公司简介

  • GE Healthcare
    • 公司简介
    • 产品组合和描述
    • 财务概览
    • 主要进展
  • Bio-Rad Laboratories, Inc.
  • Merck KGaA
  • Thermo Fisher Scientific Inc.
  • Tosoh Bioscience LLC
  • Cytiva
  • IPSUM LIFESCIENCES LLP
  • Repligen Corporation
  • Purolite Corporation
  • Avantor Inc.

第 13 章:附录

简介目录
Product Code: BT7377

Overview

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.

Market Dynamics: Drivers

Increasing demand for antibodies

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.

Restraints

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.

Segment Analysis

The global protein A resin market is segmented based on product type, application, end-user and region.

The agarose-based protein A resins segment accounted for approximately 43.2% of the protein A resin market share

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.

Geographical Analysis

North America accounted for approximately 40.2% of the market share

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.

Competitive Landscape

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.

COVID-19 Impact Analysis

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.

Market Segmentation

By Product Type

  • Agarose-Based Protein A Resins
  • Silica-Based Protein A Resins
  • Magnetic Protein A Resins
  • Organic Polymer-based Protein A Resins
  • Others

By Application

  • Monoclonal Antibody Production
  • Antibody Purification
  • Immunoprecipitation
  • Others

By End-User

  • Biotechnology Companies
  • Pharmaceutical Companies
  • Biopharmaceutical Companies
  • Academic and Research Institutes
  • Others

By Region

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • U.K.
    • France
    • Spain
    • Italy
    • Rest of Europe
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa

Why Purchase the Report?

  • To visualize the global protein A resin market segmentation based on product type, application, end-user and region as well as understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development
  • Excel data sheet with numerous data points of protein A resin market-level with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping available as excel consisting of key products of all the major players.

The global protein A resin market report would provide approximately 61 tables, 62 figures, and 187 Pages.

Target Audience 2023

  • Manufacturers/ Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by Product Type
  • 3.2. Snippet by Application
  • 3.3. Snippet by End-User
  • 3.4. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Increasing Demand for Antibodies
    • 4.1.2. Restraints
      • 4.1.2.1. Low pH Elution
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's Five Force Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis
  • 5.5. Pipeline Analysis
  • 5.6. Unmet Needs
  • 5.7. DMI Opinion

6. COVID-19 Analysis

  • 6.1. Analysis of COVID-19
    • 6.1.1. Scenario Before COVID
    • 6.1.2. Scenario During COVID
    • 6.1.3. Scenario Post COVID
  • 6.2. Pricing Dynamics Amid COVID-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During the Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. By Product Type

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 7.1.2. Market Attractiveness Index, By Product Type
  • 7.2. Agarose-Based Protein A Resin*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Silica-Based Protein A Resin
  • 7.4. Magnetic Protein A Resin
  • 7.5. Organic Polymer-based Protein A Resin
  • 7.6. Others

8. By Application

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 8.1.2. Market Attractiveness Index, By Application
  • 8.2. Monoclonal Antibody Production*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Antibody Purification
  • 8.4. Immunoprecipitation
  • 8.5. Others

9. By End-User

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.1.2. Market Attractiveness Index, By End-User
  • 9.2. Biotechnology Companies*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Pharmaceutical Companies
  • 9.4. Biopharmaceutical Companies
  • 9.5. Academic and Research Institutes
  • 9.6. Others

10. By Region

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 10.1.2. Market Attractiveness Index, By Region
  • 10.2. North America
    • 10.2.1. Introduction
    • 10.2.2. Key Region-Specific Dynamics
    • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.2.6.1. U.S.
      • 10.2.6.2. Canada
      • 10.2.6.3. Mexico
  • 10.3. Europe
    • 10.3.1. Introduction
    • 10.3.2. Key Region-Specific Dynamics
    • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.3.6.1. Germany
      • 10.3.6.2. UK
      • 10.3.6.3. France
      • 10.3.6.4. Italy
      • 10.3.6.5. Spain
      • 10.3.6.6. Rest of Europe
  • 10.4. South America
    • 10.4.1. Introduction
    • 10.4.2. Key Region-Specific Dynamics
    • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.4.6.1. Brazil
      • 10.4.6.2. Argentina
      • 10.4.6.3. Rest of South America
  • 10.5. Asia-Pacific
    • 10.5.1. Introduction
    • 10.5.2. Key Region-Specific Dynamics
    • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.5.6.1. China
      • 10.5.6.2. India
      • 10.5.6.3. Japan
      • 10.5.6.4. Australia
      • 10.5.6.5. Rest of Asia-Pacific
  • 10.6. Middle East and Africa
    • 10.6.1. Introduction
    • 10.6.2. Key Region-Specific Dynamics
    • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

11. Competitive Landscape

  • 11.1. Competitive Scenario
  • 11.2. Market Positioning/Share Analysis
  • 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

  • 12.1. GE Healthcare*
    • 12.1.1. Company Overview
    • 12.1.2. Product Portfolio and Description
    • 12.1.3. Financial Overview
    • 12.1.4. Key Developments
  • 12.2. Bio-Rad Laboratories, Inc.
  • 12.3. Merck KGaA
  • 12.4. Thermo Fisher Scientific Inc.
  • 12.5. Tosoh Bioscience LLC
  • 12.6. Cytiva
  • 12.7. IPSUM LIFESCIENCES LLP
  • 12.8. Repligen Corporation
  • 12.9. Purolite Corporation
  • 12.10. Avantor Inc.

LIST NOT EXHAUSTIVE

13. Appendix

  • 13.1. About Us and Services
  • 13.2. Contact Us