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1374855

全球蛋白 A 樹脂市場 - 2023-2030

Global Protein A Resin Market - 2023-2030

出版日期: 2023年11月01日 | 出版商:

DataM Intelligence | 英文 187 Pages | 商品交期: 約2個工作天內

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簡介目錄

概述

Protein A 樹脂是一種層析介質，特別用於生物製藥和生物技術工藝，主要用於純化抗體，特別是單株抗體 (mAb)。這種樹脂是生物製造下游加工的關鍵成分。此樹脂固定有蛋白 A，使其能夠從細胞培養上清液或生物製程液等混合物中捕獲抗體。

此外，純化過程包括將混合物加載到裝有 Protein A 樹脂的柱上，抗體與樹脂結合。將樹脂結合的抗體進行洗脫和處理以獲得高純度的抗體。該技術對於生產治療性抗體和確保生物製藥產品的安全性和有效性至關重要。

市場動態：促進因素

對抗體的需求不斷增加

預計對抗體的需求不斷成長將在預測期內推動市場發展。抗體所提供的優勢不僅限於單一疾病，它們主要用於治療多種疾病，包括各種類型的癌症、自體免疫疾病和傳染病。因此，許多研究中心和市場參與者都在關注 Protein A 樹脂市場的成長。

例如，2023 年 9 月 14 日，利默里克大學的愛爾蘭科學基金會 (SFI) 製藥研究中心 SPC 啟動了與領先產業合作夥伴的第二階段合作夥伴關係，以應對 Protein A 樹脂市場的成長。該合作計畫正在利用最先進的研究儀器來探索重複使用樹脂的可能性和可行性，使抗體藥物的生產更具成本效益和環境友好。

此外，單株抗體專門設計用於靶向參與疾病途徑的特定分子，使其能夠高效治療各種嚴重疾病。這種特異性最大限度地減少了與其相關的副作用，並使單株抗體成為許多醫療狀況的首選。甚至，許多關鍵參與者都專注於用於純化和製造 mAb 的 Protein A 樹脂。

例如，2020 年 3 月 18 日，全球領先的生命科學、先進技術和應用材料行業客戶關鍵型產品和服務提供商 Avantor, Inc. 推出了一種新型重組 Protein A 親和層析樹脂，用於在mAb 生產過程中純化抗體。 Protein A 層析是 mAb 生產中經過驗證的下游純化步驟。然而，仍需要降低總純化成本，同時提高純度和產率。眾所周知，新型 Avantor 重組蛋白 A 樹脂可以解決這些挑戰。

此外，癌症和慢性病的盛行率不斷增加、FDA 對 Protein A 樹脂的批准不斷增加、透過 Protein A 樹脂純化抗體的臨床試驗不斷增加、人們對 Protein A 樹脂優勢的認知不斷提高以及蛋白質開發的進步色譜樹脂是預計在預測期內推動市場的因素。

限制

與蛋白 A 樹脂相關的複雜性、蛋白 A 浸出和毒性、低 pH 洗脫以及與蛋白 A 樹脂相關的高成本等因素預計會阻礙市場發展。

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.

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

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