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市場調査レポート
商品コード
1219674
プロテインA樹脂の世界市場規模、シェア、産業動向分析レポート製品タイプ別(アガロースベース、ガラス/シリカベース、有機ポリマーベース)、最終用途別、タイプ別、用途別、地域別展望・予測、2022年~2028年Global 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 |
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プロテインA樹脂の世界市場規模、シェア、産業動向分析レポート製品タイプ別(アガロースベース、ガラス/シリカベース、有機ポリマーベース)、最終用途別、タイプ別、用途別、地域別展望・予測、2022年~2028年 |
出版日: 2023年01月31日
発行: KBV Research
ページ情報: 英文 235 Pages
納期: 即納可能
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プロテインA樹脂の世界市場規模は、2028年には19億米ドルに達し、予測期間中にCAGR6.1%の市場成長率で上昇すると予測されています。
ネイティブプロテインAは、5つのIgG結合部といくつかの役割不明な部分から構成されています。リコンビナントプロテインAは、5つの高親和性IgG結合部と、非特異的結合を減少させるために不要なドメインを切り離したものから構成されています。5つの免疫グロブリン結合部があり、それぞれがFc領域内の重い結合部でIgG(Immunoglobulin G)をはじめとする複数の哺乳類種のタンパク質を結合することができます。
これらは、バイオ製造において最も頻繁に利用されているアフィニティーレジンです。製薬会社やバイオテクノロジー企業による薬剤の進化への重点的な取り組みや、合成生物学産業への投資の増加が、市場の成長を後押しすると思われます。バイオ医薬品ビジネスは、タンパク質ベースの薬剤を幅広く展開するための研究活動で、タンパク質工学製品を広く活用しています。
COVID-19インパクト分析
創薬・治療法の進歩には、SARS-CoV-2ウイルス対策におけるタンパク質樹脂の役割と構造を正しく理解し、分析することが必要です。SARS-CoV-2ウイルスの感染により、研究機関が閉鎖され、研究分析に支障をきたしました。さらに、COVID-19患者を治療するためのmAbを開発するために、いくつかの計画的な措置が主要なプレーヤーによって実施されています。このように、バイオテクノロジーと生物薬剤ビジネスは、COVID-19患者の治療に使用されるワクチンの成長のために合併やコラボレーションにも関与しています。プロテインA樹脂は抗体の精製に必要なため、パンデミック対策としてmAbの生産が増加しており、パンデミック期の市場にプラスの影響を与えると予測されています。
市場の成長要因
医薬用抗体の需要拡大
クロマトグラフィーはmAb(モノクローナル抗体)の精製に不可欠な手段です。その結果、自己免疫疾患、炎症性疾患、神経疾患などを含む腫瘍学やその他の医薬品分野において、モノクローナル抗体の膨大な需要が発生しています。このため、ほぼすべての主要な製薬会社は、医薬品用抗体の研究開発に注力しています。医薬品用抗体の需要の高まりは、プロテインA樹脂市場の成長を著しく加速させています。
CMOSとCROSの増加
世界中の製薬会社に施設を提供するCMOやCROの数が増加しています。このことは、予測される期間中、プロテインA樹脂の生産者に潜在的な発展の機会を提供すると予想されます。製薬会社は、コスト削減や専門的な能力といった本質的なニーズを達成するために、いくつかの研究分野で委託製造業者に依存するようになってきています。医薬品CMOはここ数年、力強い発展を遂げており、この傾向は今後数年間も続くと予想されます。さらに、医療費削減や研究開発の効率化を求める各国政府の圧力が強まり、主要な製薬メーカーはCMOへの依存を余儀なくされています。これは、プロテインA樹脂市場の成長にとって重要な要因となっています。
市場の抑制要因
樹脂のコスト高
プロテインA樹脂のコストは、他の樹脂の5倍から10倍程度です。プロテインA樹脂ほど高い精製度を達成できる方法はありませんが、コストが高いため、顧客は代替方法を求めています。そこで、ノンクロマトグラフィーとクロマトグラフィーを併用した精製方法がいくつか提案されています。PEG(ポリエチレングリコール)沈殿法やmAb結晶化法は、プロテインAクロマトグラフィーの他の方法として研究されています。この阻害要因の影響は、ラテンアメリカやアジア太平洋地域などの新興国市場においてより顕著です。このため、プロテインA樹脂の市場は予測期間中に成長する可能性があります。
タイプ別展望
タイプに基づき、プロテインA樹脂市場は天然と組み換えに分けられます。2021年に、天然セグメントは、タンパク質A樹脂市場で重要な収益シェアを獲得しました。mAbsの精製のために、黄色ブドウ球菌の種の細菌細胞は、派生して取得されます。その上、天然プロテインA樹脂は、アフィニティークロマトグラフィー、ワクチン&治療薬生産、抗体精製のための生物医学研究において様々な用途があります。さらに、従来の天然プロテインA樹脂が抱えていたリガンド排出の手順や安定性の問題を軽減できることから、この分野の拡大が予測されています。
製品タイプ別の展望
製品タイプに基づいて、プロテインA樹脂市場は、アガロースベースプロテインA、ガラス/シリカベースプロテインA、有機ポリマーベースプロテインAに分類されます。2021年、有機ポリマーベースプロテインAセグメントは、プロテインA樹脂市場でかなりの収益シェアを記録しています。これは、分子の剥離効果が大きく高速であることに起因しています。さらに、高い生分解性と生体適合性を持ち、バイオセンサー、イメージング、バイオセパレーション、ドラッグデリバリーなど幅広い用途で使用されています。
アプリケーションの展望
プロテインA樹脂市場は、アプリケーションの種類によって、抗体精製と免疫沈降に二分されます。2021年には、抗体精製セグメントがプロテインA樹脂市場で最も高い収益シェアを示しました。研究、産業目的、治療用生産のために、mAbの一貫した需要があります。抗体精製には、腹水、mAbの細胞培養上清、ポリクローナルAbsからの抗体の濃縮と単離が含まれます。
最終用途の展望
プロテインA樹脂市場は、エンドユースタイプに基づき、製薬&バイオ製薬会社、学術研究機関、その他に分類されます。2021年のプロテインA樹脂市場では、製薬・バイオ製薬企業分野が最も高い収益シェアを占めています。バイオ医薬品製造におけるmAb、創薬、治療薬、ワクチン製造工程でのプロテインA樹脂の使用量の増加、および一定の製造手順の利用がプロテインA樹脂の要因です。
地域別の展望
地域別に見ると、プロテインA樹脂市場は、北米、欧州、アジア太平洋、LAMEAで分析されています。2021年には、北米地域が最大の収益シェアを獲得し、プロテインA樹脂市場を牽引しました。これは、伝染病を治すためのタンパク質ベースの治療薬に対する需要が高まっていることと、この地域でFDA認可のバイオテクノロジーおよび製薬事業が増加しているためです。さらに、市場の成長を後押しする主要企業間の合併・買収・提携の件数も増加しています。
List of Figures
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