PEG化タンパク質の市場規模：地域別、範囲および予測

PEG化タンパク質の市場規模と予測

PEG化タンパク質の市場規模は、2023年に13億4,000万米ドルと評価され、2024年から2031年にかけて11.22%のCAGRで成長し、2031年には31億4,000万米ドルに達すると予測されています。PEG化タンパク質は、その表面にポリエチレングリコール（PEG）鎖を付加して化学的に変化させたものです。この手順には、タンパク質の特定の位置にPEG分子を共有結合させることが含まれ、溶解性、安定性、薬物動態などの特徴に影響を与えます。PEG化は、タンパク質医薬品の治療効果と安全性を高めるためにバイオ医薬品に用いられる典型的な技術です。PEG鎖を組み込むことにより、クリアランス率を低下させ、バイオアベイラビリティを高め、投与レジメンの回数を少なくすることにより、血流中でのタンパク質の循環時間を長くすることができます。

さらに、PEG化は免疫原性やタンパク質分解のリスクを最小限に抑え、タンパク質療法の安定性と効力を高めることができます。この技術は、成長因子、酵素、ホルモン、モノクローナル抗体などのタンパク質ベースの薬剤の長時間作用型製剤を作成するために、腫瘍学、血液学、免疫学、代謝性疾患などのさまざまな医療分野で使用されています。

PEG化タンパク質の世界市場力学

主な市場促進要因

薬効と安定性の向上：

タンパク質にポリエチレングリコール（PEG）鎖を結合させるPEG化は、タンパク質ベースの治療薬の安定性と溶解性を著しく向上させる。この変化によって薬物の半減期が延び、免疫原性が低下し、バイオアベイラビリティが向上するため、治療用途での需要が高まる。

慢性疾患の有病率の増加：

がん、糖尿病、自己免疫疾患などの慢性疾患の有病率が上昇しているため、効果的な治療薬に対する需要が高まっています。その結果、PEG化タンパク質は薬物動態が向上し、投与回数が少なくて済むため、これらの疾患の治療に使用される機会が増えており、市場の成長を後押ししています。

ドラッグデリバリー技術の進歩：

ドラッグ・デリバリー・システムの技術的進歩は、特定の組織や臓器により正確に標的を定めることができるPEG化タンパク質の製造に役立っており、副作用を軽減し、治療効果を高めています。このため、個別化医療への導入が加速しています。

バイオ医薬品の研究開発の増加：

バイオ医薬品業界が革新的な生物製剤の研究開発に力を入れるようになった結果、PEG化はタンパク質ベースの医薬品の質を向上させるために研究され、利用されています。バイオ医薬品の研究開発に対する資金提供や支援の増加は、PEG化タンパク質市場を前進させています。

主な課題

開発・製造コストの高さ：

タンパク質をPEG化するプロセスは難しく、技術や経験に多大な投資を必要とするため、開発・生産コストが上昇します。このような費用の増加は、市場へのアクセスや入手を制限し、市場成長の障壁となります。

潜在的な免疫原性と安全性の懸念：

PEG化は免疫原性を最小化するために利用されるが、PEG分子自体が特定の患者に免疫学的反応を引き起こします。こうした安全性の問題に対処し、長期的な有効性と安全性を実証することは、市場にとって大きな課題となります。

代替ドラッグデリバリーシステムとの競合：

脂質ナノ粒子やポリマーベースのシステムなどの新しいドラッグデリバリー技術が、PEG化タンパク質市場を圧迫しています。これらの代替技術は、薬物の安定性、有効性、標的分布の点で同等またはそれ以上の利点を提供し、PEG化タンパク質の優位性に課題しています。

主要動向：

標的ドラッグデリバリーの革新：

標的薬物送達が可能なPEG化タンパク質を製造する傾向が高まっています。この方法は、特にがんや慢性疾患の治療において、傷害を受けた細胞に選択的に薬剤を誘導し、副作用を抑え、有効性を高めることで治療効果を高めようとするものです。

希少疾患への拡大：

PEG化タンパク質の市場は、希少疾患や希少疾病の治療へとシフトしています。PEG化によって薬物動態が改善され、免疫原性が低下するため、これらの医薬品は代替療法が限られている希少疾患の治療に適しています。

併用療法：

PEG化タンパク質の併用療法への関心が高まっています。これは、PEG化医薬品を他の治療薬と組み合わせることで、治療効果を向上させ、薬剤耐性をなくし、特にがんのような複雑な病態における疾病管理に包括的なアプローチを与えるものです。

PEG化技術の進歩：

この分野では、PEG分子のタンパク質への部位特異的な結合を達成することに焦点を当て、PEG化法を常に改良しています。この精度は薬剤の治療プロファイルを最適化し、患者の転帰を改善し、副作用を減少させ、より効果的で安全な治療をもたらします。

目次

第1章 PEG化タンパク質の世界市場イントロダクション

• 市場概要
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 PEG化タンパク質の世界市場展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 PEG化タンパク質の世界市場：エンドユーザー別

• 概要
• 製薬・バイオテクノロジー企業
• 受託研究機関
• 学術研究機関

第6章 PEG化タンパク質の世界市場：用途別

• 概要
• がん治療
• 肝炎
• 慢性腎臓病
• 血友病
• 多発性硬化症
• 胃腸障害
• その他

第7章 PEG化タンパク質の世界市場：製品別

• 概要
• 消耗品
• サービス

第8章 PEG化タンパク質の世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他アジア太平洋地域
• 世界のその他の地域
  • ラテンアメリカ
  • 中東・アフリカ

第9章 PEG化タンパク質の世界市場：競合情勢

• 概要
• 各社の市場ランキング
• 主な開発戦略

第10章 企業プロファイル

• Merck Millipore
• Thermo Fisher Scientific Inc.
• NOF American Corporation（A Subsidiary of NOF Corporation）
• Jenkem Technology
• Creative Pegworks
• Celares GmbH
• Quanta Biodesign, Ltd
• Biomatrik, Inc.
• Iris Biotech GmbH
• Laysan Bio, Inc.

第11章 主な発展

• 製品上市／開発
• 合併と買収
• 事業拡大
• パートナーシップと提携

第12章 付録

• 関連調査

PEGylated Proteins Market Size And Forecast

PEGylated Proteins Market size was valued at USD 1.34 Billion in 2023 and is projected to reach USD 3.14 Billion by 2031, growing at a CAGR of 11.22% from 2024 to 2031. PEGylated proteins are those that have been chemically changed by adding polyethylene glycol (PEG) chains to their surfaces. This procedure includes covalently attaching PEG molecules to specific protein locations, affecting features like solubility, stability, and pharmacokinetics. PEGylation is a typical technique used in biopharmaceuticals to enhance the therapeutic efficacy and safety of protein medicines. The inclusion of PEG chains can increase protein circulation time in the bloodstream by lowering clearance rates, increasing bioavailability and allowing for fewer frequent dosage regimens.

Furthermore, PEGylation can also minimize immunogenicity and the risk of proteolytic degradation, increasing the stability and potency of protein therapies. This technology has been used in a variety of medical fields, including oncology, haematology, immunology, and metabolic disorders, to create long-acting formulations of protein-based drugs like growth factors, enzymes, hormones, and monoclonal antibodies.

Global PEGylated Proteins Market Dynamics

The key market dynamics that are shaping the PEGylated proteins market include:

Key Market Drivers

Enhanced Drug Efficacy and Stability:

PEGylation, which involves connecting polyethylene glycol (PEG) chains to proteins, significantly improves the stability and solubility of protein-based therapies. This change increases the drug's half-life, decreases immunogenicity, and improves bioavailability, boosting demand in therapeutic applications.

Growing Prevalence of Chronic Diseases:

The rising prevalence of chronic diseases such as cancer, diabetes, and autoimmune diseases has created a greater demand for effective treatment agents. As a result, PEGylated proteins are increasingly being used to treat these disorders due to their enhanced pharmacokinetics and lower dose frequency, propelling the market growth.

Advancements in Drug Delivery Technologies:

Technological advances in drug delivery systems have aided in the production of PEGylated proteins that may be targeted more accurately to specific tissues or organs, reducing side effects and enhancing therapeutic outcomes. This has accelerated their uptake in personalised medicine.

Increased Biopharmaceutical R&D:

PEGylation is being explored and used to improve the qualities of protein-based medicines as a result of the biopharmaceutical industry's increasing focus on the study and development of innovative biologics. Increased funding and support for biopharmaceutical R&D are propelling the PEGylated proteins market forward.

Key Challenges:

High Cost of Development and Production:

The process of PEGylating proteins is difficult and needs significant investment in technology and experience, which raises development and production costs. These increasing expenses limit accessibility and affordability, creating a barrier to market growth.

Potential Immunogenicity and Safety Concerns:

Even though PEGylation is utilized to minimize immunogenicity, the PEG molecule itself provokes immunological responses in certain patients. Addressing these safety issues and demonstrating long-term efficacy and safety pose considerable challenges for the market.

Competition from Alternative Drug Delivery Systems:

Emerging drug delivery technologies such as lipid nanoparticles and polymer-based systems are putting pressure on the PEGylated protein market. These alternatives provide comparable or superior benefits in terms of medication stability, effectiveness, and targeted distribution, challenging the dominance of PEGylated proteins.

Key Trends:

Targeted Drug Delivery Innovations:

There is a growing trend in producing PEGylated proteins capable of targeted medication delivery. This method strives to enhance therapeutic outcomes by directing the medicine selectively to damaged cells, lowering side effects and enhancing efficacy, especially in the treatment of cancer and chronic disorders.

Expansion into Rare Diseases:

The market for PEGylated proteins is shifting towards the treatment of rare and orphan diseases. PEGylation enhances pharmacokinetics and reduces immunogenicity, making these medicines good candidates for treating uncommon illnesses with limited therapy alternatives.

Combination Therapies:

There is increasing interest in utilizing PEGylated proteins in combination therapy. This entails combining PEGylated pharmaceuticals with other therapeutic agents to improve treatment efficacy, eliminate drug resistance, and give a comprehensive approach to illness management, particularly in complicated conditions such as cancer.

Advances in PEGylation Techniques:

The field is constantly improving PEGylation methods, with a focus on attaining site-specific attachment of PEG molecules to proteins. This precision optimizes the drug's therapeutic profile, improves patient outcomes, and reduces unwanted effects, resulting in more effective and safer treatments.

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Global PEGylated Proteins Market Regional Analysis

Here is a more detailed regional analysis of the PEGylated proteins market:

North America:

According to Verified Market Research, North America is estimated to dominate the PEGylated Proteins Market over the forecast period. North America, particularly the United States, has a highly developed healthcare system, with cutting-edge medical facilities and research organizations. This advanced infrastructure enables substantial research and development operations, resulting in the rapid advancement and implementation of PEGylated protein therapeutics.

The region is experiencing significant investments in biopharmaceutical research and development, led by both the public and commercial sectors. This financial support hastens the discovery of new PEGylated proteins, propelling North America forward in the worldwide market.

Furthermore, North America is home to many of the world's leading biotech and pharmaceutical businesses, which play an important role in the development and commercialization of PEGylated proteins. The region's market supremacy is due in large part to these companies' strategic concentration on PEGylation technologies.

Europe:

Europe's well-established healthcare infrastructure, which includes widespread access to healthcare services and high-quality medical facilities, promotes the acceptance and dissemination of novel treatments. The infrastructure also aids clinical trials and research, which improves the region's ability to develop and execute PEGylated protein therapeutics.

Investment in biopharmaceutical R&D is on the rise in Europe, due to both public and private funding. This financial support drives the discovery and development of new PEGylated protein medicines, which helps the region flourish in the market.

Furthermore, the European Medicines Agency (EMA) provides a cohesive regulatory framework for Europe, facilitating the approval and commercialization of sophisticated medicinal products such as PEGylated proteins. Also, some EU member states provide incentives for pharmaceutical research and innovation, thereby encouraging expansion in this sector.

Asia Pacific:

The Asia Pacific region's healthcare sector is rapidly expanding, driven by increased investments in healthcare infrastructure and a greater emphasis on modern medical treatments. This expansion promotes the use and integration of novel medicines, such as PEGylated proteins.

Chronic disease prevalence is increasing in Asia Pacific countries, with cancer, diabetes, and cardiovascular ailments being particularly common. This expanding disease burden increases the demand for effective and innovative treatments, with PEGylated proteins emerging as a possible answer due to their increased efficacy and lower adverse effects.

Furthermore, the region has emerged as a hotspot for pharmaceutical research and development, due to cheaper costs and a competent workforce. This environment promotes the creation and testing of PEGylated proteins, with backing from both domestic and international pharmaceutical businesses looking to capitalize on the burgeoning market.

Global PEGylated Proteins Market Segmentation Analysis

The PEGylated Proteins Market is segmented based on Product, Protein Type, Application, End-User and Geography.

PEGylated Proteins Market, By Product

• Consumables
• PEGylation Reagents
• PEGylation Kits
• Services

Based on the Product, the market is segmented into Consumables and Services. The consumables segment is estimated to dominate the PEGylated proteins market due to the vital role these consumables play in the PEGylation process, which improves the stability, solubility, and half-life of protein-based therapies. The consistent demand for these consumables at both the research and commercial production levels contributes greatly to their market dominance.

PEGylated Proteins Market, By Protein Type

• Colony Stimulating Factors (CSFs)
• Interferons
• Erythropoietin
• Monoclonal Antibodies
• Recombinant Factor VIII
• Others

Based on Protein Type, the market is segmented into Colony Stimulating Factors, Interferons, Erythropoietin, Monoclonal Antibodies, Recombinant Factor VIII and Others. The colony-stimulating factors (CSFs) segment is estimated to dominate the PEGylated proteins market due to its vital role in the treatment of neutropenia, a common side effect of chemotherapy, especially in cancer patients. CSFs are necessary for increasing the generation of white blood cells, which reduces the risk of infection in people with impaired immune systems. The discovery of PEGylated versions of CSFs has greatly enhanced clinical efficacy by prolonging their half-life, reducing dose frequency and increasing patient compliance.

PEGylated Proteins Market, By Application

• Cancer Treatment
• Hepatitis
• Chronic Kidney Diseases
• Hemophilia
• Multiple Sclerosis
• Gastrointestinal Disorders
• Others

Based on Application, the market is segmented into Cancer Treatment, Hepatitis, Chronic Kidney Diseases, Hemophilia, Multiple Sclerosis, Gastrointestinal Disorders and Others. The cancer treatment segment is estimated to dominate the PEGylated proteins market due to the rising global cancer incidence and the urgent demand for effective treatments. PEGylated proteins have shown great promise in enhancing the efficacy and lowering the adverse effects of cancer medicines, making them an essential component of oncology therapy regimens. The targeted delivery properties of PEGylated proteins allow for the precision targeting of malignant cells while minimizing damage to healthy tissues and improving patient outcomes.

PEGylated Proteins Market, By End-User

• Pharmaceutical & Biotechnology Companies
• Contract Research Organizations (CROs)
• Academic Research Institutes

Based on End-User, the market is divided into Pharmaceutical & Biotechnology Companies, Contract Research Organizations (CROs) and Academic Research Institutes. The pharmaceutical & biotechnology companies segment is estimated to dominate the market over the forecast period due to their critical role throughout the whole lifetime of PEGylated proteins, from discovery and development to commercialization. These firms make major investments in research and development, fueling innovation in PEGylated protein therapeutics to meet unmet medical needs. Furthermore, they have the infrastructure, resources, and knowledge to traverse the complicated regulatory channels, enabling the successful market debut of these products.

PEGylated Proteins Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the world

Based on Geography, the PEGylated proteins market is classified into North America, Europe, Asia Pacific, and the Rest of the world. North America is estimated to dominate the market during the forecasted period. North America, particularly the United States, has a well-developed healthcare infrastructure as well as a vibrant pharmaceutical research and development ecosystem, which is supported by major public and private sector investments. This region is home to some of the world's leading biopharmaceutical companies, which drive innovation in medication research, including the progress of PEGylated protein therapeutics. Furthermore, the presence of strong regulatory organizations such as the FDA assures that pharmaceutical products are of high quality and safe, encouraging more investment in the sector.

Key Players

• The "PEGylated Proteins Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
• Merck KGaA, F. Hoffmann-La Roche Ltd, Johnson & Johnson, Pfizer Inc., Novartis AG, Amgen Inc., Eli Lilly and Company, AbbVie Inc., Celgene Corporation, Samsung BioLogics Co., Bristol-Myers Squibb Company, GlaxoSmithKline plc, Sanofi S.A., Bayer AG, AstraZeneca plc and Boehringer Ingelheim GmbH.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Key Developments

• In November 2022, Nektar Therapeutics made significant progress by presenting preclinical data for NKTR-288 at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. NKTR-288, a PEG-conjugate of interferon-gamma (IFN-Y), intends to change IFN-Y binding to substrates and optimize the duration of IFN-Y signalling, with potential uses in oncology and infectious disorders.
• In July 2022, Merck KGaA announced the purchase of Exelead, a biopharmaceutical CDMO that specializes in PEGylated pharmaceuticals and complicated injectable formulations, incorporating lipid nanoparticle (LNP)-based drug delivery technology. Merck KGaA's acquisition enhances its ability to provide novel PEGylated protein medicines.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL PEGYLATED PROTEINS MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL PEGYLATED PROTEINS MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL PEGYLATED PROTEINS MARKET, BY END-USER

• 5.1 Overview
• 5.2 Pharmaceutical & Biotechnology Companies
• 5.3 Contract Research Organisations
• 5.4 Academic Research Institutes

6 GLOBAL PEGYLATED PROTEINS MARKET, BY APPLICATION

• 6.1 Overview
• 6.2 Cancer Treatment
• 6.3 Hepatitis
• 6.4 Chronic Kidney Disease
• 6.5 Hemophilia
• 6.6 Multiple Sclerosis
• 6.7 Gastrointestinal Disorder
• 6.8 Other

7 GLOBAL PEGYLATED PROTEINS MARKET, BY PRODUCT

• 7.1 Overview
• 7.2 Consumables
• 7.3 Services

8 GLOBAL PEGYLATED PROTEINS MARKET, BY GEOGRAPHY

• 8.1 Overview
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 U.K.
  • 8.3.3 France
  • 8.3.4 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Rest of Asia Pacific
• 8.5 Rest of the World
  • 8.5.1 Latin America
  • 8.5.2 Middle East and Africa

9 GLOBAL PEGYLATED PROTEINS MARKET COMPETITIVE LANDSCAPE

• 9.1 Overview
• 9.2 Company Market Ranking
• 9.3 Key Development Strategies

10 COMPANY PROFILES

• 10.1 Merck Millipore
  • 10.1.1 Overview
  • 10.1.2 Financial Performance
  • 10.1.3 Product Outlook
  • 10.1.4 Key Developments
• 10.2 Thermo Fisher Scientific Inc.
  • 10.2.1 Overview
  • 10.2.2 Financial Performance
  • 10.2.3 Product Outlook
  • 10.2.4 Key Developments
• 10.3 NOF American Corporation (A Subsidiary of NOF Corporation)
  • 10.3.1 Overview
  • 10.3.2 Financial Performance
  • 10.3.3 Product Outlook
  • 10.3.4 Key Developments
• 10.4 Jenkem Technology
  • 10.4.1 Overview
  • 10.4.2 Financial Performance
  • 10.4.3 Product Outlook
  • 10.4.4 Key Developments
• 10.5 Creative Pegworks
  • 10.5.1 Overview
  • 10.5.2 Financial Performance
  • 10.5.3 Product Outlook
  • 10.5.4 Key Developments
• 10.6 Celares GmbH
  • 10.6.1 Overview
  • 10.6.2 Financial Performance
  • 10.6.3 Product Outlook
  • 10.6.4 Key Developments
• 10.7 Quanta Biodesign, Ltd
  • 10.7.1 Overview
  • 10.7.2 Financial Performance
  • 10.7.3 Product Outlook
  • 10.7.4 Key Developments
• 10.8 Biomatrik, Inc.
  • 10.8.1 Overview
  • 10.8.2 Financial Performance
  • 10.8.3 Product Outlook
  • 10.8.4 Key Developments
• 10.9 Iris Biotech GmbH
  • 10.9.1 Overview
  • 10.9.2 Financial Performance
  • 10.9.3 Product Outlook
  • 10.9.4 Key Developments
• 10.10 Laysan Bio, Inc.
  • 10.10.1 Overview
  • 10.10.2 Financial Performance
  • 10.10.3 Product Outlook
  • 10.10.4 Key Developments

11 KEY DEVELOPMENTS

• 11.1 Product Launches/Developments
• 11.2 Mergers and Acquisitions
• 11.3 Business Expansions
• 11.4 Partnerships and Collaborations

12 Appendix

• 12.1 Related Research