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1624403

聚乙二醇化蛋白質市場規模（按地區、範圍和預測）

PEGylated Proteins Market Size By Product, By Protein Type, By Application, By End-User (Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic Research Institutes), By Geographic Scope And Forecast

出版日期: 2024年07月31日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

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簡介目錄

聚乙二醇化蛋白質的市場規模及預測

聚乙二醇化蛋白質市場規模預計在 2023 年達到 13.4 億美元，到 2031 年將達到 31.4 億美元，2024 年至 2031 年的複合年增長率為 11.22%。聚乙二醇化蛋白質是透過在其表面附著聚乙二醇（PEG）鏈進行化學修飾的蛋白質。該過程涉及將 PEG 分子共價連接到蛋白質上的特定位置，從而影響溶解度、穩定性和藥物動力學等特性。聚乙二醇化是生物製藥中用於增強蛋白質藥物治療效果和安全性的典型技術。透過降低清除率、提高生物利用度和減少給藥方案，PEG 鏈的加入可以增加蛋白質在血液中循環的時間。

此外，聚乙二醇化可以最大限度地降低免疫原性和蛋白水解的風險，並增強蛋白質療法的穩定性和功效。該技術已應用於腫瘤學、血液學、免疫學和代謝疾病等各個醫學領域，以創建生長因子、酵素、荷爾蒙和單株抗體等蛋白質類藥物的長效製劑。

聚乙二醇化蛋白質的全球市場動態

主要市場驅動因子

提高功效和穩定性：

聚乙二醇化，即將聚乙二醇 (PEG) 鏈附著到蛋白質上，可顯著提高蛋白質治療的穩定性和溶解度。這種變化增加了藥物的半衰期，降低了免疫原性並提高了生物利用度，使其更適合用於治療。

慢性病發生率不斷上升：

癌症、糖尿病和自體免疫疾病等慢性疾病的發生率不斷上升，對有效治療的需求也日益增長。因此，聚乙二醇化蛋白質由於其藥物動力學改善和給藥頻率減少而越來越多地用於治療這些疾病，從而推動了市場的成長。

藥物傳遞技術的進步：

藥物傳遞系統的技術進步有助於生產聚乙二醇化蛋白質，這些蛋白質可以更精確地針對特定的組織和器官，減少副作用並提高治療效果。這正在加速個人化醫療的採用。

加強生物製藥研發：

隨著生物製藥行業專注於創新生物製劑的研究和開發，聚乙二醇化正在被探索和利用來改進基於蛋白質的藥物。對生物製藥研發的資金和支持的增加正在推動聚乙二醇化蛋白質市場向前發展。

主要問題

開發及製造成本高：

蛋白質聚乙二醇化過程困難，需要大量的技術和經驗投入，增加了開發和生產成本。這些增加的成本限制了市場准入和供應，阻礙了市場的成長。

潛在的免疫原性和安全性問題：

PEG化用於最大限度地降低免疫原性，但PEG分子本身可以在某些患者中引發免疫反應。解決這些安全問題並證明長期的有效性和安全性將為市場帶來重大課題。

與替代藥物輸送系統的競爭：

脂質奈米顆粒和基於聚合物的系統等新型藥物傳輸技術正在推動聚乙二醇化蛋白質市場的發展。這些替代技術在藥物穩定性、療效以及標靶分佈等方面提供了類似甚至更好的優勢，對聚乙二醇化蛋白質的優越性提出了課題。

主要趨勢：

標靶藥物傳遞的創新：

生產能夠進行標靶藥物輸送的聚乙二醇化蛋白質的趨勢日益增長。該方法旨在透過選擇性地將藥物輸送到受損細胞來改善治療效果，特別是在癌症和慢性病的治療中，從而減少副作用並提高療效。

擴展到罕見疾病：

聚乙二醇化蛋白質市場正在轉向治療罕見疾病和孤兒疾病。聚乙二醇化可改善藥物動力學並降低免疫原性，使這些藥物適合治療替代療法有限的罕見疾病。

合併治療：

人們對聚乙二醇化蛋白質聯合療法的興趣日益濃厚。這使得聚乙二醇化藥物可以與其他治療劑結合，以提高治療效果，對抗抗藥性，並為疾病管理提供全面的方法，特別是在癌症等複雜情況下。

聚乙二醇化技術的進展：

該領域正在不斷改進聚乙二醇化方法，專注於實現聚乙二醇分子與蛋白質的位點特異性連接。這種精確度優化了藥物的治療效果，改善了患者的治療效果並減少了副作用，從而實現了更有效、更安全的治療。

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.

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