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全球生物改良藥市場 - 2023-2030
市場調查報告書
商品編碼
1279706

全球生物改良藥市場 - 2023-2030

Global Biobetters Market - 2023-2030
出版日期: | 出版商: DataM Intelligence | 英文 195 Pages | 商品交期: 約2個工作天內

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簡介目錄

市場概覽

生物改良藥的全球市場規模預計到 2022 年將達到 453.36 億美元，到 2030 年將達到 859.17 億美元，增長勢頭強勁。 在預測期內（2023 年至 2030 年），全球生物改良藥市場的複合年增長率為 8.5%。

生物改良藥 市場趨勢包括 PEG 化融合蛋白、EKylation、XTEN 技術和 Pasylation。 融合蛋白是通過組合編碼不同蛋白質的基因製成的。 所產生的單一多□顯示出兩種原生物分子的功能特性。

一般來說，一個合作夥伴具有分子識別功能，而另一個合作夥伴則傳達特定功能，例如降低細胞毒性、改善半衰期或穩定性、新靶向或新遞送途徑。 全球 生物改良藥 市場受到產品半衰期延長、聚集潛力降低、效力、純度提高和不良事件減少等因素的推動，隨著生物仿製藥競爭的加劇，這將成為製約市場增長的一個因素。

市場動態

生物改良藥 不良事件較少的優勢

生物改良藥 是一項生物技術進步，具有更低的副作用、更長的產品半衰期、更高的功效以及其他推動市場增長的驅動因素。

生物改良藥s 可能會因其改進的特性而獲得溢價，同時可以通過減少劑量來節省成本。 這會影響付款人的購買意願。

聚乙二醇化和對 XTEN 技術不斷增長的需求

聚乙二醇化是聚乙二醇 (PEG) 鏈與功能分子的共價連接，可有效改善藥代動力學並降低毒性和免疫原性。 它已成為克服生物製劑局限性的主要途徑，市場上聚乙二醇化產品的數量不斷增加。 聚乙二醇化蛋白質已被證明可以增加尺寸和流體動力學體積，降低免疫原性，防止體內蛋白水解和內吞作用，增加水溶性，並減少由於空間排斥引起的蛋白質聚集，同時提高熱穩定性和機械穩定性。

XTEN 技術，也稱為 XTENylation，是 864 個氨基酸的非結構化重組多□的基因融合，僅由丙氨酸、谷氨酸、甘氨酸、脯氨酸、絲氨酸和蘇氨酸殘基組成。 它已被證明可以增加蛋白質血清半衰期、水溶性和穩定性，並且可以在溶液中表達和製造。

生物仿製藥競爭加劇

在預測期內，生物仿製藥對生物改良劑的競爭日益激烈，抑制了市場增長。 生物仿製藥開發的進步正在減少生物改良藥市場的需求。

COVID-19 影響分析

類風濕性關節炎和炎症性腸病等自身免疫性疾病感染 COVID-19 的風險增加，之後在英國接受靜脈治療的患者可以改用相同的皮下注射治療方案。已發布新指南以評估性別。

從醫院輸液治療到皮下注射治療，對於生物改良藥這一新一代創新療法來說至關重要，可以確保患者及時得到所需的護理。可以說，這是一個例子，表明它可以成為一個強大的工具。 在 COVID-19 大流行期間，我們看到了生物更好的進展，也注意到了一些意想不到的情況。

俄烏衝突分析

它討論了戰爭對全球科學界的長期影響，以及在俄烏戰爭期間失去烏克蘭學術、醫學和科學研究機會的風險。

根據 FDA 的臨床試驗數據庫，烏克蘭一直在測試 251 種藥物、設備和藥劑。 2022 年，烏克蘭正在進行或計劃進行 1000 多項藥物臨床試驗。 俄烏戰爭影響了 生物改良藥 市場，導致對藥品、藥物和醫療設備的需求增加，在某些情況下，該地區 生物改良藥 市場的需求減少。

內容

第一章調查方法及範圍

  • 調查方法
  • 調查目的和範圍

第 2 章定義和概述

第 3 章執行摘要

  • 按藥物類別分類的片段
  • 使用特定片段
  • 按給藥途徑分類的片段
  • 區域摘要

第四章市場動態

  • 影響因素
    • 主持人
      • 較低的副作用
      • 產品半衰期長
    • 約束因素
      • 生物仿製藥競爭加劇
    • 機會
    • 影響分析

第五章行業分析

  • 波特的五力分析
  • 供應鏈分析
  • 價格分析
  • 法律法規分析

第 6 章 COVID-19 分析

  • COVID-19 分析
    • COVID-19 之前的情景
    • COVID-19 期間的情景
    • COVID-19 後或未來情景
  • COVID-19 期間的價格和動態
  • 供需範圍
  • 大流行期間與市場相關的政府舉措
  • 製造商的戰略舉措
  • 總結

第 7 章藥物類別

  • 雙特異性抗體生物創業公司
  • 聚乙二醇化生物企業
  • 聚醣工程生物風險投資
  • Fc Engineering Bio 投注者
  • 抗體片段 生物改良藥
  • 抗體藥物偶聯 (ADC) Bioventure
  • 融合蛋白生物創業
  • 生物前藥、生物前體、生物改良劑

第 8 章應用

  • 癌症
  • 糖尿病
  • 腎臟疾病
  • 神經退行性疾□□病
  • 遺傳性疾病

第8章給藥途徑

  • 皮下給藥
  • 靜脈給藥
  • 口語
  • 吸入
  • 肌肉注射

第9章按地區

  • 北美
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 意大利
    • 西班牙
    • 其他歐洲
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他南美洲
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 澳大利亞
    • 其他亞太地區
  • 中東和非洲

第10章競爭格局

  • 競爭場景
  • 市場情況/份額分析
  • 併購分析

第11章公司簡介

  • 安進公司
    • 公司簡介
    • 產品組合和說明
    • 財務摘要
    • 主要發展狀況
  • Merck KGaA.
  • Mabpharm Limited
  • F. Hoffmann-La Roche Ltd
  • GlaxoSmithKline plc
  • CELLTRION INC.
  • Novo Nordisk A/S
  • Biogen
  • Aequilibrium Pharma
  • Pfizer Inc

第12章 附錄

簡介目錄
Product Code: PH4034

Market Overview

The global biobetters market size reached US$ 45,336.0 million in 2022 and is projected to witness lucrative growth by reaching up to US$ 85,917.0 million by 2030. The global biobetters market is exhibiting at a CAGR of 8.5% during the forecast period (2023-2030).

The market trends of biobetters are PEGylation fusion proteins, EKylation, XTEN technology, Pasylation, and so on. Fusion proteins are created by combining genes that encode separate proteins. The single polypeptide produced displays the functional properties of both originator biomolecules.

Commonly, one partner has a molecular recognition function while the other transfers a certain functionality, such as decreased cytotoxicity, improved half-life, and stability, novel targeting, or a new delivery route.The global biobetters market is driven by factors such as longer product half-life, lower likelihood of aggregation, greater efficacy, purity, and fewer adverse events and the increasing biosimilar competition restraints the biobetters market growth.

Market Dynamics

The Advantage of Lower Adverse Effect of Biobetters

Biobetters are biotechnological advancements that have lower adverse effects, longer product half-life, greater efficacy, and other driving factors, driving the market growth.

A biobetter can be assigned a premium price due to its improved characteristics, but cost savings can be achieved due to reduced dosages. This affects payers' willingness to purchase the product.

Growing Demand for PEGylation, and XTEN Technology

PEGylation is the covalent attachment of polyethylene glycol (PEG) chains to a functional molecule, which is effective in improving pharmacokinetics and reducing toxicity and immunogenicity. It has become the main approach to overcome the limitations of biological drugs, with an increasing number of PEGylated products on the market. PEGylated proteins are characterized by increased size and hydrodynamic volume, reduced immunogenicity, protection against in vivo proteolysis and endocytosis, greater solubility in water, decreased protein aggregation due to steric repulsion, and increased thermal and mechanical stability.

XTEN technology also known as XTENylation is a genetic fusion of an unstructured recombinant polypeptide of 864 amino acids, composed entirely of alanine, glutamate, glycine, proline, serine, and threonine residues. It has been demonstrated to increase the serum half-life and water solubility and stability of proteins, allowing their expression in solution and manufacturing.

Increasing Biosimilar Competition

Increasing biosimilar competition for the biobetters restraining the market growth during the forecast period. Advancements in the development of biosimilars is decreasing the demand for biobetter market.

COVID-19 Impact Analysis

Autoimmune conditions such as rheumatoid arthritis or inflammatory bowel disease are at higher risk of COVID-19 infection, and then new guidance was issued in the UK to ensure that patients receiving intravenous treatment were assessed for possible switching to the same therapy in subcutaneous form.

This switch from hospital-based intravenous infusion therapy to administration via subcutaneous injection is an example of how biobetters, a new generation of innovative therapeutic medicines, could become an important tool to help ensure that patients can gain access to the treatment they need in a timely fashion. During the COVID-19 pandemic, advancements in the biobetters are seen, and some anticipating conditions have also been noticed.

Russia-Ukraine Conflict Analysis

Risk about the war's long-term impact on the scientific community worldwide and the missed opportunities for research in Ukraine's academic, medical, and scientific disciplines during Russia Ukraine war.

Ukraine was testing 251 medicines, devices, and drugs, according to the FDA's clinical trials database. According to the clinical trials database, in 2022, over 1,000 medication clinical trials were underway or planned in Ukraine. The Russia-Ukraine war impacted the biobetters market, resulting in increased demand for medicines, drugs, and medical devices, and in some cases decreased demand for the biobetters market in the region.

Segment Analysis

The global biobetters market is segmented based on Drug Class, By Application, By Route of Administration and By Distribution Channel.

Bispecific Antibodies Biobetters Segment is Expected to Dominate the Biobetters Market

The bispecific antibodies biobetters segment is expected to dominate the biobetters capturing a market share of around 36.1%. The advanced healthcare infrastructure coupled with rapid advancements in technology is expected to play an imperative role in boosting the growth of the biobetters market in the forecast period.

Bispecific antibodies (BsAbs) consist of two binding sites directed at two antigens or two epitopes of the same antigen. The primary application of BsAbs has been to shift cytotoxic immune effector cells for the enhanced killing of tumor cells by Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and other cytotoxic mechanisms carried out by the effector cells.

Geographical Analysis

North America Region Holds the Largest Market Share of Around 39.4% in the Global Biobetters Market

Biobetters are approved through the biologics approval pathway, providing 10-12 years of market exclusivity in the North American region. The United States is the global leader in the Biopharmaceutical market, accounting for one-third of the global market. Over half of the world's R&D and Intellectual Property Rights of most new medicines are held by the United States.

Competitive Landscape

The major global players include: Amgen Inc., Merck KGaA., Mabpharm Limited, F. Hoffmann-La Roche Ltd, GlaxoSmithKline plc, Celltrion Healthcare, Novo Nordisk A/S, Biogen, Aequilibrium Pharma, Pfizer, and others.

Why Purchase the Report?

  • To visualize the global biobetters market segmentation based on product, application, 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 global biobetters 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 biobetters market report would provide approximately 54 tables, 46 figures, and 195 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 Drug Class
  • 3.2. Snippet by Application
  • 3.3. Snippet by Route of Administration
  • 3.4. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Lower adverse effects
      • 4.1.1.2. Longer Product Half-life
    • 4.1.2. Restraints
      • 4.1.2.1. Increasing Biosimilar Competition
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's 5 Forces Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis

6. COVID-19 Analysis

  • 6.1. Analysis of COVID-19
    • 6.1.1. Scenario Before COVID-19
    • 6.1.2. Scenario During COVID-19
    • 6.1.3. Post COVID-19 or Future Scenario
  • 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. Manufacturer's Strategic Initiatives
  • 6.6. Conclusion

7. By Drug Class

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
    • 7.1.2. Market Attractiveness Index, By Drug Class
  • 7.2. Bispecific Antibodies Biobetters
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. PEGylation Biobetters
  • 7.4. Glyco-engineering Biobetters
  • 7.5. Fc Engineering Biobetters
  • 7.6. Antibody Fragment Biobetters
  • 7.7. Antibody Drug Conjugation (ADC) Biobetters
  • 7.8. Fusion Protein Biobetters
  • 7.9. Bio Prodrug/Bioprecursor Biobetters

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. Cancer*
    • 8.2.1. Introduction
    • 8.2.2 Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Diabetes
  • 8.4. Renal Disease
  • 8.5. Neurodegenerative Disease
  • 8.6. Genetic Disorders

8. By Route of Administration

  • 8.5. Introduction
    • 8.5.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 8.5.2. Market Attractiveness Index, By Route of Administration
  • 8.6. Subcutaneous
    • 8.6.1. Introduction
    • 8.6.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.7. Intravenous
  • 8.8. Oral
  • 8.9. Inhaled
  • 8.10. Intramuscular

9. By Region

  • 9.5. Introduction
    • 9.5.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 9.5.2. Market Attractiveness Index, By Region
  • 9.6. North America
    • 9.6.1. Introduction
    • 9.6.2. Key Region-Specific Dynamics
    • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
    • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 9.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 9.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.6.7.1. Canada
      • 9.6.7.2. Mexico
  • 9.7. Europe
    • 9.7.1. Introduction
    • 9.7.2. Key Region-Specific Dynamics
    • 9.7.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
    • 9.7.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.7.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 9.7.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 9.7.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.7.7.1. Germany
      • 9.7.7.2. The U.K.
      • 9.7.7.3. France
      • 9.7.7.4. Italy
      • 9.7.7.5. Spain
      • 9.7.7.6. Rest of Europe
  • 9.8. South America
    • 9.8.1. Introduction
    • 9.8.2. Key Region-Specific Dynamics
    • 9.8.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
    • 9.8.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.8.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 9.8.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 9.8.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.8.7.1. Brazil
      • 9.8.7.2. Argentina
      • 9.8.7.3. Rest of South America
  • 9.9. Asia-Pacific
    • 9.9.1. Introduction
    • 9.9.2. Key Region-Specific Dynamics
    • 9.9.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
    • 9.9.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.9.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 9.9.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 9.9.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.9.7.1. China
      • 9.9.7.2. India
      • 9.9.7.3. Japan
      • 9.9.7.4. Australia
      • 9.9.7.5. Rest of Asia-Pacific
  • 9.10. Middle East and Africa
    • 9.10.1. Introduction
    • 9.10.2. Key Region-Specific Dynamics
    • 9.10.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
    • 9.10.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application

10. Competitive Landscape

  • 10.5. Competitive Scenario
  • 10.6. Market Positioning/Share Analysis
  • 10.7. Mergers and Acquisitions Analysis

11. Company Profiles

  • 11.5. Amgen Inc*
    • 11.5.1. Company Overview
    • 11.5.2. Product Portfolio and Description
    • 11.5.3. Financial Overview
    • 11.5.4. Key Developments
  • 11.6. Merck KGaA.
  • 11.7. Mabpharm Limited
  • 11.8. F. Hoffmann-La Roche Ltd
  • 11.9. GlaxoSmithKline plc
  • 11.10. CELLTRION INC.
  • 11.11. Novo Nordisk A/S
  • 11.12. Biogen
  • 11.13. Aequilibrium Pharma
  • 11.14. Pfizer Inc

LIST NOT EXHAUSTIVE

12. Appendix

  • 12.5. About Us and Services
  • 12.6. Contact Us