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全球生物改良药市场 - 2023-2030
市场调查报告书
商品编码
1279706

全球生物改良药市场 - 2023-2030

Global Biobetters Market - 2023-2030
出版日期: | 出版商: DataM Intelligence | 英文 195 Pages | 商品交期: 约2个工作天内

价格

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简介目录

市场概览

生物改良药的全球市场规模预计到 2022 年将达到 453.36 亿美元，到 2030 年将达到 859.17 亿美元，增长势头强劲。 在预测期内（2023 年至 2030 年），全球生物改良药市场的复合年增长率为 8.5%。

生物改良药 市场趋势包括 PEG 化融合蛋白、EKylation、XTEN 技术和 Pasylation。 融合蛋白是通过组合编码不同蛋白质的基因製成的。 所产生的单一多□显示出两种原生物分子的功能特性。

一般来说，一个合作伙伴具有分子识别功能，而另一个合作伙伴则传达特定功能，例如降低细胞毒性、改善半衰期或稳定性、新靶向或新递送途径。 全球 生物改良药 市场受到产品半衰期延长、聚集潜力降低、效力、纯度提高和不良事件减少等因素的推动，随着生物仿製药竞争的加剧，这将成为製约市场增长的一个因素。

市场动态

生物改良药 不良事件较少的优势

生物改良药 是一项生物技术进步，具有更低的副作用、更长的产品半衰期、更高的功效以及其他推动市场增长的驱动因素。

生物改良药s 可能会因其改进的特性而获得溢价，同时可以通过减少剂量来节省成本。 这会影响付款人的购买意愿。

聚乙二醇化和对 XTEN 技术不断增长的需求

聚乙二醇化是聚乙二醇 (PEG) 链与功能分子的共价连接，可有效改善药代动力学并降低毒性和免疫原性。 它已成为克服生物製剂局限性的主要途径，市场上聚乙二醇化产品的数量不断增加。 聚乙二醇化蛋白质已被证明可以增加尺寸和流体动力学体积，降低免疫原性，防止体内蛋白水解和内吞作用，增加水溶性，并减少由于空间排斥引起的蛋白质聚集，同时提高热稳定性和机械稳定性。

XTEN 技术，也称为 XTENylation，是 864 个氨基酸的非结构化重组多□的基因融合，仅由丙氨酸、谷氨酸、甘氨酸、脯氨酸、丝氨酸和苏氨酸残基组成。 它已被证明可以增加蛋白质血清半衰期、水溶性和稳定性，并且可以在溶液中表达和製造。

生物仿製药竞争加剧

在预测期内，生物仿製药对生物改良剂的竞争日益激烈，抑制了市场增长。 生物仿製药开发的进步正在减少生物改良药市场的需求。

COVID-19 影响分析

类风湿性关节炎和炎症性肠病等自身免疫性疾病感染 COVID-19 的风险增加，之后在英国接受静脉治疗的患者可以改用相同的皮下注射治疗方案。已发布新指南以评估性别。

从医院输液治疗到皮下注射治疗，对于生物改良药这一新一代创新疗法来说至关重要，可以确保患者及时得到所需的护理。可以说，这是一个例子，表明它可以成为一个强大的工具。 在 COVID-19 大流行期间，我们看到了生物更好的进展，也注意到了一些意想不到的情况。

俄乌衝突分析

它讨论了战争对全球科学界的长期影响，以及在俄乌战争期间失去乌克兰学术、医学和科学研究机会的风险。

根据 FDA 的临床试验数据库，乌克兰一直在测试 251 种药物、设备和药剂。 2022 年，乌克兰正在进行或计划进行 1000 多项药物临床试验。 俄乌战争影响了 生物改良药 市场，导致对药品、药物和医疗设备的需求增加，在某些情况下，该地区 生物改良药 市场的需求减少。

内容

第一章调查方法及范围

  • 调查方法
  • 调查目的和范围

第 2 章定义和概述

第 3 章执行摘要

  • 按药物类别分类的片段
  • 使用特定片段
  • 按给药途径分类的片段
  • 区域摘要

第四章市场动态

  • 影响因素
    • 主持人
      • 较低的副作用
      • 产品半衰期长
    • 约束因素
      • 生物仿製药竞争加剧
    • 机会
    • 影响分析

第五章行业分析

  • 波特的五力分析
  • 供应链分析
  • 价格分析
  • 法律法规分析

第 6 章 COVID-19 分析

  • COVID-19 分析
    • COVID-19 之前的情景
    • COVID-19 期间的情景
    • COVID-19 后或未来情景
  • COVID-19 期间的价格和动态
  • 供需范围
  • 大流行期间与市场相关的政府举措
  • 製造商的战略举措
  • 总结

第 7 章药物类别

  • 双特异性抗体生物创业公司
  • 聚乙二醇化生物企业
  • 聚醣工程生物风险投资
  • Fc Engineering Bio 投注者
  • 抗体片段 生物改良药
  • 抗体药物偶联 (ADC) Bioventure
  • 融合蛋白生物创业
  • 生物前药、生物前体、生物改良剂

第 8 章应用

  • 癌症
  • 糖尿病
  • 肾臟疾病
  • 神经退行性疾□□病
  • 遗传性疾病

第8章给药途径

  • 皮下给药
  • 静脉给药
  • 口语
  • 吸入
  • 肌肉注射

第9章按地区

  • 北美
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 法国
    • 意大利
    • 西班牙
    • 其他欧洲
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他南美洲
  • 亚太地区
    • 中国
    • 印度
    • 日本
    • 澳大利亚
    • 其他亚太地区
  • 中东和非洲

第10章竞争格局

  • 竞争场景
  • 市场情况/份额分析
  • 併购分析

第11章公司简介

  • 安进公司
    • 公司简介
    • 产品组合和说明
    • 财务摘要
    • 主要发展状况
  • 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 附录

简介目录
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