全球生技改良药市场－2025-2030年预测

生技改良药市场预计将从 2025 年的 666.03 亿美元成长到 2030 年的 979.07 亿美元，复合年增长率为 8.01%。

由于生物改良药的研发成本低于原厂生物药，且在生物相似药竞争日益激烈的背景下，生技改良药市场将保持温和成长。生技改良药是指在现有生物製药的基础上进行改进的产品，它们靶向相同的生物通路，但在疗效、安全性或给药途径方面有所提升。这些改进是透过化学修饰、蛋白质融合、胺基酸序列改变和糖基化优化等技术实现的，可以延长药效持续时间、降低剂量并减少副作用。与旨在达到与参考产品临床等效性的生物相似药不同，生技改良药作为新分子实体（NME），必须遵守与新药相同的严格监管标准。在美国和其他地区，生物改良药物会依照药物发现分子框架进行评估，以确保其安全性和有效性得到充分检验。

本报告检验了当前市场趋势，重点关註生技改良药领域的最新进展以及供需和销售动态。主要驱动因素是主要生产商加大对生技改良药的投资，使其与生物相似药区分开来。利用成熟的临床路径可以简化研发流程，并提高核准的可能性。此外，重磅生物製药的专利到期也为企业开发生技改良药创造了机会，使具有改良特性的专利保护新型分子得以推向市场。然而，患者对生技改良药的认知度仍然较低，这可能是限制在某些地区推广应用和市场渗透的主要阻碍因素。

本报告按类型和地区对全球生技改良药市场进行细分。按类型划分，包括单株抗体、疫苗、重组蛋白和其他产品。由于新兴经济体有利的监管政策和较高的采用率，单株抗体预计将占据市场主导地位。其治疗多样性和已取得的临床成功也巩固了其市场优势。按地区划分，市场分为北美、南美、欧洲、中东和非洲以及亚太地区。由于欧洲拥有明确的监管核准指南和广泛的生技改良药研发活动，预计欧洲将占据相当大的市场份额。这些因素正在推动该地区的创新和市场成长。

本分析深入剖析了市场演变，重点阐述了先进给药系统的整合以及以患者为中心的製剂研发等趋势。对法规结构的全面检验，使相关人员能够清晰了解合规要求，包括临床试验义务和智慧财产权方面的考虑。这些框架塑造了市场策略，尤其是在欧洲等标准严格的地区。

基于二手研究的竞争情报揭示了生技改良药主要企业为维持市场领先地位而采取的策略性措施。本研究采用由下而上和自上而下相结合的方法来估算市场规模，按产品细分市场汇总数据，并利用来自生技改良药价值链各相关人员的第一手资讯检验。资料三角验证法提供了准确的市场区隔和可靠的预测，而分析性说明、图表和图形则有助于读者更有效地理解市场状况。

对业内人士而言，本研究阐明了创新、监管和竞争三者如何相互作用，共同推动生技改良药市场的发展。相关人员可利用这些洞见进行策略规划、投资优先排序和市场定位，以最大限度地掌握专利到期和高性能生物製药需求带来的机会。儘管面临诸如患者认知度不断提高等挑战，生技改良药市场仍为那些在不断变化的生物製药格局中寻求发展机会的公司提供了极具吸引力的成长路径。

本报告的主要优势：

• 深入分析：取得以客户群、政府政策和社会经济因素、消费者偏好、垂直产业和其他细分市场为重点的深入市场洞察，涵盖主要地区和新兴地区。
• 竞争格局：了解主要企业采取的策略倡议，并了解透过正确的策略打入市场的潜力。
• 市场驱动因素与未来趋势：探索动态因素和关键市场趋势，以及它们将如何塑造未来的市场发展。
• 可执行的建议：利用洞察力为策略决策提供讯息，从而在动态环境中开拓新的业务管道和收入来源。
• 受众范围广：对新兴企业、研究机构、顾问公司、中小企业和大型企业都有益处且经济高效。

它是用来做什么的？

产业与市场洞察、商业机会评估、产品需求预测、打入市场策略、地理扩张、资本投资决策、法律规范及影响、新产品开发、竞争影响

分析范围

• 历史资料（2022-2024 年）和预测资料（2025-2030 年）
• 成长机会、挑战、供应链前景、法规结构、客户行为和趋势分析
• 竞争对手定位、策略和市场占有率分析
• 按业务板块和地区（国家）分類的收入成长和预测分析
• 公司概况（策略、产品、财务资讯、关键趋势等）

目录

第一章执行摘要

第二章市场概述

• 市场概览
• 市场定义
• 分析范围
• 市场区隔

第三章 商业情境

• 市场驱动因素
• 市场限制
• 市场机会
• 波特五力分析
• 产业价值链分析
• 政策和法规
• 策略建议

第四章 技术展望

第五章 全球生技改良药市场（按类型划分）

• 介绍
• 单株抗体（mAbs）
• 疫苗
• 重组蛋白
• 抗体药物复合体（ADC）
• 其他的

6. 全球生技改良药市场（依应用领域划分）

• 介绍
• 瘤
• 神经系统疾病
• 肾臟疾病
• 自体免疫疾病/发炎性疾病
• 感染疾病
• 其他的

7. 全球生技改良药市场（以最终用户划分）

• 介绍
• 生物製药公司
• CRO（委外研发机构）
• 学术和研究机构

8. 全球生技改良药市场（依地区划分）

• 介绍
• 北美洲
  • 按类型
  • 透过使用
  • 最终用户
  • 按国家/地区
    • 美国
    • 加拿大
    • 墨西哥
• 南美洲
  • 按类型
  • 透过使用
  • 最终用户
  • 按国家/地区
    • 巴西
    • 阿根廷
    • 其他的
• 欧洲
  • 按类型
  • 透过使用
  • 最终用户
  • 按国家/地区
    • 英国
    • 德国
    • 法国
    • 西班牙
    • 其他的
• 中东和非洲
  • 按类型
  • 透过使用
  • 最终用户
  • 按国家/地区
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 其他的
• 亚太地区
  • 按类型
  • 透过使用
  • 最终用户
  • 按国家/地区
    • 中国
    • 日本
    • 印度
    • 韩国
    • 台湾
    • 其他的

第九章：竞争格局与分析

• 主要企业和策略分析
• 市占率分析
• 企业合併、协议、商业合作
• 竞争对手仪錶板

第十章：公司简介

• Celltrion
• GC Pharma
• Ildong Pharmaceutical Co., Ltd.
• Samsung Bioepis
• Amgen Inc.
• Novartis AG
• Galil-Ofek

第十一章附录

• 货币
• 先决条件
• 基准年和预测年时间表
• 相关人员的主要收益
• 分析方法
• 简称

The Biobetters Market is anticipated to expand from USD 66.603 billion in 2025 to USD 97.907 billion in 2030, registering an 8.01% CAGR.

The biobetters market is poised for modest growth, driven by their lower development costs compared to originator biologics and their strategic importance amid rising biosimilar competition. Biobetters are enhanced versions of existing biologics, designed to target the same biological pathways but with improvements in efficacy, safety, or administration. These enhancements, achieved through chemical modifications, protein fusion, altered amino acid sequences, or optimized glycosylation patterns, result in longer-lasting effects, lower dosing requirements, and reduced side effects. Unlike biosimilars, which aim for clinical equivalence to reference products, biobetters are distinct new molecular entities (NMEs) subject to rigorous regulatory standards akin to novel drugs. In the United States and other regions, they are evaluated under frameworks for innovator molecules, ensuring robust safety and efficacy validation.

This research study examines current market trends, focusing on demand, supply, and sales dynamics, alongside recent developments in the biobetters sector. Key drivers include major manufacturers' investments in biobetters to differentiate from biosimilars, leveraging established clinical pathways to streamline development and improve approval odds. The expiration of patents for blockbuster biologics creates opportunities for companies to develop biobetters, offering patent-protected NMEs with enhanced profiles. However, a significant restraint is the lack of awareness among patients regarding biobetters, which may hinder adoption and market penetration in certain regions.

The study segments the global biobetters market by type and geography. By type, the market includes monoclonal antibodies, vaccines, recombinant proteins, and others, with monoclonal antibodies expected to dominate due to favorable regulatory policies and high adoption rates in emerging economies. Their therapeutic versatility and established clinical success drive their prominence. Geographically, the market is divided into North America, South America, Europe, the Middle East and Africa, and the Asia Pacific. Europe is anticipated to hold a significant share, attributed to well-defined regulatory approval guidelines and extensive research activities focused on biobetter development. These factors foster innovation and market growth in the region.

The analysis provides in-depth insights into market evolution, highlighting trends such as the integration of advanced delivery systems and the focus on patient-centric formulations. Regulatory frameworks are thoroughly examined, offering stakeholders clarity on compliance requirements, including clinical trial mandates and intellectual property considerations. These frameworks shape market strategies, particularly in regions with stringent standards like Europe.

Competitive intelligence, derived from secondary research, underscores the strategic moves of key players investing in biobetters to maintain market leadership. The study employs both bottom-up and top-down approaches to estimate market size, aggregating data from product segments and validating it through primary inputs from stakeholders across the biobetters value chain. Data triangulation ensures accurate market breakdowns and reliable forecasts, presented through analytical narratives, charts, and graphics for efficient comprehension.

For industry experts, this study highlights the interplay of innovation, regulation, and competition in driving the biobetters market. Stakeholders can leverage these insights for strategic planning, investment prioritization, and market positioning, capitalizing on the opportunities presented by patent expirations and the demand for enhanced biologics. Despite challenges like patient awareness, the biobetters market offers a compelling growth trajectory for companies navigating the evolving biopharmaceutical landscape.

Key Benefits of this Report:

• Insightful Analysis: Gain detailed market insights covering major as well as emerging geographical regions, focusing on customer segments, government policies and socio-economic factors, consumer preferences, industry verticals, and other sub-segments.
• Competitive Landscape: Understand the strategic maneuvers employed by key players globally to understand possible market penetration with the correct strategy.
• Market Drivers & Future Trends: Explore the dynamic factors and pivotal market trends and how they will shape future market developments.
• Actionable Recommendations: Utilize the insights to exercise strategic decisions to uncover new business streams and revenues in a dynamic environment.
• Caters to a Wide Audience: Beneficial and cost-effective for startups, research institutions, consultants, SMEs, and large enterprises.

What do businesses use our reports for?

Industry and Market Insights, Opportunity Assessment, Product Demand Forecasting, Market Entry Strategy, Geographical Expansion, Capital Investment Decisions, Regulatory Framework & Implications, New Product Development, Competitive Intelligence

Report Coverage:

• Historical data from 2022 to 2024 & forecast data from 2025 to 2030
• Growth Opportunities, Challenges, Supply Chain Outlook, Regulatory Framework, and Trend Analysis
• Competitive Positioning, Strategies, and Market Share Analysis
• Revenue Growth and Forecast Assessment of segments and regions including countries
• Company Profiling (Strategies, Products, Financial Information, and Key Developments among others.

Segmentation

By Type

• Monoclonal Antibodies (mAbs)
• Vaccines
• Recombinant Proteins
• Antibody-Drug Conjugates (ADCs)
• Others

By Application

• Oncology
• Neurology
• Nephrology
• Autoimmune & Inflammatory Diseases
• Infectious Diseases
• Others

By End-User

• Biopharmaceutical Companies
• Contract Research Organizations (CROs)
• Academic & Research Institutes

By Geography

• North America
• USA
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• United Kingdom
• Germany
• France
• Spain
• Others
• Middle East and Africa
• Saudi Arabia
• UAE
• Others
• Asia Pacific
• China
• Japan
• India
• South Korea
• Taiwan
• Others

TABLE OF CONTENTS

1. EXECUTIVE SUMMARY

2. MARKET SNAPSHOT

• 2.1. Market Overview
• 2.2. Market Definition
• 2.3. Scope of the Study
• 2.4. Market Segmentation

3. BUSINESS LANDSCAPE

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Porter's Five Forces Analysis
• 3.5. Industry Value Chain Analysis
• 3.6. Policies and Regulations
• 3.7. Strategic Recommendations

4. TECHNOLOGICAL OUTLOOK

5. GLOBAL BIOBETTERS MARKET BY TYPE

• 5.1. Introduction
• 5.2. Monoclonal Antibodies (mAbs)
• 5.3. Vaccines
• 5.4. Recombinant Proteins
• 5.5. Antibody-Drug Conjugates (ADCs)
• 5.6. Others

6. GLOBAL BIOBETTERS MARKET BY APPLICATION

• 6.1. Introduction
• 6.2. Oncology
• 6.3. Neurology
• 6.4. Nephrology
• 6.5. Autoimmune & Inflammatory Diseases
• 6.6. Infectious Diseases
• 6.7. Others

7. GLOBAL BIOBETTERS MARKET BY END-USER

• 7.1. Introduction
• 7.2. Biopharmaceutical Companies
• 7.3. Contract Research Organizations (CROs)
• 7.4. Academic & Research Institutes

8. GLOBAL BIOBETTERS MARKET BY GEOGRAPHY

• 8.1. Introduction
• 8.2. North America
  • 8.2.1. By Type
  • 8.2.2. By Application
  • 8.2.3. By End-User
  • 8.2.4. By Country
    • 8.2.4.1. USA
    • 8.2.4.2. Canada
    • 8.2.4.3. Mexico
• 8.3. South America
  • 8.3.1. By Type
  • 8.3.2. By Application
  • 8.3.3. By End-User
  • 8.3.4. By Country
    • 8.3.4.1. Brazil
    • 8.3.4.2. Argentina
    • 8.3.4.3. Others
• 8.4. Europe
  • 8.4.1. By Type
  • 8.4.2. By Application
  • 8.4.3. By End-User
  • 8.4.4. By Country
    • 8.4.4.1. United Kingdom
    • 8.4.4.2. Germany
    • 8.4.4.3. France
    • 8.4.4.4. Spain
    • 8.4.4.5. Others
• 8.5. Middle East and Africa
  • 8.5.1. By Type
  • 8.5.2. By Application
  • 8.5.3. By End-User
  • 8.5.4. By Country
    • 8.5.4.1. Saudi Arabia
    • 8.5.4.2. UAE
    • 8.5.4.3. Others
• 8.6. Asia Pacific
  • 8.6.1. By Type
  • 8.6.2. By Application
  • 8.6.3. By End-User
  • 8.6.4. By Country
    • 8.6.4.1. China
    • 8.6.4.2. Japan
    • 8.6.4.3. India
    • 8.6.4.4. South Korea
    • 8.6.4.5. Taiwan
    • 8.6.4.6. Others

9. COMPETITIVE ENVIRONMENT AND ANALYSIS

• 9.1. Major Players and Strategy Analysis
• 9.2. Market Share Analysis
• 9.3. Mergers, Acquisitions, Agreements, and Collaborations
• 9.4. Competitive Dashboard

10. COMPANY PROFILES

• 10.1. Celltrion
• 10.2. GC Pharma
• 10.3. Ildong Pharmaceutical Co., Ltd.
• 10.4. Samsung Bioepis
• 10.5. Amgen Inc.
• 10.6. Novartis AG
• 10.7. Galil-Ofek

11. APPENDIX

• 11.1. Currency
• 11.2. Assumptions
• 11.3. Base and Forecast Years Timeline
• 11.4. Key benefits for the stakeholders
• 11.5. Research Methodology
• 11.6. Abbreviations