全球生技改良藥市場－2025-2030年預測

生技改良藥市場預計將從 2025 年的 666.03 億美元成長到 2030 年的 979.07 億美元，複合年成長率為 8.01%。

由於生物改良藥的研發成本低於原廠生物藥，且在生物相似藥競爭日益激烈的背景下，生技改良藥市場將保持溫和成長。生技改良藥是指在現有生物製藥的基礎上進行改進的產品，它們靶向相同的生物通路，但在療效、安全性或給藥途徑方面有所提升。這些改進是透過化學修飾、蛋白質融合、胺基酸序列改變和糖基化最佳化等技術實現的，可以延長藥效持續時間、降低劑量並減少副作用。與旨在達到與參考產品臨床等效性的生物相似藥不同，生技改良藥作為新分子實體（NME），必須遵守與新藥相同的嚴格監管標準。在美國和其他地區，生物改良藥物會依照藥物發現分子框架進行評估，以確保其安全性和有效性得到充分檢驗。

本報告檢驗了當前市場趨勢，重點關注生技改良藥領域的最新進展以及供需和銷售動態。主要促進因素是主要生產商加大對生技改良藥的投資，使其與生物相似藥區分開來。利用成熟的臨床路徑可以簡化研發流程，並提高核准的可能性。此外，重磅生物製藥的專利到期也為企業開發生技改良藥創造了機會，使具有改良特性的專利保護新型分子得以推向市場。然而，患者對生技改良藥的認知度仍然較低，這可能是限制在某些地區推廣應用和市場滲透的主要阻礙因素。

本報告按類型和地區對全球生技改良藥市場進行細分。按類型分類，包括單株抗體、疫苗、重組蛋白和其他產品。由於新興經濟體有利的監管政策和較高的採用率，單株抗體預計將佔據市場主導地位。其治療多樣性和已取得的臨床成功也鞏固了其市場優勢。按地區分類，市場分為北美、南美、歐洲、中東和非洲以及亞太地區。由於歐洲擁有明確的監管核准指南和廣泛的生技改良藥研發活動，預計歐洲將佔據相當大的市場佔有率。這些因素正在推動該地區的創新和市場成長。

本分析深入剖析了市場演變，重點闡述了先進給藥系統的整合以及以患者為中心的製劑研發等趨勢。對法規結構的全面檢驗，使相關人員能夠清晰了解合規要求，包括臨床試驗義務和智慧財產權方面的考慮。這些框架塑造了市場策略，尤其是在歐洲等標準嚴格的地區。

基於二手研究的競爭情報揭示了生技改良藥主要企業為維持市場領先地位而採取的策略性措施。本研究採用由下而上和自上而下相結合的方法來估算市場規模，按產品細分市場匯總數據，並利用來自生技改良藥價值鏈各相關人員的第一手資訊檢驗。資料三角驗證法提供了準確的市場區隔和可靠的預測，而分析性說明、圖表和圖形則有助於讀者更有效地理解市場狀況。

對業內人士而言，本研究闡明了創新、監管和競爭三者如何相互作用，共同推動生技改良藥市場的發展。相關人員可利用這些洞見進行策略規劃、投資優先排序和市場定位，以最大限度地掌握專利到期和高性能生物製藥需求帶來的機會。儘管面臨諸如患者認知度不斷提高等挑戰，生技改良藥市場仍為那些在不斷變化的生物製藥格局中尋求發展機會的公司提供了極具吸引力的成長路徑。

本報告的主要優勢：

• 深入分析：取得以客戶群、政府政策和社會經濟因素、消費者偏好、垂直產業和其他細分市場為重點的深入市場洞察，涵蓋主要地區和新興地區。
• 競爭格局：了解主要企業採取的策略舉措，並了解透過正確的策略打入市場的潛力。
• 市場促進因素與未來趨勢：探索動態因素和關鍵市場趨勢，以及它們將如何塑造未來的市場發展。
• 可執行的建議：利用洞察力為策略決策提供訊息，從而在動態環境中開拓新的業務管道和收入來源。
• 受眾範圍廣：對新興企業、研究機構、顧問公司、中小企業和大型企業都有益處且經濟高效。

它是用來做什麼的？

產業與市場洞察、商業機會評估、產品需求預測、打入市場策略、地理擴張、資本投資決策、法律規範及影響、新產品開發、競爭影響

分析範圍

• 歷史資料（2022-2024 年）和預測資料（2025-2030 年）
• 成長機會、挑戰、供應鏈前景、法規結構、客戶行為和趨勢分析
• 競爭對手定位、策略和市場佔有率分析
• 按業務板塊和地區（國家）分類的收入成長和預測分析
• 公司概況（策略、產品、財務資訊、關鍵趨勢等）

目錄

第1章執行摘要

第2章市場概述

• 市場概覽
• 市場定義
• 分析範圍
• 市場區隔

第3章 商業情境

• 市場促進因素
• 市場限制
• 市場機遇
• 波特五力分析
• 產業價值鏈分析
• 政策和法規
• 策略建議

第4章 技術展望

第5章 全球生技改良藥市場（按類型分類）

• 介紹
• 單株抗體（mAbs）
• 疫苗
• 重組蛋白
• 抗體藥物複合體（ADC）
• 其他

6. 全球生技改良藥市場（依應用領域分類）

• 介紹
• 瘤
• 神經系統疾病
• 腎臟疾病
• 自體免疫疾病/發炎性疾病
• 感染疾病
• 其他

7. 全球生技改良藥市場（以最終用戶分類）

• 介紹
• 生物製藥公司
• CRO（委外研發機構）
• 學術和研究機構

8. 全球生技改良藥市場（依地區分類）

• 介紹
• 北美洲
  • 按類型
  • 透過使用
  • 最終用戶
  • 按國家/地區
    • 美國
    • 加拿大
    • 墨西哥
• 南美洲
  • 按類型
  • 透過使用
  • 最終用戶
  • 按國家/地區
    • 巴西
    • 阿根廷
    • 其他
• 歐洲
  • 按類型
  • 透過使用
  • 最終用戶
  • 按國家/地區
    • 英國
    • 德國
    • 法國
    • 西班牙
    • 其他
• 中東和非洲
  • 按類型
  • 透過使用
  • 最終用戶
  • 按國家/地區
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 其他
• 亞太地區
  • 按類型
  • 透過使用
  • 最終用戶
  • 按國家/地區
    • 中國
    • 日本
    • 印度
    • 韓國
    • 台灣
    • 其他

第9章：競爭格局與分析

• 主要企業和策略分析
• 市佔率分析
• 企業合併、協議、商業合作
• 競爭對手儀錶板

第10章：公司簡介

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

第11章附錄

• 貨幣
• 先決條件
• 基準年和預測年時間表
• 相關人員的主要收益
• 分析方法
• 簡稱

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