生物製剤の世界市場：製品別、医薬品分類別、投与経路別、購入形態別、流通チャネル別、地域別

世界の生物製剤の市場規模は、2025年には5億7,750万米ドルと推定され、2032年には11億6,980万米ドルに達すると予測され、2025年～2032年のCAGRは10.6%で成長する見込みです。

図.生物製剤市場シェア（%）、2025年、地域別

生物製剤とは、ヒトの疾病を予防、治療、治癒するために使用される、生物から作られた医薬品を指します。これには、ワクチン、血液成分、アレルゲン、体細胞、遺伝子治療、組織、組み換え治療用タンパク質などが含まれます。様々な病気にかかりやすい高齢者人口の増加と相まって、世界的に慢性疾患の有病率が増加しており、生物製剤の需要を押し上げる可能性があります。バイオテクノロジーの急速な革新と進歩により、安全性、有効性、作用特異性が改善された新規の生物学的製剤の開発が可能になりました。これにより、がん、リウマチ性疾患、自己免疫疾患など、生命を脅かすいくつかの疾患に対する治療の選択肢が広がっています。規制当局の承認と生物製剤の商業化の拡大は、市場の成長を促進する可能性があります。

市場力学

世界の生物製剤市場の成長は、糖尿病、がん、心血管疾患などの慢性疾患の世界的な蔓延と、生物製剤の研究開発に対するヘルスケア支出の増加が牽引しています。また、タンパク質ベースの医薬品に対する需要の増加、先進的な生物製剤の迅速な承認、新規生物製剤候補の強力なパイプラインも市場成長の原動力となっています。バイオプロセスや品質分析における絶え間ない技術進歩は、商業規模での生物製剤のコスト効率的な製造に資する高収率生産プラットフォームの開発を可能にしています。しかし、バイオ製造施設の設置には多額の設備投資が必要であること、規制基準が厳しいこと、生物学的分子が複雑であることなどが、バイオシミラー開発における課題となっています。アジア太平洋やラテンアメリカなどの新興国市場は、利害関係者にとって、新たな市場開拓と市場抑制要因の相殺という有利な機会を提供しています。

本調査の主な特徴

本レポートでは、世界の生物製剤市場を詳細に分析し、2024年を基準年とした予測期間（2025～2032年）の市場規模およびCAGR%を掲載しています。

また、さまざまなセグメントにわたる潜在的な収益機会を明らかにし、この市場の魅力的な投資提案マトリクスを解説しています。

また、市場促進要因、抑制要因、機会、新製品の上市や承認、市場動向、地域別の展望、主要企業が採用する競争戦略などに関する重要な考察も提供しています。

世界の生物製剤市場における主要企業を、企業ハイライト、製品ポートフォリオ、主要ハイライト、業績、戦略などのパラメータに基づいてプロファイルしています。

本調査の対象となる主要企業には、エフ・ホフマン・ラ・ロシュ、アッヴィ、アムジェン、ジョンソン・エンド・ジョンソンサービス、メルク、ファイザー、サノフィ、ギリアド・サイエンシズ、ノバルティス、ブリストル・マイヤーズスクイブ、リジェネロン、武田薬品工業、バイオジェン、イーライリリー・アンド・カンパニー、セルトリオンヘルスケアなどが含まれます。

本レポートからの洞察により、マーケティング担当者や企業の経営陣は、将来の製品上市、タイプのアップグレード、市場拡大、マーケティング戦術に関する情報に基づいた意思決定を行うことができます。

世界の生物製剤市場レポートは、投資家、サプライヤー、製品メーカー、流通業者、新規参入者、財務アナリストなど、この業界の様々な利害関係者に対応しています。

利害関係者は、世界の生物製剤市場を分析する際に使用される様々な戦略マトリックスを通じて、意思決定が容易になります。

目次

第1章 調査の目的と前提条件

• 調査目的
• 前提条件
• 略語

第2章 市場の展望

• レポートの説明
  • 市場の定義と範囲
• エグゼクティブサマリー

第3章 市場力学、規制、動向分析

• 市場力学
• 影響分析
• 主な発展
• 規制シナリオ
• 製品の発売/承認
• PEST分析
• ポーターの分析
• 合併と買収のシナリオ
• 業界動向

第4章 世界の生物製剤市場：製品別（2020年～2032年）

• モノクローナル抗体
• ワクチン
• 組み換えホルモン/タンパク質
• 細胞ベースの生物製剤
• 遺伝子ベースの生物製剤
• その他

第5章 世界の生物製剤市場：医薬品分類別（2020年～2032年）

• ブランド医薬品
• ジェネリック医薬品

第6章 世界の生物製剤市場：投与経路別（2020年～2032年）

• 経口
• 非経口
• その他の経路

第7章 世界の生物製剤市場：購入形態別（2020年～2032年）

• 処方薬
• 市販薬

第8章 世界の生物製剤市場：流通チャネル別（2020年～2032年）

• 院内薬局
• 小売薬局
• オンライン薬局

第9章 世界の生物製剤市場：地域別（2020年～2032年）

• 北米
• ラテンアメリカ
• 欧州
• アジア太平洋
• 中東
• アフリカ

第10章 競合情勢

• Hoffmann-La Roche Ltd.
• AbbVie Inc.
• Amgen Inc.
• Johnson & Johnson Services, Inc.
• Merck & Co., Inc.
• Pfizer Inc.
• Sanofi S.A.
• Gilead Sciences, Inc.
• Novartis AG
• Bristol-Myers Squibb Company
• Regeneron Pharmaceuticals, Inc.
• Takeda Pharmaceutical Company Limited
• Biogen Inc.
• Eli Lilly and Company
• Celltrion Healthcare Co., Ltd.

第11章 参考文献と調査手法

• 参考文献
• 調査手法
• 出版社について

Global Biologics Market is estimated to be valued at USD 577.5 Mn in 2025 and is expected to reach USD 1,169.8 Mn by 2032, growing at a compound annual growth rate (CAGR) of 10.6% from 2025 to 2032.

Figure. Biologics Market Share (%), By Region 2025

Biologics refers to medicines created from living organisms that are used to prevent, treat, and cure human diseases. These include vaccines, blood components, allergenics, somatic cells, gene therapies, tissues, and recombinant therapeutic proteins. Increasing prevalence of chronic diseases worldwide coupled with rising elderly population prone to various illnesses can boost demand for biologics. Rapid innovations and advancements in biotechnology have enabled development of novel biologic agents with improved safety, efficacy and specificity of action. This has expanded treatment options for several life-threatening conditions such as cancer, rheumatic disorders, and autoimmune diseases. Growing regulatory approvals and commercialization of biologics can drive the market growth.

Market Dynamics

Global biologics market growth is driven by growing prevalence of chronic diseases worldwide such as diabetes, cancer, cardiovascular diseases along with rising healthcare expenditure on biopharmaceutical R&D. Increasing demand for protein-based drugs, rapid approvals of advanced biologics and strong pipeline of novel biologic candidates can also drive the market growth. Constant technological advancements in bioprocessing and quality analytics enables development of high-yield production platforms conducive for cost-effective manufacturing of biologics at commercial scale. However, factors such as high capital investment needs for setting up bio-manufacturing facilities, stringent regulatory norms, and complexity of biological molecules poses challenges in biosimilar development. Emerging markets across developing regions such as Asia Pacific and Latin America offer lucrative opportunities for stakeholders to tap into new geographic territories and offset restraint impact.

Key Features of the Study

This report provides in-depth analysis of the global biologics market, and provides market size (US$ Million) and compound annual growth rate (CAGR%) for the forecast period (2025-2032), considering 2024 as the base year

It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market

This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players

It profiles key players in the global biologics market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, and strategies

Key companies covered as a part of this study include F. Hoffmann-La Roche Ltd., AbbVie Inc., Amgen Inc., Johnson & Johnson Services, Inc., Merck & Co., Inc., Pfizer Inc., Sanofi S.A., Gilead Sciences, Inc., Novartis AG, Bristol-Myers Squibb Company, Regeneron Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited, Biogen Inc., Eli Lilly and Company, and Celltrion Healthcare Co., Ltd.

Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics

Global biologics market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts

Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global biologics market

Market Segmentation

• By Product Insights (Revenue, USD Mn, 2019 - 2032)
  • Monoclonal Antibodies
  • Vaccines
  • Recombinant Hormones/Proteins
  • Cellular-based Biologics
  • Gene-based Biologics
  • Others
• By Drug Classification Insights (Revenue, USD Mn, 2019 - 2032)
  • Branded Drugs
  • Generic Drugs
• By Route of Administration Insights (Revenue, USD Mn, 2019 - 2032)
  • Oral
  • Parenteral
  • Other Routes
• By Mode of Purchase Insights (Revenue, USD Mn, 2019 - 2032)
  • Prescription-Based Drugs
  • Over-The-Counter Drugs
• By Distribution Channel Insights (Revenue, USD Mn, 2019 - 2032)
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• Regional Insights (Revenue, USD Mn, 2019 - 2032)
  • North America
  • U.S.
  • Canada
  • Latin America
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
  • Europe
  • Germany
  • U.K.
  • Spain
  • France
  • Italy
  • Russia
  • Rest of Europe
  • Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
  • Middle East
  • GCC Countries
  • Israel
  • Rest of Middle East
  • Africa
  • South Africa
  • North Africa
  • Central Africa
• Key Players Insights
  • F. Hoffmann-La Roche Ltd.
  • AbbVie Inc.
  • Amgen Inc.
  • Johnson & Johnson Services, Inc.
  • Merck & Co., Inc.
  • Pfizer Inc.
  • Sanofi S.A.
  • Gilead Sciences, Inc.
  • Novartis AG
  • Bristol-Myers Squibb Company
  • Regeneron Pharmaceuticals, Inc.
  • Takeda Pharmaceutical Company Limited
  • Biogen Inc.
  • Eli Lilly and Company
  • Celltrion Healthcare Co., Ltd.

Table of Contents

1. Research Objectives and Assumptions

• Research Objectives
• Assumptions
• Abbreviations

2. Market Purview

• Report Description
  • Market Definition and Scope
• Executive Summary
  • Global Biologics Market, By Product
  • Global Biologics Market, By Drug Classification
  • Global Biologics Market, By Route of Administration
  • Global Biologics Market, By Mode of Purchase
  • Global Biologics Market, By Distribution Channel
  • Global Biologics Market, By Region

3. Market Dynamics, Regulations, and Trends Analysis

• Market Dynamics
  • Driver
  • Restraint
  • Opportunity
• Impact Analysis
• Key Developments
• Regulatory Scenario
• Product Launches/Approvals
• PEST Analysis
• PORTER's Analysis
• Merger and Acquisition Scenario
• Industry Trends

4. Global Biologics Market, By Product, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Monoclonal Antibodies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Vaccines
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Recombinant Hormones/Proteins
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Cellular-based Biologics
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Gene-based Biologics
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Others
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)

5. Global Biologics Market, By Drug Classification, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Branded Drugs
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Generic Drugs
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)

6. Global Biologics Market, By Route of Administration, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Oral
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Parenteral
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Other Routes
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)

7. Global Biologics Market, By Mode of Purchase, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Prescription-Based Drugs
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Over-The-Counter Drugs
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)

8. Global Biologics Market, By Distribution Channel, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Hospital Pharmacies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Retail Pharmacies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Online Pharmacies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)

9. Global Biologics Market, By Region, 2020 - 2032, (USD Mn)

• Introduction
  • Market Share (%) Analysis, 2025,2028 & 2032, (USD Mn)
  • Market Y-o-Y Growth Analysis (%), 2021 - 2032, (USD Mn)
  • Regional Trends
• North America
  • Introduction
  • Market Size and Forecast, By Product, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Drug Classification, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Route of Administration, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Mode of Purchase, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Distribution Channel, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • U.S.
    • Canada
• Latin America
  • Introduction
  • Market Size and Forecast, By Product, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Drug Classification, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Route of Administration, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Mode of Purchase, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Distribution Channel, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
• Europe
  • Introduction
  • Market Size and Forecast, By Product, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Drug Classification, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Route of Administration, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Mode of Purchase, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Distribution Channel, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
• Asia Pacific
  • Introduction
  • Market Size and Forecast, By Product, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Drug Classification, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Route of Administration, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Mode of Purchase, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Distribution Channel, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
• Middle East
  • Introduction
  • Market Size and Forecast, By Product, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Drug Classification, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Route of Administration, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Mode of Purchase, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Distribution Channel, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • GCC Countries
    • Israel
    • Rest of Middle East
• Africa
  • Introduction
  • Market Size and Forecast, By Product, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Drug Classification, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Route of Administration, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Mode of Purchase, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Distribution Channel, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country/Region, 2020 - 2032, (USD Mn)
    • South Africa
    • North Africa
    • Central Africa

10. Competitive Landscape

• Hoffmann-La Roche Ltd.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• AbbVie Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Amgen Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Johnson & Johnson Services, Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Merck & Co., Inc.
• Pfizer Inc.
• Sanofi S.A.
• Gilead Sciences, Inc.
• Novartis AG
• Bristol-Myers Squibb Company
• Regeneron Pharmaceuticals, Inc.
• Takeda Pharmaceutical Company Limited
• Biogen Inc.
• Eli Lilly and Company
• Celltrion Healthcare Co., Ltd.

11. References and Research Methodology

• References
• Research Methodology
• About us