インスリンバイオシミラーの市場規模、シェア、成長分析、タイプ別、適応症別、流通チャネル別、地域別 - 産業予測、2025-2032年

インスリンバイオシミラーの世界市場規模は2023年に29億米ドルとなり、予測期間（2025-2032年）のCAGRは6.2%で、2024年の30億8,000万米ドルから2032年には49億8,000万米ドルに成長する見通しです。

インスリンバイオシミラー市場は、糖尿病有病率の上昇に加え、糖尿病の研究開発（R&D）への投資の増加により、大きな成長が見込まれています。効果的な糖尿病管理の必要性が世界的に高まっていることから、今後数年間はこれらの製品に対する需要が高まると予想されます。革新的なインスリンバイオシミラーのための新たな臨床試験は市場拡大をさらに促進し、オリジナル・インスリン製剤の特許満了が間近に迫っていることも、市場プレーヤーに新たなビジネスチャンスをもたらしています。しかし、厳しい規制要件や新たなバイオシミラーの臨床的受容をめぐる問題など課題は残っており、長期的には市場開拓全体の妨げとなる可能性は残っています。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次データと一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析

インスリンバイオシミラー市場規模：タイプ別

• 市場概要
• 速効性インスリン
  • 速効型インスリンアナログ
  • 通常のヒトインスリン
• 中間型インスリン
  • NPHヒトインスリン
  • 混合インスリン
• 持続性インスリン

インスリンバイオシミラー市場規模：適応症別

• 市場概要
• 1型糖尿病
• 2型糖尿病

インスリンバイオシミラー市場規模：流通チャネル別

• 市場概要
• 病院薬局
• 小売薬局
• ドラッグストア
• オンライン薬局

インスリンバイオシミラー市場規模& CAGR（2025-2032）

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 市場の最近の動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 会社概要
  • 製品ポートフォリオ分析
  • セグメント別シェア分析
  • 収益の前年比比較（2022-2024）

主要企業プロファイル

• Viatris Inc.（USA）
• Pfizer Inc.（USA）
• Sanofi S.A.（France）
• Eli Lilly and Company（USA）
• Novartis AG（Switzerland）
• Merck & Co., Inc.（USA）
• Boehringer Ingelheim GmbH（Germany）
• Biocon Ltd.（India）
• Samsung Bioepis（South Korea）
• Teva Pharmaceutical Industries Ltd.（Israel）
• Fresenius Kabi AG（Germany）
• Coherus BioSciences, Inc.（USA）
• Dr. Reddy's Laboratories Ltd.（India）
• Amgen Inc.（USA）
• Celltrion Inc.（South Korea）
• Aurobindo Pharma Ltd.（India）
• Intas Pharmaceuticals Ltd.（India）
• Fujifilm Kyowa Kirin Biologics Co., Ltd.（Japan）
• Mochida Pharmaceutical Co., Ltd.（Japan）

結論と推奨事項

Global Insulin Biosimilars Market size was valued at USD 2.9 billion in 2023 and is poised to grow from USD 3.08 billion in 2024 to USD 4.98 billion by 2032, growing at a CAGR of 6.2% during the forecast period (2025-2032).

The market for insulin biosimilars is poised for significant growth due to the rising prevalence of diabetes, coupled with increasing investments in diabetes research and development (R&D). The ongoing need for effective diabetes management globally is expected to drive demand for these products in the coming years. New clinical trials for innovative insulin biosimilars will further facilitate market expansion, supported by the impending patent expirations of original insulin products, which presents fresh opportunities for market players. However, challenges remain, including stringent regulatory requirements and issues surrounding the clinical acceptance of new biosimilars, which could hinder overall market development in the long term.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Insulin Biosimilars market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Insulin Biosimilars Market Segmental Analysis

Global Insulin Biosimilars Market is segmented by Type, Indication, Distribution Channel, and region. Based on Type, the market is segmented into Fast-acting Insulin, Intermediate-acting Insulin and Long-acting Insulin. Based on Indication, the market is segmented into Diabetes Type 1 and Diabetes Type 2. Based on Distribution Channel, the market is segmented into Hospital Pharmacies, Retail Pharmacies, Drug Stores and Online Pharmacies. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Insulin Biosimilars Market

The Global Insulin Biosimilars market is significantly driven by the impending patent expirations of established originator insulin products. As these long-standing products become less protected, it is expected to increase the demand for innovative new biosimilars. Furthermore, the rising investment in medical research and development is anticipated to open up new avenues for manufacturers of insulin biosimilars, facilitating the introduction of advanced therapeutic options to the market. This combination of patent expirations and heightened R&D activities is poised to transform the competitive landscape, ultimately benefiting patients with more affordable and effective insulin alternatives.

Restraints in the Global Insulin Biosimilars Market

The global insulin biosimilars market faces significant constraints due to complex regulatory mandates imposed by governments and regulatory authorities. These stringent regulations create challenges for new companies aiming to develop and introduce insulin biosimilars to the market. The arduous approval processes and extensive requirements can hinder innovation and slow down the entry of novel products. As a result, many potential developers may find it daunting to navigate the regulatory landscape, ultimately limiting competition and variety within the market. This restrictive environment poses a substantial barrier to the growth and expansion of the insulin biosimilars sector on a global scale.

Market Trends of the Global Insulin Biosimilars Market

The Global Insulin Biosimilars market is witnessing a significant trend towards the adoption of biologic and biosimilar therapies for diabetes management. As patients and healthcare institutions increasingly prioritize cost-effective treatment options, the demand for high-quality insulin biosimilars is rising, presenting lucrative opportunities for suppliers. This shift is fueled by the need for affordable alternatives to traditional insulin therapies, alongside growing awareness of the efficacy and safety of biosimilars. Companies that innovate and develop novel biosimilar products in alignment with this market trend are poised to enhance their market presence and drive revenue growth in the competitive diabetes care landscape.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global Insulin Biosimilars Market Size by Type: & CAGR (2025-2032)

• Market Overview
• Fast-acting Insulin
  • Rapid-acting Insulin Analogs
  • Regular Human Insulin
• Intermediate-acting Insulin
  • NPH Human Insulin
  • Pre-mixed Insulin
• Long-acting Insulin

Global Insulin Biosimilars Market Size by Indication: & CAGR (2025-2032)

• Market Overview
• Diabetes Type 1
• Diabetes Type 2

Global Insulin Biosimilars Market Size by By Distribution Channel: & CAGR (2025-2032)

• Market Overview
• Hospital Pharmacies
• Retail Pharmacies
• Drug Stores
• Online Pharmacies

Global Insulin Biosimilars Market Size & CAGR (2025-2032)

• North America (Type:, Indication:, By Distribution Channel:)
  • US
  • Canada
• Europe (Type:, Indication:, By Distribution Channel:)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Type:, Indication:, By Distribution Channel:)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Type:, Indication:, By Distribution Channel:)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Type:, Indication:, By Distribution Channel:)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Viatris Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pfizer Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sanofi S.A. (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eli Lilly and Company (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Novartis AG (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Merck & Co., Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Boehringer Ingelheim GmbH (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biocon Ltd. (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Samsung Bioepis (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Teva Pharmaceutical Industries Ltd. (Israel)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Fresenius Kabi AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Coherus BioSciences, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Dr. Reddy's Laboratories Ltd. (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Amgen Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Celltrion Inc. (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Aurobindo Pharma Ltd. (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Intas Pharmaceuticals Ltd. (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Fujifilm Kyowa Kirin Biologics Co., Ltd. (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Mochida Pharmaceutical Co., Ltd. (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations