バイオシミラーの市場規模、シェア、成長分析：適応症別、薬剤タイプ別、地域別 - 産業予測、2024年～2031年

世界のバイオシミラーの市場規模は、2022年に約234億5,000万米ドルとなり、予測期間（2024年～2031年）のCAGRは16.4%で、2023年の273億米ドルから上昇し、2031年までには920億米ドルに達すると予測されています。

バイオシミラー市場は、主要な生物学的製剤の特許満了が間近に迫り、ヘルスケアコスト削減の必要性が高まっていることから、大きな成長が見込まれています。多くの主要な生物学的製剤の特許が失効する中、腫瘍学、免疫学、内分泌学などの治療分野でビジネスチャンスが生まれつつあります。規制当局は、より迅速な承認プロセスや代替政策を実施することで、バイオシミラーの採用を支援しています。強固な規制枠組みを持つ欧州連合（EU）は、バイオシミラーの採用をリードしており、他の地域と比較して高い採用率を達成しています。このような機会にもかかわらず、バイオシミラー市場はいくつかの課題に直面しています。バイオシミラーの市場開拓と製造に必要な高額な設備投資は、厳しい規制要件と相まって、中小企業の市場参入を阻む可能性があります。類似性を証明するための大規模で費用のかかる臨床試験が必要なことも、状況をさらに複雑にしています。さらに、オリジナルの生物製剤に対する確立されたブランドロイヤリティと信頼が大きな障壁となっています。こうした問題に対処するため、バイオシミラー医薬品メーカーは戦略的提携やパートナーシップを結び、既存の市場プレゼンスや流通網を活用しています。また、医師や患者の間でバイオシミラーが受け入れられることも、市場の成長と競争にとって極めて重要です。バイオシミラー市場の可能性は大きいですが、その拡大にはさらなる調査と規制の調整が必要です。

目次

イントロダクション

• 調査の目的
• 定義
• 市場範囲

調査手法

• 情報調達
• 二次・一次情報源
• 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

• 市場概要見通し
• 供給需要動向分析
• セグメント別機会分析

市場力学と見通し

• 市場力学
  • 促進要因
  • 機会
  • 抑制要因
  • 課題
• ポーターの分析

主要なグリーンケミカルの洞察

• パイプライン分析
• 市場のエコシステム
• バリューチェーン分析
• 特許分析
• 価格分析
• 規制情勢
• イノベーションマトリクス
• ケーススタディ分析
  • バイオシミラー - 分析ケーススタディ
• 主要な投資分析
• 主要な成功要因
• 競合の程度

バイオシミラー市場：薬剤タイプ別

• 市場概要
• モノシナール抗体
  • インフリキシマブ
  • トラスツズマブ
  • リツキシマブ
  • アダリムマブ
  • その他
• インスリン
• 顆粒球
• コロニー刺激因子
• エリスロポエチン
• 組み換えヒト成長ホルモン
• エタネルセプト
• フォリトロピン
• テリパラチド
• インターフェロン
• 抗凝固剤
• その他

バイオシミラー市場：適応症別

• 市場概要
• 腫瘍学
• 炎症性疾患・自己免疫疾患
• 慢性疾患
• 血液疾患
• 成長ホルモン欠乏症
• 感染症
• その他

バイオシミラー市場規模：地域別

• 市場概要
• 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
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋
• 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（MEA）
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ地域

競合情勢

• 上位5社の比較
• 主要企業の市場ポジショニング（2023年）
• 主要な市場企業が採用した戦略
• 市場における最近の活動
• 主要企業の市場シェア（2023年）

主要企業プロファイル

• Pfizer Inc.（US）
• Amgen Inc.（US）
• Samsung Bioepis（South Korea）
• Novartis AG（Switzerland）
• Celltrion Inc.（South Korea）
• Viatris Inc.（US）
• Coherus BioSciences（US）
• Biogen（US）
• Teva Pharmaceutical（Israel）
• Merck & Co（US）
• Biocon（India）
• FHoffman-La Roche Ltd.（Switzerland）
• Dr. Reddy's Laboratories（India）
• Sandoz International GmbH（Germany）
• AbbVie Inc（US）
• Fresenius Kabi（Germany）
• Formycon（Germany）
• Alvotech（Iceland）
• AMPHASTAR PHARMACEUTICALS, INC.（US）

Global Biosimilars Market size was valued at around USD 23.45 billion in 2022 and is expected to rise from USD 27.30 billion in 2023 to reach a value of USD 92 Billion by 2031, at a CAGR of 16.4% over the forecast period (2024-2031).

The biosimilars market is poised for significant growth due to the impending expiration of key biological patents and the increasing need to reduce healthcare costs. As patents for many major biologic drugs expire, opportunities are emerging in therapeutic areas such as oncology, immunology, and endocrinology. Regulatory bodies are supporting the adoption of biosimilars by implementing faster approval processes and substitution policies. The European Union, with its robust regulatory framework, has led the way in adopting biosimilars, achieving higher adoption rates compared to other regions. Despite these opportunities, the biosimilars market faces several challenges. High capital investment required for the development and manufacturing of biosimilars, coupled with stringent regulatory requirements, can deter smaller companies from entering the market. The need for extensive, costly clinical trials to prove similarity further complicates the situation. Additionally, the established brand loyalty and trust in original biologics pose significant barriers. To address these issues, biosimilar manufacturers are forming strategic alliances and partnerships to leverage existing market presence and distribution networks. The acceptance of biosimilars among physicians and patients is also crucial for market growth and competition. While the potential in the biosimilars market is substantial, further research and regulatory adjustments are needed to foster its expansion.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global 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 Biosimilars Market Segmental Analysis

The biosimilars market is segmented into Drug Type, Indication, and region. Based on Drug Type, the market is segmented into Monocional Antibodies (Infliximab, Trastuzumab, Rituximab, Adalimumab, and Others), Insulin, Granulocyte Colony-Stimulating Factor, Erythropoietin, Recombinant Human Growth Hormone, Etanercept, Follitropin, Teriparatide, Interferons, Anticoagulants, and Others. Based on Indication, the market is segmented into Oncology, Inflammatory & Autoimmune Disorders, Chronic Diseases, Blood Disorders, Growth Hormones Deficiency, Infectious Diseases, and Others. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Latin America, and Middle East and Africa.

Drivers of the Global Biosimilars Market

The rising prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders is driving the growth of the biosimilars market, as there is an increasing demand for effective and cost-efficient treatments. Analysis indicates that the U.S. population aged 50 and older is expected to grow by 61.11%, from 137.25 million in 2020 to 221.13 million by 2050. During the same period, the number of individuals in this age group with at least one chronic disease is projected to nearly double, increasing by 99.5%, from 71.52 million in 2020 to 142.66 million by 2050. This significant rise in chronic disease prevalence is expected to drive demand for biosimilars, further fueling market expansion.

Restraints in the Global Biosimilars Market

The biosimilars industry faces significant challenges due to the diverse and stringent regulations across different countries, which pose substantial obstacles for companies. The lack of regulatory harmonization leads to a complex and time-consuming process, often delaying market entry and increasing development costs. Companies must navigate varying requirements from different regulatory bodies, including extensive clinical trials and detailed analytical characterization. This fragmented approach results in duplicated efforts and high compliance costs, particularly disadvantaging smaller firms. Additionally, frequent changes in policies and regulations contribute to uncertainty and extend the approval process. As a result, these regulatory hurdles significantly hinder the biosimilars industry's ability to introduce new products more quickly and cost-effectively.

Market Trends of the Global Biosimilars Market

If patients are the primary beneficiaries, then reduced prices for biosimilars will significantly boost global demand. Recent trends indicate that manufacturers are focusing on substantial cost reductions in emerging biosimilar markets. This trend is expected to persist throughout the forecast period, contributing to the growth of the global biosimilars market. Additionally, biosimilar manufacturers are likely to explore different production volumes and strategies. The ability to produce multiple biosimilar medications at a single facility may offer considerable advantages, enhancing value for manufacturers and supporting market expansion over time.

Table of Contents

Introduction

• Objectives of the Study
• Definitions
• Market Scope

Research Methodology

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

Executive Summary

• Market Overview Outlook
• Supply Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of Substitute Products
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers

Key Green Chemical Insights

• Pipeline Analysis
• Ecosystem of the Market
• Value Chain Analysis
• Patent Analysis
• Pricing Analysis
• Regulatory Landscape
• Innovation Matrix
• Case Study Analysis
  • Biosimilar - An Analytical Case Study
• Top Investment Analysis
• Key Success Factor
• Degree of Competition

Biosimilars Market by Drug Type

• Market Overview
• Monocional Antibodies
  • Infliximab
  • Trastuzumab
  • Rituximab
  • Adalimumab
  • Others
• Insulin
• Granulocyte
• Colony-Stimulating Factor
• Erythropoietin
• Recombinant Human Growth Hormone
• Etanercept
• Follitropin
• Teriparatide
• Interferons
• Anticoagulants
• Others

Biosimilars Market by Indication

• Market Overview
• Oncology
• Inflammatory & Autoimmune Disorders
• Chronic Diseases
• Blood Disorders
• Growth Hormones Deficiency
• Infectious Diseases
• others

Biosimilars Market Size by Region

• Market Overview
• North America
  • USA
  • Canada
• Europe
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC Countries
  • South Africa
  • Rest of MEA

Competitive Landscape

• Top 5 Player Comparison
• Market Positioning of Key Players, 2023
• Strategies Adopted by Key Market Players
• Recent Activities in the Market
• Key Companies Market Share (%), 2023

Key Company Profiles

• Pfizer Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Amgen Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Samsung Bioepis (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Novartis AG (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Celltrion Inc. (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Viatris Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Coherus BioSciences (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biogen (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Teva Pharmaceutical (Israel)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
  • Eli Lilly (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Merck & Co (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biocon (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• FHoffman-La Roche Ltd. (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Dr. Reddy's Laboratories (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sandoz International GmbH (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AbbVie Inc (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Fresenius Kabi (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Formycon (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Alvotech (Iceland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AMPHASTAR PHARMACEUTICALS, INC. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments