1 序文
2 範囲と方法論
2.1 本調査の目的
2.2 利害関係者
2.3 データソース
2.3.1 一次ソース
2.3.2 二次ソース
2.4 市場予測
2.4.1 ボトムアップアプローチ
2.4.2 トップダウンアプローチ
2.5 予測方法論
3 エグゼクティブサマリー
4 バイオシミラー市場 – はじめに
4.1 概要
4.2 WHOとFDAによるバイオシミラーの用語
4.3 バイオシミラーとジェネリック医薬品
4.4 バイオシミラーとブランド生物学的製剤
5 バイオシミラーはなぜこれほどまでに利益を生み出すのか？
5.1 大型生物学的製剤の特許切れ
5.2 バイオシミラーと先発医薬品間の大幅な価格差
5.3 政府および第三者支払者のコスト削減
5.4 生活習慣病の増加
5.5 処方者、薬剤師、患者に対するインセンティブ
5.6 欧州および新興市場における新たなプレイヤーの出現
5.7 メーカーが医薬品送達デバイス企業と提携することで、製品差別化が進む
6 バイオシミラーの研究、開発、製造
6.1 研究開発：バイオシミラー vs. 先発医薬品
6.2 製造：バイオシミラー vs. 先発医薬品
7 世界のバイオシミラー市場
7.1 市場概要
7.2 過去の業績
7.3 COVID-19 の影響
7.4 セグメント別市場内訳
7.5 製造タイプ別市場内訳
7.6 疾患別市場内訳
7.7 地域別市場内訳
7.8 市場予測
7.9 バイオシミラー特許の概観
7.9.1 米国の特許の概観
7.9.2 欧州の特許の概観
7.9.3 日本の特許の概観
7.10 SWOT分析
7.10.1 概要
7.10.2 強み
7.10.3 弱み
7.10.4 機会
7.10.5 脅威
7.11 バリューチェーン分析
7.11.1 既存の革新的医薬品の特性
7.11.2 研究開発
7.11.2.1 バイオシミラーの特性
7.11.2.2 独自の細胞株の開発
7.11.3 製品開発
7.11.3.1 事前試験
7.11.3.2 中間臨床試験（PK/PD
7.11.3.3 臨床第III相試験
7.11.4 最終製品処方
7.11.5 マーケティングおよび流通
7.12 ポーターのファイブフォース分析
7.12.1 概要
7.12.2 買い手の交渉力
7.12.3 売り手の交渉力
7.12.4 競争の度合い
7.12.5 新規参入の脅威
7.12.6 代替品の脅威
7.13 価格分析
7.13.1 価格の主要指標
7.13.2 価格動向
7.13.3 利益分析
8 分子別市場分解
8.1 インフリキシマブ
8.2 インスリングラルギン
8.3 エポエチンアルファ
8.4 エタネルセプト
8.5 フィルグラスチム
8.6 ソマトロピン
8.7 リツキシマブ
8.8 フォリトロピンアルファ
8.9 アダリムマブ
8.10 Pegfilgrastim
8.11 Trastuzumab
8.12 Bevacizumab
8.13 その他
9 製造タイプ別市場
9.1 自社製造
9.1.1 市場動向
9.1.2 市場予測
9.2 受託製造
9.2.1 市場動向
9.2.2 市場予測
10 疾患別市場
10.1 自己免疫疾患
10.1.1 市場動向
10.1.2 市場予測
10.2 血液疾患
10.2.1 市場動向
10.2.2 市場予測
10.3 糖尿病
10.3.1 市場動向
10.3.2 市場予測
10.4 腫瘍学
10.4.1 市場動向
10.4.2 市場予測
10.5 成長不全
10.5.1 市場動向
10.5.2 市場予測
10.6 女性不妊症
10.6.1 市場動向
10.6.2 市場予測
10.7 その他
10.7.1 市場動向
10.7.2 市場予測
11 地域別市場
11.1 ヨーロッパ
11.1.1 市場実績
11.1.2 主要企業とバイオシミラー
11.1.3 国別の市場内訳
11.1.4 市場予測
11.1.5 イタリア
11.1.5.1 市場実績
11.1.5.2 主要企業とバイオシミラー
11.1.5.3 市場予測
11.1.6 ドイツ
11.1.6.1 市場実績
11.1.6.2 主要企業とバイオシミラー
11.1.6.3 市場予測
11.1.7 フランス
11.1.7.1 市場実績
11.1.7.2 主要企業とバイオシミラー
11.1.7.3 市場予測
11.1.8 イギリス
11.1.8.1 市場実績
11.1.8.2 主要企業とバイオシミラー
11.1.8.3 市場予測
11.1.9 スペイン
11.1.9.1 市場実績
11.1.9.2 主要企業とバイオシミラー
11.1.9.3 市場予測
11.1.10 その他の欧州
11.1.10.1 市場実績
11.1.10.2 市場予測
11.2 米国
11.2.1 現在の市場動向
11.2.2 主要企業とバイオシミラー
11.2.3 市場予測
11.3 日本
11.3.1 市場実績
11.3.2 主要企業とバイオシミラー
11.3.3 市場予測
11.4 インド
11.4.1 現在の市場動向
11.4.2 主要企業とバイオシミラー
11.4.3 市場予測
11.5 韓国
11.5.1 現在の市場動向
11.5.2 主要企業とバイオシミラー
11.5.3 市場予測
11.6 世界のその他の地域
11.6.1 現在の市場動向
11.6.2 市場予測
12 バイオシミラー製造プラントの設置要件
12.1 製造プロセス
12.2 原材料要件
12.3 原材料の写真
12.4 土地および建設要件
12.5 機械およびインフラ要件
12.6 機械の写真
12.7 プラントレイアウト
12.8 パッケージ要件
12.9 ユーティリティ要件
12.10 人員要件
13 競合状況
13.1 市場構造
13.2 主要企業
13.3 主要企業のプロフィール
Sandoz International GmbH
Pfizer Inc
Teva Pharmaceutical Industries Limited
Celltrion Inc
Biocon Limited
Samsung Biologics
Amgen. Inc
Dr. Reddy’s Laboratories Limited
Stada Arzneimittel Ag.
Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product. They are developed to have the same mechanism of action, route of administration, dosage form, and strength as the original product. While they are not identical to their reference products due to their complex nature and production methods, they maintain comparable safety, purity, and potency. These biologic drugs offer a more affordable alternative to high-cost reference biologics, creating competition, and making treatment more accessible for patients. Their introduction in the market is subject to rigorous testing and stringent regulatory scrutiny to ensure therapeutic equivalence and patient safety. In recent years, biosimilars have gained immense traction biosimilars in different therapeutic areas such as oncology, diabetes, and autoimmune diseases.
One of the key factors driving the market is the upcoming expiry of patents for several blockbuster biologics, which has opened the field for biosimilars, creating ample opportunities for market expansion. As biosimilars are less expensive alternatives to costly biologic therapies, they offer significant potential for healthcare cost savings, making them appealing for healthcare systems and patients. This, coupled with the rising global burden of chronic diseases including cancer, diabetes, and autoimmune disorders, where biologics play a crucial role in management, is also augmenting the product demand. In addition to this, various regulatory bodies such as the FDA and EMA have streamlined the approval pathways for biosimilars, encouraging their development and market entry. Moreover, the rapid globalization of biosimilar companies looking to expand their footprint to unexplored markets. Besides this, continual innovations in biopharmaceutical manufacturing technologies have made it feasible to produce biosimilars with high efficacy and safety, further driving the market growth.
Biosimilar Market Trends/Drivers:
Upcoming Patent Expiry of Blockbuster Drugs
The expiry of patents on branded biologics is one of the key factors driving the growth of the market. Biologics are often protected by robust patent portfolios that prevent the entry of competing products for extended periods. However, once these patents expire, it opens the door for companies to develop and market comparable, more affordable alternatives. Over the next few years, multiple blockbuster biologics with billions in annual sales are set to lose patent protection. The end of these patent protections, therefore, represents a massive opportunity for manufacturers to bring their alternatives to market and gain a substantial market share, catalyzing the market growth.
Cost-Effectiveness
Biosimilars are less expensive to produce than their reference biologics, mainly due to reduced research and development (R&D) costs, as manufacturers do not need to repeat all the original clinical trials that were done for the reference product. Therefore, biosimilars can be priced significantly lower, offering an affordable alternative to often costly biologic therapies. This cost-effectiveness is particularly appealing for healthcare systems striving to manage increasing healthcare costs and for patients who may struggle with the high cost of biologic therapies. Furthermore, in emerging markets where biologic therapies may have previously been unaffordable, biosimilars can facilitate easier access to essential treatments.
Increase in Prevalence of Chronic Diseases
The prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes is on the rise worldwide. These conditions typically require long-term treatment with biologics, fueling the demand for these drugs. As biosimilars offer similar efficacy and safety profiles to the original biologics but at a lower cost, their use in the treatment of these chronic diseases is increasingly becoming the preferred choice. For instance, the rising incidences of diseases, including rheumatoid arthritis and psoriasis, which are managed with biologic drugs like tumor necrosis factor inhibitors, presents a large market for biosimilars of these drugs. As the global burden of chronic diseases continues to grow, it is anticipated that the product demand will similarly increase, propelling the market growth.
Biosimilar Market Segmentation:
IMARC Group provides an analysis of the key trends in each segment of the global biosimilar market report, along with forecasts at the global and regional levels from 2025-2033. Our report has categorized the market based on molecule, indication and manufacturing type.
Breakup by Molecule:
Infliximab
Insulin Glargine
Epoetin Alfa
Etanercept
Filgrastim
Somatropin
Rituximab
Follitropin Alfa
Adalimumab
Pegfilgrastim
Trastuzumab
Bevacizumab
Others
Infliximab represents the largest market segment
The report has provided a detailed breakup and analysis of the market based on the molecule. This includes Infliximab, Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, Follitropin Alfa, Adalimumab, Pegfilgrastim, Trastuzumab, Bevacizumab, and others. According to the report, infliximab accounted for the majority of the share in the market.
Infliximab, a monoclonal antibody, is used for the treatment of several chronic conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, and ulcerative colitis. A high prevalence of these conditions worldwide has augmented the demand for effective treatments. Moreover, the wide range of indications leads to a large patient population that could potentially benefit from infliximab.
The original reference product, Remicade, has been on the market for a long time, with a well-established efficacy and safety profile. Once its patent expired, the entry of infliximab biosimilars offered a more cost-effective treatment option for these chronic conditions. Furthermore, the relatively earlier patent expiry of Remicade compared to other biologics has significantly contributed to its widespread popularity. Besides this, the manufacturing process and formulation for monoclonal antibodies such as infliximab are now well-established, facilitating the development and production of biosimilars, thereby propelling the segment growth.
Breakup by Indication:
Auto-Immune Diseases
Blood Disorder
Diabetes
Oncology
Growth Deficiency
Female Infertility
Others
Auto-immune diseases dominate the market
The report has provided a detailed breakup and analysis of the market based on the indication. This includes auto-immune diseases, blood disorders, diabetes, oncology, growth deficiency, female infertility, and others. According to the report, auto-immune diseases represented the largest segment.
Autoimmune diseases include conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease, which are prevalent worldwide, affecting millions of people. This high prevalence results in a substantial increase in the demand for effective treatments. These diseases are typically chronic, requiring long-term treatment, leading to a consistent demand for the associated therapies. Over the years, biologics have revolutionized the treatment of numerous autoimmune diseases, offering improved control and prognosis. Many of these biologics have now lost or are losing patent protection, opening the way for biosimilars. Additionally, the original biologics used to treat autoimmune diseases can be expensive, placing a financial burden on healthcare systems and patients. Since biosimilars offer a more affordable alternative, they are becoming the preferred choice for patients and healthcare professionals. Furthermore, the increasing acceptance of biosimilars among physicians, patients, and healthcare systems for treating autoimmune diseases owing to their similar efficacy and safety profiles to the reference biologics is fueling the growth of this segment.
Breakup by Manufacturing Type:
In-house Manufacturing
Contract Manufacturing
In-house manufacturing accounts for the majority of the market share
The report has provided a detailed breakup and analysis of the market based on the manufacturing type. This includes in-house and contract manufacturing. According to the report, in-house manufacturing represented the largest segment.
In-house manufacturing allows complete control over the product quality, which is essential for biosimilars. Given the complexity of biologics and the strict regulations surrounding their manufacture, companies usually prefer to handle production themselves to ensure high standards are met. Moreover, biologic manufacturing processes often involve proprietary methods and technologies. In-house production helps protect these trade secrets, making it the preferred choice of manufacturing type. While the initial setup cost may be high, maintaining production in-house can significantly reduce costs per unit over time. Also, in-house manufacturing enables companies to minimize the risk of supply chain disruptions, ensuring a consistent supply of their products while facilitating flexibility and agility in production, including making adjustments or adaptations to the product or process as needed.
Breakup by Region:
Europe
Germany
France
Italy
Spain
United Kingdom
Rest of Europe
United States
Japan
India
South Korea
Others
Europe exhibits a clear dominance in the market
The report has also provided a comprehensive analysis of all the major regional markets, which include Europe (Germany, France, Italy, Spain, the United Kingdom, and Rest of Europe); the United States, Japan, India, South Korea, and Others. According to the report, Europe accounted for the largest market share.
Europe held the biggest share in the market since the region has a supportive regulatory environment, allowing several biosimilars to enter the European market well before other regions. This early start enabled Europe to gain a significant share of the market. Furthermore, the European Medicines Agency (EMA) has been a forerunner in creating a clear and supportive regulatory framework for the approval of biosimilars since 2005, earlier than many other regions. This early framework encouraged the development and marketing of biosimilars in the region. Various European countries have nationalized healthcare systems focused on cost-containment. Since biosimilars offer comparable clinical results to original biologics but at lower costs, they have become an attractive option in these settings. In addition to this, Europe has a high prevalence of diseases treated with biologics, such as autoimmune conditions and cancers. This high demand is supporting the growth of the market in the region. Apart from this, the increasing awareness and acceptance of biosimilars among healthcare professionals and patients in Europe has fueled their uptake, contributing to the market growth.
Competitive Landscape:
The market is experiencing a rise in strategic initiatives by key players aimed at capturing a larger share of the market. Companies are investing heavily in research and development (R&D) activities to introduce new biosimilars and improve their manufacturing processes. Numerous vendors are entering into strategic alliances, partnerships, and licensing deals to leverage the expertise of other companies and speed up the development, production, and marketing of their biosimilars. Besides this, several industry players are seeking regulatory approval for their biosimilars in new geographic markets to expand their global footprint. To build trust and confidence in their biosimilars, the leading manufacturers are conducting post-marketing surveillance studies to confirm the long-term safety and efficacy of their products. We also expect the market to witness a surge in product innovations, launch of new patient support programs, and rise in mergers and acquisitions (M&As) among key players to drive healthy competition within the domain during the forecast period.
The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:
Sandoz International GmbH
Pfizer Inc.
Teva Pharmaceutical Industries Limited
Celltrion Inc.
Biocon Limited
Samsung Biologics
Amgen, Inc.
Dr. Reddy's Laboratories Limited
Stada Arzneimittel Ag
Key Questions Answered in This Report
1. What was the size of the global biosimilar market in 2024?
2. What is the expected growth rate of the global biosimilar market during 2025-2033?
3. What are the key factors driving the global biosimilar market?
4. What has been the impact of COVID-19 on the global biosimilar market?
5. What is the breakup of the global biosimilar market based on the molecule?
6. What is the breakup of the global biosimilar market based on the indication?
7. What is the breakup of the global biosimilar market based on the manufacturing type?
8. What are the key regions in the global biosimilar market?
9. Who are the key companies/players in the global biosimilar market?
1 Preface
2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Forecasting Methodology
3 Executive Summary
4 Biosimilar Market – Introduction
4.1 Overview
4.2 WHO and FDA Terminology on Biosimilars
4.3 Biosimilars and Generics
4.4 Biosimilars and Branded Biological Products
5 Why are Biosimilars So Lucrative?
5.1 Patent Expiry of Blockbuster Biological Drugs
5.2 Significant Price Differential between Biosimilars and Innovator Drugs
5.3 Savings for the Government and Third Party Payers
5.4 Rising Prevalence of Lifestyle Diseases
5.5 Incentives for Prescribers, Pharmacists and Patients
5.6 Emergence of New Players in Europe and Emerging Markets
5.7 Increasing Product Differentiation as Manufacturers Tie-Up with Drug Delivery Device Companies
6 Biosimilar Research, Development and Manufacturing
6.1 Research and Development: Biosimilars vs. Innovator Drugs
6.2 Manufacturing: Biosimilars vs. Innovator Drugs
7 Global Biosimilar Market
7.1 Market Overview
7.2 Historical Performance
7.3 Impact of COVID-19
7.4 Market Breakup by Segment
7.5 Market Breakup by Manufacturing Type
7.6 Market Breakup by Indication
7.7 Market Breakup by Region
7.8 Market Forecast
7.9 Biosimilar Patent Landscape
7.9.1 Patent Landscape in the US
7.9.2 Patent Landscape in Europe
7.9.3 Patent Landscape in Japan
7.10 SWOT Analysis
7.10.1 Overview
7.10.2 Strengths
7.10.3 Weaknesses
7.10.4 Opportunities
7.10.5 Threats
7.11 Value Chain Analysis
7.11.1 Characterizing the Existing Innovator Drug
7.11.2 Research and Development
7.11.2.1 Characterization of Biosimilars
7.11.2.2 Developing a Unique Cell Line
7.11.3 Product Development
7.11.3.1 Pre-Testing
7.11.3.2 Intermediary Clinical Testing (PK/PD)
7.11.3.3 Confirmatory Clinical Phase-III
7.11.4 Final Product Formulation
7.11.5 Marketing and Distribution
7.12 Porter’s Five Forces Analysis
7.12.1 Overview
7.12.2 Bargaining Power of Buyers
7.12.3 Bargaining Power of Suppliers
7.12.4 Degree of Competition
7.12.5 Threat of New Entrants
7.12.6 Threat of Substitutes
7.13 Price Analysis
7.13.1 Key Price Indicators
7.13.2 Price Trends
7.13.3 Margin Analysis
8 Market Breakup by Molecule
8.1 Infliximab
8.2 Insulin Glargine
8.3 Epoetin Alfa
8.4 Etanercept
8.5 Filgrastim
8.6 Somatropin
8.7 Rituximab
8.8 Follitropin Alfa
8.9 Adalimumab
8.10 Pegfilgrastim
8.11 Trastuzumab
8.12 Bevacizumab
8.13 Others
9 Market Breakup by Manufacturing Type
9.1 In-house Manufacturing
9.1.1 Market Trends
9.1.2 Market Forecast
9.2 Contract Manufacturing
9.2.1 Market Trends
9.2.2 Market Forecast
10 Market Breakup by Indication
10.1 Auto-Immune Diseases
10.1.1 Market Trends
10.1.2 Market Forecast
10.2 Blood Disorder
10.2.1 Market Trends
10.2.2 Market Forecast
10.3 Diabetes
10.3.1 Market Trends
10.3.2 Market Forecast
10.4 Oncology
10.4.1 Market Trends
10.4.2 Market Forecast
10.5 Growth Deficiency
10.5.1 Market Trends
10.5.2 Market Forecast
10.6 Female Infertility
10.6.1 Market Trends
10.6.2 Market Forecast
10.7 Others
10.7.1 Market Trends
10.7.2 Market Forecast
11 Market Breakup by Region
11.1 Europe
11.1.1 Market Performance
11.1.2 Key Players and Biosimilars
11.1.3 Market Breakup by Country
11.1.4 Market Forecast
11.1.5 Italy
11.1.5.1 Market Performance
11.1.5.2 Key Players and Biosimilars
11.1.5.3 Market Forecast
11.1.6 Germany
11.1.6.1 Market Performance
11.1.6.2 Key Players and Biosimilars
11.1.6.3 Market Forecast
11.1.7 France
11.1.7.1 Market Performance
11.1.7.2 Key Players and Biosimilars
11.1.7.3 Market Forecast
11.1.8 United Kingdom
11.1.8.1 Market Performance
11.1.8.2 Key Players and Biosimilars
11.1.8.3 Market Forecast
11.1.9 Spain
11.1.9.1 Market Performance
11.1.9.2 Key Players and Biosimilars
11.1.9.3 Market Forecast
11.1.10 Rest of Europe
11.1.10.1 Market Performance
11.1.10.2 Market Forecast
11.2 United States
11.2.1 Current Market Trends
11.2.2 Key Players and Biosimilars
11.2.3 Market Forecast
11.3 Japan
11.3.1 Market Performance
11.3.2 Key Players and Biosimilars
11.3.3 Market Forecast
11.4 India
11.4.1 Current Market Trends
11.4.2 Key Players and Biosimilars
11.4.3 Market Forecast
11.5 South Korea
11.5.1 Current Market Trends
11.5.2 Key Players and Biosimilars
11.5.3 Market Forecast
11.6 Rest of the World
11.6.1 Current Market Trends
11.6.2 Market Forecast
12 Requirements for Setting Up a Biosimilar Manufacturing Plant
12.1 Manufacturing Process
12.2 Raw Material Requirements
12.3 Raw Material Pictures
12.4 Land and Construction Requirements
12.5 Machinery and Infrastructure Requirements
12.6 Machinery Pictures
12.7 Plant Layout
12.8 Packaging Requirements
12.9 Utility Requirements
12.10 Manpower Requirements
13 Competitive Landscape
13.1 Market Structure
13.2 Key Players
13.3 Profiles of Key Players
13.3.1 Sandoz International GmbH
13.3.2 Pfizer Inc.
13.3.3 Teva Pharmaceutical Industries Limited
13.3.4 Celltrion Inc.
13.3.5 Biocon Limited
13.3.6 Samsung Biologics
13.3.7 Amgen, Inc.
13.3.8 Dr. Reddy's Laboratories Limited
13.3.9 Stada Arzneimittel Ag
*** バイオシミラーの世界市場に関するよくある質問(FAQ) ***
・バイオシミラーの世界市場規模は？
→IMARC社は2024年のバイオシミラーの世界市場規模を265億米ドルと推定しています。
・バイオシミラーの世界市場予測は？
→IMARC社は2033年のバイオシミラーの世界市場規模を1851億米ドルと予測しています。
・バイオシミラー市場の成長率は？
→IMARC社はバイオシミラーの世界市場が2025年～2033年に年平均24.1%成長すると展望しています。
・世界のバイオシミラー市場における主要プレイヤーは？
→「Sandoz International GmbH, Pfizer Inc., Teva Pharmaceutical Industries Limited, Celltrion Inc., Biocon Limited, Samsung Biologics, Amgen, Inc., Dr. Reddy's Laboratories Limited, Stada Arzneimittel Ag.など ...」をバイオシミラー市場のグローバル主要プレイヤーとして判断しています。
※上記FAQの市場規模、市場予測、成長率、主要企業に関する情報は本レポートの概要を作成した時点での情報であり、最終レポートの情報と少し異なる場合があります。
*** 免責事項 ***
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