1 序文
2 調査範囲と方法論
2.1 調査の目的
2.2 ステークホルダー
2.3 データソース
2.3.1 一次情報源
2.3.2 二次情報源
2.4 市場推定
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
3 エグゼクティブサマリー
4 欧州バイオシミラー市場-序論
4.1 概要
4.2 バイオシミラーに関するWHOとEMA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 欧州バイオシミラー市場
5.1 市場概要
5.2 過去と現在の市場動向
5.3 COVID-19の影響
5.4 国別市場構成
5.5 分子別市場構成比
5.6 適応症別市場構成比
5.7 製造タイプ別市場構成比
5.8 特許状況
5.9 市場予測
6 国別市場構成
6.1 イタリア
6.1.1 市場パフォーマンス
6.1.2 主要企業とバイオシミラー
6.1.3 市場予測
6.2 ドイツ
6.2.1 市場パフォーマンス
6.2.2 主要プレーヤーとバイオシミラー
6.2.3 市場予測
6.3 フランス
6.3.1 市場パフォーマンス
6.3.2 主要プレーヤーとバイオシミラー
6.3.3 市場予測
6.4 イギリス
6.4.1 市場パフォーマンス
6.4.2 主要プレーヤーとバイオシミラー
6.4.3 市場予測
6.5 スペイン
6.5.1 市場パフォーマンス
6.5.2 主要プレーヤーとバイオシミラー
6.5.3 市場予測
6.6 その他の欧州
6.6.1 市場パフォーマンス
6.6.2 市場予測
7 分子別市場内訳
7.1 インフリキシマブ
7.2 インスリングラルギン
7.3 エポエチンアルファ
7.4 エタネルセプト
7.5 フィルグラスチム
7.6 ソマトローピン
7.7 リツキシマブ
7.8 フォリトロピン・アルファ
7.9 アダリムマブ
8 製造タイプ別市場
8.1 自社製造
8.1.1 市場動向
8.1.2 市場予測
8.2 受託製造
8.2.1 市場動向
8.2.2 市場予測
9 適応症別市場
9.1 自己免疫疾患
9.2 血液疾患
9.3 糖尿病
9.4 腫瘍
9.5 成長不全
9.6 女性不妊症
10 欧州バイオシミラー市場SWOT分析
10.1 概要
10.2 長所
10.3 弱点
10.4 機会
10.5 脅威
11 欧州バイオシミラー市場バリューチェーン分析
11.1 既存の革新的医薬品の特徴づけ
11.2 研究開発
11.2.1 バイオシミラーの特性化
11.2.2 独自細胞株の開発
11.3 製品開発
11.3.1 予備試験
11.3.2 中間臨床試験（PK/PD）
11.3.3 確認臨床第III相試験
11.4 最終製剤化
11.5 マーケティングと流通
12 ポーターのファイブフォース分析
12.1 概要
12.2 買い手の交渉力
12.3 供給者の交渉力
12.4 競争の程度
12.5 新規参入の脅威
12.6 代替品の脅威
13 価格分析
13.1 主要価格指標
13.2 価格動向
14 ジェネリック医薬品製造工場設立の要件
14.1 製造プロセス
14.2 原材料の要件
14.3 原材料写真
14.4 土地と建設の要件
14.5 機械およびインフラの要件
14.6 機械の写真
14.7 工場レイアウト
14.8 梱包要件
14.9 ユーティリティ要件
14.10 人員要件
15 競争環境
15.1 市場構造
15.2 主要プレーヤー
15.3 主要プレーヤーのプロフィール
15.3.1 ノバルティス
15.3.2 ファイザー
15.3.3 テバ
15.3.4 セルトリオン
15.3.5 メルク・シャープ・アンド・ドーム
15.3.6 サムスンバイオエピス
15.3.7 イーライリリー
15.3.8 アコードヘルスケア
15.3.9 アムジェン
15.3.10 ベーリンガーインゲルハイム
15.3.11 Hexal Ag
15.3.12 アポテックス
15.3.13 Stada Arzneimittel Ag
15.3.14 ラチオファーム
15.3.15 マイラン
図1：欧州：バイオシミラー市場：売上金額（単位：百万米ドル）、2019-2024年
図2：欧州：バイオシミラー市場：図2：欧州：バイオシミラー市場：分子別構成比（単位：%）、2024年
図3：欧州：バイオシミラー市場：図3：欧州：バイオシミラー市場：製造タイプ別構成比（%）、2024年
図4：欧州：バイオシミラー市場：図4：欧州：バイオシミラー市場：適応症別構成比（%）、2024年
図5：欧州：バイオシミラー市場：国別構成比（%）、2024年図5：欧州：バイオシミラー市場：国別構成比（%）、2024年
図6：欧州：バイオシミラー市場予測：販売金額（単位：百万米ドル）、2025年〜2033年
図7：イタリアイタリア：バイオシミラー市場販売額（単位：百万米ドル）、2019年〜2024年
図8：イタリアバイオシミラー市場予測：販売額（単位：百万米ドル）、2025-2033年
図9：ドイツバイオシミラー市場：販売額（単位：百万米ドル）、2019年～2024年
図10：ドイツバイオシミラー市場予測：販売額（単位：百万米ドル）、2025-2033年
図11：フランスバイオシミラー市場：販売額（単位：百万米ドル）、2019年～2024年
図12：フランスバイオシミラー市場予測：販売額（単位：百万米ドル）、2025-2033年
図13：イギリスバイオシミラー市場：販売額（単位：百万米ドル）、2019年～2024年
図14：イギリスバイオシミラー市場予測：販売額（単位：百万米ドル）、2025-2033年
図15：スペインバイオシミラー市場：販売額（単位：百万米ドル）、2019年～2024年
図16：スペインバイオシミラー市場予測：販売額（単位：百万米ドル）、2025年～2033年
図17：その他のヨーロッパ：バイオシミラー市場：販売額（単位：百万米ドル）、2019年～2024年
図18：その他のヨーロッパ：バイオシミラー市場予測：販売額（単位：百万米ドル）、2025年～2033年
図19：欧州リツキシマブのバイオシミラー市場：販売金額（単位：百万米ドル）、2017年
図20: 欧州: インフリキシマブバイオシミラー市場：販売額（単位：百万米ドル）、2015～2017年
図21: 欧州: インスリングラルギンバイオシミラー市場：販売額（単位：百万米ドル）、2016年・2017年
図22: 欧州：エポエチンアルファバイオシミラー市場：販売額（単位：百万米ドル）、2014年～2017年
図23：欧州フィルグラスチムバイオシミラー市場：販売額（単位：百万米ドル）、2014～2017年
図24: 欧州: ソマトロピンバイオシミラー市場：販売額（単位：百万米ドル）、2014～2017年
図25：欧州エタネルセプトバイオシミラー市場：販売額（単位：百万米ドル）、2016年および2017年
図26：欧州：フォリトロピン・アルファフォリトロピン・アルファ・バイオシミラー市場：販売額（単位：百万米ドル）、2015年～2017年
図27：欧州：アダリムマブのバイオシミラー市場アダリムマブのバイオシミラー市場：販売額（単位：百万米ドル）、2018年
図28：欧州：バイオシミラー市場（自社製造）：販売額（単位：百万米ドル）、2019年および2024年
図29：欧州：バイオシミラー市場予測（自社製造）：販売額（単位：百万米ドル）、2025年～2033年
図30：欧州：バイオシミラー市場予測（受託製造）：売上金額（単位：百万米ドル）、2019年および2024年
図31：欧州：バイオシミラー市場予測（受託製造）：販売額（単位：百万米ドル）、2025年～2033年
図32：欧州：バイオシミラー市場予測（自己免疫疾患）：売上金額（単位：百万米ドル）、2019年および2024年
図33：欧州：バイオシミラー市場予測（自己免疫疾患）：販売金額（単位：百万米ドル）、2025年～2033年
図34：欧州：バイオシミラー市場予測（血液疾患）：販売金額（単位：百万米ドル）、2019年および2024年
図35：欧州：バイオシミラー市場予測（血液疾患）：販売金額（単位：百万米ドル）、2025年～2033年
図36：欧州：バイオシミラー市場（糖尿病）：売上金額（単位：百万米ドル）、2019年および2024年
図37：欧州：バイオシミラー市場予測（糖尿病）：販売金額（単位：百万米ドル）、2025年～2033年
図38：欧州：バイオシミラー市場（がん領域）：売上金額（単位：百万米ドル）、2019年および2024年
図39：欧州：バイオシミラー市場予測（がん領域）：販売金額（単位：百万米ドル）、2025年～2033年
図40：欧州：バイオシミラー市場予測（成長不良）：販売金額（単位：百万米ドル）、2019年および2024年
図41：欧州：バイオシミラー市場予測（成長不足）：販売額（単位：百万米ドル）、2025年～2033年
図42：欧州：バイオシミラー市場（女性不妊症）：販売金額（単位：百万米ドル）、2019年および2024年
図43：欧州：バイオシミラー市場予測（女性不妊）：販売金額（単位：百万米ドル）、2025年～2033年
図44：欧州：バイオシミラー産業：SWOT分析
図45：欧州：バイオシミラー産業：バリューチェーン分析
図46：欧州：バイオシミラー産業：ポーターのファイブフォース分析
図47：バイオシミラー製造：詳細なプロセスフロー
表一覧
表1：欧州：ブロックバスター生物学的製剤の売上と特許切れ（単位：百万米ドル）
表2：バイオシミラーとイノベーターの医薬品開発
表3：バイオシミラーと生物製剤の製造比較
表4：欧州：バイオシミラー市場：主要産業ハイライト、2024年および2033年
表5：欧州：バイオシミラー市場：特許の状況
表6：欧州：バイオシミラー市場：バイオシミラーと先発品の価格比較
表7：欧州：バイオシミラー市場予測：欧州：バイオシミラー市場予測：地域別内訳（単位：百万米ドル）、2025-2033年
表8：欧州：バイオシミラー市場：主要プレーヤーとバイオシミラー
表9: イタリア：イタリア：バイオシミラー市場：主要プレーヤーとバイオシミラー
表10: ドイツ：バイオシミラー市場：主要プレーヤーとバイオシミラー
表11：フランスバイオシミラー市場：主要メーカーとバイオシミラー
表12: イギリス：バイオシミラー市場主要メーカーとバイオシミラー
表13：スペインバイオシミラー市場：主要メーカーとバイオシミラー
表14: 欧州：リツキシマブ：ブランドとバイオシミラー市場の概要
表15：欧州：インフリキシマブ：ブランド＆バイオシミラー市場概況
表16：欧州：インスリングラルギンのブランド＆バイオシミラー市場概況
表17：欧州エポエチンアルファ：エポエチンアルファ：ブランド＆バイオシミラー市場概況
表18：ヨーロッパフィルグラスチム：ブランド＆バイオシミラーの市場概況
表19：欧州：ソマトロピン：ブランド＆バイオシミラー市場概況
表20：ヨーロッパエタネルセプトエタネルセプトのブランド＆バイオシミラー市場概況
表21：欧州フォリトロピン・アルファ：ブランド＆バイオシミラー市場概況
表22：欧州：バイオシミラー市場予測：製造タイプ別内訳（単位：百万ドル）、2025-2033年
表23：欧州：バイオシミラー市場予測：適応症別構成比（単位：百万米ドル）、2025-2033年
表24：バイオシミラー製造工場：原材料の所要量
表25：バイオシミラー製造工場：土地と建設の必要条件
表26：バイオシミラー製造工場：機械要件
表27：バイオシミラー製造工場：必要人員
表28：欧州：バイオシミラー市場：競争構造
表29：欧州：バイオシミラー市場：主要プレーヤー
The Europe biosimilar market size reached USD 13,864 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 59,733.3 Million by 2033, exhibiting a growth rate (CAGR) of 17.1% during 2025-2033. The implementation of favorable reimbursement policies to encourage the use of biosimilars, the expansion of production facilities to ensure a consistent supply of the products, and continuous technological advancements are among the key factors driving the growth market.
Biosimilars are biological products designed to have similar safety, efficacy, and therapeutic characteristics as an already approved biological product, known as the reference product. While they aren't identical, due to the complex nature of biological products, they match closely in terms of their function, administration, and intended use. The goal of a biosimilar is to provide an equivalent treatment option that can be marketed at a potentially lower cost once the original product's patent expires. The development of biosimilars undergoes a rigorous process, involving multiple phases of trials to demonstrate their comparability to the reference product. The key focus lies in achieving "biosimilarity" that assures no clinically meaningful differences from the reference product in terms of safety and effectiveness. Therefore, biosimilars play a significant role in increasing access to life-changing biological treatments by offering cost-effective alternatives.
Europe has one of the highest proportions of elderly people globally. Aging is often associated with an increased prevalence of chronic diseases, many of which require biological treatments. Biosimilars, offering affordable options for biologic drugs, therefore cater to this demographic and the associated increased demand for therapeutics. Along with this, European countries are implementing favorable reimbursement policies to encourage the use of biosimilars. Such policies, for instance in Germany and France, facilitate better access to biosimilars for patients and help to reduce the financial burden on healthcare systems. In addition, the rising manufacturing capacities for biosimilars in Europe are also positively influencing the market. Several biosimilar companies are investing in expanding their production facilities to ensure a consistent supply of these products, which in turn supports market growth. Apart from this, the escalating educational initiatives for healthcare professionals and patients, and measures to incentivize prescription is contributing to the market. Furthermore, innovations in bioprocessing and analytical methods to reduce the time and cost of biosimilar production and development are creating a positive market outlook.
Biosimilar Market in Europe Market Trends/Drivers:
Patent Expiries and Cost Containment
One of the most prominent market drivers for the biosimilars industry in Europe is the expiry of patents for a host of high-revenue biologic drugs. These patent expiries create lucrative opportunities for biosimilar manufacturers to introduce less costly alternatives in the market, which in turn accelerates the adoption of biosimilars. As European countries grapple with rising healthcare costs, cost containment has become a crucial aspect. In addition, biosimilars typically enter the market at a significantly reduced price compared to their reference biologic, contributing to savings in healthcare expenditure. Several European healthcare systems are encouraging the use of biosimilars as a cost-effective strategy. For instance, government organizations are introducing policies to incentivize the prescription of biosimilars. As a result, cost containment strategies coupled with patent expirations are fostering the growth of the biosimilars market in Europe.
Increased Adoption due to Awareness and Acceptance
The growing level of awareness and acceptance of biosimilars among healthcare providers and patients in Europe is positively influencing the market. This can be supported by the educational initiatives of regulatory bodies and industry groups, which aim to dispel misconceptions about biosimilars and highlight their comparable safety and efficacy to reference biologics. Such initiatives have led to increased trust and wider acceptance of biosimilars. In confluence with this, successful case studies, such as the introduction and usage of biosimilar infliximab in several European countries, have showcased potential cost savings without compromising patient outcomes. This increased acceptance and trust in biosimilars, supported by positive real-world evidence, is a significant driver for the growth of the biosimilars industry in Europe.
Biosimilar Market in Europe Industry Segmentation:
IMARC Group provides an analysis of the key trends in each segment of the biosimilar market in Europe report, along with forecasts at the regional and country levels from 2025-2033. Our report has categorized the market based on molecule, indication and manufacturing type.
Breakup by Country:
Italy
Germany
United Kingdom
France
Spain
Rest of Europe
Italy exhibits a clear dominance, accounting for the largest biosimilar market share in Europe
The report has also provided a comprehensive analysis of all the major regional markets, which includes Italy, Germany, France, the United Kingdom, Spain, and the rest of Europe. According to the report, Italy accounted for the largest market share.
The biosimilar market in Italy is driven by the rising prevalence of chronic diseases in the country, such as autoimmune disorders, cancer, and diabetes, which has led to an increased demand for cost-effective treatment options. Biosimilars offer significant cost savings compared to their originator counterparts, making them a compelling choice for healthcare providers and patients alike. Along with this, the Italian government is implementing policies and incentives to encourage the adoption of biosimilars, recognizing their potential to improve patient access to essential therapies while reducing healthcare expenditures. The country's well-established regulatory framework and robust guidelines for biosimilar approval have instilled confidence in these products, further fostering their acceptance and utilization in the Italian market. Additionally, collaborations between biosimilar manufacturers and Italian healthcare organizations have played a crucial role in driving market growth, as they work together to raise awareness, educate stakeholders, and establish best practices for biosimilar integration into the healthcare system.
Breakup by Molecule:
Infliximab
Insulin Glargine
Epoetin Alfa
Etanercept
Filgrastim
Somatropin
Rituximab
Follitropin Alfa
Adalimumab
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, and adalimumab.
In the Europe biosimilar market, Infliximab has emerged as a prominent product with significant market drivers. Infliximab, a monoclonal antibody used to treat various autoimmune diseases, has witnessed growing demand due to its efficacy and cost-effectiveness. Along with this, the rising prevalence of chronic conditions, such as rheumatoid arthritis, Crohn's disease, and psoriasis, has propelled the demand for Infliximab biosimilars in recent years. Additionally, the expiry of patents on originator biologic products has opened opportunities for biosimilar manufacturers to enter the market, further intensifying competition. Furthermore, healthcare systems in Europe's cost-containment measures and the emphasis on providing access to affordable treatments have fueled the adoption of Infliximab biosimilars.
On the contrary, insulin glargine, a long-acting insulin analog, is widely used to manage diabetes, a chronic condition affecting a substantial population in Europe. the increasing prevalence of diabetes, coupled with the growing need for cost-effective treatment options, has fueled the demand for insulin glargine biosimilars. As the patents for originator insulin products have expired, it has created an opportunity for biosimilar manufacturers to enter the market and offer more affordable alternatives. in addition, the rising pressure on healthcare systems to optimize expenditure on diabetes care has also accelerated the adoption of insulin glargine biosimilars. these factors, along with the Europe medicines agency's stringent regulatory framework for biosimilars, contribute to the market's growth, positioning insulin glargine biosimilars as key drivers in the expanding landscape of biosimilar utilization in Europe.
Breakup by Indication:
Auto-Immune Diseases
Blood Disorder
Diabetes
Oncology
Growth Deficiency
Female Infertility
A detailed breakup and analysis of the market based on the indication has also been provided in the report. This includes auto-immune diseases, blood disorder, diabetes, oncology, growth deficiency, and female infertility.
In the region, the indication for auto-immune diseases has emerged as a significant driver for growth. Auto-immune diseases, encompassing a wide range of conditions like rheumatoid arthritis, psoriasis, and inflammatory bowel disease, affect a substantial number of patients across the region. In confluence with this, the growing prevalence of these chronic disorders has driven the demand for cost-effective and accessible treatment options. Biosimilars, as comparable alternatives to originator biologics, offer the potential for significant cost savings, making them an attractive choice for healthcare systems aiming to manage expenditure while ensuring quality care for patients. Moreover, the expiry of patents on several originator biologics has created opportunities for biosimilar developers to enter the market, fostering competition and promoting innovation. As regulatory agencies in Europe, such as the European Medicines Agency, continue to establish robust guidelines for biosimilar approval, the confidence in the safety and efficacy of these products grows, further supporting their adoption.
On the contrary, blood disorders, including anemia, thrombocytopenia, and various hematologic malignancies, affect a considerable number of patients in the region. The escalating prevalence of these conditions, coupled with the rising demand for cost-effective and efficient treatments, has stimulated the adoption of biosimilars as viable alternatives to originator biologics. Biosimilars offer the potential for substantial cost savings, making them an attractive option for healthcare providers and systems striving to manage their budgets effectively. In addition, as patents for several originator biologics used in the treatment of blood disorders have expired or are nearing expiration, it has paved the way for biosimilar manufacturers to enter the market and introduce competitive products. Moreover, the growing confidence in the safety and efficacy of biosimilars, supported by the stringent regulatory framework established by agencies, has further boosted their acceptance and utilization.
Breakup by Manufacturing Type:
In-house Manufacturing
Contract Manufacturing
The report has provided a detailed breakup and analysis of the market based on the manufacturing type. This includes in-house manufacturing and contract manufacturing.
In-house manufacturing refers to the practice of biosimilar companies producing their products internally rather than outsourcing the manufacturing process. This trend has been fueled by several factors. Additionally, in-house manufacturing allows for better control over the entire production process, ensuring higher quality standards and reducing the risk of supply chain disruptions. In addition, it offers greater flexibility in responding to market demands and regulatory changes, enabling companies to adapt quickly to emerging opportunities and challenges. Apart from this, it often results in cost efficiencies, as it eliminates the need for third-party involvement and reduces transportation and logistics expenses. In confluence with this, companies can protect their intellectual property and maintain a competitive edge by safeguarding their manufacturing know-how. As biosimilar competition intensifies, in-house manufacturing provides companies with a means to differentiate their products and establish themselves as reliable and competent players in the European biosimilar market.
On the other hand, the utilization of contract manufacturing has emerged as a compelling market driver. Contract manufacturing involves biosimilar companies outsourcing the production of their products to specialized manufacturing facilities. This trend has been fueled by several key factors. Moreover, contract manufacturing offers cost advantages, allowing companies to leverage the expertise and economies of scale of established manufacturing facilities without significant capital investments. This enables them to focus on research, development, and commercialization aspects, ultimately expediting time-to-market for their biosimilars. Additionally, access to contract manufacturing facilities with cutting-edge technologies and regulatory compliance expertise ensures high-quality production, meeting the stringent standards required by regulatory authorities. Moreover, contract manufacturing allows biosimilar companies to maintain flexibility in their operations, scaling production up or down as market demands fluctuate.
Competitive Landscape:
The key players in the market are investing significantly in research and development to identify suitable reference biologics and develop biosimilar versions. This involved conducting pre-clinical and clinical studies to demonstrate similarity in efficacy, safety, and quality with the originator biologics. Along with this, the rising utilization of pricing and marketing initiatives to gain market share and compete with originator biologics effectively is significantly supporting the market. In addition, companies are managing their supply chains to ensure a consistent and reliable supply of biosimilar products to meet market demand, such as establishing partnerships with contract manufacturing organizations and distribution networks. Thus, it is positively influencing the market. With increasing competition in the biosimilar market, manufacturers are employing cost-effective pricing, and value-added services, and developing a strong brand reputation. Furthermore, negotiating reimbursement and formulary inclusion to ensure widespread adoption is contributing to the market.
The report has provided a comprehensive analysis of the competitive landscape in the biosimilar market in Europe market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:
Novartis
Pfizer
Teva
Celltrion
Merck Sharp & Dohme
Samsung Bioepis
Eli Lilly
Accord Healthcare Ltd.
Amgen
Boehringer Ingelheim
Hexal Ag
Apotex
Stada Arzneimittel Ag
Ratiopharm
Mylan
Key Questions Answered in This Report
1. What was the size of the Europe biosimilar market in 2024?
2. What is the expected growth rate of the Europe biosimilar market during 2025-2033?
3. What are the key factors driving the Europe biosimilar market?
4. What has been the impact of COVID-19 on Europe biosimilar market?
5. What is the breakup of Europe biosimilar market breakup based on the molecule?
6. What is the breakup of Europe biosimilar market based on the indication?
7. What is the breakup of Europe biosimilar market based on the manufacturing type?
8. What are the key regions in the Europe biosimilar market?
9. Who are the key players/companies in the Europe biosimilar market?
