バイオシミラー市場レポート：分子、適応症、製造タイプ、地域別、2025-2033年

バイオシミラー市場の世界市場規模は2024年に265億米ドルに達しました。IMARC Groupは、2025年から2033年にかけて24.1%の成長率（CAGR）を示し、2033年には1,851億米ドルに達すると予測しています。主要な生物学的製剤の特許切れ、バイオシミラーの有効性と費用対効果に関する意識の高まり、世界の慢性疾患の有病率の上昇、バイオ医薬品製造技術の継続的な進歩などが、市場成長を促進する主な要因の一部です。

バイオシミラーとは、FDAが承認した既存の基準製品と類似性が高く、臨床的に意味のある違いがない生物学的製剤です。バイオシミラー医薬品は、先発品と同じ作用機序、投与経路、剤形、強度を持つように開発されます。生物学的製剤は、その複雑な性質や製造方法のため、基準製剤と同一ではありませんが、同等の安全性、純度、効力が維持されています。これらの生物学的製剤は、高コストの基準生物学的製剤に代わる、より手頃な価格の代替品を提供し、競合を生み出し、患者にとって治療がより身近なものとなります。市場にイントロダクションされる際には、治療上の同等性と患者の安全性を確保するため、厳格な試験と厳しい規制当局の監視が行われます。近年、バイオシミラーは、がん、糖尿病、自己免疫疾患などのさまざまな治療分野で絶大な支持を得ています。

市場を牽引する主な要因の1つは、いくつかの大ヒット生物学的製剤の特許切れが間近に迫っていることであり、これによりバイオシミラーの活躍の場が広がり、市場拡大の機会が十分に生まれています。バイオシミラー医薬品は高額な生物学的製剤に代わる安価な代替品であるため、ヘルスケアコストを大幅に削減できる可能性があり、医療システムや患者にとって魅力的な医薬品です。このことは、がん、糖尿病、自己免疫疾患など、生物学的製剤が管理において重要な役割を果たす慢性疾患の世界の負担増と相まって、製品需要を増大させています。これに加えて、FDAやEMAといった様々な規制機関がバイオシミラーの承認経路を合理化し、その開発と市場開拓を後押ししています。さらに、バイオシミラー企業の急速な世界化により、未開拓市場への進出が期待されています。このほか、バイオ医薬品製造技術の絶え間ない革新により、高い有効性と安全性を備えたバイオシミラーの製造が可能となり、市場の成長をさらに後押ししています。

バイオシミラー市場動向/促進要因：

今後の大ヒット医薬品の特許切れ

ブランド生物学的製剤の特許失効は、市場の成長を促進する重要な要因の一つです。生物学的製剤は、競合製品の参入を長期間阻止する強固な特許ポートフォリオによって保護されていることが多いです。しかし、これらの特許が失効すれば、より手頃な価格で同等の代替品を開発・販売する企業に門戸が開かれることになります。今後数年の間に、年間売上高が数十億米ドルに上る複数の大ヒット生物学的製剤が特許保護を失うことになっています。したがって、これらの特許保護が終了することは、メーカーが代替品を市場に投入し、大きな市場シェアを獲得する大きな機会となり、市場成長の起爆剤となります。

費用対効果

バイオシミラー医薬品の製造コストは、主に研究開発（R&D）コストの削減によるものです。そのため、バイオシミラーは大幅に価格を下げることができ、高額になりがちな生物学的製剤に代わる手頃な代替品を提供することができます。この費用対効果は、増大する医療費の管理に努めるヘルスケアシステムや、生物学的製剤の高額な費用に苦しむ患者にとって特に魅力的です。さらに、これまで生物学的製剤が手の届かなかった新興市場では、バイオシミラーによって必要な治療へのアクセスが容易になります。

慢性疾患の増加

がん、自己免疫疾患、糖尿病などの慢性疾患の有病率は世界的に上昇傾向にあります。これらの疾患は通常、生物学的製剤による長期的な治療を必要とするため、これらの薬剤に対する需要が高まっています。バイオシミラーは、オリジナルの生物学的製剤と同様の有効性と安全性プロファイルを有しながら、より低コストであるため、これらの慢性疾患の治療において、バイオシミラーの使用がますます好ましい選択肢となりつつあります。例えば、腫瘍壊死因子阻害剤のような生物学的製剤で管理される関節リウマチや乾癬を含む疾病の発生率の増加は、これらの薬剤のバイオシミラーの大きな市場を提示しています。慢性疾患の世界の負担が増加し続ける中、製品の需要も同様に増加し、市場の成長を促進すると予想されます。

目次

第1章 序文

第2章 調査範囲と調査手法

• 調査の目的
• ステークホルダー
• データソース
  • 一次情報
  • 二次情報
• 市場推定
  • ボトムアップアプローチ
  • トップダウンアプローチ
• 調査手法

第3章 エグゼクティブサマリー

第4章 バイオシミラー市場-イントロダクション

• 概要
• バイオシミラーに関するWHOとFDAの用語
• バイオシミラーとジェネリック
• バイオシミラーとブランド生物学的製剤

第5章 バイオシミラーはなぜそれほど利益が上がるのか

• 生物学的製剤の特許切れ
• バイオシミラーと先発医薬品の大きな価格差
• 政府と第三者支払者の節約
• 生活習慣病の蔓延
• 処方医、薬剤師、患者へのインセンティブ
• 欧州と新興市場における新規企業ーの出現
• 医薬品メーカーとドラッグデリバリーデバイス企業との提携による製品差別化の強化

第6章 バイオシミラーの調査、開発、製造

• 研究開発：バイオシミラーと先発医薬品
• 製造：バイオシミラーと先発医薬品

第7章 世界のバイオシミラー市場

• 市場概要
• 過去の実績
• COVID-19の影響
• 市場内訳：セグメント別
• 市場内訳：製造タイプ別
• 市場内訳：適応症別
• 市場内訳：地域別
• 市場予測
• バイオシミラーの特許情勢
  • 米国の特許情勢
  • 欧州の特許情勢
  • 日本の特許情勢
• SWOT分析
  • 概要
  • 強み
  • 弱み
  • 機会
  • 脅威
• バリューチェーン分析
  • 既存のイノベーター医薬品の特徴
  • 研究開発
    • バイオシミラーの特性
    • 独自の細胞株の開発
  • 製品開発
    • 事前テスト
    • 中間臨床試験（PK/PD）
    • 確認臨床第III相試験
  • 最終製品の配合
  • マーケティングと流通
• ポーターのファイブフォース分析
  • 概要
  • バイヤーの交渉力
  • サプライヤーの交渉力
  • 競合の度合い
  • 新規参入業者の脅威
  • 代替品の脅威
• 価格分析
  • 主要価格指標
  • 価格動向
  • マージン分析

第8章 市場内訳：分子別

• インフリキシマブ
• インスリングラルギン
• エポエチンアルファ
• エタネルセプト
• フィルグラスチム
• ソマトロピン
• リツキシマブ
• フォリトロピンアルファ
• アダリムマブ
• ペグフィルグラスチム
• トラスツズマブ
• ベバシズマブ
• その他

第9章 市場内訳：製造タイプ別

• 自社製造
  • 市場動向
  • 市場予測
• 契約製造
  • 市場動向
  • 市場予測

第10章 市場内訳別：適応症別

• 自己免疫疾患
  • 市場動向
  • 市場予測
• 血液疾患
  • 市場動向
  • 市場予測
• 糖尿病
  • 市場動向
  • 市場予測
• がん
  • 市場動向
  • 市場予測
• 成長不全
  • 市場動向
  • 市場予測
• 女性の不妊症
  • 市場動向
  • 市場予測
• その他
  • 市場動向
  • 市場予測

第11章 市場内訳：地域別

• 欧州
  • 市場実績
  • 主要プレーヤーとバイオシミラー
  • 市場内訳：国別
  • 市場予測
  • イタリア
  • ドイツ
  • フランス
  • 英国
  • スペイン
  • 上記以外の欧州諸国
• 米国
  • 現在の市場動向
  • 主要プレーヤーとバイオシミラー
  • 市場予測
• 日本
  • 市場実績
  • 主要プレーヤーとバイオシミラー
  • 市場予測
• インド
  • 現在の市場動向
  • 主要プレーヤーとバイオシミラー
  • 市場予測
• 韓国
  • 現在の市場動向
  • 主要プレーヤーとバイオシミラー
  • 市場予測
• その他地域
  • 現在の市場動向
  • 市場予測

第12章 バイオシミラー製造工場の設立要件

• 製造工程
• 原材料要件
• 原材料の写真
• 土地と建設の要件
• 機械およびインフラストラクチャの要件
• 機械写真
• 工場レイアウト
• 梱包要件
• ユーティリティ要件
• 人材要件

第13章 競合情勢

• 市場構造
• 主要企業
• 主要企業のプロファイル
  • 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

List of Figures

• Figure 1: Global: Biosimilar Market: Sales Value (in Billion USD), 2019-2024
• Figure 2: Global: Biosimilar Market: Breakup by Molecule (in %), 2024
• Figure 3: Global: Biosimilar Market: Breakup by Manufacturing Type (in %), 2024
• Figure 4: Global: Biosimilar Market: Breakup by Indication (in %), 2024
• Figure 5: Global: Biosimilar Market: Breakup by Region (in %), 2024
• Figure 6: Global: Biosimilar Market Forecast: Sales Value (in Billion USD), 2025-2033
• Figure 7: Global: Biosimilars Industry: SWOT Analysis
• Figure 8: Global: Biosimilar Industry: Value Chain Analysis
• Figure 9: Global: Biosimilars Industry: Porter's Five Forces Analysis
• Figure 10: Global: Biosimilar Market: Average Price Trends of Inflectra
• Figure 11: Global: Biosimilar Market: Average Price Trends of Zarxio
• Figure 12: Biosimilars Industry: Breakup of Profit Margins at Various Level of the Value Chain
• Figure 13: Infliximab: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 14: Infliximab: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 15: Insulin Glargine: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 16: Insulin Glargine: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 17: Epoetin Alfa: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 18: Epoetin Alfa: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 19: Etanercept: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 20: Etanercept: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 21: Filgrastim: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 22: Filgrastim: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 23: Somatropin: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 24: Somatropin: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 25: Rituximab: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 26: Rituximab: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 27: Follitropin Alfa: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 28: Follitropin Alfa: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 29: Adalimumab: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 30: Adalimumab: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 31: Pegfilgrastim: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 32: Pegfilgrastim: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 33: Trastuzumab: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 34: Trastuzumab: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 35: Bevacizumab: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 36: Others: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 37: In-House Manufacturing: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 38: In-House Manufacturing: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 39: Contract Manufacturing: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 40: Contract Manufacturing: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 41: Global: Biosimilar Market (Autoimmune Diseases): Sales Value (in Million USD), 2019 & 2024
• Figure 42: Global: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million USD), 2025-2033
• Figure 43: Global: Biosimilar Market (Blood Disorders): Sales Value (in Million USD), 2019 & 2024
• Figure 44: Global: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million USD), 2025-2033
• Figure 45: Global: Biosimilar Market (Diabetes): Sales Value (in Million USD), 2019 & 2024
• Figure 46: Global: Biosimilar Market Forecast (Diabetes): Sales Value (in Million USD), 2025-2033
• Figure 47: Global: Biosimilar Market (Oncology): Sales Value (in Million USD), 2019 & 2024
• Figure 48: Global: Biosimilar Market Forecast (Oncology): Sales Value (in Million USD), 2025-2033
• Figure 49: Global: Biosimilar Market (Growth Deficiency): Sales Value (in Million USD), 2019 & 2024
• Figure 50: Global: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million USD), 2025-2033
• Figure 51: Global: Biosimilar Market (Female Infertility): Sales Value (in Million USD), 2019 & 2024
• Figure 52: Global: Biosimilar Market Forecast (Female Infertility): Sales Value (in Million USD), 2025-2033
• Figure 53: Global: Biosimilar Market (Others): Sales Value (in Million USD), 2019 & 2024
• Figure 54: Global: Biosimilar Market Forecast (Others): Sales Value (in Million USD), 2025-2033
• Figure 55: Europe: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 56: Europe: Biosimilar Market: Breakup by Country (in %), 2024
• Figure 57: Europe: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 58: Italy: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 59: Italy: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 60: Germany: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 61: Germany: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 62: France: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 63: France: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 64: United Kingdom: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 65: United Kingdom: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 66: Spain: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 67: Spain: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 68: Rest of Europe: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 69: Rest of Europe: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 70: United States: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 71: United States: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 72: Japan: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 73: Japan: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 74: India: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 75: India: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 76: South Korea: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 77: South Korea: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 78: Others: Biosimilar Market: Sales Value (in Million USD), 2019-2024
• Figure 79: Others: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 80: Biosimilar Manufacturing: Detailed Process Flow
• Figure 81: Biosimilar Manufacturing Plant: Raw Materials Requirement
• Figure 82: Biosimilar Manufacturing Process: Conversion Rates of Feedstocks
• Figure 83: Biosimilar Manufacturing Plant: Machinery Costs (in USD)
• Figure 84: Biosimilar Manufacturing Plant: Primary Packaging
• Figure 85: Biosimilar Manufacturing Plant: Secondary Packaging
• Figure 86: Biosimilar Manufacturing Plant: Tertiary Packaging

List of Tables

• Table 1: Global: Sales and Patent Expiry of Blockbuster Biological Drugs (in Million USD), 2024
• Table 2: Global: Biosimilar Market: Biosimilars Vs Innovators Drug Development
• Table 3: Global: Biosimilar Market: Biosimilars Vs Biologics Manufacturing
• Table 4: Global: Biosimilar Market: Key Industry Highlights, 2024 and 2033
• Table 5: US: Biosimilar Market: Patent Landscape
• Table 6: Europe: Biosimilar Market: Patent Landscape
• Table 7: Japan: Biosimilar Market: Patent Landscape
• Table 8: Global: Biosimilar Market: Price Comparison Between Biosimilar and Originator Drugs
• Table 9: Global: Biosimilar Market: Breakup by Molecule (in Million USD), 2025-2033
• Table 10: Global: Infliximab: Brand & Biosimilar Market Overview
• Table 11: Global: Insulin Glargine: Brand & Biosimilar Market Overview
• Table 12: Global: Epoetin Alfa: Brand & Biosimilar Market Overview
• Table 13: Global: Etanercept: Brand & Biosimilar Market Overview
• Table 14: Global: Filgrastim: Brand & Biosimilar Market Overview
• Table 15: Global: Somatropin: Brand & Biosimilar Market Overview
• Table 16: Global: Rituximab: Brand & Biosimilar Market Overview
• Table 17: Global: Follitropin Alfa: Brand & Biosimilar Market Overview
• Table 18: Global: Adalimumab: Brand & Biosimilar Market Overview
• Table 19: Global: Pegfilgrastim: Brand & Biosimilar Market Overview
• Table 20: Global: Trastuzumab: Brand & Biosimilar Market Overview
• Table 21: Global: Bevacizumab: Brand & Biosimilar Market Overview
• Table 22: Global: Biosimilar Market Forecast: Breakup by Manufacturing Type (in Million USD), 2025-2033
• Table 23: Global: Biosimilar Market Forecast: Breakup by Indication (in Million USD), 2025-2033
• Table 24: Global: Biosimilar Market Forecast: Breakup by Region (in Million USD), 2025-2033
• Table 25: Europe: Biosimilar Market: Key Players and Biosimilars
• Table 26: Italy: Biosimilar Market: Key Players and Biosimilars
• Table 27: Germany: Biosimilar Market: Key Players and Biosimilars
• Table 28: France: Biosimilar Market: Key Players and Biosimilars
• Table 29: United Kingdom: Biosimilar Market: Key Players and Biosimilars
• Table 30: Spain: Biosimilar Market: Key Players and Biosimilars
• Table 31: United States: Biosimilar Market: Key Players and Biosimilar
• Table 32: United States: Biosimilar Market: Launch of Expected Biosimilar
• Table 33: Japan: Biosimilar Market: Key Players and Biosimilars
• Table 34: India: Biosimilar Market: Key Players and Biosimilars
• Table 35: South Korea: Biosimilar Market: Key Players and Biosimilar
• Table 36: Biosimilar Manufacturing Plant: Manpower Requirements
• Table 37: Biosimilar Market: Competitive Structure
• Table 38: Global: Biosimilar Market: Key Players

The global biosimilar market size reached USD 26.5 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 185.1 Billion by 2033, exhibiting a growth rate (CAGR) of 24.1% during 2025-2033. The expiration of patents for major biological drugs, growing awareness about the efficacy and cost-effectiveness of biosimilars, the rising prevalence of chronic diseases worldwide, and continual advancements in biopharmaceutical manufacturing technologies are some of the major factors propelling the market growth.

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:

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

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

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

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?

Table of Contents

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