デフォルト表紙
市場調査レポート
商品コード
1718934

バイオシミラー市場:製品クラス別、適応症別、流通チャネル別、地域別、機会、予測、2018年~2032年

Biosimilars Market Assessment, By Product Class, By Indication By Distribution Channel, By Region, Opportunities and Forecast, 2018-2032F


出版日
ページ情報
英文 240 Pages
納期
3~5営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=146.08円
バイオシミラー市場:製品クラス別、適応症別、流通チャネル別、地域別、機会、予測、2018年~2032年
出版日: 2025年05月05日
発行: Market Xcel - Markets and Data
ページ情報: 英文 240 Pages
納期: 3~5営業日
GIIご利用のメリット
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界のバイオシミラーの市場規模は、2025年~2032年の予測期間中に16.73%のCAGRで拡大し、2024年の320億3,000万米ドルから2032年には1,104億4,000万米ドルに成長すると予測されています。バイオシミラー市場は、手頃な価格の生物学的治療薬に対する需要の高まり、ブロックバスター生物製剤の急速な特許切れ、バイオシミラー承認を支援する有利な規制改革によって牽引されています。また、バイオ製造における技術革新により、生産効率と拡張性が向上しています。さらに、医師や患者の間で受け入れが進んでいることも、市場への浸透を後押ししています。

例えば、2025年1月、欧州医薬品庁(EMA)のヒト用医薬品委員会(CHMP)は、3つのバイオシミラー医薬品の販売承認を推奨する良好な見解を発表しました:AmgenのPAVBLUとSKOJOY、およびCuraTeQ BiologicsのDYRUPEGです。AmgenのPAVBLUとSKOJOYは、いずれもEYLEA(アフリベルセプト)をリファレンスとするバイオシミラーで、新生血管(ウェット)型加齢黄斑変性症(AMD)、網膜静脈閉塞症(ブランチRVOまたはセントラルRVO)による黄斑浮腫による視力障害、近視性脈絡膜新生血管(近視性CNV)による視力障害の治療薬として承認されています。

当レポートでは、世界のバイオシミラー市場について調査し、市場の概要とともに、製品クラス別、適応症別、流通チャネル別、地域別動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 プロジェクトの範囲と定義

第2章 調査手法

第3章 米国の関税の影響

第4章 エグゼクティブサマリー

第5章 世界のバイオシミラー市場の見通し、2018年~2032年

  • 市場規模分析と予測
  • 市場シェア分析と予測
    • 製品クラス別
      • モノクローナル抗体
      • 組み換えホルモン
      • 免疫調節薬
      • 抗炎症剤
      • その他
    • 適応症別
      • 腫瘍学
      • 成長ホルモン欠乏症
      • 血液疾患
      • 慢性疾患および自己免疫疾患
      • 感染症
      • その他
    • 流通チャネル別
      • 病院
      • がんケアセンター
      • その他
    • 地域別
      • 北米
      • 欧州
      • アジア太平洋
      • 南米
      • 中東・アフリカ
    • 企業別市場シェア分析(上位5社およびその他- 金額別、2024年)
  • 2024年の市場マップ分析

第6章 北米のバイオシミラー市場の見通し、2018年~2032年

  • 市場規模分析と予測
  • 市場シェア分析と予測
  • 国別市場評価
    • 米国
    • カナダ
    • メキシコ

第7章 欧州のバイオシミラー市場の見通し、2018年~2032年

  • ドイツ
  • フランス
  • イタリア
  • 英国
  • ロシア
  • オランダ
  • スペイン
  • トルコ
  • ポーランド

第8章 アジア太平洋のバイオシミラー市場の見通し、2018年~2032年

  • インド
  • 中国
  • 日本
  • オーストラリア
  • ベトナム
  • 韓国
  • インドネシア
  • フィリピン

第9章 南米のバイオシミラー市場の見通し、2018年~2032年

  • ブラジル
  • アルゼンチン

第10章 中東・アフリカのバイオシミラー市場の見通し、2018年~2032年

  • サウジアラビア
  • アラブ首長国連邦
  • 南アフリカ

第11章 需要供給分析

第12章 バリューチェーン分析

第13章 ポーターのファイブフォース分析

第14章 PESTLE分析

第15章 価格分析

第16章 市場力学

  • 市場の促進要因
  • 市場の課題

第17章 市場動向と発展

第18章 規制枠組みとイノベーション

  • 規制当局の承認
  • 臨床試験

第19章 特許の情勢

第20章 ケーススタディ

第21章 競合情勢

  • 市場リーダートップ5の競合マトリックス
  • 参入企業トップ5のSWOT分析
  • 市場の主要企業トップ10の情勢
    • Novartis AG
    • Pfizer, Inc.
    • Dr. Reddy's Laboratories Ltd.
    • Amgen, Inc.
    • Eli Lilly and Company
    • Celltrion Inc.
    • Teva Pharmaceutical Industries Ltd.
    • Viatris Inc.
    • Samsung Bioepis Co., Ltd.
    • Bristol-Myers Squibb Company

第22章 戦略的提言

第23章 調査会社について・免責事項

図表

List of Tables

  • Table 1. Competition Matrix of Top 5 Market Leaders
  • Table 2. Mergers & Acquisitions/ Joint Ventures (If Applicable)
  • Table 3. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

  • Figure 1. Global Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 2. Global Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 3. Global Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 4. Global Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 5. Global Biosimilars Market Share (%), By Region, 2018-2032F
  • Figure 6. North America Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 7. North America Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 8. North America Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 9. North America Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 10. North America Biosimilars Market Share (%), By Country, 2018-2032F
  • Figure 11. United States Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 12. United States Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 13. United States Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 14. United States Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 15. Canada Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 16. Canada Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 17. Canada Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 18. Canada Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 19. Mexico Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 20. Mexico Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 21. Mexico Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 22. Mexico Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 23. Europe Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 24. Europe Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 25. Europe Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 26. Europe Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 27. Europe Biosimilars Market Share (%), By Country, 2018-2032F
  • Figure 28. Germany Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 29. Germany Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 30. Germany Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 31. Germany Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 32. France Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 33. France Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 34. France Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 35. France Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 36. Italy Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 37. Italy Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 38. Italy Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 39. Italy Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 40. United Kingdom Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 41. United Kingdom Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 42. United Kingdom Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 43. United Kingdom Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 44. Russia Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 45. Russia Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 46. Russia Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 47. Russia Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 48. Netherlands Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 49. Netherlands Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 50. Netherlands Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 51. Netherlands Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 52. Spain Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 53. Spain Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 54. Spain Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 55. Spain Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 56. Turkey Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 57. Turkey Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 58. Turkey Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 59. Turkey Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 60. Poland Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 61. Poland Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 62. Poland Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 63. Poland Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 64. South America Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 65. South America Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 66. South America Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 67. South America Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 68. South America Biosimilars Market Share (%), By Country, 2018-2032F
  • Figure 69. Brazil Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 70. Brazil Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 71. Brazil Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 72. Brazil Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 73. Argentina Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 74. Argentina Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 75. Argentina Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 76. Argentina Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 77. Asia-Pacific Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 78. Asia-Pacific Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 79. Asia-Pacific Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 80. Asia-Pacific Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 81. Asia-Pacific Biosimilars Market Share (%), By Country, 2018-2032F
  • Figure 82. India Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 83. India Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 84. India Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 85. India Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 86. China Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 87. China Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 88. China Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 89. China Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 90. Japan Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 91. Japan Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 92. Japan Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 93. Japan Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 94. Australia Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 95. Australia Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 96. Australia Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 97. Australia Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 98. Vietnam Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 99. Vietnam Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 100. Vietnam Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 101. Vietnam Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 102. South Korea Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 103. South Korea Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 104. South Korea Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 105. South Korea Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 106. Indonesia Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 107. Indonesia Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 108. Indonesia Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 109. Indonesia Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 110. Philippines Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 111. Philippines Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 112. Philippines Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 113. Philippines Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 114. Middle East & Africa Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 115. Middle East & Africa Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 116. Middle East & Africa Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 117. Middle East & Africa Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 118. Middle East & Africa Biosimilars Market Share (%), By Country, 2018-2032F
  • Figure 119. Saudi Arabia Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 120. Saudi Arabia Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 121. Saudi Arabia Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 122. Saudi Arabia Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 123. UAE Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 124. UAE Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 125. UAE Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 126. UAE Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 127. South Africa Biosimilars Market, By Value, In USD Billion, 2018-2032F
  • Figure 128. South Africa Biosimilars Market Share (%), By Product Class, 2018-2032F
  • Figure 129. South Africa Biosimilars Market Share (%), By Indication, 2018-2032F
  • Figure 130. South Africa Biosimilars Market Share (%), By Distribution Channel, 2018-2032F
  • Figure 131. By Product Class Map-Market Size (USD Billion) & Growth Rate (%), 2024
  • Figure 132. By Indication Map-Market Size (USD Billion) & Growth Rate (%), 2024
  • Figure 133. By Distribution Channel Map-Market Size (USD Billion) & Growth Rate (%), 2024
  • Figure 134. By Region Map-Market Size (USD Billion) & Growth Rate (%), 2024
目次
Product Code: MX13059

Global biosimilars market is projected to witness a CAGR of 16.73% during the forecast period 2025-2032, growing from USD 32.03 billion in 2024 to USD 110.44 billion in 2032. The biosimilars market is being driven by the rising demand for affordable biologic therapies, rapid patent expirations of blockbuster biologics, and favorable regulatory reforms supporting biosimilar approvals. Technological innovations in biomanufacturing are also improving production efficiency and scalability. Additionally, the growing acceptance among physicians and patients is fueling broader market penetration.

For instance, in January 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued favorable opinions recommending the approval of marketing authorizations for three biosimilar products: Amgen's PAVBLU and SKOJOY, as well as DYRUPEG from CuraTeQ Biologics. Amgen's PAVBLU and SKOJOY, both biosimilars that reference EYLEA (aflibercept), are approved for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment resulting from macular edema due to retinal vein occlusion (branch RVO or central RVO), and visual impairment caused by myopic choroidal neovascularization (myopic CNV).

Rising Global Demand for Cost-Effective Therapies

The global biosimilars market is experiencing significant expansion driven by the increasing need for affordable therapeutic alternatives to branded biologics. As the prevalence of chronic illnesses such as cancer, diabetes, and autoimmune diseases rises, healthcare systems face mounting pressure to offer cost-effective treatment options. Biosimilars provide considerable cost reductions while ensuring efficacy and safety, which is propelling their adoption in both developed and emerging markets. Additionally, the expiration of patents for key biologics has created opportunities for biosimilar producers. Governments and insurance companies are actively promoting the use of biosimilars to lower healthcare costs. This escalating demand for accessible treatment options is fostering the global adoption of biosimilars. For instance, the introduction of Wezlana (ustekinumab-auub) as the first ustekinumab biosimilar in January 2025, three additional products entered the market, thereby enhancing the availability of more 'low-cost' alternatives to the widely used Stelara (ustekinumab). Samsung Bioepis/Sandoz, Biocon Biologics, and Teva/Alvotech subsequently launched their ustekinumab formulations: Pyzchiva (ustekinumab-ttwe), Yesintek (ustekinumab-kfce), and Selarsdi (ustekinumab-aekn).

Technological Advancements in Manufacturing and Development

Recent advancements in biologics manufacturing technologies are greatly improving the development, scalability, and quality of biosimilars. Innovations such as single-use bioreactors, enhanced cell line development, and AI-driven analytics are facilitating quicker and more efficient production. These improvements also contribute to cost reduction and enhance batch-to-batch consistency, thereby increasing the competitiveness of biosimilar production. Regulatory bodies in various regions are also expediting approval processes for biosimilars through accelerated pathways and standardized guidelines. As manufacturers adopt contemporary bioprocessing methods, biosimilars are becoming increasingly accessible and dependable. This technological progress fosters wider market penetration and acceptance among healthcare professionals and patients. For instance, in March 2024, Biocon Biologics Limited announced a patent settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals Inc., which paves the way for the launch of a biosimilar product in Canada. This agreement permits the introduction of Yesafili, a proposed biosimilar to Eeylea (aflibercept) injection, into the Canadian market, as indicated by Biocon Biologics in a regulatory filing. Under the terms of the agreement, Biocon Biologics has set a launch date for the product no later than July 1, 2025. Yesafili, an ophthalmology product, is intended for the treatment of neovascular (wet AMD) and age-related macular degeneration, among other conditions.

Oncology Segment Dominating the Market

Among all indications, oncology remains the dominant segment in the biosimilars market, driven by the high cost of cancer biologics and increasing global cancer burden. Biosimilars for oncology biologics such as bevacizumab, rituximab, and trastuzumab offer a cost-effective alternative without compromising treatment efficacy. The growing incidence of cancers and rising adoption of biosimilars in cancer care centers and hospitals are further propelling segmental growth. As oncologists gain confidence in the real-world effectiveness and safety profiles of biosimilars, their prescription rates continue to rise. Biosimilars in oncology are also supported by regulatory advantages and expedited market approvals to meet critical therapeutic demands. For example, in October 2024, Teva Pharmaceutical Industries Ltd. and Mabxience Holding S.L. revealed an enhanced collaboration agreement aimed at developing an anti-PD1 oncology biosimilar candidate.

Europe Leading Global Biosimilars Adoption

Europe continues to dominate the global biosimilars market due to its early regulatory framework, proactive policies, and widespread acceptance among physicians and payers. The region's healthcare systems emphasize cost-containment, making biosimilars a critical strategy in managing drug expenditures. Countries such as Germany, the UK, and France have implemented supportive pricing, substitution policies, and physician incentives to encourage biosimilar adoption. Moreover, the European Medicines Agency (EMA) maintains a robust and transparent approval process, fostering trust in biosimilar efficacy and safety. These favorable dynamics have enabled Europe to achieve one of the highest biosimilar penetration rates globally, setting a benchmark for other regions. In October 2023, Sandoz Group AG (a division of Novartis AG) launched Hyrimoz (adalimumab) high-concentration biosimilar in Germany, further reinforcing Europe's leadership in biosimilar uptake.

Future Market Scenario (2025-2032F)

The global biosimilars market is poised for substantial growth over the coming years, driven by the increasing expiration of biologic drug patents, rising healthcare costs, and growing prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes. As regulatory pathways mature and streamline, biosimilars are becoming more accepted among healthcare providers, patients, and payers. With advancements in bio-manufacturing technologies, companies are now able to produce high-quality biosimilars more efficiently and cost-effectively. Emerging economies, particularly in Asia-Pacific and Latin America, are expected to witness accelerated adoption due to supportive government policies and growing demand for affordable biologics. Moreover, the expanding application of biosimilars across diverse therapeutic areas will further bolster market expansion globally.

Key Players Landscape and Outlook

The key players in the market are significantly investing in the development of biosimilars and are utilizing strategies such as mergers, acquisitions, partnerships, and new product launches to improve their services and competitiveness. Such efforts will propel significant growth in the market, allowing large-cap industry players to increase their presence and, therefore, find new opportunities in this market.

For example, in February 2025, Teva Pharmaceutical Industries Ltd. and Alvotech hf1 officially announced the launch of Selarsdi (ustekinumab-aekn) injection in the United States, which is a biosimilar to Johnson & Johnson's Stelara (ustekinumab). This medication is approved for treating Crohn's disease, pediatric plaque psoriasis, pediatric psoriatic arthritis, plaque psoriasis, psoriatic arthritis, and ulcerative colitis. This represents the second biosimilar introduced in the country because of the strategic partnership between the two companies.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Impact of U.S. Tariffs

4. Executive Summary

5. Global Biosimilars Market Outlook, 2018-2032F

  • 5.1. Market Size Analysis & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share Analysis & Forecast
    • 5.2.1. By Product Class
      • 5.2.1.1. Monoclonal Antibodies
        • 5.2.1.1.1. Adalimumab
        • 5.2.1.1.2. Infliximab
        • 5.2.1.1.3. Rituximab
        • 5.2.1.1.4. Trastuzumab
        • 5.2.1.1.5. Others
      • 5.2.1.2. Recombinant Hormones
        • 5.2.1.2.1. Insulin
        • 5.2.1.2.2. Erythropoietin
        • 5.2.1.2.3. Others
      • 5.2.1.3. Immunomodulators
      • 5.2.1.4. Anti-Inflammatory Agents
      • 5.2.1.5. Others
    • 5.2.2. By Indication
      • 5.2.2.1. Oncology
      • 5.2.2.2. Growth Hormone Deficiency
      • 5.2.2.3. Blood Disorders
      • 5.2.2.4. Chronic and Autoimmune Disorders
      • 5.2.2.5. Infectious Diseases
      • 5.2.2.6. Others
    • 5.2.3. By Distribution Channel
      • 5.2.3.1. Hospitals
      • 5.2.3.2. Cancer Care Centers
      • 5.2.3.3. Others
    • 5.2.4. By Region
      • 5.2.4.1. North America
      • 5.2.4.2. Europe
      • 5.2.4.3. Asia-Pacific
      • 5.2.4.4. South America
      • 5.2.4.5. Middle East and Africa
    • 5.2.5. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
  • 5.3. Market Map Analysis, 2024
    • 5.3.1. By Product Class
    • 5.3.2. By Indication
    • 5.3.3. By Distribution Channel
    • 5.3.4. By Region

6. North America Biosimilars Market Outlook, 2018-2032F

  • 6.1. Market Size Analysis & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share Analysis & Forecast
    • 6.2.1. By Product Class
      • 6.2.1.1. Monoclonal Antibodies
        • 6.2.1.1.1. Adalimumab
        • 6.2.1.1.2. Infliximab
        • 6.2.1.1.3. Rituximab
        • 6.2.1.1.4. Trastuzumab
        • 6.2.1.1.5. Others
      • 6.2.1.2. Recombinant Hormones
        • 6.2.1.2.1. Insulin
        • 6.2.1.2.2. Erythropoietin
        • 6.2.1.2.3. Others
      • 6.2.1.3. Immunomodulators
      • 6.2.1.4. Anti-Inflammatory Agents
      • 6.2.1.5. Others
    • 6.2.2. By Indication
      • 6.2.2.1. Oncology
      • 6.2.2.2. Growth Hormone Deficiency
      • 6.2.2.3. Blood Disorders
      • 6.2.2.4. Chronic and Autoimmune Disorders
      • 6.2.2.5. Infectious Diseases
      • 6.2.2.6. Others
    • 6.2.3. By Distribution Channel
      • 6.2.3.1. Hospitals
      • 6.2.3.2. Cancer Care Centers
      • 6.2.3.3. Others
    • 6.2.4. By Country Share
      • 6.2.4.1. United States
      • 6.2.4.2. Canada
      • 6.2.4.3. Mexico
  • 6.3. Country Market Assessment
    • 6.3.1. United States Biosimilars Market Outlook, 2018-2032F*
      • 6.3.1.1. Market Size Analysis & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share Analysis & Forecast
        • 6.3.1.2.1. By Product Class
          • 6.3.1.2.1.1. Monoclonal Antibodies
          • 6.3.1.2.1.1.1. Adalimumab
          • 6.3.1.2.1.1.2. Infliximab
          • 6.3.1.2.1.1.3. Rituximab
          • 6.3.1.2.1.1.4. Trastuzumab
          • 6.3.1.2.1.1.5. Others
          • 6.3.1.2.1.2. Recombinant Hormones
          • 6.3.1.2.1.2.1. Insulin
          • 6.3.1.2.1.2.2. Erythropoietin
          • 6.3.1.2.1.2.3. Others
          • 6.3.1.2.1.3. Immunomodulators
          • 6.3.1.2.1.4. Anti-Inflammatory Agents
          • 6.3.1.2.1.5. Others
        • 6.3.1.2.2. By Indication
          • 6.3.1.2.2.1. Oncology
          • 6.3.1.2.2.2. Growth Hormone Deficiency
          • 6.3.1.2.2.3. Blood Disorders
          • 6.3.1.2.2.4. Chronic and Autoimmune Disorders
          • 6.3.1.2.2.5. Infectious Diseases
          • 6.3.1.2.2.6. Others
        • 6.3.1.2.3. By Distribution Channel
          • 6.3.1.2.3.1. Hospitals
          • 6.3.1.2.3.2. Cancer Care Centers
          • 6.3.1.2.3.3. Others
    • 6.3.2. Canada
    • 6.3.3. Mexico

All segments will be provided for all regions and countries covered

7. Europe Biosimilars Market Outlook, 2018-2032F

  • 7.1. Germany
  • 7.2. France
  • 7.3. Italy
  • 7.4. United Kingdom
  • 7.5. Russia
  • 7.6. Netherlands
  • 7.7. Spain
  • 7.8. Turkey
  • 7.9. Poland

8. Asia-Pacific Biosimilars Market Outlook, 2018-2032F

  • 8.1. India
  • 8.2. China
  • 8.3. Japan
  • 8.4. Australia
  • 8.5. Vietnam
  • 8.6. South Korea
  • 8.7. Indonesia
  • 8.8. Philippines

9. South America Biosimilars Market Outlook, 2018-2032F

  • 9.1. Brazil
  • 9.2. Argentina

10. Middle East and Africa Biosimilars Market Outlook, 2018-2032F

  • 10.1. Saudi Arabia
  • 10.2. UAE
  • 10.3. South Africa

11. Demand Supply Analysis

12. Value Chain Analysis

13. Porter's Five Forces Analysis

14. PESTLE Analysis

15. Pricing Analysis

16. Market Dynamics

  • 16.1. Market Drivers
  • 16.2. Market Challenges

17. Market Trends and Developments

18. Regulatory Framework and Innovation

  • 18.1. Regulatory Approvals
  • 18.2. Clinical Trials

19. Patent Landscape

20. Case Studies

21. Competitive Landscape

  • 21.1. Competition Matrix of Top 5 Market Leaders
  • 21.2. SWOT Analysis for Top 5 Players
  • 21.3. Key Players Landscape for Top 10 Market Players
    • 21.3.1. Novartis AG
      • 21.3.1.1. Company Details
      • 21.3.1.2. Key Management Personnel
      • 21.3.1.3. Products and Services
      • 21.3.1.4. Financials (As Reported)
      • 21.3.1.5. Key Market Focus and Geographical Presence
      • 21.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
    • 21.3.2. Pfizer, Inc.
    • 21.3.3. Dr. Reddy's Laboratories Ltd.
    • 21.3.4. Amgen, Inc.
    • 21.3.5. Eli Lilly and Company
    • 21.3.6. Celltrion Inc.
    • 21.3.7. Teva Pharmaceutical Industries Ltd.
    • 21.3.8. Viatris Inc.
    • 21.3.9. Samsung Bioepis Co., Ltd.
    • 21.3.10. Bristol-Myers Squibb Company

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

22. Strategic Recommendations

23. About Us and Disclaimer