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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2024-2032

Biosimilar Market Report by Molecule, Indication, Manufacturing Type, and Region 2024-2032
出版日: | 発行: IMARC | ページ情報: 英文 145 Pages | 納期: 2～3営業日

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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2024-2032
出版日: 2024年03月02日
発行: IMARC
ページ情報: 英文 145 Pages
納期: 2～3営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界のバイオシミラー市場規模は2023年に212億米ドルに達しました。今後、IMARCグループは、2024年から2032年にかけて25.1%の成長率（CAGR）を示し、2032年までに1,645億米ドルに達すると予測しています。ブロックバスター生物学的製剤の特許切れが迫っていること、バイオシミラーの有効性と費用対効果に対する認識が高まっていること、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、市場を推進する主な要因となっています。

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のことです。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から、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、ヘルスケアコスト削減の可能性が大きく、医療制度や患者にとって魅力的です。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の動向と促進要因：

ブロックバスター医薬品の今後の特許切れ

ブランド生物製剤の特許失効は、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・販売する企業への道が開かれます。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ブロックバスター生物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

バイオシミラーは、主に研究開発（R&D）コストの削減により、参照生物製剤よりも製造コストが低いです。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、生物学的製剤がこれまで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薬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けるバイオシミラーの使用は、ますます好ましい選択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の一途をたどるなか、製品の需要も同様に増加し、市場の成長を後押しすると予想されます。

インフリキシマブが最大の市場セグメントを占める

本レポートでは、分子別の市場内訳を詳細に分析しています。これには、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、その他が含まれます。報告書によると、市場シェアの大半を占めるのはインフリキシマブです。

モノクローナル抗体であるインフリキシマブは、関節リウマチ、乾癬性関節炎、強直性脊椎炎、クローン病、尋常性乾癬、潰瘍性大腸炎などの慢性疾患の治療に使用されています。これらの疾患は世界的に有病率が高く、効果的な治療法に対する需要が高まっています。さらに、適応症が多岐にわたるため、インフリキシマブの恩恵を受ける可能性のある患者集団は多いです。

最初のリファレンス製品であるレミケードは、有効性と安全性のプロファイルが確立され、長い間市販されてきました。その特許が切れると、インフリキシマブ・バイオシミラーの参入により、これらの慢性疾患に対してより費用対効果の高い治療選択肢が提供されることになった。さらに、レミケードの特許失効が他の生物学的製剤に比べて比較的早かったことも、その普及に大きく貢献しました。このほか、インフリキシマブなどのモノクローナル抗体の製造プロセスや製剤が確立され、バイオシミラーの開発や製造が容易になったことも、同分野の成長を後押ししています。

自己免疫疾患が市場を独占

本レポートでは、適応症に基づく市場の詳細な区分と分析を行っています。これには、自己免疫疾患、血液疾患、糖尿病、腫瘍学、成長不全、女性不妊症、その他が含まれます。報告書によると、自己免疫疾患が最大のセグメントを占めています。

自己免疫疾患には、関節リウマチ、乾癬、炎症性腸疾患などの疾患が含まれ、これらは世界中で流行しており、何百万人もの人々に影響を及ぼしています。このような高い有病率は、効果的な治療に対する需要の大幅な増加をもたらしています。これらの疾患は一般的に慢性疾患であり、長期にわたる治療が必要であるため、関連する治療薬に対する需要が常に高まっています。長年にわたり、生物学的製剤は多くの自己免疫疾患の治療に革命をもたらし、コントロールと予後を改善してきました。これらの生物学的製剤の多くは現在特許保護を失い、あるいは失いかけており、バイオシミラーの道が開かれています。さらに、自己免疫疾患の治療に使用されるオリジナルの生物学的製剤は高価であり、ヘルスケアシステムと患者に経済的負担を強います。バイオシミラーはより安価な代替品を提供するため、患者やヘルスケア専門家にとって好ましい選択肢となりつつあります。さらに、基準生物製剤と同様の有効性と安全性プロファイルを有することから、医師、患者、ヘルスケアシステムの間で自己免疫疾患の治療にバイオシミラーが受け入れられつつあることが、この分野の成長を後押ししています。

自社製造が市場シェアの大半を占める

本レポートでは、製造タイプ別に市場を詳細に区分・分析しています。これには、自社製造と受託製造が含まれます。報告書によると、自社製造が最大のセグメントを占めています。

自社製造では、バイオシミラーに不可欠な製品品質の完全な管理が可能です。生物学的製剤は複雑であり、その製造を取り巻く規制も厳しいことから、企業は高水準の製造が確実に行われるよう、自社で製造することを通常好みます。さらに、生物学的製剤の製造プロセスには、独自の方法や技術が含まれることが多いです。自社製造は、こうした企業秘密の保護に役立つため、製造タイプの選択肢として好まれます。初期設定費用は高くつくかもしれませんが、自社生産を維持することで、長期的にはユニットあたりのコストを大幅に削減することができます。また、内製化により、企業はサプライチェーンが寸断されるリスクを最小限に抑え、製品の安定供給を確保することができる一方、必要に応じて製品やプロセスを調整・適応させるなど、生産における柔軟性と俊敏性を促進することができます。

欧州が市場で明確な優位性を示す

欧州は規制環境が整備されているため、複数のバイオシミラー医薬品が他の地域に先駆けて欧州市場に参入しました。このような早期のスタートにより、欧州は市場で大きなシェアを獲得することができました。さらに、欧州医薬品庁（EMA）は、他の多くの地域よりも早い2005年以降、バイオシミラーの承認に向けた明確かつ支援的な規制枠組みをいち早く構築してきました。この早期の枠組みは、この地域におけるバイオシミラーの開発と販売を後押ししました。欧州各国は、コスト抑制に重点を置いたヘルスケア制度を国営化しています。バイオシミラー医薬品は先発品の生物製剤に匹敵する臨床成績が得られ、しかも低コストであるため、このような環境では魅力的な選択肢となっています。これに加えて、欧州では自己免疫疾患やがんなど、生物製剤で治療される疾患の有病率が高いです。この高い需要が、同地域の市場成長を支えています。これとは別に、欧州では医療従事者や患者の間でバイオシミラーの認知度と受容度が高まっていることが、バイオシミラーの取り込みを促進し、市場成長に寄与しています。

本レポートで扱う主な質問

  • 2023年の世界のバイオシミラー市場規模は？
  • 2024～2032年のバイオシミラー世界市場の予想成長率は？
  • 世界のバイオシミラー市場を牽引する主要因は何か
  • COVID-19が世界のバイオシミラー市場に与えた影響は？
  • バイオシミラー世界市場の分子別区分は？
  • 適応症に基づくバイオシミラー世界市場の内訳は？
  • 製造タイプに基づくバイオシミラーの世界市場内訳は？
  • バイオシミラー世界市場の主要地域は？
  • バイオシミラーの世界市場における主要企業/プレーヤーは？

目次

第1章 序文

第2章 調査範囲と調査手法

  • 調査目的
  • 利害関係者
  • 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医薬品
  • 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儲かるのか？

  • 大ヒット生物学的製剤の特許切れ
  • バイオシミラーとイノベーター医薬品の価格差の大きさ
  • 政府と第三者支払機関の節約
  • 生活習慣病の増加
  • 処方者、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参入企業の出現
  • ドラッグデリバリー・デバイス企業との提携による製品の差別化の進展

第6章 バイオシミラーの研究開発と製造

  • 研究開発：バイオシミラーとイノベーター医薬品の比較
  • 製造：バイオシミラーとイノベーター医薬品の比較

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
  • バイオシミラー特許情勢
    • 米国の特許状況
    • 欧州の特許状況
    • 日本の特許状況
  • 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
      • ユニークな細胞株の開発
    • 製品開発
      • 予備試験
      • 中間臨床試験（PK/PD）
      • 確認臨床第III相試験
    • 最終製剤化
    • 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
    • 買い手の交渉力
    • 供給企業の交渉力
    • 競合の程度
    • 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
  • 受託製造
    • 市場動向
    • 市場予測

第10章 市場内訳：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
  • 腫瘍学
    • 市場動向
    • 市場予測
  • 成長不足
    • 市場動向
    • 市場予測
  • 女性不妊症
    • 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
    • 主要企業とバイオシミラー
    • 市場内訳：国別
    • 市場予測
    • イタリア
      • 市場実績
      • 主要企業とバイオシミラー
      • 市場予測
    • ドイツ
      • 市場実績
      • 主要企業とバイオシミラー
      • 市場予測
    • フランス
      • 市場実績
      • 主要企業とバイオシミラー
      • 市場予測
    • 英国
      • 市場実績
      • 主要企業とバイオシミラー
      • 市場予測
    • スペイン
      • 市場実績
      • 主要企業とバイオシミラー
      • 市場予測
    • その他欧州
      • 市場実績
      • 市場予測
  • 米国
    • 現在の市場動向
    • 主要企業とバイオシミラー
    • 市場予測
  • 日本
    • 市場実績
    • 主要企業とバイオシミラー
    • 市場予測
  • インド
    • 現在の市場動向
    • 主要企業とバイオシミラー
    • 市場予測
  • 韓国
    • 現在の市場動向
    • 主要企業とバイオシミラー
    • 市場予測
  • 世界のその他の地域
    • 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設立の要件

  • 製造プロセス
  • 原材料の要件
  • 原材料の写真
  • 土地と建設の要件
  • 機械とインフラの要件
  • 機械写真
  • 工場レイアウト
  • 梱包要件
  • ユーティリティ要件
  • 人員要件

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
図表

List of Figures

  • Figure 1: Global: Biosimilar Market: Sales Value (in Billion US$), 2018-2023
  • Figure 2: Global: Biosimilar Market: Breakup by Molecule (in %), 2023
  • Figure 3: Global: Biosimilar Market: Breakup by Manufacturing Type (in %), 2023
  • Figure 4: Global: Biosimilar Market: Breakup by Indication (in %), 2023
  • Figure 5: Global: Biosimilar Market: Breakup by Region (in %), 2023
  • Figure 6: Global: Biosimilar Market Forecast: Sales Value (in Billion US$), 2024-2032
  • 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 US$), 2018-2023
  • Figure 14: Infliximab: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 15: Insulin Glargine: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 16: Insulin Glargine: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 17: Epoetin Alfa: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 18: Epoetin Alfa: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 19: Etanercept: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 20: Etanercept: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 21: Filgrastim: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 22: Filgrastim: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 23: Somatropin: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 24: Somatropin: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 25: Rituximab: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 26: Rituximab: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 27: Follitropin Alfa: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 28: Follitropin Alfa: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 29: Adalimumab: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 30: Adalimumab: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 31: Pegfilgrastim: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 32: Pegfilgrastim: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 33: Trastuzumab: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 34: Trastuzumab: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 35: Bevacizumab: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 36: Others: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 37: In-House Manufacturing: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 38: In-House Manufacturing: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 39: Contract Manufacturing: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 40: Contract Manufacturing: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 41: Global: Biosimilar Market (Autoimmune Diseases): Sales Value (in Million US$), 2018 & 2023
  • Figure 42: Global: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million US$), 2024-2032
  • Figure 43: Global: Biosimilar Market (Blood Disorders): Sales Value (in Million US$), 2018 & 2023
  • Figure 44: Global: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million US$), 2024-2032
  • Figure 45: Global: Biosimilar Market (Diabetes): Sales Value (in Million US$), 2018 & 2023
  • Figure 46: Global: Biosimilar Market Forecast (Diabetes): Sales Value (in Million US$), 2024-2032
  • Figure 47: Global: Biosimilar Market (Oncology): Sales Value (in Million US$), 2018 & 2023
  • Figure 48: Global: Biosimilar Market Forecast (Oncology): Sales Value (in Million US$), 2024-2032
  • Figure 49: Global: Biosimilar Market (Growth Deficiency): Sales Value (in Million US$), 2018 & 2023
  • Figure 50: Global: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million US$), 2024-2032
  • Figure 51: Global: Biosimilar Market (Female Infertility): Sales Value (in Million US$), 2018 & 2023
  • Figure 52: Global: Biosimilar Market Forecast (Female Infertility): Sales Value (in Million US$), 2024-2032
  • Figure 53: Global: Biosimilar Market (Others): Sales Value (in Million US$), 2018 & 2023
  • Figure 54: Global: Biosimilar Market Forecast (Others): Sales Value (in Million US$), 2024-2032
  • Figure 55: Europe: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 56: Europe: Biosimilar Market: Breakup by Country (in %), 2023
  • Figure 57: Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 58: Italy: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 59: Italy: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 60: Germany: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 61: Germany: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 62: France: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 63: France: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 64: United Kingdom: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 65: United Kingdom: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 66: Spain: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 67: Spain: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 68: Rest of Europe: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 69: Rest of Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 70: United States: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 71: United States: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 72: Japan: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 73: Japan: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 74: India: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 75: India: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 76: South Korea: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 77: South Korea: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 78: Others: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 79: Others: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • 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 US$)
  • 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 US$), 2023
  • Table 2: Global: Biosimilar Market: Biosimilars Vs Innovators Drug Development
  • Table 3: Global: Biosimilar Market: Biosimilars Vs Biologics Manufacturing
  • Table 4: Global: Biosimilar Market: Key Industry Highlights, 2023 and 2032
  • Table 5: US: Biosimilar Market: Patent Landscape
  • Table 6: Europe: Biosimilar Market: Patent Landscape
  • Table 7: Japan: Biosimilar Market: Patent Landscape
  • Table 8: Global: Biosimilar Market: Price Comparison Between Biosimilar and Originator Drugs
  • Table 9: Global: Biosimilar Market: Breakup by Molecule (in Million US$), 2024-2032
  • 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 US$), 2024-2032
  • Table 23: Global: Biosimilar Market Forecast: Breakup by Indication (in Million US$), 2024-2032
  • Table 24: Global: Biosimilar Market Forecast: Breakup by Region (in Million US$), 2024-2032
  • 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
目次
Product Code: SR112024A497

The global biosimilar market size reached US$ 21.2 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 164.5 Billion by 2032, exhibiting a growth rate (CAGR) of 25.1% during 2024-2032. The upcoming expiry of patents on blockbuster biologic drugs, growing awareness about the efficacy and cost-effectiveness of biosimilars, rising prevalence of chronic diseases worldwide, and continual advancements in biopharmaceutical manufacturing technologies are some of the major factors propelling the market.

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 2024-2032. 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

Recent Developments:

In Jan 2023, Amgen Inc. announced that AMJEVITA (adalimumab-atto), a biosimilar to Humira (adalimumab), is now available in the United States. AMJEVITA was the first biosimilar to Humira approved by the U.S. Food and Drug Administration (FDA), in 2016.

In October 2022, Biocon Biologics Ltd., a subsidiary of Biocon Ltd., announced that it has entered into a strategic out-licensing agreement with Japanese pharmaceuticals company Yoshindo Inc. Under the terms of this deal, Yoshindo will get exclusive commercialization rights in the Japanese market for two of the company's pipeline biosimilar assets, bUstekinumab and bDenosumab.

In June 2020, Pfizer Inc. received the approval from the United States (U.S.) Food and Drug Administration (FDA) for NYVEPRIA (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim). This biosimilar is indicated to lower the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Key Questions Answered in This Report

  • 1. What was the size of the global biosimilar market in 2023?
  • 2. What is the expected growth rate of the global biosimilar market during 2024-2032?
  • 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