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市場調查報告書
商品編碼
1450883

2024-2032 年生物相似藥市場報告（按分子、適應症、製造類型和地區）

Biosimilar Market Report by Molecule, Indication, Manufacturing Type, and Region 2024-2032
出版日期: | 出版商: IMARC | 英文 145 Pages | 商品交期: 2-3個工作天內

價格

2023年全球生物相似藥市場規模達212億美元。展望未來， IMARC Group預計到2032年市場規模將達到1,645億美元，2024-2032年複合年成長率（CAGR）為25.1%。重磅生物藥物的專利即將到期、人們對生物學名藥的功效和成本效益的認知不斷提高、全球慢性病患病率的上升以及生物製藥製造技術的不斷進步是推動市場的一些主要因素。

生物相似藥是與 FDA 批准的現有參考產品高度相似且沒有臨床意義差異的生物製品。它們的作用機轉、給藥途徑、劑型和強度與原產品相同。雖然由於其複雜的性質和生產方法，它們與參考產品並不相同，但它們保持了相當的安全性、純度和效力。這些生物藥物為高成本的參考生物製劑提供了更實惠的替代品，創造了競爭，並使患者更容易獲得治療。它們在市場上的推出需要經過嚴格的測試和嚴格的監管審查，以確保治療等效性和患者安全。近年來，生物相似藥在腫瘤、糖尿病和自體免疫疾病等不同治療領域中獲得了巨大的吸引力。

推動市場的關鍵因素之一是幾種重磅生物製劑的專利即將到期，為生物相似藥打開了領域，為市場擴張創造了充足的機會。由於生物相似藥是昂貴的生物療法的較便宜的替代品，因此它們具有節省醫療成本的巨大潛力，對醫療保健系統和患者俱有吸引力。再加上全球慢性疾病負擔不斷增加，包括癌症、糖尿病和自體免疫疾病（生物製劑在這些疾病的管理中發揮至關重要的作用），也增加了產品需求。除此之外，FDA 和 EMA 等多個監管機構也簡化了生物相似藥的核准途徑，鼓勵其開發和市場進入。此外，生物相似藥公司正在迅速全球化，希望將其足跡擴展到未開發的市場。除此之外，生物製藥製造技術的不斷創新使得生產高效、安全的生物相似藥成為可能，進一步推動市場成長。

生物相似藥市場趨勢/促進因素：

重磅藥物的專利即將到期

品牌生物製劑專利到期是推動市場成長的關鍵因素之一。生物製劑通常受到強大的專利組合的保護，可以長期防止競爭產品進入。然而，一旦這些專利到期，就會為公司開發和銷售類似的、更實惠的替代品打開大門。未來幾年，多種年銷售額數十億的重磅生物製劑將失去專利保護。因此，這些專利保護的結束為製造商提供了巨大的機會，可以將其替代品推向市場並獲得可觀的市場佔有率，從而促進市場成長。

成本效益

生物相似藥的生產成本低於參考生物製劑，主要是由於研發 (R&D) 成本降低，因為製造商不需要重複為參考產品進行的所有原始臨床試驗。因此，生物相似藥的價格可以顯著降低，為通常昂貴的生物療法提供負擔得起的替代品。這種成本效益對於努力管理不斷增加的醫療保健成本的醫療保健系統以及可能與生物療法的高成本作鬥爭的患者特別有吸引力。此外，在以前可能無法負擔生物療法的新興市場，生物相似藥可以讓人們更容易獲得基本治療。

慢性病盛行率增加

癌症、自體免疫疾病和糖尿病等慢性疾病的盛行率在全球範圍內呈上升趨勢。這些疾病通常需要使用生物製劑進行長期治療，從而刺激了對這些藥物的需求。由於生物相似藥具有與原廠生物製劑相似的功效和安全性，但成本較低，因此它們在治療這些慢性疾病中的應用日益成為首選。例如，使用腫瘤壞死因子抑制劑等生物藥物治療的類風濕性關節炎和牛皮癬等疾病的發生率不斷上升，為這些藥物的生物相似藥提供了巨大的市場。隨著全球慢性病負擔持續增加，產品需求預計將同樣增加，推動市場成長。

生物相似藥市場細分：

IMARC Group提供了全球生物相似藥市場報告各細分市場主要趨勢的分析，以及 2024 年至 2032 年全球和區域層面的預測。我們的報告根據分子、適應症和製造類型對市場進行了分類。

依分子分解：

英夫利西單抗

甘精胰島素

阿爾法依泊汀

依那西普

非格司亭

生長激素

利妥昔單抗

促卵泡素阿爾法

阿達木單抗

聚乙二醇非格司亭

曲妥珠單抗

貝伐珠單抗

其他

英夫利西單抗代表最大的細分市場

該報告根據分子提供了詳細的市場區隔和分析。這包括英夫利西單抗、甘精胰島素、依泊汀阿爾法、依那西普、非格司亭、生長激素、利妥昔單抗、促卵泡素阿爾法、阿達木單抗、培非格司亭、曲妥珠單抗、貝伐珠單抗等。報告稱，英夫利西單抗佔據了市場的大部分佔有率。

英夫利西單抗是一種單株抗體，用於治療多種慢性疾病，如類風濕性關節炎、乾癬性關節炎、僵直性脊椎炎、克隆氏症、斑塊狀乾癬和潰瘍性結腸炎。這些疾病在世界範圍內的高盛行率增加了對有效治療的需求。此外，廣泛的適應症導致大量患者可能受益於英夫利西單抗。

原始參考產品 Remicade 已上市很長時間，具有良好的療效和安全性。專利到期後，英夫利西單抗生物相似藥的進入為這些慢性病提供了更具成本效益的治療選擇。此外，與其他生物製劑相比，Remicade 的專利到期相對較早，這極大地促進了其廣泛流行。除此之外，英夫利西單抗等單株抗體的生產流程和配方現已完善，促進了生物相似藥的開發和生產，從而推動了該細分市場的成長。

按指示細分：

自體免疫疾病

血液失調

糖尿病

腫瘤學

生長不足

女性不孕症

其他

自體免疫疾病主導市場

該報告根據該指標提供了詳細的市場細分和分析。這包括自體免疫疾病、血液疾病、糖尿病、腫瘤、生長缺陷、女性不孕症等。報告稱，自體免疫疾病佔最大部分。

自體免疫疾病包括類風濕性關節炎、牛皮癬和發炎性腸道疾病等疾病，這些疾病在世界各地普遍流行，影響數百萬人。這種高盛行率導致對有效治療的需求大幅增加。這些疾病通常是慢性的，需要長期治療，導致對相關療法的持續需求。多年來，生物製劑徹底改變了許多自體免疫疾病的治療方法，改善了控制和預後。其中許多生物製劑現已失去或正在失去專利保護，為生物相似藥開闢了道路。此外，用於治療自體免疫疾病的原始生物製劑可能價格昂貴，對醫療保健系統和患者造成經濟負擔。由於生物相似藥提供了更實惠的替代品，因此它們正在成為患者和醫療保健專業人員的首選。此外，由於生物相似藥與參考生物製劑具有相似的功效和安全性，醫生、患者和醫療保健系統擴大接受用於治療自體免疫疾病的生物相似藥，這也推動了這一領域的成長。

按製造類型細分：

內部製造

合約起草（名詞

內部製造佔大部分市場佔有率

該報告根據製造類型對市場進行了詳細的細分和分析。這包括內部和合約製造。報告稱，內部製造佔最大部分。

內部製造可以完全控制產品質量，這對於生物相似藥至關重要。鑑於生物製劑的複雜性及其製造的嚴格規定，公司通常更願意自行處理生產，以確保達到高標準。此外，生物製造過程通常涉及專有方法和技術。內部生產有助於保護這些商業機密，使其成為製造類型的首選。雖然初始設定成本可能很高，但隨著時間的推移，維持內部生產可以顯著降低單位成本。此外，內部製造使公司能夠最大限度地降低供應鏈中斷的風險，確保產品的持續供應，同時促進生產的靈活性和敏捷性，包括根據需要對產品或流程進行調整或適應。

按地區分類：

歐洲

德國

法國

義大利

西班牙

英國

歐洲其他地區

美國

日本

印度

韓國

其他

歐洲在市場上表現出明顯的主導地位

該報告還對所有主要區域市場進行了全面分析，其中包括歐洲（德國、法國、義大利、西班牙、英國和歐洲其他地區）；美國、日本、印度、韓國等。報告稱，歐洲佔了最大的市場佔有率。

歐洲佔了最大的市場佔有率，因為該地區擁有支持性的監管環境，使得多種生物相似藥能夠先於其他地區進入歐洲市場。這一早期起步使歐洲獲得了相當大的市場佔有率。此外，自 2005 年以來，歐洲藥品管理局 (EMA) 一直是為生物相似藥核准創建明確和支持性監管框架的先行者，早於許多其他地區。這個早期框架鼓勵了該地區生物相似藥的開發和行銷。歐洲多個國家已將醫療保健系統國有化，並專注於成本控制。由於生物相似藥可提供與原廠生物製劑相當的臨床結果，但成本較低，因此它們已成為這些環境中有吸引力的選擇。除此之外，歐洲用生物製劑治療的疾病的盛行率很高，例如自體免疫疾病和癌症。這種高需求正在支持該地區市場的成長。除此之外，歐洲醫療保健專業人員和患者對生物相似藥的認知和接受度不斷提高，推動了生物相似藥的使用，促進了市場的成長。

競爭格局：

市場上主要參與者正在採取越來越多的策略性舉措，旨在佔領更大的市場佔有率。該公司正在大力投資研發 (R&D) 活動，以推出新的生物相似藥並改進其製造流程。許多供應商正在建立策略聯盟、合作夥伴關係和授權交易，以利用其他公司的專業知識並加快其生物相似藥的開發、生產和行銷。除此之外，一些行業參與者正在尋求監管機構批准其生物相似藥在新的地理市場上的發展，以擴大其全球足跡。為了建立對其生物相似藥的信任和信心，領先的製造商正在進行上市後監督研究，以確認其產品的長期安全性和有效性。我們還預計，在預測期內，市場將見證產品創新的激增、新患者支援計劃的推出以及主要參與者之間的併購 (M&A) 的增加，以推動該領域內的健康競爭。

該報告對市場競爭格局進行了全面分析。也提供了所有主要公司的詳細資料。市場上的一些主要參與者包括：

山德士國際有限公司

輝瑞公司

梯瓦製藥工業股份有限公司

賽特瑞恩公司

百康有限公司

三星生物製劑

安進公司

雷迪博士實驗室有限公司

斯塔達阿茲內米特爾股份公司

最近的發展：

2023 年 1 月，安進公司宣布，修美樂（阿達木單抗）的生物相似藥 AMJEVITA（阿達木單抗-atto）現已在美國上市。 AMJEVITA 是美國食品藥物管理局 (FDA) 於 2016 年批准的第一個 Humira 生物相似藥。

2022年10月，Biocon Ltd.的子公司Biocon Biologics Ltd.宣布與日本製藥公司Yoshindo Inc.簽訂策略授權協議。根據該協議條款，Yoshindo將獲得該藥物的獨家商業化權。該公司兩種在研生物相似藥資產bUstekinumab 和bDenosumab 的日本市場。

2020年6月，輝瑞的Neulasta（pegfilgrastim）生物相似藥NYVEPRIA（pegfilgrastim-apgf）獲得美國（US）食品藥物管理局（FDA）的批准。此生物相似藥可降低接受骨髓抑制抗癌藥物（與臨床上顯著的發燒性嗜中性白血球減少症發生率相關）的非髓性惡性腫瘤患者的感染發生率，如發燒性嗜中性白血球減少症所表現的感染發生率。

本報告回答的關鍵問題

  • 2023年全球生物相似藥市場規模是多少
  • 2024-2032年全球生物相似藥市場的預期成長率是多少
  • 推動全球生物相似藥市場的關鍵因素是什麼
  • COVID-19 對全球生物相似藥市場有何影響
  • 基於分子的全球生物相似藥市場的細分是什麼
  • 根據適應症，全球生物相似藥市場的細分如何
  • 根據製造類型，全球生物相似藥市場的細分如何
  • 全球生物相似藥市場的重點區域有哪些
  • 全球生物相似藥市場的主要公司/參與者有哪些

本報告回答的關鍵問題

  • 2023年全球生物相似藥市場規模有多大？
  • 2024-2032年全球生物相似藥市場的預期成長率是多少？
  • 推動全球生物相似藥市場的關鍵因素是什麼？
  • COVID-19 對全球生物相似藥市場有何影響？
  • 基於該分子的全球生物相似藥市場的詳細情形如何？
  • 根據此適應症，全球生物相似藥市場的詳細情形如何？
  • 根據製造類型，全球生物相似藥市場的詳細情形如何？
  • 全球生物相似藥市場的重點區域有哪些？
  • 全球生物相似藥市場的主要公司/參與者有哪些？

目錄

第1章：前言

第 2 章：範圍與方法

  • 研究目的
  • 利害關係人
  • 資料來源
    • 主要資源
    • 二手資料
  • 市場預測
    • 自下而上的方法
    • 自上而下的方法
  • 預測方法

第 3 章：執行摘要

第 4 章：生物相似藥市場 - 簡介

  • 概述
  • WHO 和 FDA 生物相似藥術語
  • 生物相似藥和學名藥
  • 生物相似藥和品牌生物製品

第 5 章：為什麼生物相似藥如此有利可圖？

  • 重磅生物藥專利到期
  • 生物相似藥和創新藥之間存在顯著的價格差異
  • 為政府和第三方付款人節省開支
  • 生活方式疾病的盛行率上升
  • 對處方者、藥劑師和患者的激勵措施
  • 歐洲和新興市場新參與者的出現
  • 製造商與給藥設備公司合作，提高產品差異化

第 6 章：生物相似藥研究、開發與製造

  • 研究與發展：生物相似藥與創新藥
  • 製造：生物相似藥與創新藥物

第 7 章：全球生物相似藥市場

  • 市場概況
  • 歷史表現
  • COVID-19 的影響
  • 市場區隔：按細分市場
  • 市場區隔：依製造類型
  • 市場區隔：依指標
  • 市場區隔：按地區
  • 市場預測
  • 生物相似藥專利格局
    • 美國的專利格局
    • 歐洲的專利格局
    • 日本的專利格局
  • SWOT分析
    • 概述
    • 優勢
    • 弱點
    • 機會
    • 威脅
  • 價值鏈分析
    • 表徵現有創新藥物
    • 研究與開發
      • 生物相似藥的表徵
      • 開發獨特的細胞株
    • 產品開發
      • 預測試
      • 中間臨床測試（PK/PD）
      • 驗證性臨床III期
    • 最終產品配方
    • 行銷與分銷
  • 波特五力分析
    • 概述
    • 買家的議價能力
    • 供應商的議價能力
    • 競爭程度
    • 新進入者的威脅
    • 替代品的威脅
  • 價格分析
    • 主要價格指標
    • 價格趨勢
    • 利潤分析

第 8 章：市場區隔：依分子

  • 英夫利西單抗
  • 甘精胰島素
  • 阿爾法依泊汀
  • 依那西普
  • 非格司亭
  • 生長激素
  • 利妥昔單抗
  • 促卵泡素阿爾法
  • 阿達木單抗
  • 聚乙二醇非格司亭
  • 曲妥珠單抗
  • 貝伐珠單抗
  • 其他

第 9 章：市場區隔：依製造類型

  • 內部製造
    • 市場走向
    • 市場預測
  • 合約起草（名詞
    • 市場走向
    • 市場預測

第 10 章：市場區隔：依跡象

  • 自體免疫疾病
    • 市場走向
    • 市場預測
  • 血液失調
    • 市場走向
    • 市場預測
  • 糖尿病
    • 市場走向
    • 市場預測
  • 腫瘤學
    • 市場走向
    • 市場預測
  • 生長不足
    • 市場走向
    • 市場預測
  • 女性不孕症
    • 市場走向
    • 市場預測
  • 其他
    • 市場走向
    • 市場預測

第 11 章：市場區隔：按地區

  • 歐洲
    • 市場業績
    • 關鍵參與者和生物相似藥
    • 市場細分：按國家/地區
    • 市場預測
    • 義大利
      • 市場業績
      • 關鍵參與者和生物相似藥
      • 市場預測
    • 德國
      • 市場業績
      • 關鍵參與者和生物相似藥
      • 市場預測
    • 法國
      • 市場業績
      • 關鍵參與者和生物相似藥
      • 市場預測
    • 英國
      • 市場業績
      • 關鍵參與者和生物相似藥
      • 市場預測
    • 西班牙
      • 市場業績
      • 關鍵參與者和生物相似藥
      • 市場預測
    • 歐洲其他地區
      • 市場業績
      • 市場預測
  • 美國
    • 當前市場趨勢
    • 關鍵參與者和生物相似藥
    • 市場預測
  • 日本
    • 市場業績
    • 關鍵參與者和生物相似藥
    • 市場預測
  • 印度
    • 當前市場趨勢
    • 關鍵參與者和生物相似藥
    • 市場預測
  • 韓國
    • 當前市場趨勢
    • 關鍵參與者和生物相似藥
    • 市場預測
  • 世界其他地區
    • 當前市場趨勢
    • 市場預測

第 12 章：設立生物相似藥工廠的要求

  • 製造流程
  • 原料要求
  • 原料圖片
  • 土地和建設要求
  • 機械和基礎設施需求
  • 機械圖片
  • 工廠佈局
  • 包裝要求
  • 實用要求
  • 人力需求

第13章：競爭格局

  • 市場結構
  • 關鍵參與者
  • 關鍵參與者簡介
    • 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
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

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