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市場調查報告書
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1379995

蛋白質治療市場 - 2018-2028 年全球產業規模、佔有率、趨勢、機會和預測，按蛋白質功能、產品類型、地區和競爭細分

Protein Therapeutics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented by Protein Function, by Product Type, by region, and Competition
出版日期: | 出版商: TechSci Research | 英文 190 Pages | 商品交期: 2-3個工作天內

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簡介目錄

2022年全球蛋白質治療市場價值為2,712.6億美元，預計在預測期內將出現令人印象深刻的成長，到2028年複合CAGR為6.80%。蛋白質治療是指利用蛋白質或勝肽作為治療劑的一類醫學治療方法診斷、預防或治療疾病。這些治療性蛋白質可以是天然存在的蛋白質、基因工程蛋白質或合成勝肽​​。蛋白質療法已成為現代醫學的基本組成部分，為管理各種醫療狀況提供有針對性且高度具體的方法。蛋白質治療劑可以透過多種方法生產，包括重組 DNA 技術、細胞培養和生物加工。這些方法確保生產出純淨且一致的蛋白質產品。蛋白質療法的主要優點之一是其高特異性。與傳統小分子藥物相比，它們可以被設計為針對特定分子或受體，最大限度地減少脫靶效應並減少副作用。蛋白質生產和純化製程的持續技術創新正在降低製造成本並提高蛋白質療法的品質和安全性。

主要市場促進因素

市場概況
預測期 2024-2028
2022 年市場規模 2712.6億美元
2028 年市場規模 3971億美元
2023-2028 年CAGR 6.80%
成長最快的細分市場 疫苗
最大的市場 北美洲

蛋白質工程的進展

定向進化是一種強大的技術，可以模仿自然選擇的過程來改善蛋白質的特性。它涉及生成蛋白質變體庫，選擇具有所需特徵的蛋白質變體，然後通過多輪突變和選擇迭代地完善它們。定向進化已被用來增強工業和治療應用中酶的活性、穩定性和特異性。分子建模和結構分析等計算方法使科學家能夠預測蛋白質氨基酸序列的變化將如何影響其結構和功能。合理的蛋白質設計允許對具有特定特性的蛋白質進行客製化工程，包括增強的結合親和力或改變的催化活性。抗體工程技術導致了用於標靶治療的高度專業化的單株抗體的開發。這包括創建可以同時結合兩個不同標靶的雙特異性抗體，以及向癌細胞輸送細胞毒性藥物的抗體藥物偶聯物 (ADC)。融合蛋白是透過組合兩個或多個蛋白質結構域或序列來創建多功能分子。這些融合蛋白可以具有增強的穩定性、溶解度和治療特性。例如，一些融合蛋白將抗體的 Fc 區域與另一種蛋白質結合起來，以延長其在體內的半衰期。

合成生物學技術能夠創建具有設計功能的完全合成的蛋白質和蛋白質組裝體。此領域可應用於創建新的生物催化劑、生物感測器和藥物傳輸系統。蛋白質藥物綴合物 (PDC) 旨在透過將細胞毒性藥物附著到特定蛋白質或抗體上，將細胞毒性藥物直接遞送至目標細胞。這種方法可以最大限度地減少對健康組織的損害並提高癌症治療的治療指數。蛋白質工程在疫苗的設計和開發中起著至關重要的作用。科學家可以設計病毒蛋白或抗原區域，引發更有效、更特異的免疫反應，同時減少潛在的副作用。 CRISPR-Cas9 等技術已適用於蛋白質工程，可對編碼蛋白質的基因進行精確修改。這使得能夠創建具有所需特性的設計蛋白。噬菌體展示是一種用於發現和設計具有特定結合特性的新蛋白質的技術。它涉及在噬菌體（感染細菌的病毒）表面上展示蛋白質變體文庫，並選擇那些與感興趣的標靶結合的蛋白質變體。了解蛋白質折疊動力學和熱力學的進步提高了我們設計具有穩定和可預測結構的蛋白質的能力，這對於蛋白質的功能至關重要。這項因素將有助於全球蛋白質治療市場的發展。

人口老化加劇

隨著年齡的成長，罹患癌症、糖尿病、阿茲海默症和心血管疾病等與年齡相關的慢性疾病的風險也會增加。其中許多病症可以透過蛋白質為基礎的療法來治療，包括單株抗體、細胞激素和生長因子。老年人通常患有多種慢性病，需要持續治療。蛋白質療法可以有效管理和控制這些病症，並改善老年人的生活品質。免疫系統往往會隨著年齡的成長而減弱，使老年人更容易受到感染，並且對傳統疫苗的反應較差。基於蛋白質的疫苗和免疫療法，例如單株抗體，可以幫助增強免疫力並預防疾病。

癌症發生率隨著年齡的成長而增加，許多癌症標靶療法都是基於單株抗體和其他蛋白質療法。與傳統治療相比，這些療法可以提供更好的結果並減少副作用。老年黃斑部病變（AMD）和糖尿病視網膜病變在老年人中更為常見。蛋白質療法，如抗 VEGF 抗體，已成為這些眼部疾病治療的標準治療方法。隨著年齡的成長，骨質疏鬆和骨折的風險也會增加。副甲狀腺素類似物等蛋白質療法可用於提高老年人的骨密度並降低骨折風險。年齡是阿茲海默症和帕金森氏症等神經退化性疾病的重要危險因子。正在開發基於蛋白質的療法來針對這些疾病的潛在機制。一些與年齡相關的健康問題，例如荷爾蒙失衡，可以透過基於蛋白質的荷爾蒙替代療法來控制。老年人可能會經歷傷口癒合和組織修復延遲。生長因子和細胞激素是基於蛋白質的療法，可以幫助這些過程。醫療保健的改善和醫療進步導致了預期壽命的延長。隨著人們壽命的延長，他們可能需要持續的醫療和干涉措施，包括基於蛋白質的療法。這項因素將加快全球蛋白質治療市場的需求。

不斷發展的免疫療法

免疫療法徹底改變了癌症的治療。單株抗體、檢查點抑制劑和CAR-T細胞療法都是基於蛋白質的免疫療法，在某些癌症類型中顯示出顯著的療效。它們的作用是增強免疫系統辨識和靶向癌細胞的能力。這些療法的成功顯著增加了腫瘤學中基於蛋白質的治療的需求。免疫療法不僅限於癌症治療。它還正在探索用於治療自體免疫疾病、傳染病和其他疾病。隨著研究擴展到這些領域，它為新的蛋白質療法的開發和商業化創造了機會。許多免疫療法是根據患者的特定免疫特徵和疾病特徵針對個別患者量身定做的。這種個人化的治療方法正在推動客製化蛋白質療法的發展，這種療法比一刀切的療法更有效且毒性更低。正在探索不同免疫療法的組合或免疫療法與其他形式的治療（例如化療或放射療法）的組合，以增強治療效果。這些組合通常涉及基於蛋白質的療法，進一步增加了它們的需求。

免疫療法的成功促進了生物相似藥的發展，生物相似藥與原廠生物製劑相似但不相同。生物相似藥為患者和醫療保健系統提供了更實惠的選擇，同時推動了市場競爭。免疫療法的監管環境已經發展，以適應其獨特的機制和患者群體。監管部門的批准促進了基於蛋白質的免疫療法進入市場。免疫療法研究臨床試驗的持續成長推動了對蛋白質療法的需求。製藥公司和研究機構正在大力投資開發和測試新的免疫療法。免疫療法已在全球範圍內採用，增加了其可及性和市場範圍。新興市場也開始在推動蛋白質療法（包括免疫療法）的需求方面發揮重要作用。免疫療法的成功鼓勵製藥和生技公司投資新蛋白質療法的研發。這項投資催生了處於不同開發階段的強大免疫療法產品線。患有癌症等疾病的患者擴大尋求免疫療法作為治療選擇，因為與傳統療法相比，免疫療法具有持久的反應潛力和更少的副作用。這項因素將加速全球蛋白質治療市場的需求。

主要市場挑戰

製造複雜性

蛋白質本質上是具有精確3D結構的複雜分子。製造過程必須確保蛋白質的正確折疊、翻譯後修飾（例如糖基化）和組裝，以維持其治療功效。蛋白質治療藥物通常使用基因工程細胞系生產，例如中國倉鼠卵巢 (CHO) 細胞或人類細胞系。開發穩定且高產量的細胞係是一個耗時且複雜的過程。上游加工涉及細胞培養，細胞在生物反應器中生長並補充營養以產生治療性蛋白質。維持細胞生長和蛋白質表現的最佳條件具有挑戰性，需要精確控制溫度、pH 值和營養供應等變數。下游加工涉及從細胞培養物中純化和分離治療蛋白。此步驟包括多個色譜和過濾步驟以去除雜質，確保最終產品的純度和安全性。嚴格的品質控制措施對於驗證蛋白質療法的特性、純度和效力至關重要。分析技術必須具有高度敏感度和特異性，才能檢測和定量雜質或變異。從小規模實驗室生產過渡到大規模製造面臨技術挑戰。在更大範圍內保持產品的一致性和品質至關重要。蛋白質療法受到嚴格的監管審查。製造商必須遵守良好生產規範 (GMP) 並滿足嚴格的監管要求，這些要求可能因地區和國家而異。

產品定價和訪問

開發以蛋白質為基礎的療法是一個成本高且資源密集的過程。這包括研究和開發、臨床前和臨床試驗、法規遵循和生產規模擴大。這些費用通常計入最終產品的定價中。蛋白質治療藥物的生產涉及複雜的生物加工技術、嚴格的品質控制和專業設施的使用。所有這些因素都會導致製造成本高昂，進而影響產品定價。 FDA 和 EMA 等監管機構對生物製劑和蛋白質治療藥物有嚴格的品質和安全標準。遵守這些法規需要進行大量的測試和記錄，這會增加開發成本。公司在研發方面投入巨資，通常依賴專利保護來回收投資。這可能導致品牌蛋白質治療藥物的壟斷和高價格。許多蛋白質療法的競爭有限，特別是對於罕見疾病或患者群體較少的病症。缺乏競爭可能導致價格上漲。雖然生物相似藥具有節省成本的潛力，但生物相似藥的開發和法規核准可能既耗時又昂貴。因此，生物相似藥可能並不總是會導致價格大幅下降。國家和地區之間醫療保健報銷政策的差異可能會影響患者獲得昂貴的蛋白質治療的能力。在某些情況下，保險範圍可能有限，要求患者承擔重大的經濟負擔。

主要市場趨勢

生物製劑主導地位

生物製劑，包括以蛋白質為基礎的治療藥物，如單株抗體、酵素和疫苗，在製藥業中佔據了重要地位。與化學合成的小分子藥物相比，這些生物製劑源自活的有機體或細胞。生物製劑以其高特異性和有效性而聞名。它們可以被設計為針對疾病所涉及的精確分子或途徑，從而減少脫靶效應並增強治療效果。用於癌症免疫治療的單株抗體和其他生物製劑的開發和批准是這一趨勢的主要驅動力。免疫檢查點抑制劑、CAR-T 細胞療法和標靶療法徹底改變了癌症治療。生物製劑在類風濕性關節炎、多發性硬化症和牛皮癬等自體免疫疾病的治療中也發揮了關鍵作用。調節免疫反應的單株抗體在控制這些疾病方面發揮了重要作用。生物製劑用於開發疫苗和抗病毒療法。 COVID-19 大流行凸顯了生物學在應對全球健康危機中的重要性。生物製劑為個人化醫療方法提供了機會。它們可以根據個別患者的遺傳或疾病特徵進行客製化，從而有可能改善治療結果。生物相似藥與原廠生物製劑相似但不相同，其出現加劇了競爭，並為患者提供了更實惠的選擇。生物相似藥有助於擴大生物治療的可近性。

細分市場洞察

蛋白質功能見解

2022 年，全球蛋白質治療市場最大佔有率由疫苗領域佔據，預計未來幾年將繼續擴大。蛋白質治療通常涉及使用蛋白質，例如單株抗體或重組蛋白質，以達到治療目的。許多疫苗是使用蛋白質作為抗原製成的。這些抗原可以是源自目標病原體的蛋白質或蛋白質亞基。例如，一些 COVID-19 疫苗使用 SARS-CoV-2 病毒的刺突蛋白作為抗原來觸發免疫反應。當注射疫苗時，免疫系統將外來抗原識別為潛在威脅並發起免疫反應。這涉及抗體的產生以及T細胞等免疫細胞的激活，這些細胞可以識別並消滅病原體。疫苗預防了無數傳染病，降低了死亡率，甚至消除了一些疾病（例如天花），對全球公共衛生產生了深遠影響。它們是對抗流行病和大流行病的重要工具。

產品類型見解

2022年，全球蛋白質治療市場最大佔有率由單株抗體領域佔據，預計未來幾年將繼續擴大。單株抗體在治療多種疾病方面表現出顯著的療效，包括癌症、自體免疫疾病和傳染病。它們高精度地針對特定抗原，降低了脫靶效應的風險。單株抗體用途廣泛，可針對各種疾病相關蛋白質和受體進行設計。這種多功能性使其可用於廣泛的醫療條件。與其他類型的蛋白質療法相比，單株抗體具有更長的成功開發和臨床使用記錄。這段成功的歷史讓人們對它們的治療潛力充滿信心。免疫療法，包括使用單株抗體，在癌症治療中得到了重視。檢查點抑制劑（例如 PD-1 和 CTLA-4 抑制劑）和 CAR-T 細胞療法等藥物（其中包含單株抗體）徹底改變了癌症治療。單株抗體的生物相似藥市場一直在快速成長。隨著一些原創單株抗體的專利到期，生物相似藥版本提供了更實惠的治療選擇，增加了患者的可及性。

區域洞察

到2022年，北美地區將主導全球蛋白質治療市場。北美，特別是美國和加拿大，擁有高度發展的醫療基礎設施。其中包括世界知名的研究機構、學術醫療中心以及促進蛋白質療法創新和發展的強大製藥業。北美擁有強大的研發生態系統，包括政府機構、私人研究組織和生技公司。來自公共和私人來源的資金支持生物技術和蛋白質療法的前沿研究。許多世界上最大的製藥和生物技術公司的總部都位於北美。這些公司擁有投資蛋白質療法研究、開發和商業化的資源和專業知識。北美吸引了大量蛋白質療法的臨床試驗。美國食品藥物管理局 (FDA) 等監管機構為藥物核准提供了明確的監管途徑，使其成為臨床研究的有吸引力的地區。

目錄

第 1 章：產品概述

  • 市場定義
  • 市場範圍
    • 涵蓋的市場
    • 研究年份
    • 主要市場區隔

第 2 章：研究方法

  • 研究目的
  • 基線方法
  • 主要產業夥伴
  • 主要協會和二手資料來源
  • 預測方法
  • 數據三角測量與驗證
  • 假設和限制

第 3 章：執行摘要

  • 市場概況
  • 主要市場細分概述
  • 主要市場參與者概述
  • 重點地區/國家概況
  • 市場促進因素、挑戰、趨勢概述

第 4 章：客戶之聲

第 5 章：全球蛋白質治療市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依蛋白質功能（酵素與調節、蛋白質診斷、疫苗）
    • 依產品類型（凝血因子、促紅血球生成素、卵泡刺激素、G-CSF、胰島素、干擾素、單株抗體）
    • 按公司分類 (2022)
  • 市場地圖

第 6 章：亞太地區蛋白質治療市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依蛋白質功能分類
    • 依產品類型
    • 按國家/地區
  • 亞太地區：國家分析
    • 中國蛋白療法
    • 印度蛋白質療法
    • 澳洲蛋白質治療公司
    • 日本蛋白質治療公司
    • 韓國蛋白質療法

第 7 章：歐洲蛋白質治療市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依蛋白質功能分類
    • 依產品類型
    • 按國家/地區
  • 歐洲：國家分析
    • 法國
    • 德國
    • 西班牙
    • 義大利
    • 英國

第 8 章：北美蛋白質治療市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依蛋白質功能分類
    • 依產品類型
    • 按國家/地區
  • 北美：國家分析
    • 美國
    • 墨西哥
    • 加拿大

第 9 章：南美洲蛋白質治療市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依蛋白質功能分類
    • 依產品類型
    • 按國家/地區
  • 南美洲：國家分析
    • 巴西
    • 阿根廷
    • 哥倫比亞

第 10 章：中東和非洲蛋白質治療市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依蛋白質功能分類
    • 依產品類型
    • 按國家/地區
  • MEA：國家分析
    • 南非蛋白質治療公司
    • 沙烏地阿拉伯蛋白質療法
    • 阿拉伯聯合大公國蛋白質療法

第 11 章：市場動態

  • 促進要素
  • 挑戰

第 12 章：市場趨勢與發展

  • 最近的發展
  • 產品發布
  • 併購

第 13 章：全球蛋白質治療市場：SWOT 分析

第 14 章：波特的五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的力量
  • 客戶的力量
  • 替代產品的威脅

第 15 章：大環境分析

第16章：競爭格局

  • 安進公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 禮來公司。
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • F.霍夫曼-拉羅氏有限公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 強生服務公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 默克公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 輝瑞公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 阿斯特捷利康公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 梯瓦製藥工業股份有限公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 艾伯維公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 百時美施貴寶公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis

第 17 章：策略建議

第 18 章：關於我們與免責聲明

簡介目錄
Product Code: 17277

Global Protein Therapeutics Market has valued at USD 271.26 billion in 2022 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 6.80% through 2028. Protein therapeutics refers to a class of medical treatments that utilize proteins or peptides as therapeutic agents to diagnose, prevent, or treat diseases. These therapeutic proteins can be naturally occurring proteins, genetically engineered proteins, or synthetic peptides. Protein therapeutics have become a fundamental part of modern medicine, offering targeted and highly specific approaches to managing various medical conditions. Protein therapeutics can be produced through various methods, including recombinant DNA technology, cell culture, and bioprocessing. These methods ensure the production of pure and consistent protein products. One of the key advantages of protein therapeutics is their high specificity. They can be designed to target specific molecules or receptors, minimizing off-target effects, and reducing side effects compared to traditional small-molecule drugs. Continued technological innovations in protein production and purification processes were reducing manufacturing costs and improving the quality and safety of protein therapeutics.

Continuous innovations in protein engineering, including antibody-drug conjugates, bispecific antibodies, and fusion proteins, were expanding the therapeutic capabilities of protein-based drugs. Immunotherapies, such as immune checkpoint inhibitors and CAR-T cell therapies, were gaining traction in the treatment of cancer and autoimmune diseases, propelling market growth. The aging global population was leading to an increased prevalence of age-related diseases, creating a larger patient pool for protein therapeutics. The growth of biosimilars, which are similar but not identical versions of biologics, was enhancing competition and providing cost-effective treatment options for patients. Advances in genomics and biomarker discovery were promoting personalized medicine approaches, leading to the development of protein therapeutics tailored to individual patient profiles. Developing countries were experiencing increased healthcare expenditure, better access to healthcare, and a growing demand for advanced therapies, driving market expansion in these regions.

Key Market Drivers

Market Overview
Forecast Period2024-2028
Market Size 2022USD 271.26 Billion
Market Size 2028USD 397.10 Billion
CAGR 2023-20286.80%
Fastest Growing SegmentVaccines
Largest MarketNorth America

Advancements in Protein Engineering

Directed evolution is a powerful technique that mimics the process of natural selection to improve the properties of proteins. It involves generating a library of protein variants, selecting those with desired traits, and then iteratively refining them through multiple rounds of mutation and selection. Directed evolution has been used to enhance enzyme activity, stability, and specificity for industrial and therapeutic applications. Computational methods, such as molecular modeling and structural analysis, enable scientists to predict how changes in a protein's amino acid sequence will impact its structure and function. Rational protein design allows for the custom engineering of proteins with specific properties, including enhanced binding affinity or altered catalytic activity. Antibody engineering techniques have led to the development of highly specialized monoclonal antibodies for targeted therapies. This includes the creation of bispecific antibodies that can simultaneously bind two different targets, as well as antibody-drug conjugates (ADCs) that deliver cytotoxic drugs to cancer cells. Fusion proteins are created by combining two or more protein domains or sequences to create multifunctional molecules. These fusion proteins can have enhanced stability, solubility, and therapeutic properties. For example, some fusion proteins combine the Fc region of an antibody with another protein to extend its half-life in the body.

Synthetic biology techniques enable the creation of entirely synthetic proteins and protein assemblies with designed functions. This field has applications in creating new biocatalysts, biosensors, and drug delivery systems. Protein-Drug Conjugates (PDCs) are designed to deliver cytotoxic drugs directly to target cells by attaching them to specific proteins or antibodies. This approach minimizes damage to healthy tissues and improves the therapeutic index of cancer treatments. Protein engineering plays a crucial role in the design and development of vaccines. Scientists can engineer viral proteins or antigenic regions to elicit a more potent and specific immune response while reducing potential side effects. Technologies like CRISPR-Cas9 have been adapted for protein engineering, allowing for precise modifications of genes encoding proteins. This enables the creation of designer proteins with desired properties. Phage display is a technique used to discover and engineer new proteins with specific binding properties. It involves displaying a library of protein variants on the surface of bacteriophages (viruses that infect bacteria) and selecting those that bind to a target of interest. Advancements in understanding protein folding kinetics and thermodynamics have improved our ability to design proteins with stable and predictable structures, which is essential for their function. This factor will help in the development of the Global Protein Therapeutics Market.

Rising Aging Population

With aging comes a higher risk of developing age-related and chronic diseases such as cancer, diabetes, Alzheimer's disease, and cardiovascular disorders. Many of these conditions are treated with protein-based therapeutics, including monoclonal antibodies, cytokines, and growth factors. Older adults often have multiple chronic conditions that require ongoing treatment. Protein therapeutics can provide effective management and control of these conditions, improving the quality of life for aging individuals. The immune system tends to weaken with age, making older adults more susceptible to infections and less responsive to traditional vaccines. Protein-based vaccines and immunotherapies, such as monoclonal antibodies, can help bolster immunity and protect against diseases.

Cancer incidence increases with age, and many targeted therapies for cancer are based on monoclonal antibodies and other protein therapeutics. These therapies can provide better outcomes and reduced side effects compared to traditional treatments. Age-related macular degeneration (AMD) and diabetic retinopathy are more common in older adults. Protein therapeutics, like anti-VEGF antibodies, have become a standard of care for treating these eye conditions. As people age, the risk of osteoporosis and fractures increases. Protein therapeutics like parathyroid hormone analogs are used to improve bone density and reduce the risk of fractures in older adults. Age is a significant risk factor for neurodegenerative diseases like Alzheimer's and Parkinson's disease. Protein-based therapies are being developed to target the underlying mechanisms of these conditions. Some age-related health issues, such as hormonal imbalances, can be managed with protein-based hormone replacement therapies. Older adults may experience delayed wound healing and tissue repair. Growth factors and cytokines, which are protein-based therapeutics, can aid in these processes. Improved healthcare and medical advancements have led to longer life expectancy. As people live longer, they may require ongoing medical treatment and interventions that include protein-based therapies. This factor will pace up the demand of the Global Protein Therapeutics Market.

Growing Immunotherapy

Immunotherapy has revolutionized the treatment of cancer. Monoclonal antibodies, checkpoint inhibitors, and CAR-T cell therapies, which are all protein-based immunotherapies, have shown remarkable efficacy in certain cancer types. They work by enhancing the immune system's ability to identify and target cancer cells. The success of these therapies has significantly increased the demand for protein-based treatments in oncology. Immunotherapy is not limited to cancer treatment. It is also being explored for the treatment of autoimmune diseases, infectious diseases, and other conditions. As research expands into these areas, it creates opportunities for new protein therapeutics to be developed and commercialized. Many immunotherapies are tailored to individual patients based on their specific immune profiles and the characteristics of their diseases. This personalized approach to treatment is driving the development of customized protein therapeutics, which can be more effective and less toxic than one-size-fits-all treatments. Combinations of different immunotherapies or immunotherapy with other forms of treatment, such as chemotherapy or radiation therapy, are being explored to enhance treatment efficacy. These combinations often involve protein-based therapeutics, further increasing their demand.

The success of immunotherapies has led to the development of biosimilars, which are similar but not identical versions of originator biologics. Biosimilars offer more affordable options for patients and healthcare systems while driving competition in the market. The regulatory landscape for immunotherapies has evolved to accommodate their unique mechanisms and patient populations. Regulatory approvals have facilitated the market entry of protein-based immunotherapies. The continued growth of clinical trials in immunotherapy research has driven the demand for protein therapeutics. Pharmaceutical companies and research institutions are investing heavily in developing and testing new immunotherapies. Immunotherapies have been adopted globally, increasing their accessibility and market reach. Emerging markets are also starting to play a significant role in driving demand for protein therapeutics, including immunotherapies. The success of immunotherapies has encouraged pharmaceutical and biotechnology companies to invest in R&D for new protein therapeutics. This investment has resulted in a robust pipeline of immunotherapies in various stages of development. Patients with conditions like cancer are increasingly seeking immunotherapy as a treatment option due to its potential for durable responses and fewer side effects compared to traditional treatments. This factor will accelerate the demand of the Global Protein Therapeutics Market.

Key Market Challenges

Manufacturing Complexities

Proteins are inherently complex molecules with precise three-dimensional structures. The manufacturing process must ensure the correct folding, post-translational modifications (e.g., glycosylation), and assembly of proteins to maintain their therapeutic efficacy. Protein therapeutics are often produced using genetically engineered cell lines, such as Chinese hamster ovary (CHO) cells or human cell lines. Developing stable and high-yielding cell lines is a time-consuming and intricate process. Upstream processing involves cell culture, where cells are grown in bioreactors and fed with nutrients to produce therapeutic protein. Maintaining optimal conditions for cell growth and protein expression is challenging and requires precise control of variables such as temperature, pH, and nutrient supply. Downstream processing involves the purification and isolation of the therapeutic protein from the cell culture. This step includes multiple chromatography and filtration steps to remove impurities, ensuring the final product's purity and safety. Stringent quality control measures are essential to verify the identity, purity, and potency of protein therapeutics. Analytical techniques must be highly sensitive and specific to detect and quantify impurities or variants. Transitioning from small-scale laboratory production to large-scale manufacturing presents technical challenges. Maintaining product consistency and quality on larger scales is critical. Protein therapeutics are subject to rigorous regulatory scrutiny. Manufacturers must adhere to good manufacturing practices (GMP) and meet stringent regulatory requirements, which can vary by region and country.

Product Pricing and Access

Developing protein-based therapeutics is a costly and resource-intensive process. This includes research and development, preclinical and clinical trials, regulatory compliance, and manufacturing scale-up. These expenses are often factored into the pricing of the final products. The production of protein therapeutics involves complex bioprocessing techniques, stringent quality control, and the use of specialized facilities. All these factors contribute to high manufacturing costs, which can impact product pricing. Regulatory agencies like the FDA and EMA have strict quality and safety standards for biologics and protein therapeutics. Complying with these regulations necessitates extensive testing and documentation, which adds to development costs. Companies invest heavily in research and development, and they often rely on patent protections to recoup their investments. This can lead to monopolies and high prices for branded protein therapeutics. Many protein therapeutics have limited competition, especially for rare diseases or conditions with a small patient population. This lack of competition can result in higher prices. While biosimilars offer the potential for cost savings, the development and regulatory approval of biosimilars can be time-consuming and expensive. Consequently, biosimilars may not always lead to substantial price reductions. Variations in healthcare reimbursement policies among countries and regions can impact patients' ability to access expensive protein therapeutics. In some cases, insurance coverage may be limited, requiring patients to bear a significant financial burden.

Key Market Trends

Biologics Dominance

Biologics, which include protein-based therapeutics such as monoclonal antibodies, enzymes, and vaccines, have gained prominence in the pharmaceutical industry. These biologics are derived from living organisms or cells, in contrast to small-molecule drugs that are chemically synthesized. Biologics are known for their high specificity and efficacy. They can be designed to target precise molecules or pathways involved in diseases, resulting in reduced off-target effects and enhanced therapeutic outcomes. The development and approval of monoclonal antibodies and other biologics for cancer immunotherapy have been a major driver of this trend. Immune checkpoint inhibitors, CAR-T cell therapies, and targeted therapies have revolutionized cancer treatment. Biologics have also played a critical role in the treatment of autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, and psoriasis. Monoclonal antibodies that modulate immune responses have been instrumental in managing these conditions. Biologics are used in the development of vaccines and antiviral therapies. The COVID-19 pandemic has highlighted the importance of biology in responding to global health crises. Biologics offer opportunities for personalized medicine approaches. They can be customized to match the genetic or disease profiles of individual patients, potentially improving treatment outcomes. The emergence of biosimilars, which are similar but not identical versions of originator biologics, has increased competition and provided more affordable options for patients. Biosimilars are helping to expand access to biologic treatments.

Segmental Insights

Protein Function Insights

In 2022, the Global Protein Therapeutics Market largest share was held by Vaccines segment and is predicted to continue expanding over the coming years. Protein therapeutics generally involve the use of proteins, such as monoclonal antibodies or recombinant proteins, for therapeutic purposes. Many vaccines are made using proteins as antigens. These antigens can be proteins or protein subunits derived from the target pathogen. For example, some COVID-19 vaccines use the spike protein of the SARS-CoV-2 virus as the antigen to trigger an immune response. When a vaccine is administered, the immune system recognizes the foreign antigen as a potential threat and mounts an immune response. This involves the production of antibodies and the activation of immune cells, such as T cells, that can recognize and destroy the pathogen. Vaccines have had a profound impact on global public health by preventing countless cases of infectious diseases, reducing mortality rates, and even leading to the eradication of some diseases (e.g., smallpox). They are essential tools in combating epidemics and pandemics.

Product Type Insights

In 2022, the Global Protein Therapeutics Market largest share was held by Monoclonal Antibodies segment in the forecast period and is predicted to continue expanding over the coming years. Monoclonal antibodies have demonstrated remarkable therapeutic efficacy in treating a wide range of diseases, including cancer, autoimmune disorders, and infectious diseases. They target specific antigens with high precision, reducing the risk of off-target effects. Monoclonal antibodies are versatile and can be designed to target various disease-related proteins and receptors. This versatility has led to their use in a broad spectrum of medical conditions. Monoclonal antibodies have a longer track record of successful development and clinical use compared to other types of protein therapeutics. This history of success has built confidence in their therapeutic potential. Immunotherapy, which includes the use of monoclonal antibodies, has gained prominence in cancer treatment. Drugs like checkpoint inhibitors (e.g., PD-1 and CTLA-4 inhibitors) and CAR-T cell therapies, which incorporate mAbs, have revolutionized cancer care. The biosimilars market for monoclonal antibodies has been growing rapidly. As patents for some originator mAbs expire, biosimilar versions offer more affordable treatment options, increasing accessibility for patients.

Regional Insights

The North America region dominates the Global Protein Therapeutics Market in 2022. North America, particularly the United States and Canada, has a highly developed healthcare infrastructure. This includes world-renowned research institutions, academic medical centers, and a robust pharmaceutical industry that fosters innovation and the development of protein therapeutics. North America has a robust R&D ecosystem that includes government agencies, private research organizations, and biotechnology companies. Funding from both public and private sources supports cutting-edge research in biotechnology and protein therapeutics. Many of the world's largest pharmaceutical and biotechnology companies are headquartered in North America. These companies have the resources and expertise to invest in protein therapeutics research, development, and commercialization. North America attracts a significant number of clinical trials for protein therapeutics. Regulatory agencies like the U.S. Food and Drug Administration (FDA) provide a clear regulatory pathway for drug approvals, making it an attractive region for conducting clinical research.

Key Market Players

  • Amgen Inc.
  • Eli Lilly and Company.
  • F. Hoffmann-La Roche Ltd.
  • Johnson & Johnson Services, Inc
  • Merck KGaA
  • Pfizer Inc
  • AstraZeneca Plc.
  • Teva Pharmaceutical Industries Ltd
  • Bristol-Myers Squibb Company
  • AbbVie Inc.

Report Scope:

In this report, the Global Protein Therapeutics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Protein Therapeutics Market, By Protein Function:

  • Enzymatic & Regulatory
  • Protein Diagnostics
  • Vaccines

Protein Therapeutics Market, By Product Type:

  • Blood Clotting Factor
  • Erythropoietin
  • Follicle Stimulating Hormone
  • G-CSF
  • Insulin
  • Interferons
  • Monoclonal Antibodies

Global Protein Therapeutics Market, By region:

  • North America
  • United States
  • Canada
  • Mexico
  • Asia-Pacific
  • China
  • India
  • South Korea
  • Australia
  • Japan
  • Europe
  • Germany
  • France
  • United Kingdom
  • Spain
  • Italy
  • South America
  • Brazil
  • Argentina
  • Colombia
  • Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

  • Company Profiles: Detailed analysis of the major companies present in the Global Protein Therapeutics Market.

Available Customizations:

  • Global Protein Therapeutics Market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Protein Therapeutics Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Protein Function (Enzymatic & Regulatory, Protein Diagnostics, Vaccines)
    • 5.2.2. By Product Type (Blood Clotting Factor, Erythropoietin, Follicle Stimulating Hormone, G-CSF, Insulin, Interferons, Monoclonal Antibodies)
    • 5.2.3. By Company (2022)
  • 5.3. Market Map

6. Asia Pacific Protein Therapeutics Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Protein Function
    • 6.2.2. By Product Type
    • 6.2.3. By Country
  • 6.3. Asia Pacific: Country Analysis
    • 6.3.1. China Protein Therapeutics Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Protein Function
        • 6.3.1.2.2. By Product Type
    • 6.3.2. India Protein Therapeutics Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Protein Function
        • 6.3.2.2.2. By Product Type
    • 6.3.3. Australia Protein Therapeutics Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Protein Function
        • 6.3.3.2.2. By Product Type
    • 6.3.4. Japan Protein Therapeutics Market Outlook
      • 6.3.4.1. Market Size & Forecast
        • 6.3.4.1.1. By Value
      • 6.3.4.2. Market Share & Forecast
        • 6.3.4.2.1. By Protein Function
        • 6.3.4.2.2. By Product Type
    • 6.3.5. South Korea Protein Therapeutics Market Outlook
      • 6.3.5.1. Market Size & Forecast
        • 6.3.5.1.1. By Value
      • 6.3.5.2. Market Share & Forecast
        • 6.3.5.2.1. By Protein Function
        • 6.3.5.2.2. By Product Type

7. Europe Protein Therapeutics Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Protein Function
    • 7.2.2. By Product Type
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. France Protein Therapeutics Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Protein Function
        • 7.3.1.2.2. By Product Type
    • 7.3.2. Germany Protein Therapeutics Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Protein Function
        • 7.3.2.2.2. By Product Type
    • 7.3.3. Spain Protein Therapeutics Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Protein Function
        • 7.3.3.2.2. By Product Type
    • 7.3.4. Italy Protein Therapeutics Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Protein Function
        • 7.3.4.2.2. By Product Type
    • 7.3.5. United Kingdom Protein Therapeutics Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Protein Function
        • 7.3.5.2.2. By Product Type

8. North America Protein Therapeutics Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Protein Function
    • 8.2.2. By Product Type
    • 8.2.3. By Country
  • 8.3. North America: Country Analysis
    • 8.3.1. United States Protein Therapeutics Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Protein Function
        • 8.3.1.2.2. By Product Type
    • 8.3.2. Mexico Protein Therapeutics Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Protein Function
        • 8.3.2.2.2. By Product Type
    • 8.3.3. Canada Protein Therapeutics Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Protein Function
        • 8.3.3.2.2. By Product Type

9. South America Protein Therapeutics Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Protein Function
    • 9.2.2. By Product Type
    • 9.2.3. By Country
  • 9.3. South America: Country Analysis
    • 9.3.1. Brazil Protein Therapeutics Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Protein Function
        • 9.3.1.2.2. By Product Type
    • 9.3.2. Argentina Protein Therapeutics Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Protein Function
        • 9.3.2.2.2. By Product Type
    • 9.3.3. Colombia Protein Therapeutics Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Protein Function
        • 9.3.3.2.2. By Product Type

10. Middle East and Africa Protein Therapeutics Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Protein Function
    • 10.2.2. By Product Type
    • 10.2.3. By Country
  • 10.3. MEA: Country Analysis
    • 10.3.1. South Africa Protein Therapeutics Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Protein Function
        • 10.3.1.2.2. By Product Type
    • 10.3.2. Saudi Arabia Protein Therapeutics Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Protein Function
        • 10.3.2.2.2. By Product Type
    • 10.3.3. UAE Protein Therapeutics Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Protein Function
        • 10.3.3.2.2. By Product Type

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Recent Developments
  • 12.2. Product Launches
  • 12.3. Mergers & Acquisitions

13. Global Protein Therapeutics Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Product

15. PESTLE Analysis

16. Competitive Landscape

  • 16.1. Amgen Inc.
    • 16.1.1. Business Overview
    • 16.1.2. Company Snapshot
    • 16.1.3. Products & Services
    • 16.1.4. Financials (In case of listed companies)
    • 16.1.5. Recent Developments
    • 16.1.6. SWOT Analysis
  • 16.2. Eli Lilly and Company.
    • 16.2.1. Business Overview
    • 16.2.2. Company Snapshot
    • 16.2.3. Products & Services
    • 16.2.4. Financials (In case of listed companies)
    • 16.2.5. Recent Developments
    • 16.2.6. SWOT Analysis
  • 16.3. F. Hoffmann-La Roche Ltd
    • 16.3.1. Business Overview
    • 16.3.2. Company Snapshot
    • 16.3.3. Products & Services
    • 16.3.4. Financials (In case of listed companies)
    • 16.3.5. Recent Developments
    • 16.3.6. SWOT Analysis
  • 16.4. Johnson & Johnson Services, Inc.
    • 16.4.1. Business Overview
    • 16.4.2. Company Snapshot
    • 16.4.3. Products & Services
    • 16.4.4. Financials (In case of listed companies)
    • 16.4.5. Recent Developments
    • 16.4.6. SWOT Analysis
  • 16.5. Merck KGaA
    • 16.5.1. Business Overview
    • 16.5.2. Company Snapshot
    • 16.5.3. Products & Services
    • 16.5.4. Financials (In case of listed companies)
    • 16.5.5. Recent Developments
    • 16.5.6. SWOT Analysis
  • 16.6. Pfizer Inc.
    • 16.6.1. Business Overview
    • 16.6.2. Company Snapshot
    • 16.6.3. Products & Services
    • 16.6.4. Financials (In case of listed companies)
    • 16.6.5. Recent Developments
    • 16.6.6. SWOT Analysis
  • 16.7. AstraZeneca Plc.
    • 16.7.1. Business Overview
    • 16.7.2. Company Snapshot
    • 16.7.3. Products & Services
    • 16.7.4. Financials (In case of listed companies)
    • 16.7.5. Recent Developments
    • 16.7.6. SWOT Analysis
  • 16.8. Teva Pharmaceutical Industries Ltd
    • 16.8.1. Business Overview
    • 16.8.2. Company Snapshot
    • 16.8.3. Products & Services
    • 16.8.4. Financials (In case of listed companies)
    • 16.8.5. Recent Developments
    • 16.8.6. SWOT Analysis
  • 16.9. AbbVie Inc.
    • 16.9.1. Business Overview
    • 16.9.2. Company Snapshot
    • 16.9.3. Products & Services
    • 16.9.4. Financials (In case of listed companies)
    • 16.9.5. Recent Developments
    • 16.9.6. SWOT Analysis
  • 16.10. Bristol-Myers Squibb Company
    • 16.10.1. Business Overview
    • 16.10.2. Company Snapshot
    • 16.10.3. Products & Services
    • 16.10.4. Financials (In case of listed companies)
    • 16.10.5. Recent Developments
    • 16.10.6. SWOT Analysis

17. Strategic Recommendations

18. About Us & Disclaimer