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市场调查报告书
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蛋白质治疗市场 - 2018-2028 年全球产业规模、份额、趋势、机会和预测，按蛋白质功能、产品类型、地区和竞争细分

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个工作天内

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简介目录

2022年全球蛋白质治疗市场价值为2,712.6亿美元，预计在预测期内将出现令人印象深刻的成长，到2028年复合CAGR为6.80%。蛋白质治疗是指利用蛋白质或胜肽作为治疗剂的一类医学治疗方法诊断、预防或治疗疾病。这些治疗性蛋白质可以是天然存在的蛋白质、基因工程蛋白质或合成胜肽​​。蛋白质疗法已成为现代医学的基本组成部分，为管理各种医疗状况提供有针对性且高度具体的方法。蛋白质治疗剂可以透过多种方法生产，包括重组 DNA 技术、细胞培养和生物加工。这些方法确保生产出纯净且一致的蛋白质产品。蛋白质疗法的主要优点之一是其高特异性。与传统小分子药物相比，它们可以被设计为针对特定分子或受体，最大限度地减少脱靶效应并减少副作用。蛋白质生产和纯化製程的持续技术创新正在降低製造成本并提高蛋白质疗法的品质和安全性。

主要市场驱动因素

市场概况
预测期 2024-2028
2022 年市场规模 2712.6亿美元
2028 年市场规模 3971亿美元
2023-2028 年CAGR 6.80%
成长最快的细分市场 疫苗
最大的市场 北美洲

蛋白质工程的进展

定向进化是一种强大的技术，可以模仿自然选择的过程来改善蛋白质的特性。它涉及生成蛋白质变体库，选择具有所需特征的蛋白质变体，然后通过多轮突变和选择迭代地完善它们。定向进化已被用来增强工业和治疗应用中酶的活性、稳定性和特异性。分子建模和结构分析等计算方法使科学家能够预测蛋白质氨基酸序列的变化将如何影响其结构和功能。合理的蛋白质设计允许对具有特定特性的蛋白质进行客製化工程，包括增强的结合亲和力或改变的催化活性。抗体工程技术导致了用于标靶治疗的高度专业化的单株抗体的开发。这包括创建可以同时结合两个不同标靶的双特异性抗体，以及向癌细胞输送细胞毒性药物的抗体药物偶联物 (ADC)。融合蛋白是透过组合两个或多个蛋白质结构域或序列来创建多功能分子。这些融合蛋白可以具有增强的稳定性、溶解度和治疗特性。例如，一些融合蛋白将抗体的 Fc 区域与另一种蛋白质结合起来，以延长其在体内的半衰期。

合成生物学技术能够创建具有设计功能的完全合成的蛋白质和蛋白质组装体。此领域可应用于创建新的生物催化剂、生物感测器和药物传输系统。蛋白质药物缀合物 (PDC) 旨在透过将细胞毒性药物附着到特定蛋白质或抗体上，将细胞毒性药物直接递送至目标细胞。这种方法可以最大限度地减少对健康组织的损害并提高癌症治疗的治疗指数。蛋白质工程在疫苗的设计和开发中起着至关重要的作用。科学家可以设计病毒蛋白或抗原区域，引发更有效、更特异的免疫反应，同时减少潜在的副作用。 CRISPR-Cas9 等技术已适用于蛋白质工程，可对编码蛋白质的基因进行精确修改。这使得能够创建具有所需特性的设计蛋白。噬菌体展示是一种用于发现和设计具有特定结合特性的新蛋白质的技术。它涉及在噬菌体（感染细菌的病毒）表面上展示蛋白质变体文库，并选择那些与感兴趣的标靶结合的蛋白质变体。了解蛋白质折迭动力学和热力学的进步提高了我们设计具有稳定和可预测结构的蛋白质的能力，这对于蛋白质的功能至关重要。这项因素将有助于全球蛋白质治疗市场的发展。

人口老化加剧

随着年龄的增长，罹患癌症、糖尿病、阿兹海默症和心血管疾病等与年龄相关的慢性疾病的风险也会增加。其中许多病症可以透过蛋白质为基础的疗法来治疗，包括单株抗体、细胞激素和生长因子。老年人通常患有多种慢性病，需要持续治疗。蛋白质疗法可以有效管理和控制这些病症，并改善老年人的生活品质。免疫系统往往会随着年龄的增长而减弱，使老年人更容易受到感染，并且对传统疫苗的反应较差。基于蛋白质的疫苗和免疫疗法，例如单株抗体，可以帮助增强免疫力并预防疾病。

癌症发生率随着年龄的增长而增加，许多癌症标靶疗法都是基于单株抗体和其他蛋白质疗法。与传统治疗相比，这些疗法可以提供更好的结果并减少副作用。老年黄斑部病变（AMD）和糖尿病视网膜病变在老年人中更为常见。蛋白质疗法，如抗 VEGF 抗体，已成为这些眼部疾病治疗的标准治疗方法。随着年龄的增长，骨质疏鬆和骨折的风险也会增加。副甲状腺素类似物等蛋白质疗法可用于提高老年人的骨密度并降低骨折风险。年龄是阿兹海默症和帕金森氏症等神经退化性疾病的重要危险因子。正在开发基于蛋白质的疗法来针对这些疾病的潜在机制。一些与年龄相关的健康问题，例如荷尔蒙失衡，可以透过基于蛋白质的荷尔蒙替代疗法来控制。老年人可能会经历伤口癒合和组织修復延迟。生长因子和细胞激素是基于蛋白质的疗法，可以帮助这些过程。医疗保健的改善和医疗进步导致了预期寿命的延长。随着人们寿命的延长，他们可能需要持续的医疗和干预措施，包括基于蛋白质的疗法。这项因素将加快全球蛋白质治疗市场的需求。

不断发展的免疫疗法

免疫疗法彻底改变了癌症的治疗。单株抗体、检查点抑制剂和CAR-T细胞疗法都是基于蛋白质的免疫疗法，在某些癌症类型中显示出显着的疗效。它们的作用是增强免疫系统辨识和靶向癌细胞的能力。这些疗法的成功显着增加了肿瘤学中基于蛋白质的治疗的需求。免疫疗法不仅限于癌症治疗。它还正在探索用于治疗自体免疫疾病、传染病和其他疾病。随着研究扩展到这些领域，它为新的蛋白质疗法的开发和商业化创造了机会。许多免疫疗法是根据患者的特定免疫特征和疾病特征针对个别患者量身定制的。这种个人化的治疗方法正在推动客製化蛋白质疗法的发展，这种疗法比一刀切的疗法更有效且毒性更低。正在探索不同免疫疗法的组合或免疫疗法与其他形式的治疗（例如化疗或放射疗法）的组合，以增强治疗效果。这些组合通常涉及基于蛋白质的疗法，进一步增加了它们的需求。

免疫疗法的成功促进了生物相似药的发展，生物相似药与原厂生物製剂相似但不相同。生物相似药为患者和医疗保健系统提供了更实惠的选择，同时推动了市场竞争。免疫疗法的监管环境已经发展，以适应其独特的机制和患者群体。监管部门的批准促进了基于蛋白质的免疫疗法进入市场。免疫疗法研究临床试验的持续成长推动了对蛋白质疗法的需求。製药公司和研究机构正在大力投资开发和测试新的免疫疗法。免疫疗法已在全球范围内采用，增加了其可及性和市场范围。新兴市场也开始在推动蛋白质疗法（包括免疫疗法）的需求方面发挥重要作用。免疫疗法的成功鼓励製药和生技公司投资新蛋白质疗法的研发。这项投资催生了处于不同开发阶段的强大免疫疗法产品线。患有癌症等疾病的患者越来越多地寻求免疫疗法作为治疗选择，因为与传统疗法相比，免疫疗法具有持久的反应潜力和更少的副作用。这项因素将加速全球蛋白质治疗市场的需求。

主要市场挑战

製造复杂性

蛋白质本质上是具有精确三维结构的复杂分子。製造过程必须确保蛋白质的正确折迭、翻译后修饰（例如糖基化）和组装，以维持其治疗功效。蛋白质治疗药物通常使用基因工程细胞系生产，例如中国仓鼠卵巢 (CHO) 细胞或人类细胞系。开发稳定且高产量的细胞係是一个耗时且复杂的过程。上游加工涉及细胞培养，细胞在生物反应器中生长并补充营养以产生治疗性蛋白质。维持细胞生长和蛋白质表现的最佳条件具有挑战性，需要精确控制温度、pH 值和营养供应等变数。下游加工涉及从细胞培养物中纯化和分离治疗蛋白。此步骤包括多个色谱和过滤步骤以去除杂质，确保最终产品的纯度和安全性。严格的品质控制措施对于验证蛋白质疗法的特性、纯度和效力至关重要。分析技术必须具有高度敏感度和特异性，才能检测和定量杂质或变异。从小规模实验室生产过渡到大规模製造面临技术挑战。在更大范围内保持产品的一致性和品质至关重要。蛋白质疗法受到严格的监管审查。製造商必须遵守良好生产规范 (GMP) 并满足严格的监管要求，这些要求可能因地区和国家而异。

产品定价和访问

开发以蛋白质为基础的疗法是一个成本高且资源密集的过程。这包括研究和开发、临床前和临床试验、法规遵循和生产规模扩大。这些费用通常计入最终产品的定价中。蛋白质治疗药物的生产涉及复杂的生物加工技术、严格的品质控制和专业设施的使用。所有这些因素都会导致製造成本高昂，进而影响产品定价。 FDA 和 EMA 等监管机构对生物製剂和蛋白质治疗药物有严格的品质和安全标准。遵守这些法规需要进行大量的测试和记录，这会增加开发成本。公司在研发方面投入巨资，通常依赖专利保护来回收投资。这可能导致品牌蛋白质治疗药物的垄断和高价格。许多蛋白质疗法的竞争有限，特别是对于罕见疾病或患者群体较少的病症。缺乏竞争可能导致价格上涨。虽然生物相似药具有节省成本的潜力，但生物相似药的开发和监管审批可能既耗时又昂贵。因此，生物相似药可能并不总是会导致价格大幅下降。国家和地区之间医疗保健报销政策的差异可能会影响患者获得昂贵的蛋白质治疗的能力。在某些情况下，保险范围可能有限，要求患者承担重大的经济负担。

主要市场趋势

生物製剂主导地位

生物製剂，包括以蛋白质为基础的治疗药物，如单株抗体、酵素和疫苗，在製药业中占据了重要地位。与化学合成的小分子药物相比，这些生物製剂源自活的有机体或细胞。生物製剂以其高特异性和有效性而闻名。它们可以被设计为针对疾病所涉及的精确分子或途径，从而减少脱靶效应并增强治疗效果。用于癌症免疫治疗的单株抗体和其他生物製剂的开发和批准是这一趋势的主要驱动力。免疫检查点抑制剂、CAR-T 细胞疗法和标靶疗法彻底改变了癌症治疗。生物製剂在类风湿性关节炎、多发性硬化症和牛皮癣等自体免疫疾病的治疗中也发挥了关键作用。调节免疫反应的单株抗体在控制这些疾病方面发挥了重要作用。生物製剂用于开发疫苗和抗病毒疗法。 COVID-19 大流行凸显了生物学在应对全球健康危机中的重要性。生物製剂为个人化医疗方法提供了机会。它们可以根据个别患者的遗传或疾病特征进行定制，从而有可能改善治疗结果。生物相似药与原厂生物製剂相似但不相同，其出现加剧了竞争，并为患者提供了更实惠的选择。生物相似药有助于扩大生物治疗的可近性。

细分市场洞察

蛋白质功能见解

2022 年，全球蛋白质治疗市场最大份额由疫苗领域占据，预计未来几年将继续扩大。蛋白质治疗通常涉及使用蛋白质，例如单株抗体或重组蛋白质，以达到治疗目的。许多疫苗是使用蛋白质作为抗原製成的。这些抗原可以是源自目标病原体的蛋白质或蛋白质亚基。例如，一些 COVID-19 疫苗使用 SARS-CoV-2 病毒的刺突蛋白作为抗原来触发免疫反应。当注射疫苗时，免疫系统将外来抗原识别为潜在威胁并发起免疫反应。这涉及抗体的产生以及T细胞等免疫细胞的激活，这些细胞可以识别并消灭病原体。疫苗预防了无数传染病，降低了死亡率，甚至消除了一些疾病（例如天花），对全球公共卫生产生了深远影响。它们是对抗流行病和大流行病的重要工具。

产品类型见解

2022年，全球蛋白质治疗市场最大份额由单株抗体领域占据，预计未来几年将继续扩大。单株抗体在治疗多种疾病方面表现出显着的疗效，包括癌症、自体免疫疾病和传染病。它们高精度地针对特定抗原，降低了脱靶效应的风险。单株抗体用途广泛，可针对各种疾病相关蛋白质和受体进行设计。这种多功能性使其可用于广泛的医疗条件。与其他类型的蛋白质疗法相比，单株抗体具有更长的成功开发和临床使用记录。这段成功的历史让人们对它们的治疗潜力充满信心。免疫疗法，包括使用单株抗体，在癌症治疗中得到了重视。检查点抑制剂（例如 PD-1 和 CTLA-4 抑制剂）和 CAR-T 细胞疗法等药物（其中包含单株抗体）彻底改变了癌症治疗。单株抗体的生物相似药市场一直在快速成长。随着一些原创单株抗体的专利到期，生物相似药版本提供了更实惠的治疗选择，增加了患者的可及性。

区域洞察

到2022年，北美地区将主导全球蛋白质治疗市场。北美，特别是美国和加拿大，拥有高度发展的医疗基础设施。其中包括世界知名的研究机构、学术医疗中心以及促进蛋白质疗法创新和发展的强大製药业。北美拥有强大的研发生态系统，包括政府机构、私人研究组织和生技公司。来自公共和私人来源的资金支持生物技术和蛋白质疗法的前沿研究。许多世界上最大的製药和生物技术公司的总部都位于北美。这些公司拥有投资蛋白质疗法研究、开发和商业化的资源和专业知识。北美吸引了大量蛋白质疗法的临床试验。美国食品药物管理局 (FDA) 等监管机构为药物审批提供了明确的监管途径，使其成为临床研究的有吸引力的地区。

目录

第 1 章：产品概述

  • 市场定义
  • 市场范围
    • 涵盖的市场
    • 考虑学习的年份
    • 主要市场区隔

第 2 章：研究方法

  • 研究目的
  • 基线方法
  • 主要产业伙伴
  • 主要协会和二手资料来源
  • 预测方法
  • 数据三角测量与验证
  • 假设和限制

第 3 章：执行摘要

  • 市场概况
  • 主要市场细分概述
  • 主要市场参与者概述
  • 重点地区/国家概况
  • 市场驱动因素、挑战、趋势概述

第 4 章：客户之声

第 5 章：全球蛋白质治疗市场展望

  • 市场规模及预测
    • 按价值
  • 市占率及预测
    • 依蛋白质功能（酵素与调节、蛋白质诊断、疫苗）
    • 依产品类型（凝血因子、促红血球生成素、卵泡刺激素、G-CSF、胰岛素、干扰素、单株抗体）
    • 按公司划分 (2022)
  • 市场地图

第 6 章：亚太地区蛋白质治疗市场展望

  • 市场规模及预测
    • 按价值
  • 市占率及预测
    • 依蛋白质功能分类
    • 依产品类型
    • 按国家/地区
  • 亚太地区：国家分析
    • 中国蛋白疗法
    • 印度蛋白质疗法
    • 澳洲蛋白质治疗公司
    • 日本蛋白质治疗公司
    • 韩国蛋白质疗法

第 7 章：欧洲蛋白质治疗市场展望

  • 市场规模及预测
    • 按价值
  • 市占率及预测
    • 依蛋白质功能分类
    • 依产品类型
    • 按国家/地区
  • 欧洲：国家分析
    • 法国
    • 德国
    • 西班牙
    • 义大利
    • 英国

第 8 章：北美蛋白质治疗市场展望

  • 市场规模及预测
    • 按价值
  • 市占率及预测
    • 依蛋白质功能分类
    • 依产品类型
    • 按国家/地区
  • 北美：国家分析
    • 美国
    • 墨西哥
    • 加拿大

第 9 章：南美洲蛋白质治疗市场展望

  • 市场规模及预测
    • 按价值
  • 市占率及预测
    • 依蛋白质功能分类
    • 依产品类型
    • 按国家/地区
  • 南美洲：国家分析
    • 巴西
    • 阿根廷
    • 哥伦比亚

第 10 章：中东和非洲蛋白质治疗市场展望

  • 市场规模及预测
    • 按价值
  • 市占率及预测
    • 依蛋白质功能分类
    • 依产品类型
    • 按国家/地区
  • MEA：国家分析
    • 南非蛋白质治疗公司
    • 沙乌地阿拉伯蛋白质疗法
    • 阿联酋蛋白质疗法

第 11 章：市场动态

  • 司机
  • 挑战

第 12 章：市场趋势与发展

  • 最近的发展
  • 产品发布
  • 併购

第 13 章：全球蛋白质治疗市场：SWOT 分析

第 14 章：波特的五力分析

  • 产业竞争
  • 新进入者的潜力
  • 供应商的力量
  • 客户的力量
  • 替代产品的威胁

第 15 章：大环境分析

第16章：竞争格局

  • 安进公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 礼来公司。
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • F.霍夫曼-拉罗氏有限公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 强生服务公司
    • 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
  • 辉瑞公司
    • 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
  • 梯瓦製药工业股份有限公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 艾伯维公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 百时美施贵宝公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis

第 17 章：策略建议

第 18 章：关于我们与免责声明

简介目录
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