全球蛋白质和胜肽类药物治疗市场成长机会：2030 年预测

跨治疗领域的拓展将推动变革性成长，而新的剂型和更聪明的给药方式将起到关键作用。

蛋白质和胜肽类药物产业正经历一场重大变革时期，其驱动力来自新一代生技药品，例如多特异性抗体、抗体药物复合体（ADC）和GLP-1疗法。这些进步加剧了市场竞争，同时，重磅抗体专利到期加速了生物相似药的上市，并促使现有企业采取生活方式管理策略。

新型单株抗体（mAbs）定义了针对自体免疫、感染疾病和心血管疾病的药物开发趋势，具有延长半衰期的融合蛋白、酵素替代疗法创新、细胞激素工程等。缓释性和患者友善製剂提高了成本效益、依从性和可及性，而基于平台的胜肽方法则专注于具有更高受体选择性和持久性的多功能药物。

蛋白质和胜肽类疗法正逐渐成为精准标靶和生理有效的治疗选择，以应对日益增长的全球疾病负担，尤其是在肿瘤、代谢和自体免疫疾病领域。其中，GLP-1 和多重促效剂胜肽类药物在全球肥胖症流行的推动下经历了快速增长。

市场动态，包括价格快速下降、生物类似药的扩张以及治疗偏好转向 GLP-1 受体促效剂，导致自 2024 年以来，Humalog（Humalog）、来得时（Lantus）、巴沙格（Basaglar）和特雷西巴（Tresiba）等传统胰岛素的销量下降。这些药物现在不仅可以治疗糖尿病，还可以治疗肥胖、睡眠呼吸中止症和心血管风险。

这项研究服务涵盖北美、欧洲、亚太、拉丁美洲以及中东和北非（MENA）地区，并提供蛋白质和胜肽治疗市场未来六年（2025-2030年）的全球收入预测，涵盖单株抗体、融合蛋白、GLP-1类似物、肽激素、凝血因子、细胞激素、细胞激素白细胞介素和治疗性酵素等细分领域。该服务深入分析了区域市场趋势、技术进步和临床路径，重点关注肿瘤学、内分泌学、感染疾病和免疫学领域的重磅药物、生物相似药和新兴治疗方法。

策略洞察重点在于市场进入、成长机会、合作模式以及创新热点，例如口服胜肽递送、靶向蛋白质降解和多功能生技药品。

收入和预测

2024 年基准年预计营收为 4,227.1 亿美元，2024-2030 年研究期间的复合年增长率为 9.1%。

三大策略挑战对蛋白质和胜肽类治疗产业的影响

地缘政治动盪

原因

随着美国政府考虑对进口药品课税，製药公司正在调整生产和供应链策略。 《生物安全法案》（BIOSECURE Act）一旦通过，将限制联邦政府使用与外国敌对国家（尤其是中国）相关的生物技术产品。

地缘政治紧张局势加剧，导致西方製药公司寻求中国供应商的替代方案，例如Astra Zeneca和Amicus Therapeutics等公司已转向印度、欧洲和美国的供应商。

弗罗斯特的观点

某些糖蛋白、免疫球蛋白和单株抗体通常需要复杂的生产工艺，且容易受到供应链中断的影响。为了确保稳定的供应，相关人员在投资建造本地和区域性的生产工厂。

肽类激素和酵素的生产严重依赖从中国采购原材料和耗材，因此供应商多元化对于降低地缘政治紧张局势的风险至关重要。例如，葛兰素史克（GSK）已在美国投入大量资金建设生产设施。

颠覆性技术

原因

人工智慧正在革新蛋白质和胜肽类药物的发现和开发，加速药物候选物的识别和优化。例如，Generate Biomedicines公司已与诺华製药达成合作，一项价值可能超过10亿美元的交易将利用其GenAI平台开发蛋白质疗法。

递送技术的进步提高了蛋白质和胜肽类药物的生物有效性，从而提高了患者的依从性。

该行业也正在采用更环保的生产技术，以减少对环境的影响并提高效率。

弗罗斯特的观点

模组化平台与人工智慧/机器学习的结合加速了抗体的发现、人源化和优化。例如，Esai 和 Absci 正在利用人工智慧设计具有特定可开发特性的抗体。

奈米颗粒和脂质体可提高胜肽的稳定性和标靶分布，减少传统给药途径带来的副作用。

变革性的技术进步使得以需求主导的研究成为可能，从而提高了患者的舒适度和便利性。

旨在提高早期疗效和应用现成胜肽疗法的研究，很可能在改变治疗定价模式方面发挥关键作用。

竞争加剧

原因

受快速的技术发展、生物相似药参与企业以及老牌製药公司和新兴生物技术公司战略倡议的推动，市场竞争异常激烈。 Keytruda、 Opdivo和Soliris等重磅抗体药物的专利即将到期。

下一代设计，如多特异性抗体、抗体药物复合体(ADC)、口服 GLP-1（例如辉瑞的 danugliplon、诺和诺德的 Ryvelsus）以及基于 GLP-1 的双/三肽促效剂（GLP-1/葡萄糖依赖性促胰岛素多肽[GIP]/升糖素受体 [GCGR]组合药物），预计将进一步加剧竞争。

弗罗斯特的观点

在应对生物相似药带来的挑战的同时，各公司需要投资研发，以开发和区分自己的产品。

安进和山德士生物製品等公司正积极研发程序性细胞死亡蛋白 1 (PD-1) 和 IL-6 的生物相似药。

推出延长半衰期 (EHL) 的皮下 (SC) 版本的第二代物质对于确保其新鲜度至关重要。

儘早与 FDA 接洽、即时生物标记和改进设计将加速进展。

分割

市场定义

• 本研究分析了2025年至2030年预测期内全球蛋白质和胜肽类生物製剂生物製药，包括单株抗体（mAb）、融合蛋白、Glucagon-Like Peptide-1促效剂（GLP-1）类似物、胜肽激素、凝血因子、细胞激素、白细胞介素（IL）和治疗性酵素。本研究不包括疫苗领域。
• 该研究全面深入分析了治疗领域的动态、创新趋势、竞争活动和相关人员策略，还包括 2025 年至 2030 年的成长预测和复合年增长率分析，以及按药理类别分類的全球和区域处方药销售额。
• 市场进入和报销趋势，尤其关注高成本注射型生技药品和GLP-1药物，是本报告的重要补充内容。此外，报告还考察了生物製药、数位生物技术、CDMO（合约研发受託製造厂商）、CRO（委外研发机构）、数位健康平台和人工智慧公司等利益相关者的生态系统和商业模式，重点关注合作研究、相关利益者许可和整合医疗经营模式。
• 该研究确定了几个由未满足的临床需求、支付方模式和新的给药技术驱动的策略性成长领域，包括将 GLP-1 扩展到预防和上游持续性注射剂、提高依从性的长效胜肽和经皮长效胜肽、生物相似药的扩展以及数位和治疗的融合。
• 对于生物製药公司、科技生物公司、CDMO/CRO、人工智慧公司、数位健康平台、支付方和投资者而言，本研究提供了可操作的见解，并可作为策略蓝图，以应对将塑造未来十年蛋白质和胜肽类药物的监管、准入和创新趋势。

竞争环境

竞争对手数量

• 33家年销售额超过10亿美元的公司

竞争因素

• 治疗费用、疗效、技术、安全性、耐受性、治疗方案、免疫毒性

主要终端用户产业

• 医疗保健、製造业

主要竞争对手

• 罗氏、诺和诺德、礼来、强生、默克

前十家公司销售额份额（2024 年）

• 70.5%

其他值得关注的竞争对手

• 艾伯维、安进、赛诺菲、百时美施贵宝、Astra Zeneca、武田製药、辉瑞

流通结构

• 零售和直销

值得关注的收购与合併

• 艾伯维收购Immunogen AG，诺华收购Anthos Therapeutics

主要竞争对手

大型生物製药公司

• Roche
• AbbVie
• Johnson & Johnson
• Amgen
• Sanofi
• Novo Nordisk
• AstraZeneca
• Pfizer
• Merck & Co.
• Bristol Myers Squibb
• Takeda
• Eli Lilly
• Regeneron
• Biogen
• UCB Pharma
• Csl Behring
• Onlylam
• BioMarin
• Gilead Sciences

新兴生物製药

• Kailera Therapeutics
• Metsera
• Cardurion Pharmaceuticals
• Alumis Inc.
• Aktis Oncology
• Pan Cancer T
• Beacon Therapeutics
• EvolutionaryScale
• Ottimo Pharma
• GRO Biosciences
• Quotient Therapeutics
• TG Therapeutics
• Arcturus Therapeutics
• Amicus Therapeutics
• Argo Biopharma
• Charm Therapeutics

签约服务供应商

• Lonza Group
• Bachem
• Polypeptide
• Thermo Fisher Scientific
• Catalent Pharma Solutions
• WuXi Biologics
• Samsung Biologics
• Fujifilm Diosynth Biotechnologies
• AGC Biologics
• Boehringer Ingelheim BioXcellence
• WuXi AppTec
• ICON plc
• IQVIA
• Paraxel International
• Syneos Health
• Labcorp Drug Development
• Precision for Medicine
• MedeAnalytics

基于技术的解决方案

• Tempus
• BostonGene
• Owkin
• Immunai
• CytoReason
• Onc.AI
• Exscientia
• PathAI
• Flatiron Health
• Certis Oncology Solutions
• AbSci
• Insilico Medicine
• Quiris-AI
• Menten AI
• AI Proteins
• AbCellera

数位疗法 (DTx)

• Voluntis
• Prosomat
• The C Signs
• Happify Health
• CureApp, Inc.
• Augmedix
• Omada Health Inc.
• GAIA AG
• C2I Genomics
• Health Catalyst
• Hinge Health
• NantHealth
• Biocept
• Noom
• One Drop
• Dario Health
• Biofutur

成长驱动因素

• 肥胖和第二型糖尿病盛行率的不断上升、代谢和减肥药（GLP-1和肽激素）的爆炸性发展，以及GLP-1受体促效剂日益增长的重要性，正在重塑治疗模式。诺和诺德的Wegovy和Ozempic已证实除血糖控制外，还具有心血管获益，改变了肥胖治疗的模式。这些药物目前也正在研究用于其他适应症，包括阿兹海默症和非酒精性脂肪性肝炎（NASH）。製药公司正在研究下一代肠泌素类似药物，例如口服胜促效剂製剂以及双重和三重促效剂，如礼来公司的tirzepatide和retatrutide。
• 对精准生技药品的需求以及自体免疫疾病的日益增多，正推动着标靶治疗的发展，例如基于胜肽的疗法，这类疗法能够提供精准的免疫调节，例如安进和优时比（UCB）联合开发的用于治疗银屑病和干癣性关节炎的bimekizumab（IL-17A/F抑製剂）。不断丰富的细胞激素调变器和T细胞标靶胜肽类药物的研发，为组织特异性、免疫抑製作用较小的替代疗法提供了可能。
• 美国FDA提案逐步取消单株抗体（mAb）的动物试验，这将缩短研发週期并降低研发成本。采用与人体相关的创新方法（NAMs），例如晶片器官和基于人工智慧的模型，将提高试验的可预测性和效率。此项变革也将解决伦理方面的担忧，并鼓励对更广泛的mAb产品线进行创新和投资。 FDA计划立即将此政策应用于新药临床试验申请（IND），并在三到五年内逐步推广。
• 研发人员正在克服蛋白质和胜肽类药物的传统局限性，例如口服生物生物有效性低、半衰期短和免疫抗原性等问题。 Rani Therapeutics 和 Enteris BioPharma 正在利用机器人胶囊技术开发口服生物製药平台。长效注射剂和口服 GLP-1（例如诺和诺德的 Rybelsus）正在提高患者的依从性。合成生物学和胜肽工程技术正在协助开发出作用时间更长、稳定性更高、功能更全面的胜肽药物。例如，基于长效 GLP-1 受体的治疗方法在多肽代谢领域正日益受到关注。

成长抑制因素

• GLP-1受体促效剂，包括Semaglutide，用于治疗第2型糖尿病和肥胖症。然而，由于膜渗透性差和消化降解，其口服生物有效性受到限制。例如，口服Semaglutide（Libels）使用吸收促进剂水杨酸钠（SNAC）来提高吸收，但生物有效性仍低于1%。此外，该药物对给药有严格的要求——空腹服用，并儘量减少液体摄入，且需在餐前服用——这可能会影响患者的依从性。
• 设计和进行大规模胜肽疫苗临床试验极具挑战性。针对肿瘤抗原的胜肽类癌症疫苗临床试验需要大规模招募患者并进行严格监测。招募足够的受试者是一项挑战。针对感染疾病（包括新冠肺炎）的胜肽类疫苗临床试验必须招募不同背景的患者群体。在整个试验过程中保持资料的完整性至关重要，因为监管部门的核准取决于准确且一致的资料收集。
• 蛋白质和胜肽类疗法的研发和生产成本高昂，限制了其可及性。复杂的生产流程和严格的监管要求推高了研发成本，而这些成本最终往往会转嫁给消费者。这些成本可能会限制资源匮乏地区的患者获得治疗，并加剧全球健康不平等。例如，用于治疗非小细胞肺癌和乳癌的抗体偶联药物（ADC）BNT 326/YL020的早期研究，由于高剂量下可能存在安全隐患，被美国食品药物管理局（FDA）暂时中止。 BioNTech公司必须采取额外的风险缓解措施，这凸显了ADC药物所需的严格安全标准和监管审查。
• 蛋白质和胜肽类药物对环境因素，尤其是温度，高度敏感，需要严格的低温运输管理以维持其稳定性。虽然肽类疫苗通常较为稳定，但它们容易发生氧化。现代低温运输技术和低温储存技术为应对这些挑战提供了有效的解决方案。

目录

调查范围

• 市场定义、范围和细分
• 分割
• 定义

成长环境：蛋白质和胜肽类治疗药物市场的转型

• 为什么成长变得越来越难？
• The Strategic Imperative 8（TM）
• 三大策略挑战对蛋白质和胜肽类治疗产业的影响

蛋白质和胜肽类治疗市场生态系统

• 主要亮点
• 药物研发趋势：蛋白质药物
• 药物研发趋势：胜肽类药物
• 推动市场成长的趋势
• 生物相似药的影响：近期生物相似药的核准和上市
• 生物相似药的影响：即将到期的主要专利到期
• 策略伙伴关係与联盟
• 创投估值
• 竞争环境
• 主要竞争对手

蛋白质和胜肽类治疗市场成长要素

• 成长指标
• 成长驱动因素
• 成长抑制因素
• 调查方法与过程
• 预测考量
• 收入和预测
• 按技术分類的收入预测
• 按地区分類的收入预测
• 收入预测分析
• 市场准入和报销趋势：单株抗体
• 市场进入与报销趋势：GLP-1
• 定价趋势和成本降低策略
• 整合式照护模式：GLP-1 肥胖治疗方案
• 收益分成
• 收入份额分析

成长要素：蛋白质疗法

• 成长指标
• 收入预测
• 按子技术分類的收入预测
• 按应用预测收入
• 按地区分類的收入预测
• 预测分析：单株抗体
• 预测分析：融合Fc蛋白
• 预测分析：凝血
• 预测分析：酶
• 预测分析：荷尔蒙
• 预测分析：生长因子、细胞激素及其他
• 预测分析：应用
• 预测分析：区域
• 预测分析：蛋白质疗法

成长要素：胜肽类疗法，全球

• 成长指标
• 收入预测
• 按子技术分類的收入预测
• 按应用预测收入
• 按地区分類的收入预测
• 预测分析：GLP 及其他
• 预测分析：应用
• 预测分析：区域
• 预测分析：胜肽类药物

成长机会领域

• 成长机会 1：工程化特异性抗体
• 成长机会2：用于抗体发现的生成式人工智慧
• 成长机会3：将GLP-1上游开发应用于预防性METABOLIC INC.护理
• 成长机会 4：下一代 GLP-1 给药系统

附录与后续步骤

• 成长机会的益处和影响
• 下一步
• 附件清单
• 免责声明

Cross-Therapeutic Expansion is Driving Transformational Growth Fueled by Novel Formats and Smarter Delivery

The protein and peptide therapeutics industry is undergoing a profound transformation, driven by next-generation biologics, including multi-specific antibodies, antibody-drug conjugates (ADCs), and GLP-1 treatments. These advances are intensifying competition, while the patent expiries of blockbuster antibodies are accelerating the entry of biosimilars and prompting lifestyle management strategies by incumbents.

New monoclonal antibodies (mAbs) define drug development trends, targeting autoimmune, infectious, and cardiovascular disorders; fusion proteins with extended half-lives; innovations in enzyme replacement therapies; and cytokine engineering. Extended-release and patient-friendly formulations are improving cost efficiency, adherence, and access, while platform-based peptide methods emphasize multifunctional medicines with higher receptor selectivity and durability.

Protein and peptide therapies are becoming central to precision-targeted, physiologically potent treatment options as the global disease burden rises-particularly in oncology, metabolic disorders, and autoimmune conditions. Among the fastest-growing classes are GLP-1s and multi-agonist peptides, propelled by the global obesity epidemic.

Market dynamics-including steep price cuts, biosimilar expansion, and shifting treatment preferences toward GLP-1 receptor agonists-are driving a sales decline in traditional insulin products such as NovoRapid (NovoLog), Humalog, Lantus, Basaglar, and Tresiba beyond 2024. These drugs now treat not only diabetes but also obesity, sleep apnea, and cardiovascular risk.

This research service covers North America, Europe, Asia-Pacific, Latin America, and the Middle East & North Africa (MENA), providing a 6-year global revenue forecast (2025-2030) for the protein and peptide therapeutics market across segments including mAbs, fusion proteins, GLP-1 analogs, peptide hormones, coagulation factors, cytokines, interleukins, and therapeutic enzymes. It offers detailed insights into regional market trends, technological advancements, and clinical pathways, with emphasis on blockbuster drugs, biosimilars, and emerging modalities across oncology, endocrinology, infectious diseases, and immunology.

Strategic insights highlight market access, growth opportunities, collaboration models, and innovation hotspots such as oral peptide delivery, targeted protein degradation, and multifunctional biologics.

Revenue Forecast

The revenue estimate for the base year 2024 is $422.71 billion, with a CAGR of 9.1% for the study period from 2024 to 2030.

The Impact of the Top 3 Strategic Imperatives on the Protein and Peptide Therapeutics Industry

Geopolitical Chaos

Why

Pharmaceutical firms are altering their production and supply chain policies as the US government considers taxing pharmaceutical imports. If passed, the BIOSECURE Act will restrict federal use of biotech products tied to foreign adversaries, particularly China.

Rising geopolitical tensions are driving Western pharmaceutical firms to replace Chinese suppliers. For example, AstraZeneca and Amicus Therapeutics are shifting to suppliers in India, Europe, and the United States.

Frost Perspective

Certain glycoproteins, immunoglobulins, and mAbs often require complex production procedures and face supply chain interruptions. To ensure steady supply, stakeholders are investing in local and regional manufacturing plants.

Manufacturing peptide-derived hormones and enzymes largely depends on raw ingredients and materials sourced from China, making supplier diversification critical to reduce risks from geopolitical tensions. For instance, GSK is investing heavily in domestic manufacturing within the United States.

Disruptive Technologies

Why

AI is revolutionizing the discovery and development of protein and peptide medicines by accelerating drug candidate identification and optimization. For example, Generate Biomedicines partnered with Novartis in a deal potentially worth over $1 billion to develop protein therapeutics using its GenAI platform.

Advances in delivery technologies are improving the bioavailability of protein and peptide therapies and boosting patient compliance.

The sector is also adopting greener manufacturing techniques to reduce environmental impact and increase efficiency.

Frost Perspective

Combining modular platforms with AI/ML accelerates antibody discovery, humanization, and optimization. For example, Esai and Absci use AI to design antibodies with specific developability characteristics.

Nanoparticles and liposomes improve peptide stability and targeted distribution, reducing adverse effects associated with traditional routes.

Advances in transformational technologies enable need-driven research that enhances patient comfort and convenience.

Research on improving early-stage effectiveness and administrating readily available peptide therapies will play a crucial role in transforming therapy pricing models.

Competitive Intensity

Why

The market shows intense competition, fueled by rapid technology developments, a surge in biosimilar entrants, and strategic moves by both established pharmaceutical corporations and emerging biotech firms. Major blockbuster antibodies such as Keytruda, Opdivo, and Soliris are nearing patent cliffs.

Next-generation designs-including multispecifics, antibody-drug conjugates (ADCs), oral GLP-1s (e.g., Pfizer's danuglipron, Novo's Rybelsus), and GLP-1-based dual/tripeptide agonists (GLP-1/glucose-dependent insulinotropic polypeptide [GIP]/glucagon receptor [GCGR] combinations)-will intensify competition further.

Frost Perspective

While addressing the challenges posed by biosimilars, companies must invest in R&D to develop and differentiate their products.

Firms such as Amgen and Sandoz Biologics are actively pursuing programmed cell death protein 1 (PD-1) and IL-6 biosimilars.

Launching extended half-life (EHL), subcutaneous (SC) versions of second-generation substances is critical to secure freshness.

Early FDA engagement, real-time biomarkers, and enhanced design will accelerate progress.

Segmentation

Market Definition

• This research analyzes the global protein and peptide therapeutics market for the forecast period of 2025-2030, covering biologic modalities such as monoclonal antibodies (mAbs), fusion proteins, glucagon-like peptide-1 agonists (GLP-1) analogs, peptide hormones, coagulation factors, cytokines, interleukins (Il's), and therapeutic enzymes. The study excludes the vaccines segment.
• The study delivers comprehensive insights on therapeutic area dynamics, innovation trends, competitive activities, and stakeholder strategies. It also presents growth forecasts and CAGR analysis for 2025-2030, along with worldwide and regional prescription medication sales by pharmacological class.
• Important additions include trends in market access and reimbursement, with special focus on expensive injectables for biologics and GLP-1s. The research also covers stakeholder ecosystems and business models that emphasize collaborations, platform licensing, and integrated care models, spanning biopharma, digital biotech, contract development and manufacturing organizations (CDMOs), contract research organizations (CROs), digital health platforms, and AI companies.
• Drawing on unmet clinical needs, payer models, and new delivery technologies, the study identifies several strategic growth areas: GLP-1 expansion into preventive and upstream care, depot and transdermal long-acting peptides for better adherence, biosimilar expansion, and digital-therapeutic convergence.
• For biopharma, techbio, CDMOs/CROs, AI companies, digital health platforms, payers, and investors, this study provides practical insights. It serves as a strategic roadmap to navigate regulatory, access, and innovation trends shaping the next decade of protein and peptide medicines.

Competitive Environment

Number of Competitors

• 33 with revenue greater than $1 billion

Competitive Factors

• Cost, efficacy, technology, safety, resistance, line of treatment, immuno-toxicity

Key End-User Industry Verticals

• Healthcare and manufacturing

Leading Competitors

• Roche, Novo Nordisk, Eli Lilly, Johnson & Johnson, Merck & Co.

Revenue Share of Top 10 Competitors (2024)

• 70.5%

Other Notable Competitors

• AbbVie, Amgen, Sanofi, Bristol Myers Squibb, AstraZeneca, Takeda, Pfizer

Distribution Structure

• Retail sales and direct sales

Notable Acquisitions and Mergers

• AbbVie acquiring Immunogen AG; Novartis acquiring Anthos Therapeutics

Key Competitors

Big Biopharma

• Roche
• AbbVie
• Johnson & Johnson
• Amgen
• Sanofi
• Novo Nordisk
• AstraZeneca
• Pfizer
• Merck & Co.
• Bristol Myers Squibb
• Takeda
• Eli Lilly
• Regeneron
• Biogen
• UCB Pharma
• Csl Behring
• Onlylam
• BioMarin
• Gilead Sciences

Emerging Biopharma

• Kailera Therapeutics
• Metsera
• Cardurion Pharmaceuticals
• Alumis Inc.
• Aktis Oncology
• Pan Cancer T
• Beacon Therapeutics
• EvolutionaryScale
• Ottimo Pharma
• GRO Biosciences
• Quotient Therapeutics
• TG Therapeutics
• Arcturus Therapeutics
• Amicus Therapeutics
• Argo Biopharma
• Charm Therapeutics

Contract Service Provider

• Lonza Group
• Bachem
• Polypeptide
• Thermo Fisher Scientific
• Catalent Pharma Solutions
• WuXi Biologics
• Samsung Biologics
• Fujifilm Diosynth Biotechnologies
• AGC Biologics
• Boehringer Ingelheim BioXcellence
• WuXi AppTec
• ICON plc
• IQVIA
• Paraxel International
• Syneos Health
• Labcorp Drug Development
• Precision for Medicine
• MedeAnalytics

Tech-Based solutions

• Tempus
• BostonGene
• Owkin
• Immunai
• CytoReason
• Onc.AI
• Exscientia
• PathAI
• Flatiron Health
• Certis Oncology Solutions
• AbSci
• Insilico Medicine
• Quiris-AI
• Menten AI
• AI Proteins
• AbCellera

Digital Therapeutics (DTx)

• Voluntis
• Prosomat
• The C Signs
• Happify Health
• CureApp, Inc.
• Augmedix
• Omada Health Inc.
• GAIA AG
• C2I Genomics
• Health Catalyst
• Hinge Health
• NantHealth
• Biocept
• Noom
• One Drop
• Dario Health
• Biofutur

Growth Drivers

• Rising obesity and type 2 diabetes incidence, explosive development in metabolic and obesity treatments (GLP-1 and peptide hormones), and growing importance of GLP-1 receptor agonists are reshaping the therapeutic landscape. Novo Nordisk's Wegovy and Ozempic, which demonstrate CV effects beyond glycemic control, have changed the paradigm for treating obesity. These medications are under investigation for other indications, including Alzheimer's disease and non-alcoholic steatohepatitis (NASH). Pharma companies are exploring oral peptide delivery and next-generation incretin mimics, such as dual and triple agonists like Eli Lilly's tirzepatide and retatrutide.
• Demand for precision biologics and the growing incidence of autoimmune disorders are driving targeted therapies. Peptide-based treatments offering focused immune regulation-such as Amgen and UCB's bimekizumab (IL-17A/F inhibitor) for psoriasis and psoriatic arthritis-are examples. A growing pipeline of cytokine modulators and T-cell-targeting peptides enables tissue-specific, less immunosuppressive therapy alternatives.
• The US FDA's proposal to phase out required animal testing for mAbs will likely hasten development timelines and reduce R&D costs. Adoption of human-relevant new approach methodologies (NAMs), including organ-on-chip and AI-based models, will boost trial predictability and efficiency. This change also addresses ethical concerns, promoting broader mAb pipeline innovation and investment. The FDA plans to apply this policy immediately to IND submissions and gradually roll it out over 3 to 5 years, beginning with mAbs and progressing to other biologics and small molecules.
• Developers are overcoming conventional limits of protein and peptide therapeutics, such as low oral bioavailability, short half-life, and immunogenicity. Rani Therapeutics and Enteris BioPharma are developing oral biologic platforms using robotic pill capsules. Long-acting injectable formulations and oral GLP-1s-such as Novo Nordisk's Rybelsus-are improving patient adherence. Synthetic biology and peptide engineering now enable longer-acting, more stable, multifunctional peptides. For example, long-acting peptide glp-1 receptor-based therapy is gaining traction in metabolism in polypeptide arena.

Growth Restraints

• Semaglutide and other GLP-1 receptor agonists treat type 2 diabetes and obesity. However, weak membrane permeability and gastrointestinal degradation limit their oral bioavailability. For example, oral semaglutide (Rybelsus) uses SNAC salcaprozate sodium (SNAC), an absorption enhancer, to improve uptake; nonetheless, its bioavailability remains below 1%. Moreover, the medication requires strict administration conditions-taking it on an empty stomach with minimal water and waiting before eating-which can affect patient compliance.
• Designing and executing large-scale clinical studies for peptide vaccines can be challenging. Clinical trials targeting tumor antigens for peptide cancer vaccines require large patient enrollment and careful monitoring. Recruiting sufficient participants can be difficult. Trials for peptide vaccines against infectious diseases, including COVID-19, must enroll diverse patient populations. Maintaining data integrity throughout the trial is essential, as regulatory approval depends on accurate and consistent data collection.
• The high cost of developing and producing protein and peptide therapies can limit their availability. Complicated production processes and strict regulatory requirements drive development costs, which often pass on to consumers. These costs may restrict access in resource-limited regions, exacerbating global health inequities. For example, the FDA temporarily halted BioNTech's early-stage research of BNT 326/YL020, an ADC for non-small cell lung and breast cancer, due to potential safety concerns at higher doses. BioNTech had to implement additional risk mitigation measures, highlighting the stringent safety standards and regulatory oversight for ADCs.
• Protein and peptide therapies are highly sensitive to environmental factors, especially temperature, requiring careful cold-chain management to maintain stability. mAbs and GLP-1 treatments face risks of degradation and aggregation from improper storage. Peptide-based vaccines, while generally more stable, can still undergo oxidation. Modern cold-chain technologies and cryogenic storage provide effective solutions to these challenges.

Table of Contents

Research Scope

• Market Definition, Scope, and Segmentation
• Segmentation
• Definitions

Growth Environment: Transformation in the Protein and Peptide Therapeutics Market

• Why is it Increasingly Difficult to Grow?
• The Strategic Imperative 8™
• The Impact of the Top 3 Strategic Imperatives on the Protein and Peptide Therapeutics Industry

Ecosystem in Protein and Peptide Therapeutics Market

• Key Highlights
• Drug Development Trends-Protein Drugs
• Drug Development Trends-Peptide Drugs
• Trends Advancing Market Growth
• Impact of Biosimilars-Recent Biosimilar Approvals and Launches
• Impact of Biosimilars-Upcoming Major Patent Expirations
• Strategic Partnerships and Collaborations
• Venture Financing Assessment
• Competitive Environment
• Key Competitors

Growth Generator in the Protein and Peptides Therapeutics Market

• Growth Metrics
• Growth Drivers
• Growth Restraints
• Research Process and Methodology
• Forecast Considerations
• Revenue Forecast
• Revenue Forecast by Technology
• Revenue Forecast by Region
• Revenue Forecast Analysis
• Market Access and Reimbursement Trends-mAbs
• Market Access and Reimbursement Trends-GLP-1
• Pricing Trends and Cost Reduction Strategies
• Integrated Care Models-Bundled Obesity Program for GLP-1
• Revenue Share
• Revenue Share Analysis

Growth Generator: Protein Therapeutics

• Growth Metrics
• Revenue Forecast
• Revenue Forecast by Sub-technology
• Revenue Forecast by Application
• Revenue Forecast by Region
• Forecast Analysis-mAbs
• Forecast Analysis-Fusion Fc Proteins
• Forecast Analysis-Coagulation
• Forecast Analysis-Enzyme
• Forecast Analysis-Hormones
• Forecast Analysis-Growth Factors, Cytokines, and Others
• Forecast Analysis-Application
• Forecast Analysis-Region
• Forecast Analysis-Protein Therapeutics

Growth Generator: Peptide Therapeutics, Global

• Growth Metrics
• Revenue Forecast
• Revenue Forecast by Sub-technology
• Revenue Forecast by Application
• Revenue Forecast by Region
• Forecast Analysis-GLP and Others
• Forecast Analysis-Application
• Forecast Analysis-Region
• Forecast Analysis-Peptide Therapeutics

Growth Opportunity Universe

• Growth Opportunity 1: Engineered Multi-Specific Antibodies
• Growth Opportunity 2: Generative AI for Antibody Discovery
• Growth Opportunity 3: Advancing GLP-1s Upstream into Preventive Metabolic Care
• Growth Opportunity 4: Next-Generation GLP-1 Delivery Systems

Appendix & Next Steps

• Benefits and Impacts of Growth Opportunities
• Next Steps
• List of Exhibits
• Legal Disclaimer