全球蛋白質和胜肽類藥物治療市場成長機會：2030 年預測

跨治療領域的拓展將推動變革性成長，而新的劑型和更聰明的給藥方式將起到關鍵作用。

蛋白質和胜肽類藥物產業正經歷一場重大變革時期，其驅動力來自新一代生技藥品，例如多特異性抗體、抗體藥物複合體（ADC）和GLP-1療法。這些進步加劇了市場競爭，同時，重磅抗體專利到期加速了生物相似藥的上市，並促使現有企業採取生活方式管理策略。

新型單株抗體（mAbs）定義了針對自體免疫、感染疾病和心血管疾病的藥物開發趨勢，具有延長半衰期的融合蛋白、酵素替代療法創新、細胞激素工程等。緩釋性和患者友善製劑提高了成本效益、依從性和可及性，而基於平台的胜肽方法則專注於具有更高受體選擇性和持久性的多功能藥物。

蛋白質和胜肽類療法正逐漸成為精準標靶和生理有效的治療選擇，以應對日益成長的全球疾病負擔，尤其是在腫瘤、代謝和自體免疫疾病領域。其中，GLP-1 和多重促效劑胜肽類藥物在全球肥胖症流行的推動下經歷了快速成長。

市場動態，包括價格快速下降、生物類似藥的擴張以及治療偏好轉向 GLP-1 受體促效劑，導致自 2024 年以來，Humalog（Humalog）、來得時（Lantus）、巴沙格（Basaglar）和特雷西巴（Tresiba）等傳統胰島素的銷量下降。這些藥物現在不僅可以治療糖尿病，還可以治療肥胖、睡眠呼吸中止症和心血管風險。

這項研究服務涵蓋北美、歐洲、亞太、拉丁美洲以及中東和北非（MENA）地區，並提供蛋白質和胜肽治療市場未來六年（2025-2030年）的全球收入預測，涵蓋單株抗體、融合蛋白、GLP-1類似物、肽激素、凝血因子、細胞激素、細胞激素白細胞介素和治療性酵素等細分領域。該服務深入分析了區域市場趨勢、技術進步和臨床路徑，重點關注腫瘤學、內分泌學、感染疾病和免疫學領域的重磅藥物、生物相似藥和新興治療方法。

策略洞察重點在於市場進入、成長機會、合作模式以及創新熱點，例如口服胜肽遞送、靶向蛋白質分解和多功能生技藥品。

收入和預測

2024 年基準年預計營收為 4,227.1 億美元，2024-2030 年研究期間的複合年成長率為 9.1%。

三大策略挑戰對蛋白質和胜肽類治療產業的影響

地緣政治動盪

原因

隨著美國政府考慮對進口藥品課稅，製藥公司正在調整生產和供應鏈策略。 《生物安全法案》（BIOSECURE Act）一旦通過，將限制聯邦政府使用與外國敵對國家（尤其是中國）相關的生物技術產品。

地緣政治緊張局勢加劇，導致西方製藥公司尋求中國供應商的替代方案，例如Astra Zeneca和Amicus Therapeutics等公司已轉向印度、歐洲和美國的供應商。

弗羅斯特的觀點

某些糖蛋白、免疫球蛋白和單株抗體通常需要複雜的生產流程，且容易受到供應鏈中斷的影響。為了確保穩定的供應，相關人員在投資建造本地和區域性的生產工廠。

肽類激素和酵素的生產嚴重依賴從中國採購原料和耗材，因此供應商多元化對於降低地緣政治緊張局勢的風險至關重要。例如，葛蘭素史克（GSK）已在美國投入大量資金建設生產設施。

顛覆性技術

原因

人工智慧正在革新蛋白質和胜肽類藥物的發現和開發，加速藥物候選物的識別和最佳化。例如，Generate Biomedicines公司已與諾華製藥達成合作，一項價值可能超過10億美元的交易將利用其GenAI平台開發蛋白質療法。

遞送技術的進步提高了蛋白質和胜肽類藥物的生物有效性，從而提高了患者的依從性。

該行業也正在採用更環保的生產技術，以減少對環境的影響並提高效率。

弗羅斯特的觀點

模組化平台與人工智慧/機器學習的結合加速了抗體的發現、人源化和最佳化。例如，Esai 和 Absci 正在利用人工智慧設計具有特定可開發特性的抗體。

奈米顆粒和脂質體可提高胜肽的穩定性和標靶分佈，減少傳統給藥途徑帶來的副作用。

變革性的技術進步使得以需求主導的研究成為可能，從而提高了患者的舒適度和便利性。

旨在提高早期療效和應用現成胜肽療法的研究，很可能在改變治療定價模式方面發揮關鍵作用。

競爭加劇

原因

受快速的技術發展、生物相似藥參與企業以及老牌製藥公司和新興生物技術公司戰略舉措的推動，市場競爭異常激烈。 Keytruda、 Opdivo和Soliris等重磅抗體藥物的專利即將到期。

下一代設計，如多特異性抗體、抗體藥物複合體(ADC)、口服 GLP-1（例如輝瑞的 danugliplon、諾和諾德的 Ryvelsus）以及基於 GLP-1 的雙/三肽促效劑（GLP-1/葡萄糖依賴性促胰島素多肽[GIP]/升糖素受體 [GCGR]組合藥物），預計將進一步加劇競爭。

弗羅斯特的觀點

在應對生物相似藥帶來的挑戰的同時，各公司需要投資研發，以開發和區分自己的產品。

安進和山德士生物製品等公司正積極研發程序性細胞死亡蛋白 1 (PD-1) 和 IL-6 的生物相似藥。

推出延長半衰期 (EHL) 的皮下 (SC) 版本的第二代物質對於確保其新鮮度至關重要。

儘早與 FDA 接洽、即時生物標記和改進設計將加速進展。

分割

市場定義

• 本研究分析了2025年至2030年預測期內全球蛋白質和胜肽類生物製劑生物製藥，包括單株抗體（mAb）、融合蛋白、Glucagon-Like Peptide-1促效劑（GLP-1）類似物、胜肽激素、凝血因子、細胞激素、白細胞介素（IL）和治療性酵素。本研究不包括疫苗領域。
• 該研究全面深入分析了治療領域的動態、創新趨勢、競爭活動和相關人員策略，還包括 2025 年至 2030 年的成長預測和複合年成長率分析，以及按藥理類別分類的全球和區域處方藥銷售額。
• 市場進入和報銷趨勢，尤其關注高成本注射型生技藥品和GLP-1藥物，是本報告的重要補充內容。此外，報告還考察了生物製藥、數位生物技術、CDMO（合約研發受託製造廠商）、CRO（委外研發機構）、數位健康平台和人工智慧公司等利益相關者的生態系統和商業模式，重點關注合作研究、相關利益者許可和整合醫療經營模式。
• 該研究確定了幾個由未滿足的臨床需求、支付方模式和新的給藥技術驅動的策略性成長領域，包括將 GLP-1 擴展到預防和上游持續性注射劑、提高依從性的長效胜肽和經皮長效胜肽、生物相似藥的擴展以及數位和治療的融合。
• 對於生物製藥公司、科技生物公司、CDMO/CRO、人工智慧公司、數位健康平台、支付方和投資者而言，本研究提供了可操作的見解，並可作為策略藍圖，以應對將塑造未來十年蛋白質和胜肽類藥物的監管、准入和創新趨勢。

競爭環境

競爭對手數量

• 33家年銷售額超過10億美元的公司

競爭因素

• 治療費用、療效、技術、安全性、耐受性、治療方案、免疫毒性

主要終端用戶產業

• 醫療保健、製造業

主要競爭對手

• 羅氏、諾和諾德、禮來、強生、默克

前十家公司銷售額佔有率（2024 年）

• 70.5%

其他值得關注的競爭對手

• 艾伯維、安進、賽諾菲、百時美施貴寶、Astra Zeneca、武田製藥、輝瑞

流通結構

• 零售和直銷

值得關注的收購與合併

• 艾伯維收購Immunogen AG，諾華收購Anthos Therapeutics

主要競爭對手

大型生物製藥公司

• 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

新興生物製藥

• 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

簽約服務供應商

• 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

基於技術的解決方案

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

數位療法 (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

成長促進因素

• 肥胖和第二型糖尿病盛行率的不斷上升、代謝和減肥藥（GLP-1和肽激素）的爆炸性發展，以及GLP-1受體促效劑日益成長的重要性，正在重塑治療模式。諾和諾德的Wegovy和Ozempic已證實除血糖控制外，還具有心血管獲益，改變了肥胖治療的模式。這些藥物目前也正在研究用於其他適應症，包括阿茲海默症和非酒精性脂肪性肝炎（NASH）。製藥公司正在研究下一代腸泌素類似藥物，例如口服勝促效劑製劑以及雙重和三重促效劑，如禮來公司的tirzepatide和retatrutide。
• 對精準生技藥品的需求以及自體免疫疾病的日益增多，正推動著標靶治療的發展，例如基於胜肽的療法，這類療法能夠提供精準的免疫調節，例如安進和優時比（UCB）聯合開發的用於治療銀屑病和乾癬性關節炎的bimekizumab（IL-17A/F抑製劑）。不斷豐富的細胞激素調變器和T細胞標靶胜肽類藥物的研發，為組織特異性、免疫抑製作用較小的替代療法提供了可能。
• 美國FDA提案逐步取消單株抗體（mAb）的動物試驗，這將縮短研發週期並降低研發成本。採用與人體相關的創新方法（NAMs），例如晶片器官和基於人工智慧的模型，將提高試驗的可預測性和效率。此項變革也將解決倫理方面的擔憂，並鼓勵對更廣泛的mAb產品線進行創新和投資。 FDA計劃立即將此政策應用於新藥臨床試驗申請（IND），並在三到五年內逐步推廣。
• 研發人員正在克服蛋白質和胜肽類藥物的傳統局限性，例如口服生物生物有效性低、半衰期短和免疫抗原性等問題。 Rani Therapeutics 和 Enteris BioPharma 正在利用機器人膠囊技術開發口服生物製藥平台。長效注射劑和口服 GLP-1（例如諾和諾德的 Rybelsus）正在提高患者的依從性。合成生物學和胜肽工程技術正在協助開發出作用時間更長、穩定性更高、功能更全面的胜肽藥物。例如，基於長效 GLP-1 受體的治療方法在多肽代謝領域正日益受到關注。

成長抑制因素

• GLP-1受體促效劑，包括Semaglutide，用於治療第2型糖尿病和肥胖症。然而，由於膜滲透性差和消化分解，其口服生物有效性受到限制。例如，口服Semaglutide（Libels）使用吸收促進劑水楊酸鈉（SNAC）來提高吸收，但生物有效性仍低於1%。此外，該藥物對給藥有嚴格的要求——空腹服用，並儘量減少液體攝入，且需在餐前服用——這可能會影響患者的依從性。
• 設計和進行大規模胜肽疫苗臨床試驗極具挑戰性。針對腫瘤抗原的胜肽類癌症疫苗臨床試驗需要大規模招募患者並進行嚴格監測。招募足夠的受試者是一項挑戰。針對感染疾病（包括新冠肺炎）的胜肽類疫苗臨床試驗必須招募不同背景的患者群體。在整個試驗過程中保持資料的完整性至關重要，因為監管部門的核准取決於準確且一致的資料收集。
• 蛋白質和胜肽類療法的研發和生產成本高昂，限制了其可及性。複雜的生產流程和嚴格的監管要求推高了研發成本，而這些成本最終往往會轉嫁給消費者。這些成本可能會限制資源匱乏地區的患者獲得治療，並加劇全球健康不平等。例如，用於治療非小細胞肺癌和乳癌的抗體偶聯藥物（ADC）BNT 326/YL020的早期研究，由於高劑量下可能存在安全隱患，被美國食品藥物管理局（FDA）暫時中止。 BioNTech公司必須採取額外的風險緩解措施，這凸顯了ADC藥物所需的嚴格安全標準和監管審查。
• 蛋白質和胜肽類藥物對環境因素，尤其是溫度，高度敏感，需要嚴格的低溫運輸管理以維持其穩定性。雖然肽類疫苗通常較為穩定，但它們容易發生氧化。現代低溫運輸技術和低溫儲存技術為應對這些挑戰提供了有效的解決方案。

目錄

調查範圍

• 市場定義、範圍和細分
• 分割
• 定義

成長環境：蛋白質和胜肽類治療藥物市場的轉型

• 為什麼成長變得越來越難？
• The Strategic Imperative 8（TM）
• 三大策略挑戰對蛋白質和胜肽類治療產業的影響

蛋白質和胜肽類治療市場生態系統

• 主要亮點
• 藥物研發趨勢：蛋白質藥物
• 藥物研發趨勢：胜肽類藥物
• 推動市場成長的趨勢
• 生物相似藥的影響：近期生物相似藥的核准和上市
• 生物相似藥的影響：即將到期的主要專利到期
• 策略夥伴關係與聯盟
• 創投估值
• 競爭環境
• 主要競爭對手

蛋白質和胜肽類治療市場成長要素

• 成長指標
• 成長促進因素
• 成長抑制因素
• 調查方法與過程
• 預測考量
• 收入和預測
• 按技術分類的收入預測
• 按地區分類的收入預測
• 收入預測分析
• 市場准入和報銷趨勢：單株抗體
• 市場進入與報銷趨勢：GLP-1
• 定價趨勢和成本降低策略
• 整合式照護模式：GLP-1 肥胖治療方案
• 收益分成
• 收入佔有率分析

成長要素：蛋白質療法

• 成長指標
• 收入預測
• 按子技術分類的收入預測
• 按應用預測收入
• 按地區分類的收入預測
• 預測分析：單株抗體
• 預測分析：融合Fc蛋白
• 預測分析：凝血
• 預測分析：酶
• 預測分析：荷爾蒙
• 預測分析：生長因子、細胞激素及其他
• 預測分析：應用
• 預測分析：區域
• 預測分析：蛋白質療法

成長要素：胜肽類療法，全球

• 成長指標
• 收入預測
• 按子技術分類的收入預測
• 按應用預測收入
• 按地區分類的收入預測
• 預測分析：GLP 及其他
• 預測分析：應用
• 預測分析：區域
• 預測分析：胜肽類藥物

成長機會領域

• 成長機會 1：工程化特異性抗體
• 成長機會2：用於抗體發現的生成式人工智慧
• 成長機會3：將GLP-1上游開發應用於預防性METABOLIC INC.護理
• 成長機會 4：下一代 GLP-1 給藥系統

附錄與後續步驟

• 成長機會的益處和影響
• 下一步
• 附件清單
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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