세계의 단백질 및 펩티드 치료제 성장 기회 및 예측(-2030년)

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