단일클론항체 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the monoclonal antibodies market size was valued at USD 286.65 billion in 2025 and estimated to grow from USD 323.89 billion in 2026 to reach USD 596.12 billion by 2031, at a CAGR of 12.99% during the forecast period (2026-2031).

This report Segments the Industry Into by Production Method (In Vivo, and in Vitro), Source (Human, Humanized, Chimeric, and Murine), Indication (Oncology, Autoimmune Diseases, and More), End User (Hospitals, Academic Research Institutes, and More), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Monoclonal Antibodies Market Trends and Insights

Rising Technological Advancements in Antibody-Engineering Platforms

High-throughput microfluidics and single-B-cell screening have condensed discovery cycles from months to weeks, enabling developers to locate rare, high-affinity clones with precision. Samsung Biologics' 2024 launch of the S-HiCon platform allows liquid formulations exceeding 200 mg/mL, resolving viscosity and stability barriers for subcutaneous delivery. Site-specific conjugation techniques now dominate antibody-drug conjugate (ADC) pipelines, cutting batch variability and smoothing regulatory reviews; 14 bispecific antibodies already hold global approvals as of 2024. These scalable, standardized toolkits shift negotiating leverage to CDMOs that can amortize platform investments over multiple programs, tilting competitive advantage toward large-scale manufacturers.

Escalating Global Cancer & Chronic-Disease Incidence

Projected 77% growth in worldwide cancer cases by 2050 and surging autoimmune diagnoses keep therapeutic demand robust. Checkpoint inhibitors illustrate convergence: mechanistic insights gained in oncology are migrating into autoimmune protocols, shrinking development timelines and enlarging patient pools. Monoclonal antibodies serve dual roles-as independent biologics and as precision payload carriers in ADCs-reinforcing their indispensability across disease clusters. Demographic aging in North America, Europe, and Asia-Pacific further raises prevalence, ensuring sustained therapy volumes.

High Therapy & Manufacturing Costs

Median launch prices for specialty biologics reached USD 300,000 per course in 2024, straining payer budgets. Cost-effectiveness studies indicate eculizumab requires a 93% discount to meet QALY thresholds, underscoring affordability gaps. Complex ADC containment, extensive QC protocols, and Protein A resin expenses sustain high cost bases despite single-use bioreactor adoption. Although rituximab biosimilars generated annual savings of USD 208,553 in Chile, uptake lags in the United States, muting price-compression benefits.

Other drivers and restraints analyzed in the detailed report include:

1. Expanding Government & VC Funding for mAb R&D
2. AI-Driven De-Novo Antibody Design Accelerates Discovery Cycles
3. Patent Expiries & Biosimilar Pricing Pressure

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

In Vitro systems controlled 54.68% of the monoclonal antibodies market in 2025 and are set to advance at a 13.95% CAGR through 2031. This segment's productivity edge underpins 2025 revenue dominance as Chinese hamster ovary cell lines push titers above 11.5 g/L, tripling fed-batch output. Continuous perfusion and multicolumn chromatography lower Protein A resin use by 40%, shaving raw-material costs while boosting recovery to 87%. The monoclonal antibodies market size for In Vitro platforms is forecast to widen in lockstep with CDMO capacity rollouts across South Korea and China.

Viral-vector or glycoengineered In Vivo methods now occupy niche applications requiring exotic post-translational patterns. As single-use benchtop systems proliferate, smaller biotech firms gain capital-light manufacturing access, reinforcing the monoclonal antibodies market's outsourcing narrative. CDMOs integrating continuous upstream and downstream flows can pivot capacity between standard IgG and complex ADC runs without extensive retrofits, a flexibility premium that attracts pipeline-heavy sponsors.

Human antibodies maintained 59.02% revenue share in 2025, yet humanized constructs are accelerating at an 18.02% CAGR on the strength of better immunogenicity profiles. Phage display, yeast display, and transgenic mouse platforms converge to produce quasi-germline sequences that evade anti-drug antibodies, critical for chronic dosing regimens. The monoclonal antibodies market share leadership remains with fully human assets, but the monoclonal antibodies market size attributable to humanized variants is projected to climb sharply alongside autoimmune pipeline expansions.

Computational epitope screening now flags immunogenic hot spots before IND filing, shortening iterative redesign cycles. Chimeric formats persist where speed outweighs tolerability, particularly in late-stage oncology trials. However, third-generation transgenic mice capable of producing diversified human heavy and light chains promise to close the gap, challenging humanized constructs for future mindshare.

Complete Report Scope:

• By Production Method
  • In Vitro
  • In Vivo
• By Source
  • Human
  • Humanized
  • Chimeric
  • Murine
• By Indication
  • Oncology
  • Autoimmune Diseases
  • Infectious Diseases
  • Inflammatory Diseases
  • Other Indications
• By End User
  • Hospitals
  • Academic Research Institutes
  • Specialty & Ambulatory Centers
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America controlled 40.62% of 2025 revenue, underpinned by dense innovation hubs, generous insurance coverage, and a supportive regulatory highway for expedited designations. The region's multi-year PHEMCE appropriation guarantees baseline demand for antibody countermeasures, while Canada's Health Emergency Readiness program adds domestic surge capacity. Yet exclusivity cliffs for Stelara and Prolia/Xgeva foreshadow intensifying biosimilar jockeying, prompting a pivot toward value-based contracts and real-world evidence requirements. Health-technology assessment scrutiny already influences formulary adoption, nudging manufacturers toward differential pricing.

Asia-Pacific is the fastest climber at a projected 13.11% CAGR. Capacity supremacy is decisive: Samsung Biologics will bring total volume to 784 kL by April 2025, and WuXi Biologics' USD 20.6 billion backlog testifies to global sponsor reliance. Policymakers in China, South Korea, and Singapore bundle tax incentives with expedited GMP clearances, luring pipeline assets from Western biotech firms. However, overdependence on regional factories presents geopolitical and logistics fragility, spurring conversations about dual-sourcing and near-shoring strategies in North America and Europe.

Europe remains an innovation heavyweight thanks to entrenched pharmaceutical clusters and sophisticated regulators. Biosimilar adoption rates outpace the United States, sharpening price competition but also validating pathway predictability. Subcutaneous delivery innovation resonates with the region's cost-containment ethos; Roche's Phesgo adoption data show 91% of surveyed patients preferring home administration, bolstering pay-for-performance schemes. Emerging markets in Latin America, the Middle East, and Africa contribute incremental volumes as national immunization and oncology programs mature, although reimbursement constraints cap near-term penetration.

1. Abbvie
2. Amgen
3. AstraZeneca
4. BeiGene Ltd.
5. Bristol-Myers Squibb
6. Eli Lilly and Company
7. Roche
8. GlaxoSmithKline
9. Johnson & Johnson
10. Merck
11. Novartis
12. Pfizer
13. Regeneron Pharmaceuticals
14. Sanofi
15. Seagen
16. Samsung Bioepis Co. Ltd.
17. Sinopharm Group Co. Ltd.
18. Thermo Fisher Scientific
19. Wuxi Biologics
20. Zai Lab Ltd.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Technological Advancements in Antibody-Engineering Platforms
  • 4.2.2 Escalating Global Cancer & Chronic-Disease Incidence
  • 4.2.3 Expanding Government & VC Funding for mAb R&D
  • 4.2.4 AI-Driven De-Novo Antibody Design Accelerates Discovery Cycles
  • 4.2.5 Demand For Highly Potent Single-Use ADC Bioreactors
  • 4.2.6 Pandemic-Preparedness Stockpiling Initiatives
• 4.3 Market Restraints
  • 4.3.1 High Therapy & Manufacturing Costs
  • 4.3.2 Patent Expiries & Biosimilar Pricing Pressure
  • 4.3.3 Biomanufacturing-Capacity Crunch Vs. Cell-&-Gene Therapies
  • 4.3.4 HTA Reimbursement Push-Back on Real-World Cost-Effectiveness
• 4.4 Regulatory Landscape
• 4.5 Porter's Five Forces Analysis
  • 4.5.1 Bargaining Power of Buyers/Consumers
  • 4.5.2 Bargaining Power of Suppliers
  • 4.5.3 Threat of New Entrants
  • 4.5.4 Threat of Substitute Products
  • 4.5.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value in USD)

• 5.1 By Production Method
  • 5.1.1 In Vitro
  • 5.1.2 In Vivo
• 5.2 By Source
  • 5.2.1 Human
  • 5.2.2 Humanized
  • 5.2.3 Chimeric
  • 5.2.4 Murine
• 5.3 By Indication
  • 5.3.1 Oncology
  • 5.3.2 Autoimmune Diseases
  • 5.3.3 Infectious Diseases
  • 5.3.4 Inflammatory Diseases
  • 5.3.5 Other Indications
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Academic Research Institutes
  • 5.4.3 Specialty & Ambulatory Centers
  • 5.4.4 Other End Users
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as Available, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 AbbVie Inc.
  • 6.3.2 Amgen Inc.
  • 6.3.3 AstraZeneca PLC
  • 6.3.4 BeiGene Ltd.
  • 6.3.5 Bristol Myers Squibb Co.
  • 6.3.6 Eli Lilly and Company
  • 6.3.7 F. Hoffmann-La Roche Ltd.
  • 6.3.8 GSK plc
  • 6.3.9 Johnson & Johnson (Janssen)
  • 6.3.10 Merck & Co., Inc.
  • 6.3.11 Novartis AG
  • 6.3.12 Pfizer Inc.
  • 6.3.13 Regeneron Pharmaceuticals Inc.
  • 6.3.14 Sanofi SA
  • 6.3.15 Seagen Inc.
  • 6.3.16 Samsung Bioepis Co. Ltd.
  • 6.3.17 Sinopharm Group Co. Ltd.
  • 6.3.18 Thermo Fisher Scientific Inc.
  • 6.3.19 WuXi Biologics
  • 6.3.20 Zai Lab Ltd.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment