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

According to Mordor Intelligence, the monoclonal antibody therapeutics market size is expected to increase from USD 287.13 billion in 2025 to USD 326.38 billion in 2026 and reach USD 619.38 billion by 2031, growing at a CAGR of 13.67% over 2026-2031.

This report is Segmented by Application (Oncology, Autoimmune Diseases, and More), Source (Human, and More), Production Platform (Mammalian Cell Culture, Microbial Expression, and More), End-User (Hospitals, Specialty Clinics, and More), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Monoclonal Antibody Therapeutics Market Trends and Insights

Rising Global Disease Burden of Cancer and Autoimmune Disorders

Cancer incidence grew to 20 million new cases in 2024, and autoimmune diagnoses now top 80 million worldwide. Eight novel oncology antibodies cleared the U.S. market in 2025, cementing multi-step sequencing that extends survival but raises per-patient costs. Standard regimens now rely on PD-1, PD-L1, and TNF-alpha blockade that outranks historical chemotherapy in efficacy and tolerability. Autoimmune care follows a similar arc as IL-23 inhibitors, with eight-week dosing to lift adherence among chronic patients. Given this macro backdrop, the monoclonal antibody therapeutics market continues to scale through volume expansion, even before price effects are factored in.

Expanding Geriatric Population Base

Individuals aged 65 and above will represent 22% of global citizens by 2030. Older cohorts carry a higher prevalence of cancers, immune disorders, and age-related ophthalmic conditions that rely on biologic modulation. Medicare spending on infused antibodies reached USD 48 billion in 2025, despite emerging price controls, showing double-digit growth. Convenience remains paramount; subcutaneous versions of legacy infusions achieved 35% penetration among osteoporosis patients aged 70+ within 18 months. The demographic swell safeguards demand for the monoclonal antibody therapeutics market even if unit prices face negotiated reductions.

High Treatment Costs and Reimbursement Challenges

Wholesale prices run from USD 80,000 to USD 250,000 per course, and Germany cut oncology antibody reference prices by 22% in 2025. The U.S. Inflation Reduction Act placed three antibodies into negotiation for 2026 rebates that can slice 40% off list, trimming manufacturer yield. Emerging economies apply even harsher caps which dilute multinational revenue but boost local access. To safeguard gross margin, firms lean on value-based contracts that refund payers if endpoints falter. Successful real-world datasets become crucial evidence as stakeholders scrutinize budget impact.

Other drivers and restraints analyzed in the detailed report include:

1. Accelerated Regulatory Approval Pathways for Biologics
2. Increasing Preference for Targeted Therapies Over Small Molecules
3. Complex Manufacturing and Supply Chain Requirements

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

Segment Analysis

Oncology accounted for 46.43% of 2025 revenue, yet infectious diseases are forecast to have the fastest 15.76% CAGR, driven by state stockpiles and pandemic insurance programs. The monoclonal antibody therapeutics market size for infectious applications is slated to swell as BARDA awards exceed USD 1.2 billion for pre-purchase of respiratory virus countermeasures. Government procurement secures volumes independent of insurer dynamics, giving newcomers a dependable launchpad.

Oncology still grows due to widening eligibility of checkpoint inhibition, but saturation in mature tumors tempers the pace. Autoimmune conditions add stable repeat dosing, while ophthalmology slows as extended-interval injectables limit vial turns. Neurology remains small today, yet gains mindshare with disease-modifying success in Alzheimer's. Each subfield illustrates the broadening canvas that propels the monoclonal antibody therapeutics market.

Humanized antibodies delivered 49.54% of 2025 sales and stay prominent due to low immunogenicity and known processes. Still, bispecific constructs, though only 8% today, book a rapid 15.89% CAGR. Their dual-target action bypasses resistance, and early launches already seize share in refractory hematologic lines. The monoclonal antibody therapeutics market share for bispecifics is set to widen as 62% of Phase I entrants now carry multi-specific geometry.

Chimeric products lose steam under biosimilar assault, while fully human antibodies defend blockbuster franchises like pembrolizumab. Murine assets fall to niche imaging use where single-dose exposure sidesteps immune buildup. The shift forces manufacturing innovation, since only fifteen global sites can assemble heterodimers at scale, giving incumbents a supply advantage.

Complete Report Scope:

• By Application
  • Oncology
  • Autoimmune Diseases
  • Hematological Diseases
  • Infectious Diseases
  • Ophthalmology
  • Neurology
  • Other Applications
• By Source
  • Human
  • Humanized
  • Chimeric
  • Murine
  • Bispecific / Multispecific
• By Production Platform
  • Mammalian Cell Culture (CHO, NS0, HEK-293)
  • Microbial Expression (E. Coli, Yeast)
  • Transgenic Animals & Plants
  • Cell-Free / Continuous Manufacturing
• By End-User
  • Hospitals
  • Specialty Clinics
  • Home-Care / Self-Administration
  • Research & Academic Institutes
• 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 commanded 42.76% of 2025 revenue, benefiting from Medicare co-insurance coverage and a dense trial network. Yet the Inflation Reduction Act introduces managed pricing from 2026, tightening net yields though not likely dampening volume. Canada negotiated 18% to 25% cuts that widened provincial access, and Mexico listed six oncology antibodies on its public formulary, albeit with lower per-capita utilization.

Asia-Pacific is the standout growth engine at 14.65% CAGR. China approved eleven novel antibodies in 2025 and pooled them into the national reimbursement list that covers 1.3 billion residents. India's low-cost CDMO build-out combines with export-friendly regulation, letting local firms capture value from biosimilar orders across emerging regions. South Korea's capacity surge rounds out a regional manufacturing corridor that underpins the monoclonal antibody therapeutics market.

Europe accounted for 28% of 2025 turnover. Health technology assessments in Germany, France, and the UK force manufacturers to meet strict cost-effectiveness thresholds, prompting 22% average price cuts on select oncology agents. Automatic substitution rules fast-track biosimilar share near 50% within a year of launch. Despite these headwinds, Western Europe remains central for early launches that cascade to global uptake once national payers conclude negotiations.

1. Abbvie
2. Amgen
3. AstraZeneca
4. BeiGene
5. Boehringer Ingelheim
6. Bristol-Myers Squibb
7. Daiichi Sankyo
8. Eli Lilly and Company
9. Roche
10. GlaxoSmithKline
11. Johnson & Johnson
12. Merck
13. Merck
14. Novartis
15. Pfizer
16. Regeneron
17. Samsung Bioepis
18. Sanofi
19. Seagen
20. UCB

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 Global Disease Burden of Cancer And Autoimmune Disorders
  • 4.2.2 Expanding Geriatric Population Base
  • 4.2.3 Accelerated Regulatory Approval Pathways for Biologics
  • 4.2.4 Increasing Preference for Targeted Therapies Over Small Molecules
  • 4.2.5 Advancements in Antibody Engineering and Delivery Technologies
  • 4.2.6 Growing Biologics Manufacturing Capacity in Emerging Markets
• 4.3 Market Restraints
  • 4.3.1 High Treatment Costs and Reimbursement Challenges
  • 4.3.2 Complex Manufacturing and Supply Chain Requirements
  • 4.3.3 Safety Concerns and Adverse Event Profiles
  • 4.3.4 Intensifying Biosimilar Competition Post-Patent Expiries
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat Of New Entrants
  • 4.7.2 Bargaining Power Of Buyers
  • 4.7.3 Bargaining Power Of Suppliers
  • 4.7.4 Threat Of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Application
  • 5.1.1 Oncology
  • 5.1.2 Autoimmune Diseases
  • 5.1.3 Hematological Diseases
  • 5.1.4 Infectious Diseases
  • 5.1.5 Ophthalmology
  • 5.1.6 Neurology
  • 5.1.7 Other Applications
• 5.2 By Source
  • 5.2.1 Human
  • 5.2.2 Humanized
  • 5.2.3 Chimeric
  • 5.2.4 Murine
  • 5.2.5 Bispecific / Multispecific
• 5.3 By Production Platform
  • 5.3.1 Mammalian Cell Culture (CHO, NS0, HEK-293)
  • 5.3.2 Microbial Expression (E. Coli, Yeast)
  • 5.3.3 Transgenic Animals & Plants
  • 5.3.4 Cell-Free / Continuous Manufacturing
• 5.4 By End-User
  • 5.4.1 Hospitals
  • 5.4.2 Specialty Clinics
  • 5.4.3 Home-Care / Self-Administration
  • 5.4.4 Research & Academic Institutes
• 5.5 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 for Key Companies, Products & Services, and Recent Developments)}
  • 6.3.1 Abbvie Inc
  • 6.3.2 Amgen Inc
  • 6.3.3 AstraZeneca
  • 6.3.4 BeiGene
  • 6.3.5 Boehringer Ingelheim
  • 6.3.6 Bristol Myers Squibb
  • 6.3.7 Daiichi Sankyo
  • 6.3.8 Eli Lilly
  • 6.3.9 F. Hoffmann-La Roche
  • 6.3.10 GSK
  • 6.3.11 Johnson & Johnson (Janssen)
  • 6.3.12 Merck & Co.
  • 6.3.13 Merck KGaA
  • 6.3.14 Novartis
  • 6.3.15 Pfizer
  • 6.3.16 Regeneron
  • 6.3.17 Samsung Bioepis
  • 6.3.18 Sanofi
  • 6.3.19 Seagen
  • 6.3.20 UCB S.A., Belgium (UCB Inc)

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment