항체 요법 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the antibody therapy market size is projected to be USD 310.12 billion in 2025, USD 336.79 billion in 2026, and reach USD 605.53 billion by 2031, growing at a CAGR of 12.45% from 2026 to 2031.

This report is Segmented by Product Type (Monoclonal Antibodies, Bispecific Antibodies, and More), Disease Area (Oncology, Autoimmune & Inflammatory Disorders, and More), Route of Administration (Intravenous, Subcutaneous, Intramuscular, Intravitreal, and More), End-User (Hospitals, Specialty Clinics, Homecare/Self-administration), and Geography. The Market Forecasts are Provided in Terms of Value (USD).

Global Antibody Therapy Market Trends and Insights

Checkpoint Inhibitors And Oncology Label Expansions Accelerate Patient Pools

Regulatory momentum is widening checkpoint inhibitor reach, including perioperative use in muscle-invasive bladder cancer, where PADCEV plus pembrolizumab secured FDA Priority Review based on EV-304 results that reduced event-free survival risk and improved pathological complete response versus chemotherapy. Specialty players also opened new niches, such as cosibelimab-ipdl for metastatic cutaneous squamous cell carcinoma, which delivered durable responses and later received a label update based on longer-term outcomes. Autoimmune pathways are expanding as well, with guselkumab approvals that now span inflammatory bowel disease segments, further reinforcing chronic-use volumes for immune-modulating biologics.

These approvals increase per-asset revenue potential and strengthen oncology backbones across major tumor types, which keeps the antibody therapy market focused on both perioperative and metastatic settings. At the same time, payer and policy demands are pulling in more real-world evidence for oncology pricing and coverage decisions, which encourages manufacturers to plan for outcomes beyond traditional clinical endpoints.

Immunology IL-23/IL-4/IL-13 Class Growth Sustains Chronic-use Volumes

The immunology backbone is broadening with oral and subcutaneous options that improve access and adherence for chronic conditions. Icotrokinra became the first oral IL-23 inhibitor approved for plaque psoriasis in 2026, supporting clear or almost clear skin targets in pivotal studies and positioning oral peptides as alternatives to injectables in dermatology. Subcutaneous biologics continue to shift administration patterns as illustrated by Saphnelo's EU approval for self-administration with a pre-filled pen, which aligns with patient preferences for non-infusion formats in diseases such as lupus.

Adherence advantages in home settings are also well documented in immunoglobulin therapy, where subcutaneous regimens achieve very high adherence in real-world use, which indicates the broader behavioral pull toward convenient administration. Payers and HTA bodies are in turn benchmarking high-cost immunology biologics against more affordable comparators, which heightens both price discipline and evidence standards in the antibody therapy market.

High Therapy And Biomanufacturing Costs Constrain Access

Over the long term, cost structures continue to influence access as commercial-scale antibody production depends on high-titer mammalian cell culture and capital-heavy facilities. Process advances have reduced per-gram costs over time, but complex modalities like ADCs bring new development and CMC burdens that include high-potency payload controls and critical quality attributes such as drug-to-antibody ratio. Failures linked to conjugation and scale-up reinforce the need for early CMC risk mitigation and platform consistency for growing ADC pipelines.

Sponsors and CDMOs are also navigating lead times and competition for sterile fill-finish capacity as many brands target pre-filled syringes and autoinjectors to support subcutaneous use. Single-use systems can improve flexibility in selected steps, which helps reduce facility footprint and speed transfers, although consumables add meaningful operating costs at scale.

Other drivers and restraints analyzed in the detailed report include:

1. Subcutaneous And Long-Acting Formats Enable Home/Self-Administration
2. Biosimilar Monoclonal Antibodies Expand Access In Mature Categories
3. Patent Expiries And Biosimilar Price Erosion

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

Segment Analysis

Monoclonal antibodies commanded 64.23% of the antibody therapy market share in 2025 as checkpoint inhibitors and chronic immunology brands anchored use across large patient populations and treatment lines. Bispecific antibodies are the fastest-growing product class with a projected 16.84% CAGR over 2026-2031, supported by robust late-stage pipelines and strategic alliances that combine immune engagement with angiogenesis modulation and other tumor microenvironment targets.

Regeneron's linvoseltamab received accelerated approval in 2025 for relapsed or refractory multiple myeloma after at least four prior lines, which illustrates the potential for T-cell-engaging bispecifics to become hematology backbones under defined risk management programs. Antibody-drug conjugates also continue to expand in solid tumors and lymphomas as sponsors push payload and linker diversity and execute confirmatory programs. Platform partnerships and acquisitions underscore the pace of innovation and the intent to secure modality leadership ahead of patent expiries.

Manufacturing and CMC factors shape scale-up for newer modalities in the antibody therapy market as ADCs require specialized containment, reliable conjugation controls, and reproducible drug-to-antibody ratios at commercial scale. These requirements raise cost and complexity but are being met by process design, platform standardization, and investments in external capacity. Sponsors are balancing facility flexibility and cost when adopting single-use systems, which can shorten timelines yet add consumable costs as commercial volumes rise.

Meanwhile, innovation in next-generation ADC payloads and tumor-selective designs is expanding therapeutic windows and renewing interest in targets once thought to be saturated. As pipelines grow, portfolio rationalization and selective partnering remain central to sustaining capital efficiency across the antibody therapy industry.

The oncology segment accounted for a 48.62% share of the antibody therapy market size in 2025 as checkpoint inhibitors, ADCs, and emerging bispecifics expanded use across perioperative and relapsed settings. FDA Priority Review for PADCEV plus pembrolizumab in perioperative muscle-invasive bladder cancer highlights deepening use of antibodies outside metastatic-only settings based on strong EV-304 outcomes. Label progress in cutaneous squamous cell carcinoma with cosibelimab-ipdl and the conversion of bispecific programs to broader hematology use reflect the breadth of oncology demand.

ADC programs also continued to advance in lymphomas, which supports targeted therapy backbones and second-line strategies. Respiratory is the fastest-growing disease area with a projected 16.09% CAGR from 2026 to 2031 on the strength of long-acting RSV monoclonal antibodies and supportive pediatric recommendations. Clesrovimab's clinical progress and ACIP guidance that endorses preventive use in infants broaden seasonal protection at a population level. Real-world experience in Europe shows large reductions in RSV hospitalizations during initial rollouts, which reinforces health-system value while prioritizing reliable supply and planning across seasons. Collectively, these dynamics support sustained growth for respiratory prevention and treatment in the antibody therapy market through 2031.

Geography Analysis

North America accounted for 42.44% of global revenue in 2025 as accelerated development paths, subcutaneous innovations, and steady biosimilar entry shaped uptake in oncology and immunology. Priority Review for PADCEV plus pembrolizumab in perioperative bladder cancer underscores the region's leadership in first-in-class and new-setting indications for antibody combinations. Regeneron's 2025 accelerated approval for linvoseltamab in advanced multiple myeloma further demonstrates the path for T cell engaging bispecifics in hematology-oncology. U.S. launches of interchangeable denosumab biosimilars in 2026 add competition in osteoporosis and oncology supportive care. In parallel, real-world evidence plays a larger role in policy and negotiation for oncology drugs, which influences pricing dynamics in the antibody therapy market. RSV prophylaxis policy also supports demand through clear recommendations for infant protection, which sustains seasonal planning.

Europe shows sustained progress in biosimilar adoption and access as more companies launch monoclonal biosimilars across member states and extend category depth. Commercial availability of ustekinumab biosimilar options and ongoing oncology collaborations with manufacturers such as Henlius point to continued competition in immune and cancer pathways. As more subcutaneous indications receive approval, European systems can reduce infusion burden and align with patient preferences, which supports decentralization of care. Real-world practice and policy in Europe also maintain a strong focus on value evidence to sustain coverage for high-cost biologics.

Asia-Pacific is the fastest-growing region at a projected 15.27% CAGR from 2026 to 2031, supported by local development, manufacturing partnerships, and cross-border licensing that broaden category availability. Partnerships such as Henlius and Dr. Reddy's for investigational daratumumab biosimilar coverage across many countries expand access pathways for oncology. Indian developers have also moved into the United States with denosumab biosimilars, which demonstrates APAC's rising role in global launches. Additional Asia-based programs in bispecific antibodies and ADCs highlight regional pipelines that complement multinational development, including NMPA-cleared studies that add to global evidence generation. ultinational alliances such as the BMS and BioNTech partnership for BNT327 include large pan-regional programs that touch APAC centers, which reinforces global reach for new modalities in the antibody therapy market.

1. Abbvie
2. Amgen
3. AstraZeneca
4. BeOne Medicines
5. Biogen
6. Bristol-Myers Squibb
7. Daiichi Sankyo
8. Roche
9. Genmab
10. GlaxoSmithKline
11. Innovent
12. Jiangsu Hengrui Pharmaceuticals Co., Ltd.
13. Johnson & Johnson
14. Eli Lilly and Company
15. Merck
16. Novartis
17. Pfizer
18. Regeneron Pharmaceuticals
19. Sanofi
20. Takeda Pharmaceuticals
21. 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 Checkpoint Inhibitors and Oncology Label Expansions Accelerate Patient Pools
  • 4.2.2 Immunology IL-23/IL-4/IL-13 Class Growth Sustains Chronic-use Volumes
  • 4.2.3 Subcutaneous And Long-Acting Formats Enable Home/Self-Administration
  • 4.2.4 Biosimilar Monoclonal Antibodies Expand Access in Mature Categories
  • 4.2.5 ADCs and Bispecifics Open High-Value Oncology Niches
  • 4.2.6 Long-Acting Antibodies for Infectious Disease Prevention
• 4.3 Market Restraints
  • 4.3.1 High Therapy and Biomanufacturing Costs Constrain Access
  • 4.3.2 Patent Expiries and Biosimilar Price Erosion
  • 4.3.3 Biologics/ADC Supply Chain and Capacity Bottlenecks
  • 4.3.4 HTA and Real-world Evidence Hurdles to Reimbursement
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porters Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product Type
  • 5.1.1 Monoclonal Antibodies (mAbs)
  • 5.1.2 Bispecific Antibodies
  • 5.1.3 Antibody-Drug Conjugates (ADCs)
  • 5.1.4 Polyclonal Antibodies
  • 5.1.5 Others (Antibody Fragments, Radiolabeled antibodies)
• 5.2 By Disease Area
  • 5.2.1 Oncology
  • 5.2.2 Autoimmune & Inflammatory Disorders
  • 5.2.3 Infectious Diseases
  • 5.2.4 Respiratory
  • 5.2.5 Hematology
  • 5.2.6 Cardiometabolic
  • 5.2.7 Others (Ophthalmology, Neurology)
• 5.3 By Route of Administration
  • 5.3.1 Intravenous (IV)
  • 5.3.2 Subcutaneous (SC)
  • 5.3.3 Intramuscular (IM)
  • 5.3.4 Intravitreal
• 5.4 By End-user
  • 5.4.1 Hospitals
  • 5.4.2 Specialty Clinics
  • 5.4.3 Homecare / Self-administration
• 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 India
    • 5.5.3.3 Japan
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and 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 BeOne Medicines
  • 6.3.5 Biogen
  • 6.3.6 Bristol-Myers Squibb Company
  • 6.3.7 DAIICHI SANKYO COMPANY, LIMITED
  • 6.3.8 F. Hoffmann-La Roche Ltd
  • 6.3.9 Genmab A/S
  • 6.3.10 GSK plc.
  • 6.3.11 Innovent
  • 6.3.12 Jiangsu Hengrui Pharmaceuticals Co., Ltd.
  • 6.3.13 Johnson & Johnson
  • 6.3.14 Lilly
  • 6.3.15 Merck & Co., Inc.
  • 6.3.16 Novartis AG
  • 6.3.17 Pfizer Inc.
  • 6.3.18 Regeneron Pharmaceuticals Inc.
  • 6.3.19 Sanofi
  • 6.3.20 Takeda Pharmaceutical Company Limited
  • 6.3.21 UCB S.A.

7 Market Opportunities & Future Outlook

• 7.1 White-space & unmet-need assessment