유럽의 이중특이성 및 다중특이성 항체 시장 - 분석 및 예측(2025-2035년)

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Introduction to Europe Bispecific and Multispecific Antibodies Market

The Europe bispecific and multispecific antibodies market is projected to reach $1,707.3 million by 2035 from $365.8 million in 2024, growing at a CAGR of 14.78% during the forecast period 2025-2035. In Europe, bispecific and multispecific antibodies are becoming increasingly popular as cutting-edge therapeutic approaches that target several biological targets at once. IgG-based and fragment-based bispecifics, as well as new multispecific structures that improve stability, therapeutic accuracy, and clinical performance, are advancing quickly in the area. These biologics facilitate mechanisms like immune checkpoint regulation, T-cell redirection, multi-pathway inhibition, and receptor agonism-providing potent remedies for complicated and treatment-resistant diseases. With increasing applications in autoimmune and inflammatory illnesses, oncology continues to be the most popular field of adoption in Europe. Protein engineering, modular antibody platforms, and AI-enabled discovery are driving the expansion of development pipelines by pharmaceutical businesses, biotech companies, and academic research institutions around the region. Europe is positioned as a major center for targeted biologics innovation thanks to favorable legislative frameworks, strategic partnerships, and increased investment activity. Therefore, bispecific and multispecific antibodies are defining the next phase of personalized healthcare and changing precision medicine in the area.

Market Introduction

The market for bispecific and multispecific antibodies in Europe is expanding at a rate never seen before, making it the fastest-growing global hub for this revolutionary therapeutic class. Despite North America's greater present market share, Europe is quickly solidifying its leadership in bispecific antibody invention, development, and commercialization.

Europe's dominance is a result of both strong regulatory backing from the European Medicines Agency (EMA) through rapid assessment and PRIME designation schemes, as well as top-notch research infrastructure centered in Germany, Switzerland, and the UK. While new applications in autoimmune disorders, ophthalmology, and infectious illnesses broaden therapeutic frontiers, the cancer category drives market growth, accounting for 46-68% of global development activities.

There are currently about 15 bispecific antibodies that have been approved by European regulators. The most popular ones are Hemlibra (emicizumab), which brings in more than €5.3 billion a year, and more recently approved drugs like Tecvayli (teclistamab) and Vabysmo (faricimab). Significant obstacles still exist, though, including complicated manufacturing procedures that call for specific chemistry, manufacturing, and controls (CMC) techniques, a small CDMO capacity, high development and production costs, and disjointed healthcare reimbursement systems among European member states.

Despite these challenges, Europe is positioned as a vital innovation engine propelling the substantial contribution to the global market thanks to its strategic investments in bispecific antibody manufacturing infrastructure, cooperative research networks, and supportive regulatory environment.

Market Segmentation:

Segmentation 1: By Region

• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Rest-of-Europe

Europe Bispecific and Multispecific Antibodies Market Trends, Drivers and Challenges-

Market Trends

• Fastest Regional Growth: Europe is the fastest-growing region for bispecific and multispecific antibodies, significantly outpacing other regions despite North America's larger current market share
• Accelerating Market Expansion: The European bispecific antibodies market is experiencing exponential growth,
• Oncology Dominance: The cancer segment commands 46.76-68% of the global market, with European researchers and pharmaceutical companies driving innovation in T-cell engagers, dual checkpoint inhibitors, and tumor-targeting bispecific platforms
• Expanding Therapeutic Indications: Beyond oncology, bispecific antibodies are increasingly developed for inflammatory and autoimmune disorders, infectious diseases, ocular conditions, and neurological diseases, with autoimmune disorders representing the fastest-growing segment at a notable CAGR
• 15+ Approved Therapeutics: As of 2024-2025, 15 bispecific antibodies have received regulatory approval, with European and North American markets driving commercialization. Notable approvals include Genentech's Columvi (glofitamab), Amgen's Imdelltra (tarlatamab), and others demonstrating clinical efficacy in hematological and solid malignancies
• Hospital Pharmacy Dominance: Hospital pharmacies command 42-49% market share in distribution, reflecting high demand within clinical settings, specialized handling requirements, and the complexity of bispecific administration protocols
• IgG-Based Format Leadership: IgG-based bispecific constructs dominate with 80% market share by molecular format, though fragment-based formats (BiTE, scFv) and T-cell engager platforms continue gaining adoption for specialized applications
• Strategic M&A Activity: Major acquisitions accelerating market consolidation: BioNTech acquired Biotheus (USD 800M+ November 2024), Merck acquired CN201 (USD 700M+ August 2024), reflecting strategic investments in expanding bispecific portfolios
• Collaborative Partnerships: Intensified collaborations between European biotech firms, CROs, and CDMOs (e.g., Biohaven-Merus partnership, WuXi-Candid Therapeutics deal) advancing development timelines and addressing manufacturing challenges

Market Drivers

• Rising Cancer Prevalence: Europe projected to record rising cancer burden with Spain registering 279,260 new cases (2023), driving urgent demand for innovative therapeutic solutions. WHO projects cancer cases to increase 77% globally by 2050, creating compelling market opportunities for bispecific antibodies
• Dual-Target Therapeutic Advantages: Bispecific antibodies enable simultaneous targeting of two distinct antigens or epitopes, providing synergistic effects, enhanced efficacy, reduced resistance development, and improved patient outcomes compared to monospecific antibodies or combination therapies
• Addressing Unmet Medical Needs: Particularly in treatment-refractory cancers, autoimmune disorders with complex pathologies, and chronic inflammatory diseases where single-target approaches prove inadequate. Bispecific antibodies offer innovative solutions to patients with limited treatment options
• Advanced Immune Modulation: T-cell engagers redirect cytotoxic immune cells to tumor sites, activating CD3 signaling, forming cytolytic synapses, and mounting antitumor responses-offering novel mechanisms superior to traditional checkpoint inhibitors alone
• Chronic Disease Burden: Europe's aging population and prevalence of chronic diseases (cancer, autoimmune disorders, inflammatory conditions, infectious diseases) create sustained demand for sophisticated immunotherapeutic solutions
• World-Class Research Infrastructure: Europe hosts leading academic institutions, medical research centers, and biotech hubs (Germany, UK, Switzerland) providing robust discovery and development capabilities, advancing bispecific antibody innovation
• Strong Regulatory Support: European Medicines Agency (EMA) provides clear regulatory pathways, publishes comprehensive guidelines for bispecific development (CMC, nonclinical, clinical programs), and actively collaborates with developers to facilitate approvals
• Healthcare System Commitment: Europe's advanced healthcare systems, strong reimbursement mechanisms, and government support for innovative medicines create market conditions favorable for rapid bispecific adoption and commercialization
• Personalized Medicine Momentum: Growing focus on tailored therapeutic approaches and precision medicine aligns with bispecific antibodies' ability to address individual disease heterogeneity and patient-specific treatment responses
• Combination Therapy Potential: Increasing clinical adoption of combination approaches leveraging bispecific antibodies alongside immunotherapies or conventional treatments for enhanced synergistic efficacy and improved patient responses

Market Challenges

• Complex Manufacturing Processes: IgG-like bispecific production requires correct pairing of heavy and light chains; random chain association creates up to 10 potential combinations, with only 1 being the desired product. Only 1-2 of remaining 9 combinations yield partially functional antibodies
• Chemistry, Manufacturing & Controls (CMC) Complexity: Stringent EMA regulatory requirements demand detailed CMC strategies covering raw material testing, process validation, facility qualification, equipment sterilization, environmental monitoring, bioburden control, viral safety, and comprehensive documentation
• Manufacturing Scale-Up Challenges: Advancing from preclinical to clinical to commercial production at scale presents significant obstacles. Third-party manufacturing concerns have led to FDA rejections (e.g., Regeneron's linvoseltamab complete response letter), reflecting production complexities
• High Development & Production Costs: Sophisticated bispecific antibody engineering, process optimization, clinical trials, and manufacturing infrastructure require substantial R&D investments. Production costs remain significantly higher than conventional monoclonal antibodies
• Limited Manufacturing Cacapcity: European CMOs (contract manufacturing organizations) face capacity constraints meeting surging demand. Few facilities possess expertise and specialized equipment for bispecific manufacturing at commercial scale
• Immunogenicity Concerns: Novel bispecific structures carry increased immunogenicity risk compared to conventional antibodies. Patients may develop anti-drug antibodies (ADAs) reducing efficacy or triggering adverse immune responses-requiring extensive preclinical and clinical assessment
• Product Variability & Consistency: Post-translational modifications (PTMs), including N- and C-terminal processing, glycosylation patterns, and disulfide bond formation, create batch-to-batch variability challenges. EMA requires rigorous characterization and consistency demonstrations across manufacturing lots
• Regulatory Complexity & Data Requirements: Bispecific developers must provide comprehensive regulatory submissions including preclinical data, clinical trial results, CMC information, risk management plans, and comparability studies-extending timelines and escalating costs
• Fragmented Technical Standards: Lack of uniform global standards for bispecific formats, characterization methodologies, and manufacturing controls creates regulatory uncertainty, requiring custom approaches for different markets and regulators
• Supply Chain Fragmentation: Raw material sourcing, specialized component procurement (bioreactors, purification systems, analytical equipment), and expertise concentration in limited geographic regions create supply vulnerabilities
• Limited Pooled Expertise: Relatively few European contract research organizations (CROs) and CDMOs possess deep bispecific antibody expertise, creating bottlenecks in discovery, preclinical development, manufacturing, and analytical support
• Patent Landscape Complexity: European Patent Office (EPO) examination standards for antibody inventions remain evolving. Challenges in securing broad patent scope for bispecific formats, particularly when combining known binding specificities, limit IP protection strategies
• Autoimmune Disease Development Complexity: Autoimmune and inflammatory disorders involve intricate multifactorial pathologies. Bispecific therapeutic targeting requires nuanced understanding of disease mechanisms and careful safety evaluation to avoid exacerbating immune dysregulation
• Immunotherapy Combination Safety: While combination therapies offer synergistic potential, co-administering bispecific antibodies with other immunotherapies increases risks of cytokine release syndrome (CRS), immune-related adverse events (irAEs), and dose-limiting toxicities requiring careful clinical management
• Market Access & Reimbursement: High prices reflecting development complexity and manufacturing costs create healthcare system affordability concerns. European payers increasingly demand health economic evidence, real-world outcomes data, and justified pricing relative to alternatives
• Limited Clinical Trial Infrastructure: Conducting bispecific antibody trials requires specialized expertise, experienced investigator networks, and patient populations. Some European regions face investigator shortages or limited trial infrastructure for complex immunotherapy studies
• Competitive Landscape Intensification: Increasing competition from North American biopharmaceutical giants and emerging Asian players requires European companies to innovate continuously and secure differentiated positioning to maintain market competitiveness
• Biosimilar Development Trajectory: While limited bispecific biosimilar experience currently exists, future biosimilar development will create additional CMC, analytical, and regulatory complexities, potentially impacting originator pricing and market dynamics

How can this report add value to an organization?

Product/Innovation Strategy: The report offers in-depth insights into the latest technological advancements in Bispecific and Multispecific Antibodies, enabling organizations to drive innovation and develop cutting-edge products tailored to market needs.

Growth/Marketing Strategy: By providing comprehensive market analysis and identifying key growth opportunities, the report equips organizations with the knowledge to craft targeted marketing strategies and expand their market presence effectively.

Competitive Strategy: The report includes a thorough competitive landscape analysis, helping organizations understand their competitors' strengths and weaknesses in Bispecific and Multispecific Antibodies and allowing them to strategize effectively to gain a competitive edge in the market.

Regulatory and Compliance Strategy: It provides updates on evolving regulatory frameworks, approvals, and industry guidelines specific to Bispecific and Multispecific Antibodies, ensuring organizations stay compliant and accelerate market entry for new Bispecific and Multispecific Antibodies

Investment and Business Expansion Strategy: By analyzing market trends, funding patterns, and partnership opportunities, the report assists organizations in making informed investment decisions and identifying potential M&A opportunities for business growth.

Table of Contents

Executive Summary

Scope and Definition

1 Europe Bispecific and Multispecific Antibodies Market: Industry Outlook

• 1.1 Market Overview
  • 1.1.1 Bispecific Vs. Multispecific Antibodies
  • 1.1.2 Evolution of Antibody Therapeutics
  • 1.1.3 Advantages and Challenges
  • 1.1.4 Technology Platforms
• 1.2 Market Trends
  • 1.2.1 Expanding Influence of Contract Research Organizations in Bispecific and Multispecific Antibody Development
  • 1.2.2 AI-Enabled Platforms Revolutionizing Bispecific and Multispecific Antibody Discovery
• 1.3 Regulatory Landscape / Compliance
  • 1.3.1 Europe
    • 1.3.1.1 Germany
    • 1.3.1.2 France
    • 1.3.1.3 Italy
• 1.4 Pricing Analysis
• 1.5 Implementation Strategies
  • 1.5.1 Snapshot of Approved Bispecific Drugs
  • 1.5.2 Pipeline Trends for Multispecific Antibodies
  • 1.5.3 Case Studies
• 1.6 Market Dynamics
  • 1.6.1 Market Drivers
    • 1.6.1.1 Accelerating Oncology and Immunology Indications through Advanced Antibody Platforms and Services
    • 1.6.1.2 Strategic Clinical Pipelines Driving Bispecific and Multispecific Market Expansion
  • 1.6.2 Market Challenges
    • 1.6.2.1 Structural and Functional Complexity in Antibody Engineering
    • 1.6.2.2 High Development and Platform Costs in Bispecific and Multispecific Antibodies
  • 1.6.3 Market Opportunities
    • 1.6.3.1 AI/ML-Powered in Silico Design and Optimization Workflows Boosting Bispecific and Multispecific Antibody Market

2 Bispecific and Multispecific Antibodies Market, by Region

• 2.1 Europe
  • 2.1.1 Regional Overview
  • 2.1.2 Driving Factors for Market Growth
  • 2.1.3 Factors Challenging the Market
  • 2.1.4 Market Sizing and Forecast
    • 2.1.4.1 Germany
      • 2.1.4.1.1 Country Overview
      • 2.1.4.1.2 Driving Factors for Market Growth
      • 2.1.4.1.3 Factors Challenging the Market
      • 2.1.4.1.4 Market Sizing and Forecast
    • 2.1.4.2 U.K.
      • 2.1.4.2.1 Country Overview
      • 2.1.4.2.2 Driving Factors for Market Growth
      • 2.1.4.2.3 Factors Challenging the Market
      • 2.1.4.2.4 Market Sizing and Forecast
    • 2.1.4.3 France
      • 2.1.4.3.1 Country Overview
      • 2.1.4.3.2 Driving Factors for Market Growth
      • 2.1.4.3.3 Factors Challenging the Market
      • 2.1.4.3.4 Market Sizing and Forecast
    • 2.1.4.4 Italy
      • 2.1.4.4.1 Country Overview
      • 2.1.4.4.2 Driving Factors for Market Growth
      • 2.1.4.4.3 Factors Challenging the Market
      • 2.1.4.4.4 Market Sizing and Forecast
    • 2.1.4.5 Spain
      • 2.1.4.5.1 Country Overview
      • 2.1.4.5.2 Driving Factors for Market Growth
      • 2.1.4.5.3 Factors Challenging the Market
      • 2.1.4.5.4 Market Sizing and Forecast
    • 2.1.4.6 Rest-of-Europe
      • 2.1.4.6.1 Country Overview
      • 2.1.4.6.2 Driving Factors for Market Growth
      • 2.1.4.6.3 Factors Challenging the Market
      • 2.1.4.6.4 Market Sizing and Forecast

3 Competitive Benchmarking and Company Profiles

• 3.1 Key Strategies and Developments
• 3.2 Company Profiles
  • 3.2.1 Absolute Antibody
    • 3.2.1.1 Overview
    • 3.2.1.2 Top Products/ Product Portfolio
    • 3.2.1.3 Target Customers
    • 3.2.1.4 Key Personnel
    • 3.2.1.5 Analyst View
  • 3.2.2 ProteoGenix
    • 3.2.2.1 Overview
    • 3.2.2.2 Top Products/ Product Portfolio
    • 3.2.2.3 Target Customers
    • 3.2.2.4 Key Personnel
    • 3.2.2.5 Analyst View

4 Research Methodology

• 4.1 Data Sources
  • 4.1.1 Primary Data Sources
  • 4.1.2 Secondary Data Sources
  • 4.1.3 Data Triangulation
• 4.2 Market Estimation and Forecast