바이오의약품 라이선싱 시장 예측(-2032년) : 딜 유형, 라이선싱 모델, 개발 단계, 모달리티, 용도, 최종 사용자, 지역별 세계 분석

According to Stratistics MRC, the Global Biopharmaceutical Licensing Market is accounted for $240.5 billion in 2025 and is expected to reach $2,599.6 billion by 2032 growing at a CAGR of 40.5% during the forecast period. Biopharmaceutical licensing is a formal agreement wherein intellectual property rights typically patents or proprietary technologies are granted by one party (licensor) to another (licensee) for development, manufacturing, or commercialization of biologic-based products. These arrangements enable companies to access innovative therapies, expand portfolios, and share risks and costs associated with R&D and regulatory approval. Licensing may be exclusive or non-exclusive, and often includes provisions for royalties, milestone payments, and co-development rights, fostering strategic collaboration across the biopharma value chain

Market Dynamics:

Driver:

Patent cliffs and pipeline replenishment

Licensing agreements especially out-licensing have become strategic tools to monetize underutilized assets and accelerate development timelines. Emerging biotech firms are increasingly sought after for their innovative platforms, offering novel therapeutic candidates that can fill gaps in large pharma portfolios. This dynamic is fostering a surge in deal activity, particularly in areas with unmet clinical needs. Moreover, the urgency to maintain competitive advantage is driving companies to explore early-stage licensing opportunities and collaborative R&D models.

Restraint:

Valuation and deal structure challenges

Determining fair market value for early-stage technologies is inherently complex, often involving speculative forecasts and limited clinical data. Negotiations are further complicated by royalty structures, milestone payments, and territorial rights, which can dilute perceived value. Smaller firms may lack the financial or legal expertise to navigate these intricacies, while larger players are cautious about overpaying for unproven assets. These hurdles can delay or derail promising partnerships, especially in competitive therapeutic areas.

Opportunity:

Focus on niche and high-value therapeutic areas

Licensing activity is increasingly concentrated in specialized domains such as rare diseases, oncology, and cell & gene therapies, where innovation is rapid and pricing power remains strong. These segments offer attractive returns due to limited competition and high unmet medical needs. Companies are targeting assets with orphan drug designation or breakthrough therapy status to capitalize on regulatory incentives and expedited approval pathways. This trend is reshaping portfolio strategies across the industry.

Threat:

Macroeconomic instability & lack of due diligence

Licensing negotiations are also vulnerable to inadequate due diligence, which can result in unforeseen liabilities, IP disputes, or clinical setbacks post-deal. As competition intensifies, some firms may rush into agreements without fully assessing regulatory risks, manufacturing scalability, or market access barriers. This can lead to costly renegotiations or failed partnerships. Ensuring robust technical, legal, and commercial evaluations is critical to mitigating these risks and sustaining long-term value creation.

Covid-19 Impact:

The pandemic reshaped licensing dynamics by accelerating interest in infectious disease platforms and digital therapeutics. While initial disruptions in clinical trials and regulatory reviews slowed deal flow, the urgency to develop COVID-related treatments and diagnostics led to a spike in licensing agreements, particularly for mRNA technologies and antiviral candidates. Remote collaboration tools and virtual due diligence processes became standard, streamlining cross-border transactions.

The out-licensing segment is expected to be the largest during the forecast period

The out-licensing segment is expected to account for the largest market share during the forecast period due to its strategic role in monetizing non-core assets and expanding market reach. It enables originator companies to leverage external expertise for clinical development and commercialization, especially in regions where they lack infrastructure. This model is particularly favored by biotech firms seeking upfront capital and risk-sharing arrangements fueling out-licensing activity, making it the preferred route for portfolio optimization and global expansion.

The cell & gene therapies (CGT) segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the cell & gene therapies (CGT) segment is predicted to witness the highest growth rate driven by breakthroughs in regenerative medicine, immuno-oncology, and personalized therapies. Licensing deals in this space are surging as companies seek access to proprietary vectors, manufacturing platforms, and delivery technologies. High clinical success rates and premium pricing potential make CGT assets highly attractive for licensing, despite their complex regulatory and production requirements.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share attributed to robust innovation ecosystem, favorable IP frameworks, and strong venture capital activity. The region hosts numerous biotech hubs, academic research centers, and regulatory agencies that facilitate deal-making. U.S.-based companies are particularly active in out-licensing and cross-border collaborations, leveraging their advanced R&D capabilities and global networks.

Region with highest CAGR:

Over the forecast period, the North America region is anticipated to exhibit the highest CAGR reflecting its dynamic pipeline and aggressive pursuit of novel therapies. The region's emphasis on precision medicine, digital health integration, and accelerated approval pathways is attracting global interest in licensing U.S.-originated assets. Strategic policy initiatives, such as tax incentives for R&D and streamlined regulatory processes, are further enhancing deal velocity.

Key players in the market

Some of the key players in Biopharmaceutical Licensing Market include Novartis, Pfizer, Roche, Johnson & Johnson, Merck & Co., AstraZeneca, Sanofi, GlaxoSmithKline (GSK), AbbVie, Bristol-Myers Squibb (BMS), Amgen, Eli Lilly & Company, Takeda Pharmaceutical Company, Gilead Sciences, Regeneron Pharmaceuticals, Biogen, Vertex Pharmaceuticals, Moderna, Bayer AG, and Incyte Corporation.

Key Developments:

In July 2025, AstraZeneca reported Priority Review & Breakthrough Therapy designation (US) for IMFINZI(R) in resectable early-stage gastric/gastroesophageal junction cancers. The company cited positive Phase 3 results and said the regulatory designations could accelerate patient access.

In July 2025, Novartis received approval for Coartem(R) Baby, the first malaria medicine formulated for newborns and very young infants. The company said this enables faster regulatory routes in African countries and expands access for the most vulnerable patients.

In June 2025, AbbVie announced a definitive agreement to acquire Capstan Therapeutics and later public filings/updates on the transaction. AbbVie said the deal adds an in-vivo tLNP CAR-T candidate and strengthens its immunology and cell-engineering capabilities.

Deal Types Covered:

• In-Licensing
• Out-Licensing
• Co-Development
• Joint Venture
• Manufacturing Licenses
• Other Deal Types

Licensing Models Covered:

• Exclusive License
• Field-Limited License
• Non-Exclusive License

Stage of Developments Covered:

• Discovery & Preclinical Stage
• Phase I
• Phase II
• Phase III
• Commercialization/Marketed Product Stage

Modalities Covered:

• Monoclonal Antibodies (mAbs) & Biologics
• Cell & Gene Therapies (CGT)
• mRNA & Nucleic Acid Therapies
• Vaccines
• Small Biologics-Derived Molecules
• Recombinant Proteins
• Other Modalities

Applications Covered:

• Oncology
• Immunology
• Infectious Diseases
• Cardiovascular Diseases
• Neurological Diseases
• Metabolic & Endocrine Diseases
• Rare Diseases
• Other Applications

End Users Covered:

• Biotech & Mid-Caps
• Contract Research Organizations
• Contract Development & Manufacturing Organizations
• Academic & Research Institutes
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Application Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Biopharmaceutical Licensing Market, By Deal Type

• 5.1 Introduction
• 5.2 In-Licensing
• 5.3 Out-Licensing
• 5.4 Co-Development
• 5.5 Joint Venture
• 5.6 Manufacturing Licenses
• 5.7 Other Deal Types

6 Global Biopharmaceutical Licensing Market, By Licensing Model

• 6.1 Introduction
• 6.2 Exclusive License
• 6.3 Field-Limited License
• 6.4 Non-Exclusive License

7 Global Biopharmaceutical Licensing Market, By Stage of Development

• 7.1 Introduction
• 7.2 Discovery & Preclinical Stage
• 7.3 Phase I
• 7.4 Phase II
• 7.5 Phase III
• 7.6 Commercialization/Marketed Product Stage

8 Global Biopharmaceutical Licensing Market, By Modality

• 8.1 Introduction
• 8.2 Monoclonal Antibodies (mAbs) & Biologics
• 8.3 Cell & Gene Therapies (CGT)
• 8.4 mRNA & Nucleic Acid Therapies
• 8.5 Vaccines
• 8.6 Small Biologics-Derived Molecules
• 8.7 Recombinant Proteins
• 8.8 Other Modalities

9 Global Biopharmaceutical Licensing Market, By Application

• 9.1 Introduction
• 9.2 Oncology
• 9.3 Immunology
• 9.4 Infectious Diseases
• 9.5 Cardiovascular Diseases
• 9.6 Neurological Diseases
• 9.7 Metabolic & Endocrine Diseases
• 9.8 Rare Diseases
• 9.9 Other Applications

10 Global Biopharmaceutical Licensing Market, By End User

• 10.1 Introduction
• 10.2 Biotech & Mid-Caps
• 10.3 Contract Research Organizations
• 10.4 Contract Development & Manufacturing Organizations
• 10.5 Academic & Research Institutes
• 10.6 Other End Users

11 Global Biopharmaceutical Licensing Market, By Geography

• 11.1 Introduction
• 11.2 North America
  • 11.2.1 US
  • 11.2.2 Canada
  • 11.2.3 Mexico
• 11.3 Europe
  • 11.3.1 Germany
  • 11.3.2 UK
  • 11.3.3 Italy
  • 11.3.4 France
  • 11.3.5 Spain
  • 11.3.6 Rest of Europe
• 11.4 Asia Pacific
  • 11.4.1 Japan
  • 11.4.2 China
  • 11.4.3 India
  • 11.4.4 Australia
  • 11.4.5 New Zealand
  • 11.4.6 South Korea
  • 11.4.7 Rest of Asia Pacific
• 11.5 South America
  • 11.5.1 Argentina
  • 11.5.2 Brazil
  • 11.5.3 Chile
  • 11.5.4 Rest of South America
• 11.6 Middle East & Africa
  • 11.6.1 Saudi Arabia
  • 11.6.2 UAE
  • 11.6.3 Qatar
  • 11.6.4 South Africa
  • 11.6.5 Rest of Middle East & Africa

12 Key Developments

• 12.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 12.2 Acquisitions & Mergers
• 12.3 New Product Launch
• 12.4 Expansions
• 12.5 Other Key Strategies

13 Company Profiling

• 13.1 Novartis
• 13.2 Pfizer
• 13.3 Roche
• 13.4 Johnson & Johnson
• 13.5 Merck & Co.
• 13.6 AstraZeneca
• 13.7 Sanofi
• 13.8 GlaxoSmithKline (GSK)
• 13.9 AbbVie
• 13.10 Bristol-Myers Squibb (BMS)
• 13.11 Amgen
• 13.12 Eli Lilly & Company
• 13.13 Takeda Pharmaceutical Company
• 13.14 Gilead Sciences
• 13.15 Regeneron Pharmaceuticals
• 13.16 Biogen
• 13.17 Vertex Pharmaceuticals
• 13.18 Moderna
• 13.19 Bayer AG
• 13.20 Incyte Corporation