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市场调查报告书
商品编码
1813460
2032 年生物製药许可市场预测:按交易类型、许可模式、开发阶段、方式、应用、最终用户和地区进行的全球分析Biopharmaceutical Licensing Market Forecasts to 2032 - Global Analysis By Deal Type, Licensing Model, Stage of Development, Modality, Application, End User and By Geography |
根据 Stratistics MRC 的数据,全球生物製药授权市场预计在 2025 年达到 2,405 亿美元,到 2032 年将达到 2,5996 亿美元,预测期内的复合年增长率为 40.5%。
生物製药授权是一种正式协议,其中一方(授权人)将智慧财产权(通常是专利和专有技术)授予另一方(被授权人),用于开发、生产和商业化生物製药。此类协议使公司能够获得创新治疗方法,扩展其产品组合,并分担与研发和监管核准相关的风险和成本。许可安排可以是排他性的,也可以是非排他性的,通常包含特许权使用费、里程碑付款和共同开发权等条款,以促进整个生物製药价值链的策略合作。
专利悬崖和管线再填充
许可协议,尤其是对外授权,已成为将未充分利用的资产收益并缩短开发週期的策略工具。新兴生物技术公司因其创新平台而日益受到追捧,这些平台提供的新型候选疗法能够填补大型製药公司产品组合的空白。这种动态推动了交易的激增,尤其是在未满足需求的领域。此外,维持竞争优势的迫切性促使企业探索早期授权机会和合作研发模式。
估价和交易结构挑战
确定早期技术的公平市场价值本身就很复杂,通常涉及推测性预测和有限的临床数据。特许权使用费结构、里程碑付款和地理权利等因素会使谈判更加复杂,这些因素可能会稀释感知价值。规模较小的公司可能缺乏处理这些复杂问题的财务或法律专业知识,而规模较大的公司则担心为未经证实的资产支付过高的费用。这些障碍可能会延迟或破坏有前景的合作关係,尤其是在竞争激烈的治疗领域。
专注于利基、高价值治疗领域
许可活动日益集中于创新迅速、定价能力强的专业领域,例如罕见疾病、肿瘤学以及细胞和基因治疗。由于竞争有限且未满足的医疗需求较高,这些领域提供了颇具吸引力的回报。各公司正瞄准获得孤儿药和突破性疗法认定的资产,以利用优惠的监管治疗和快速核准途径。这一趋势正在重塑整个产业的投资组合策略。
宏观经济不稳定和缺乏实质审查
许可谈判也可能因实质审查不足而受到影响,这可能导致意外的责任、智慧财产权纠纷以及协议达成后的临床挫折。在竞争日益激烈的背景下,一些公司在没有充分评估监管风险、生产扩充性和市场进入障碍的情况下仓促达成交易。这可能导致代价高昂的重新谈判和失败的合作。确保严谨的技术、法律和商业性评估对于降低这些风险并维持长期价值创造至关重要。
疫情加速了人们对感染疾病平台和数位疗法的兴趣,再形成了许可格局。儘管临床试验和监管审查的早期中断减缓了交易流程,但开发新冠相关疗法和诊断方法的迫切需求导致许可交易激增,尤其是在mRNA技术和抗病毒药物候选药物方面。远端协作工具和虚拟实质审查流程已成为常态,简化了跨国交易。
预计在预测期内,对外授权业务将占据最大份额
预计在预测期内,转出授权业务将占据最大的市场份额,因为它在非核心资产收益和扩大市场覆盖范围方面发挥战略作用。这种模式使原厂公司能够利用外部专业知识进行临床开发和商业化,尤其是在缺乏基础设施的地区。这种模式尤其受到寻求前期投资和风险共担的生物技术公司的青睐,活性化了对外授权业务的发展,使其成为优化投资组合和全球扩张的良好途径。
细胞和基因治疗(CGT)领域预计在预测期内实现最高复合年增长率
预计在预测期内,细胞和基因治疗 (CGT) 领域将呈现最高成长率,这得益于再生医学、免疫肿瘤学和个人化治疗领域的突破。随着各公司寻求获得专有载体、生产平台和递送技术,该领域的授权交易正在激增。儘管监管和生产要求复杂,但较高的临床成功率和溢价潜力使 CGT 资产在许可方面极具吸引力。
在预测期内,北美预计将占据最大的市场份额,这得益于其强大的创新生态系统、良好的智慧财产权框架和强劲的创业投资活动。该地区拥有众多生物技术中心、学术研究中心和监管机构,为交易撮合提供了便利。美国公司在授权和跨境合作方面特别活跃,充分利用其先进的研发能力和全球网路。
预计北美将在预测期内实现最高的复合年增长率,这反映出该地区拥有充满活力的研发管线,并积极关注新型疗法。该地区对精准医疗、数位健康整合和快速核准途径的关注,正吸引全球对美国原产药物许可的兴趣。研发税收优惠和简化监管流程等策略性政策倡议正在进一步加快交易速度。
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
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.
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.
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.
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.
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.
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.
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.
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.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.