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市場調查報告書
商品編碼
1813460
2032 年生物製藥許可市場預測:按交易類型、許可模式、開發階段、方式、應用、最終用戶和地區進行的全球分析Biopharmaceutical Licensing Market Forecasts to 2032 - Global Analysis By Deal Type, Licensing Model, Stage of Development, Modality, Application, End User and By Geography |
根據 Stratistics MRC 的數據,全球生物製藥授權市場預計在 2025 年達到 2,405 億美元,到 2032 年將達到 2,5996 億美元,預測期內的複合年成長率為 40.5%。
生物製藥授權是一種正式協議,其中一方(授權人)將智慧財產權(通常是專利和專有技術)授予另一方(被授權人),用於開發、生產和商業化生物製藥。此類協議使公司能夠獲得創新治療方法,擴展其產品組合,並分擔與研發和監管核准相關的風險和成本。許可安排可以是排他性的,也可以是非排他性的,通常包含特許權使用費、里程碑付款和共同開發權等條款,以促進整個生物製藥價值鏈的策略合作。
專利懸崖和管線再填充
許可協議,尤其是對外授權,已成為將未充分利用的資產收益並縮短開發週期的策略工具。新興生物技術公司因其創新平台而日益受到追捧,這些平台提供的新型候選療法能夠填補大型製藥公司產品組合的空白。這種動態推動了交易的激增,尤其是在未滿足需求的領域。此外,維持競爭優勢的迫切性促使企業探索早期授權機會和合作研發模式。
估價和交易結構挑戰
確定早期技術的公平市場價值本身就很複雜,通常涉及推測性預測和有限的臨床數據。特許權使用費結構、里程碑付款和地理權利等因素會使談判更加複雜,這些因素可能會稀釋感知價值。規模較小的公司可能缺乏處理這些複雜問題的財務或法律專業知識,而規模較大的公司則擔心為未經證實的資產支付過高的費用。這些障礙可能會延遲或破壞有前景的合作關係,尤其是在競爭激烈的治療領域。
專注於利基、高價值治療領域
許可活動日益集中於創新迅速、定價能力強的專業領域,例如罕見疾病、腫瘤學以及細胞和基因治療。由於競爭有限且未滿足的醫療需求較高,這些領域提供了頗具吸引力的回報。各公司正瞄準獲得孤兒藥和突破性療法認定的資產,以利用優惠的監管治療和快速核准途徑。這一趨勢正在重塑整個產業的投資組合策略。
宏觀經濟不穩定和缺乏實質審查
許可談判也可能因實質審查不足而受到影響,這可能導致意外的責任、智慧財產權糾紛以及協議達成後的臨床挫折。在競爭日益激烈的背景下,一些公司在沒有充分評估監管風險、生產擴充性和市場進入障礙的情況下倉促達成交易。這可能導致代價高昂的重新談判和失敗的合作。確保嚴謹的技術、法律和商業性評估對於降低這些風險並維持長期價值創造至關重要。
疫情加速了人們對感染疾病平台和數位療法的興趣,再形成了許可格局。儘管臨床試驗和監管審查的早期中斷減緩了交易流程,但開發新冠相關療法和診斷方法的迫切需求導致許可交易激增,尤其是在mRNA技術和抗病毒藥物候選藥物方面。遠端協作工具和虛擬實質審查流程已成為常態,簡化了跨國交易。
預計在預測期內,對外授權業務將佔據最大佔有率
預計在預測期內,轉出授權業務將佔據最大的市場佔有率,因為它在非核心資產收益和擴大市場覆蓋範圍方面發揮戰略作用。這種模式使原廠公司能夠利用外部專業知識進行臨床開發和商業化,尤其是在缺乏基礎設施的地區。這種模式尤其受到尋求前期投資和風險共擔的生物技術公司的青睞,活性化了對外授權業務的發展,使其成為最佳化投資組合和全球擴張的良好途徑。
細胞和基因治療(CGT)領域預計在預測期內實現最高複合年成長率
預計在預測期內,細胞和基因治療 (CGT) 領域將呈現最高成長率,這得益於再生醫學、免疫腫瘤學和個人化治療領域的突破。隨著各公司尋求獲得專有載體、生產平台和遞送技術,該領域的授權交易正在激增。儘管監管和生產要求複雜,但較高的臨床成功率和溢價潛力使 CGT 資產在許可方面極具吸引力。
在預測期內,北美預計將佔據最大的市場佔有率,這得益於其強大的創新生態系統、良好的智慧財產權框架和強勁的創業投資活動。該地區擁有眾多生物技術中心、學術研究中心和監管機構,為交易撮合提供了便利。美國公司在授權和跨境合作方面特別活躍,充分利用其先進的研發能力和全球網路。
預計北美將在預測期內實現最高的複合年成長率,這反映出該地區擁有充滿活力的研發管線,並積極關注新型療法。該地區對精準醫療、數位健康整合和快速核准途徑的關注,正吸引全球對美國原產藥物許可的興趣。研發稅收優惠和簡化監管流程等策略性政策舉措正在進一步加快交易速度。
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.