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市場調査レポート
商品コード
1679110
生物製剤CDMO市場- 世界および地域別分析:細胞タイプ別、適応症別、分子タイプ別、地域別 - 分析と予測(2025年~2035年)Biologics CDMO Market - A Global and Regional Analysis: Focus on Cell Type, Indication, Molecule Type, and Region - Analysis and Forecast, 2025-2035 |
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カスタマイズ可能
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生物製剤CDMO市場- 世界および地域別分析:細胞タイプ別、適応症別、分子タイプ別、地域別 - 分析と予測(2025年~2035年) |
出版日: 2025年03月14日
発行: BIS Research
ページ情報: 英文 120 Pages
納期: 1~5営業日
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世界の生物製剤CDMOの市場規模は、生物学的製剤に対する需要の高まりと、開発・製造工程のアウトソーシング傾向の高まりにより、急成長を遂げています。
製薬企業は、専門知識、高度なインフラ、厳格な規制遵守を必要とする複雑な生物学的製剤の製造に対応するため、生物製剤CDMOへの依存を高めています。生物製剤CDMOにアウトソーシングすることで、企業は業務を合理化し、コストを削減し、市場投入までの時間を短縮することができ、研究開発のコアコンピタンスにより集中することができます。
生物製剤CDMO市場の拡大には、がん、糖尿病、自己免疫疾患などの慢性疾患の有病率の上昇が革新的な生物製剤治療の必要性を高めるなど、いくつかの要因が後押ししています。さらに、バイオテクノロジーの進歩により、モノクローナル抗体、細胞・遺伝子治療薬、組換えタンパク質を含む次世代生物製剤の開発が可能になっています。世界の高齢化により、これらの治療薬に対する需要はさらに高まっており、製薬会社は柔軟でスケーラブルな製造ソリューションを求めています。その結果、生物製剤CDMO市場は力強い成長軌道を維持し、進化する医薬品業界において重要な役割を果たすと予想されます。
製薬企業が生物学的製剤の開発と商業化を加速するために生物学的製剤CDMOを利用する傾向が強まっており、生物学的製剤CDMO市場は継続的な成長が期待できます。生物製剤CDMOは、上流工程、下流工程、分析サービスを含む包括的なサービスを提供し、製薬企業が生物製剤をより迅速かつ効率的に市場に投入できるようにします。生物製剤の需要が増加し続ける中、生物製剤CDMOは生産を最適化し、高品質の製造を確保する上で重要な役割を果たしています。
生物製剤CDMO市場は、生物製剤製造サービスに対する需要の増加に対応するため、CDMOの生産能力を拡大するための大規模な投資からも恩恵を受けています。競争力を維持し業務効率を高めるため、生物製剤CDMOはシングルユース・バイオリアクターや連続製造などの先進技術を採用しています。これらの技術革新は、生物製剤製造における拡張性の向上、コストの削減、柔軟性の強化に役立っています。継続的な進歩とアウトソーシングサービスへの依存度の増加により、生物製剤CDMO市場は今後数年間、持続的な成長が見込まれています。
生物製剤CDMO市場の出現と拡大は、バイオ医薬品業界を大きく変貌させました。生物製剤CDMOは、専門知識、最先端技術、スケーラブルなソリューションを提供することで、医薬品開発と製造を加速させる重要なイネーブラーとしての役割を果たしています。生物製剤CDMOは、特に新興企業や小規模企業にコスト効率の高い代替手段を提供することで、複雑な規制状況に伴うリスクを軽減しながら、多額の設備投資の必要性を低減します。さらに、生物製剤CDMOの世界的な事業展開と多様な能力は、製薬会社が地域の規制枠組みをより容易に利用できるようにし、バイオ製造の世界化に貢献しています。生物製剤CDMOセクターの競争は、絶え間ない革新と技術進歩を促進し、バイオ医薬品エコシステム全体の進歩を促しています。生物製剤を専門とする大手CDMOは、高度なタンパク質発現システムを活用して、治療用タンパク質の開発とスケーラブルな生産を加速し、高い収率、純度、規制遵守を確保しています。戦略的パートナーとして、生物製剤CDMOは業界の能力、柔軟性、効率性を高め、世界中で高まる生物製剤の需要を満たすために不可欠な役割を果たしています。
当レポートでは、世界の生物製剤CDMO市場について調査し、市場の概要とともに、細胞タイプ別、適応症別、分子タイプ別、地域別の動向、および市場に参入する企業のプロファイルなどを提供しています。
Global Biologics CDMO Market Overview
The global biologics CDMO market is experiencing rapid growth, driven by the increasing demand for biologic therapies and the growing trend of outsourcing development and manufacturing processes. Pharmaceutical companies are increasingly relying on biologics CDMOs to handle the complexities of biologic drug production, which requires specialized expertise, advanced infrastructure, and stringent regulatory compliance. By outsourcing to biologics CDMOs, companies can streamline operations, reduce costs, and accelerate time-to-market, allowing them to focus more on their core competencies in research and development.
Several factors are fueling the expansion of the biologics CDMO market, including the rising prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders, which drive the need for innovative biologic treatments. Additionally, advancements in biotechnology are enabling the development of next-generation biologics, including monoclonal antibodies, cell and gene therapies, and recombinant proteins. The aging global population is further increasing the demand for these therapies, prompting pharmaceutical companies to seek flexible and scalable manufacturing solutions. As a result, the biologics CDMO market is expected to continue its strong growth trajectory, playing a crucial role in the evolving pharmaceutical landscape.
The biologics CDMO market is well-positioned for continued growth as pharmaceutical companies increasingly turn to biologics CDMOs to accelerate the development and commercialization of biologic therapies. Biologics CDMOs offer a comprehensive range of services, including upstream processing, downstream processing, and analytical services, enabling pharmaceutical companies to bring their biologics products to market more quickly and efficiently. As the demand for biologics continues to rise, biologics CDMOs are playing a crucial role in optimizing production and ensuring high-quality manufacturing.
The biologics CDMO market is also benefiting from significant investments in expanding CDMO capacity to meet the increasing demand for biologics manufacturing services. To stay competitive and enhance operational efficiency, biologics CDMOs are adopting advanced technologies such as single-use bioreactors and continuous manufacturing. These innovations help improve scalability, reduce costs, and enhance flexibility in biologics production. With continuous advancements and increasing reliance on outsourced services, the biologics CDMO market is poised for sustained growth in the coming years.
Industry Impact
The emergence and expansion of the biologics CDMO market have profoundly reshaped the biopharmaceutical industry. Biologics CDMOs serve as critical enablers of accelerated drug development and manufacturing, offering specialized expertise, cutting-edge technologies, and scalable solutions. By providing cost-efficient alternatives, particularly for startups and smaller enterprises, biologics CDMOs reduce the need for substantial capital investment while mitigating risks associated with complex regulatory landscapes. Additionally, the global reach and diverse capabilities of biologics CDMOs have contributed to the globalization of biomanufacturing, allowing pharmaceutical companies to navigate regional regulatory frameworks with greater ease. The competitive nature of the biologics CDMO sector fosters continuous innovation and technological advancements, driving progress across the entire biopharmaceutical ecosystem. Leading CDMOs specializing in biologics leverage advanced protein expression systems to accelerate the development and scalable production of therapeutic proteins, ensuring high yield, purity, and regulatory compliance. As strategic partners, biologics CDMOs enhance industry capacity, flexibility, and efficiency, playing an indispensable role in meeting the growing demand for biologic drugs worldwide.
Market Segmentation:
Segmentation 1: by Cell Type
Mammalian Segment to Dominate the Global Biologics CDMO Market (by Cell Type)
The mammalian segment dominated the global biologics CDMO market (by cell type) in FY2024, driven by its ability to accurately replicate complex proteins with high bioactivity and minimal post-translational modifications. Widely preferred for biopharmaceutical production, mammalian cell lines are particularly suited for manufacturing monoclonal antibodies, which constitute a significant share of biologic drugs. Offering scalability, robust performance, and compatibility with the intricate demands of therapeutic protein production, mammalian cell cultures play a crucial role in advancing biomanufacturing. As the biologics CDMO market continues to grow, the prominence of mammalian cell culture technology underscores its importance in meeting the global demand for cutting-edge biopharmaceuticals.
Segmentation 2: by Indication
Oncology Segment to Dominate the Global Biologics CDMO Market (by Indication)
The oncology segment led the global biologics CDMO market (by indication) in FY2024, driven by the surge in cancer research and the development of targeted therapies and immunotherapies. A significant portion of biopharmaceutical innovations is focused on oncology, leading biologics CDMOs to increasingly specialize in manufacturing monoclonal antibodies, cell-based therapies, and other cancer-targeting biologics. This trend underscores the growing emphasis on personalized medicine and the need for advanced manufacturing capabilities to address the complexities of oncology treatments, reinforcing the pivotal role of biologics CDMOs in supporting the evolving landscape of cancer therapeutics.
Segmentation 3: by Molecule Type
Monoclonal Antibodies Segment to Dominate the Global Biologics CDMO Market (by Molecule Type)
The monoclonal antibodies (mAbs) segment dominated the global biologics CDMO market (by molecule type) in FY2024, driven by their widespread adoption in treating cancer, autoimmune disorders, and infectious diseases. As precision medicine continues to gain momentum, mAbs offer highly targeted and specific therapeutic approaches, further increasing their demand. This surge has led biologics CDMOs to experience growing requests for the development and manufacturing of monoclonal antibodies, reinforcing their critical role in the evolving landscape of biologic drug development and advanced therapeutics.
Segmentation 4: by Region
The biologics CDMO market in the Asia-Pacific (APAC) region is experiencing rapid growth, driven by increasing demand for biopharmaceuticals, technological advancements, and the rising burden of chronic diseases. Among APAC countries, China is leading the market, fueled by strong government support, a growing biosimilars industry, and an expanding biomanufacturing infrastructure. The country's strategic investments in biologics production, coupled with evolving regulatory frameworks that favor contract biomanufacturing, have positioned China as a key hub for biologics CDMO services in the region.
Recent Developments in the Global Biologics CDMO Market
Demand - Drivers, Restraints, and Opportunities
Market Drivers:
Market Restraints:
Market Opportunities:
How can this report add value to an organization?
Workflow/Innovation Strategy: The biologics CDMO market (by molecule type) is categorized based on various molecular types utilized in biologics development. Additionally, the study offers a comprehensive analysis of different cell types and indications, providing readers with a deeper understanding of the key components shaping the biologics manufacturing landscape.
Growth/Marketing Strategy: The biologics CDMO market's growth and marketing strategy are driven by a combination of technical excellence, strategic collaborations, and global market positioning. Biologics CDMOs capitalize on their specialized expertise in bioprocessing and manufacturing to provide comprehensive solutions tailored to the needs of biopharmaceutical companies. By leveraging advanced technologies, regulatory expertise, and scalable production capabilities, CDMOs strengthen their competitive edge and expand their market presence in the evolving biopharmaceutical landscape.
Competitive Strategy: The study provides an in-depth analysis and profiling of key players in the global biologics CDMO market, highlighting new product launches, acquisitions, expansions, and strategic collaborations. A detailed competitive benchmarking has been conducted to offer insights into how these players compare, presenting a clear view of the market landscape. Additionally, a comprehensive examination of competitive strategies, including partnerships, agreements, and collaborations, helps identify untapped revenue opportunities, enabling a deeper understanding of growth prospects within the biologics CDMO market.
Methodology
Key Considerations and Assumptions in Market Engineering and Validation
Primary Research
The primary sources involve industry experts from the biologics CDMO stakeholders. Respondents such as CEOs, vice presidents, marketing directors, and technology and innovation directors have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.
Secondary Research
This research study involves the usage of extensive secondary research, directories, company websites, and annual reports. It also makes use of databases, such as Hoovers, Bloomberg, Businessweek, and Factiva, to collect useful and effective information for an extensive, technical, market-oriented, and commercial study of the global market. In addition to the aforementioned data sources, the study has been undertaken with the help of other data sources and websites, such as the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), World Health Organization (WHO), National Center for Biotechnology Information, and others.
The key data points taken from the secondary sources include:
Key Market Players and Competition Synopsis
The biologics CDMO market is undergoing rapid expansion, solidifying its role as a crucial component of the biopharmaceutical industry. This dynamic sector is driven by the increasing demand for outsourcing services in the development and manufacturing of biologic drugs. Biologics, including monoclonal antibodies, recombinant proteins, and gene therapies, constitute a rapidly growing segment within the pharmaceutical landscape. As pharmaceutical and biotech companies strive to bring innovative biologics to market, they increasingly rely on biologics CDMO providers for specialized expertise, cutting-edge technologies, and cost-efficient solutions. The market is characterized by a diverse range of biologics CDMO players, each offering unique capabilities across the entire biologics development and manufacturing value chain.
With a global footprint, biologics CDMO providers are well-equipped to meet the industry's growing demand for flexible, high-quality, and efficient solutions in biologics development and manufacturing. As the biopharmaceutical market continues to expand, the biologics CDMO market is set to play a pivotal role in accelerating the transition of innovative therapies from concept to commercialization. By leveraging advanced technologies, regulatory expertise, and scalable production capabilities, biologics CDMO firms are becoming indispensable partners in the evolving biopharmaceutical landscape.
Some of the prominent companies in this market are:
Companies that are not a part of the aforementioned pool have been well-represented across different sections of the report (wherever applicable).
Research Methodology