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市場調査レポート
商品コード
1641382
バイオ医薬品受託製造の世界市場:注目の洞察(2024年~2029年)Global Biopharmaceutical Contract Manufacturing Market - Focused Insights 2024-2029 |
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バイオ医薬品受託製造の世界市場:注目の洞察(2024年~2029年) |
出版日: 2025年01月21日
発行: Arizton Advisory & Intelligence
ページ情報: 英文 163 Pages
納期: 即納可能
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世界のバイオ医薬品受託製造の市場規模は、2023年から2029年にかけて16.51%のCAGRで成長すると予測されています。
2024年、大手CMOの1つであるSanofiは、フランスでの医薬品生産能力を強化するため、フランスでのバイオ製造に10億米ドル以上の投資を行っています。2023年、GTP Biowaysがフランスに2つのバイオ医薬品製造施設を新設しました。2024年、Lonzaが米国のGenentechの製造部門をRocheから12億米ドルで買収することで合意したと発表しました。
2024年、Thermo Fischer Scientific がOlink Holding ABを買収しました。Olinkは次世代プロテオミクスソリューション開発のパイオニア企業です。2023年、Wuxi Biologicsは、ドイツの施設で製造能力を増強すると発表しました。2020年以降、同社はドイツ国内の2つの新施設の建設と適応に投資しました。2023年、MerckはmRNAサービスの先駆けとしてドイツに2つの新しい製造工場を開設しました。さらに、コストを43%削減し、バイオセーフティ試験時間を66%短縮できる遺伝子安定性プラットフォームの発売を発表しました。
2023年には、世界有数のCDMOであるACG Biologicsが、ミラノのCell & Gene Center of Excellence製造拠点における製造プラントの拡張を完了しました。
医薬品製造受託機関(CMO)は、ロボット、自動化、連続製造など、革新的でより高度な製造技術にシフトしています。The Manufacturing Diveの記事(2024年)は、契約製造業者は記録的な高水準の医薬品不足と複雑な新薬の需要に対応するため、製造プロセスの最適化を模索していると報告しています。連続製造技術はCMOの間で人気が高まっています。この技術では、投入材料は連続的に生産に投入され、変換され、処理された出力材料は連続的に除去されます。自動化はCMOの間で急速に広まりつつある動向で、より一貫性と精度を高め、人的ミスを最小限に抑えます。現在、自動化、プロセス制御システム、高度なロボット工学は、バイオプロセスの継続的なモニタリングと最適化を可能にし、製品の品質を向上させ、より高い歩留まりを実現するために普及しています。
バイオ医薬品業界では、研究開発、臨床試験、製品承認、新製品の市場開拓がますます複雑化しており、バイオ医薬品企業は、より多様で経験豊富な老舗の受託製造会社を求めています。しかし最近では、よりニッチでケアの必要な治療領域への注目が高まるにつれ、バイオ医薬品企業はCMOにより専門的なサービスと能力を求めるようになっています。バイオ医薬品業界が大きな競争と規制当局からの課題に見舞われる中、バイオ医薬品企業は特定または単一分野の専門家であるCMOを探しています。この要因は、バイオ医薬品企業独自の要件を満たすためにオーダーメイドのソリューションやサービスを提供できる、小規模で新興の専門CMOにチャンスを生み出しています。
当レポートでは、世界のバイオ医薬品受託製造市場について調査し、市場の概要とともに、製品別、バイオ医薬品別、発現システム別、事業規模別、企業規模別、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。
The global biopharmaceutical contract manufacturing market is expected to grow at a CAGR of 16.51% from 2023 to 2029.
RECENT VENDORS ACTIVITIES
KEY TAKEAWAYS
MARKET TRENDS & DRIVERS
Attention Towards Technology Adoption
Contract Manufacturing Organizations (CMOs) are shifting towards innovative and more advanced manufacturing technologies, such as robotics, automation, and continuous manufacturing. The Manufacturing Dive article (2024) reported that contract manufacturers seek to optimize manufacturing processes to meet demand for combat record-high drug shortages and new and complex drugs. Where Continuous Manufacturing technology become more popular among CMOs. In this technology, input materials are continuously fed into production and transformed, and processed output materials are continuously removed. Automation is a rapidly growing trend among CMOs that delivers more consistency, and precision and minimizes human error. Currently, automation, process control systems, and advanced robotics, that becoming popular to enable continued monitoring and optimization of bioprocesses, to improve product quality and lead to higher yield.
Attention Towards Specialized Capabilities and Services
In the biopharmaceutical industry, research and development, clinical trials, product approvals, and new products in the market have become more and more complex, the biopharma companies seeking more diverse, experienced, and well-established contract manufacturers. However, in recent days, with the growing attention toward more niche and care-demanding therapeutic areas, now biopharma companies looking for more specialized services and capabilities in CMOs. As the biopharmaceutical industry experiences huge competition and challenges from regulatory bodies, biopharma companies looking for CMOs who are experts in specific or single areas. This factor creates opportunities for small and emerging specialized CMOs that can offer tailored solutions and services to meet the unique requirements of biopharma companies.
Increasing Drug Approvals by Emerging, Small & Medium-Sized Biopharma Companies
Small & Medium pharma biotech companies are the most potential clients for CMOs/CDMOs as these entities face several issues in the development and manufacturing of their drugs. New and often small-sized to mid-sized biotech companies are seeking contract manufacturing companies to introduce their products due to a lack of resources and associated capabilities to invest in manufacturing facilities of their own. In the past few years, small-sized biopharma companies have accelerated their R&D and launched around 30% to 40% of new drugs. There are more than 5,500 total small and mid-sized biopharma companies present across the world revealed by Contract Pharma news in 2023, and it is expected that in upcoming years (by 2026-2027) they will contribute more than 55% of new drugs launched.
Rapid Developments in Biopharma Contract Production Services with AI
With the growing competition across the biopharmaceutical contract manufacturing industry, vendors are advancing them with new approaches that drive their efficiency in contract manufacturing. The partnership with the right contract manufacturer is an emerging trend that led to rising advancements among the vendors to stay competitive in the market. The majority of CMOs/CDMOs are developing and expanding their services to keep pace with rapidly evolving the global market. These factors attract more and more biopharma companies towards contract manufacturing and drive market growth. CMOs are advancing their performance with artificial intelligence (AI) and electronic platforms to become more cost-effective and speed up production time.
INDUSTRY RESTRAINTS
High Cost of Biologics Contract Manufacturing
Biopharmaceuticals are medicines made from living cells that treat common and serious diseases, such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. These are highly targeted and effective, and they are increasingly important in the fight against these diseases. They are relatively complex molecules and are usually composed of proteins for transplantation, carbohydrates, nucleic acids, cells or tissues, or complex complexes of these substances. Their examples include hormones, vaccines, blood products, allergens, mAbs, recombinant therapeutic proteins, C>, growth factors, cytokines, and insulin. Unfortunately, most patients cannot afford biologics. Medical costs divide consumers into rich and poor categories. Both categories are stressed due to high biological costs, but the poor stress much more. Expensive biological products are not easily accessible to poor patients. This is more pronounced in low- and middle-income countries.
SEGMENTATION INSIGHTS
INSIGHTS BY PRODUCT
The global biopharmaceutical contract manufacturing market by product is segmented into finished dosage form (FDF) and active pharmaceutical ingredients (API). The finished dosage form (FDF) accounted for the largest market share in 2023. An FDF (Finished Dosage Form) is a drug product that has undergone all stages of production, including manufacturing, testing, and regulatory approval before being made available to the public. The FDF contains both active pharmaceutical ingredients (APIs), which are responsible for the therapeutic effects experienced by the user, and inactive ingredients (excipients), which serve as carriers to facilitate the function of the active ingredients. Producing finished dosage forms requires specialized equipment, advanced technologies, and expertise. As the biopharmaceutical industry continues to expand, many companies are partnering with contract manufacturers to meet global FDF demand and ensure compliance with regulatory standards.
By Product
INSIGHTS BY BIOLOGICS
The global biopharmaceutical contract manufacturing market by biologics is categorized into monoclonal antibodies, vaccines, and other biologics. The monoclonal antibodies segment holds the largest market share of over 46% in 2023. Monoclonal antibodies (mAbs) currently dominate the biopharmaceutical product category, primarily driven by the rising prevalence of complex and severe health conditions, such as cancer, and the increasing sophistication of treatment approaches. Furthermore, 53 Biologics, a leading CDMO (Contract Development and Manufacturing Organization), reported a significant rise in research and development activities for monoclonal antibodies following the COVID-19 pandemic. As the demand for highly specific and immune-supportive biopharmaceutical products grows, the need for monoclonal antibody contract manufacturing is rapidly increasing worldwide.
By Biologics
INSIGHTS BY EXPRESSION SYSTEMS
The global biopharmaceutical contract manufacturing market by expression systems is segmented into mammalian and non-mammalian. The mammalian segment shows significant growth, with the fastest-growing CAGR of 16.78% during the forecast period. The development of biopharmaceuticals using transgenic mammalian cell lines remains a cornerstone of the biotechnology and pharmaceutical industries, with the market experiencing exponential growth since the introduction of human tissue plasminogen activator in 1987 and erythropoietin in 1988. Mammalian cells are widely considered for expression systems in biologics manufacturing, particularly for producing monoclonal antibodies. Chinese Hamster Ovary (CHO) cells, for instance, are responsible for over 70% of recombinant pharmaceutical protein production. Their unique ability to perform post-translational modifications, which are critical for drug safety and efficacy, makes mammalian expression systems essential for producing therapeutic proteins, complex proteins, and monoclonal antibodies, further driving their widespread application in the industry.
By Expression Systems
INSIGHT BY SCALE OF OPERATION
Based on the scale of operation, the commercial segment dominates and holds the largest share of the global biopharmaceutical contract manufacturing market. The commercial-scale operation in biopharma, driven by the outsourcing of biologics production, is significantly contributing to the growth of the commercial segment. By leveraging contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), biopharma companies can achieve large-scale production efficiently, reducing costs and time-to-market for essential biologics like vaccines, monoclonal antibodies, and cell and gene therapies. This scalability allows companies to meet the rising global demand driven by infectious diseases, chronic illnesses, cancers, and autoimmune disorders. Moreover, outsourcing enables biopharma companies to focus on research and innovation while relying on expert manufacturers to handle production complexities. This model also facilitates faster regulatory compliance and access to advanced manufacturing technologies, enhancing productivity. As a result, the commercial segment benefits from expanded market reach, improved profitability, and the ability to address global health challenges effectively, further fueling its growth.
By Scale of Operation
INSIGHT BY COMPANY SIZE
Based on the company size, the large companies segment accounted for the largest global biopharmaceutical contract manufacturing market share. Following the COVID-19 pandemic, budget constraints have become a common issue for large biopharma companies, primarily due to the substantial financial burden of investments in vaccine and therapeutic development. As a result, many companies are shifting from in-house manufacturing to outsourcing, allowing them to focus on core competencies like innovation while taking advantage of cost-effective contract manufacturing services. This trend is driven by the need to reduce manufacturing costs while ensuring high-quality production. CMOs in developing countries, such as India, South Korea, and Switzerland, are emerging as key players in this shift, offering advanced manufacturing facilities, a familiar regulatory environment, and significant cost savings. This movement toward outsourcing to developing countries is helping large biopharma companies optimize production and remain competitive in the global market.
By Company Size
GEOGRAPHICAL ANALYSIS
North America dominates and holds the largest share of the global biopharmaceutical contract manufacturing market. The market dominance of these regions can be attributed to the high concentration of biopharma companies, the growing trend of outsourcing biopharma contract manufacturing due to cost and regulatory compliance considerations, and the presence of several leading market players. In North America, numerous biopharma companies are actively involved in developing novel biologics. Significant investments in research and development aimed at strengthening pipelines for chronic autoimmune diseases are expected to drive the launch of new therapeutics in the region. The increasing number of approvals for novel therapeutics is creating valuable opportunities for market growth in North America.
By Geography
COMPETITIVE LANDSCAPE
The global biopharmaceutical contract manufacturing market report consists of exclusive data on 45 vendors. The market is highly competitive. There are several leading, growing, and emerging market players are present across the global market. Some emerging players compete against large and small medium-sized market players. Boehringer Ingelheim, Lonza, Samsung Biologics, AbbVie, Catalent, Emergent BioSolution, FUJIFILM, Merck KGaA, Pfizer, and Wuxi Biologics are leading companies that accounted for major market share in the global biopharmaceutical contract manufacturing market. These vendors are continuously focusing on expanding their biopharmaceutical contract manufacturing services that meet clients' requirements, international regulations, and increase the efficiency of their product, strengthen their market position.
Key Vendors
Other Prominent Vendors
KEY QUESTIONS ANSWERED:
CHAPTER - 1: Competitive Landscape of Biopharmaceutical Contract Manufacturing Market Overview
CHAPTER - 2: Competitive Landscape of Biopharmaceutical Contract Manufacturing Market
CHAPTER - 3: Biopharmaceutical Contract Manufacturing Market Prospects & Opportunities
CHAPTER - 4: Biopharmaceutical Contract Manufacturing Market Segmentation Data
CHAPTER - 5: Key Regions Overview
CHAPTER - 6: Biopharmaceutical Contract Manufacturing Market Industry Overview
CHAPTER - 7: Appendix