![]() |
市場調査レポート
商品コード
1629878
開発製造受託(CDMO)の世界市場-2025~2033年Global Contract Development and Manufacturing (CDMO) Market - 2025-2033 |
||||||
カスタマイズ可能
適宜更新あり
|
開発製造受託(CDMO)の世界市場-2025~2033年 |
出版日: 2024年12月30日
発行: DataM Intelligence
ページ情報: 英文 176 Pages
納期: 即日から翌営業日
|
世界の開発製造受託(CDMO)市場は、2024年に1,501億9,000万米ドルに達し、2033年には2,800億7,000万米ドルに達すると予測され、予測期間2025~2033年のCAGRは7.4%で成長すると予測されています。
開発製造受託機関(CDMO)とは、製薬・バイオテクノロジー業界において、医薬品の開発・製造プロセス全体を全面的にサポートする専門サービスプロバイダーです。CDMOは、製品開発、製剤化、製造、包装といったさまざまな要素をアウトソーシングすることで、製薬会社の業務合理化を支援します。企業は、医薬品開発・製造のための自社施設を維持する代わりにCDMOと協力することで、経費を節約することができます。CDMOは、規制遵守、品質保証、最新の製造技術などの専門知識を提供し、製品の品質向上と市場投入のスピードアップに貢献します。製薬会社は研究とマーケティングに専念し、CDMOは医薬品開発の技術的側面を担当することができます。
医薬品・バイオ医薬品に対する需要の高まりが、予測期間中の市場を牽引する要因です。医薬品の需要増に対応するため、必要な製造ユニットや技術が様々な組織によって設立されています。例えば、2024年9月、Lonzaはフランスのコルマールに新しい製造工場を開設しました。新しいInnovaform Acceleratorは、経口および肺投与のためのカプセルベースの製造および送達技術を創造し、革新するための卓越センターとして機能します。
促進要因と阻害要因
医薬品・バイオ医薬品の需要増加
医薬品・バイオ医薬品に対する需要の高まりは、世界の開発製造受託(CDMO)市場の成長において重要な要因となることが予想されます。医薬品・バイオ医薬品の需要増加の主な要因の一つは、糖尿病、がん、心血管疾患などの慢性疾患の有病率の上昇です。人口が高齢化し、生活習慣に関連した健康状態が頻発するようになるにつれ、製薬会社は効果的な治療法を迅速に提供する必要に迫られています。このような緊急性から臨床試験が増加し、医薬品開発と生産を効率的に管理できるCDMOサービスへの需要が高まっています。
例えば、世界の開発製造受託機関(CDMO)であるSamsung Biologicsは2024年10月、高用量バイオ医薬品の開発と製造を支援する新しい高濃度製剤プラットフォームを発表しました。S-HiConTMは、望ましくないpH変化を検出し、製剤の安定性を向上させ、粘度を最小限に抑えることで、有効性と最大限の薬物分布を確保することができます。
さらに、高度な製造技術の使用はCDMO市場に変化をもたらしています。連続製造技術は、効率を向上させ、無駄を省き、医薬品製造のコストを下げるため、ますます普及しています。この技術的進歩により、CDMOは高い品質基準を維持しながら、現在の医薬品の複雑なニーズに対応することができます。例えば、2024年10月、創薬、開発、商業供給のサービスを提供する完全統合型CDMOであるEnzeneは、イタリアで開催されたCPHIミラノのイベントで、新しいEnzeneX 2.0技術を発表しました。この特許取得済みの方法は、商業用生物製剤供給のための同社の完全統合連続製造(FCCM)プラットフォームを拡張したものです。
CDMO業界のもう一つの重要な原動力は、アウトソーシングの傾向の高まりです。製薬会社は研究開発プロセスをスピードアップするために外部の専門知識を求めるようになり、特定の知識やリソースを求めてCDMOを利用するようになりました。例えば、2024年11月、スイスのCDMOであるSiegfriedは、薬理学的化合物の新しい世界研究開発センターをエヴィオンナズ施設内に設立しました。4,500平方メートルの施設には、化学・分析施設、研究室、フローケミストリー、蒸留、プロセス分析などの最先端技術のほか、オフィススペースもあります。約100のワークスペースが用意され、40の新規雇用が創出されました。これには、臨床ウイルスベクター研究用のパイロットスケール設備や、細胞・遺伝子治療用の分析・製造サービスも含まれます。
厳しい規制要件
厳しい規制要件などの要因が、世界の開発製造受託(CDMO)市場を阻害すると予想されています。CDMOは、適正製造規範(GMP)、適正臨床規範(GCP)、適正試験所規範(GLP)を含む広範な要件に従わなければならないです。これらの要件は、患者の安全と製品の品質を守ることを目的としていますが、CDMOに大きな業務負担を強いるものでもあります。CDMOは、これらの基準を満たすために、品質管理システムの維持、従業員の教育、頻繁な監査の実施に多大な資源を投入しなければなりません。このような規制遵守への継続的なコミットメントは、特にインフラや専門知識の乏しい中小企業にとっては、CDMOの財務および運営能力に負担をかけることになります。
The global contract development and manufacturing (CDMO) market reached US$ 150.19 billion in 2024 and is expected to reach US$ 280.07 billion by 2033, growing at a CAGR of 7.4% during the forecast period 2025-2033.
A Contract Development and Manufacturing Organization (CDMO) is a specialized service provider in the pharmaceutical and biotechnology industries that provides full support throughout the drug development and manufacturing processes. CDMOs help pharmaceutical companies streamline their operations by outsourcing different components of product development, formulation, manufacturing, and packaging. Companies may save expense by collaborating with CDMOs instead of maintaining in-house facilities for drug development and manufacture. CDMOs contribute specialized knowledge in regulatory compliance, quality assurance, and modern manufacturing technologies, which can help improve product quality and speed to market. Pharmaceutical companies can focus on research and marketing while CDMOs handle the technical aspects of medication development.
The rising demand for pharmaceutical and biopharmaceutical products is the driving factor that drives the market over the forecast period. Inorder to meet the rising demand of pharnmaceuticals, the required manufacturing units and technologies are established by various organizations. For instance, in September 2024, Lonza inaugurated its new manufacturing plant in Colmar, France. The new Innovaform Accelerator will function as a Center of Excellence for creating and innovating capsule-based manufacturing and delivery technologies for oral and pulmonary administration.
Market Dynamics: Drivers & Restraints
Rising demand for pharmaceutical and biopharmaceutical products
The rising demand for pharmaceutical and biopharmaceutical products is expected to be a significant factor in the growth of the global contract development and manufacturing (CDMO) market. One of the primary drivers for rising demand for pharmaceutical and biopharmaceutical products is the rising prevalence of chronic diseases such as diabetes, cancer, and cardiovascular disease. As populations age and lifestyle-related health conditions become more frequent, pharmaceutical companies under increased pressure to provide effective therapies quickly. This urgency has resulted in an increase in clinical trials, as well as a greater demand for CDMO services capable of efficiently managing drug development and production.
For instance, in October 2024, Samsung Biologics, a global contract development and manufacturing organization (CDMO), has launched a new high-concentration formulation platform to help with the development and production of high-dose biopharmaceuticals. S-HiConTM can detect undesired pH changes, improve formulation stability, and minimize viscosity to ensure efficacy and maximum medication distribution.
Furthermore, the use of sophisticated manufacturing techniques is altering the CDMO market. Continuous manufacturing techniques are becoming increasingly popular because they improve efficiency and reduce waste, lowering the cost of drug production. This technical progress allows CDMOs to handle the complicated needs of current medications while maintaining high quality standards. For instance, in October 2024, Enzene, a fully integrated CDMO offering services in discovery, development, and commercial supply, launched its new EnzeneX 2.0 technology at the CPHI Milan event in Italy. The patented method is an extension of the company's fully integrated continuous manufacturing (FCCM) platform for commercial biologics supply.
Another significant driver of the CDMO industry is the growing tendency of outsourcing. As pharmaceutical companies seek external expertise to speed up their R&D processes, they turn to CDMOs for specific knowledge and resources. For instance, in November 2024, Siegfried, a Swiss CDMO, has established its new global R&D center for pharmacological compounds at its Evionnaz facility. The 4,500 m2 facility includes chemical and analytical facilities, laboratories, and cutting-edge technology such as flow chemistry, distillation, and process analytics, as well as office space. There are approximately 100 workspaces available, and 40 new jobs have been created. This includes pilot-scale equipment for clinical viral vector research, as well as analytical and manufacturing services for cell and gene therapies.
Stringent regulatory requirements
Factors such as stringent regulatory requirements are expected to hamper the global contract development and manufacturing (CDMO) market. CDMOs must follow an extensive array of requirements that include Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP). These requirements are intended to safeguard patient safety and product quality, but they also place a significant operational burden on CDMOs. CDMOs must invest significant resources in maintaining quality management systems, educating employees, and conducting frequent audits to satisfy these criteria. This ongoing commitment to regulatory compliance can put a strain on CDMOs' financial and operational capacities, particularly for smaller firms with little infrastructure or expertise.
The global contract development and manufacturing (CDMO) market is segmented based on service type, research phase, end-user and region.
Finished dosage formulation (FDF) development and manufacturing segment is expected to dominate the global contract development and manufacturing (CDMO) market share
The Finished dosage formulation (FDF) development and manufacturing segment is anticipated to dominate the global home healthcare devices market. These formulations are preferred due to their long shelf life, convenience of administration, and usefulness in controlling a variety of health issues with minimal side effects. As the global disease burden grows, the demand for effective and dependable dosage forms becomes increasingly important, establishing FDF development as a vital area of growth within the CDMO landscape. In order to develop the formulations and improve the efficiency of medication, organizations has established various production units and latest production methodologies. For instance, in November 2023, Xellia Pharmaceuticals ('Xellia'), a global pioneer in the manufacture of specialty anti-infective treatments and critical care medications, has received approval from the US FDA to manufacture its first premix bag products at its Cleveland, Ohio, facility. Production has begun, and the initial commercial quantities have been released. The Xellia team has worked closely with the FDA to bring the entire Cleveland facility into operation, securing permission for the commercial manufacturing of its first injectable medicinal product.
Another important factor driving the expansion of the FDF industry is the shift toward scientific innovation in medicine formulation. Pharmaceutical companies are increasingly investing on R&D to produce novel treatments that address changing patient needs. CDMOs play an important role in this process by providing specialized skills and resources that allow pharmaceutical companies to develop breakthrough formulations without incurring major capital expenditures in infrastructure. For instance, in November 2024, BioPharma Spec, a global contract research organization (CRO) that specializes in biopharmaceutical discovery and preclinical characterization, recently launched three new European facilities in Freiburg, Germany; Bergamo, Italy; and Vilnius, Lithuania. These facilities will focus on discovery and R&D. The facilities will provide structural and physicochemical characterization services for a broad range of biopharmaceutical goods, such as monoclonal antibodies, antibody-drug conjugates, cell and gene
North America is expected to hold a significant position in the global contract development and manufacturing (CDMO) market share
One of the key factors driving North America's dominant position in the CDMO market is the region's pharmaceutical sector's emphasis on innovation and technological advancement. Many top-tier pharmaceutical corporations and research organizations, particularly in the United States, place an emphasis on cutting-edge drug development techniques. This emphasis on innovation encourages a collaborative atmosphere in which CDMOs can use advanced manufacturing technology and techniques to address the complicated requirements of modern pharmaceuticals. As a result, CDMOs in North America are well-equipped to tackle the complexities associated with biologics, sophisticated generics, and customized medicine, making them appealing partners for pharmaceutical corporations eager to increase their product offerings.
For instance, OmniaBio, a contract development and manufacturing organization (CDMO), has announced the inauguration of a new cell and gene therapy (CGT) manufacturing and artificial intelligence (AI) center of excellence in McMaster Innovation Park in Hamilton, Ontario, Canada. The 120,000-square-foot complex cost CAD 580 million ($417 million) to develop and will employ 250 people. OmniaBio offers services to organizations ranging from preclinical to commercial manufacturing. The new building is intended to allow the corporation to expand its reach throughout North America.
The strategic partnerships in this region, helps to propel market in this region. For instance, in March 2024, Hovione, an integrated CDMO specializing in spray drying and particle engineering, and GEA, a global process technology provider, expanded their collaboration with new development agreements, the launch of the ConsiGma CDC flex, and the installation of a new lab-scale R&D Continuous Tableting rig at Hovione's facility. The two firms combined and complementary experience of continuous tableting is being used to streamline the technology and make it more accessible to pharmaceutical customers around the world. Two teams are working together to bring continuous tableting to the same degree of maturity as batch tableting, allowing for the benefits of continuous manufacturing while minimizing the drawbacks. The presence of advanced machinery, technological advancements and strategic partnerships help to propel market in this region.
Asia Pacific is growing at the fastest pace in the global contract development and manufacturing (CDMO) market
The Asia Pacific region is emerging as the fastest-growing market for contract development and manufacturing (CDMO). This rapid rise is fueled by a number of interconnected factors, including rising pharmaceutical demand, a strong emphasis on research and development (R&D), and a substantial tendency toward outsourcing drug development and manufacturing operations. As pharmaceutical businesses aim to increase efficiency and cut costs, the Asia Pacific area has emerged as a top choice for CDMO services, owing to its lower manufacturing costs compared to North America and Europe.
The recent establishments and technological advancements propels the market in this region. For instance, in April 2024, Goldman Sachs has extended its coverage of the India CRO/CDMO (contract research organization/contract development and manufacturing organization) area as supply diversification in the global pharmaceutical sector.
The major global players in the global contract research organizations (CROs) market include Catalent Inc, Recipharm AB, Jubilant Pharmova Limited, Thermo Fisher Scientific Inc., Boehringer Ingelheim International GmbH, IQVIA, Syneos Health, Parexel International (MA) Corporation, Curia Global, Inc., NextPharma Technologies among others.
Emerging Players
Helix Biotech, Andelyn Biosciences, and Celloid among others
The global contract research organizations (CROs) market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
LIST NOT EXHAUSTIVE