![]() |
市場調査レポート
商品コード
1668168
経口固形製剤(OSD)受託製造市場- 世界の産業規模、シェア、動向、機会、予測、製品別、エンドユーザー別、地域別、競合別、2020~2030年Oral Solid dosage Contract Manufacturing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product, By End User, By Region and Competition, 2020-2030F |
||||||
カスタマイズ可能
|
経口固形製剤(OSD)受託製造市場- 世界の産業規模、シェア、動向、機会、予測、製品別、エンドユーザー別、地域別、競合別、2020~2030年 |
出版日: 2025年02月28日
発行: TechSci Research
ページ情報: 英文 182 Pages
納期: 2~3営業日
|
世界の経口固形製剤(OSD)受託製造市場は、2024年に409億2,000万米ドルと評価され、2030年までのCAGRは6.52%で、予測期間には598億6,000万米ドルに達すると予測されています。
世界の経口固形製剤(OSD)受託製造市場は、費用対効果の高い医薬品製造に対する需要の増加、製薬企業のアウトソーシング動向、医薬品製剤の技術進歩により、大幅な成長を遂げています。錠剤、カプセル剤、粉末剤などのOSD製剤は、その安定性、投与のしやすさ、保存期間の長さなどから、医薬品メーカーにとって好ましい選択肢であり続けています。製薬会社は、コストを最適化し、効率を向上させ、研究開発などのコアコンピタンスに集中するため、OSDの製造を開発・製造受託機関(CDMO)に委託するケースが増えています。このアウトソーシング動向は、専門的な専門知識と高度な製造能力を必要とする医薬品製剤の複雑化によってさらに拍車がかかっています。慢性疾患の有病率の上昇と高齢者人口の増加が、特に心血管疾患、腫瘍、中枢神経障害などの治療分野における経口固形製剤の需要を牽引しています。
市場概要 | |
---|---|
予測期間 | 2026-2030 |
市場規模:2024年 | 409億2,000万米ドル |
市場規模:2030年 | 598億6,000万米ドル |
CAGR:2025年~2030年 | 6.52% |
急成長セグメント | カプセル |
最大市場 | 北米 |
バイオアベイラビリティの向上、放出制御型製剤、患者中心の剤形など、製剤技術の進歩や革新が市場を形成しています。新規賦形剤の開発や、連続製造や3Dプリンティングなどの高度な製造技術により、製薬会社は医薬品の有効性と生産効率を向上させています。規制当局は厳格なコンプライアンス要件を重視しており、受託製造業者は一貫した製品品質を確保するため、品質管理、適正製造基準(GMP)、自動化への投資を促しています。持続可能性も重要な動向として浮上しており、環境に優しい製造プロセスの採用、廃棄物管理の最適化、二酸化炭素排出量の削減を進める企業が増えています。個別化医療や精密投与へのシフトは、より小さなバッチサイズやカスタマイズされた製剤を可能にする柔軟な製造ソリューションへの需要の高まりにつながり、この分野での技術革新をさらに促進しています。
世界のOSD受託製造市場における課題には、規制上のハードル、価格圧力、サプライチェーンの混乱などがあります。さまざまな地域にわたる厳しいコンプライアンス要件は、規制に関する専門知識や施設のアップグレードに多額の投資を要求し、受託製造業者の運営コストを増加させる。CDMO間の競合価格戦略は利益率に下方圧力をかけ、付加価値サービスや技術力による差別化が不可欠となっています。原材料の不足、輸送の遅れ、地政学的な不確実性など、サプライチェーンの複雑さは、製造スケジュールや製品の入手可能性にリスクをもたらします。知的財産に関する懸念やデータ・セキュリティの問題も、特に機密保持要件の厳しい市場においては、アウトソーシングの意思決定に影響を与えます。こうした課題にもかかわらず、市場は大きな成長機会をもたらしています。特に、強力な医薬品、小児用製剤、老人にやさしい剤形に対する需要の高まりが、高度な製剤技術や製造技術革新への投資を後押ししています。
コアコンピテンシーへの注力
品質管理と品質保証
バイオ医薬品と複雑な製剤へのシフトの高まり
Global Oral Solid dosage (OSD) Contract Manufacturing Market was valued at USD 40.92 Billion in 2024 and is expected to reach USD 59.86 Billion in the forecast period with a CAGR of 6.52% through 2030. The Global Oral Solid Dosage (OSD) Contract Manufacturing Market is witnessing substantial growth due to the increasing demand for cost-effective pharmaceutical production, outsourcing trends among pharmaceutical companies, and technological advancements in drug formulation. OSD forms, including tablets, capsules, and powders, remain the preferred choice for drug manufacturers due to their stability, ease of administration, and extended shelf life. Pharmaceutical companies are increasingly outsourcing OSD manufacturing to contract development and manufacturing organizations (CDMOs) to optimize costs, improve efficiency, and focus on core competencies such as research and development. This outsourcing trend is further fueled by the growing complexity of drug formulations, which requires specialized expertise and advanced manufacturing capabilities. The rising prevalence of chronic diseases, coupled with a growing geriatric population, is driving the demand for solid oral dosage forms, particularly in therapeutic areas such as cardiovascular diseases, oncology, and central nervous system disorders.
Market Overview | |
---|---|
Forecast Period | 2026-2030 |
Market Size 2024 | USD 40.92 Billion |
Market Size 2030 | USD 59.86 Billion |
CAGR 2025-2030 | 6.52% |
Fastest Growing Segment | Capsules |
Largest Market | North America |
Technological advancements and innovation in drug formulation are shaping the market landscape, with a focus on bioavailability enhancement, controlled-release formulations, and patient-centric dosage forms. The development of novel excipients and advanced manufacturing technologies, such as continuous manufacturing and 3D printing, is enabling pharmaceutical companies to improve drug efficacy and production efficiency. Regulatory agencies are emphasizing stringent compliance requirements, pushing contract manufacturers to invest in quality control, Good Manufacturing Practices (GMP), and automation to ensure consistent product quality. Sustainability has also emerged as a key trend, with companies increasingly adopting eco-friendly manufacturing processes, optimizing waste management, and reducing carbon footprints. The shift towards personalized medicine and precision dosing has led to increased demand for flexible manufacturing solutions that allow for smaller batch sizes and customized formulations, further driving innovation in the sector.
Challenges in the Global OSD Contract Manufacturing Market include regulatory hurdles, pricing pressures, and supply chain disruptions. Stringent compliance requirements across different regions demand substantial investments in regulatory expertise and facility upgrades, increasing operational costs for contract manufacturers. Competitive pricing strategies among CDMOs exert downward pressure on profit margins, making it essential for companies to differentiate through value-added services and technological capabilities. Supply chain complexities, including raw material shortages, transportation delays, and geopolitical uncertainties, pose risks to manufacturing timelines and product availability. Intellectual property concerns and data security issues also impact outsourcing decisions, particularly in markets with stringent confidentiality requirements. Despite these challenges, the market presents significant growth opportunities, particularly with increasing demand for high-potency drugs, pediatric formulations, and geriatric-friendly dosage forms, driving investments in advanced formulation techniques and manufacturing innovations.
Key Market Drivers
Focus on Core Competencies
Pharmaceutical companies are increasingly focusing on their core competencies, such as drug discovery, research, and commercialization, while outsourcing manufacturing to specialized contract development and manufacturing organizations (CDMOs). This strategic shift is a key driver for the Global Oral Solid Dosage (OSD) Contract Manufacturing Market, allowing pharmaceutical firms to enhance efficiency, reduce operational costs, and allocate resources toward innovation and market expansion. The complexity of modern drug development, coupled with stringent regulatory requirements, has made in-house manufacturing less viable for many companies, prompting them to rely on CDMOs that offer expertise in formulation, production, and compliance.
CDMOs provide end-to-end manufacturing solutions, including process optimization, quality control, and packaging, which help pharmaceutical companies accelerate time-to-market for new drugs. By outsourcing OSD manufacturing, companies can mitigate the risks associated with facility maintenance, equipment upgrades, and workforce management. This is particularly beneficial for small and mid-sized pharmaceutical firms that lack the infrastructure to establish large-scale production facilities. Access to advanced manufacturing technologies, such as continuous manufacturing and automation, allows pharmaceutical companies to improve product quality while ensuring regulatory adherence without making significant capital investments.
The increasing complexity of oral drug formulations, including controlled-release tablets, orally disintegrating tablets (ODTs), and high-potency active pharmaceutical ingredients (HPAPIs), has further fueled the demand for specialized CDMO services. Pharmaceutical companies seek manufacturing partners with the expertise and infrastructure to handle sophisticated formulations while maintaining production efficiency. Global pharmaceutical firms are also leveraging CDMOs to support geographic expansion, enabling localized manufacturing and regulatory compliance in multiple markets. This trend is expected to continue as companies prioritize core activities while relying on contract manufacturers to handle the complexities of large-scale OSD production. The shift toward outsourcing is transforming the pharmaceutical landscape, positioning CDMOs as essential partners in the industry's growth.
Key Market Challenges
Quality Control and Assurance
Quality Control (QC) and Quality Assurance (QA) are paramount in the Oral Solid Dosage (OSD) Contract Manufacturing Market, ensuring that pharmaceutical products meet stringent quality standards throughout the manufacturing process. QC encompasses the systematic inspection and testing of raw materials, in-process samples, and finished dosage forms to verify their compliance with predetermined specifications. This involves a series of analytical techniques, such as chromatography, spectroscopy, and dissolution testing, to assess attributes like potency, purity, and dissolution rates. Simultaneously, QA focuses on the overarching systems, procedures, and processes that safeguard product quality from the initial development phase to the final delivery of the product to the market. This includes establishing and maintaining robust quality management systems, implementing GMP guidelines, conducting audits, and overseeing compliance with regulatory requirements. In the OSD Contract Manufacturing Market, ensuring QC and QA is critical for several reasons. Firstly, pharmaceutical products must consistently meet safety and efficacy standards to protect patient health and maintain regulatory compliance. Secondly, pharmaceutical companies rely on contract manufacturers to maintain high-quality standards to safeguard their reputation and prevent regulatory penalties. Thirdly, the global nature of pharmaceutical markets means that products manufactured by OSD CMOs may need to meet different regulatory requirements in various regions, making comprehensive QA and QC systems indispensable. Finally, the complexity of OSD manufacturing processes, the multitude of dosage forms, and the evolving regulatory landscape necessitate a commitment to ongoing QA and QC improvements, including the implementation of cutting-edge analytical technologies and process controls to ensure the highest quality standards are met. Ultimately, QC and QA play a pivotal role in the OSD Contract Manufacturing Market by guaranteeing the safety, efficacy, and consistency of pharmaceutical products, fostering trust between contract manufacturers and pharmaceutical companies, and facilitating compliance with global regulatory standards.
Key Market Trends
Growing Shift towards Biopharmaceuticals and Complex Formulations
The Global Oral Solid Dosage (OSD) Contract Manufacturing Market is experiencing a significant shift towards biopharmaceuticals and complex formulations, driven by the need for innovative drug delivery solutions and enhanced patient compliance. Advancements in formulation science have enabled the development of oral solid biopharmaceuticals, including peptide and protein-based drugs, which were traditionally administered via injection. This transition to oral forms not only improves patient adherence but also broadens therapeutic options for chronic conditions such as diabetes, autoimmune disorders, and oncology. Contract Development and Manufacturing Organizations (CDMOs) are investing in specialized technologies, such as enteric coatings, lipid-based delivery systems, and nanoparticle formulations, to enhance the bioavailability and stability of these complex molecules.
The demand for high-potency active pharmaceutical ingredients (HPAPIs) is on the rise, necessitating advanced containment systems and sophisticated manufacturing capabilities. The adoption of modified-release and multi-layer tablet technologies allows for precise control over drug release profiles, thereby improving therapeutic efficacy. Pharmaceutical companies are increasingly leveraging the expertise of CDMOs in these areas to develop customized solutions that meet stringent regulatory standards while maintaining production efficiency. Continuous manufacturing processes are gaining traction, offering benefits such as improved scalability, cost reduction, and shorter production timelines compared to traditional batch processing methods.
The integration of artificial intelligence (AI) and digital analytics into formulation development is revolutionizing the industry by enabling data-driven decision-making, optimizing drug design, and accurately predicting stability outcomes. Regulatory agencies, including the U.S. Food and Drug Administration (FDA), are actively exploring the application of AI in drug manufacturing to enhance process control and product quality. Sustainability concerns are also prompting manufacturers to adopt eco-friendly excipients, solvent-free production techniques, and energy-efficient processes. As pharmaceutical pipelines increasingly incorporate biologics and complex oral formulations, CDMOs that invest in specialized capabilities, regulatory expertise, and advanced process controls are well-positioned to capitalize on this evolving market landscape.
In this report, the Global Oral Solid dosage (OSD) Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Oral Solid dosage (OSD) Contract Manufacturing Market.
Global Oral Solid dosage (OSD) Contract Manufacturing Market report with the given Market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: