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市场调查报告书
商品编码
1668168
口服固体剂型合约製造市场 - 全球产业规模、份额、趋势、机会和预测,按产品、最终用户、地区和竞争细分,2020-2030 年预测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 |
2024 年全球口服固体剂量 (OSD) 合约製造市场价值为 409.2 亿美元,预计到 2030 年将达到 598.6 亿美元,复合年增长率为 6.52%。全球口服口服剂量 (OSD) 合约製造市场正在经历大幅成长,原因是对具有成本效益的药物生产的需求量增加药物以及药物生产的技术趋势以及药物生产的技术趋势以及药物生产的需求以及製药公司。 OSD 形式,包括片剂、胶囊和粉末,由于其稳定性、易于给药和延长的保质期,仍然是药品製造商的首选。製药公司越来越多地将 OSD 製造外包给合约开发和製造组织 (CDMO),以优化成本、提高效率并专注于研发等核心竞争力。药物配方日益复杂,需要专业知识和先进的製造能力,这进一步推动了这种外包趋势。慢性病盛行率的上升,加上老年人口的不断增长,推动了对固体口服剂型的需求,特别是在心血管疾病、肿瘤学和中枢神经系统疾病等治疗领域。
市场概况 | |
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预测期 | 2026-2030 |
2024 年市场规模 | 409.2 亿美元 |
2030 年市场规模 | 598.6 亿美元 |
2025-2030 年复合年增长率 | 6.52% |
成长最快的领域 | 胶囊 |
最大的市场 | 北美洲 |
药物配方的技术进步和创新正在塑造市场格局,重点是提高生物利用度、控释配方和以患者为中心的剂型。新型辅料和连续製造、3D列印等先进製造技术的开发,使製药公司能够提高药物功效和生产效率。监管机构正在强调严格的合规要求,推动合约製造商投资于品质控制、良好生产规范 (GMP) 和自动化,以确保产品品质的一致性。永续性也已成为一个主要趋势,越来越多的公司采用环保製造流程、优化废弃物管理并减少碳足迹。个人化医疗和精准剂量的转变导致对灵活製造解决方案的需求增加,这些解决方案允许更小的批量和定製配方,从而进一步推动该领域的创新。
全球OSD合约製造市场面临的挑战包括监管障碍、定价压力和供应链中断。不同地区的严格合规要求要求在监管专业知识和设施升级方面进行大量投资,从而增加了合约製造商的营运成本。 CDMO 之间的竞争性定价策略对利润率造成了下行压力,因此企业必须透过增值服务和技术能力来实现差异化。供应链的复杂性,包括原材料短缺、运输延误和地缘政治不确定性,对製造时间表和产品可用性构成风险。智慧财产权问题和资料安全问题也会影响外包决策,特别是在保密要求严格的市场。儘管面临这些挑战,但市场仍呈现出巨大的成长机会,特别是对高效药物、儿科製剂和老年人友善剂型的需求不断增加,推动了对先进製剂技术和製造创新的投资。
专注于核心竞争力
品质控制和保证
生物製药和复杂配方的日益转变
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 | |
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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: