![]() |
市場調查報告書
商品編碼
1668168
口服固體劑型合約製造市場 - 全球產業規模、佔有率、趨勢、機會和預測,按產品、最終用戶、地區和競爭細分,2020-2030 年預測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 年全球口服固體劑量 (OSD) 合約製造市場價值為 409.2 億美元,預計到 2030 年將達到 598.6 億美元,複合年成長率為 6.52%。全球口服口服劑量 (OSD) 合約製造市場正在經歷大幅成長,原因是對具有成本效益的藥物生產的需求量增加藥物以及藥物生產的技術趨勢以及藥物生產的技術趨勢以及藥物生產的需求以及製藥公司。 OSD 形式,包括片劑、膠囊和粉末,由於其穩定性、易於給藥和延長的保存期限,仍然是藥品製造商的首選。製藥公司擴大將 OSD 製造外包給合約開發和製造組織 (CDMO),以最佳化成本、提高效率並專注於研發等核心競爭力。藥物配方日益複雜,需要專業知識和先進的製造能力,這進一步推動了這種外包趨勢。慢性病盛行率的上升,加上老年人口的不斷成長,推動了對固體口服劑型的需求,特別是在心血管疾病、腫瘤學和中樞神經系統疾病等治療領域。
市場概況 | |
---|---|
預測期 | 2026-2030 |
2024 年市場規模 | 409.2 億美元 |
2030 年市場規模 | 598.6 億美元 |
2025-2030 年複合年成長率 | 6.52% |
成長最快的領域 | 膠囊 |
最大的市場 | 北美洲 |
藥物配方的技術進步和創新正在塑造市場格局,重點是提高生物利用度、控釋配方和以患者為中心的劑型。新型輔料和連續製造、3D列印等先進製造技術的開發,使製藥公司能夠提高藥物功效和生產效率。監管機構正在強調嚴格的合規要求,推動合約製造商投資於品質控制、良好生產規範 (GMP) 和自動化,以確保產品品質的一致性。永續性也已成為一個主要趨勢,越來越多的公司採用環保製造流程、最佳化廢棄物管理並減少碳足跡。個人化醫療和精準劑量的轉變導致對靈活製造解決方案的需求增加,這些解決方案允許更小的批量和定製配方,從而進一步推動該領域的創新。
全球OSD合約製造市場面臨的挑戰包括監管障礙、定價壓力和供應鏈中斷。不同地區的嚴格合規要求要求在監管專業知識和設施升級方面進行大量投資,從而增加了合約製造商的營運成本。 CDMO 之間的競爭性定價策略對利潤率造成了下行壓力,因此企業必須透過增值服務和技術能力來實現差異化。供應鏈的複雜性,包括原料短缺、運輸延誤和地緣政治不確定性,對製造時間表和產品可用性構成風險。智慧財產權問題和資料安全問題也會影響外包決策,特別是在保密要求嚴格的市場。儘管面臨這些挑戰,但市場仍呈現出巨大的成長機會,特別是對高效藥物、兒科製劑和老年人友善劑型的需求不斷增加,推動了對先進製劑技術和製造創新的投資。
專注於核心競爭力
品質控制和保證
生物製藥和複雜配方的日益轉變
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: