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시장보고서
상품코드
1668168
경구 고형 제제(OSD) 수탁제조 시장 : 세계 산업 규모, 점유율, 동향, 기회, 예측 - 제품별, 최종사용자별, 지역별, 경쟁별(2020-2030년)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 |
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세계의 경구 고형 제제(OSD) 수탁제조 시장은 2024년에 409억 2,000만 달러로 평가되며, 2030년까지 CAGR은 6.52%로, 예측 기간에는 598억 6,000만 달러에 달할 것으로 예측됩니다.
세계 경구용 고형제(OSD) 수탁제조 시장은 비용 효율적인 의약품 제조에 대한 수요 증가, 제약사의 아웃소싱 동향, 의약품 제제의 기술 발전으로 인해 크게 성장하고 있습니다. 정제, 캡슐제, 분말제 등 OSD 제제는 안정성, 투여 용이성, 긴 저장 기간 등으로 인해 제약사들에게 선호되는 선택이 되고 있습니다. 제약사들은 비용 최적화, 효율성 향상, 연구개발 등 핵심 역량에 집중하기 위해 OSD 제조를 개발 및 제조수탁기관(CDMO)에 위탁하는 사례가 증가하고 있습니다. 이러한 아웃소싱 추세는 전문적인 전문지식과 첨단 제조 역량을 필요로 하는 의약품 제제의 복잡성으로 인해 더욱 가속화되고 있습니다. 만성질환의 유병률 증가와 노인 인구 증가는 특히 심혈관 질환, 종양, 중추신경계 질환 등의 치료 분야에서 경구용 고형제제 수요를 견인하고 있습니다.
| 시장 개요 | |
|---|---|
| 예측 기간 | 2026-2030년 |
| 시장 규모 : 2024년 | 409억 2,000만 달러 |
| 시장 규모 : 2030년 | 598억 6,000만 달러 |
| CAGR: 2025-2030년 | 6.52% |
| 급성장 부문 | 캡슐 |
| 최대 시장 | 북미 |
생체 이용률 향상, 방출 제어형 제제, 환자 중심의 제형 등 제제 기술의 발전과 혁신이 시장을 형성하고 있습니다. 새로운 부형제 개발, 연속 생산 및 3D 프린팅과 같은 첨단 제조 기술을 통해 제약사들은 의약품의 효능과 생산 효율을 향상시키고 있습니다. 규제 당국은 엄격한 컴플라이언스 요건을 강조하고 있으며, 수탁제조업체는 일관된 제품 품질을 보장하기 위해 품질관리, 우수 제조 기준(GMP) 및 자동화에 대한 투자를 장려하고 있습니다. 지속가능성도 중요한 동향으로 부상하고 있으며, 친환경 제조 공정 채택, 폐기물 관리 최적화, 이산화탄소 배출량 감축을 추진하는 기업이 증가하고 있습니다. 맞춤형 의료와 정밀 투여로의 전환은 더 작은 배치 크기와 맞춤형 제형을 가능하게 하는 유연한 제조 솔루션에 대한 수요 증가로 이어져 이 분야의 기술 혁신을 더욱 촉진하고 있습니다.
세계 OSD 수탁제조 시장이 해결해야 할 과제는 규제적 장애물, 가격 압력, 공급망 혼란 등 여러 가지가 있습니다. 다양한 지역의 엄격한 규제 준수 요건은 규제 전문 지식과 시설 업그레이드에 많은 투자를 요구하고, CDMO의 운영 비용을 증가시키며, CDMO 간의 경쟁적인 가격 전략은 이익률에 하락 압력을 가하고, 부가가치 서비스 및 기술력 차별화가 필수적입니다. 원자재 부족, 운송 지연, 지정학적 불확실성 등 공급망의 복잡성은 제조 일정과 제품 가용성에 위험을 초래할 수 있습니다. 지적재산권 및 데이터 보안 문제도 특히 기밀 유지 요건이 까다로운 시장에서는 아웃소싱 의사결정에 영향을 미칩니다. 이러한 문제에도 불구하고 시장은 큰 성장 기회를 제공합니다. 특히 강력한 의약품, 소아용 의약품, 고령자 친화적 제형에 대한 수요가 증가하면서 첨단 제형 기술 및 제조 혁신에 대한 투자가 증가하고 있습니다.
핵심 역량에 집중
품질관리 및 품질 보증
바이오의약품과 복잡한 제제로의 이동 증가
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: