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시장보고서
상품코드
1753970
의약품 연속 제조 시장 보고서 : 치료 유형별, 제제별, 용도별, 최종사용자별, 지역별(2025-2033년)Pharmaceutical Continuous Manufacturing Market Report by Therapeutics Type, Formulation, Application, End User, and Region 2025-2033 |
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세계 의약품 연속 제조 시장 규모는 2024년 15억 달러에 달했습니다. 향후 IMARC Group은 이 시장이 2033년까지 33억 달러에 달해 2025년부터 2033년까지 9.62%의 연평균 성장률(CAGR)을 기록할 것으로 예상하고 있습니다. 건강에 대한 관심의 증가와 연구개발 활동의 활성화가 시장 성장을 촉진하고 있습니다.
약물전달 시스템의 혁신
첨단 재료, 공정 분석 기술(PAT), 표적 나노 의약품과 같은 약물전달 시스템의 현대적 발전은 표적 전달, 안정성, 안정성, 실시간 모니터링, 용해도를 개선한 약물의 연속 생산 라인을 가능하게 합니다. 이러한 요인들이 결합되어 시장이 가속화되고 있습니다. 예를 들어, 국립의학도서관이 2024년 5월에 발표한 논문에 따르면, 리포솜과 지질나노입자(LNP)와 같은 기술과 스마트, 캐리어 기반, 3D 프린팅을 통한 약물전달 방법의 개발에 집중함으로써 생체 이용률이 향상되고, 기존의 한계를 극복하고, 연구가 진행될 것으로 예상됩니다. 연구 진행이 가능하다고 합니다.
제조 공정의 규제 지원
규제 기관들은 제품의 일관성 및 효율성 향상과 같은 연속 제조의 이점을 인정하고 있습니다. 이들 기관은 연속 제조 기술을 도입하기 위한 명확한 기준과 규제 경로를 제시하는 종합적인 가이드라인과 프로그램을 수립했습니다. 예를 들어, 미국 식품의약국(FDA)은 2024년 5월 희귀질환 치료제 개발을 촉진하기 위해 START 파일럿 프로그램을 시작했습니다. 이는 임상시험 지원 및 규제 지침에 중점을 두어 신제품 개발을 가속화하고 생산 요구 사항을 최적화하여 연속 생산에 이익을 가져다주고 의약품 연속 제조 시장 통계를 증가시키고 있습니다.
만성질환 발생률 증가
심혈관질환, 당뇨병, 만성 호흡기질환과 같은 만성질환이 만연함에 따라 신뢰할 수 있는 장기적인 치료에 대한 수요가 증가하고 있습니다. 연속 제조 공정은 효율성과 일관된 품질로 고품질의 의약품을 대규모로 생산할 수 있기 때문에 이러한 수요에 대응할 수 있습니다. 이에 따라, 의약품 연속 제조의 가격 추세에 따라 제조 비용과 낭비가 감소하고, 더 저렴한 가격으로 치료를 받을 수 있게 될 것입니다. 예를 들어, 2024년 2월 Public Health Research가 발표한 조사에 따르면, 미국에서는 약 1억 2,900만 명이 적어도 한 가지 이상의 주요 만성질환을 앓고 있습니다.
The global pharmaceutical continuous manufacturing market size reached USD 1.5 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 3.3 Billion by 2033, exhibiting a growth rate (CAGR) of 9.62% during 2025-2033. The rising health concerns and the increasing research and development activities are propelling the market growth.
Innovation in Drug Delivery System
Modern advances in drug delivery systems, like advanced materials, process analytical technology (PAT), and targeted nanomedicine, enable continuous production lines to produce drugs with improved targeted delivery, stability, real-time monitoring, and solubility. Collectively, these factors accelerate the market. For instance, an article published by the National Library of Medicine in May 2024 mentioned that focusing on technologies, such as liposomes and lipid nanoparticles (LNPs) and development in smart, carrier-based, and 3D-printed drug delivery methods improve bioavailability, address conventional limitations, and advance research.
Regulatory Support in Manufacturing Process
Regulatory bodies have increasingly acknowledged the benefits of continuous manufacturing, like product consistency and enhanced efficiency. These agencies established comprehensive guidelines and programs that provide clear standards and regulatory pathways for implementing continuous manufacturing technologies. For instance, in May 2024, the U.S. Food and Drug Administration (FDA) launched the START pilot program to accelerate the development of rare disease therapeutics. It focuses on clinical trial support and regulatory guidance, which benefits continuous manufacturing by accelerating novel product development and optimizing production requirements, which is increasing the pharmaceutical continuous manufacturing market statistics.
Increasing Incidence of Chronic Disease
As chronic conditions such as cardiovascular diseases, diabetes, and chronic respiratory diseases become more prevalent, there is an increased demand for reliable and long-term treatments. Continuous manufacturing processes meet this demand due to their ability to produce quality pharmaceuticals at scale with efficiency and consistent quality. In line with this, the adoption of pharmaceutical continuous manufacturing price trends reduces production costs and waste, thereby making treatments more affordable and accessible. For example, research published by Public Health Research in February 2024 showed that approximately 129 million people in the United States have at least one major chronic disease.
Small molecules dominate the pharmaceutical continuous manufacturing market
Continuous manufacturing enhances efficiency and consistency in small-molecule drugs. Vertex Pharmaceuticals introduced Suzetrigine, a small molecule drug manufactured using continuous processes, optimizing production efficiency and ensuring consistent quality for pain management.
Solid formulation currently holds most of the pharmaceutical continuous manufacturing market demand
Solid formulations, such as capsules and tablets, excel in continuous manufacturing due to improved consistency and efficiency. For example, XenoPharma's tablet production ensures uniform quality and scalable output, which is acting as another significant growth-inducing factor.
Final drug product manufacturing dominates the market
Final drug product manufacturing in continuous processes ensures efficient production with consistent quality and scalability, thereby reducing waste and enhancing overall process control. It also results in cost savings. This is bolstering the pharmaceutical continuous manufacturing market revenue.
Pharmaceutical companies hold most of the pharmaceutical continuous manufacturing market outlook
Pharmaceutical companies increasingly adopt continuous manufacturing to enhance efficiency, streamline production processes, and ensure consistent product quality. This is leading to faster and more cost-effective drug development.
North America exhibits a clear dominance, accounting for the largest pharmaceutical continuous manufacturing market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.
As per the pharmaceutical continuous manufacturing market research report, North America accounted for the largest share, driven by advanced drug delivery technologies. Moreover, regulatory bodies in the region are highly supportive of continuous manufacturing practices. The corporation with regulatory bodies encourages pharmaceutical companies to adopt continuous manufacturing solutions, thereby propelling the market growth. For instance, in May 2024, the U.S. Food and Drug Administration (FDA) introduced the START pilot program to catalyze the development of rare disease therapeutics.
The market research report has provided a comprehensive analysis of the competitive landscape. Detailed profiles of all major market pharmaceutical continuous manufacturing companies have also been provided. Some of the key players in the market include: