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

발행일: | 리서치사: IMARC | 페이지 정보: 영문 150 Pages | 배송안내 : 2-3일 (영업일 기준)

    
    
    




※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.

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.

의약품 연속 제조 시장 분석:

  • 주요 시장 촉진요인 : 제품 품질 향상, 오염 위험 감소, 제조 공정의 실시간 모니터링 가능성으로 인해 규제 기관은 연속 제조를 지지하고 있습니다.
  • 주요 시장 동향 : 효과적인 의약품 제조 시스템에 대한 수요 증가가 시장 성장에 긍정적인 영향을 미치고 있습니다.
  • 경쟁 상황 : 이 시장의 주요 기업으로는 Baker Perkins, Coperion GmbH(Hillenbrand Inc.), Eli Lilly and Company, GEA Group Aktiengesellschaft, Glatt GmbH, Korsch AG, Novartis AG, Siemens, SK biotek, Thermo Fisher Scientific Inc., Viatris Inc. 등이 있습니다.
  • 지리적 동향 : 북미는 첨단 기술 인프라로 인해 시장에서 뚜렷한 우위를 보이고 있습니다. 이와는 별도로, 이 지역의 고도로 숙련된 노동력과 강력한 규제 지원은 시장 성장을 가속화하고 있습니다.
  • 도전과 기회 : 높은 시스템 비용이 시장의 걸림돌로 작용하고 있습니다. 그러나 업계의 협력과 자원 공유는 비용과 지식의 분산에 도움이 되어 시장 성장을 강화하고 있습니다.

의약품 연속 제조 시장 동향:

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.

목차

제1장 서문

제2장 조사 범위와 조사 방법

  • 조사 목적
  • 이해관계자
  • 데이터 소스
    • 1차 정보
    • 2차 정보
  • 시장 추정
    • 상향식 접근
    • 하향식 접근
  • 조사 방법

제3장 주요 요약

제4장 소개

  • 개요
  • 주요 업계 동향

제5장 세계의 의약품 연속 제조 시장

  • 시장 개요
  • 시장 실적
  • COVID-19의 영향
  • 시장 예측

제6장 시장 내역 : 치료 유형별

  • 고분자
  • 저분자

제7장 시장 내역 : 제제별

  • 고형 제제
  • 액체·반고체 제제

제8장 시장 내역 : 용도별

  • 최종 의약품 제조
  • API 제조

제9장 시장 내역 : 최종사용자별

  • 제약 기업
  • CMO
  • 기타

제10장 시장 내역 : 지역별

  • 북미
    • 미국
    • 캐나다
  • 아시아태평양
    • 중국
    • 일본
    • 인도
    • 한국
    • 호주
    • 인도네시아
    • 기타
  • 유럽
    • 독일
    • 프랑스
    • 영국
    • 이탈리아
    • 스페인
    • 러시아
    • 기타
  • 라틴아메리카
    • 브라질
    • 멕시코
    • 기타
  • 중동 및 아프리카
    • 시장 내역 : 국가별

제11장 SWOT 분석

  • 개요
  • 강점
  • 약점
  • 기회
  • 위협

제12장 밸류체인 분석

제13장 Porter's Five Forces 분석

  • 개요
  • 구매자의 교섭력
  • 공급 기업의 교섭력
  • 경쟁 정도
  • 신규 참여업체의 위협
  • 대체품의 위협

제14장 가격 분석

제15장 경쟁 구도

  • 시장 구조
  • 주요 기업
  • 주요 기업 개요
    • Baker Perkins
    • Coperion GmbH(Hillenbrand Inc.)
    • Eli Lilly and Company
    • GEA Group Aktiengesellschaft
    • Glatt GmbH
    • Korsch AG
    • Novartis AG
    • Siemens
    • SK biotek
    • Thermo Fisher Scientific Inc.
    • Viatris Inc.
ksm 25.06.30

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.

Pharmaceutical Continuous Manufacturing Market Analysis:

  • Major Market Drivers: Regulatory agencies are supportive of continuous manufacturing due to its potential to enhance product quality, reduce contamination risks, and provide real-time monitoring of the production process.
  • Key Market Trends: The rising demand for effective medicine production systems is positively impacting the market growth.
  • Competitive Landscape: Some of the prominent companies in the market include Baker Perkins, Coperion GmbH (Hillenbrand Inc.), Eli Lilly and Company, GEA Group Aktiengesellschaft, Glatt GmbH, Korsch AG, Novartis AG, Siemens, SK biotek, Thermo Fisher Scientific Inc., and Viatris Inc., among many others.
  • Geographical Trends: North America exhibits a clear dominance in the market due to its advanced technological infrastructure. Apart from this, the region's highly skilled workforce and strong regulatory support accelerate the market growth.
  • Challenges and Opportunities: The high cost of systems is hindering the market. However, industry collaborations and shared resources help in distributing the cost and knowledge, which strengthens the market growth.

Pharmaceutical Continuous Manufacturing Market Trends:

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.

Global Pharmaceutical Continuous Manufacturing Industry Segmentation:

Breakup by Therapeutics Type:

  • Large Molecules
  • Small Molecules

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.

Breakup by Formulation:

  • Solid Formulation
  • Liquid and Semi-solid Formulation

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.

Breakup by Application:

  • Final Drug Product Manufacturing
  • API Manufacturing

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.

Breakup by End User:

  • Pharmaceutical Companies
  • Contract Manufacturing Organizations
  • Others

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.

Breakup by Region:

  • North America
    • United States
    • Canada
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Indonesia
    • Others
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Russia
    • Others
  • Latin America
    • Brazil
    • Mexico
    • Others
  • Middle East and Africa

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.

Competitive Landscape:

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:

  • Baker Perkins
  • Coperion GmbH (Hillenbrand Inc.)
  • Eli Lilly and Company
  • GEA Group Aktiengesellschaft
  • Glatt GmbH
  • Korsch AG
  • Novartis AG
  • Siemens
  • SK biotek
  • Thermo Fisher Scientific Inc.
  • Viatris Inc.

Key Questions Answered in This Report

  • 1.How big is the global pharmaceutical continuous manufacturing market?
  • 2.What is the expected growth rate of the global pharmaceutical continuous manufacturing market during 2025-2033?
  • 3.What are the key factors driving the global pharmaceutical continuous manufacturing market?
  • 4.What has been the impact of COVID-19 on the global pharmaceutical continuous manufacturing market growth?
  • 5.What is the breakup of the global pharmaceutical continuous manufacturing market based on the therapeutics type?
  • 6.What is the breakup of the global pharmaceutical continuous manufacturing market based on formulation?
  • 7.What is the breakup of the global pharmaceutical continuous manufacturing market based on the application?
  • 8.What is the breakup of the global pharmaceutical continuous manufacturing market based on the end user?
  • 9.What are the key regions in the global pharmaceutical continuous manufacturing market?
  • 10.Who are the key players/companies in the global pharmaceutical continuous manufacturing market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Pharmaceutical Continuous Manufacturing Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Therapeutics Type

  • 6.1 Large Molecules
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Small Molecules
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast

7 Market Breakup by Formulation

  • 7.1 Solid Formulation
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Liquid and Semi-solid Formulation
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast

8 Market Breakup by Application

  • 8.1 Final Drug Product Manufacturing
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 API Manufacturing
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast

9 Market Breakup by End User

  • 9.1 Pharmaceutical Companies
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 Contract Manufacturing Organizations
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast
  • 9.3 Others
    • 9.3.1 Market Trends
    • 9.3.2 Market Forecast

10 Market Breakup by Region

  • 10.1 North America
    • 10.1.1 United States
      • 10.1.1.1 Market Trends
      • 10.1.1.2 Market Forecast
    • 10.1.2 Canada
      • 10.1.2.1 Market Trends
      • 10.1.2.2 Market Forecast
  • 10.2 Asia-Pacific
    • 10.2.1 China
      • 10.2.1.1 Market Trends
      • 10.2.1.2 Market Forecast
    • 10.2.2 Japan
      • 10.2.2.1 Market Trends
      • 10.2.2.2 Market Forecast
    • 10.2.3 India
      • 10.2.3.1 Market Trends
      • 10.2.3.2 Market Forecast
    • 10.2.4 South Korea
      • 10.2.4.1 Market Trends
      • 10.2.4.2 Market Forecast
    • 10.2.5 Australia
      • 10.2.5.1 Market Trends
      • 10.2.5.2 Market Forecast
    • 10.2.6 Indonesia
      • 10.2.6.1 Market Trends
      • 10.2.6.2 Market Forecast
    • 10.2.7 Others
      • 10.2.7.1 Market Trends
      • 10.2.7.2 Market Forecast
  • 10.3 Europe
    • 10.3.1 Germany
      • 10.3.1.1 Market Trends
      • 10.3.1.2 Market Forecast
    • 10.3.2 France
      • 10.3.2.1 Market Trends
      • 10.3.2.2 Market Forecast
    • 10.3.3 United Kingdom
      • 10.3.3.1 Market Trends
      • 10.3.3.2 Market Forecast
    • 10.3.4 Italy
      • 10.3.4.1 Market Trends
      • 10.3.4.2 Market Forecast
    • 10.3.5 Spain
      • 10.3.5.1 Market Trends
      • 10.3.5.2 Market Forecast
    • 10.3.6 Russia
      • 10.3.6.1 Market Trends
      • 10.3.6.2 Market Forecast
    • 10.3.7 Others
      • 10.3.7.1 Market Trends
      • 10.3.7.2 Market Forecast
  • 10.4 Latin America
    • 10.4.1 Brazil
      • 10.4.1.1 Market Trends
      • 10.4.1.2 Market Forecast
    • 10.4.2 Mexico
      • 10.4.2.1 Market Trends
      • 10.4.2.2 Market Forecast
    • 10.4.3 Others
      • 10.4.3.1 Market Trends
      • 10.4.3.2 Market Forecast
  • 10.5 Middle East and Africa
    • 10.5.1 Market Trends
    • 10.5.2 Market Breakup by Country
    • 10.5.3 Market Forecast

11 SWOT Analysis

  • 11.1 Overview
  • 11.2 Strengths
  • 11.3 Weaknesses
  • 11.4 Opportunities
  • 11.5 Threats

12 Value Chain Analysis

13 Porters Five Forces Analysis

  • 13.1 Overview
  • 13.2 Bargaining Power of Buyers
  • 13.3 Bargaining Power of Suppliers
  • 13.4 Degree of Competition
  • 13.5 Threat of New Entrants
  • 13.6 Threat of Substitutes

14 Price Analysis

15 Competitive Landscape

  • 15.1 Market Structure
  • 15.2 Key Players
  • 15.3 Profiles of Key Players
    • 15.3.1 Baker Perkins
      • 15.3.1.1 Company Overview
      • 15.3.1.2 Product Portfolio
    • 15.3.2 Coperion GmbH (Hillenbrand Inc.)
      • 15.3.2.1 Company Overview
      • 15.3.2.2 Product Portfolio
    • 15.3.3 Eli Lilly and Company
      • 15.3.3.1 Company Overview
      • 15.3.3.2 Product Portfolio
      • 15.3.3.3 Financials
      • 15.3.3.4 SWOT Analysis
    • 15.3.4 GEA Group Aktiengesellschaft
      • 15.3.4.1 Company Overview
      • 15.3.4.2 Product Portfolio
      • 15.3.4.3 Financials
      • 15.3.4.4 SWOT Analysis
    • 15.3.5 Glatt GmbH
      • 15.3.5.1 Company Overview
      • 15.3.5.2 Product Portfolio
    • 15.3.6 Korsch AG
      • 15.3.6.1 Company Overview
      • 15.3.6.2 Product Portfolio
    • 15.3.7 Novartis AG
      • 15.3.7.1 Company Overview
      • 15.3.7.2 Product Portfolio
      • 15.3.7.3 Financials
      • 15.3.7.4 SWOT Analysis
    • 15.3.8 Siemens
      • 15.3.8.1 Company Overview
      • 15.3.8.2 Product Portfolio
      • 15.3.8.3 Financials
      • 15.3.8.4 SWOT Analysis
    • 15.3.9 SK biotek
      • 15.3.9.1 Company Overview
      • 15.3.9.2 Product Portfolio
    • 15.3.10 Thermo Fisher Scientific Inc.
      • 15.3.10.1 Company Overview
      • 15.3.10.2 Product Portfolio
      • 15.3.10.3 Financials
      • 15.3.10.4 SWOT Analysis
    • 15.3.11 Viatris Inc.
      • 15.3.11.1 Company Overview
      • 15.3.11.2 Product Portfolio
      • 15.3.11.3 Financials
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