全球连续製药市场：增长机会

连续製造可以帮助製药公司显着加快其化学和製造过程，缩短整体製造时间表，尤其是对于关键的救命药物。 製药行业已将该技术应用于有限的过程，例如可能含有有毒试剂的批处理过程以及涉及电化学和光化学反应的放大反应。 通过引入过程分析技术 (PAT) 和数字孪生等技术改进实时决策，将能够更好地控制批次和 CM 等製造过程。

本报告审视了全球製药连续製造市场，并提供了市场概览、战略要务、增长机会等。

内容

战略要务

• 为什么增长越来越难？
• 战略要务
• 三大战略要务对连续製药行业的影响
• 增长机会加速增长管道引擎

增长机会分析

• 分析范围
• 细分
• 市场趋势分析
• 批量製造和 CM（连续製造）
• 引入 CM 的好处
• 供应商生态系统
• 司机
• 抑制生长

CM市场场景

• CM- 采用时间表 (FDA)
• CM 增长的当前市场情景
• CM-技术概述

投资趋势 - 合作与扩张

• 投资趋势 - 合作伙伴关係和扩张
• 扩大/收购设施
• 伙伴关係/协作

增长机会分析 - 全球医药 CM 市场

• 增长指数
• 预测假设
• 全球医药市场
• 收入预测
• 收入预测分析
• 区域视角

增长机会分析 - 内部与外包

增长机会分析 - 小型与大型

增长机会分析 - API 和药物

增长机会分析 - 竞争评估

竞争对手概况 - 提供 CM 服务的 CDMO

• Cambrex Corporation - 概览
• SK Biotek - 概览
• Corden Pharma-概览
• Patheon（Thermo Fisher Scientific）- 概述
• 药明生物 - 概览
• Fujifilm Diosynth Biotechnologies-Overview

CM设备製造商

• CM 设备製造商

成长机会

• 增长机会 1 - 在亚太地区推广 CM
• 增长机会 2 - 专注于流程自动化以提高生产力
• 增长机会 3 - 用于基因治疗 - 病毒载体 CM

下一步

Regulatory Acceptance Propelling Continuous Manufacturing Investments through Partnerships and In-house Expansions

Continuous manufacturing (CM) is a method for manufacturing end-to-end pharmaceutical products on a single, uninterrupted production line. While batch manufacturing requires transporting, testing, and refeeding materials from one process to the next, continuous processes execute all testing, feeding, and processing inline at a single manufacturing site. The global pharma industry is slowly shifting its focus from primary care to specialty medicine and rare diseases. To modify research and development (R&D) models to address and adapt to challenges associated with rare, ultra-rare, and specialty diseases, the strategy is changing from being present in a few large segments to many small segments and exploring new disease areas with high unmet needs.

CM helps pharma companies significantly speed up the chemistry and manufacturing processes, which can cut down on the overall manufacturing timelines, especially in critical life-saving drugs. To date, the US Food and Drug Administration (FDA) has approved the manufacture of over 7 drugs using continuous processes, which started off from only one product less than 4 years ago. In 2020 alone, the FDA approved 4 new drugs to be manufactured using CM. Alongside the FDA, health authorities in Canada, Europe, Australia, Japan, Switzerland, and New Zealand have approved CM application for the production of solid oral dosage forms, indicating the growing acceptance of the technology worldwide.

With such nascent technology, the pharma industry has been applying the technique for processes that are off limits for batch processes, which might include toxic reagents, and for scale-up reactions that include electrochemical or photochemical reactions. Implementing technologies, such as process analytical technology (PAT) and digital twins, for improved real-time decision making will allow for the better control of manufacturing processes, including batch and CM.

Considering the large-scale benefits of flexibility and timeline management and a quantifiable reduction in the cost of manufacturing through automated processes and better resource management, CM is expected to witness large-scale adoption in the form of integrated processes. Furthermore, the ecosystem is currently focused on pharma companies that take the majority share, in terms of setting up facilities. Contract development and manufacturing organizations (CDMOs), however, are slowly expanding their facilities by collaborating with CM platform vendors, with system integrators and automation experts providing additional support in the optimization manufacturing value chain. In the coming years, as the regulatory and operational benefits become more realized, CDMOs and pharma companies will likely continue enhancing and building their CM capabilities and expertise to remain competitive.

Table of Contents

Strategic Imperatives

• Why is it Increasingly Difficult to Grow?
• The Strategic Imperative 8™
• The Impact of the Top 3 Strategic Imperatives on the Pharmaceutical Continuous Manufacturing (CM) Industry
• Growth Opportunities Fuel the Growth Pipeline Engine™

Growth Opportunity Analysis

• Scope of Analysis
• Segmentation
• Market Trend Analysis
• Market Trend Analysis (continued)
• Batch Manufacturing versus CM
• Batch Manufacturing versus CM (continued)
• Benefits of Adopting CM
• Vendor Ecosystem
• Growth Drivers
• Growth Restraints

CM Market Scenario

• CM-Adoption Timeline (FDA)
• CM-Adoption Timeline (FDA) (continued)
• Current Market Scenario of CM Growth
• CM-Technology Overview

Investment Trends-Partnerships and Expansions

• Investment Trends-Partnerships and Expansions
• Facility Expansions/Acquisitions
• Facility Expansions/Acquisitions (continued)
• Facility Expansions/Acquisitions (continued)
• Facility Expansions/Acquisitions (continued)
• Partnerships/Collaborations
• Partnerships/Collaborations (continued)
• Partnerships/Collaborations (continued)
• Partnerships/Collaborations (continued)

Growth Opportunity Analysis-Global Pharmaceutical CM Market

• Growth Metrics
• Forecast Assumptions
• Forecast Assumptions (continued)
• Global Pharmaceutical Market
• Revenue Forecast
• Revenue Forecast Analysis
• Revenue Forecast Analysis (continued)
• Regional Perspective

Growth Opportunity Analysis-In-house versus Outsourced

• Revenue Forecast-In-house versus Outsourced
• Percent Revenue Forecast-In-house versus Outsourced
• Revenue Forecast Analysis-In-house versus Outsourced
• Revenue Forecast Analysis-In-house versus Outsourced (continued)

Growth Opportunity Analysis-Small Molecules versus Large Molecules

• Revenue Forecast-Small Molecules versus Large Molecules
• Percent Revenue Forecast-Small Molecules versus Large Molecules
• Revenue Forecast Analysis-Small Molecules versus Large Molecules

Growth Opportunity Analysis-Drug Substance versus Drug Product

• Revenue Forecast-DS versus DP (Large Molecules)
• Revenue Forecast-API versus FDF (Small Molecules)
• Revenue Forecast Analysis by Segments

Growth Opportunity Analysis-Competitor Assessment

• Competitive Environment
• Key Competitors by Region-End Users

Competitor Profiles-CDMOs Providing CM Services

• Cambrex Corporation-Overview
• Cambrex Corporation-Overview (continued)
• SK Biotek-Overview
• SK Biotek-Overview (continued)
• Corden Pharma-Overview
• Corden Pharma-Overview (continued)
• Patheon (Thermo Fisher Scientific)-Overview
• Patheon (Thermo Fisher Scientific)-Overview (continued)
• Wuxi Biologics-Overview
• Wuxi Biologics-Overview (continued)
• Fujifilm Diosynth Biotechnologies-Overview
• Fujifilm Diosynth Biotechnologies-Overview (continued)

CM-Equipment Manufacturers

• CM-Equipment Manufacturers
• CM-Equipment Manufacturers (continued)

Growth Opportunity Universe

• Growth Opportunity 1-Capability Expansion for CM in APAC
• Growth Opportunity 1-Capability Expansion for CM in APAC (continued)
• Growth Opportunity 2-Focus on Process Automation for Enhanced Productivity
• Growth Opportunity 2-Focus on Process Automation for Enhanced Productivity (continued)
• Growth Opportunity 3-Viral Vector CM for Gene Therapy
• Growth Opportunity 3-Viral Vector CM for Gene Therapy (continued)

Next Steps

• Your Next Steps
• Why Frost, Why Now?
• List of Exhibits
• Legal Disclaimer