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全球生物製剂合约製造市场 - 按提供的服务类型、按製造的生物製剂类型、按使用的表达系统类型、按业务规模、按公司规模、按关键地区：行业趋势和全球预测（2022-2035）
市场调查报告书
商品编码
1398313

全球生物製剂合约製造市场 - 按提供的服务类型、按製造的生物製剂类型、按使用的表达系统类型、按业务规模、按公司规模、按关键地区：行业趋势和全球预测（2022-2035）

Biologics Contract Manufacturing Market by Type of Service Offered, Type of Biologic Manufactured, Type of Expression System Used, Scale of Operation, Company Size, and Key Geographical Regions : Industry Trends and Global Forecasts, 2022 - 2035
出版日期: | 出版商: Roots Analysis | 英文 799 Pages | 商品交期: 最快1-2个工作天内

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简介目录

2023 年，全球生物製品合约製造市场价值为 190 亿美元，在预测期内（2023-2035 年）复合年增长率为 9%。

生物製药合约製造市场被认为是生物製药 CMO（合约製造商）行业，已显示出强劲的活力和快速扩张，许多企业实体投资于研发以开拓新的治疗方法。 这些创新包括抗体药物偶联物、生物相似药以及细胞和基因疗法。 多年来，全球这个快速成长的市场中已经出现了 250 多种生物疗法和疫苗。 值得注意的是，生物製剂比传统小分子药物具有更高的成功率，因为它们的脱靶毒性较小，这是小分子药物开发的重大挫折。

随着人们对生物製剂的兴趣增加，製药业的投资已从小分子药物明显转向生物製剂。 这一转变，加上持续的科学进步和 FDA 批准的生物製剂的激增，预示着生物製剂时代的开始。 生物製药有望从根本上塑造製药业，并成为传统医学不可或缺的一部分。

这些服务提供者提供全面的解决方案，包括生物製程开发和优化、加快工作进度并降低与製造复杂生物製剂相关的高昂成本。这就是我的目标。 一些製造商可能会外包某些任务，以利用最先进的设备和专业知识。 尤其是当合约製造商采用软体驱动的机器人等尖端技术来增强製造流程并降低与体力劳动相关的风险时。 随着外包作为该领域可行且利润丰厚的商业模式变得流行，全球生物製品合约製造市场预计将在预测期内显着增长。

本报告分析了全球生物製品合约製造市场，概述了技术和服务、生产的生物製品类型、总体市场规模趋势预测、按细分市场和地区划分的详细趋势、资本交易和业务趋势近期市场的联盟情况，以及主要BCMO（生物製药CMO）概述。

市场主要参与者

  • AGC Biologics
  • Boehringer Ingelheim
  • Catalent
  • Cell Therapies
  • Charles River Laboratories
  • FUJIFILM Diosynth Biotechnologies
  • KBI Biopharma
  • Kemwell Biopharma
  • Lonza
  • Miltenyi Biotec
  • Minaris Regenerative Medicine
  • Samsung Biologics
  • Sandoz
  • Vetter Pharma
  • Wuxi Biologics

目录

第一章简介

第二章分析方法

第 3 章经济与其他专案特定考量

第 4 章执行摘要

第 5 章简介

  • 分析概述
  • 生物製药概述
  • 生物製药表达系统
  • 生物製药製造工艺
  • 合约製造概要
  • 需要外包生物製药製造业务
  • 选择合约製造伙伴时的主要考量因素
  • 未来前景

第六章市场状况

  • 分析概述
  • 生物製药合约製造商：整体市场情势

第七章分地区产能分析

  • 分析概述
  • 关键先决条件与参数
  • 生物製药合约生产设施概览
  • 按地区划分的产能分析：北美生物製药合约生产设施
  • 按地区划分的产能分析：欧洲生物製药合约生产设施
  • 按地区划分的产能分析：亚太地区生物製药合约生产设施
  • 按地区划分的产能分析：世界其他地区的生物製药合约生产设施

第 8 章北美生物製药合约製造

  • 分析概述
  • 美国生物製药合约製造：监管情景
  • 北美主要生物製药 CMO
  • 北美其他主要生物製药 CMO

第 9 章欧洲生物製药合约製造

  • 分析概述
  • 欧洲生物製药合约製造：监管情景
  • 欧洲领先的生物製药 CMO
  • 欧洲其他主要生物製药 CMO

第十章亚太及其他地区生物製药合约生产

  • 分析概述
  • 中国的生物製药合约製造
  • 中国主要生物製药CMO
  • 印度的生物製药合约製造
  • 印度领先的生物製药 CMO
  • 日本的生物製药合约製造
  • 日本主要生物製药CMO
  • 韩国的生物製药合约製造
  • 韩国主要生物製药CMO
  • 澳洲的生物製药合约製造
  • 澳洲领先的生物製药 CMO
  • 亚太地区和世界其他地区 (ROW) 领先的生物製药 CMO

第11章利基生物药学领域

  • 分析概述
  • 双特异性抗体
  • 抗体药物偶联物 (ADC)
  • 细胞疗法
  • 基因治疗
  • 病毒载体
  • 质粒 DNA

第 12 章案例研究：生物相似药的合约生产

  • 分析概述
  • 生物相似药概述
  • 生物相似药开发阶段
  • 生物相似药许可的监管要求
  • 需要外包製造业务
  • 生物相似药对全球合约製造市场的影响
  • 生物相似药合约製造服务提供商
  • 与生物相似药製造业务外包相关的问题

第13章案例研究：小分子药物与高分子药物/疗法的比较

  • 分析概述
  • 小分子与大分子药物/疗法

第 14 章个案研究：内部生产

  • 分析概述
  • 内部生产
  • 生物製药产业外包趋势
  • 用于核准的生物製品的製造方法（2016-2022）
  • 选择正确的策略：内部与外包

第 15 章 "自製还是外购：决策架构"

  • 分析概述
  • 关键先决条件与参数
  • 生物製药合约製造商： "製造与采购" 决策
  • 结论

第十六章主要药厂的举措

  • 分析概述
  • 主要製药公司的生物製药相关举措

第十七章商业伙伴/合作

  • 分析概述
  • 业务伙伴模式
  • 生物製药的合约生产：商业联盟/合作

第十八章企业併购（M&A）

  • 分析概述
  • 併购模式
  • 生物製药合约生产：併购
  • 主要收购：交易倍数

第十九章近期扩充

  • 分析概述
  • 生物製药合约製造：近期扩张

第 20 章近期趋势

  • 分析概述
  • 资金类型
  • 生物製药代工：融资与投资分析
  • 技术进步

第21章产能分析

  • 分析概述
  • 重要假设与分析方法
  • 生物製药合约製造：全球已安装生产能力
  • 结论

第22章需求分析

  • 分析概述
  • 重要假设与分析方法
  • 世界对生物製药的需求
  • 全球对新兴新型生物製剂的需求

第 23 章生物製药合约製造组织的总拥有成本

  • 分析概述
  • 主要参数
  • 假设和分析方法
  • 总拥有成本（范例资料集）
  • 中型生物製药合约製造组织的总拥有成本（2000-2020 年）
  • 大型/超大型生物製药合约製造组织的总拥有成本（2000-2020 年）

第24章全球生物製药合约製造市场

  • 分析概述
  • 假设和分析方法
  • 全球生物製药合约製造市场、过去趋势（2018-2022 年）和预测（2023-2035 年）
  • 主要市场细分

第 25 章生物製药合约製造市场：依提供的服务类型划分

  • 分析概述
  • 重要假设与分析方法
  • 生物製药合约製造市场：依提供的服务类型划分（2018 年、2023 年、2035 年）
  • 数据测量与验证

第 26 章生物製药合约製造市场：依生产的生物製品类型划分

  • 分析概述
  • 重要假设与分析方法
  • 生物製药合约製造市场：依生产的生物製药类型划分（2018 年、2023 年、2035 年）
  • 数据测量与验证

第 27 章生物製药合约製造市场：依所用表达系统类型划分

  • 分析概述
  • 重要假设与分析方法
  • 生物製药合约製造市场：依所用表达系统类型划分（2018 年、2023 年、2035 年）
  • 数据测量与验证

第 28 章生物製药合约製造市场：依业务规模划分

  • 分析概述
  • 重要假设与分析方法
  • 生物製药合约製造市场：依业务规模划分（2018 年、2023 年、2035 年）
  • 数据测量与验证

第 29 章生物製药合约製造市场：依公司规模划分

  • 分析概述
  • 重要假设与分析方法
  • 生物製药合约製造市场：依公司规模划分（2018 年、2023 年、2035 年）
  • 数据测量与验证

第 30 章生物製药合约製造市场：按地区划分

  • 分析概述
  • 重要假设与分析方法
  • 生物製药合约製造市场：按地区划分（2018 年、2023 年、2035 年）
  • 数据测量与验证

第 31 章生物製药合约製造市场：按主要公司划分

  • 分析概述
  • 重要假设与分析方法
  • 生物製药合约製造市场：依主要公司划分
  • 数据测量与验证

第 32 章案例研究：虚拟製药公司

  • 分析概述
  • 虚拟商业模式的历史演变
  • 虚拟製药公司是整个生物製药产业的一部分
  • 将营运外包给虚拟服务供应商的优势
  • 与将营运外包给虚拟服务提供者相关的主要挑战

第33章SWOT分析

  • 分析概述
  • 优势
  • 弱点
  • 机会
  • 威胁
  • SWOT要素比较
  • 结论

第34章生物製药CMO市场未来前景

  • 分析概述
  • 外包活动：未来几年可望大幅成长
  • 从一次性合约过渡到策略伙伴关係
  • 整合/采用新的创新技术
  • 专注于利基治疗领域
  • 不断成长的生物相似药市场有助于合约製造服务业的成长
  • 增强 CMO 职能，打造一站式服务
  • 旨在实现利润最大化和扩展现有能力的离岸外包活动
  • 资金流入与外包预算增加
  • 赞助商和服务提供者面临的挑战
  • 结论

第35章结论

第36章管理分析

  • 分析概述
  • RoslinCT
  • JAFRAL Biosolutions
  • Discovery Life Sciences
  • Bioworkshops
  • Aldevron
  • Resilience
  • Minaris Regenerative Medicine
  • 53Biologics
  • Richter-Helm BioLogics

第 37 章附录一：表格资料

第38章附录二：公司与组织名单

第 39 章附录 III：业务伙伴关係/合作详情

简介目录
Product Code: RA100465

The global biologics contract manufacturing market is valued at USD 19 billion in 2023 growing at a CAGR of 9% during the forecast period 2023-2035.

The biologics contract manufacturing market, recognized as the biopharmaceutical CMO sector, demonstrates robust dynamism and rapid expansion, attracting numerous entities investing in research and development for pioneering new therapeutic modalities. These innovations encompass antibody drug conjugates, biosimilars, and cell and gene therapies. Over the years, this burgeoning market has seen the emergence of more than 250 biologic therapies and vaccines worldwide. Notably, biologics exhibit higher success rates compared to traditional small-molecule drugs due to their reduced off-target toxicity, a prevalent cause of setbacks in small molecule drug development.

The escalating interest in biologics has prompted a notable shift in investment within the pharmaceutical landscape, transitioning from small molecule drugs to biologics. This shift, coupled with continuous scientific advancements and the proliferation of FDA-approved biologics, heralds the dawn of the biologic's era. Biopharmaceuticals are anticipated to fundamentally shape the pharmaceutical industry, progressively becoming an indispensable component of conventional medical treatments.

These service providers offer comprehensive solutions encompassing bioprocess development and optimization, aiming to expedite operational timelines and mitigate the exorbitant costs associated with producing complex biologic drugs. Some manufacturers opt to outsource specific operations to leverage state-of-the-art facilities and expertise, especially when contract manufacturing firms employ cutting-edge technologies like software-driven robotics to enhance manufacturing processes and mitigate risks linked to manual methods. As outsourcing gains traction as a viable and advantageous business model within this sphere, the global market for biologics contract manufacturing is poised to witness remarkable growth in the forecast period.

Key Market Segments:

Type of Service Offered

  • API Manufacturing
  • FDF Manufacturing

Type of Biologic Manufactured

  • Antibodies
  • Cell Therapies
  • Vaccines
  • Other Biologics

Type of Expression System

  • Mammalian
  • Microbial
  • Others

Scale of Operation

  • Preclinical / Clinical
  • Commercial

Company Size

  • Small
  • Mid-sized
  • Large
  • Very Large

Key Geographical Region

  • North America
  • Europe
  • Asia
  • Latin America
  • Middle East and North Africa

Research Coverage:

  • The report studies the biologics contract manufacturing market based on type of services offered, type of biologic manufactured, type of expression system used, scale of operation, company size and key geographical regions
  • The report analyzes factors (such as drivers, restraints, opportunities, and challenges) affecting the market growth
  • The report assesses the potential advantages and obstacles within the market for those involved and offers information on the competitive environment for top players in the market.
  • The report forecasts the revenue of market segments with respect to five major regions
  • Executive summary of biologics contract manufacturing market key research insights on the current state and expected evolution of the biologics contract manufacturing market in the short to long term.
  • Introduction to biopharmaceuticals, manufacturing processes, expression systems used, and the significance of outsourcing in this industry.
  • Current market landscape of contract manufacturing companies analyzing companies offering biologics contract manufacturing services based on various parameters like services offered, biologic types, scale of operation, expression systems, and geographic locations.
  • Elaborated profiles of key contract manufacturing organizations in each region, highlighting their services, facilities, recent developments, and future outlook.
  • Case studies on biosimilars market examining opportunities for CMOs in the biosimilars market and comparing small and large molecule drug characteristics and manufacturing processes.
  • Big pharma manufacturing initiatives and collaborations reviewing initiatives by top pharma companies, collaborations, trends, and activities impacting biologics contract manufacturing.
  • Examining recent partnerships, mergers, acquisitions, and their impact on the biologics contract manufacturing industry.
  • Reviewing expansion initiatives, funding investments, and technological advancements in biomanufacturing.
  • Estimating manufacturing capacity and annual demand for top biologics based on patient population, dosing, and strength.
  • Analyzing the total cost of ownership for CMOs based on company size between 2023-2043.
  • Examining industry trends, drivers, challenges through a SWOT analysis and their relative impact on the biopharmaceutical industry.
  • Exploring the role of the virtual business model in biopharmaceuticals, its advantages, risks, and its impact on outsourcing operations.
  • Discussing anticipated market growth, opportunities, and trends expected to influence the biologics contract manufacturing industry in the forecast period.

Key Benefits of Buying this Report:

  • The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
  • Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
  • The report provides stakeholders with a pulse on biologics contract manufacturing market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.

Key Market Companies:

  • AGC Biologics
  • Boehringer Ingelheim
  • Catalent
  • Cell Therapies
  • Charles River Laboratories
  • FUJIFILM Diosynth Biotechnologies
  • KBI Biopharma
  • Kemwell Biopharma
  • Lonza
  • Miltenyi Biotec
  • Minaris Regenerative Medicine
  • Samsung Biologics
  • Sandoz
  • Vetter Pharma
  • Wuxi Biologics

TABLE OF CONTENTS

1. PREFACE

  • 1.1. Biopharmaceutical Contract Manufacturing Market Overview
  • 1.2. Key Market Insights
  • 1.3. Scope of the Report
  • 1.4. Research Methodology
  • 1.5. Key Questions Answered
  • 1.6. Chapter Outlines

2. RESEARCH METHODOLOGY

  • 2.1. Chapter Overview
  • 2.2. Research Assumptions
  • 2.3. Project Methodology
  • 2.4. Forecast Methodology
  • 2.5. Robust Quality Control
  • 2.6. Key Market Segmentations
  • 2.7. Key Considerations
    • 2.7.1. Demographics
    • 2.7.2. Economic Factors
    • 2.7.3. Government Regulations
    • 2.7.4. Supply Chain
    • 2.7.5. COVID Impact / Related Factors
    • 2.7.6. Market Access
    • 2.7.7. Healthcare Policies
    • 2.7.8. Industry Consolidation

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

  • 3.1. Chapter Overview
  • 3.2. Market Dynamics
    • 3.2.1. Time Period
      • 3.2.1.1. Historical Trends
      • 3.2.1.2. Current and Forecasted Estimates
    • 3.2.2. Currency Coverage
      • 3.2.2.1. Overview of Major Currencies Affecting the Market
      • 3.2.2.2. Impact of Currency Fluctuations on the Industry
    • 3.2.3. Foreign Exchange Impact
      • 3.2.3.1. Evaluation of Foreign Exchange Rates and Their Impact on Market
      • 3.2.3.2. Strategies for Mitigating Foreign Exchange Risk
    • 3.2.4. Recession
      • 3.2.4.1. Historical Analysis of Past Recessions and Lessons Learnt
      • 3.2.4.2. Assessment of Current Economic Conditions and Potential Impact on the Market
    • 3.2.5. Inflation
      • 3.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
      • 3.2.5.2. Potential Impact of Inflation on the Market Evolution

4. EXECUTIVE SUMMARY

5. INTRODUCTION

  • 5.1. Chapter Overview
  • 5.2. Overview of Biopharmaceuticals
  • 5.3. Expression Systems for Biopharmaceuticals
    • 5.3.1. Insect Expression Systems
    • 5.3.2. Mammalian Expression Systems
    • 5.3.3. Microbial Expression Systems
      • 5.3.3.1. Bacterial Expression Systems
      • 5.3.3.2. Fungal Expression Systems
      • 5.3.3.3. Yeast Expression Systems
    • 5.3.4. Plant Expression Systems
    • 5.3.5. Mammalian versus Microbial Expression Systems
  • 5.4. Manufacturing Process of Biopharmaceuticals
    • 5.4.1. Upstream Processing
    • 5.4.2. Fermentation
    • 5.4.3. Downstream Processing
  • 5.5. Overview of Contract Manufacturing
  • 5.6. Need for Outsourcing Biopharmaceutical Manufacturing Operations
    • 5.6.1. Commonly Outsourced Manufacturing Operations for Biopharmaceuticals
    • 5.6.2. Advantages of Outsourcing Biopharmaceutical Manufacturing Operations
    • 5.6.3. Risks and Challenges Associated with Outsourcing Biopharmaceutical Manufacturing Operations
  • 5.7. Key Considerations While Selecting a Contract Manufacturing Partner
  • 5.8. Future Perspectives

6. MARKET LANDSCAPE

  • 6.1. Chapter Overview
  • 6.2. Biopharmaceutical Contract Manufacturers: Overall Market Landscape
    • 6.2.1. Analysis by Year of Establishment
    • 6.2.2. Analysis by Company Size
    • 6.2.3. Analysis by Location of Headquarters
    • 6.2.4. Analysis by Type of Service Offered
    • 6.2.5. Analysis by Type of Biologic Manufactured
    • 6.2.6. Analysis by Scale of Operation
    • 6.2.7. Analysis by Type of Expression System Used
    • 6.2.8. Analysis by Type of Bioreactor Used
    • 6.2.9. Analysis by Mode of Operation of Bioreactor

7. REGIONAL CAPABILITY ANALYSIS

  • 7.1. Chapter Overview
  • 7.2. Key Assumptions and Parameter
  • 7.3. Overview of Biopharmaceutical Contract Manufacturing Facilities
    • 7.3.1. Analysis by Type of Service Offered
    • 7.3.2. Analysis by Scale of Operation
  • 7.4. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in North America
  • 7.5. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in Europe
  • 7.6. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in Asia-Pacific
  • 7.7. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in Rest of the World

8. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN NORTH AMERICA

  • 8.1. Chapter Overview
  • 8.2. Biopharmaceutical Contract Manufacturing in the US: Regulatory Scenario
  • 8.3. Leading Biopharmaceutical CMOs in North America
    • 8.3.1. AGC Biologics
      • 8.3.1.1. Company Overview
      • 8.3.1.2. Service Portfolio
        • 8.3.1.2.1. Process Development
        • 8.3.1.2.2. cGMP Manufacturing
        • 8.3.1.2.3. Quality and Regulatory Services
        • 8.3.1.2.4. Process Validation
      • 8.3.1.3. Financial Information
      • 8.3.1.4. Manufacturing Facilities
      • 8.3.1.5. Recent Developments and Future Outlook
    • 8.3.2. Catalent
      • 8.3.2.1. Company Overview
      • 8.3.2.2. Service Portfolio
        • 8.3.2.2.1. Cell Line Development
        • 8.3.2.2.2. Biomanufacturing
        • 8.3.2.2.3. ADCs and Bioconjugates Manufacturing
        • 8.3.2.2.4. Biosimilars Development and Manufacturing
        • 8.3.2.2.5. Fill / Finish Solutions and Delivery Services
        • 8.3.2.2.6. Analytical Services
      • 8.3.2.3. Clinical Supply Services
      • 8.3.2.4. Financial Information
      • 8.3.2.5. Manufacturing Facilities
      • 8.3.2.6. Recent Developments and Future Outlook
    • 8.3.3. FUJIFILM Diosynth Biotechnologies
      • 8.3.3.1. Company Overview
      • 8.3.3.2. Service Portfolio
        • 8.3.3.2.1. Strain Development
        • 8.3.3.2.2. Process Development
        • 8.3.3.2.3. cGMP Manufacturing
        • 8.3.3.2.4. Analytical Solutions
      • 8.3.3.3. Financial Information
      • 8.3.3.4. Manufacturing Facilities
      • 8.3.3.5. Recent Developments and Future Outlook
    • 8.3.4. KBI Biopharma
      • 8.3.4.1. Company Overview
      • 8.3.4.2. Service Portfolio
        • 8.3.4.2.1. Process Development
        • 8.3.4.2.2. Analytical Development
        • 8.3.4.2.3. GMP Manufacturing
        • 8.3.4.2.4. Clinical Cell Therapy Support
      • 8.3.4.3. Manufacturing Facilities
      • 8.3.4.4. Recent Developments and Future Outlook
    • 8.3.5. Charles River Laboratories
      • 8.3.5.1. Company Overview
      • 8.3.5.2. Service Portfolio
        • 8.3.5.2.1. Cell Sourcing
        • 8.3.5.2.2. Cell and Gene Therapy Solutions
        • 8.3.5.2.3. Biologics Testing Solutions
        • 8.3.5.2.4. Avian Vaccine Services
        • 8.3.5.2.5. QC Microbial Solutions
        • 8.3.5.2.6. Scientific and Regulatory Advisory Services
      • 8.3.5.3. Financial Information
      • 8.3.5.4. Manufacturing Facilities
      • 8.3.5.5. Recent Developments and Future Outlook
  • 8.4. Other Leading Biopharmaceutical CMOs in North America
    • 8.4.1. Cytiva
      • 8.4.1.1. Company Overview
    • 8.4.2. Patheon
      • 8.4.2.1. Company Overview
    • 8.4.3. Piramal Pharma Solutions
      • 8.4.3.1. Company Overview

9. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN EUROPE

  • 9.1. Chapter Overview
  • 9.2. Biopharmaceutical Contract Manufacturing in Europe: Regulatory Scenario
    • 9.2.1. EMA's cGMP Regulations
  • 9.3. Leading Biopharmaceutical CMOs in Europe
    • 9.3.1. Boehringer Ingelheim (BioXcellence)
      • 9.3.1.1. Company Overview
      • 9.3.1.2. Service Portfolio
        • 9.3.1.2.1. Process Development
          • 9.3.1.2.1.1. Expression Systems
          • 9.3.1.2.1.2. Upstream Technology
          • 9.3.1.2.1.3. Downstream Technology
          • 9.3.1.2.1.4. Other Process Development Services
        • 9.3.1.2.2. Quality Assurance
        • 9.3.1.2.3. Fill / Finish Services
      • 9.3.1.3. Financial Information
      • 9.3.1.4. Manufacturing Facilities
      • 9.3.1.5. Recent Developments and Future Outlook
    • 9.3.2. Lonza
      • 9.3.2.1. Company Overview
      • 9.3.2.2. Service Portfolio
      • 9.3.2.3. Manufacturing Services
      • 9.3.2.4. Financial Information
      • 9.3.2.5. Manufacturing Facilities
      • 9.3.2.6. Recent Developments and Future Outlook
    • 9.3.3. Sandoz
      • 9.3.3.1. Company Overview
      • 9.3.3.2. Service Portfolio
      • 9.3.3.3. Financial Information
      • 9.3.3.4. Manufacturing Facilities
      • 9.3.3.5. Recent Developments and Future Outlook
    • 9.3.4. Vetter Pharma
      • 9.3.4.1. Company Overview
      • 9.3.4.2. Service Portfolio
      • 9.3.4.3. Manufacturing Facilities
      • 9.3.4.4. Recent Developments and Future Outlook
    • 9.3.5. Miltenyi Biotec
      • 9.3.5.1. Company Overview
      • 9.3.5.2. Service Portfolio
      • 9.3.5.3. Manufacturing Facilities
      • 9.3.5.4. Recent Developments and Future Outlook
  • 9.4. Other Leading Biopharmaceutical CMOs in Europe
    • 9.4.1. Novasep
      • 9.4.1.1. Company Overview
    • 9.4.2. Olon
      • 9.4.2.1. Company Overview
    • 9.4.3. Rentschler Biopharma
      • 9.4.3.1. Company Overview

10. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN ASIA-PACIFIC AND REST OF THE WORLD

  • 10.1. Chapter Overview
  • 10.2. Biopharmaceutical Contract Manufacturing in China
    • 10.2.1. Biopharmaceutical Contract Manufacturing in China: Regulatory Scenario
  • 10.3. Leading Biopharmaceutical CMOs in China
    • 10.3.1. WuXi Biologics
      • 10.3.1.1. Company Overview
      • 10.3.1.2. Service Portfolio
        • 10.3.1.2.1. Discovery Services
        • 10.3.1.2.2. Development Services
        • 10.3.1.2.3. Testing Services
        • 10.3.1.2.4. Clinical Manufacturing Services
      • 10.3.1.3. Financial Information
      • 10.3.1.4. Manufacturing Facilities
      • 10.3.1.5. Recent Developments and Future Outlook
  • 10.4. Biopharmaceutical Contract Manufacturing in India
    • 10.4.1. Biopharmaceutical Contract Manufacturing in India: Regulatory Scenario
  • 10.5. Leading Biopharmaceutical CMOs in India
    • 10.5.1. Kemwell Biopharma
      • 10.5.1.1. Company Overview
      • 10.5.1.2. Service Portfolio
        • 10.5.1.2.1. Development Services for Biopharmaceuticals
        • 10.5.1.2.2. Manufacturing Services for Biopharmaceuticals
      • 10.5.1.3. Manufacturing Facilities
      • 10.5.1.4. Recent Developments and Future Outlook
  • 10.6. Biopharmaceutical Contract Manufacturing in Japan
    • 10.6.1. Biopharmaceutical Contract Manufacturing in Japan: Regulatory Scenario
  • 10.7. Leading Biopharmaceutical CMOs in Japan
    • 10.7.1. Minaris Regenerative Medicine
      • 10.7.1.1. Company Overview
      • 10.7.1.2. Service Portfolio
        • 10.7.1.2.1. Manufacturing Development Services
        • 10.7.1.2.2. GMP Manufacturing
      • 10.7.1.3. Manufacturing Facilities
      • 10.7.1.4. Recent Developments and Future Outlook
  • 10.8. Biopharmaceutical Contract Manufacturing in South Korea
    • 10.8.1. Biopharmaceutical Contract Manufacturing in South Korea: Regulatory Scenario
  • 10.9. Leading Biopharmaceutical CMOs in South Korea
    • 10.9.2. Samsung Biologics
      • 10.9.2.1. Company Overview
      • 10.9.2.2. Service Portfolio
        • 10.9.2.2.1. Process Development
        • 10.9.2.2.2. Analytical Services
        • 10.9.2.2.3. cGMP Manufacturing Services
        • 10.9.2.2.4. Aseptic Fill / Finish Services
        • 10.9.2.2.5. Quality Services
      • 10.9.2.3. Financial Information
      • 10.9.2.4. Manufacturing Facilities
      • 10.9.2.5. Recent Developments and Future Outlook
  • 10.10. Biopharmaceutical Contract Manufacturing in Australia
    • 10.10.1. Biopharmaceutical Contract Manufacturing in Australia: Regulatory Scenario
  • 10.11. Leading Biopharmaceutical CMOs in Australia
    • 10.11.1. Cell Therapies
      • 10.11.1.1. Company Overview
      • 10.11.1.2. Service Portfolio
      • 10.11.1.3. Manufacturing Facilities
      • 10.11.1.4. Recent Developments and Future Outlook
  • 10.12. Other Leading Biopharmaceutical CMOs in Asia-Pacific and Rest of the World
    • 10.12.1. AcuraBio (Formerly Known as Luina Bio)
      • 10.12.1.1. Company Overview
    • 10.12.2. Celltrion
      • 10.12.2.1. Company Overview
    • 10.12.3. Takara Bio
      • 10.12.3.1. Company Overview

11. NICHE BIOPHARMACEUTICAL SECTORS

  • 11.1. Chapter Overview
  • 11.2. Bispecific Antibodies
    • 11.2.1. Approved and Clinical Bispecific Antibody Therapeutics: Overall Market Landscape
    • 11.2.2. Bispecific Antibodies: Pipeline Analysis
      • 11.2.2.1. Analysis by Phase of Development
      • 11.2.2.2. Analysis by Target Indication
    • 11.2.3. Bispecific Antibody Therapeutics: Technology Platforms
    • 11.2.4. Key Considerations for Manufacturing and Associated Challenges
    • 11.2.5. Role of CMOs in Offering Services for Bispecific Antibodies
      • 11.2.5.1. CMOs Offering Services for Bispecific Antibodies
  • 11.3. Antibody Drug Conjugates (ADCs)
    • 11.3.1. Components of ADCs
      • 11.3.1.1. Antibody
      • 11.3.1.2. Cytotoxin
      • 11.3.1.3. Linker
    • 11.3.2. Antibody Drug Conjugates (ADCs): Pipeline Analysis
      • 11.3.2.1. Analysis by Status of Development
      • 11.3.2.2. Analysis by Target Disease Indication
      • 11.3.2.3. Most Active Players: Analysis by Number of Therapies
    • 11.3.3. Antibody Drug Conjugate Developers
    • 11.3.4. Manufacturing Process
  • 11.4. Cell Therapies
    • 11.4.5. Technical Challenges Related to Antibody Drug Conjugates Manufacturing
    • 11.4.6. Role of CMOs in Offering Services for ADCs
      • 11.4.6.1. CMOs Offering Services for ADCs
    • 11.4.1. Cell Therapies: Overall Market Landscape
    • 11.4.2. Overview of Cell Therapy Manufacturing
      • 11.4.2.1. Cell Therapy Manufacturing Models
        • 11.4.2.1.1. Centralized Manufacturing
        • 11.4.2.1.2. Decentralized Manufacturing
    • 11.4.3. Key Challenges for Manufacturing Cell Therapies
    • 11.4.4. Key Factors Impacting Cell Therapy Manufacturing
      • 11.4.4.1. Characterization
      • 11.4.4.2. Cost of Goods
      • 11.4.4.3. Automation of Cell Therapy Manufacturing
    • 11.4.5. Cell Therapies: Pipeline Analysis
      • 11.4.5.1. Analysis by Type of Cell Manufactured
    • 11.4.6. Stem Cell Therapies: Analysis by Phase of Development
    • 11.4.7. T-Cell Therapies: Analysis by Phase of Development
    • 11.4.8. Role of CMOs in Offering Services for Cell Therapies
      • 11.4.8.1. CMOs Offering Services for Cell Therapies
  • 11.5. Gene Therapies
    • 11.5.1. Gene Therapies: Pipeline Analysis
      • 11.5.1.1. Analysis by Stage of Development
      • 11.5.1.2. Analysis by Phase of Development
      • 11.5.1.3. Analysis by Type of Vector Used
        • 11.5.1.3.1. Clinical Pipeline
        • 11.5.1.3.2. Preclinical Pipeline
      • 11.5.1.4. Analysis by Therapeutic Area
        • 11.5.1.4.1. Clinical and Commercial Pipeline
        • 11.5.1.4.2. Preclinical Pipeline
    • 11.5.2. Role of CMOs in Offering Services for Gene Therapies
      • 11.5.2.1. CMOs Offering Services for Gene Therapies
  • 11.6. Viral Vectors
    • 11.6.1. Viral Vectors: Pipeline Analysis
      • 11.6.1.1. Analysis by Location of Viral Vectors Manufacturing Facilities
      • 11.6.1.2. Analysis by Type of Viral Vector Manufactured
    • 11.6.2. Role of CMOs in Offering Services for Viral Vectors
      • 11.6.2.1. CMOs Offering Services for Viral Vectors
  • 11.7. Plasmid DNA
    • 11.7.1. Plasmid DNA: Pipeline Analysis
      • 11.7.1.1. Analysis by Location of Manufacturing Facilities
    • 11.7.2. Role of CMOs in Offering Services for Plasmid DNA
      • 11.7.2.1. CMOs Offering Services for Plasmid DNA

12. CASE STUDY: OUTSOURCING OF BIOSIMILARS

  • 12.1. Chapter Overview
  • 12.2. Overview of Biosimilars
  • 12.3. Development Stages of Biosimilars
  • 12.4. Regulatory Requirements for Licensing of Biosimilars
  • 12.5. Need for Outsourcing Manufacturing Operations
  • 12.6. Impact of Biosimilars on the Global Contract Manufacturing Market
    • 12.6.1. Biosimilars: Historical Trend of FDA Approvals
  • 12.7. Biosimilars Contract Manufacturing Service Providers
  • 12.8. Challenges Associated with Outsourcing of Biosimilar Manufacturing Operations

13. CASE STUDY: COMPARISON OF SMALL AND LARGE MOLECULE DRUGS / THERAPIES

  • 13.1. Chapter Overview
  • 13.2. Small Molecule and Large Molecule Drugs / Therapies
    • 13.2.1. Comparison of General Characteristics
    • 13.2.2. Comparison of Key Specifications
    • 13.2.3. Comparison of Manufacturing Process
    • 13.2.4. Comparison of Key Manufacturing Challenges

14. CASE STUDY: IN-HOUSE MANUFACTURING

  • 14.1. Chapter Overview
  • 14.2. In-House Manufacturing
    • 14.2.1. Benefits Associated with In-House Manufacturing
    • 14.2.2. Risks Associated with In-House Manufacturing
  • 14.3. Outsourcing Trends in the Biopharmaceutical Industry
    • 14.3.1. Types of Outsourcing Partners
  • 14.4. Manufacturing Approaches Used for Approved Biologics, 2016-2022
  • 14.5. Choosing the Right Strategy: In-House Manufacturing versus Outsourcing

15. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

  • 15.1. Chapter Overview
  • 15.2. Key Assumptions and Parameters
  • 15.3. Biopharmaceutical Contract Manufacturers: Make versus Buy Decision Making
    • 15.3.1. Scenario 1
    • 15.3.2. Scenario 2
    • 15.3.3. Scenario 3
    • 15.3.4. Scenario 4
  • 15.4. Conclusion

16. BIG PHARMA INITIATIVES

  • 16.1. Chapter Overview
  • 16.2. Biopharmaceutical Related Initiatives by Big Pharmaceutical Players
    • 16.2.1. Analysis by Number of Initiatives
    • 16.2.2. Analysis by Year of Initiative
    • 16.2.3. Analysis by Purpose of Initiative
    • 16.2.4. Analysis by Type of Initiative
      • 16.2.4.1. Analysis by Type of Partnership
      • 16.2.4.2. Analysis by Type of Expansion
    • 16.2.5. Analysis by Scale of Operation
    • 16.2.6. Analysis by Type of Biologic Manufactured
    • 16.2.7. Analysis of Big Pharma Players by Year of Initiative
    • 16.2.8. Analysis of Big Pharma Players by Purpose of Initiative
    • 16.2.9. Analysis by Year and Type of Initiative
    • 16.2.10. Analysis of Big Pharma Players by Region of Expansion
    • 16.2.11. Analysis of Big Pharma Players by Type of Biologic Manufactured

17. PARTNERSHIPS AND COLLABORATIONS

  • 17.1. Chapter Overview
  • 17.2. Partnership Models
  • 17.3. Biopharmaceutical Contract Manufacturing: Partnerships and Collaborations
    • 17.3.1. Analysis by Year of Partnership
    • 17.3.2. Analysis by Type of Partnership
    • 17.3.3. Analysis by Year and Type of Partnership
    • 17.3.4. Analysis by Type of Biologic Manufactured
    • 17.3.5. Analysis by Year of Partnership and Type of Biologic Manufactured
    • 17.3.6. Analysis by Type of Partnership and Type of Biologic Manufactured
    • 17.3.7. Analysis by Scale of Operation
    • 17.3.8. Analysis by Therapeutic Area
    • 17.3.9. Most Active Players: Analysis by Number of Partnerships
    • 17.3.10. Analysis by Geography
      • 17.3.10.1. Local and International Agreements
      • 17.3.10.2. Intracontinental and Intercontinental Agreements

18. MERGERS AND ACQUISITIONS

  • 18.1. Chapter Overview
  • 18.2. Merger and Acquisition Models
  • 18.3. Biopharmaceutical Contract Manufacturing: Mergers and Acquisitions
    • 18.3.1. Cumulative Year-wise Trend of Mergers and Acquisitions
    • 18.3.2. Analysis by Type of Acquisition
    • 18.3.3. Analysis by Geography
      • 18.3.3.1. Local and International Mergers and Acquisitions
      • 18.3.3.2. Intracontinental and Intercontinental Mergers and Acquisitions
      • 18.3.3.3. Year-wise Trend in North America, Europe and Asia-Pacific
    • 18.3.4. Most Active Acquirers: Analysis by Number of Acquisitions
    • 18.3.5. Analysis by Key Value Drivers
    • 18.3.6. Analysis by Year of Acquisition and Key Value Drivers
    • 18.3.7. Analysis by Type of Biologic Manufactured
    • 18.3.8. Analysis by Key Value Drivers and Type of Biologic Manufactured
  • 18.4. Key Acquisitions: Deal Multiples
    • 18.4.1. Year-wise Trend of Deal Multiple Amount

19. RECENT EXPANSIONS

  • 19.1. Chapter Overview
  • 19.2. Biopharmaceutical Contract Manufacturing: Recent Expansions
    • 19.2.1. Analysis by Year of Expansion
    • 19.2.2. Analysis by Purpose of Expansion
    • 19.2.3. Analysis by Year and Purpose of Expansion
    • 19.2.4. Analysis by Type of Biologic Manufactured
    • 19.2.5. Analysis by Purpose of Expansion and Type of Biologic Manufactured
    • 19.2.6. Analysis by Location of Expanded Facility
    • 19.2.7. Most Active Players: Analysis by Number of Recent Expansions
    • 19.2.8. Analysis by Purpose of Expansion and Location of Expanded Facility
    • 19.2.9. Analysis by Amount Invested
    • 19.2.10. Recent Expansions: 2016-2020 and 2021-2023 Scenario

20. RECENT DEVELOPMENTS

  • 20.1. Chapter Overview
  • 20.2. Types of Funding
  • 20.3. Biopharmaceutical Contract Manufacturing: Funding and Investment Analysis
    • 20.3.1. Analysis by Year of Funding
    • 20.3.2. Analysis by Amount Invested
    • 20.3.3. Analysis by Type of Funding
    • 20.3.4. Analysis by Year and Type of Funding
    • 20.3.5. Analysis of Funding Instances and Amount Invested by Geography (Continent)
    • 20.3.6. Analysis of Funding Instances and Amount Invested by Geography (Country)
    • 20.3.7. Most Active Players: Analysis by Number of Funding Instances
    • 20.3.8. Most Active Players: Analysis by Total Amount Raised
    • 20.3.9. Leading Investors: Analysis by Number of Funding Instances
    • 20.3.10. Leading Investors: Analysis by Total Amount Raised
  • 20.4. Technological Advancements
    • 20.4.1. Single-Use Technology
    • 20.4.2. Process Analytical Technology (PAT)
    • 20.4.3. Continuous Processing
    • 20.4.4. Quality by Design (QbD) in Bio-processing
    • 20.4.5. Modular / Podular Biopharma Facilities

21. CAPACITY ANALYSIS

  • 21.1. Chapter Overview
  • 21.2. Key Assumptions and Methodology
  • 21.3. Biopharmaceutical Contract Manufacturing: Global Installed Capacity
    • 21.3.1. Analysis by Company Size
    • 21.3.2. Analysis by Type of Expression System Used
    • 21.3.3. Analysis by Geography
      • 21.3.3.1. Analysis of Biopharmaceutical Contract Manufacturing Capacity in North America
      • 21.3.3.2. Analysis of Biopharmaceutical Contract Manufacturing Capacity in Europe
      • 21.3.3.3. Analysis of Biopharmaceutical Contract Manufacturing Capacity in Asia-Pacific
      • 21.3.3.4. Analysis of Biopharmaceutical Contract Manufacturing Capacity in Rest of the World
  • 21.4. Concluding Remarks

22. DEMAND ANALYSIS

  • 22.1. Chapter Overview
  • 22.2. Key Assumptions and Methodology
  • 22.3. Global Demand for Biopharmaceuticals
  • 22.4. Global Demand for Emerging Novel Biologics
    • 22.4.1. Global Demand for ADC Therapeutics
    • 22.4.2. Global Demand for Cell Therapy Manufacturing

23. TOTAL COST OF OWNERSHIP FOR BIOPHARMACEUTICAL CONTRACT MANUFACTURING ORGANIZATIONS

  • 23.1. Chapter Overview
  • 23.2. Key Parameters
  • 23.3. Assumptions and Methodology
  • 23.4. Total Cost of Ownership (Sample Dataset)
  • 23.5. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations, Y0-Y20
    • 23.5.1. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Analysis by CAPEX, Y0
    • 23.5.2. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Analysis by OPEX, Y1-Y20
  • 23.7. Total Cost of Ownership for Large / Very Large Biopharmaceutical Contract Manufacturing Organizations, Y0-Y20
    • 23.7.1. Total Cost of Ownership for Large / Very Large Biopharmaceutical Contract Manufacturing Organizations: Analysis by CAPEX, Y0
    • 23.7.2. Total Cost of Ownership for Large / Very Large Biopharmaceutical Contract Manufacturing Organizations: Analysis by OPEX, Y1-Y20

24. GLOBAL BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET

  • 24.1. Chapter Overview
  • 24.2. Assumptions and Methodology
  • 24.3. Global Biopharmaceutical Contract Manufacturing Market, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 24.3.1. Scenario Analysis
      • 24.3.1.1. Conservative Scenario
      • 24.3.1.2. Optimistic Scenario
  • 24.4. Key Market Segmentations

25. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY TYPE OF SERVICE OFFERED

  • 25.1. Chapter Overview
  • 25.2. Key Assumptions and Methodology
  • 25.3. Biopharmaceutical Contract Manufacturing Market: Distribution by Type of Service Offered, 2018, 2023 and 2035
    • 25.3.1. API Manufacturing: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 25.3.2. FDF Manufacturing: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  • 25.4. Data Triangulation and Validation

26. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY TYPE OF BIOLOGIC MANUFACTURED

  • 26.1. Chapter Overview
  • 26.2. Key Assumptions and Methodology
  • 26.3. Biopharmaceutical Contract Manufacturing Market: Distribution by Type of Biologic Manufactured, 2018, 2023 and 2035
    • 26.3.1. Antibodies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 26.3.2. Cell Therapies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 26.3.3. Vaccines: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 26.3.4. Other Biologics: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  • 26.4. Data Triangulation and Validation

27. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY TYPE OF EXPRESSION SYSTEM USED

  • 27.1. Chapter Overview
  • 27.2. Key Assumptions and Methodology
  • 27.3. Biopharmaceutical Contract Manufacturing Market: Distribution by Type of Expression System Used, 2018, 2023 and 2035
    • 27.3.1. Mammalian Expression Systems: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 27.3.2. Microbial Expression Systems: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 27.3.3. Other Expression Systems: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  • 27.4. Data Triangulation and Validation

28. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY SCALE OF OPERATION

  • 28.1. Chapter Overview
  • 28.2. Key Assumptions and Methodology
  • 28.3. Biopharmaceutical Contract Manufacturing Market: Distribution by Scale of Operation, 2018, 2023 and 2035
    • 28.3.1. Preclinical / Clinical Operations: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 28.3.2. Commercial Operations: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  • 28.4. Data Triangulation and Validation

29. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY COMPANY SIZE

  • 29.1. Chapter Overview
  • 29.2. Key Assumptions and Methodology
  • 29.3. Biopharmaceutical Contract Manufacturing Market: Distribution by Company Size, 2018, 2023 and 2035
    • 29.3.1. Small Companies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 29.3.2. Mid-sized Companies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 29.3.3. Large and Very Large Companies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  • 29.4. Data Triangulation and Validation

30. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY GEOGRAPHY

  • 30.1. Chapter Overview
  • 30.2. Key Assumptions and Methodology
  • 30.3. Biopharmaceutical Contract Manufacturing Market: Distribution by Geography, 2018, 2023 and 2035
    • 30.3.1. North America: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.1.1. US: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.1.2. Canada: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 30.3.2. Europe: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.2.1. Italy: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.2.2. Germany: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.2.3. France: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.2.4. Spain: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.2.5. UK: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.2.6. Rest of Europe: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 30.3.3. Asia-Pacific: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.3.1. China: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.3.2. India: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.3.3. South Korea: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.3.4. Japan: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
      • 30.3.3.5. Rest of Asia-Pacific: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 30.3.4. Latin America: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
    • 30.3.5. Middle East and North Africa: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  • 30.8. Data Triangulation and Validation

31. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY LEADING PLAYERS

  • 31.1. Chapter Overview
  • 31.2. Key Assumptions and Methodology
  • 31.3. Biopharmaceutical Contract Manufacturing Market: Distribution by Leading Players
  • 31.4. Data Triangulation and Validation

32. CASE STUDY: VIRTUAL PHARMACEUTICAL COMPANIES

  • 32.1. Chapter Overview
  • 32.2. Historical Evolution of the Virtual Business Model
  • 32.3. Virtual Pharmaceutical Companies as a Subset of the Overall Biopharmaceutical Industry
  • 32.4. Advantages Associated with Outsourcing Operations to Virtual Service Providers
  • 32.5. Key Challenges Associated with Outsourcing Operations to Virtual Service Providers

33. SWOT ANALYSIS

  • 33.1. Chapter Overview
  • 33.2. Strengths
  • 33.3. Weaknesses
  • 33.4. Opportunities
  • 33.5. Threats
  • 33.6. Comparison of SWOT Factors
  • 33.7. Conclusion

34. FUTURE OF THE BIOPHARMACEUTICAL CMO MARKET

  • 34.1. Chapter Overview
  • 34.2. Outsourcing Activities to Witness Significant Growth in the Coming Years
  • 34.3. Shift from One-time Contracts to Strategic Partnerships
  • 34.4. Integration / Adoption of New and Innovative Technologies
    • 34.4.1. Single-use Bioreactors
    • 34.4.2. Novel Bioprocess Techniques
    • 34.4.3. Bioprocess Automation
  • 34.5. Focus on Niche Therapeutic Areas
  • 34.6. Growing Biosimilars Market to Contribute to the Growth of the Contract Services Segment
  • 34.7. Capability Expansion by CMOs to become One-Stop-Shops
  • 34.8. Offshoring Outsourcing Activities to Maximize Profits and Expand Existing Capacities
  • 34.9. Increase in Financial Inflow and Outsourcing Budgets
  • 34.10. Challenges Faced by Sponsors and Service Providers
    • 34.10.1. Concerns Related to Single-use Systems
    • 34.10.2. Issues Related to Capacity Fluctuations
  • 34.11. Concluding Remarks

35. CONCLUSION

36. EXECUTIVE INSIGHTS

  • 36.1. Chapter Overview
  • 36.2. RoslinCT
    • 36.2.1. Company Snapshot
    • 36.2.2. Interview Transcript: Peter Coleman, Chief Executive Officer
  • 36.3. Chapter Overview
  • 36.3. JAFRAL Biosolutions
    • 36.3.1. Company Snapshot
    • 36.3.2. Interview Transcript: Frenk Smrekar, Chief Executive Officer And Co-Founder
  • 36.4. Chapter Overview
  • 36.4. Discovery Life Sciences
    • 36.4.1. Company Snapshot
    • 36.4.2. Interview Transcript: Dominic Clarke, Chief Technical Officer, Cell And Gene Therapy
  • 36.5. Chapter Overview
  • 36.5. Bioworkshops
    • 36.5.1. Company Snapshot
    • 36.5.2. Interview Transcript: Nick Kotlarski, President and Chief Operating Officer
  • 36.6. Aldevron
    • 36.6.1. Company Snapshot
    • 36.6.2. Interview Transcript: Jeff Briganti, Senior Director Of Global Strategic Marketing
  • 36.7. Resilience
    • 36.7.1. Company Snapshot
    • 36.7.2. Interview Transcript: Tarek Abdel-Gawad, Senior Director of Commercial Strategy and Market Insights
  • 36.8. Minaris Regenerative Medicine
    • 36.8.1. Company Snapshot
    • 36.8.2. Interview Transcript: Luc St-Onge, Global Head of Sales and Marketing and Head of Business Development (Germany)
  • 36.9. 53Biologics
    • 36.9.1. Company Snapshot
    • 36.9.2. Interview Transcript: Francisco Manuel Reyes Sosa, Business Development Manager
  • 36.10. Richter-Helm BioLogics
    • 36.10.1. Company Snapshot
    • 36.10.2. Interview Transcript Antje Weingarth, Manager Marketing and Sales

37. APPENDIX I: TABULATED DATA

38. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

39. APPENDIX III: DETAILS OF PARTNERSHIPS AND COLLABORATIONS