The biopharmaceutical contract manufacturing market is projected to grow at an annualized rate of ~8%, till 2030 - Rootsanalysis

Roots Analysis has done a detailed study on Biopharma Contract Manufacturing Market (3rd Edition), 2019-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.
To order this 750+ page report, which features 200+ figures and 250+ tables, please visit this link
Key Market Insights 
  • Over 235 companies worldwide claim to offer contract manufacturing services for various types of biopharmaceutical drug / therapy products.
  • The market landscape is highly fragmented featuring the presence of both established players and new entrants; majority of biopharmaceutical CMOs are based in the developed geographies.
  • Case study: CMOs focusing on niche biologic markets, primarily novel product candidates for which in-house biomanufacturing expertise is low, are likely to experience significant growth in the coming years.
  • The installed global contract manufacturing capacity, spread across various geographies, is currently estimated to be over 4.5 million liters.
  • The demand for contract manufacturing services is expected to rise across different therapeutic areas; closer inspection of available capacity and expected utilization trend are required to optimize supply parameters.
  • With over 450 deals inked in the past six years, there has been a surge in the partnership activity; majority of the collaborations have been signed for the development and manufacturing of cell therapies and antibodies.
  • In order to cater the increasing demand for biologics, stake holders are actively expanding their existing capabilities; this is evident from the various acquisitions that have recently been reported.
  • We expect the developers to continue to outsource their manufacturing operations in the short to mid-term, resulting in an annualized growth rate of more than 8%.
  • In the long term, the projected opportunity is anticipated to be well distributed across various types of expression systems used for biomanufacturing, scale of operation and size of contract service providers
For more information, please visit https://rootsanalysis.com/reports/view_document/biopharma-contract-manufacturing-market-3rd-edition-2019-2030/250.html
 
Table of Contents
 
1.          PREFACE
1.1.       Scope of the Report
1.2.       Research Methodology
1.3.       Chapter Outlines
 
2.          EXECUTIVE SUMMARY
 
3.         INTRODUCTION
3.1.      Context and Background
3.2.      An Overview of Biopharmaceuticals
3.3.      Biopharmaceutical Manufacturing
3.3.1.    Types of Expression Systems 
3.3.1.1. Bacterial Expression Systems
3.3.1.2. Yeast Expression Systems
3.3.1.3. Fungal Expression Systems
3.3.1.4. Insect Expression Systems
3.3.1.5. Plant Expression Systems
3.3.1.6. Mammalian Expression Systems
 
3.3.2.    Manufacturing Steps
3.3.2.1. Upstream Processing
3.3.2.2. Downstream Processing
 
3.4.      An Overview of Contract Manufacturing
3.5.      Need for Outsourcing in the Biopharmaceutical Industry
3.6.      Commonly Outsourced Operations in the Biopharmaceutical Industry
3.7.      Basic Guidelines for Selecting a CMO Partner
3.8.      Advantages of Outsourcing Manufacturing Services
3.9.      Risks and Challenges Associated with Biopharmaceutical Contract Manufacturing
3.10.     Concluding Remarks
 
4.         COMPETITIVE LANDSCAPE
4.1.      Chapter Overview
4.2.      Biopharmaceuticals Contract Manufacturers: Overall Market Landscape
4.2.1.    Analysis by Size of Employee Base
4.2.2.    Analysis by Location of Headquarters
4.2.3.    Analysis by Year of Establishment
4.2.4.    Analysis by Location of Manufacturing Facilities
4.2.5.    Analysis by Type of Biologics Manufactured
4.2.6.    Analysis by Scale of Operation
4.2.7.    Analysis by Expression Systems 
4.2.8.    Analysis by Type of Bioreactor and Modes of Operation
4.2.9.    Analysis by Biomanufacturing Capacity
4.2.10.  Analysis by Packaging Form
4.3.      Concluding Remarks
 
5.         BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN NORTH AMERICA
5.1.      Chapter Overview
5.2.      Biopharmaceutical Outsourcing in the US: Regulatory Scenario
5.2.1.    Impact of Current Political Situation
5.3.      Leading Biopharma CMOs in North America
5.3.1.    AMRI (OsoBio)
5.3.1.1. Company Overview
5.3.1.2. Services Portfolio
5.3.1.3. Financial Information
5.3.1.4. Manufacturing Facilities
5.3.1.5. Partnerships
5.3.1.6. Recent Developments
5.3.1.7. Future Outlook
 
5.3.2.    Baxter BioPharma Solutions
5.3.2.1. Company Overview
5.3.2.2. Services Portfolio
5.3.2.3. Financial Information
5.3.2.4. Manufacturing Facilities
5.3.2.5. Partnerships
5.3.2.6. Recent Developments
5.3.2.7. Future Outlook
 
5.3.3.    Catalent Biologics (Catalent Pharma Solutions)
5.3.3.1. Company Overview
5.3.3.2. Services Portfolio
5.3.3.3. Financial Information
5.3.3.4. Manufacturing Facilities
5.3.3.5. Partnerships
5.3.3.6. Recent Developments
5.3.3.7. Future Outlook
 
5.3.4.    Cytovance Biologics
5.3.4.1. Company Overview
5.3.4.2. Services Portfolio
5.3.4.3. Partnerships
5.3.4.4. Recent Developments
5.3.4.5. Future Outlook
 
5.3.5.    Patheon
5.3.5.1. Company Overview
5.3.5.2. Services Portfolio
5.3.5.3. Financial Information
5.3.5.4. Manufacturing Facilities
5.3.5.5. Partnerships
5.3.5.6. Recent Developments
5.3.5.7. Future Outlook
 
5.3.6.    Piramal Pharma Solutions
5.3.6.1. Company Overview
5.3.6.2. Services Portfolio
5.3.6.3. Financial Information
5.3.6.4. Facilities
5.3.6.5. Partnerships
5.3.6.6. Recent Developments
5.3.6.7. Future Outlook
 
6.         BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN EUROPE
6.1.      Chapter Overview
6.2.      Biopharmaceutical Outsourcing in Europe: Regulatory Scenario
6.3.      Leading Biopharmaceutical CMOs in Europe
6.3.1.    3P Biopharmaceuticals
6.3.1.1. Company Overview
6.3.1.2. Services Portfolio
6.3.1.3. Manufacturing Facilities
6.3.1.4. Partnerships
6.3.1.5. Recent Developments
6.3.1.6. Future Outlook
 
6.3.2.    Boehringer Ingelheim BioXcellence™
6.3.2.1. Company Overview
6.3.2.2. Services Portfolio
6.3.2.3. Financial Information
6.3.2.4. Manufacturing Facilities
6.3.2.5. Partnerships
6.3.2.6. Recent Developments
6.3.2.7. Future Outlook
 
6.3.3.    Celonic
6.3.3.1. Company Overview
6.3.3.2. Services Portfolio
6.3.3.3. Manufacturing Facilities
6.3.3.4. Partnerships
6.3.3.5. Recent Developments
6.3.3.6. Future Outlook
 
6.3.4.    FUJIFILM Diosynth Biotechnologies
6.3.4.1. Company Overview
6.3.4.2. Services Portfolio
6.3.4.3. Financial Information
6.3.4.4. Manufacturing Capabilities
6.3.4.5. Partnerships
6.3.4.6. Recent Developments
6.3.4.7. Future Outlook
 
6.3.5.    LFB Group
6.3.5.1. Company Overview
6.3.5.2. Services Portfolio
6.3.5.3. Financial Information
6.3.5.4. Manufacturing Facilities
6.3.5.5. Partnerships
6.3.5.6. Recent Developments
6.3.5.7. Future Outlook
 
6.3.6.    Lonza
6.3.6.1. Company Overview
6.3.6.2. Services Portfolio
6.3.6.3. Financial Information
6.3.6.4. Manufacturing Facilities
6.3.6.5. Partnerships
6.3.6.6. Recent Developments
6.3.6.7. Future Outlook
 
6.3.7.    Menarini Biotech
6.3.7.1. Company Overview
6.3.7.2. Services Portfolio
6.3.7.3. Partnerships
6.3.7.4. Future Outlook
 
6.3.8.    Novasep
6.3.8.1. Company Overview
6.3.8.2. Services Portfolio
6.3.8.3. Financial Information
6.3.8.4. Partnerships
6.3.8.5. Recent Developments
6.3.8.6. Future Outlook
 
6.3.9.    Rentschler BioPharma
6.3.9.1. Company Overview
6.3.9.2. Services Portfolio
6.3.9.3. Manufacturing Facilities
6.3.9.4. Partnerships
6.3.9.5. Recent Developments
6.3.9.6. Future Outlook
 
7.         BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN ASIA PACIFIC AND THE REST OF THE WORLD
7.1.      Chapter Overview
 
7.2.      Biopharmaceutical Contract Manufacturing in China
7.2.1.    Biopharmaceutical Outsourcing in China: Regulatory Scenario
7.2.2.    Challenges Faced while Outsourcing to China
 
7.3.      Biopharmaceutical CMOs in China
7.3.1.    AutekBio
7.3.1.1. Company Overview
7.3.1.2. Services Portfolio
7.3.1.3. Manufacturing Facilities
7.3.1.4. Future Outlook
 
7.3.2.    WuXi AppTec (WuXi Biologics)
7.3.2.1. Company Overview
7.3.2.2. Services Portfolio
7.3.2.3. Financial Information
7.3.2.4. Manufacturing Facilities
7.3.2.5. Partnerships
7.3.2.6. Recent Developments
7.3.2.7. Future Outlook
 
7.4.      Biopharmaceutical Contract Manufacturing in India
7.4.1.    Biopharmaceutical Outsourcing in India: Regulatory Scenario
7.4.2.    Challenges Faced while Outsourcing to India
 
7.5.      Biopharmaceutical CMOs in India
7.5.1.    Intas Pharmaceuticals
7.5.1.1. Company Overview
7.5.1.2. Services Portfolio
7.5.1.3. Financial Information
7.5.1.4. Manufacturing Facilities
7.5.1.5. Future Outlook
 
7.5.2.    Kemwell Biopharma
7.5.2.1. Company Overview
7.5.2.2. Services Portfolio
7.5.2.3. Manufacturing Facilities
7.5.2.4. Partnerships
7.5.2.5. Recent Developments
7.5.2.6. Future Outlook
 
7.5.3.    Shasun Pharmaceuticals
7.5.3.1. Company Overview
7.5.3.2. Services Portfolio
7.5.3.3. Financial Information
7.5.3.4. Future Outlook
 
7.5.5.    Syngene
7.5.5.1. Company Overview
7.5.5.2. Services Portfolio
7.5.5.3. Financial Information
7.5.5.4. Manufacturing Facilities
7.5.5.5. Partnerships
7.5.5.6. Recent Developments
7.5.5.7. Future Outlook
 
7.6.      Biopharmaceutical Contract Manufacturing in Japan
7.6.1.    Biopharmaceutical Outsourcing in Japan: Regulatory Scenario
 
7.6.      Biopharmaceutical CMOs in Japan
7.6.1.    Asahi Glass
7.6.1.1. Company Overview
7.6.1.2. Services Portfolio
7.6.1.3. Financial Information
7.6.1.4. Manufacturing Facilities
7.6.1.5. Partnerships
7.7.1.6. Recent Developments
7.7.1.7. Future Outlook
 
7.7.      Biopharmaceutical Contract Manufacturing in South Korea
7.7.1.    Biopharmaceutical Outsourcing in South Korea: Regulatory Scenario
 
7.7.      Biopharmaceutical CMOs in South Korea
7.7.1.    DM Bio
7.7.1.1. Company Overview
7.7.1.2. Services Portfolio
7.7.1.3. Manufacturing Facilities
7.7.1.4. Future Outlook
 
7.7.2.    Samsung BioLogics
7.7.2.1. Company Overview
7.7.2.2. Services Portfolio
7.7.2.3. Financial Information
7.7.2.4. Manufacturing Facilities
7.7.2.5. Partnerships
7.7.2.6. Recent Developments
7.7.2.7. Future Outlook
 
7.8.      Biopharmaceutical Contract Manufacturing in Australia
7.8.1.    Biopharmaceutical Outsourcing in Australia: Regulatory Scenario
 
7.8.      Biopharmaceutical CMOs in Australia
7.8.2.    Cell Therapies
7.8.2.1. Company Overview
7.8.2.2. Services Portfolio
7.8.2.3. Manufacturing Facilities
7.8.2.4. Partnerships
7.8.2.5. Recent Developments
7.8.2.6. Future Outlook
 
7.8.3.    Luina Bio
7.8.3.1. Company Overview
7.8.3.2. Services Portfolio
7.8.3.3. Manufacturing Facilities
7.8.3.4. Partnerships
7.8.3.5. Future Outlook
 
8.         NICHE BIOPHARMACEUTICAL SECTORS
8.1.      Chapter Overview
8.2.      Antibody Drug Conjugates
8.2.1.    Introduction
8.2.1.1. Manufacturing Process
8.2.1.2. Key Technologies and Technology Providers
 
8.2.2.    Pipeline Analysis
8.2.2.1. ADC Pipeline: Marketed and Clinical Molecules
8.2.2.2. ADC Pipeline: Preclinical and Discovery Stage Molecules
8.2.2.3. ADC Manufacturing: Key Challenges 
 
8.3.      Bispecific Antibodies
8.3.1.    Introduction
8.3.1.1. The Bispecific Advantage
8.3.2.    Pipeline Analysis
8.3.3.    Bispecific Antibody Technology Providers
8.3.4.    Contract Manufacturing Scenario
 
8.4.      Cell Therapies
8.4.1.    Introduction
8.4.2.    Current Market Landscape
8.4.3.    Cell Therapy Manufacturing
8.4.4.    Cell Therapy Manufacturing Models
8.4.4.1. Centralized Manufacturing Model
8.4.4.2. Decentralized Manufacturing Model
 
8.4.5.    Cell Therapy Manufacturing: Key Challenges and Growth Drivers
8.4.6.    Important Factors for Cell Therapy Manufacturing
8.4.6.1. Cell Characterization
8.4.6.2. Cost of Goods
8.4.7.    Contract Manufacturing Scenario
8.4.7.1. Analysis by Type of Cells Manufactured
8.4.7.2. Analysis by Scale of Operation
 
8.5.      Gene Therapy
8.5.1.    Introduction
8.5.2.    Gene Therapy: Pipeline Analysis
8.5.2.1. Analysis by Phase of Development
8.5.2.2. Analysis by Type of Vector
8.5.2.3. Analysis by Therapeutic Area
 
8.5.3.    Contract Manufacturing Market Landscape
8.5.3.1. Analysis by Location
8.5.3.2. Analysis by Type of Viral Vector
8.5.3.3. Analysis by Scale of Production
 
8.6.      Plasmid DNA
8.6.1.    Introduction
8.6.2.    Contract Manufacturing Market Landscape
8.6.3.    Analysis by Location of Manufacturing Facility
8.6.4.    Analysis by Scale of Production
 
9.         CASE STUDY: OUTSOURCING OF BIOSIMILARS
9.1.      Chapter Overview
9.2.      Biosimilars: An Introduction
9.3.      Biosimilars: Development Stages
9.4.      Regulatory Requirements for Licensing of Biosimilars
9.5.      Need for Outsourcing Biosimilar Development and Manufacturing 
9.6.      Impact of Biosimilars on the Global Contract Manufacturing Market
9.6.1.    Region-wise Distribution of Biosimilar Development / Manufacturing Activity
9.7.      List of Biosimilars Contract Manufacturing Service Provider
9.8.      Challenges Associated with Biosimilar Outsourcing
 
10.       CASE STUDY: COMPARISON OF SMALL AND LARGE MOLECULE DRUGS / THERAPIES 
10.1.     Chapter Overview
10.2.     Small Molecule and Large Molecule Drugs / Therapies
10.2.1. Comparison of General Characteristics
10.2.2. Comparison of Key Specifications
10.2.3. Comparison of Manufacturing Processes
10.2.4. Comparison of Key Manufacturing Challenges
 
11.       CASE STUDY ON IN-HOUSE MANUFACTURING
11.1.     Chapter Overview
11.2.     In-House Manufacturing
11.2.1. Benefits Associated with In-House Manufacturing
11.2.2. Risks Associated with In-House Manufacturing
 
11.3.     Outsourcing in the Biomanufacturing Industry
11.3.1. Types of Outsourcing Partners
 
11.4.     Manufacturing Approaches Used for Approved Biologics (2016-2018)
11.4.1. Approved Biologics: Distribution by Size of Type of Manufacturing Approach
11.4.2. Approved Biologics: Distribution by Size of Developer and Type of Biologic
 
11.5.     Choosing the Right Strategy: In-House Manufacturing versus Outsourcing
 
12.       COLLABORATIONS
12.1.     Chapter Overview
12.2.     Partnership Models
12.3.     Biopharmaceutical Contract Manufacturing: List of Partnerships and Collaborations
12.3.1.  Analysis by Year of Partnerships
12.3.2.  Analysis by Type of Partnerships
12.3.2.1. Year-Wise Trend of Product-based Agreements
12.3.2.2. Year-Wise Trend of Process-based Agreements
12.3.2.3. Year-Wise Trend of Licensing Agreements
12.3.2.4. Year-Wise Trend of Co-service Agreements / Ventures
12.3.2.5. Year-Wise Trend of R&D Agreements
12.3.2.6. Year-Wise Trend of Out-sourcing Services Agreements
 
12.3.3. Analysis by Focus Area
12.3.4. Analysis by Type of Biologics
12.3.4.1. Analysis by Type of Biologic and Type of Partnership Model
12.3.4.2. Analysis of Cell Therapy-related Deals by Year and Type of Partnership Model
12.3.4.3. Analysis of Monoclonal Antibody-related Deals by Year and Type of Partnership Model
12.3.4.4. Analysis of Vaccine-related Deals by Year and Type of Partnership Model
12.3.4.5. Analysis of Protein-related Deals by Year and Type of Partnership Model
12.3.4.6. Analysis of Antibody Drug Deals by Year and Type of Partnership Model
12.3.4.7. Analysis of Vector-related Deals by Year and Type of Partnership Model
12.3.4.8. Analysis of Gene Therapy-related Deals by Year and Type of Partnership Model
12.3.4.9. Analysis of Biosimilar-related Deals by Year and Type of Partnership Model
12.3.4.10. Analysis of Other Biologic-related Deals by Type of Partnership Model
12.3.4.11. Analysis by Type of Biologics and Geography
 
12.3.5.  Analysis by Therapeutic Area
12.3.6.  Analysis of Most Active Players by Number of Partnerships
12.3.7.  Regional Analysis
12.3.7.1. Intercontinental and Intracontinental Agreements
 
12.4.     Mergers and Acquisitions
12.4.1.  Acquisitions Models
12.4.2.  Biopharmaceutical Contract Manufacturing: Mergers and Acquisitions 
12.4.3.  Cumulative Year-wise Trend
12.4.4.  Analysis by Type of Acquisition
12.4.5.  Geographical Activity 
12.4.5.1. Mergers and Acquisitions: Continent-wise Distribution
12.4.5.2. Mergers and Acquisitions: Country-wise Distribution
12.4.5.3. Mergers and Acquisitions: Intercontinental and Intracontinental Deals
 
12.4.6.  Most Active Acquirers: Analysis by Number of Acquisitions
12.4.7   Mergers and Acquisitions: Distribution by Key Value Drivers and Type of Biologics 
12.4.7.1. Mergers and Acquisitions: Analysis by Key Value Drivers
12.4.7.2. Mergers and Acquisitions: Analysis by Key Value Drivers and Year of Acquisition
12.4.7.3. Mergers and Acquisitions: Analysis by Type of Biologics
12.4.7.4. Mergers and Acquisitions: Analysis by Type of Biologics and Key Value Drivers
12.5.     Key Acquisitions: Deal Multiples
 
13.       RECENT DEVELOPMENTS
13.1.     Chapter Overview
13.2.     Biopharma Contract Manufacturing Market: Facility Expansions
13.2.1.  Cumulative Year-wise Distribution
13.2.2.  Analysis by Purpose of Facility Expansion
13.2.3.  Analysis by Type of Biologics
13.2.4.  Analysis by Type of Biologics and Purpose of Expansion
13.2.5.  Analysis by Location of Manufacturing Facility
13.2.6.  Regional Analysis
13.2.7. Most Active Players: Analysis by Number of Recent Expansions
13.2.8. Analysis by Headquarters and Purpose
13.2.9. Facility Expansions: Pre-2015 and Post-2015
13.3.     Biopharmaceutical Contract Manufacturing Market: Funding Instances
13.4.     Technological Advancements
13.4.1. Single Use Technology
13.4.2.  Process Analytical Technology (PAT)
13.4.3. Continuous Processing 
13.4.3.  Quality by Design in Bioprocessing 
 
 
13.3.     Biopharmaceutical Contract Manufacturing Market: Funding Instances
13.4.     Technological Advancements
13.4.1.  Single Use Technology
13.4.2.  Process Analytical Technology
13.4.3.  Continuous Processing
13.4.4.  Quality by Design in Bioprocessing
 
14.       CAPACITY ANALYSIS
14.1.     Chapter Overview
14.2.     Assumptions and Methodology
14.3.     Biopharmaceutical Contract Manufacturers: Global Production Capacity
14.3.1.  Analysis by Size of the CMO
14.3.2. Analysis by Expression Systems 
14.3.3.  Analysis by Scale of Operation
14.3.4. Analysis by Region
14.3.4.1. Capacity Analysis: North America
14.3.4.2. Capacity Analysis: Europe
14.3.4.3. Capacity Analysis: Asia and Middle East
14.4.     Emerging Biologics: Capacity Analysis
14.4.1.  ADC Manufacturing Installed Global Capacity: Regional Distribution
14.5.     Cell Therapy Manufacturing Capacity: Regional Distribution
14.6.     Viral Vectors Installed Manufacturer Capacity: Distribution by Location of Manufacturing Facility

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