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Biologics Contract Manufacturing Market by Type of Service Offered (API Manufacturing, FDF Manufacturing), Type of Biologic Manufactured (Antibodies, Cell Therapies, Vaccines and Other Biologics), Type of Expression System Used (Mammalian, Microbial and Others), Scale of Operation (Preclinical / Clinical and Commercial), Company Size (Small, Mid-sized, and Large and Very Large), and Key Geographical Regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America): Industry Trends and Global Forecasts, 2023-2035

November 2023 | 799 pages | ID: BD3EA71EE833EN
Roots Analysis

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The global biologics contract manufacturing market is estimated to reach USD 19 billion in 2023 and is anticipated to grow at a CAGR of 9% during the forecast period 2023-2035.

The biologics contract manufacturing sector, synonymous with the biopharmaceutical CMO industry, exemplifies robust dynamism and rapid expansion, drawing considerable interest from various entities dedicated to research and development in pioneering new therapeutic modalities. These groundbreaking innovations encompass a spectrum of advancements, including antibody drug conjugates, biosimilars, and cell and gene therapies. Over time, this burgeoning market has seen a proliferation of more than 250 biologic therapies and vaccines worldwide. Notably, biologics demonstrate heightened success rates compared to traditional small-molecule drugs owing to their reduced off-target toxicity, a prevalent setback in small molecule drug development.

The escalating enthusiasm for biologics has triggered a discernible shift in investment trends within the pharmaceutical landscape, transitioning away from small molecule drugs and favoring biologics. This transition, combined with continuous scientific progress and the increasing number of FDA-approved biologics, signifies the advent of the biologics era. Biopharmaceuticals are expected to fundamentally redefine the pharmaceutical industry, gradually evolving into an indispensable component of mainstream medical treatments.

These service providers offer comprehensive solutions encompassing bioprocess development and optimization, aiming to expedite operational timelines and mitigate the substantial costs associated with manufacturing intricate biologic drugs. Some manufacturers choose to outsource specific operations to capitalize on state-of-the-art facilities and expertise, particularly when contract manufacturing firms employ cutting-edge technologies such as software-driven robotics to elevate manufacturing processes and minimize risks associated with 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.

Report Coverage
  • The report delves into 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
  • It analyzes factors such as drivers, restraints, opportunities, and challenges influencing market growth.
  • Assessment of potential advantages and obstacles within the market, providing insights into the competitive landscape among top players.
  • Revenue forecasts for market segments across five major regions.
  • An executive summary detailing key research insights into the current state and anticipated evolution of the biologics contract manufacturing market in the short and long term.
  • Introduction to biopharmaceuticals, manufacturing processes, expression systems, and the significance of outsourcing in this industry.
  • Examination of the current market landscape of contract manufacturing companies, evaluating their services, biologic types, operational scale, expression systems, and geographical locations.
  • Detailed profiles of key contract manufacturing organizations in each region, spotlighting their services, facilities, recent developments, and future prospects.
  • Case studies on the biosimilars market, exploring opportunities for Contract Manufacturing Organizations (CMOs) and comparing small and large molecule drug characteristics and manufacturing processes.
  • Assessment of big pharma manufacturing initiatives and collaborations, reviewing top companies' initiatives, collaborations, trends, and activities impacting biologics contract manufacturing.
  • Analysis of recent partnerships, mergers, acquisitions, and their influence on the biologics contract manufacturing industry.
  • Review of expansion initiatives, funding investments, and technological advancements in biomanufacturing.
  • Estimation of manufacturing capacity and annual demand for top biologics based on patient population, dosing, and strength.
  • Evaluation of the total cost of ownership for CMOs based on company size from 2023-2043.
  • Examination of industry trends, drivers, challenges through a SWOT analysis and their impact on the biopharmaceutical industry.
  • Exploration of the role of the virtual business model in biopharmaceuticals, including its advantages, risks, and impact on outsourcing operations.
  • Discussion of anticipated market growth, opportunities, and trends likely to shape the biologics contract manufacturing industry in the forecast period.
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
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
  15.3.2. Scenario
  15.3.3. Scenario
  15.3.4. Scenario
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


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