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

Description

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

Product Code: RA100465

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

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