Biopharma Contract Manufacturing Market (3rd Edition), 2019-2030

Report
850 Pages
April 2019
Region: Global
Roots Analysis
ID: 4773532

Over the years, the biopharmaceutical market has grown into a prominent and promising segment of the overall pharmaceutical industry. Characterized by a number of blockbuster therapies (Humira, Rituxan, Lantus, Avastin, Herceptin, and Remicade) and a robust pipeline of product/therapy candidates, the market is poised for significant growth in the coming years. It is worth mentioning that much of the anticipated success of the biopharmaceutical market is dependent on new biologics currently under development and biosimilars. The impending growth also indicates the rising importance of manufacturing capacity within the industry. The costs associated with acquiring manufacturing capabilities are exorbitant and, therefore, it is difficult for companies with limited finances and capacity constraints to succeed by themselves. These constraints have led many of the smaller players in the industry and, at times, certain pharma giants as well, to outsource a significant part of their business operations to contract service providers. Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are known to offer significant cost-benefits, access to larger production capacities and reductions in time-to-market.

Owing to the growing number of start-ups that are engaged in R&D of novel biologics, there is a significant opportunity for the CMOs in this domain. It is worth highlighting that, since 2000, more than 115 new CMOs have been established in order to cater to the growing demand for novel biologics that have specific manufacturing requirements. The contemporary contract services market features a mix of large and small-sized CMOs and is characterized by multiple mergers and acquisitions as stakeholders strive to broaden their respective service portfolios. This has enabled several CMOs to offer end-to-end services, ranging from drug development, including preliminary R&D, preclinical and clinical trials, to commercial scale production and regulatory filings. Despite the fact that the biopharmaceutical sector is amongst the most highly regulated industries, we expect the demand for core competencies to continue to drive sponsor companies to outsource various parts of their product development and manufacturing operations. Amidst tough competition, the availability of advanced tools and technologies is an important differentiating factor and is likely to grant a competitive edge to certain CMOs over other stakeholders.

Scope of the Report

The “Biopharmaceutical Contract Manufacturing Market (3rd edition), 2019 – 2030” report features an extensive study on the contract service providers within the biopharmaceutical industry. The study features in-depth analysis, highlighting the capabilities of a diverse set of biopharmaceutical CMOs and CDMOs. Amongst other elements, the report includes:

A detailed review of the overall landscape of the biopharmaceutical contract manufacturing market, featuring a comprehensive list of active CMOs and detailed analysis of the manufacturing service providers based on a number of parameters, such as scale of operation (preclinical, clinical and commercial), type of biologics manufactured (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, antibody drug conjugates, vectors, biosimilars, nucleic acids and others), type of expression systems used (mammalian, microbial and others), year of establishment, employee size, geographical location of the CMO, number of manufacturing facilities, as well as the location of these facilities, GMP compliance, affiliations to regulatory agencies, type of bioreactors used (single-use bioreactors and stainless steel bioreactors), mode of operation of bioreactors (batch, fed-batch and perfusion) and bioprocessing capacity.
Elaborate profiles of key players that have a diverse range of capabilities for the development, manufacturing and packaging of biologics. Each profile provides an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, and details on partnerships, recent developments (expansions), as well as a comprehensive future outlook.
A detailed discussion on the key enablers in this domain, including certain niche product classes, such as antibody-drug conjugates (ADCs), bispecific antibodies, cell therapies, gene therapies and viral vectors, which are likely to have a significant impact on the growth of the contract services market.
A case study on the growing global biosimilars market, highlighting the opportunities for biopharmaceutical CMOs and CDMOs.
A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps involved in their respective manufacturing processes.
A discussion on challenges related to in-house manufacturing, featuring a brief overview of the various parameters that a drug/therapy developer may need to take into consideration while deciding whether to manufacture its products in-house or outsource.
An analysis of the recent collaborations (signed since 2013) focused on the contract manufacturing of biologics; the analysis is based on various parameters, such as the year in which the agreement was signed, type of agreement, focus area and type of biologics.
A detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2013-2018, along with the geographical distribution of this activity. The analysis also depicts the relationship between important deal multiples based on the revenue, number of employees and experience of the acquired company.
An analysis of the recent trends within the biopharmaceutical contract manufacturing industry, highlighting various facility and capability expansions. In addition, it provides information on the technology advancements related to biomanufacturing.
A detailed capacity analysis, taking into consideration the individual development and manufacturing capacities of various stakeholders (small-sized, mid-sized, large and very large CMOs / CDMOs) in the market, using data from both secondary and primary research. The study examines the distribution of global biopharmaceutical manufacturing capacity by scale of operation (preclinical/clinical, commercial), size of company (small-sized, mid-sized, large and very large), and geography (North America (the US and Canada), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia and Middle East (China, India, Japan, South Korea and rest of the Asia and Middle East), and rest of the world (including Australia).
An informed estimate of the annual demand for biologics, taking into account the top 20 biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products.
A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall pharmaceutical industry.
A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing CMO services to medical device developers.
One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as the growth of the overall biopharmaceutical market, cost of goods sold, and direct manufacturing costs, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2019-2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] commonly outsourced business operations (active pharmaceutical ingredients (APIs) and finished dosage formulations (FDFs)), [B] types of expression systems (mammalian, microbial and others), [C] size of the company (small-sized, mid-sized and large / very large), [D] scale of operation (preclinical, clinical and commercial) and [E] key geographical regions (North America (US, Canada), Europe (UK, France, Germany, Italy and Spain), Asia (China and India) and rest of the world (Australia)). To account for the uncertainties associated with the manufacturing of biopharmaceuticals and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

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. Processing 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. Future Perspectives

4. Competitive Landscape

4.1. Chapter Overview
4.2. Biopharmaceutical Contract Manufacturers: Overall Market Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Size of Employee Base
4.2.3. Analysis by Location of Headquarters
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 Mode of Operation
4.2.9. Analysis by Biomanufacturing Capacity
4.2.10. Analysis by Packaging Form

5. Biopharmaceutical Contract Manufacturing In North America

5.1. Chapter Overview
5.2. Biopharmaceutical Outsourcing in the US: Regulatory Scenario
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. Biomanufacturing Services
5.3.1.4. Financial Information
5.3.1.5. Manufacturing facilities
5.3.1.6. Partnerships
5.3.1.7. Recent Developments
5.3.1.8. Awards and Accolades
5.3.1.9. 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. Awards and Accolades
5.3.2.8. 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. Awards and Accolades
5.3.3.8. 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. Awards and Accolades
5.3.4.6. 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. Awards and Accolades
5.3.5.8. 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
7.3. 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
7.4. Biopharmaceutical Contract Manufacturing in India
7.4.1. Biopharmaceutical Outsourcing in India: Regulatory Scenario
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. Partnerships
7.5.1.6. 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
7.5.4. Syngene
7.5.4.1. Company Overview
7.5.4.2. Services Portfolio
7.5.4.3. Financial Information
7.5.4.4. Manufacturing Facilities
7.5.4.5. Partnerships
7.5.4.6. Recent Developments
7.5.4.7. Future Outlook
7.6. Biopharmaceutical Contract Manufacturing in Japan
7.6.1. Biopharmaceutical Outsourcing in Japan: Regulatory Scenario
7.7. Biopharmaceutical CMOs in Japan
7.7.1. Asahi Glass
7.7.1.1. Company Overview
7.7.1.2. Services Portfolio
7.7.1.3. Financial Information
7.7.1.4. Manufacturing Facilities
7.7.1.5. Partnerships
7.7.1.6. Recent Developments
7.7.1.7. Future Outlook
7.8. Biopharmaceutical Contract Manufacturing in South Korea
7.8.1. Biopharmaceutical Outsourcing in South Korea: Regulatory Scenario
7.9. Biopharmaceutical CMOs in South Korea
7.9.1. DM Bio
7.9.1.1. Company Overview
7.9.1.2. Services Portfolio
7.9.1.3. Manufacturing Facilities
7.9.1.4. Recent Developments
7.9.1.5. Future Outlook
7.9.2. Samsung BioLogics
7.9.2.1. Company Overview
7.9.2.2. Services Portfolio
7.9.2.3. Financial Information
7.9.2.4. Manufacturing Facilities
7.9.2.5. Partnerships
7.9.2.6. Recent Developments
7.9.2.7. Future Outlook
7.10. Biopharmaceutical Contract Manufacturing in Australia
7.10.1. Biopharmaceutical Outsourcing in Australia: Regulatory Scenario
7.11. Biopharmaceutical CMOs in Australia
7.11.1. Cell Therapies
7.11.1.1. Company Overview
7.11.1.2. Services Portfolio
7.11.1.3. Manufacturing Facilities
7.11.1.4. Partnerships
7.11.1.5. Recent Developments
7.11.1.6. Future Outlook
7.11.2. Luina Bio
7.11.2.1. Company Overview
7.11.2.2. Services Portfolio
7.11.2.3. Manufacturing Facilities
7.11.2.4. Partnerships
7.11.2.5. 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
8.4.7. Contract Manufacturing Scenario
8.4.7.1. Contract Manufacturing Market Landscape
8.4.7.2. Analysis by Type of Cells Manufactured
8.4.7.3. 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 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. Challenges Associated with Outsourcing Biosimilars

10. Case Study: Comparison Of Small Molecule Andlarge 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: Analysis by Size of Developer and Type of Manufacturing Approach
11.4.2. Approved Biologics: Analysis 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 Partnership
12.3.2. Analysis by Type of Partnership
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 Biologic
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 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 Conjugate-related 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 Biologic 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. Biopharmaceutical Contract Manufacturing: Mergers and Acquisitions
12.4.1. Cumulative Year-wise Trend
12.4.2. Analysis by Type of Acquisition
12.4.3. Regional Analysis
12.4.3.1. Continent-wise Distribution
12.4.3.2. Country-wise Distribution
12.4.3.3. Intercontinental and Intracontinental Deals
12.4.4. Analysis of Most Active Acquirers by Number of Acquisitions
12.4.5. Analysis by Key Value Drivers
12.4.5.1. Analysis by Key Value Drivers and Year of Acquisition
12.4.6. Analysis by Type of Biologic
12.5.6.1. Analysis by Type of Biologic and Key Value Drivers
12.4.7 Key Acquisitions: Deal Multiples

13. Recent Developments

13.1. Chapter Overview
13.2. Biopharmaceutical 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 Biologic
13.2.4. Analysis by Location of Facility
13.2.5. Regional Analysis
13.2.6. Analysis by Region and Purpose
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 Bio-processing

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 Region
14.3.2. Analysis by Expression Systems
14.3.3. Analysis by Scale of Operation
14.4. ADC Contract Manufacturers: Global Production Capacity
14.5. Cell Therapy Manufacturers: Production Capacity
14.6. Vector Manufacturers: Production Capacity
14.7. Concluding Remarks

15. Demand Analysis

15.1. Chapter Overview
15.2. Key Assumptions and Methodology
15.3. Biopharmaceutical Contract Manufacturing Market: Overall Annual Demand
15.3.1. Analysis by Therapeutic Area
15.4. ADCs: Overall Annual Demand
15.4.1. ADCs: Demand and Supply Analysis

16. Market Forecast

16.1. Chapter Overview
16.2. Forecast Methodology and Key Assumptions
16.3. Overall Biopharmaceutical Contract Manufacturing Market, 2019-2030
16.3.1. Biopharmaceutical Contract Manufacturing Market for API Manufacturing, 2019-2030
16.3.2. Biopharmaceutical Contract Manufacturing Market for FDF Manufacturing, 2019-2030
16.4. Biopharmaceutical Contract Manufacturing Market, 2019-2030: Distribution by Expression Systems Used
16.5. Biopharmaceutical Contract Manufacturing Market, 2019-2030: Distribution by Scale of Operation
16.6. Biopharmaceutical Contract Manufacturing Market, 2019-2030: Distribution by Size of Manufacturers
16.7. Biopharmaceutical Contract Manufacturing Market, 2019-2030: Distribution by Geography
16.7.1. Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030
16.7.1.1. Biopharmaceutical Contract Manufacturing Market in the US, 2019-2030
16.7.1.2. Biopharmaceutical Contract Manufacturing Market in Rest of North America, 2019-2030
16.7.1.3. Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Mammalian Cell-based Operations
16.7.1.4. Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Microbial Cell-based Operations
16.7.1.5. Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Other Expression System-based Operations
16.7.1.6. Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Preclinical / Clinical Scale Operations
16.7.1.7. Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Commercial Operations
16.7.1.8. Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Small-sized Companies
16.7.1.9. Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Mid-sized Companies
16.7.1.10. Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Large / Very Large Companies
16.7.2. Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030
16.7.2.1. Biopharmaceutical Contract Manufacturing Market in Italy, 2019-2030
16.7.2.2. Biopharmaceutical Contract Manufacturing Market in Germany, 2019-2030
16.7.2.3. Biopharmaceutical Contract Manufacturing Market in France, 2019-2030
16.7.2.4. Biopharmaceutical Contract Manufacturing Market in Spain, 2019-2030
16.7.2.5. Biopharmaceutical Contract Manufacturing Market in the UK, 2019-2030
16.7.2.6. Biopharmaceutical Contract Manufacturing Market in Rest of Europe, 2019-2030
16.7.2.7. Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Mammalian Cell-based Operations
16.7.2.8. Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Microbial Cell-based Operations
16.7.2.9. Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Other Expression System-based Operations
16.7.2.10. Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Preclinical / Clinical Operations
16.7.2.11. Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Commercial Operations
16.7.1.12. Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Small-sized Companies
16.7.1.13. Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Mid-sized Companies
16.7.1.14. Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Large / Very Large Companies
16.7.2. Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030
16.7.2.1. Biopharmaceutical Contract Manufacturing Market in China, 2019-2030
16.7.2.2. Biopharmaceutical Contract Manufacturing Market in India, 2019-2030
16.7.2.3. Biopharmaceutical Contract Manufacturing Market in South Korea, 2019-2030
16.7.2.4. Biopharmaceutical Contract Manufacturing Market in Japan, 2019-2030
16.7.2.5. Biopharmaceutical Contract Manufacturing Market in Australia, 2019-2030
16.7.2.6. Biopharmaceutical Contract Manufacturing Market in Rest of Asia and Other Regions, 2019-2030
16.7.2.7. Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Mammalian Cell-based Operations
16.7.2.8. Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Microbial Cell-based Operations
16.7.2.9. Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Other Expression System-based Operations
16.7.2.10. Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Preclinical / Clinical Operations
16.7.2.11. Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Commercial Operations
16.7.1.12. Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Small-sized Companies
16.7.1.13. Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Mid-sized Companies
16.7.1.14. Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Large / Very Large Companies

17. SWOT Analysis

17.1 Chapter Overview
17.2. Strengths
17.3. Weaknesses
17.4. Opportunities
17.5. Threats
17.6. Comparison of Swot Factors
17.7. Concluding Remarks

18. Future Of The Biopharmaceutical CMO Market

18.1. Chapter Overview
18.2. Outsourcing Activities to Witness Significant Growth in the Coming Years
18.3. Shift from One-time Contracts to Strategic Partnerships
18.4. Integration / Adoption of New and Innovative Technologies
18.4.1. Single use Bioreactors
18.4.2. Novel Bioprocess Techniques
18.4.3. Bioprocess Automation
18.5. Focus on Niche Therapeutic Areas
18.6. Growing Biosimilars Market to Contribute to the Growth of the Contract Services Segment
18.7. Capability and Expertise Expansions by CMOs to become One Stop Shops
18.8. Offshoring Outsourcing Activities to Maximize Profits and Expand Existing Capacities
18.9. Increase in Financial Inflow and Outsourcing Budgets
18.10. The Need for Humanized Products to Drive the Growth of Mammalian Expression Technologies
18.11. Challenges Faced by both Sponsors and Service Providers
18.11.1. Concerns related to Single Use Systems
18.11.2. Issues Related to Capacity Fluctuations
18.12. Concluding Remarks

19. Survey Analysis

19.1. Chapter Overview
19.1.1. Overview of Respondents
19.1.2. Designation of Respondents
19.2. Biologics Manufacturing Expertise
19.3. Scale of Manufacturing
19.4. Location of Production Facilities
19.5. Types of Expression Systems Used
19.6. Types of Bioreactors
19.7. Modes of Operation of Bioreactors

20. Interview Transcripts

20.1. Chapter Overview
20.2. Astrid Brammer, Senior Manager Business Development, Richter-Helm
20.3. Birgit Schwab, Senior Manager Strategic Marketing, Rentschler Biotechnologie
20.4. Christian Bailly, Director of CDMO, Pierre Fabre
20.5. Claire Otjes, Assistant Marketing Manager, Batavia Biosciences
20.6. David C Cunningham, Director Corporate Development, Goodwin Biotechnology
20.7. Dietmar Katinger, Chief Executive Officer, Polymun Scientific
20.8. Denis Angioletti, Chief Commercial Officer, Cerbios-Pharma
20.9. Jeffrey Hung, Chief Commercial Officer, Vigene Biosciences
20.10. Kevin Daley, Director Pharmaceuticals, Novasep
20.11. Mark Wright, Site Head, Grangemouth, Piramal Healthcare
20.12. Nicolas Grandchamp, R&D Leader, GEG Tech
20.13. Raquel Fortunato, Chief Executive Officer, GenIbet Biopharmaceuticals
20.14. Sebastian Schuck, Head of Business Development, Wacker Biotech
20.15. Stephen Taylor, Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies
20.16. Tatjana Buchholz, Marketing Manager, PlasmidFactory and Marco Schmeer, Project Manager, PlasmidFactory
20.17. Tim Oldham, Chief Executive Officer, Cell Therapies

21. Appendix 1: List Of Non-Industry Players22. Appendix 2: Tabulated Data23. Appendix 3: List Of Companies And Organizations

List of Figures

Figure 3.1 Types of Biopharmaceuticals
Figure 3.2 Stages of the Biomanufacturing Process
Figure 3.3 Types of Third-Party Service Providers
Figure 3.4 Commonly Outsourced Business Operations
Figure 3.5 Key Factors to Consider while Selecting a CMO Partner
Figure 3.6 Risks and Challenges Associated with Contract Manufacturing
Figure 4.1 Biopharmaceutical CMOs: Distribution by Year of Establishment
Figure 4.2 Biopharmaceutical CMOs: Distribution by Size of Employee Base
Figure 4.3 Biopharmaceutical CMOs: Distribution by Location of Headquarters (Region-wise)
Figure 4.4 Biopharmaceutical CMOs: Distribution by Location of Headquarters (Country-wise)
Figure 4.5 Biopharmaceutical CMOs: Distribution by Location of Manufacturing Facility (Region-wise)
Figure 4.6 Biopharmaceutical CMOs: Distribution by Location of Manufacturing Facility (Country-wise)
Figure 4.7 Biopharmaceutical CMOs: Distribution by Types of Biologics Manufactured
Figure 4.8 Biopharmaceutical CMOs: Distribution by Scale of Operation
Figure 4.9 Biopharmaceutical CMOs: Distribution by Types of Expression Systems Used
Figure 5.1 Biopharmaceutical Industry: The US Market Scenario
Figure 5.2 Biopharmaceutical Contract Manufacturing in the US: Growth Drivers and Challenges
Figure 5.3 US FDA Guidelines: Elements of a Quality Agreement
Figure 5.4 US FDA Guidelines: Key Considerations for Biologic Manufacturing Operations
Figure 5.5 Common Manufacturing Operations Offered by CMOs
Figure 5.6 AMRI: Service Portfolio
Figure 5.7 AMRI: Annual Revenues (USD Million)
Figure 5.8 AMRI: Revenues by Business Divisions (USD Million)
Figure 5.9 Baxter BioPharma Solutions: Customized Support Services Portfolio
Figure 5.10 Baxter BioPharma Solutions: ADCs Related Services
Figure 5.11 Baxter BioPharma Solutions: Regulatory Services
Figure 5.12 Baxter International: Annual Revenues (USD Billion)
Figure 5.13 Catalent: Biologics Services Portfolio
Figure 5.14 Catalent: Biosimilars Services Portfolio
Figure 5.15 Catalent: Annual Revenues (USD Million)
Figure 5.16 Catalent: Annual Revenues by Business Divisions (USD Million)
Figure 5.17 Cytovance: Services Portfolio
Figure 5.18 Patheon: Services Portfolio
Figure 5.19 Patheon: Services and Solutions for Biologics
Figure 5.20 Patheon: Services and Solutions for Small Molecules
Figure 5.21 Patheon: Annual Revenues (USD Million)
Figure 5.22 Patheon: Revenues by Business Segments (USD Million)
Figure 5.23 Piramal Pharma Solutions: Annual Revenues (USD Million)
Figure 6.1 Biopharmaceutical Contract Manufacturing in Europe: Growth Drivers and Challenges
Figure 6.2 EMA GMP Guidelines: Key Considerations of the Contract Giver, Contract Acceptor and the Contract
Figure 6.3 LFB Group: Services Portfolio
Figure 6.4 LFB Biomanufacturing Services: Services Portfolio
Figure 6.5 LFB Group: Annual Revenues (EUR Million)
Figure 6.6 LFB Group: Revenues by Therapeutic Area and Services (EUR Million)
Figure 6.7 Menarini Biotech: Services Portfolio
Figure 6.8 Novasep: Products Portfolio
Figure 6.9 Novasep: Annual Revenues (EUR Million)
Figure 6.10 Rentschler Biopharma: Services Portfolio
Figure 6.11 Boehringer Ingelheim BioXcellence™: Services Portfolio
Figure 6.12 Boehringer Ingelheim: Annual Revenues (EUR Billion)
Figure 6.13 Boehringer Ingelheim: Revenues by Business Divisions (EUR Billion)
Figure 6.14 Celonic: Services Portfolio
Figure 6.15 Lonza: Services Portfolio
Figure 6.16 Lonza: Annual Revenues (CHF Billion)
Figure 6.17 FUJIFILM Diosynth Biotechnologies: Services Portfolio
Figure 6.18 FUJIFILM Diosynth Biotechnologies: Annual Revenues (JPY Billion)
Figure 6.19 FUJIFILM Holdings: Annual Revenues by Business Divisions (JPY Billion)
Figure 6.20 3P Biopharmaceuticals: Services Portfolio
Figure 7.1 Biopharmaceutical Contract Manufacturing in China: Growth Drivers
Figure 7.2 Biopharmaceutical Contract Manufacturing in China: Challenges
Figure 7.3 Chinese Regulatory Guidelines: Key Considerations of the Contract Giver
Figure 7.4 Chinese Regulatory Guidelines: Key Considerations of the Contract Acceptor
Figure 7.5 Chinese Regulatory Guidelines: Key Aspects of the Contract
Figure 7.6 Autotek Bio: Services Portfolio
Figure 7.7 Autotek Bio: DisposUp Technology
Figure 7.8 WuXi Biologics: Services Portfolio
Figure 7.9 WuXi Biologics: Antibody Discovery Procedure
Figure 7.10 Wuxi Biologics: Annual Revenues (RMB Million)
Figure 7.11 Wuxi Biologics: Annual Revenues by Regions of Operation (RMB million)
Figure 7.12 Biopharmaceutical Contract Manufacturing in India: Growth Drivers
Figure 7.13 Biopharmaceutical Contract Manufacturing in India: Challenges
Figure 7.14 Intas Pharmaceuticals: Annual Revenues (INR Million)
Figure 7.15 Strides Shasun: Annual Revenues (INR Million)
Figure 7.16 Syngene: Services Portfolio
Figure 7.17 Syngene: Annual Revenues (INR Million)
Figure 7.18 Asahi Glass: Services Portfolio
Figure 7.19 Asahi Glass: Annual Revenues (JPY Million)
Figure 7.20 DM Bio: Services Portfolio
Figure 7.21 DM Bio: Manufacturing Services
Figure 7.22 Samsung BioLogics: Services Portfolio
Figure 7.23 Samsung BioLogics: Annual Revenues from CMO Operations (KRW Billion)
Figure 7.24 Cell Therapies: Services Portfolio
Figure 7.25 LuinaBio: Services Portfolio
Figure 8.1 ADCs: Structure
Figure 8.2 ADCs Pipeline: Distribution by Phase of Development
Figure 8.3 Bispecific Antibody: Structure
Figure 8.4 Bispecific Antibody Pipeline: Distribution by Phase of Development
Figure 8.5 Steps for Manufacturing Cell Therapies
Figure 8.6 Centralized Manufacturing: Process Model
Figure 8.7 Decentralized Manufacturing: Process Model
Figure 8.8 Cell Therapy: Challenges and Drivers
Figure 8.9 Cell Therapy: Critical Quality Attribute (Potency)
Figure 8.10 Gene Therapy, Clinical and Preclinical Pipeline: Distribution by Phase of Development
Figure 8.11 Gene Therapy, Clinical Pipeline: Distribution by Vector Types
Figure 8.12 Gene Therapy, Preclinical Pipeline: Distribution by Vector Types
Figure 8.13 Gene Therapy, Clinical Pipeline: Distribution by Therapeutic Area
Figure 8.14 Gene Therapy CMOs: Distribution by Region
Figure 8.15 Viral Vectors Manufacturers: Distribution by Type of Viral Vector
Figure 8.16 Viral Vectors Manufacturers: Distribution by Scale of Production
Figure 8.17 Plasmid DNA Manufacturers: Distribution by Location of Manufacturing Facility
Figure 8.18 Plasmid DNA Manufacturers: Distribution by Scale of Production
Figure 9.1 Biosimilars: Stages of Manufacturing
Figure 9.2 Biosimilars: Analytical and Functional Characterization Methods for Key Product Attributes
Figure 9.3 Regulatory Process for Licensing of a Biosimilar Product
Figure 9.4 Need for Outsourcing Biosimilar Manufacturing
Figure 9.5 Biosimilars Pipeline: Country-wise Distribution
Figure 9.6 Challenges Associated with Biosimilar Outsourcing
Figure 10.1 Small Molecule and Large Molecule Drugs: Historical Trend of FDA Approval (2005 - November 2018)
Figure 10.2 Small Molecules and Large Molecules: Comparison of Key Characteristics
Figure 10.3 Small Molecules and Large Molecules: Comparison of Manufacturing Process
Figure 11.1 Benefits Associated with In-House Manufacturing
Figure 11.2 Risks Associated with In-House Manufacturing
Figure 11.3 Advantages and Disadvantages of Different Types of Outsourcing Partnerships
Figure 11.4 Approved Biologics: Distribution by Size of Developer and Type of Manufacturing Model
Figure 11.5 Approved Biologics: Distribution by Size of Developer and Type of Biologic
Figure 12.1 Collaborations: Cumulative Trend by Year, 2013- 2018
Figure 12.2 Collaborations: Distribution by Type of Partnership Model
Figure 12.3 Collaborations: Cumulative Year-wise Trend of Product-based Agreements, 2013 - 2018
Figure 12.4 Collaborations: Cumulative Year-wise Trend of Process-based Agreements, 2013 - 2018
Figure 12.5 Collaborations: Cumulative Year-wise Trend of Licensing Agreements, 2013 - 2018
Figure 12.6 Collaborations: Cumulative Year-wise Trend of Co-Service Agreements / Ventures, 2013 - 2018
Figure 12.7 Collaborations: Cumulative Year-wise Trend of R&D Agreements, 2013 - 2018
Figure 12.8 Collaborations: Cumulative Year-wise Trend of Outsourcing Services Agreements, 2013 - 2018
Figure 12.9 Collaborations: Distribution by Focus Area
Figure 12.10 Collaborations: Distribution by Focus Area and Type of Partnership Model
Figure 12.11 Collaborations: Distribution by Type of Biologic
Figure 12.12 Collaborations: Distribution by Type of Biologic and Type of Partnership Model
Figure 12.13 Collaborations: Distribution of Cell Therapy-related Deals by Year and Type of Partnership Model
Figure 12.14 Collaborations: Distribution of Monoclonal Antibody-related Deals by Year and Type of Partnership Model
Figure 12.15 Collaborations: Distribution of Vaccine-related Deals by Year and Type of Partnership Model
Figure 12.16 Collaborations: Distribution of Protein-related Deals by Year and Type of Partnership Model
Figure 12.17 Collaborations: Distribution of Antibody Drug Conjugate-related Deals by Year and Type of Partnership Model
Figure 12.18 Collaborations: Distribution of Vector-related Deals by Year and Type of Partnership Model
Figure 12.19 Collaborations: Distribution of Gene Therapy-related Deals by Year and Type of Partnership Model
Figure 12.20 Collaborations: Distribution of Biosimilar-related Deals by Year and Type of Partnership Model
Figure 12.21 Collaborations: Distribution of Other Biologic-related Deals by Type of Partnership Model
Figure 12.22 Collaborations: Distribution of Manufacturing Agreements by Type of Biologic and Geography
Figure 12.23 Collaborations: Distribution by Therapeutic Area
Figure 12.24 Collaborations: Most Active Players
Figure 12.25 Collaborations: Regional Distribution
Figure 12.26 Collaborations: Intercontinental and Intracontinental Distribution
Figure 12.27 Mergers and Acquisitions: Year-Wise Cumulative Trend (2013- 2018)
Figure 12.28 Mergers and Acquisitions: Distribution by Type of Acquisition
Figure 12.29 Mergers and Acquisitions: Continent-wise Distribution
Figure 12.30 Mergers and Acquisitions: Country-wise Distribution
Figure 12.31 Mergers and Acquisitions: Intercontinental and Intracontinental Acquisitions
Figure 12.32 Mergers and Acquisitions: Most Active Acquirers
Figure 12.33 Mergers and Acquisitions: Key Value Drivers
Figure 12.34 Mergers and Acquisitions: Distribution by Key Value Drivers and Year of Acquisition
Figure 12.35 Mergers and Acquisitions: Distribution by Type of Biologic
Figure 12.36 Mergers and Acquisitions: Heat Map Analysis
Figure 12.37 Mergers and Acquisitions: Relationship between Important Deal Multiples
Figure 13.1 Facility Expansions: Cumulative Year-wise Trend, 2013-2018
Figure 13.2 Facility Expansions: Distribution by Purpose
Figure 13.3 Facility Expansions: Distribution by Type of Biologic
Figure 13.4 Facility Expansions: Distribution by Location of Facility (Region-wise)
Figure 13.5 Facility Expansions: Distribution by Location of Headquarters (Country-wise)
Figure 13.6 Facility Expansions: Regional Distribution
Figure 13.7 Facility Expansions: Distribution by Region and Purpose
Figure 14.1 Capacity Analysis: Global Contract Biomanufacturing Capacity by Size of Employee Base of Contract Manufacturers
Figure 14.2 Capacity Analysis: Regional Distribution of Biopharmaceutical CMOs
Figure 14.3 Capacity Analysis: Regional Production Capacity of Biopharmaceutical CMOs
Figure 14.4 Capacity Analysis: Regional Contract Biomanufacturing Capacity
Figure 14.5 Capacity Analysis: Percentage Distribution of Contract Biomanufacturing Capacity by Expression Systems Used
Figure 14.6 Capacity Analysis: Distribution by Scale of Operation
Figure 14.7 Geographical Distribution of ADC Manufacturing Capacity
Figure 14.8 Geographical Distribution of Cell Therapy Manufacturing Capacity
Figure 14.9 Geographical Distribution of Vector Manufacturing Capacity
Figure 15.1 Demand Analysis: Annual Demand for Biopharmaceuticals (in Kilograms)
Figure 15.2 Demand Analysis: Annual Demand for ADCs (in Kilograms)
Figure 16.1 Overall Biopharmaceutical Contract Manufacturing Market, 2019-2030
Figure 16.2 Biopharmaceutical Contract Manufacturing Market for API Manufacturing, 2019-2030 (USD Billion)
Figure 16.3 Biopharmaceutical Contract Manufacturing Market for FDF Manufacturing, 2019-2030 (USD Billion)
Figure 16.4 Biopharmaceutical Contract Manufacturing Market, 2019-2030: Distribution by Expression Systems Used (USD Billion)
Figure 16.5 Biopharmaceutical Contract Manufacturing Market, 2019-2030: Distribution by Scale of Operation (USD Billion)
Figure 16.6 Biopharmaceutical Contract Manufacturing Market, 2019-2030: Distribution by Size of Employee Base of Contract Manufacturers (USD Billion)
Figure 16.7 Biopharmaceutical Contract Manufacturing Market, 2019-2030: Distribution by Geography (USD Billion)
Figure 16.8 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030 (USD Billion)
Figure 16.9 Biopharmaceutical Contract Manufacturing Market in the US, 2019-2030 (USD Billion)
Figure 16.10 Biopharmaceutical Contract Manufacturing Market in Rest of North America, 2019-2030 (USD Billion)
Figure 16.11 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Mammalian Cell-based Operations (USD Billion)
Figure 16.12 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Microbial Cell-based Operations (USD Billion)
Figure 16.13 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Other Expression System-based Operations (USD Billion)
Figure 16.14 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Preclinical / Clinical Scale Operations (USD Billion)
Figure 16.15 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Commercial Operations (USD Billion)
Figure 16.16 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Small-sized Companies (USD Billion)
Figure 16.17 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Mid-sized Companies (USD Billion)
Figure 16.18 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Large / Very Large Companies (USD Billion)
Figure 16.19 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030 (USD Billion)
Figure 16.20 Biopharmaceutical Contract Manufacturing Market in Italy, 2019-2030 (USD Billion)
Figure 16.21 Biopharmaceutical Contract Manufacturing Market in Germany, 2019-2030 (USD Billion)
Figure 16.22 Biopharmaceutical Contract Manufacturing Market in France, 2019-2030 (USD Billion)
Figure 16.23 Biopharmaceutical Contract Manufacturing Market in Spain, 2019-2030 (USD Billion)
Figure 16.24 Biopharmaceutical Contract Manufacturing Market in the UK, 2019-2030 (USD Billion)
Figure 16.25 Biopharmaceutical Contract Manufacturing Market in Rest of Europe, 2019-2030 (USD Billion)
Figure 16.26 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Mammalian Cell-based Operations (USD Billion)
Figure 16.27 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Microbial Cell-based Operations (USD Billion)
Figure 16.28 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Other Expression System-based Operations (USD Billion)
Figure 16.29 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Preclinical / Clinical Operations (USD Billion)
Figure 16.30 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Commercial Operations (USD Billion)
Figure 16.31 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Small-sized Companies (USD Billion)
Figure 16.32 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Mid-sized Companies (USD Billion)
Figure 16.33 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Large / Very Large Companies (USD Billion)
Figure 16.34 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030 (USD Billion)
Figure 16.35 Biopharmaceutical Contract Manufacturing Market in China, 2019-2030 (USD Billion)
Figure 16.36 Biopharmaceutical Contract Manufacturing Market in India, 2019-2030 (USD Billion)
Figure 16.37 Biopharmaceutical Contract Manufacturing Market in South Korea, 2019-2030 (USD Billion)
Figure 16.38 Biopharmaceutical Contract Manufacturing Market in Japan, 2019-2030 (USD Billion)
Figure 16.39 Biopharmaceutical Contract Manufacturing Market in Australia, 2019-2030 (USD Billion)
Figure 16.40 Biopharmaceutical Contract Manufacturing Market in Rest of Asia and Other Regions, 2019-2030 (USD Billion)
Figure 16.41 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Mammalian Cell-based Operations (USD Billion)
Figure 16.42 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Microbial Cell-based Operations (USD Billion)
Figure 16.43 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Other Expression System-based Operations (USD Billion)
Figure 16.44 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Preclinical / Clinical Operations (USD Billion)
Figure 16.45 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Commercial Operations (USD Billion)
Figure 16.46 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Small-sized Companies (USD Billion)
Figure 16.47 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Mid-sized Companies (USD Billion)
Figure 16.48 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Large / Very Large Companies (USD Billion)
Figure 17.1 Biopharmaceutical Contract Manufacturing: SWOT Analysis
Figure 17.2 Global Biopharmaceuticals Market: Number of FDA Approvals by Year, 2002-2018
Figure 17.3 Comparison of SWOT Factors: Harvey Ball Analysis
Figure 19.1 Survey Analysis: Distribution of Respondents by Company Type
Figure 19.2 Survey Analysis: Distribution of Respondents by Location of Headquarters
Figure 19.3 Survey Analysis: Distribution of Respondents by Designation
Figure 19.4 Survey Analysis: Distribution by Biologics Manufacturing Expertise
Figure 19.5 Survey Analysis: Distribution by Scale of Manufacturing
Figure 19.6 Survey Analysis: Distribution by Location of Production Facilities
Figure 19.7 Survey Analysis: Distribution by Types of Expression Systems Used
Figure 19.8 Survey Analysis: Distribution by Types of Bioreactors
Figure 19.9 Survey Analysis: Distribution by Modes of Operation of Bioreactors

List of Tables

Table 4.1 List of Biopharmaceutical CMOs
Table 4.2 Biopharmaceutical CMOs: Information on Types of Biologics Manufactured
Table 4.3 Biopharmaceutical CMOs: Information on Scale of Operation
Table 4.4 Biopharmaceutical CMOs: Information on Types of Expression Systems Used
Table 4.5 Biopharmaceutical CMOs: Information on Types of Bioreactors
Table 4.6 Biopharmaceutical CMOs: Information on Mode of Operation of Bioreactor
Table 4.7 Biopharmaceutical CMOs: Information on Biomanufacturing Capacity
Table 4.8 Biopharmaceutical CMOs: Information on Type of Packaging Forms
Table 5.1 AMRI (OsoBio): Company Overview
Table 5.2 AMRI (OsoBio): Partnerships and Collaborations
Table 5.3 AMRI (OsoBio): Future Outlook
Table 5.4 Baxter Bio Pharma Solutions: Company Overview
Table 5.5 Baxter BioPharma Solutions: Partnerships
Table 5.6 Baxter BioPharma Solutions: Future Outlook
Table 5.7 Catalent Biologics: Company Overview
Table 5.8 Catalent Biologics: Facilities
Table 5.9 Catalent Biologics: Partnerships
Table 5.10 Catalent Biologics: Future Outlook
Table 5.11 Cytovance: Company Overview
Table 5.12 Cytovance: Partnerships
Table 5.13 Cytovance: Future Outlook
Table 5.14 Patheon: Company Overview
Table 5.15 Patheon: Biopharmaceutical Manufacturing and Development Facilities
Table 5.16 Patheon: Partnerships
Table 5.17 Patheon: Future Outlook
Table 5.18 Piramal Pharma Solutions: Company Overview
Table 5.19 Piramal Pharma Solutions: Facilities
Table 5.20 Piramal Pharma Solutions: Partnerships
Table 5.21 Piramal Pharma Solutions: Future Outlook
Table 6.1 FDA Quality Agreement and EMA cGMP Regulations: A Comparative Analysis
Table 6.2 LFB Group: Company Overview
Table 6.3 LFB Biomanufacturing: Partnerships
Table 6.4 LFB Biomanufacturing: Future Outlook
Table 6.5 Menarini Biotech: Company Overview
Table 6.6 Menarini Biotech: Partnerships
Table 6.7 Menarini Biotech: Future Outlook
Table 6.8 Novasep: Company Overview
Table 6.9 Novasep: Partnerships
Table 6.10 Novasep: Future Outlook
Table 6.11 Rentschler Biopharma: Company Overview
Table 6.12 Rentschler Biopharma: Partnerships
Table 6.13 Rentschler Biopharma: Future Outlook
Table 6.14 Boehringer Ingelheim: Company Overview
Table 6.15 Boehringer Ingelheim BioXcellence™: Biopharmaceutical Facilities
Table 6.16 Boehringer Ingelheim BioXcellence™: Partnerships
Table 6.17 Boehringer Ingelheim BioXcellence™: Future Outlook
Table 6.18 Celonic: Company Overview
Table 6.19 Celonic: Biopharmaceutical Facilities
Table 6.20 Celonic: Partnerships
Table 6.21 Celonic: Future Outlook
Table 6.22 Lonza: Company Overview
Table 6.23 Lonza: Biopharmaceutical Facilities
Table 6.24 Lonza: Partnerships
Table 6.24 Lonza: Future Outlook
Table 6.25 FUJIFILM Diosynth Biotechnologies: Company Overview
Table 6.26 FUJIFILM Diosynth Biotechnologies: Partnerships
Table 6.27 FUJIFILM Diosynth Biotechnologies: Future Outlook
Table 6.28 3P Biopharmaceuticals: Company Overview
Table 6.29 3P Biopharmaceuticals: Partnerships
Table 6.30 3P Biopharmaceuticals: Future Outlook
Table 7.1 AutekBio: Company Overview
Table 7.2 AutekBio: Future Outlook
Table 7.3 WuXi AppTec (WuXi Biologics): Company Overview
Table 7.4 Wuxi Biologics: Partnerships
Table 7.5 Wuxi Biologics: Future Outlook
Table 7.6 Intas Pharmaceuticals: Company Overview
Table 7.7 Intas Pharmaceuticals: Other Facilities
Table 7.8 Intas Pharmaceuticals: Partnerships
Table 7.9 Intas Pharmaceuticals: Future Outlook
Table 7.10 Kemwell Biopharma: Company Overview
Table 7.11 Kemwell Biopharma: Partnerships
Table 7.12 Kemwell Biopharma: Future Outlook
Table 7.13 Shashun Pharmaceuticals: Company Overview
Table 7.14 Syngene Pharmaceuticals: Company Overview
Table 7.15 Syngene: Partnerships
Table 7.16 Syngene: Future Outlook
Table 7.17 AGC Biologics: Company Overview
Table 7.18 AGC Biologics: Partnerships
Table 7.19 AGC Biologics: Future Outlook
Table 7.20 DM Bio: Company Overview
Table 7.21 DM Bio: Future Outlook
Table 7.22 Samsung BioLogics: Company Overview
Table 7.23 Samsung BioLogics: Biopharmaceutical Facilities
Table 7.24 Samsung BioLogics: Partnerships
Table 7.25 Samsung BioLogics: Future Outlook
Table 7.26 Cell Therapies: Company Overview
Table 7.27 Cell Therapies: Partnerships
Table 7.28 Cell Therapies: Future Outlook
Table 7.29 LuinaBio: Company Overview
Table 7.30 LuinaBio: Partnerships
Table 7.31 LuinaBio: Future Outlook
Table 8.1 ADC Pipeline: Marketed and Clinical Molecules
Table 8.2 ADC Pipeline: Preclinical and Discovery Stage Molecules
Table 8.3 Bispecific Antibody Pipeline: Clinical Stage Molecules
Table 8.4 Bispecific Antibody Pipeline: Preclinical and Discovery Stage Molecules
Table 8.5 Bispecific Antibody Technologies and Technology Providers
Table 8.6 Application of Cell-based Therapies
Table 8.7 Commercialized Products for Cell-based Therapies
Table 8.8 Assessment Strategies for Different Manufacturing Processes
Table 8.9 Advantages and Disadvantages of Centralized and Decentralized Manufacturing Models
Table 8.10 List of Cell Therapy Contract Manufacturers
Table 8.11 Cell Therapy Contract Manufacturers: Information on Type of Cell Therapy
Table 8.12 Cell Therapy Contract Manufacturers: Information on Scale of Operation
Table 8.13 List of Viral Vector Manufacturers
Table 8.14 Viral Vector Manufacturers: Information on Type of Viral Vectors
Table 8.15 List of Plasmid DNA Manufacturers
Table 10.1 Small Molecules and Large Molecules: Strengths and Weaknesses
Table 10.2 Small Molecules and Large Molecules: Comparison of Development Characteristics
Table 11.1 List of FDA Approved Biologics (2016-2018)
Table 12.1 Biopharmaceutical Contract Manufacturing: List of Collaborations, 2013 - 2018
Table 12.2 Biopharmaceutical Contract Manufacturing Collaborations: Information on Types of Biologics)
Table 12.3 Biopharmaceutical Contract Manufacturing: List of Mergers and Acquisitions, 2013 - 2018
Table 12.4 Biopharmaceutical Contract Manufacturing Mergers and Acquisitions: Information on Key Value Drivers
Table 12.5 Mergers and Acquisitions: Important Deal Multiples, 2013- 2018
Table 13.1 Biopharmaceutical Contract Manufacturing: Recent Developments
Table 13.2 Biopharmaceutical Contract Manufacturing: Funding Instances
Table 14.1 Capacity Analysis: CMO Size Adjustments based on Capacity
Table 14.2 Capacity Analysis: CMO Size Adjustments based on Size of Employee Base
Table 14.3 Capacity Analysis: Key Assumptions and Inputs
Table 14.4 Capacity Analysis: Global Contract Biomanufacturing Capacity
Table 14.4 Capacity Analysis: Regional Contract Biomanufacturing Capacity
Table 17.1 Global Biopharmaceuticals Market: Patent Information of Best-selling Biologics
Table 19.1 Survey Analysis: Overview of Respondents
Table 19.2 Survey Analysis: Distribution of Respondents by Designation
Table 19.3 Survey Analysis: Biologics Manufacturing Expertise
Table 19.4 Survey Analysis: Scale of Manufacturing
Table 19.5 Survey Analysis: Location of Production Facilities
Table 19.6 Survey Analysis: Type of Expression Systems Used
Table 19.7 Survey Analysis: Type of Bioreactors
Table 19.8 Survey Analysis: Mode of Operation of Bioreactors
Table 22.1 Biopharmaceutical CMOs: Distribution by Year of Establishment
Table 22.2 Biopharmaceutical CMOs: Distribution by Size of Employee Base
Table 22.3 Biopharmaceutical CMOs: Distribution by Location of Headquarters (Region-wise)
Table 22.4 Biopharmaceutical CMOs: Distribution by Location of Headquarters (Country-wise)
Table 22.5 Biopharmaceutical CMOs: Distribution by Location of Manufacturing Facility (Region-wise)
Table 22.6 Biopharmaceutical CMOs: Distribution by Location of Manufacturing Facility (Country-wise)
Table 22.7 Biopharmaceutical CMOs: Distribution by Types of Biologic
Table 22.8 Biopharmaceutical CMOs: Distribution by Scale of Operation
Table 22.9 Biopharmaceutical CMOs: Distribution by Types of Expression Systems Used
Table 22.10 AMRI: Annual Revenues (USD Million)
Table 22.11 Baxter International: Annual Revenues (USD Billion)
Table 22.12 Catalent: Annual Revenues (USD Million)
Table 22.13 Catalent: Annual Revenues by Business Divisions (USD Million)
Table 22.14 Patheon: Annual Revenues (USD Million)
Table 22.15 Patheon: Revenues by Business Segments USD Million)
Table 22.16 Piramal Pharma Solutions: Annual Revenues (USD Million)
Table 22.17 LFB Group: Annual Revenues (EUR Million)
Table 22.18 LFB Group: Revenues by Therapeutic Area and Services (EUR Million)
Table 22.19 Novasep: Annual Revenues (EUR Million)
Table 22.20 Boehringer Ingelheim: Annual Revenues (USD Billion)
Table 22.21 Boehringer Ingelheim: Revenues by Business Divisions (EUR Billion)
Table 22.22 Lonza: Annual Revenues (CHF Billion)
Table 22.23 FUJIFILM Diosynth Biotechnologies: Annual Revenues (JPY Billion)
Table 22.24 FUJIFILM Holdings: Annual Revenues by Business Divisions (JPY Billion)
Table 22.25 Wuxi Biologics: Annual Revenues (RMB Million)
Table 22.26 Wuxi Biologics: Annual Revenues by Regions of Operation (RMB million)
Table 22.27 Intas Pharmaceuticals: Annual Revenues (INR Million)
Table 22.28 Strides Shasun: Annual Revenues (INR Million)
Table 22.29 Syngene: Annual Revenues (INR Million)
Table 22.30 Asahi Glass: Annual Revenues (JPY Million)
Table 22.31 Samsung BioLogics: Annual Revenues from CMO Operations (KRW Billion)
Table 22.32 Bispecific Antibody: Distribution by Phase of Development
Table 22.33 Gene Therapy, Clinical and Preclinical Pipeline: Distribution by Phase of Development
Table 22.34 Gene Therapy, Clinical Pipeline: Distribution by Vector Type
Table 22.35 Gene Therapy, Preclinical Pipeline: Distribution by Vector Type
Table 22.36 Gene Therapy, Clinical Pipeline: Distribution by Therapeutic Area
Table 22.37 Gene Therapy CMOs: Distribution by Region
Table 22.38 Viral Vectors Manufacturers: Distribution by Type of Viral Vector
Table 22.39 Viral Vectors Manufacturers: Distribution by Scale of Production
Table 22.40 Plasmid DNA Manufacturers: Distribution by Location of Manufacturing Facility
Table 22.41 Plasmid DNA Manufacturers: Distribution by Scale of Production
Table 22.42 Biosimilars Pipeline: Country-wise Distribution
Table 22.43 Small Molecule and Large Molecule Drugs: Historical Trend of FDA Approval (2005 - November 2018)
Table 22.44 Approved Biologics: Distribution by Size of Developer and Type of Manufacturing Model
Table 22.45 Approved Biologics: Distribution by Size of Developer and Type of Biologic
Table 22.46 Collaborations: Cumulative Trend by Year, 2013-November 2018
Table 22.47 Collaborations: Distribution by Type of Partnership Model
Table 22.48 Collaborations: Cumulative Year-wise Trend of Product-based Agreements, 2013 - 2018
Table 22.49 Collaborations: Cumulative Year-wise Trend of Process-based Agreements, 2013 - 2018
Table 22.50 Collaborations: Cumulative Year-wise Trend of Licensing Agreements, 2013 - 2018
Table 22.51 Collaborations: Cumulative Year-wise Trend of Co-Service Agreements / Ventures, 2013 - 2018
Table 22.52 Collaborations: Cumulative Year-wise Trend of R&D Agreements, 2013 - 2018
Table 22.53 Collaborations: Cumulative Year-wise Trend of Outsourcing Services Agreements, 2013 - 2018
Table 22.54 Collaborations: Distribution by Focus Area
Table 22.55 Collaborations: Distribution by Focus Area and Type of Partnership Model
Table 22.56 Collaborations: Distribution by Type of Biologic
Table 22.57 Collaborations: Distribution by Type of Biologic and Type of Partnership Model
Table 22.58 Collaborations: Distribution of Cell Therapy-related Deals by Year and Type of Partnership Model
Table 22.59 Collaborations: Distribution of Monoclonal Antibody-related Deals by Year and Type of Partnership Model
Table 22.60 Collaborations: Distribution of Vaccine-related Deals by Year and Type of Partnership Model
Table 22.61 Collaborations: Distribution of Proteins-related Deals by Year and Type of Partnership Model
Table 22.62 Collaborations: Distribution of Antibody Drug Conjugate-related Deals by Year and Type of Partnership Model
Table 22.63 Collaborations: Distribution of Vector-related Deals by Year and Type of Partnership Model
Table 22.64 Collaborations: Distribution of Gene Therapy-related Deals by Year and Type of Partnership Model
Table 22.65 Collaborations: Distribution of Biosimilar-related Deals by Year and Type of Partnership Model
Table 22.66 Collaborations: Distribution of Other Biologic-related Deals by Type of Partnership Model
Table 22.67 Collaborations: Distribution of Manufacturing Agreements by Type of Biologic and Geography
Table 22.68 Collaborations: Distribution by Therapeutic Area
Table 22.69 Collaborations: Most Active Players
Table 22.70 Collaborations: Regional Distribution
Table 22.71 Collaborations: Intercontinental and Intracontinental Distribution
Table 22.72 Mergers and Acquisitions: Year-Wise Cumulative Trend, 2013- 2018
Table 22.73 Mergers and Acquisitions: Distribution by Type of Acquisitions
Table 22.74 Mergers and Acquisitions: Continental Distribution
Table 22.75 Mergers and Acquisitions: Country-wise Distribution
Table 22.76 Mergers and Acquisitions: Intercontinental and Intracontinental Acquisitions
Table 22.77 Mergers and Acquisitions: Most Active Acquirers
Table 22.78 Mergers and Acquisitions: Distribution by Key Value Drivers and Year of Acquisition
Table 22.79 Mergers and Acquisitions: Distribution by Type of Biologics
Table 22.80 Deal Multiples Analysis: Relationship between Deal Multiples for Revenue and Number of Employees
Table 22.81 Facility Expansions: Cumulative Year-wise Trend, 2013-2018
Table 22.82 Facility Expansions: Distribution by Purpose
Table 22.83 Facility Expansions: Distribution by Type of Biologic
Table 22.84 Facility Expansions: Distribution by Location of Facility (Region-wise)
Table 22.85 Facility Expansions: Distribution by Location of Headquarters (Country-wise)
Table 22.86 Facility Expansions: Regional Distribution
Table 22.87 Facility Expansions: Distribution by Region and Purpose
Table 22.88 Capacity Analysis: Global Contract Biomanufacturing Capacity by Size of Employee Base of Contract Manufacturers
Table 22.89 Capacity Analysis: Regional Distribution of Biopharmaceutical CMOs
Table 22.90 Capacity Analysis: Regional Production Capacity of Biopharmaceutical CMOs
Table 22.91 Capacity Analysis: Regional Contract Biomanufacturing Capacity
Table 22.92 Capacity Analysis: Distribution by Expression Systems Used
Table 22.93 Capacity Analysis: Distribution by Scale of Operation
Table 22.94 Geographical Distribution of ADC Manufacturing Capacity
Table 22.95 Geographical Distribution of Cell Therapy Manufacturing Capacity
Table 22.96 Geographical Distribution of Vector Manufacturing Capacity
Table 22.97 Overall Biopharmaceutical Contract Manufacturing Market, 2019-2030 (USD Billion)
Table 22.98 Biopharmaceutical Contract Manufacturing Market for API Manufacturing, 2019-2030 (USD Billion)
Table 22.99 Biopharmaceutical Contract Manufacturing Market for FDF Manufacturing, 2019-2030 (USD Billion)
Table 22.100 Biopharmaceutical Contract Manufacturing Market, 2019-2030: Distribution by Expression Systems Used (USD Billion)
Table 22.101 Biopharmaceutical Contract Manufacturing Market, 2019-2030: Distribution by Scale of Operation (USD Billion)
Table 22.102 Biopharmaceutical Contract Manufacturing Market, 2019-2030: Distribution by Size of Employee Base of Contract Manufacturers (USD Billion)
Table 22.103 Biopharmaceutical Contract Manufacturing Market, 2019-2030: Distribution by Geography (USD Billion)
Table 22.104 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030 (USD Billion)
Table 22.105 Biopharmaceutical Contract Manufacturing Market in the US, 2019-2030 (USD Billion)
Table 22.106 Biopharmaceutical Contract Manufacturing Market in Rest of North America, 2019-2030 (USD Billion)
Table 22.107 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: for Share of Mammalian Cell-based Operations (USD Billion)
Table 22.108 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Microbial Cell-based Operations (USD Billion)
Table 22.109 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Other Expression System-based Operations (USD Billion)
Table 22.110 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Preclinical / Clinical Scale Operations (USD Billion)
Table 22.111 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Commercial Operations (USD Billion)
Table 22.112 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Small-sized Companies (USD Billion)
Table 22.113 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Mid-sized Companies (USD Billion)
Table 22.114 Biopharmaceutical Contract Manufacturing Market in North America, 2019-2030: Share of Large / Very Large Companies (USD Billion)
Table 22.115 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030 (USD Billion)
Table 22.116 Biopharmaceutical Contract Manufacturing Market in Italy, 2019-2030 (USD Billion)
Table 22.117 Biopharmaceutical Contract Manufacturing Market in Germany, 2019-2030 (USD Billion)
Table 22.118 Biopharmaceutical Contract Manufacturing Market in France, 2019-2030 (USD Billion)
Table 22.119 Biopharmaceutical Contract Manufacturing Market in Spain, 2019-2030 (USD Billion)
Table 22.120 Biopharmaceutical Contract Manufacturing Market in the UK, 2019-2030 (USD Billion)
Table 22.121 Biopharmaceutical Contract Manufacturing Market in Rest of Europe, 2019-2030 (USD Billion)
Table 22.122 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Mammalian Cell-based Operations (USD Billion)
Table 22.123 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Microbial Cell-based Operations (USD Billion)
Table 22.124 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Other Expression System-based Operations (USD Billion)
Table 22.125 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Preclinical / Clinical Operations (USD Billion)
Table 22.126 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Commercial Operations (USD Billion)
Table 22.127 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Small-sized Companies (USD Billion)
Table 22.128 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Mid-sized Companies (USD Billion)
Table 22.129 Biopharmaceutical Contract Manufacturing Market in Europe, 2019-2030: Share of Large / Very Large Companies (USD Billion)
Table 22.130 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030 (USD Billion)
Table 22.131 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030 (USD Billion)
Table 22.132 Biopharmaceutical Contract Manufacturing Market in China, 2019-2030 (USD Billion)
Table 22.133 Biopharmaceutical Contract Manufacturing Market in India, 2019-2030 (USD Billion)
Table 22.134 Biopharmaceutical Contract Manufacturing Market in South Korea, 2019-2030 (USD Billion)
Table 22.135 Biopharmaceutical Contract Manufacturing Market in Japan, 2019-2030 (USD Billion)
Table 22.136 Biopharmaceutical Contract Manufacturing Market in Australia, 2019-2030 (USD Billion)
Table 22.137 Biopharmaceutical Contract Manufacturing Market in Rest of Asia and Other Regions, 2019-2030 (USD Billion)
Table 22.138 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Mammalian Cell-based Operations (USD Billion)
Table 22.139 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Microbial Cell-based Operations (USD Billion)
Table 22.140 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Other Expression System-based Operations (USD Billion)
Table 22.141 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Preclinical / Clinical Operations (USD Billion)
Table 22.142 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Commercial Operations (USD Billion)
Table 22.143 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Small-sized Companies (USD Billion)
Table 22.144 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Share of Mid-sized Companies (USD Billion)
Table 22.145 Biopharmaceutical Contract Manufacturing Market in Asia and Rest of the World, 2019-2030: Large / Very Large Companies (USD Billion)
Table 22.146 Survey Analysis: Distribution of Respondents by Company Type
Table 22.147 Survey Analysis: Distribution of Respondents by Location of Headquarters
Table 22.148 Survey Analysis: Distribution of Respondents by Designation
Table 22.149 Survey Analysis: Distribution by Biologics Manufacturing Expertise
Table 22.150 Survey Analysis: Distribution by Scale of Manufacturing
Table 22.151 Survey Analysis: Distribution by Location of Production Facility
Table 22.152 Survey Analysis: Distribution by Type of Expression System Used
Table 22.153 Survey Analysis: Distribution by Type of Bioreactor
Table 22.154 Survey Analysis: Distribution by Mode of Operation of Bioreactor

Executive Summary

Chapter Summary

Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the likely evolution of the biopharmaceutical contract manufacturing market in the mid to long term.
Chapter 3 provides a general introduction to biopharmaceuticals and biopharmaceutical manufacturing processes. The chapter also includes an overview of the various expression systems used for the development of different types of biotherapeutic products. It features a brief overview of contract manufacturing and includes a detailed discussion on the need for outsourcing within the biopharmaceutical industry. In this chapter, we have presented a list of commonly outsourced biomanufacturing activities; the chapter concludes with a discussion on the challenges that are currently associated within the market.
Chapter 4 provides a comprehensive overview of the global biopharmaceutical contract manufacturing landscape. It includes information related to over 240 CMOs that are currently active in this domain. In addition, it features an in-depth analysis of the market, based on a number of parameters, such as scale of operation, type of biologics manufactured and type of expression systems being utilized. Further, it contains details on the year of establishment, employee size, geographical location of the CMO, number of manufacturing facilities, as well as location of these facilities, GMP compliance, affiliations to regulatory agencies. Moreover, the chapter provides information on the production capabilities of CMOs, based on type of bioreactor, mode of operation of bioreactors and bioreactor capacity.
Chapter 5 features detailed profiles of some of the key players that are active in the biopharmaceutical contract manufacturing market in the US. Each profile presents a brief overview of the company, its contract service offerings, financial information (if available), manufacturing capabilities and facilities, partnerships, recent developments, and awards and accolades received.
Chapter 6 features detailed profiles of some of the key players that are active in the biopharmaceutical contract manufacturing market in Europe. Each profile presents a brief overview of the company, its contract service offerings, financial information (if available), manufacturing capabilities and facilities, partnerships, recent developments, and awards and accolades received.
Chapter 7 features detailed profiles of some of the key players that are active in the biopharmaceutical contract manufacturing market in Asia and other regions of the world. Each profile presents a brief overview of the company, its contract service offerings, financial information (if available), manufacturing capabilities and facilities, partnerships, recent developments, and awards and accolades received.
Chapter 8 focuses on the key enablers in this domain, including certain niche product classes, such as ADCs, bispecific antibodies, cell therapies, gene therapies and viral vectors, which are likely to have a significant impact on the growth of the contract services market. The chapter provides detailed a market overview, including information on the pipeline, and the presence of CMOs in each of the aforementioned segments.
Chapter 9 is a case study focused on outsourcing of operations related to biosimilars, which represents a major growth opportunity for biopharmaceutical CMOs. It provides an overview of biosimilars and captures information on the various CMOs that are actively involved in this segment of the biopharmaceutical market.
Chapter 10 is a case study comparing the key characteristics of large and small molecule drugs, along with information on the steps involved in their respective manufacturing processes.
Chapter 11 is a case study focused on challenges associated with in-house manufacturing. It also provides details on the outsourcing trends in this domain, along with information related to various partnership models that are being used by various stakeholders to partner with CMOs. In addition, it features a list of recently approved biologics, with information on the type of biologic, target indication(s), developer and manufacturing approach adopted by the developer. Further, the chapter features a brief overview of the various parameters that a drug / therapy developer may need to take into consideration while deciding whether to manufacture its products in-house or outsource.
Chapter 12 features an elaborate analysis and discussion of the various collaborations and partnerships that have been inked amongst players since 2013. It includes a brief description on the various types of partnership models (which include product-based agreements, process-based agreements, licensing agreements, co-service agreements / ventures, R&D agreements and other outsourcing service agreements) that have been adopted by stakeholders in this domain. It also consists of a schematic representation showcasing the players that have established the maximum number of alliances related to the manufacturing of cell-based therapies. Furthermore, we have provided a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents. In addition, the chapter includes a detailed analysis of the mergers and acquisitions that have taken place in this space, highlighting the trend in the number of companies acquired from 2012-2018. The analysis also provides information on the key value drivers for these mergers and acquisitions and the corresponding acquisition deal multiples.
Chapter 13 presents an analysis of the recent developments in the biopharmaceutical contract manufacturing market. It provides an overview of other market trends, such as investments and facility expansions. In addition, it provides details on the emerging technologies related to biomanufacturing processes.
Chapter 14 features a comprehensive analysis of the global / regional capacity of contract manufacturers that are engaged in the manufacturing of biopharmaceutical products. The analysis takes into consideration the individual development and manufacturing capacities of various stakeholders (small-sized, mid-sized, large and very large CMOs / CDMOs) in the market, using data from both secondary and primary research. The study examines the distribution of global biopharmaceutical manufacturing capacity by scale of operation (preclinical / clinical, commercial), size of the company (small-sized, mid-sized, large and very large), region of operation (North America (the US and Canada), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia and Middle East (China, India, Japan, South Korea and rest of the Asia and Middle East), and rest of the world(including Australia).
Chapter 15 features a comprehensive analysis of the annual demand of biotherapeutics (in grams), taking into account the top 20 biologics, based on a various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products.
Chapter 16 presents a comprehensive market forecast analysis, highlighting the likely growth of the biologics manufacturing market till the year 2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] commonly outsourced business operations (active pharmaceutical ingredients (APIs) and finished dosage formulations (FDFs)), [B] types of expression systems (mammalian, microbial and others), [C] size of the company (small-sized, mid-sized and large / very large), [D] scale of operation (preclinical, clinical and commercial) and [E] key geographical regions (North America (US, Canada), Europe (UK, France, Germany, Italy and Spain), Asia (China and India) and rest of the world (Australia)).
Chapter 17 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of biopharmaceuticals manufacturing market, under a comprehensive SWOT framework.
Chapter 18 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the biopharmaceutical CMOs market, based on the research and analysis described in the previous chapters. It also provides a recap of some of the upcoming future trends, which, we believe, are likely to influence the growth of biopharmaceutical CMOs.
Chapter 19 presents insights from the survey conducted for this study. The participants, who were primarily Director / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.
Chapter 20 contains the transcripts of interviews conducted with representatives from renowned organizations that are engaged in the biopharmaceutical contract manufacturing domain. In this study, we spoke to Astrid Brammer (Senior Manager Business Development, Richter-Helm), Birgit Schwab (Senior Manager Strategic Marketing, Rentschler Biotechnologie), Christian Bailly (Director of CDMO, Pierre Fabre), Claire Otjes (Assistant Marketing Manager, Batavia Biosciences), David C Cunningham (Director Corporate Development, Goodwin Biotechnology), Dietmar Katinger (Chief Executive Officer, Polymun Scientific), Denis Angioletti (Chief Commercial Officer, Cerbios-Pharma), Jeffrey Hung (Chief Commercial Officer, Vigene Biosciences), Kevin Daley (Director Pharmaceuticals, Novasep), Mark Wright (Site Head, Grangemouth, Piramal Healthcare), Nicolas Grandchamp (R&D Leader, GEG Tech), Raquel Fortunato (Chief Executive Officer, GenIbet Biopharmaceuticals), Sebastian Schuck (Head of Business Development, Wacker Biotech), Stephen Taylor (Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies), Tatjana Buchholz (Marketing Manager, PlasmidFactory) and Marco Schmeer (Project Manager, PlasmidFactory) and Tim Oldham (Chief Executive Officer, Cell Therapies).
Chapter 21 is an appendix that contains the list of non-industry players that offer contract services for biologics.
Chapter 22 is an appendix that contains tabulated data and numbers for all the figures provided in the report.
Chapter 23 is an appendix that provides the list of companies and organizations mentioned in the report.

Companies Mentioned

3P Biopharmaceuticals
Aalto Scientific
AbbVie Contract Manufacturing
Abeona Therapeutics
Abzena
ACES Pharma
Adar Biotech
ADC Biotechnology
Adimmune
Advanced BioScience Laboratories
Advent Bioservices
Affinity Life Sciences
Afton Scientific
AGC Biologics
Ajinomoto Bio-Pharma
Akdeniz University
Alberta Cell Therapy Manufacturing
Alcami
Aldevron
Allele Biotechnology & Pharmaceuticals
Almac
Alnylam Pharmaceuticals
Amatsigroup
AmbioPharm
AMEGA Biotech
Amgen
Andalusian Initiative for Advanced Therapies
Anogen-Yes Biotech Laboratories
apceth Biopharma
Arabio
AstraZeneca
Asymchem Laboratories
Atlantic Bio GMP
AURA Biotechnologies
Austrianova
AutekBio
Avecia
Avid Bioservices
Axcellerate Pharma
Baccinex
Bachem
Batavia Biosciences
Baxter BioPharma Solutions
Bayer
Baylor College of Medicine
BCN Peptides
Bharat Serums and Vaccines
BIBITEC
BINEX
Bio Elpida
Bio-Synthesis
BioCell
BIOFABRI
Biogen
Bioinova
BioInvent International
Biological E
BioMARC
BioMarin
Biomay
BioNTech IMFS
Biopolis
BioReliance
Biosynergy (Europe)
BioTechnique
Biotechpharma
BioVectra
Biovian
Boehringer Ingelheim BioXcellence
Boston Institute of Biotechnology
Brammer Bio
Bryllan
BSP Pharmaceuticals
Burrard Pharmaceuticals
C3i Solutions
Canada Peptide
Capua BioServices
CARBOGEN AMCIS
Case Western Reserve University
Catalent Biologics
CCGTT Centre, Royal Free Hospital
Cell and Gene Therapy Catapult
Cell Culture Company
Cell Essentials
Cell Tech Pharmed
Cell Therapies
Cell Therapy Manufacturing CRC
Cellin Technologies
Celltrion
Cellular Therapeutics
Celonic
Cenexi
Center of Excellence for Cellular Therapy
Centre for Cell and Vector Production
Century Pharmaceuticals
Cerbios-Pharma
Charles River Laboratories
Chemi Peptides
ChemPartner
Children's Hospital of Philadelphia
CinnaGen
City of Hope
Clinical Cell and Vaccine Production Facility
Cobra Biologics
Cognate BioServices
Cook MyoSite
CordenPharma
Cornell University
Creative Biolabs
CRMI
Cryosite
CSIRO
CSL Behring
Cytovance Biologics
Dalton Pharma Services
DM Bio
Dompé
Duke University
Dynavax Technologies
EirGenix
Eli Lilly
Elusys Therapeutics
EMD Serono
Emergent BioSolutions
Emory University School of Medicine
EuBiologics
EUCODIS Bioscience
EVER Pharma
Exelead
FinVector Vision Therapies
Foundation for Biomedical Research and Innovation
Fraunhofer Insitute for Cell Therapy and Immunology
Fresenius Kabi Contract Manufacturing
FUJIFILM Diosynth Biotechnologies
Gates Biomanufactuirng Facility
GC Cell
GenCure (subsidiary of BioBridge Global)
Gene Therapy Laboratory of Nantes
Gene Transfer Vector Core
GeneCure Biotechnologies
GenIbet Biopharmaceuticals
GlaxoSmithKline
Glenmark
Goodwin Biotechnology
GP Pharm
Grand River Aseptic Manufacturing
GreenPak Biotech
Grifols
GTP Technology
Guy's and St Thomas' Facility
HALIX
Harvard Gene Therapy Initiative
Health Biotech
Health Sciences Authority
Hetero Drugs
Histocell
Hisun Pharmaceuticals USA
Hong Kong Institute of Biotechnology
Hycult Biotech
IDT Biologika
IncoCell Tianjin
Indian Immunologicals
Indiana University
Inno Biologics
Institute of Medical Science Research
Institute of Translational Health Sciences
Integrity Bio
Islet and Cellular Transplant Facility, University of California
Istituto Biochimico Italiano Giovanni Lorenzini
Janssen Pharmaceuticals
Japan Tissue Engineering
Jazz Pharmaceuticals
Jenner Institute
JHL Biotech
John Goldman Centre for Cellular Therapy
Jubilant HollisterStier
Julphar Gulf Pharmaceutical Industries
KABS Pharmaceutical Services
Kamada
Kamat PharmaTech
Kaneka Eurogentec (previously known as Eurogentec, now a part of Kaneka)
KBI Biopharma
Kemwell Biopharma
King's College London
Kite Pharma
KUBio (a manufacturing unit of GE Healthcare)
Kyowa Hakko Kirin
LAMPIRE Biological Laboratories
LEUKOCARE
Leuven Viral Vector Core
Levena Biopharma
LFB BIOMANUFACTURING
Lonza
Loughborough University
LSNE Contract Manufacturing
LuinaBio
Lyophilization Technology
Mab-Venture Biopharma
Mabion
MabPlex
Maine Biotechnology Services
Massachusetts Institute of Technology
MassBiologics
MaSTherCell
Mayo Clinic Cancer Center
McMaster University
MEDINET
Medix Biochemica
MedStar Georgetown University Hospital
Memorial Sloan Kettering Cancer Center
Menarini Biotech
Merck
Meridian Life Science
MGH Vector Core
MicroBiopharm Japan
Miller School of Medicine, University of Miami
Miltenyi Biotec
Moffitt Cancer Center
MolMed
Morphotek
MuseChem
Mycenax Biotech
Mylan
National Eye Institute (NEI)
National Institute of Neurodegenerative Disorders and Stroke Center Core, University of Minnesota
National University of Ireland, Galway
Nationwide Children's Hospital
Netherlands Cancer Institute (NKI)
Neuland Laboratories
NeuroCure (Viral Core Facility)
NHS Blood and Transplant Service (NHSBT)
Nikon CeLL innovation
Nitto Avecia Pharma Services
Norwegian Institute of Public Health
Novartis
Novasep
Novex Innovations
Novo Nordisk
Octapharma
OctoPlus (a part of Dr Reddy's)
Olon
oncomed manufacturing
Oncotec Pharma Produktion
OsoBio
Oxford BioMedica
Panacea Biotec
Paragon Bioservices
Particle Sciences (A Lubrizol Company)
Patheon
PaxVax
PCI (Biotec Services International)
PCT (a subsidiary of Hitachi Chemical)
Pfizer
Pharmedartis
Pharmicell
Pierre Fabre
Piramal Pharma Solutions
PlasmidFactory
Polpharma Biologics
Polymun Scientific
PolyPeptide Group
Porton Biopharma
Praxis Pharmaceutical
Precision Antibody
PREMAS Biotech
PrimaPharma
Princess Margaret Hospital
ProBioGen
Profectus BioSciences
ProMab Biotechnologies
Protein Sciences
Provia Labs
PX'Therapeutics
PYRAMID Laboratories
QIMR Berghofer Medical Research Institute
Regeneron
Rentschler Biotechnologie
Richter-Helm BioLogics
Riyadh Pharma
Roche
Rommelag CMO
RoslinCT
Roswell Park Cancer Institute
Salk Institute for Biological Studies
Samsung BioLogics
Sandoz
Sanford Burnham Prebys Medical Discovery Institute
Sanofi
Sanquin
Sarepta Therapeutics
Scientific Protein Laboratories
Scil Proteins
Seattle Children's Hospital
Senn Chemicals
Shire
Siam Bioscience
Sicor Biotech
Siegfried
Sigma-Aldrich Fine Chemicals (SAFC)
SignaGen Laboratories
Singota Solutions
SNBTS Cellular Therapy Development Centre
South London and Maudsley NHS Foundation Trust
Spark Therapeutics
St Jude Children's Research Hospital
ST Pharm
Stanford University
Stem Cell Institute (MediStem Panama)
Swissfillon
Sydney Cell and Gene Therapy
Symbiosis Pharmaceutical Services
SynCo Bio Partners
Syngene (a subsidiary of Biocon)
Synthelis
Synthon
Sypharma
TaiMed Biologics
Takara Bio
Tanvex BioPharma
TBD-Biodiscovery
Telethon Institute of Genetics and Medicine
Teva Pharmaceutical Industries
The Centre for Stem Cell Research
The Goldyne Savad Institute of Gene Therapy, Hadassah Medical Organization
The Native Antigen Company
The Ottawa Hospital Research Institute
Therapure Biopharma
Toyobo Biologics
TranXenoGen
Trenzyme
UAB Vector Production Facility
Ultragenyx Pharmaceutical
UMC Utrecht
University College London
University Hospital Basel
University of Barcelona
University of Birmingham
University of Califonia
University of Florida
University of Iowa
University of Manchester
University of Massachusetts Medical School (UMMS)
University of Michigan Medical Center
University of Nebraska
University of Newcastle
University of North Carolina
University of Oxford
University of Pennsylvania
University of Pittsburgh
University of Rochester
University of South Carolina School of Medicine
University of Texas
University of Utah
USC School of Pharmacy
Valeant Pharmaceuticals
Vecura (Karolinska University Hospital)
Vetter Pharma
VGXI
Vibalogics
Vigene Biosciences
Viral Vector Facility (VVF), Neuroscience Center Zurich (ZNZ)
Virovek
WACKER Biotech
Waisman Biomanufacturing
Washington University School of Medicine
WuXi AppTec
Wuxi Griffin Pharmaceutical
Xellbiogene
Yale School of Medicine
YposKesi

Methodology

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Table of Contents

Executive Summary

Companies Mentioned

Methodology

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