Biopharma Contract Manufacturing Market (3rd Edition), 2019-2030 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Biopharma
Contract Manufacturing Market (3rd Edition), 2019-2030” report
has been added to ResearchAndMarkets.com’s offering.

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.

Key Topics Covered:

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)

5.3.2. Baxter BioPharma Solutions

5.3.3. Catalent Biologics (Catalent Pharma Solutions)

5.3.4. Cytovance Biologics

5.3.5. Patheon

5.3.6. Piramal Pharma Solutions

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

6.3.2. Boehringer Ingelheim BioXcellence

6.3.3. Celonic

6.3.4. FUJIFILM Diosynth Biotechnologies

6.3.5. LFB Group

6.3.6. Lonza

6.3.7. Menarini Biotech

6.3.8. Novasep

6.3.9. Rentschler BioPharma

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

7.3.2. WuXi AppTec (WuXi Biologics)

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

7.5.2. Kemwell Biopharma

7.5.3. Shasun Pharmaceuticals

7.5.4. Syngene

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

7.8. 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

7.9.2. Samsung BioLogics

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

7.11.2. Luina Bio

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 And Large Molecule
Drugs/Therapies

10.1. Chapter Overview

10.2. Small Molecule and Large Molecule Drugs / Therapies

10.2.1. Comparison of General Characteristics

10.2.2. Comparison of Key Specifications

10.2.3. Comparison of Manufacturing Processes

10.2.4. Comparison of Key Manufacturing Challenges

11. Case Study On In-House Manufacturing

11.1. Chapter Overview

11.2. In-House Manufacturing

11.2.1. Benefits Associated with In-House Manufacturing

11.2.2. Risks Associated with In-House Manufacturing

11.3. Outsourcing in the Biomanufacturing Industry

11.3.1. Types of Outsourcing Partners

11.4. Manufacturing Approaches Used for Approved Biologics (2016-2018)

11.4.1. Approved Biologics: 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

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 Players

22. Appendix 2: Tabulated Data

23. Appendix 3: List Of Companies And Organizations

For more information about this report visit https://www.researchandmarkets.com/r/vtmhmc

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