Drug Discovery Biologics CRO

PUBLISHER: Roots Analysis | PRODUCT CODE: 1130891

PUBLISHER: Roots Analysis | PRODUCT CODE: 1130891

Biopharmaceutical Contract Manufacturing Market by Type of Service Offered, Type of Biologic Manufactured, Type of Expression System Used, Scale of Operation, Company Size, and Key Geographical Regions : Industry Trends and Global Forecasts, 2022 - 2035

PUBLISHED: August 1, 2023

PAGES: 799 Pages

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Over the last few decades, the development landscape of small molecule drugs has been significantly impacted by various biotechnology breakthroughs. Further, with the advent of novel technologies, biologics have made a significant impact in the pharmaceutical domain, delivering ground-breaking treatment for a myriad of disease indications, including immunological, oncological and rare disorders. In this context, it is worth highlighting those 14 biopharmaceutical products (including cell therapies, gene therapies, monoclonal antibodies and recombinant proteins) were approved in the US alone, in 2021. Further, promising results from ongoing clinical research initiatives have encouraged various government and private firms to make significant investments in this domain. For instance, in 2021, a sum of over USD 70 billion was invested in the cell and gene therapy domain. However, manufacturing of biologics is fraught with various challenges. Some of the key concerns of contemporary innovators include rate of attrition of pipeline drugs / therapies, prolonged development timelines, current facility limitations, regulatory and compliance-related issues, and inconsistencies related to quality attributes of the final product. Therefore, therapy developers are actively exploring avenues that enable them to overcome the existing challenges. Amongst other alternatives, outsourcing has emerged as a lucrative option for biologic drug developers.

Currently, a significant number of players engaged in the biopharmaceutical domain prefer to outsource various operations to contract service providers. In fact, currently over 275 companies claim to offer contract manufacturing services for biologic therapeutics, in compliance with the regulatory standards. It is also worth highlighting that biopharmaceutical contract manufacturers are actively trying to consolidate their presence in this field by entering into strategic alliances in order to meet the indubitably rising demand for biologics. For this purpose, substantial expansions, and mergers and acquisitions have been reported in this market, as service providers strive to become one-stop-shops, to cater to the diverse needs of their clientele. With outsourcing being increasingly accepted as a viable and beneficial business model within this field, we anticipate the biopharmaceutical contract manufacturing market to grow at a commendable pace in the coming years.

SCOPE OF THE REPORT

The "Biopharmaceutical Contract Manufacturing Market by Type of Service(s) Offered (API, FDF), Type of Biologic Manufactured (Antibodies, Cell Therapies, Vaccines and Other Biologics), Type of Expression System Used (Mammalian, Microbial and Others), Scale of Operation (Preclinical / Clinical and Commercial), Company Size (Small, Mid-sized, and Large and Very Large), and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America and MENA): Industry Trends and Global Forecasts, 2022 - 2035" report features an extensive study of the current market landscape and the likely future potential associated with the biopharmaceutical contract manufacturing market, over the next decade.

The study also includes a detailed analysis of key drivers and trends within this evolving market. Amongst other elements, the report features:

A detailed overview of the overall landscape of companies engaged in offering contract manufacturing services for biologics, including a detailed analysis based on several relevant parameters, such as year of establishment, company size (based on number of employees), location of headquarters, type of service(s) offered (API and FDF manufacturing), type of biologic manufactured (ADCs, antibodies, biosimilars, cell therapies, gene therapies, nucleic acids / oligonucleotides, plasmid DNA / viral vectors, proteins / peptides, vaccines and others), scale of operation (preclinical, clinical and commercial), type of expression system used (mammalian, microbial and others), type of bioreactor used (single use, stainless steel and others) and mode of operation of bioreactor (batch, fed batch and perfusion / continuous).

A detailed landscape of the biopharmaceutical manufacturing facilities established across the key geographical regions (North America, Europe, Asia-Pacific and Rest of the World), highlighting the manufacturing hubs for biologics.

Elaborate profiles of key industry players based in North America, Europe and Asia-Pacific that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed 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 associated opportunities for biopharmaceutical CMOs and CDMOs.

A case study comparing the key characteristics of small and large molecule drugs, along with details on the various steps involved in their respective manufacturing processes.

A detailed discussion on the benefits and challenges associated with 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 the production operations.

A qualitative analysis, highlighting various factors that need to be taken into consideration by biopharmaceutical developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.

A review of the various biopharmaceutical-focused manufacturing initiatives undertaken by top 10 big pharma players (shortlisted on the basis of 2021 revenues), highlighting trends across various parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of biologic manufactured.

An analysis of the recent collaborations within the biopharmaceutical contract manufacturing industry, based on several relevant parameters, such as year of partnership, type of partnership, type of biologic manufactured, therapeutic area, most active players (in terms of number of deals inked) and regional distribution of partnership activity that have taken place in this domain, during the period 2015-2022.

A detailed analysis of the various mergers and acquisitions that have taken place within this domain, during the period 2015-2022, based on several relevant parameters, such as year of agreement, type of deal, geographical location of companies, type of acquisition, type of biologic manufactured and key value drivers.

A detailed review of expansion initiatives undertaken by biopharmaceutical contract manufacturers, during the period 2016-2022, along with information on several relevant parameters, such as year of expansion, purpose of expansion, type of biologic manufactured and location of expanded facility.

An analysis of the recent developments within the biopharmaceutical contract manufacturing industry, highlighting information on the funding investments made during the period 2016-2022, along with information on the technology advancements related to biomanufacturing.

An estimate of the overall, installed capacity for the manufacturing of biopharmaceuticals, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity, based on size of manufacturer (small, mid-sized and large and very large), scale of operation (preclinical, clinical and commercial), type of expression system used (mammalian, microbial and others) and geography (North America, Europe, Asia-Pacific and Rest of the World).

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 company size-wise, detailed analysis of the total cost of ownership for biopharmaceuticals contract manufacturing organizations, during the period 2022-2042.

A case study on the virtual business model concept, along with its role in the overall biopharmaceutical industry. It also features a discussion on the advantages and risks / challenges associated with outsourcing operations from virtual service providers.

A discussion on affiliated trends, key drivers and challenges, under an elaborate 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 biopharmaceutical industry.

A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing contract manufacturing services to biopharmaceutical developers.

One of the key objectives of the report was to estimate the existing market size and estimate the future size of biopharmaceutical contract manufacturing market. We have provided informed estimates on the evolution of the market, over the period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] type of service(s) offered (API, FDF), [B] type of biologic manufactured (antibodies, cell therapies, vaccines and other biologics), [C] type of expression system used (mammalian, microbial and others), [D] scale of operation (preclinical / clinical and commercial), [E] company size (small, mid-sized, and large and very large), and [F] key geographical regions (North America, Europe, Asia-Pacific, Latin America and MENA).

In order to account for future uncertainties associated with some of the key parameters and to add robustness to our forecast model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

KEY QUESTIONS ANSWERED

Who are the key players engaged in offering contract manufacturing services for biopharmaceuticals?

What are the different partnerships and expansion initiatives undertaken by biopharmaceutical contract manufacturers in the recent past?

Which regions represent the current key contract manufacturing hubs for biopharmaceuticals?

What is the current, installed capacity for contract manufacturing of biopharmaceuticals?

What is the current, global demand for biologics? How is the demand for such candidates likely to evolve in the foreseen future?

What percentage of the biopharmaceuticals manufacturing operations are presently outsourced?

What factors should be taken into consideration while deciding whether the manufacturing operations for biopharmaceuticals should be kept in-house or outsourced?

How is the current and future opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES

Chapter 2 is an executive summary of key insights captured during our research. It offers a high-level view on the current state of biopharmaceutical contract manufacturing market and its likely evolution in the short to mid-term and 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, along with a detailed discussion on the need for outsourcing within the biopharmaceutical industry. Furthermore, it provides information on the challenges faced by players currently engaged in this domain.

Chapter 4 provides a detailed assessment of the current market landscape of companies engaged in offering contract manufacturing services for biologics, including a detailed analysis based on several relevant parameters, such as year of establishment, company size (based on number of employees), location of headquarters, type of service(s) offered (API and FDF manufacturing), type of biologic manufactured (ADCs, antibodies, biosimilars, cell therapies, gene therapies, nucleic acids / oligonucleotides, plasmid DNA / viral vectors, proteins / peptides, vaccines and others), scale of operation (preclinical, clinical and commercial), type of expression system used (mammalian, microbial and others), type of bioreactor used (single use, stainless steel and others) and mode of operation of bioreactor (batch, fed batch and perfusion / continuous).

Chapter 5 provides a detailed landscape of the biopharmaceutical manufacturing facilities established across the key geographical regions (North America, Europe, Asia-Pacific and Rest of the World), highlighting the manufacturing hubs for biologics.

Chapter 6 provides elaborate profiles of key industry players based in North America that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

Chapter 7 provides elaborate profiles of key industry players based in Europe that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

Chapter 8 provides elaborate profiles of key industry players based in Asia-Pacific that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

Chapter 9 provides 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.

Chapter 10 presents a case study on the growing global biosimilars market, highlighting the associated opportunities for biopharmaceutical CMOs and CDMOs.

Chapter 11 presents a case study comparing the key characteristics of small and large molecule drugs, along with details on the various steps involved in their respective manufacturing processes.

Chapter 12 provides a detailed discussion on the benefits and challenges associated with 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 the production operations.

Chapter 13 presents a qualitative analysis, highlighting various factors that need to be taken into consideration by biopharmaceutical developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.

Chapter 14 provides a review of the various biopharmaceutical-focused manufacturing initiatives undertaken by top 10 big pharma players (shortlisted on the basis of 2021 revenues), highlighting trends across various parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of biologic manufactured.

Chapter 15 presents an analysis of the recent collaborations within the biopharmaceutical contract manufacturing industry, based on several relevant parameters, such as year of partnership, type of partnership, type of biologic manufactured, therapeutic area, most active players (in terms of number of deals inked) and regional distribution of partnership activity that have taken place in this domain, during the period 2015-2022.

Chapter 16 provides a detailed analysis of the various mergers and acquisitions that have taken place within this domain, during the period 2015-2022, based on several relevant parameters, such as year of agreement, type of deal, geographical location of companies, type of acquisition, type of biologic manufactured and key value drivers.

Chapter 17 presents a detailed review of expansion initiatives undertaken by biopharmaceutical contract manufacturers, during the period 2016-2022, along with information on several relevant parameters, such as year of expansion, purpose of expansion, type of biologic manufactured and location of expanded facility.

Chapter 18 presents an analysis of the recent developments within the biopharmaceutical contract manufacturing industry, highlighting information on the funding investments made during the period 2016-2022, along with information on the technology advancements related to biomanufacturing.

Chapter 19 provides an estimate of the overall, installed capacity for the manufacturing of biopharmaceuticals, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity, based on size of manufacturer (small, mid-sized, and large and very large), scale of operation (preclinical, clinical and commercial), type of expression system used (mammalian, microbial and others) and geography (North America, Europe, Asia-Pacific and Rest of the World).

Chapter 20 presents 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.

Chapter 21 presents a company size-wise, detailed analysis of the total cost of ownership for biopharmaceuticals contract manufacturing organizations, during the period 2022-2042.

Chapter 22 presents an insightful market forecast analysis, highlighting the future potential of biopharmaceutical contract manufacturing market till 2035. We have segmented the market on the basis of type of service(s) offered (API, FDF), type of biologic manufactured (antibodies, cell therapies, vaccines and other biologics), type of expression system used (mammalian, microbial and others), scale of operation (preclinical / clinical and commercial) , company size (small, mid-sized, and large and very large), and key geographical regions (North America, Europe, Asia-Pacific, Latin America and MENA).

Chapter 23 presents a case study on the virtual business model concept, along with its role in the overall biopharmaceutical industry. It also features a discussion on the advantages and risks / challenges associated with outsourcing operations from virtual service providers.

Chapter 24 provides a discussion on affiliated trends, key drivers and challenges, under an elaborate 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 biopharmaceutical industry.

Chapter 25 features an elaborate discussion on the future opportunities / trends within the biopharmaceutical contract manufacturing market that are likely to influence the growth of this domain over the coming years.

Chapter 26 provides a survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing contract manufacturing services to biopharmaceutical developers.

Chapter 27 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the biopharmaceutical contract manufacturing market, based on the research and analysis described in the previous chapters.

Chapter 28 is a collection of transcripts of interviews conducted with various stakeholders in the industry.

Chapter 29 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 30 is an appendix, which provides the list of companies and organizations mentioned in the report.

Product Code: RA100379

1. PREFACE

1.1. Scope of the Report
1.2. Market Segmentations
1.3. Research Methodology
1.4. Key Questions Answered
1.5. Chapter Outlines

2. EXECUTIVE SUMMARY

2.1. Chapter Overview

3. INTRODUCTION

3.1. Chapter Overview
3.2. Overview of Biopharmaceuticals
3.3. Expression Systems for Biopharmaceuticals
- 3.3.1. Insect Expression Systems
- 3.3.2. Mammalian Expression Systems
- 3.3.3. Microbial Expression Systems
  - 3.3.3.1. Bacterial Expression Systems
  - 3.3.3.2. Fungal Expression Systems
  - 3.3.3.3. Yeast Expression Systems
- 3.3.4. Plant Expression Systems
- 3.3.5. Mammalian versus Microbial Expression Systems
3.4. Manufacturing Process of Biopharmaceuticals
- 3.4.1. Upstream Processing
- 3.4.2. Fermentation
- 3.4.3. Downstream Processing
3.5. Overview of Contract Manufacturing
3.6. Need for Outsourcing Biopharmaceutical Manufacturing Operations
- 3.6.1. Commonly Outsourced Manufacturing Operations for Biopharmaceuticals
- 3.6.2. Advantages of Outsourcing Biopharmaceutical Manufacturing Operations
- 3.6.3. Risks and Challenges Associated with Outsourcing Biopharmaceutical Manufacturing Operations
3.7. Key Considerations While Selecting a Contract Manufacturing Partner
3.8. Future Perspectives

4. MARKET 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 Company Size
- 4.2.3. Analysis by Location of Headquarters
- 4.2.4. Analysis by Type of Service(s) Offered
- 4.2.5. Analysis by Type of Biologic Manufactured
- 4.2.6. Analysis by Scale of Operation
- 4.2.7. Analysis by Type of Expression System Used
- 4.2.8. Analysis by Type of Bioreactor Used
- 4.2.9. Analysis by Mode of Operation of Bioreactor

5. REGIONAL CAPABILITY ANALYSIS

5.1. Chapter Overview
5.2. Key Assumptions and Methodology
5.3. Overall Landscape of Biopharmaceutical Contract Manufacturing Facilities
- 5.3.1. Analysis by Type of Service(s) Offered
- 5.3.2. Analysis by Scale of Operation
- 5.3.3. Analysis by Type of Expression System Used
5.4. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in North America
5.5. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in Europe
5.6. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities in Asia-Pacific and Rest of the World

6. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN NORTH AMERICA

6.1. Chapter Overview
6.2. Regulatory Scenario of Biopharmaceutical Contract Manufacturing in the US
6.3. Leading Biopharmaceutical CMOs in North America
- 6.3.1. AGC Biologics
  - 6.3.1.1. Company Overview
  - 6.3.1.2. Service Portfolio
    - 6.3.1.2.1. Process Development
    - 6.3.1.2.2. cGMP Manufacturing
    - 6.3.1.2.3. Quality and Regulatory
    - 6.3.1.2.4. Process Validation
  - 6.3.1.3. Financial Information
  - 6.3.1.4. Manufacturing Facilities
  - 6.3.1.5. Recent Developments and Future Outlook
- 6.3.2. Catalent (Catalent Pharma Solutions)
  - 6.3.2.1. Company Overview
  - 6.3.2.2. Service Portfolio
    - 6.3.2.2.1. Cell Line Development
    - 6.3.2.2.2. Manufacturing (Biomanufacturing)
    - 6.3.2.2.3. ADCs and Bioconjugates Manufacturing
    - 6.3.2.2.4. Biosimilars Development and Manufacturing
    - 6.3.2.2.5. Proprietary Delivery and Fill / Finish Solutions
    - 6.3.2.2.6. Analytical Services
  - 6.3.2.3. Clinical Supply Services
  - 6.3.2.4. Financial Information
  - 6.3.2.5. Manufacturing Facilities
  - 6.3.2.6. Recent Developments and Future Outlook
- 6.3.3. Cytiva (GE Healthcare)
  - 6.3.3.1. Company Overview
  - 6.3.3.2. Service Portfolio
    - 6.3.3.2.1. Biomanufacturing Services
    - 6.3.3.2.2. Scientific Support
    - 6.3.3.2.3. OptiRun Service Solutions
    - 6.3.3.2.4. Instruments Qualification Services
  - 6.3.3.3. Financial Information
  - 6.3.3.4. Manufacturing Facilities
  - 6.3.3.5. Recent Developments and Future Outlook
- 6.3.4. FUJIFILM Diosynth Biotechnologies
  - 6.3.4.1. Company Overview
  - 6.3.4.2. Service Portfolio
    - 6.3.4.2.1. Strain Development
    - 6.3.4.2.2. Process Development
    - 6.3.4.2.3. GMP Contract Manufacturing
    - 6.3.4.2.4. Analytical Solutions
  - 6.3.4.3. Financial Information
  - 6.3.4.4. Manufacturing Facilities
  - 6.3.4.5. Recent Developments and Future Outlook
- 6.3.5. KBI Biopharma
  - 6.3.5.1. Company Overview
  - 6.3.5.2. Service Portfolio
    - 6.3.5.2.1. Process Development
    - 6.3.5.2.2. Analytical Development
    - 6.3.5.2.3. GMP Manufacturing
    - 6.3.5.2.4. Clinical Cell Therapy Support
  - 6.3.5.3. Recent Developments and Future Outlook
- 6.3.6. Patheon (acquired by Thermo Fisher Scientific)
  - 6.3.6.1 Company Overview
  - 6.3.6.2. Service Portfolio
    - 6.3.6.2.1. Biologics
      - 6.3.6.2.1.1. Drug Substance
    - 6.3.6.2.2. Analytical Services
    - 6.3.6.2.3. Product Development
    - 6.3.6.2.4. Commercial Product Supply
  - 6.3.6.3. Financial Information
  - 6.3.6.4. Manufacturing Facilities
  - 6.3.6.5. Recent Developments and Future Outlook
- 6.3.7. Piramal Pharma Solutions
  - 6.3.7.1 Company Overview
  - 6.3.7.2. Service Portfolio
    - 6.3.7.2.1. Antibody Drug Conjugation Services
    - 6.3.7.2.2. Other Services
  - 6.3.7.3. Financial Information
  - 6.3.7.4. Manufacturing Facilities
  - 6.3.7.5. Recent Developments and Future Outlook

7. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN EUROPE

7.1. Chapter Overview
7.2. Biopharmaceutical Contract Manufacturing in Europe: Regulatory Scenario
- 7.2.1. EMA's cGMP Regulations
7.3. Leading Biopharmaceutical CMOs in Europe
- 7.3.1. Boehringer Ingelheim (BioXcellence)
  - 7.3.1.1. Company Overview
  - 7.3.1.2. Service Portfolio
    - 7.3.1.2.1. Process Development
      - 7.3.1.2.1.1. Expression Systems
      - 7.3.1.2.1.2. Upstream Technology
      - 7.3.1.2.1.3. Downstream Technology
      - 7.3.1.2.1.4. Other Process Development Services
    - 7.3.1.2.2. Quality Assurance
    - 7.3.1.2.3. Fill / Finish
  - 7.3.1.3. Financial Information
  - 7.3.1.4. Manufacturing Facilities
  - 7.3.1.5. Recent Developments and Future Outlook
- 7.3.2. Lonza
  - 7.3.2.1. Company Overview
  - 7.3.2.2. Service Portfolio
  - 7.3.2.3. Manufacturing Services
  - 7.3.2.4. Financial Information
  - 7.3.2.5. Manufacturing Facilities
  - 7.3.2.6. Recent Developments and Future Outlook
- 7.3.3. Novasep
  - 7.3.3.1 Company Overview
  - 7.3.3.2. Service Portfolio
    - 7.3.3.2.1. Services for Viruses and Viral Vectors
    - 7.3.3.2.2. Services for Monoclonal Antibodies
    - 7.3.3.2.3. Services for ADCs
    - 7.3.3.2.4. Quality, Regulatory and Other Services
  - 7.3.3.3. Manufacturing Facilities
  - 7.3.3.4. Recent Developments and Future Outlook
- 7.3.4. Olon
  - 7.3.4.1. Company Overview
  - 7.3.4.2. Service Portfolio
  - 7.3.4.3. Manufacturing Facilities
  - 7.3.4.4. Recent Developments and Future Outlook
- 7.3.5. Rentschler Biopharma
  - 7.3.5.1. Company Overview
  - 7.3.5.2. Service Portfolio
    - 7.3.5.2.1. Bioprocess Development
    - 7.3.5.2.2. Biomanufacturing Services
    - 7.3.5.2.3. Other Services
  - 7.3.5.3. Manufacturing Facilities
  - 7.3.5.4. Recent Developments and Future Outlook
- 7.3.6. Sandoz
  - 7.3.6.1. Company Overview
  - 7.3.6.2. Service Portfolio
  - 7.3.6.3. Financial Information
  - 7.3.6.4. Recent Developments and Future Outlook

8. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN ASIA-PACIFIC AND THE REST OF THE WORLD

8.1. Chapter Overview
8.2. Biopharmaceutical Contract Manufacturing in China
- 8.2.1. Biopharmaceutical Contract Manufacturing in China: Regulatory Scenario
- 8.2.2. Challenges Faced while Outsourcing to China
8.3. Leading Biopharmaceutical CMOs in China
- 8.3.1. WuXi Biologics
  - 8.3.1.1. Company Overview
  - 8.3.1.2. Service Portfolio
    - 8.3.1.2.1. Discovery Services
    - 8.3.1.2.2. Development Services
    - 8.3.1.2.3. Testing Services
    - 8.3.1.2.4. Clinical Manufacturing Services
    - 8.3.1.2.5. Fill / Finish Operations
  - 8.3.1.3. Financial Information
  - 8.3.1.4. Manufacturing Facilities
  - 8.3.1.5. Recent Developments and Future Outlook
8.4. Biopharmaceutical Contract Manufacturing in India
- 8.4.1. Biopharmaceutical Contract Manufacturing in India: Regulatory Scenario
- 8.4.2. Challenges Faced while Outsourcing to India
8.5. Leading Biopharmaceutical CMOs in India
- 8.5.1. Kemwell Biopharma
  - 8.5.1.1. Company Overview
  - 8.5.1.2. Service Portfolio
    - 8.5.1.2.1. Development Services for Biopharmaceuticals
    - 8.5.1.2.2. Manufacturing Services for Biopharmaceuticals
  - 8.5.1.3. Manufacturing Facilities
  - 8.5.1.4. Recent Developments and Future Outlook
8.6. Biopharmaceutical Contract Manufacturing in Japan
- 8.6.1. Biopharmaceutical Contract Manufacturing in Japan: Regulatory Scenario
8.7. Leading Biopharmaceutical CMOs in Japan
- 8.7.1. Minaris Regenerative Medicine
  - 8.7.1.1. Company Overview
  - 8.7.1.2. Service Portfolio
    - 8.7.1.2.1. Manufacturing Development
    - 8.7.1.2.2. GMP Manufacturing
  - 8.7.1.3. Manufacturing Facilities
  - 8.7.1.4. Recent Developments and Future Outlook
- 8.7.2. Takara Bio
  - 8.7.2.1. Company Overview
  - 8.7.2.2. Service Portfolio
  - 8.7.2.3. Financial Information
  - 8.7.2.4. Manufacturing Facilities
  - 8.7.2.5. Recent Developments and Future Outlook
8.8. Biopharmaceutical Contract Manufacturing in South Korea
- 8.8.1. Biopharmaceutical Contract Manufacturing in South Korea: Regulatory Scenario
8.9. Leading Biopharmaceutical CMOs in South Korea
- 8.9.1. Celltrion
  - 8.9.1.1. Company Overview
  - 8.9.1.2. Service Portfolio
  - 8.9.1.3. Financial Information
  - 8.9.1.4. Manufacturing Facilities
  - 8.9.1.5. Recent Developments and Future Outlook
- 8.9.2. Samsung BioLogics
  - 8.9.2.1. Company Overview
  - 8.9.2.2. Service Portfolio
    - 8.9.2.2.1. Process Development
    - 8.9.2.2.2. Analytical Services
    - 8.9.2.2.3. cGMP Manufacturing Services
    - 8.9.2.2.4. Aseptic Fill / Finish
    - 8.9.2.2.5. Quality Services
    - 8.9.2.2.6. Other Services
  - 8.9.2.3. Financial Information
  - 8.9.2.4. Manufacturing Facilities
  - 8.9.2.5. Recent Developments and Future Outlook
8.10. Biopharmaceutical Contract Manufacturing in Australia
- 8.10.1. Biopharmaceutical Contract Manufacturing in Australia: Regulatory Scenario
8.11. Leading Biopharmaceutical CMOs in Australia
- 8.11.1. Cell Therapies
  - 8.11.1.1. Company Overview
  - 8.11.1.2. Service Portfolio
  - 8.11.1.3. Manufacturing Facilities
  - 8.11.1.4. Recent Developments and Future Outlook
- 8.11.2. Luina Bio
  - 8.11.2.1. Company Overview
  - 8.11.2.2. Service Portfolio
    - 8.11.2.2.1. Microbial Products
    - 8.11.2.2.2. Vaccines
    - 8.11.2.2.3. Support Services
    - 8.11.2.2.4. Quality-related Services
  - 8.11.2.3. Manufacturing Facilities
  - 8.11.2.4. Recent Developments and Future Outlook

9. NICHE BIOPHARMACEUTICAL SECTORS

9.1. Chapter Overview
9.2. Bispecific Antibodies
- 9.2.1. Introduction
- 9.2.2. Pipeline Analysis
  - 9.2.2.1. Bispecific Antibody Therapeutics: Clinical Pipeline
  - 9.2.2.2. Bispecific Antibody Therapeutics: Early Stage Pipeline
  - 9.2.2.3. Multivalent Drug Candidates
- 9.2.3. Analysis by Phase of Development
- 9.2.4. Analysis by Target Indication
- 9.2.5. Bispecific Antibody Therapeutics: List of Technology Providers
- 9.2.6. Key Manufacturing Considerations and Challenges
- 9.2.7. Contract Manufacturing Scenario
  - 9.2.7.1. CMOs Offering Services for Bispecific Antibodies
9.3. Antibody Drug Conjugates (ADCs)
- 9.3.1. Components of ADCs
  - 9.3.1.1. Antibody
  - 9.3.1.2. Cytotoxin
  - 9.3.1.3. Linker
- 9.3.2. Manufacturing Process
- 9.3.3. Pipeline Analysis
- 9.3.4. Analysis by Phase of Development
- 9.3.5. Analysis by Target Indication
- 9.3.6. Key Technology Players: Analysis by Number of ADC Therapeutics
- 9.3.7. Novel Drug Conjugates
- 9.3.8. Key Manufacturing Considerations and Challenges
- 9.3.9. Contract Manufacturing Scenario
  - 9.3.9.1. CMOs Offering Services for ADCs
9.4. Cell Therapies
- 9.4.1. Introduction
- 9.4.2. Current Market Landscape
- 9.4.3. Cell Therapy Manufacturing
  - 9.4.3.1. Cell Therapy Manufacturing Models
    - 9.4.3.1.1. Centralized Manufacturing
    - 9.4.3.1.2. Decentralized Manufacturing
- 9.4.4. Key Manufacturing Considerations and Challenges
- 9.4.5. Factors Influencing Cell Therapy Manufacturing
  - 9.4.5.1. Characterization
  - 9.4.5.2. Cost of Goods
  - 9.4.5.3. Automation of Cell Therapy Manufacturing
- 9.4.6. Analysis by Types of Cells Manufactured
- 9.4.7. Stem Cell Therapies: Analysis by Phase of Development
- 9.4.8. T-Cell Therapies: Analysis by Phase of Development
- 9.4.9. Contract Manufacturing Scenario
  - 9.4.9.1. CMOs Offering Services for Cell Therapy
9.5. Gene Therapies
- 9.5.1. Gene Therapies Market: Pipeline Analysis
  - 9.5.1.1. Analysis by Stage of Development
  - 9.5.1.2. Analysis by Phase of Development
  - 9.5.1.3. Analysis by Type of Vector Used
    - 9.5.1.3.1. Clinical Pipeline
    - 9.5.1.3.2. Preclinical Pipeline
  - 9.5.1.4. Analysis by Target Indication
    - 9.5.1.4.1. Clinical and Commercial Pipeline
    - 9.5.1.4.1. Preclinical Pipeline
  - 9.5.1.5. Analysis by Location of Manufacturing Facility
  - 9.5.1.6 Analysis by Type of Viral Vector Used
- 9.5.2. Contract Manufacturing Scenario
  - 9.5.2.1. CMOs Offering Services for Viral Vectors
9.6. Plasmid DNA
- 9.6.1. Introduction
- 9.6.2. Analysis by Location of Manufacturing Facility
- 9.6.3. Contract Manufacturing Scenario
  - 9.6.3.1. CMOs Offering Services for Plasmid DNA

10. CASE STUDY: OUTSOURCING OF BIOSIMILARS

10.1. Chapter Overview
10.2. Biosimilars: An Introduction
10.3. Biosimilars: Development Stages
10.4. Regulatory Requirements for Licensing of Biosimilars
10.5. Need for Outsourcing Biosimilar Development and Manufacturing
10.6. Impact of Biosimilars on the Global Contract Manufacturing Market
- 10.6.1. Biosimilars: Historical Trend of FDA Approval
10.7. Biosimilars Contract Manufacturing Service Providers
10.8. Challenges Associated with Outsourcing of Biosimilar Manufacturing Operations

11. CASE STUDY: COMPARISON OF SMALL AND LARGE MOLECULES DRUGS / THERAPIES

11.1. Chapter Overview
11.2. Small Molecule and Large Molecule Drugs / Therapies
- 11.2.1. Comparison of General Characteristics
- 11.2.2. Comparison of Key Specifications
- 11.2.3. Comparison of Manufacturing Process
- 11.2.4. Comparison of Key Manufacturing Challenges

12. CASE STUDY: IN-HOUSE MANUFACTURING

12.1. Chapter Overview
12.2. In-House Manufacturing
- 12.2.1. Benefits Associated with In-House Manufacturing
- 12.2.2. Risks Associated with In-House Manufacturing
12.3. Outsourcing Trends in the Biopharmaceutical Industry
- 12.3.1. Types of Outsourcing Partners
12.4. Manufacturing Approaches Used for Approved Biologics, 2016-2022
- 12.4.1. Approved Biologics: Analysis by Company Size and Type of Manufacturing Model Adopted
- 12.4.2. Approved Biologics: Analysis by Company Size and Type of Biologic Manufactured
12.5. Choosing the Right Strategy: In-House Manufacturing versus Outsourcing

13. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

13.1. Chapter Overview
13.2. Assumptions and Key Parameters
13.3. Biopharmaceutical Contract Manufacturers: Make versus Buy Decision Making
- 13.3.1. Scenario 1
- 13.3.2. Scenario 2
- 13.3.3. Scenario 3
- 13.3.4. Scenario 4
13.4. Conclusion

14. BIG PHARMA INITIATIVES

14.1. Chapter Overview
14.2. Biopharmaceutical Related Initiatives of Big Pharmaceutical Players
- 14.2.1. Analysis by Number of Initiatives
- 14.2.2. Analysis by Year of Initiative
- 14.2.3. Analysis by Purpose of Initiative
- 14.2.4. Analysis by Type of Initiative
  - 14.2.4.1. Analysis by Type of Partnership
  - 14.2.4.2. Analysis by Type of Expansion
- 14.2.5. Analysis by Scale of Operation
- 14.2.6. Analysis by Type of Biologic Manufactured
- 14.2.7. Analysis by Year of Initiative and Company
- 14.2.8. Analysis by Purpose of Initiative and Company
- 14.2.9. Analysis by Year and Type of Initiative
- 14.2.10. Analysis by Region of Expansion and Company
- 14.2.11. Analysis by Type of Biologic Manufactured and Company
14.3. Competitive Benchmarking of Big Pharma Players

15. PARTNERSHIPS AND COLLABORATIONS

15.1. Chapter Overview
15.2. Partnership Models
15.3. Biopharmaceutical Contract Manufacturing: Partnerships and Collaborations
- 15.3.1. Analysis by Year of Partnership
- 15.3.2. Analysis by Type of Partnership
- 15.3.3. Analysis by Year and Type of Partnership
- 15.3.4. Analysis by Type of Biologic Manufactured
- 15.3.5. Analysis by Year of Partnership and Type of Biologic Manufactured
- 15.3.6. Analysis by Type of Partnership and Type of Biologic Manufactured
- 15.3.7. Analysis by Type of Biologic Manufactured and Geography
- 15.3.8. Analysis by Therapeutic Area
- 15.3.9. Most Active Players: Analysis by Number of Partnerships
- 15.3.10. Analysis by Region
  - 15.3.10.1. Intracontinental and Intercontinental Agreements
  - 15.3.10.2. Local and International Agreements

16. MERGERS AND ACQUISITIONS

16.1. Chapter Overview
16.2. Merger and Acquisition Models
16.3. Biopharmaceutical Contract Manufacturing: Mergers and Acquisitions
- 16.3.1. Cumulative Year-wise Trend of Mergers and Acquisitions
- 16.3.2. Analysis by Type of Acquisition
- 16.3.3. Analysis by Region
  - 16.3.3.1. Mergers and Acquisitions: Continent-wise Distribution
  - 16.3.3.2. Mergers and Acquisitions: Country-wise Distribution
  - 16.3.3.3. Mergers and Acquisitions: Year-wise Trend in North America, Europe and Asia-Pacific
- 16.3.4 Most Active Acquirers: Analysis by Number of Acquisitions
- 16.3.5 Analysis by Key Value Drivers
- 16.3.6. Analysis by Year of Acquisition and Key Value Drivers
- 16.3.7. Analysis by Type of Biologic Manufactured
- 16.3.8. Analysis by Key Value Drivers and Type of Biologic Manufactured
16.4. Key Acquisitions: Deal Multiples
- 16.4.1. Year-wise Trend of Deal Multiple Amount

17. RECENT EXPANSIONS

17.1. Chapter Overview
17.2. Biopharmaceutical Contract Manufacturing: Recent Expansions
- 17.2.1. Analysis by Year of Expansion
- 17.2.2. Analysis by Purpose of Expansion
- 17.2.3. Analysis by Year and Purpose of Expansion
- 17.2.4. Analysis by Type of Biologic Manufactured
- 17.2.5. Analysis by Purpose of Expansion and Type of Biologic Manufactured
- 17.2.6. Analysis by Location of Expanded Facility
- 17.2.7. Most Active Players: Analysis by Number of Recent Expansions
- 17.2.8. Analysis by Purpose of Expansion and Location of Expanded Facility
- 17.2.9. Analysis by Amount Invested
- 17.2.10. Recent Expansions: 2016-2020 and 2016-2022 Scenario

18. RECENT DEVELOPMENTS

18.1. Chapter Overview
18.2. Types of Funding
18.3. Biopharmaceutical Contract Manufacturing: Funding and Investments
- 18.3.1. Cumulative Year-wise Distribution by Number of Instances
- 18.3.2. Cumulative Year-wise Distribution of Amount Invested
- 18.3.3. Analysis of Instances by Type of Funding
- 18.3.4. Analysis of Total Amount Invested by Type of Funding
- 18.3.5. Analysis by Year and Type of Funding
- 18.3.6. Regional Analysis of Total Amount Invested and Number of Funding Instances (Continent-wise)
- 18.3.7. Regional Analysis of Total Amount Invested and Number of Funding Instances (Country-wise)
- 18.3.8. Most Active Players: Analysis by Number of Funding Instances
- 18.3.9. Most Active Players: Analysis by Total Amount Raised
- 18.3.10. Most Active Investors: Analysis by Number of Funding Instances
18.4. Technological Advancements
- 18.4.1. Single Use Technology
- 18.4.2. Process Analytical Technology (PAT)
- 18.4.3. Continuous Processing
- 18.4.4. Quality by Design (QbD) in Bio-Processing
- 18.4.5. Modular / Podular Biopharma Facilities

19. CAPACITY ANALYSIS

19.1. Chapter Overview
19.2. Key Assumptions and Methodology
19.3. Biopharmaceutical Contract Manufacturers: Global Production Capacity
- 19.3.1. Analysis by Company Size
- 19.3.2. Analysis by Type of Expression System Used
- 19.3.3. Analysis by Scale of Operation
- 19.3.4. Analysis by Region
  - 19.3.4.1. Analysis of Biopharmaceutical Contract Manufacturing Capacity in North America
  - 19.3.4.2. Analysis of Biopharmaceutical Contract Manufacturing Capacity in Europe
  - 19.3.4.3. Analysis of Biopharmaceutical Contract Manufacturing Capacity in Asia-Pacific
19.4. Concluding Remarks

20. DEMAND ANALYSIS

20.1. Chapter Overview
20.2. Key Assumptions and Methodology
20.3. Global Demand for Biopharmaceuticals
- 20.3.1. Analysis by Therapeutic Area
20.4. Relationship Between Annual Demand and Capacity
20.5. Annual Demand for Emerging Novel Biologics
- 20.5.1. ADC Therapeutics: Overall Annual Demand
- 20.5.2. ADC Therapeutics: Demand and Supply Analysis
20.6. Global Demand for Cell Therapy Manufacturing

21. TOTAL COST OF OWNERSHIP FOR BIOPHARMACEUTICAL CONTRACT MANUFACTURING ORGANIZATIONS

21.1. Chapter Overview
21.2. Key Parameters
21.3. Assumptions and Methodology
21.4. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations, 2022-2042
21.5. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Analysis by CAPEX and OPEX, 2023-2042
- 21.5.1. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Analysis by CAPEX, 2023-2042
- 21.5.2. Total Cost of Ownership for Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Analysis by OPEX, 2023-2042

22. MARKET FORECAST AND OPPORTUNITY ANALYSIS

22.1. Chapter Overview
22.2. Key Assumptions and Methodology
22.3. Global Biopharmaceutical Contract Manufacturing Market, 2022-2035
22.4. Biopharmaceutical Contract Manufacturing Market: Analysis by Type of Service(s) Offered
- 22.4.1. Biopharmaceutical Contract Manufacturing Market for APIs, 2022-2035
- 22.4.2. Biopharmaceutical Contract Manufacturing Market for FDFs, 2022-2035
22.5. Biopharmaceutical Contract Manufacturing Market: Analysis by Type of Biologic Manufactured
- 22.5.1. Biopharmaceutical Contract Manufacturing Market for Antibodies, 2022-2035
- 22.5.2. Biopharmaceutical Contract Manufacturing Market for Cell Therapies, 2022- 2035
- 22.5.3. Biopharmaceutical Contract Manufacturing Market for Vaccines, 2022-2035
- 22.5.4. Biopharmaceutical Contract Manufacturing Market for Other Biologics, 2022- 2035
22.6. Biopharmaceutical Contract Manufacturing Market: Analysis by Type of Expression System Used
- 22.6.1. Biopharmaceutical Contract Manufacturing Market for Mammalian Cell-based Operations, 2022-2035
- 22.6.2. Biopharmaceutical Contract Manufacturing Market for Microbial Cell-based Operations, 2022-2035
- 22.6.3. Biopharmaceutical Contract Manufacturing Market for Other Expression System- based Operations, 2022-2035
22.7. Biopharmaceutical Contract Manufacturing Market: Analysis by Scale of Operation
- 22.7.1. Biopharmaceutical Contract Manufacturing Market for Preclinical / Clinical Operations, 2022-2035
- 22.7.2. Biopharmaceutical Contract Manufacturing Market for Commercial Operations, 2022-2035
22.8. Biopharmaceutical Contract Manufacturing Market: Analysis by Company Size, 2022-2035
- 22.8.1. Biopharmaceutical Contract Manufacturing Market for Small Companies, 2022- 2035
- 22.8.2. Biopharmaceutical Contract Manufacturing Market for Mid-sized Companies, 2022-2035
- 22.8.3. Biopharmaceutical Contract Manufacturing Market for Large and Very Large Companies, 2022-2035
22.9. Biopharmaceutical Contract Manufacturing Market: Analysis by Geography
- 22.9.1. Biopharmaceutical Contract Manufacturing Market in North America, 2022- 2035
  - 22.9.1.1. Biopharmaceutical Contract Manufacturing Market in the US, 2022-2035
  - 22.9.1.2. Biopharmaceutical Contract Manufacturing Market in Canada, 2022-2035
- 22.9.2. Biopharmaceutical Contract Manufacturing Market in Europe, 2022-2035
  - 22.9.2.1. Biopharmaceutical Contract Manufacturing Market in Italy, 2022-2035
  - 22.9.2.2. Biopharmaceutical Contract Manufacturing Market in Germany, 2022-2035
  - 22.9.2.3. Biopharmaceutical Contract Manufacturing Market in France, 2022-2035
  - 22.9.2.4. Biopharmaceutical Contract Manufacturing Market in Spain, 2022-2035
  - 22.9.2.5. Biopharmaceutical Contract Manufacturing Market in the UK, 2022-2035
  - 22.9.2.6. Biopharmaceutical Contract Manufacturing Market in Rest of Europe, 2022-2035
- 22.9.3. Biopharmaceutical Contract Manufacturing Market in Asia-Pacific, 2022-2035
  - 22.9.3.1. Biopharmaceutical Contract Manufacturing Market in China, 2022-2035
  - 22.9.3.2. Biopharmaceutical Contract Manufacturing Market in India, 2022-2035
  - 22.9.3.3. Biopharmaceutical Contract Manufacturing Market in South Korea, 2022-2035
  - 22.9.3.4. Biopharmaceutical Contract Manufacturing Market in Japan, 2022-2035
  - 22.9.3.5. Biopharmaceutical Contract Manufacturing Market in Rest of Asia-Pacific, 2022- 2035
- 22.9.4. Biopharmaceutical Contract Manufacturing Market in Latin America, 2022-2035
- 22.9.5. Biopharmaceutical Contract Manufacturing Market in Middle East and North Africa, 2022-2035

23. CASE STUDY: VIRTUAL PHARMACEUTICAL COMPANIES

23.1. Chapter Overview
23.2. Historical Evolution of the Virtual Business Model
23.3. Virtual Pharmaceutical Companies as a Subset of the Overall Biopharmaceutical Industry
23.4. Advantages Associated with Outsourcing Operations to Service Providers
23.5. Key Challenges Associated with Outsourcing Operations to Service Providers

24. SWOT ANALYSIS

24.1 Chapter Overview
24.2. Strengths
24.3. Weaknesses
24.4. Opportunities
24.5. Threats
24.6. Comparison of SWOT Factors
24.7. Conclusion

25. FUTURE OF THE BIOPHARMACEUTICAL CMO MARKET

25.1. Chapter Overview
25.2. Outsourcing Activities to Witness Significant Growth in the Coming Years
25.3. Shift from One-time Contracts to Strategic Partnerships
25.4. Integration / Adoption of Innovative Technologies
- 25.4.1. Single use Bioreactors
- 25.4.2. Novel Bioprocess Techniques
- 25.4.3. Bioprocess Automation
25.5. Focus on Niche Therapeutic Areas
25.6. Growing Biosimilars Market to Contribute to the Growth of the Contract Services Segment
25.7. Capability and Expertise Expansions by CMOs to become One-Stop-Shops
25.8. Offshoring Outsourcing Activities to Maximize Profits and Expand Existing Capacities
25.9. Increase in Financial Inflow and Outsourcing Budgets
25.10. Challenges Faced by both Sponsors and Service Providers
- 25.10.1. Concerns Related to Single Use Systems
- 25.10.2. Issues Related to Capacity Fluctuations
25.11. Concluding Remarks

26. SURVEY ANALYSIS

26.1. Chapter Overview
- 26.1.1. Overview of Respondents
- 26.1.2. Analysis by Designation of Respondents
26.2. Analysis by Biologic Manufacturing Expertise
26.3. Analysis by Scale of Manufacturing
26.4. Analysis by Location of Production Facilities
26.5. Analysis by Type of Expression System Used
26.6. Analysis by Type of Bioreactor Used
26.7. Analysis by Mode of Operation of Bioreactor

27. CONCLUSION

27.1. Chapter Overview

28. INTERVIEW TRANSCRIPTS

28.1. Chapter Overview
28.2. Andrea Conforto, Sales & Marketing, Bioservices Director, Olon
28.3. Astrid Brammer, Key Account Manager, Richter Helm
28.4. Birgit Schwab, Senior Manager Strategic Marketing, Rentschler Biotechnologie
28.5. Christian Bailly, ex-Director of CDMO, Pierre Fabre
28.6. Claire Otjes, Communication Manager, Batavia Biosciences
28.7. David C Cunningham, Director Corporate Development, Goodwin Biotechnology
28.8. Dietmar Katinger, Chief Executive Officer, Polymun Scientific
28.9. Denis Angioletti, Chief Commercial Officer, Cerbios-Pharma
28.10. Jeffrey Hung, General Manager, Vigene Biosciences
28.11. Kevin Daley, Director Pharmaceuticals, Novasep
28.12. Mark Wright, ex-Site Head, Grangemouth, Piramal Healthcare
28.13. Max Rossetto, General Manager - Business Development, Luina Bio
28.14. Nicolas Grandchamp, R&D Leader, GEG Tech
28.15. Raquel Fortunato, Chief Executive Officer, GenIbet Biopharmaceuticals
28.16. Sebastian Schuck, Head of Business Development, Wacker Biotech
28.17. Tatjana Buchholz, Marketing Manager, Plasmid Factory and Marco Schmeer, ex- Project Manager
28.18. Tim Oldham, ex- Chief Executive Officer, Cell Therapies
28.19. Traci Kyes, Vice President of Commercial Operations, Arranta Bio
28.20. Vijayakumar Ramaraj, Chief Manager, Shilpa Biologicals

29. APPENDIX I: TABULATED DATA

30. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS