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Vaccine Contract Manufacturing Market (2nd Edition), 2019-2030

Vaccine Contract Manufacturing Market (2nd Edition), 2019-2030

  • July 2019
  • 406 pages
  • ID: 3961394
  • Format: PDF
  • By Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
The global vaccines market is anticipated to generate revenues worth USD 100 billion by 2025.
According to the WHO, the global vaccination rate is nearly 85%, demonstrating the high clinical demand for vaccines. In addition to meeting the growing demand for vaccines, the developers of these pharmacological interventions are also plagued by high costs of development and complex production protocols. Given that vaccine manufacturing requires highly regulated, state-of-the-art technologies, it has become increasingly difficult for stakeholders to establish in-house expertise for large-scale manufacturing of vaccines. As a result, vaccine developers have begun outsourcing their manufacturing operations to contract manufacturing organizations (CMOs). Specifically, small and mid-sized players in this sector tend to outsource a substantial proportion of clinical development and commercial-scale manufacturing processes to contract service providers. In addition, even big pharma players, with established in-house capabilities, are gradually entering into long-term business relationships with CMOs in order to optimize resource utilization and manage costs.

It is worth highlighting that the contemporary contract services market for vaccines is highly fragmented. Having said that, numerous stakeholders are actively striving to expand their respective service portfolios through substantial acquisition activity. As a result, these CMOs have developed the capabilities to offer end-to-end services, ranging from vaccine development (including preliminary R&D, preclinical studies and clinical trials), to regulatory filings, and commercial scale production. In future, we expect the demand for core competencies to continue to drive sponsor companies to rely on contract service providers for various aspects of product development and manufacturing. Amidst tough competition, the availability of cutting-edge tools and technologies has emerged as a differentiating factor and is likely to grant a competitive advantage to certain CMOs over other players in the industry.

SCOPE OF THE REPORT

The “Vaccine Contract Manufacturing Market (2nd Edition), 2019 – 2030” report features an extensive study on contract service providers engaged in the development and manufacturing of vaccines. The study features in-depth analyses, highlighting the capabilities of various vaccine CMOs. Amongst other elements, the report includes:
A detailed review of the contract manufacturing landscape for vaccines, featuring a comprehensive list of active CMOs and analysis based on a number of parameters, such as year of establishment, company size, geographical location, number of vaccine manufacturing facilities, types of services offered (cell / virus banking, analytical development / testing, formulation, process development, fill / finish and regulatory filings), scale of operation (preclinical, clinical and commercial), type of expression systems used (mammalian, microbial and others) and type(s) of vaccines manufactured.
A region-wise, company competitiveness analysis, highlighting prominent vaccine contract manufacturers based on supplier strength (considering the experience of the contract manufacturer), and service strength (which takes into account the count of service offerings, number of expression systems used and scale of operation).
Elaborate profiles of the key players based in North America, Europe and Asia-Pacific that have a diverse range of capabilities for the development, manufacturing and packaging of vaccines. Each profile includes an overview of the company, its financial performance (if available), information on service portfolio, vaccine manufacturing facilities, and details on partnerships, recent developments (expansions), and awards and accolades received, as well as an informed future outlook.
An analysis of the recent collaborations (signed since 2013) focused on the contract manufacturing of vaccines, based on various parameters, such as year of agreement, type of agreement, scale of operation, types of services mentioned in the deal, types of vaccines manufactured, types of therapeutic area and location of facility where the project is to be executed.
A detailed analysis of the expansions undertaken (since 2013) by various service providers within vaccine contract manufacturing industry, based on a number of parameters, including year of expansion, type of expansion (capacity expansion, capability expansion and new facility), geographical location of facility, scale of operation, types of services involved, expansion details (in terms of new area added to existing facilities, if available) and most active players (in terms of number of instances).
An informed estimate of the annual demand for vaccines (in mL), taking into account the 20 top selling vaccines, based on various parameters, such as target patient population, dosing frequency and dose strength.
A detailed capacity analysis, taking into consideration the manufacturing capacities of various stakeholders (small-sized, mid-sized, large and very large CMOs) in the market, based on data gathered via secondary and primary research. It also provides the distribution of global vaccine manufacturing capacity by company size (small-sized, mid-sized, large and very large), and geography (North America, Europe and Asia-Pacific) and scale of operation (preclinical / clinical and commercial).
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 industry.
A discussion on the potential market drivers, such as the growing vaccines pipeline, increasing outsourcing of vaccine operations and opportunities in Asia-Pacific region, which are likely to present in the coming years.

One of the key objectives of the report was to estimate the future size of the market. Based on the parameters, such as growth of the overall vaccine 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 vaccine-related operations (cell / virus banking, analytical development / testing, formulation, process development, fill / finish and regulatory filings) [B] types of expression systems (mammalian, microbial and others), [C] size of contract service provider 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. To account for the uncertainties associated with the manufacturing of vaccines 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.

The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:
Menzo Havenga, CEO, Batavia Biosciences and Claire Otjes, Marketing Manager, Batavia Biosciences
David C Cunningham, Director Corporate Development, Goodwin Biotechnology
Ingrid Cromann, Director - Vaccine Development, Statens Serum Institut
Kevin Daley, Director Pharmaceuticals, Novasep Synthesis
Oliver Schub, Senior Business Development Manager, ProBioGen
Sebastian Schuck, Head of Business Development, Wacker Biotech

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.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
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 vaccine contract manufacturing market in the mid to long term.

Chapter 3 provides a general introduction to vaccines. The chapter also includes an overview of the various expression systems used in the development and manufacturing of vaccines. It also features a brief overview of contract manufacturing and a detailed discussion on the need for outsourcing within the vaccines industry. The chapter includes a list of commonly outsourced vaccine manufacturing services, and concludes with a discussion on the challenges that are currently associated within this market.

Chapter 4 provides a comprehensive overview of the global vaccine contract manufacturing landscape. It includes information related to over 70 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 the year of establishment, company size, geographical location, number of vaccine manufacturing facilities, types of services offered (cell / virus banking, analytical development / testing, formulation, process development, fill / finish and regulatory filings), scale of operation (preclinical, clinical and commercial), type of expression systems used (mammalian, microbial and others) and type(s) of vaccines manufactured.

Chapter 5 features a comprehensive company competitiveness analysis of vaccine contract manufacturers based in North America, Europe and Asia-Pacific, that we came across during our research. The analysis compares companies within each geography on the basis of supplier strength (considering the experience of contract manufacturer) and service strength (which takes into account the count of service offerings, number of expression systems used, and scale of operation).

Chapter 6 provides detailed profiles of some of the key players that are active in the vaccine contract manufacturing market in North America. Each profile presents a brief overview of the company, financial information (if available), its contract service offerings highlighting the capabilities of vaccine product facilities, recent developments and an informed future outlook.

Chapter 7 provides detailed profiles of some of the key players that are active in the vaccine contract manufacturing market in Europe. Each profile presents a brief overview of the company, financial information (if available), its contract service offerings highlighting the capabilities of vaccine product facilities, recent developments and an informed future outlook.

Chapter 8 provides detailed profiles of some of the key players that are active in the vaccine contract manufacturing market in Asia-Pacific. Each profile presents a brief overview of the company, financial information (if available), its contract service offerings highlighting the capabilities of vaccine product facilities, recent developments and an informed future outlook.

Chapter 9 features an elaborate analysis and discussion on the collaborations and partnerships that have been inked amongst players, since 2013. It includes brief descriptions of the various partnership models (including acquisition, distribution agreement, licensing agreements, manufacturing, product development / commercialization, product development and manufacturing, process development and manufacturing, process development, R&D agreements, service alliance and others) that have been adopted by stakeholders in this domain. It also includes analysis based on year of agreement, type of agreement, scale of operation, types of services mentioned in the deal, types of vaccines manufactured, types of therapeutic area and location of facility where the project is to be executed. Further, the chapter features a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents.

Chapter 10 presents detailed analysis on the expansions that have taken place in the vaccine manufacturing industry, since 2013. It includes information on expansions for increasing existing capabilities, as well as setting-up of new facilities by service provider entities engaged in this domain. The expansion instances that we came across were analyzed based on various parameters, including year of expansion, type of expansion (capacity expansion, capability expansion and new facility), geographical location of the facility, scale of operation (as mentioned in the expansion terms), types of services involved, expansion details (in terms of new area added to the existing facilities, if available) and also highlights the most active players (in terms of number of instances) in the domain.

Chapter 11 features an analysis of the global / regional capacity of contract manufacturers that are engaged in the manufacturing of vaccine products. The analysis takes into consideration the individual development and manufacturing capacities of various stakeholders (small-sized, mid-sized, large and very large CMOs) in the market, using data from both secondary and primary research. The study examines the distribution of global vaccine manufacturing capacity by size of the company (small-sized, mid-sized, large and very large), region of operation (North America Europe Asia and Middle East and, rest of the world and scale of operation (preclinical / clinical, commercial).

Chapter 12 features an informed view on the demand for vaccines (both clinical and commercially available) in the market, offering an informed opinion on the required scale of supply (in terms of vaccine manufacturing services). For the purpose of estimating the current clinical demand, we considered the active clinical studies of different types of vaccines that have been registered since 1971. The data was analyzed on the basis of various parameters, such as number of annual clinical doses, trial location, leading industry / non-industry sponsors, and the enrolled patient population across different geographies. Further, in order to estimate the commercial demand, we considered the top 20 vaccines, based on a various parameters, such as target patient population, dosing frequency and dose strength.

Chapter 13 presents an insightful market forecast analysis, highlighting the likely growth of the vaccine contract manufacturing market till the year 2030. In order to provide details on the future opportunity, our projections have been segmented on the basis of [A] commonly outsourced vaccine-related operations (cell / virus banking, analytical development / testing, formulation, process development, fill / finish and regulatory filings) [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 14 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 15 highlights the potential growth drivers for contract vaccine manufacturers. It highlights the various opportunities associated with the growing vaccine pipeline, increase in outsourcing of vaccine manufacturing operations, adoption of innovative technologies and opportunities in Asia-Pacific region, which are likely to have a notable influence on the future of the vaccine contract manufacturing market.

Chapter 16 features the transcripts of interviews conducted with representatives from renowned organizations that are engaged in the vaccine contract manufacturing domain. We spoke to Menzo Havenga (CEO, Batavia Biosciences) and Claire Otjes (Marketing Manager, Batavia Biosciences), David C Cunningham (Director Corporate Development, Goodwin Biotechnology), Ingrid Cromann (Director - Vaccine Development, Statens Serum Institut), Kevin Daley (Director Pharmaceuticals, Novasep Synthesis), Oliver Schub (Senior Business Development Manager, ProBioGen) and Sebastian Schuck (Head of Business Development, Wacker Biotech).

Chapter 17 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 18 is an appendix that provides the list of companies and organizations mentioned in the report.

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