NEW YORK, Oct. 6, 2016 /PRNewswire/ -- INTRODUCTION
Vaccines have always been viewed as a low-margin business characterized by high entry barriers. Developmental and production related complexities, combined with significant fixed costs and stringent regulatory standards, have limited competition among vaccine manufacturers. In addition, these complexities have also restricted innovation in this space to a great extent. However, recent advances in biotechnology and biomanufacturing have resulted in the development of advanced technologies capable of addressing the challenges associated with manufacturing vaccines. Previously, the vaccine market was solely focused on preventive vaccines developed against infectious diseases. The advent of therapeutic vaccines has renewed interest in this field by paving way for vaccines to be developed for a variety of chronic and degenerative diseases. This has led to the entry of a number of established and emerging stakeholders who are competing for a share in this growing market segment.
It is well-known that the overall trend of outsourcing has grown significantly in the biopharmaceuticals industry. Due to the complex nature of vaccine development and manufacturing processes, both large and small stakeholders are exploring outsourcing opportunities for their products. Operational and infrastructural cost-benefits and reduced time-to-market are the major factors driving outsourcing. Manufacturing vaccines requires specialized resources and highly regulated technology platforms, which are becoming increasingly difficult to establish in-house. Although big pharma players prefer to carry out most of these processes in-house, they are gradually entering into long-term partnerships with trusted contract manufacturing organizations (CMOs). On the other hand, smaller and emerging players have been known to outsource a relatively larger share of their clinical development and commercial manufacturing processes to contract manufacturing partners. The landscape is rapidly evolving. CMOs aiming to consolidate their presence in the market are expanding their service portfolios to provide end-to-end services to their clients and sponsors.
SCOPE OF THE REPORT
The Vaccine Contract Manufacturing Market, 2016 – 2026 report provides an extensive study of the current market landscape of CMOs focused on vaccines. The study presents an in-depth analysis of a diverse set of biopharmaceutical CMOs based on key parameters such as geographical location, scale of operation, use of expression systems and manufacturing capabilities. In addition, it captures some of the potential growth areas that will likely present tremendous opportunities for vaccine CMOs and contribute to an accelerated pace of growth.
The report assesses the key drivers that have governed the evolution of vaccine contract manufacturing market over the past several years, along with an elaborate discussion on the future trends that are likely to shape the market in the coming years. One of the focus areas of this study is to estimate size of the future opportunity for vaccine CMOs market over the next decade, segmented on the basis of business operations, type of expression systems and key regions.
The study also provides information on some of the most important aspects of vaccine outsourcing; these include growing collaborations, investment activity, facility expansions and technological advances. In addition to some of the well-known benefits and a promising outlook, the study highlights considerable challenges that are currently prevalent in the market. Examples include quality concerns, stringent regulations and lack of funding. Nevertheless, these challenges are resulting in new strategies and technological improvements, which are likely to prove advantageous in the long run.
The base year for the report is 2016; it provides market forecasts for the period 2016 - 2026. The research, analysis and insights presented in this report is backed by a deep understanding of key insights gathered both from secondary and primary research.
Most of 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 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 2 provides an executive summary of the key insights captured in our research. The summary offers a high level view on the current status of the vaccine contract manufacturing market and where it is headed in the mid-long term.
Chapter 3 is a general introduction to vaccines. The chapter also includes an overview of the various expression systems used in the development of different vaccines and their related manufacturing procedures. It also provides an elaborate discussion on the need for outsourcing vaccine development and manufacturing processes. In this chapter, we have also presented a list of commonly outsourced biomanufacturing activities that we came across during the course of our research. The chapter also features a section dedicated to the challenges associated with the market.
Chapter 4 provides a comprehensive overview of the global landscape of vaccine CMOs. The chapter includes in-depth analysis based on regional distribution, scale of operation, manufacturing capabilities, type of vaccines manufactured and expression systems used.
Chapter 5 features an analysis of the trends, regulatory landscape and highlights the key players in vaccine contract manufacturing located in the US and Europe, the two leading geographies in this market. The chapter also provides a sub-market forecast for vaccine contract manufacturing segmented on the basis of expression systems used.
Chapter 6 provides details of vaccine contract manufacturing activities in China and India. It includes information on the regulatory framework, growth drivers and challenges associated with vaccine contract manufacturing in these regions. It also provides a high-level view on the production capabilities of some the key players in these emerging geographies. Additionally, a sub-market forecast for vaccine contract manufacturing segmented on the basis of expression systems used is also included in this chapter.
Chapter 7 presents an analysis of the recent developments in the vaccine contract manufacturing market. It provides a listing of the partnerships established in the recent past, along with an overview of other observed market trends, including investments and facility expansions.
Chapter 8 presents a detailed market forecast for the vaccine contract manufacturing market. Additionally, we have analyzed the future potential for specific geographies across the globe and in terms of the type of expression systems used. To account for the uncertain nature of the market, we have presented three different tracks of market evolution, namely the conservative, base and optimistic scenarios.
Chapter 9 provides a SWOT analysis capturing the key elements that are likely to influence the market's future.
Chapter 10 highlights future trends that are likely to emerge in the evolving vaccine contract manufacturing market. It includes brief discussions on important aspects such as the adoption of innovative technologies and a shift to strategic partnering. The chapter also addresses the growing market demand and how it is likely to influence the future growth and evolution of this market.
Chapter 11 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the vaccine CMOs market, based on the research and analysis described in the previous chapters.
Chapter 12 contains the transcripts of interviews conducted with representatives from renowned organizations engaged in this space.
Chapter 13 is an appendix that contains tabulated data and numbers for all the figures provided in the report.
Chapter 14 is an appendix that provides the list of companies and organizations mentioned in the report.
1. Vaccine development and manufacturing, characterized by complex production processes and high entry barriers, is set in a highly regulated market landscape. Outsourcing has emerged as a rising trend in this domain and gained a lot of traction in the last few years. As the market continues to evolve, CMOs are rapidly enhancing their service offering to offer end-to-end services to their clients.
2. Developed regions, such as North America and Europe, currently dominate the vaccine contract manufacturing market. Of the 79 CMOs we identified, 41 have presence in multiple locations in the US. In Europe, the other major hub for CMOs, 20 CMOs have facilities located in Germany, France and the UK alone.
3. CMOs in emerging locations have also gained ground. With increasing support from local governments, many low-income geographies have restructured their indigenous regulatory landscape. Intellectual property protection laws have been made more stringent in favor of foreign sponsors looking to outsource business operations in the same regions. Established players in this market have also received the necessary qualifications and certifications to provide services in compliance with global standards.
4. Out of 79 CMOs, 21 offer end-to-end services across preclinical, clinical and commercial scale. We observed a rapid adoption of mammalian and insect production technologies among service providers.
5. The highly competitive market landscape is abuzz with partnership activity. We have identified 128 unique partnerships that were inked in the recent past. Of these, a sizeable proportion (25%) is mergers / acquisitions. We believe this trend is likely to continue in the future.
6. Technological advances are amongst the major driving factors in this market. The introduction of novel expression systems, such as the EB66® and GPEx® cell lines, and cell culture media platforms have sustained the interest of players in this field. Single use / disposable technologies, a key bio-manufacturing trend, are also becoming more and more popular among contract manufacturers. This is representative of the current market intensity.
7. Driven by increasing global demand and the rapidly expanding vaccine market, we expect the overall contract manufacturing market in this space to grow at an annualized rate of 9.8%. The rate of growth is likely to vary significantly across different segments / activities and across geographical regions.
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