LONDON, June 26, 2017 /PRNewswire/ — INTRODUCTION
Over the years, the biopharmaceutical market has grown into a prominent and promising segment of the overall pharmaceutical industry. Characterized by a number of blockbuster therapies (HUMIRA®, RITUXAN®, Lantus®, Avastin®, Herceptin® and REMICADE®) and a robust pipeline of product / therapy candidates, the market is poised for significant growth in the coming years. It is worth mentioning that much of the anticipated success of the biopharmaceutical market is dependent on new biologics, which are currently under development, and biosimilars, which are generic versions of these biologics. The field continues to witness significant growth in terms of innovation; this activity is clearly indicative of the growing demand for biologics to cater to existing unmet needs in the industry.
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It is necessary to highlight the fact that the development and manufacturing processes for biologics are complex, and usually require advanced capabilities and specialized expertise. In addition, the costs associated with acquiring capabilities in this field are exorbitant and, therefore, it is difficult for companies with limited finances and capacity constraints to succeed by themselves. These complications have led many stakeholders in the biopharmaceutical industry to outsource significant parts of their business operations to contract service providers.
As a result of the above mentioned industry dynamics, the contract manufacturing industry landscape is steadily evolving. CMOs aiming to consolidate their presence in the market are rapidly expanding their service portfolios to provide end-to-end services to their clients and sponsors.
SCOPE OF THE REPORT
The ‘Biopharmaceutical Contract Manufacturing Market (2nd edition), 2017 – 2027’ report provides an extensive study of the contract manufacturing market for biopharmaceuticals. As the biotechnology industry continues to strive to maximize profits, outsourcing has emerged as a promising trend. The study features in-depth analysis, highlighting capabilities of a diverse set of biopharmaceutical CMOs. In addition to other elements, it provides information on the following:
– The competitive market landscape and industry analysis based on a number of parameters, such as geographical location, scale of operation, type of biologics manufactured, expression systems used, type of bioreactors used, mode of operation of bioreactors 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, information on its manufacturing service and facilities, partnerships and recent developments.
– A detailed discussion on the key enablers, including certain niche sub-segments, such as ADCs, bispecific antibodies, cell therapies, gene therapies and viral vectors, which are likely to have a significant impact on the growth of the contract services market.
– A case study on the growing global biosimilars market, highlighting the opportunities for biopharmaceutical contract service providers.
– A detailed capacity analysis, based on global, market wide research on the individual development and manufacturing capacities of various stakeholders in the market. The analysis takes into consideration the average capacities of small, mid-sized, large and very large CMOs, and is based on robust data collection done via both secondary and primary research.
– Information on other aspects of biopharmaceutical outsourcing, which include the growing number of collaborations, partnerships and investments in facility expansions.
– Affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry’s evolution.
One of the key focus areas of the study was to estimate size of the future opportunity for biopharmaceutical CMOs over the coming decade. In order to provide a detailed future outlook, our projections have been segmented on the basis of commonly outsourced business operations (Active Pharmaceutical Ingredients (APIs) and Finished Dosage Formulations (FDFs)), types of expression systems and key geographical regions. The base year for the report is 2017, and it provides a detailed market forecast for the period between 2017 and 2027.
The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered both from secondary and primary sources. For the purpose of the study, we invited more than 200 senior stakeholders in the industry to participate in a survey. This enabled us to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. In addition, the opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Birgit Schwab (Senior Manager Strategic Marketing, Rentschler Biotechnologie), Claire Otjes (Assistant Marketing Manager, Batavia Biosciences), David C Cunningham (Director Corporate Development, Goodwin Biotechnology), Dietmar Katinger (CEO, Polymun Scientific), Kevin Daley (Director Pharmaceuticals, Novasep Synthesis), Mark Wright (Site Head, Grangemouth, Piramal Healthcare), Raquel Fortunato (CEO, GenIbet Biopharmaceuticals), Sebastian Schuck (Head of Business Development, Wacker Biotech), Stephen Taylor (Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies) and Tim Oldham (CEO, Cell Therapies).
It is worth highlighting that the biopharmaceutical market is characterized by a huge unmet need for adequate manufacturing facilities and expertise. Given the inherent complexities associated with the development of biologics, the aforementioned need is likely to translate into promising business opportunities for CMOs.
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 biopharmaceutical contract manufacturing market and where it is headed in the mid-long term.
Chapter 3 is 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 biologics and biotherapeutic products. It features a brief overview of contract manufacturing and also includes detailed discussion on the need for outsourcing in this field. We have also presented a list of commonly outsourced biomanufacturing activities; the chapter concludes with a discussion on the challenges that are currently associated with the market.
Chapter 4 provides a comprehensive view on the global landscape of biopharmaceutical CMOs. It features an in-depth market review, including regional distribution, analysis by scale of operation, type of biologics manufactured and expression systems. Moreover, the chapter provides information on the production capabilities of CMOs, based on type of bioreactor, mode of operation of bioreactors and fermentation capacity.
Chapter 5 features detailed profiles of some of the key players that are active in the biopharmaceutical contract manufacturing market in the US. Each profile presents a brief overview of the company, its contract service offerings, financial information, manufacturing capabilities and facilities, partnerships, recent developments, and awards and accolades received. The chapter also provides insights on the overall evolution of the biopharmaceutical contract manufacturing market in the US, specifically distributed on the basis of type of service and expression system used, for the period between 2017 and 2027.
Chapter 6 features detailed profiles of some of the key players that are active in the biopharmaceutical contract manufacturing market in the Europe. Each profile presents a brief overview of the company, its contract service offerings, financial information, manufacturing capabilities and facilities, partnerships, recent developments, and awards and accolades received. The chapter also provides insights on the overall evolution of the biopharmaceutical contract manufacturing market in Europe, specifically distributed on the basis of type of service and expression system used, for the period between 2017 and 2027.
Chapter 7 features detailed profiles of some of the key players that are active in the biopharmaceutical contract manufacturing market in Asia and other regions of the world. Each profile presents a brief overview of the company, its contract service offerings, financial information, manufacturing capabilities and facilities, partnerships, recent developments, and awards and accolades received. The chapter also provides insights on the overall evolution of the biopharmaceutical contract manufacturing market in the aforementioned regions, specifically distributed on the basis of type of service and expression system used, for the period between 2017 and 2027.
Chapter 8 focuses on some of the niche segments within the biopharmaceutical industry that are expected to drive the demand for outsourcing in this field. These include ADCs, bispecific antibodies, cell therapies and gene therapies. The chapter provides detailed market overviews, including information on the pipeline, partnerships, investments and the presence of CMOs in each of the aforementioned segments.
Chapter 9 is a case study focused on outsourcing of operations related to biosimilars, which represents a major growth opportunity for biopharmaceutical CMOs. It provides an overview of biosimilars and captures information on the various CMOs that are actively involved in this niche market.
Chapter 10 presents an analysis of the recent developments in the biopharmaceutical contract manufacturing market. It provides a detailed list of the various partnerships that have been established in the recent past, along with an overview of other market trends, such as investments and facility expansions.
Chapter 11 features a comprehensive analysis of the global / regional capacity of contract manufacturers that are engaged in the manufacturing of biopharmaceutical products. The results of this analysis were used to gain a more accurate understanding of outsourcing capabilities across different geographies. The analysis represents a holistic view on the supply-side of the market, allowing us to present a highly informed opinion on whether the present capacity will be able to meet the likely future demand.
Chapter 12 presents insights from the survey conducted for this study. We invited over 200 stakeholders involved in the development of different types of gene therapy vectors. The participants, who were primarily Director / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.
Chapter 13 presents a detailed market forecast for the biopharmaceutical contract manufacturing market segmented by type of business (APIs and FDFs). It features an analysis of the future of biopharmaceutical related outsourcing activities for certain 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 the market’s evolution, namely the conservative, base and optimistic scenarios.
Chapter 14 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of the contract manufacturing market within the biopharmaceutical industry, under a comprehensive SWOT framework.
Chapter 15 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the biopharmaceutical CMOs market, based on the research and analysis described in the previous chapters. It also provides a recap of some of the upcoming future trends, which, we believe, are likely to influence the growth of biopharmaceutical CMOs.
Chapter 16 contains the transcripts of interviews conducted with representatives from renowned organizations that are engaged in the biopharmaceutical contract manufacturing domain. In this study, we spoke to Birgit Schwab (Senior Manager Strategic Marketing, Rentschler Biotechnologie), Claire Otjes (Assistant Marketing Manager, Batavia Biosciences), David C Cunningham (Director Corporate Development, Goodwin Biotechnology), Dietmar Katinger (CEO, Polymun Scientific), Kevin Daley (Director Pharmaceuticals, Novasep Synthesis), Mark Wright (Site Head, Grangemouth, Piramal Healthcare), Raquel Fortunato (CEO, GenIbet Biopharmaceuticals), Sebastian Schuck (Head of Business Development, Wacker Biotech), Stephen Taylor (Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies) and Tim Oldham (CEO, Cell Therapies).
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.
1. During our research, we came across more than 200 companies offering contract manufacturing services for biopharmaceuticals. These companies possess the capabilities to handle multiple types of biologics; majority of firms offer services related to proteins and peptides (138), antibodies (116), and vaccines (79). Mammalian based manufacturing, the predominant approach, is expected to continue to achieve a relatively higher growth rate in the near future.
2. Developed regions, such as Europe and North America, currently dominate the biopharmaceutical contract manufacturing landscape. In fact, we identified close to 100 biopharmaceutical manufacturing facilities each, belonging to various players, in both Europe and North America. In addition to the developed regions, we observed that a number of prominent global and indigenous players have facilities (60) based in emerging regions of Asia and rest of the world; examples include (in alphabetical order) BioCell, CinnaGen, Cell Therapies, Concord Biotech, EirGenix, GE Healthcare, Kemwell Biopharma, LuinaBio, Meridian Life Science, Piramal Pharma Solutions, and WuXi AppTec (WuXi Biologics).
3. During our research, we identified that 69% of all CMOs offer commercial scale manufacturing services; it is also worth highlighting that 27% of all CMOs offer end-to-end services across all scales of operation; examples of such players include 3P Biopharmaceuticals, Batavia Biosciences, CARBOGEN AMCIS, Cobra Biologics and IDT Biologika.
4. The current global contract biopharmaceutical manufacturing capacity is estimated to be over 3.4 million liters. Established players, such as AbbVie Contract Manufacturing, Celltrion, FUJIFILM Diosynth Biotechnologies, Lonza, Samsung BioLogics and ST Pharm contribute a significant proportion to the overall supply. Having said that, of the over 200 CMOs we evaluated, more than 150 are relatively small or mid-sized companies; such companies are one of the key driving forces behind the heightened pace of biopharmaceutical research and development.
5. Niche and emerging therapeutic classes hold significant promise for biopharmaceutical CMOs. The rapidly growing development pipeline of antibody drug conjugates and bispecific antibodies (100+ molecules each) are likely to translate into tangible growth opportunities. In addition to antibody based therapeutics, cell and gene therapy manufacturing are other opportunities that are likely to unfold in the near future. CMOs such as 3P Biopharmaceuticals, apceth Biopharma, Batavia Biosciences, Brammer Bio, Cell and Gene Therapy Catapult, Cobra Biologics, KBI Biopharma, Meridian Life Science, Waisman Biomanufacturing and WuXi AppTec are actively offering services related to these complex biologics.
6. As numerous biopharmaceuticals near patent expiry, a wave of follow-on biologics and biosimilars are anticipated to soon enter the market. As of January 2017, there were over 800 biosimilars under development. Upcoming patent expiries of blockbuster therapies, such as infliximab, trastuzumab and adalimumab, are likely to translate into huge growth opportunities for the biosimilars market, which is likely to result in a surge in the demand for contract services providers.
7. Over 450 deals have been inked in the biopharmaceutical contract manufacturing market in the past decade. Although a significant proportion of these agreements focus on manufacturing (37%), we came across a number of acquisitions / mergers (13%) and specific collaborations (8%) where partner companies have opted to work together in order to significantly expand their respective service portfolios. Several companies have entered into multiple collaborations; these include Lonza (34), CMC Biologics (21), Emergent BioSolutions (20), Charles River Laboratories (19) and Goodwin Biotechnology (18). In addition, multiple players have made significant investments in expanding their existing operations, acquiring new facilities and / or capabilities. We came across more than 150 such instances over the past decade.
8. Driven by increasing global demand and the rapidly expanding biopharmaceutical market, we expect the overall contract manufacturing market in the biopharmaceuticals domain to grow at an annualized rate of 8.7% between 2017 and 2027. The growth is likely to be higher in emerging markets of Asia and rest of the world.
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