Market Research Report
Biopharmaceutical Contract Manufacturing Market (3rd Edition), 2019 - 2030
|Published by||ROOTS ANALYSIS||Product code||329397|
|Published||Content info||850 Pages
Delivery time: 1-2 business days
|Biopharmaceutical Contract Manufacturing Market (3rd Edition), 2019 - 2030|
|Published: April 1, 2019||Content info: 850 Pages||
We expect the developers to continue to outsource their manufacturing operations in the short mid term, resulting in an annualized growth rate of more than 8%.
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 currently under development and biosimilars. The impending growth also indicates the rising importance of manufacturing capacity within the industry. The costs associated with acquiring manufacturing capabilities are exorbitant and, therefore, it is difficult for companies with limited finances and capacity constraints to succeed by themselves. These constraints have led many of the smaller players in the industry and, at times, certain pharma giants as well, to outsource a significant part of their business operations to contract service providers. Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are known to offer significant cost-benefits, access to larger production capacities and reductions in time-to-market.
“The development pipelines of big biopharma companies are extensive and it is difficult for such players to carry out manufacturing operations using in house capacities. As a result, such companies often opt to outsource certain aspects of their production processes, predominantly drug substance manufacturing and aseptic filling. Therefore, there is a high demand for contract services from the aforementioned companies.” - Senior Manager Strategic Marketing, a Germany-based Large sized CMO.
Owing to the growing number of start-ups that are engaged in R&D of novel biologics, there is significant opportunity for the CMOs in this domain. It is worth highlighting that, since 2000, more than115 new CMOs have been established in order to cater to the growing demand for novel biologics that have specific manufacturing requirements. The contemporary contract services market features a mix of large and small-sized CMOs and is characterized by multiple mergers and acquisitions as stakeholders strive to broaden their respective service portfolios. This has enabled several CMOs to offer end-to-end services, ranging from drug development, including preliminary R&D, preclinical and clinical trials, to commercial scale production and regulatory filings. Despite the fact that the biopharmaceutical sector is amongst the most highly regulated industries, we expect the demand for core competencies to continue to drive sponsor companies to outsource various parts of their product development and manufacturing operations. Amidst tough competition, the availability of advanced tools and technologies is an important differentiating factor and is likely to grant a competitive edge to certain CMOs over other stakeholders.
The “Biopharmaceutical Contract Manufacturing Market (3rd edition), 2019 - 2030” report features an extensive study on the contract service providers within the biopharmaceutical industry. The study features in-depth analysis, highlighting the capabilities of a diverse set of biopharmaceutical CMOs and CDMOs. Amongst other elements, the report includes:
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:
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.
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 biopharmaceutical contract manufacturing market in the mid to 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 and includes a detailed discussion on the need for outsourcing within the biopharmaceutical industry. In this chapter, we have presented a list of commonly outsourced biomanufacturing activities; the chapter concludes with a discussion on the challenges that are currently associated within the market.
Chapter 4 provides a comprehensive overview of the global biopharmaceutical contract manufacturing landscape. It includes information related to over 240 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 scale of operation, type of biologics manufactured and type of expression systems being utilized. Further, it contains details on the year of establishment, employee size, geographical location of the CMO, number of manufacturing facilities, as well as location of these facilities, GMP compliance, affiliations to regulatory agencies. Moreover, the chapter provides information on the production capabilities of CMOs, based on type of bioreactor, mode of operation of bioreactors and bioreactor 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 (if available), manufacturing capabilities and facilities, partnerships, recent developments, and awards and accolades received.
Chapter 6 features detailed profiles of some of the key players that are active in the biopharmaceutical contract manufacturing market in Europe. Each profile presents a brief overview of the company, its contract service offerings, financial information (if available), manufacturing capabilities and facilities, partnerships, recent developments, and awards and accolades received.
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 (if available), manufacturing capabilities and facilities, partnerships, recent developments, and awards and accolades received.
Chapter 8 focuses on the key enablers in this domain, including certain niche product classes, 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. The chapter provides detailed a market overview, including information on the pipeline, 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 segment of the biopharmaceutical market.
Chapter 10 is a case study comparing the key characteristics of large and small molecule drugs, along with information on the steps involved in their respective manufacturing processes.
Chapter 11 is a case study focused on challenges associated with in-house manufacturing. It also provides details on the outsourcing trends in this domain, along with information related to various partnership models that are being used by various stakeholders to partner with CMOs. In addition, it features a list of recently approved biologics, with information on the type of biologic, target indication(s), developer and manufacturing approach adopted by the developer. Further, the chapter features 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.
Chapter 12 features an elaborate analysis and discussion of the various collaborations and partnerships that have been inked amongst players since 2013. It includes a brief description on the various types of partnership models (which include product-based agreements, process-based agreements, licensing agreements, co-service agreements / ventures, R&D agreements and other outsourcing service agreements) that have been adopted by stakeholders in this domain. It also consists of a schematic representation showcasing the players that have established the maximum number of alliances related to the manufacturing of cell-based therapies. Furthermore, we have provided a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents. In addition, the chapter includes a detailed analysis of the mergers and acquisitions that have taken place in this space, highlighting the trend in the number of companies acquired from 2012-2018. The analysis also provides information on the key value drivers for these mergers and acquisitions and the corresponding acquisition deal multiples.
Chapter 13 presents an analysis of the recent developments in the biopharmaceutical contract manufacturing market. It provides an overview of other market trends, such as investments and facility expansions. In addition, it provides details on the emerging technologies related to biomanufacturing processes.
Chapter 14 features a comprehensive analysis of the global / regional capacity of contract manufacturers that are engaged in the manufacturing of biopharmaceutical products. The analysis takes into consideration the individual development and manufacturing capacities of various stakeholders (small-sized, mid-sized, large and very large CMOs / CDMOs) in the market, using data from both secondary and primary research. The study examines the distribution of global biopharmaceutical manufacturing capacity by scale of operation (preclinical / clinical, commercial), size of the company (small-sized, mid-sized, large and very large), region of operation (North America (the US and Canada), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia and Middle East (China, India, Japan, South Korea and rest of the Asia and Middle East), and rest of the world(including Australia).
Chapter 15 features a comprehensive analysis of the annual demand of biotherapeutics (in grams), taking into account the top 20 biologics, based on a various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products.
Chapter 16 presents a comprehensive market forecast analysis, highlighting the likely growth of the biologics manufacturing market till the year 2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] commonly outsourced business operations (active pharmaceutical ingredients (APIs) and finished dosage formulations (FDFs)), [B] types of expression systems (mammalian, microbial and others), [C] size of the company (small-sized, mid-sized and large / very large), [D] scale of operation (preclinical, clinical and commercial) and [E] key geographical regions (North America (US, Canada), Europe (UK, France, Germany, Italy and Spain), Asia (China and India) and rest of the world (Australia)).
Chapter 17 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 18 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 19 presents insights from the survey conducted for this study. 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 20 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 Astrid Brammer (Senior Manager Business Development, Richter-Helm), Birgit Schwab (Senior Manager Strategic Marketing, Rentschler Biotechnologie), Christian Bailly (Director of CDMO, Pierre Fabre), Claire Otjes (Assistant Marketing Manager, Batavia Biosciences), David C Cunningham (Director Corporate Development, Goodwin Biotechnology), Dietmar Katinger (Chief Executive Officer, Polymun Scientific), Denis Angioletti (Chief Commercial Officer, Cerbios-Pharma), Jeffrey Hung (Chief Commercial Officer, Vigene Biosciences), Kevin Daley (Director Pharmaceuticals, Novasep), Mark Wright (Site Head, Grangemouth, Piramal Healthcare), Nicolas Grandchamp (R&D Leader, GEG Tech), Raquel Fortunato (Chief Executive Officer, GenIbet Biopharmaceuticals), Sebastian Schuck (Head of Business Development, Wacker Biotech), Stephen Taylor (Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies), Tatjana Buchholz (Marketing Manager, PlasmidFactory) and Marco Schmeer (Project Manager, PlasmidFactory) and Tim Oldham (Chief Executive Officer, Cell Therapies).
Chapter 21 is an appendix that contains the list of non-industry players that offer contract services for biologics.
Chapter 22 is an appendix that contains tabulated data and numbers for all the figures provided in the report.
Chapter 23 is an appendix that provides the list of companies and organizations mentioned in the report.