Biopharmaceutical Contract Manufacturing Market by Type of Product, Scale of Operations, Expression System, Company Size, Biologics and Key Geographical Regions - Industry Trends and Global Forecast to 2030

Biopharmaceutical Contract Manufacturing Market by Type of Product, Scale of Operations, Expression System, Company Size, Biologics and Key Geographical Regions - Industry Trends and Global Forecast to 2030

  • February 2021 •
  • 783 pages •
  • Report ID: 6076408 •
  • Format: PDF
INTRODUCTION
Over the years, the rising popularity of biologics has led to a paradigm shift in healthcare. In the last decade alone, the annual number of approvals of biopharmaceuticals, by the US FDA, have steadily risen. In fact, in 2019, a total of 28 biopharmaceutical products (including monoclonal antibodies, recombinant proteins and gene therapies) were approved in the US. Further, over 8,000 biological pharmaceutical products are currently under clinical investigation, across the world. Given the evident benefits (including high efficacy, target specificity and favorable safety profiles) of biologics over small molecule drugs, the biopharma market is poised to witness continued and consistent growth over the next several years. However, biologics production is a complex and capital-intensive process fraught with a wide range of challenges. Some of key concerns of contemporary innovators include the rate of attrition of pipeline drugs / therapies, prolonged development timelines, complex molecular structure (which demand niche and specialized expertise), current facility limitations and capacity constraints, and safety and efficacy-related issues.

Given the technical and operational challenges outlined above, an increasing number of drug developers have demonstrated the preference to outsource various parts of their biologics manufacturing operations. The landscape of contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) market, specifically those that claim to have biologics-related capabilities, features a mix of large, mid-sized and small companies. As a result of several mergers and acquisitions, the market is now fairly consolidated with a number of established players operating as one-stop-shops. Moreover, since the biopharmaceutical sector is amongst the most highly regulated industries in the world, biopharma CMOs, specifically those offering regulatory assistance, are perceived as attractive strategic partners (especially to the smaller developer companies). With outsourcing being increasingly accepted as a viable and beneficial business model within the biopharmaceutical industry, we anticipate the biologics manufacturing services market to grow at a steady pace in the coming years.

SCOPE OF THE REPORT
The “Biopharmaceutical Contract Manufacturing Market (4th Edition) by Type of Product (API, FDF), Scale of Operations (Preclinical, Clinical and Commercial), Expression System (Mammalian, Microbial and Others), Company Size (Small, Mid-sized, Large and Very Large), Biologics (Antibody, Vaccine, Cell Therapy and Other Biologics) and Key Geographical Regions (North America, Europe, Asia-Pacific, MENA and LATAM)- Industry Trends and Global Forecast to 2030” report features an extensive study on the contract service providers within the biopharmaceutical industry. The study features in-depth analyses, highlighting the capabilities of a diverse set of biopharmaceutical CMOs and contract development and manufacturing organizations (CDMOs). Amongst other elements, the report includes:
A detailed review of the overall landscape of the biopharmaceutical contract manufacturing market, featuring an elaborate list of active CMOs, along with information on a number of relevant parameters, such as year of establishment, company size, location of headquarters, types of biologics manufactured (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, antibody drug conjugates, vectors, biosimilars, nucleic acids and others), scale of operation (preclinical, clinical and commercial), types of expression systems used (mammalian, microbial and others), type of bioreactor used (single-use bioreactors and stainless steel bioreactors), mode of operation of bioreactors (batch, fed-batch and perfusion), bioprocessing capacity and type of packaging.
A detailed landscape of the biopharmaceutical manufacturing facilities established across the key geographical regions (North America, Europe, Asia-Pacific and Rest of the World), and including an analysis based on the location of these facilities, highlighting key manufacturing hubs for biologics.
Elaborate profiles of key players that claim to have a diverse range of capabilities related to the development, manufacturing and packaging of biologics. Each profile provides an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, and details on partnerships, recent developments (expansions), as well as 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 the various factors that need to be taken into consideration by biopharmaceutical therapeutics / drug developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
A review of the various biopharmaceutical based manufacturing initiatives undertaken by big pharma players (shortlisted on the basis of the revenues generated by the top 10 pharmaceutical companies in 2019), highlighting trends across various parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation, types of biologics manufactured and type of product.
An analysis of the recent collaborations (signed since 2015) focused on the contract manufacturing of biologics, based on various parameters, such as the year the agreement was signed, type of agreement, focus area, types of biologics manufactured, therapeutic area and geographical regions.
A detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired during 2015-2020, along with the geographical distribution of this activity. The analysis also depicts the relationship between important deal multiples (based on revenues), number of employees and experience of the acquired company.
A detailed analysis of the recent expansions undertaken (since 2015) by various service providers for augmenting their respective biopharma contract manufacturing service portfolios, based on a number of parameters, including year of expansion, purpose of expansion (capacity expansion and new facility), types of biologics manufactured, geographical location of facility, and most active players (in terms of number of instances).
An analysis of the recent developments within the biopharmaceutical contract manufacturing industry, highlighting information on the funding and technology advancements related to biomanufacturing.
A detailed capacity analysis, taking into consideration the individual development and manufacturing capacities of various stakeholders (small, mid-sized, large and very large CMOs / CDMOs) engaged 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), company size (small, mid-sized, large and very large), and geography (North America (the US and Canada), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia-Pacific (China, India, Japan, South Korea and Australia), Latin America, Middle East and North Africa).
An informed estimate of the annual demand for biologics, taking into account the top 25 biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products.
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 pharmaceutical 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 understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as growth of the overall biopharmaceutical 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 2020-2030. 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), finished dosage formulations (FDFs)), [B] types of expression systems used (mammalian, microbial and others), [C] scale of operation (preclinical, clinical and commercial), [D] company size (small, mid-sized and large / very large), [E] types of biologics manufactured (antibody, vaccine, cell therapy and other biologics) and [F] key geographical regions (North America (the US, Canada), Europe (the UK, France, Germany, Italy and Spain), Asia (China, India and Australia), Latin America, Middle East and North Africa). To account for the uncertainties associated with the manufacturing of biopharmaceuticals 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 (arranged in alphabetical order):
Andrea Conforto (Sales & Marketing, Bioservices Director, Olon)
Astrid Brammer (Senior Manager Business Development, Richter-Helm)
Birgit Schwab (Senior Market Intelligence Manager, Rentschler Biotechnologie)
Christian Bailly (Director of CDMO, Pierre Fabre)
Claire Otjes (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 (Market Director Pharmaceuticals, Novasep)
Mark Wright (ex-Site Head, Grangemouth, Piramal Healthcare)
Max Rossetto (General Manager – Business Development, Luina Bio)
Nicolas Grandchamp (R&D Leader, GEG Tech)
Raquel Fortunato (Chief Executive Officer, GenIbet Biopharmaceuticals)
Sebastian Schuck (Director Global Business Development, WACKER BIOTECH Biotech)
Stephen Taylor (Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies)
Marco Schmeer (Project Manager, PlasmidFactory) and Tatjana Buchholz (ex-Marketing Manager, PlasmidFactory)
Tim Oldham (ex - Chief Executive Officer, Cell Therapies)

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 till 2030, 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.

KEY QUESTIONS ANSWERED
Who are the leading players engaged in offering contract manufacturing services for biologics?
What percentage of the biopharmaceutical manufacturing operations are presently outsourced?
What factors should be taken into consideration while deciding whether the manufacturing operations for biologics should be kept in-house or outsourced?
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?
Which regions are the key manufacturing hubs for biologics?
What type of partnership models are commonly adopted by stakeholders engaged in this domain?
What are the different biopharmaceutical focused initiatives undertaken by big pharma players in the recent past?
How is the current and future market opportunity likely to be distributed across key market segments?

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 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, along with a detailed discussion on the need for outsourcing within the biopharmaceutical industry. We have also presented a list of commonly outsourced biomanufacturing activities. The chapter concludes with a discussion on the challenges faced by players currently engaged in the market.

Chapter 4 provides a detailed overview of the global biopharmaceutical contract manufacturing landscape. It includes information related to over 200 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 such as year of establishment, company size, location of headquarters of the CMO, type of biologics manufactured (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, antibody drug conjugates, vectors, biosimilars, nucleic acids and others), scale of operation (preclinical, clinical and commercial), types of expression systems used (mammalian, microbial and others), type of bioreactors used (single-use bioreactors and stainless steel bioreactors), mode of operation of bioreactors (batch, fed-batch and perfusion), bioprocessing capacity and type of packaging.

Chapter 5 provides a detailed landscape of biopharmaceutical manufacturing facilities in key regions (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa). It includes analysis and map representations based on location of these facilities, highlighting key provinces as the manufacturing hubs.

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

Chapter 7 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), information related to manufacturing facilities, partnerships, recent developments (expansions) and an informed future outlook.

Chapter 8 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), information related to manufacturing facilities, partnerships, recent developments (expansions) and an informed future outlook.

Chapter 9 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 10 is a case study focused on outsourcing of operations associated with 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 11 is a case study comparing the key characteristics of small and large molecule drugs, along with information on the steps involved in their respective manufacturing processes.

Chapter 12 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 its operations.

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

Chapter 14 provides a detailed analysis of biopharmaceutical based manufacturing related initiatives of the big pharma players (shortlisted on the basis of the revenues generated by the top 10 pharmaceutical companies in 2019), featuring trends across various parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation, types of biologics manufactured and type of product.

Chapter 15 features an elaborate analysis and discussion of the various collaborations and partnerships that have been inked amongst players since 2015. 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 biologics. 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.

Chapter 16 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 2015-2020. The analysis also provides information on the key value drivers for these mergers and acquisitions and the corresponding acquisition deal multiples.

Chapter 17 presents an analysis of the recent expansions undertaken (since 2015) by various service providers for augmenting their respective biopharma contract manufacturing service portfolios, based on a number of parameters, including year of expansion, purpose of expansion (capacity expansion and new facility), types of biologics manufactured, geographical location of facility, and most active players (in terms of number of instances).

Chapter 18 provides details on the funding instances and emerging technologies related to biomanufacturing processes.

Chapter 19 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, 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, 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-Pacific (China, India, Japan, South Korea and Australia), Latin America, Middle East and North Africa).

Chapter 20 features a comprehensive analysis of the annual demand of biotherapeutics (in grams), taking into account the top 25 biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products.

Chapter 21 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), finished dosage formulations (FDFs), [B] expression system used (mammalian, microbial and others), [C] scale of operation (preclinical, clinical and commercial), [D] company size (small, mid-sized and large / very large), [E] types of biologics manufactured (antibody, vaccine, cell therapy and other biologics) and [F] key geographical regions (North America (US, Canada), Europe (UK, France, Germany, Italy and Spain), Asia (China India and Australia), Latin America, Middle East and North Africa.

Chapter 22 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 23 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 24 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 25 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 (in alphabetical order) Andrea Conforto (Sales and Marketing, Bioservices Dierector, Olon), Astrid Brammer (Senior Manager Business Development, Richter-Helm), Birgit Schwab (Senior Market Intelligence Manager, Rentschler Biotechnologie), Christian Bailly (Director of CDMO, Pierre Fabre), Claire Otjes (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 (Market Director Pharmaceuticals, Novasep), Mark Wright (ex-Site Head, Grangemouth, Piramal Healthcare), Max Rossetto (General Manager – Business Development, Luina Bio), Nicolas Grandchamp (R&D Leader, GEG Tech), Raquel Fortunato (Chief Executive Officer, GenIbet Biopharmaceuticals), Sebastian Schuck (Director Global Business Development, Wacker Biotech Biotech), Stephen Taylor (Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies), Marco Schmeer (Project Manager, PlasmidFactory) and Tatjana Buchholz (ex-Marketing Manager, PlasmidFactory) and Tim Oldham (ex-Chief Executive Officer, Cell Therapies).

Chapter 26 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 27 is an appendix that provides the list of companies and organizations mentioned in the report.