Biopharmaceutical Contract Manufacturing Market, 2017 - 2027
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.
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.
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.
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:
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.
LIST OF COMPANIES AND ORGANIZATIONS
The following companies and organizations have been mentioned in the report:
1. 3P Biopharmaceuticals
2. Aalto Scientific
3. AbbVie Contract Manufacturing
7. ACES Pharma
8. Acticor Biotech
9. Active Biotech
10. Adar Biotech
11. ADC Therapeutics
13. Advanced BioScience Laboratories (ABL)
14. Advanced Biotherapeutics Consulting (ABC)
16. Affinity Life Sciences
18. Ajinomoto Althea
19. Albany Molecular Research (AMRI)
20. Alberta Cell Therapy Manufacturing
23. Allele Biotechnology
24. Alliance Medical Products
25. Alligator Bioscience
27. ALMAC Group
28. Altaris Capital Partners
33. AMEGA Biotech
35. Amneal Life Sciences
38. apceth Biopharma
39. Applied Biological Materials
40. Applied Viromics
43. Asahi Glass
44. Aspyrian Therapeutics
45. Astellas Pharma
48. Athenex Pharma Solutions
49. Atlantic Bio GMP
50. AURA Biotechnologies
54. Avid Biologics
55. Avid Bioservices
58. Batavia Biosciences
59. Baxter BioPharma Solutions
61. BCN Peptides
62. Beckman Research Institute
63. Beijing ABT Genetic Engineering Technology
64. Bharat Serums And Vaccines
66. Bicycle Therapeutics
68. Bio Elpida
69. Bioanalytical Sciences Department, Southern Research
76. Biological and Cellular GMP Manufacturing Facility, City of Hope
77. Biological E
78. Biological Process Development Facility, University of Nebraska
83. BiondVax Pharmaceuticals
84. BioPharmaceuticals Australia
94. Blue Stream Laboratories
95. Boehringer Ingelheim
96. Boehringer Ingelheim BioXcellence
97. Brammer Bio
98. Bristol-Myers Squibb
100. BSP Pharmaceuticals
102. CARBOGEN AMCIS
104. Catalent Biologics
105. Catalent Pharma Solutions
106. Cedarburg Pharmaceuticals
108. Cell and Gene Therapy Catapult
109. Cell Culture Company
110. Cell Essentials
111. Cell Therapies
112. Cell Therapy and Regenerative Medicine, University of Utah
113. Celldex Therapeutics
115. Cellin Technologies
116. Cells for Sight, Stem Cell Therapy Research Unit, University College London
118. Cellular Dynamics International (a FUJIFILM company)
119. Cellular Therapeutics
120. Cellular Therapy Integrated Service, Case Western Reserve University
122. Center for Biocatalysis and Bioprocessing, University of Iowa
123. Center for Biomedical Engineering and Advanced Manufacturing, McMaster University
124. Center for Cell and Gene Processing, Takara Bio
125. Center for Cell and Gene Therapy, Baylor College of Medicine
126. Center for Cellular and Molecular Therapeutics, The Children's Hospital of Philadelphia (CHOP)
127. Center of iPS Cell Research and Application, Kyoto University (CiRA)
128. Centre for Commercialization of Regenerative Medicine
130. Century Pharmaceuticals
132. CEVEC Pharmaceuticals
133. Charles River Laboratories
135. Chemi Peptides
137. Children's GMP / GMP facility St. Jude Children's Research Hospital
139. Cincinnati Children's Hospital Medical Center
141. Clinical Biomanufacturing Facility, University of Oxford
142. Clinical Research Facility, South London and Maudsley
143. CMC Biologics
144. Cobra Biologics
145. Cognate BioServices
146. Coldstream Laboratories
147. Concord Biotech
149. Cook Pharmica
150. Corden Pharma
152. Creative Biogene
153. Creative Biolabs
155. CytomX Therapeutics
156. Cytovance Biologics
157. Daiichi Sankyo
158. Dalton Pharma Services
159. Dishman Group
161. Dow Pharmaceutical Solutions
164. Eli Lilly
166. EMD Serono
167. Emergent BioSolutions
169. Encap Drug Delivery
170. Endo Pharmaceuticals
171. Epigen Biotech
172. Esperance Pharmaceuticals
174. EUCODIS Bioscience
176. Eurofins Central Global Laboratory
180. Fabion Pharmaceuticals
181. Ferro Pfanstiehl
183. Formation Biologics
184. Formosa Laboratories
185. Foundation BioPharma
186. Fraunhofer Institute for Cell Therapy and Immunology IZI
187. French National Centre for Scientific Research, Université de Toulouse
188. Frontage Laboratories
190. FUJIFILM Diosynth Biotechnologies
192. Fusion Antibodies
193. Gadea Pharmaceutical Group
194. Gala Biotech
195. Gallus BioPharmaceuticals
196. Ganymed Pharmaceuticals
197. Gates Biomanufactuirng Facility
198. GE Healthcare
199. GEG Tech
200. Gene and Cell Therapy Lab, Institute of Translational Health Sciences
201. Gene Medicine Japan / Kobe Biomedical Accelerator
202. Gene Transfer Vector Core (GTVC)
203. Gene Transfer Vector Core, Schepens Eye Research Institute and Massachusetts Eye and Ear Infirmary
204. Gene Transfer, Targeting and Therapeutics Core, Salk Institute for Biological Studies
205. Gene Vector and Virus Core, Stanford Medicine
206. GeneCure Biotechnologies
210. GenIbet Biopharmaceuticals
214. Gilead Sciences
216. Glenmark Pharmaceuticals
217. Glycotope Biotechnology
218. GNH India
219. Goodwin Biotechnology
220. GOSH Cellular Therapy Laboratories, University College of London
221. GP Pharm
222. Grand River Aseptic Manufacturing
223. Great Point Partners
224. GreenPak Biotech
226. GSEx, The Robinson Research Institute, University of Adelaide
229. GTP Technology
230. Guy's and St Thomas' Facility
232. Harvest Moon Pharmaceuticals
233. Health Biotech
234. Health Sciences Authority
235. Heidelberg Pharma
237. Hetero Drugs
239. Hisun Pharmaceuticals USA
240. Ho Research Consortium
241. Hong Kong Institute of Biotechnology
242. Hope Center Viral Vectors Core, Washington University School of Medicine
246. IDT Biologika
247. Igenica Biotherapeutics
248. ImClone Systems
251. INC Research
252. Indian Immunologicals
254. Inno Biologics
255. Innovent Biologics
256. Intas Pharmaceuticals
257. Integrity Bio
258. International Joint Cancer Institute, Military Medical University
260. Istituto Biochimico Italiano Giovanni Lorenzini
261. JHL Biotech
262. John Goldmann Centre for Cellular Therapy, Imperial College London
263. Julphar Gulf Pharmaceutical Industries
264. KABS Pharmaceutical Services
265. Kairos Therapeutics
266. Kamat Pharmatech
267. KBI Biopharma
268. Kemwell Biopharma
269. Laboratory for Cell and Gene Medicine, Stanford University
270. LAMPIRE Biological Laboratories
271. Lentigen Technology (wholly owned subsidiary of Miltenyi Biotec)
272. LFB BIOMANUFACTURING
273. Lindis Biotech
278. Maine Biotechnology Services
281. MBI International
284. Medix Biochemica
285. Menarini Biotech
287. Meridian Life Science
289. Merro Pharmaceutical
290. Mersana Therapeutics
292. MGH Vector Core (Massachusetts General Hosp