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Cell Therapy Manufacturing Market, 2017-2027

Cell Therapy Manufacturing Market, 2017-2027

INTRODUCTION
The use of live cells for therapeutic purposes can be traced back to 1968, when patients were first successfully treated with allogeneic human hematopoietic stem cell transplants. This practice has now become an integral part of clinical procedures in the space of bone marrow regeneration and organ transplantation. Cell-based therapies are an emerging segment of the overall biopharmaceutical industry. Post the approval of first cell-based therapy, Carticel®, in 1997 in the US, the field has rapidly advanced and a number of such therapies are currently under development. Given the personalized nature of these treatment options, they are highly specific and hold the potential to address unmet medical needs associated with the treatment of several disorders. The promising therapeutic potential has led many pharmaceutical companies and investors to put in a significant amount of capital towards the development and commercialization of these therapies.

Popular examples of approved cell-based therapies include (in order of their year of approval) Carticel®, CreaVax-RCC®, JACE, ReliNethra, PROVENGE® and Prochymal®. In addition, over 500 cell-based therapy candidates are currently in different stages of clinical development; these are being evaluated in over 1,000 active clinical studies in various regions across the globe. The growing number of cell therapy candidates, coupled with their rapid progression through the various phases of clinical development, continues to create an increasing demand for facilities that offer manufacturing services for these therapies. The market already has a wide array of well-established players, mid-sized companies and start-ups. Several industry players as well as academic institutes are significantly contributing to the production of GMP grade cell types. In addition, the market has witnessed the entry of several players that offer novel technology solutions, aimed at improving and upgrading existing cell-based therapies and their manufacturing processes. We have observed that such players have signed multiple partnerships / collaborations with an aim to optimize, scale-up and expand the capabilities for production of cell-based therapies.

Looking at the evolutionary trends, we believe that the cell therapy manufacturing market will continue to be steadily driven in the mid to long term by expansion of existing manufacturing facilities and establishment of new dedicated facilities. Technological advancements to mitigate challenges posed by conventional methods of production will act as a key enabler to this growth.

SCOPE OF THE REPORT
The “Cell Therapy Manufacturing Market, 2017-2027” report provides an extensive study of the rapidly growing market of cell therapy manufacturing and focuses both on contract manufacturers and cell therapy developers with in-house manufacturing facilities. These therapies are anticipated to emerge as viable alternatives to conventional treatment options. The scope of this report primarily includes manufacturing of advanced therapy medicinal products (ATMPs) that involve the use of immune cells such as T-cells, Tregs, dendritic cells, tumor cells and NK cells, and stem cells such as adult stem cells, human embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs).

Several players, including cell therapy developers, research institutes, contract manufacturing organizations, and government and non-profit organizations, are playing a critical role in the development and manufacturing of these cell therapies. In fact, a number of these players have made heavy investments to expand their existing capabilities and establish new facilities for cell therapy products in order to meet the increasing demand. Additionally, stakeholders have received significant support from governments worldwide, in terms of funding and establishment of consortiums to accelerate the transition of these therapies from laboratories to clinics. It is important to highlight that companies that offer logistics and operational services have developed systems / tools for safer and quicker delivery of therapies from manufacturing sites to patients; this has been identified as one of the key challenges in the overall development process.

During the course of our study, we identified over 110 organizations that are actively involved in the manufacturing of cell therapies. In addition to other elements, the study provides information on:
 The current status of the market with respect to key players along with information on the location of their manufacturing facilities, scale of production, type of cells manufactured, purpose of production (fulfilling in-house requirements / as a contract service provider) and the type of organization (industry / non-industry).
 Most active regions in terms of cell therapy manufacturing with schematic representations of world maps that clearly highlight the global cell therapy manufacturing hubs.
 Roadmaps published by different agencies across the globe to provide strategies to advance cell therapy manufacturing.
 Elaborate profiles of key players that offer contract manufacturing services (industry and non-industry) or manufacture cell therapies in-house; each profile covers an overview of the company, information on its manufacturing facilities, and recent collaborations.
 Partnerships that have taken place in the recent past covering manufacturing and services agreements, agreements specific to technology / instruments / process developments, and mergers and acquisitions.
 A discussion on the key enablers of the market and challenges associated with the cell therapy manufacturing process.
 Potential future growth of the cell therapy manufacturing market segmented by the type of cell therapy, source of cells (autologous and allogeneic) and purpose of manufacturing (in-house and contract services). For the purposes of our analysis, we took into consideration several parameters that are likely to impact the growth of this market over the next decade; these include the likely increase in number of clinical studies, patient population, anticipated adoption of commercial cell-therapies and expected variation in manufacturing costs.

We have provided an estimate of the size of the market in the short to mid-term and long term for the period 2017 to 2027. The base year for the report is 2016. To account for the uncertainties associated with the development of novel therapeutics 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 research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 100 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. Our 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 Tim Oldham (CEO, Cell Therapies), Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) and Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, YposKesi), Dr. Gerard MJ Bos (CEO, CiMaas).

EXAMPLE HIGHLIGHTS
1. Overall, we identified over 60 industry players and 50 academic institutes / non-profit organizations that are actively contributing in the field of cell-therapy manufacturing. We came across 68 players that are involved in manufacturing of immunotherapies and 66 players that possess capabilities for manufacturing adult stem cell therapies. Further, 28 organizations have facilities for both immunotherapies and adult stem cell therapies. Within the stem cell therapy market, we identified 15 and 17 organizations that are involved in the manufacturing of ESCs and iPSCs, respectively.
2. As majority of cell therapy products are in early phase of development, several manufacturers have facilities that meet the clinical scale production requirements. However, some players (31, as per our research) have developed / are developing commercial scale capacity for cell therapy production. Examples include (in alphabetical order) apceth Biopharma, Brammer Bio, Cell and Gene Therapy Catapult, CELLforCURE, Cognate BioServices, EUFETS, Guy's and St Thomas' Facility, Lonza, MaSTherCell, PharmaCell and WuXi AppTec.
3. Although the current market landscape is dominated by contract manufacturers, some well-established cell therapy developers have set up in-house manufacturing capabilities to support their requirements of cGMP grade cells. Examples include (in alphabetical order) Adaptimmune, Argos Therapeutics, Cell Medica, Cellular Biomedicine Group, Juno Therapeutics, Kite Pharma and SOTIO. In addition, we identified over 10 organizations that manufacture cell-based therapies for their own clinical research as well as offer contract services to other organizations Examples include (in alphabetical order) Amsterdam BioTherapeutics Unit (AmBTU), apceth Biopharma, Children's GMP / GMP facility (St. Jude Children's Research Hospital), Cook Myosite, John Goldmann Centre for Cellular Therapy (Imperial College London), MolMed, and PCT (a Caladrius Company).
4. North America has the maximum number of cell therapy manufacturing facilities (~ 43%), followed by the EU where ~40% of the global cell therapy manufacturing facilities are located. Specifically, in the EU, maximum number of manufacturing facilities are located in the UK (~44%). Other emerging pockets for cell therapy manufacturing include Australia, China, Japan, Singapore, South Korea and Israel; facilities in these regions primarily cater to the Asia-Pacific markets.
5. Over 140 collaborations have been inked between cell therapy developers, cell therapy manufacturers and other stakeholders of the industry. The motive behind the partnerships varies; they have been signed for obtaining manufacturing services, gaining access to services related to data management, reagent supply and logistics, upgrading technologies for manufacturing processes, and acquisition of manufacturing facilities.
6. The near-term demand for manufacturing of cell-based therapies will primarily be driven by clinical candidates. In the longer term, the currently approved therapies and late-stage therapies (that are likely to get commercialized in future) will act as key drivers of the market. Our outlook is highly promising; we expect the market for cell therapy manufacturing to grow at an annualized growth rate of ~42% over the course of next ten years and be worth over USD 4 billion in 2027.

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 may evolve across different regions and technology segments. Wherever 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 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.





CHAPTER OUTLINES
Chapter 2 is an executive summary of the insights captured in our report. The summary offers a high level view on the current state of the cell therapy manufacturing market and its likely evolution over the coming decade.

Chapter 3 provides a general introduction to the cell-based therapies and ATMPs, their classification and definitions. It includes a detailed discussion on manufacturing of cell-based therapies, associated challenges, and application of the currently available for cell therapies. The chapter also provides a detailed description on the regulatory landscape for cell therapies.

Chapter 4 identifies the contract service providers / in-house manufacturers that are actively involved in the manufacturing of ATMPs. It provides details on the ATMP manufacturing capabilities of these organizations, specifically focusing on the type of organization, geographic location of their facilities, scale of operation, type of cells manufactured and the purpose of manufacturing (in-house requirement / third party manufacturing). It contains world maps highlighting the geographical locations of cell therapy manufacturing facilities. Further, it discusses the development trends within the overall cell therapy manufacturing landscape.

Chapter 5 provides details on the roadmaps published by different organizations in various geographies, specifically in the US. These roadmaps describe the strategies that are helpful in accelerating the translation from laboratory to clinics.

Chapter 6 contains detailed profiles of in-house manufacturers. Each profile provides a brief overview of the company, its financial performance, details on manufacturing capabilities and facilities, and the relevant collaborations that have been inked over the last few years.

Chapter 7 contains detailed profiles of key industrial contract manufacturers that have clinical and / or commercial scale manufacturing capacities. Each profile provides a brief overview of the company, details on manufacturing capabilities and facilities, and the relevant collaborations that have been inked over the last few years.

Chapter 8 contains detailed profiles of key academic players that offer contract manufacturing services for cell therapies. Each profile provides a brief overview of the organization, and details on manufacturing capabilities and facilities.

Chapter 9 discusses the role of non-profit organizations in advancing cellular therapies. It provides a list of prominent organizations and profiles of key organizations in different regions. Additionally, the chapter provides information of international / national societies that help in disseminating knowledge about the advancement of these therapies in the community.

Chapter 10 features a comprehensive analysis of the collaborations and partnerships that have been forged between the players in this market. It includes a brief description on the various types of partnership models that are employed by stakeholders in this domain. We have categorized the deals / agreements, which have been captured during our research, into different models and have provided analysis on trend of partnerships over time.

Chapter 11 presents a ten year forecast to highlight the likely growth of the cell therapy manufacturing market. We have segregated the financial opportunity by type of cell therapy (T-cell immunotherapy, cell-based cancer vaccines, stem cell therapies and other ATMPs) and the source of cells (autologous and allogeneic). All our predictions are backed by robust analysis of data procured from both secondary and primary sources. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as the conservative, base and optimistic scenarios.

Chapter 12 provides a SWOT analysis capturing the key elements and factors that are likely to influence the market’s future.

Chapter 13 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario and evolutionary trends that are likely to determine the future of this segment of the industry.

Chapter 14 presents insights from the survey conducted for this study. We invited over 100 stakeholders involved in the development of different types of cell therapies. 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 15 is a collection of interview transcripts of the discussions held with key stakeholders in the industry.

Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures in the report.

Chapter 17 is an appendix, which contains the list of companies and organizations that have been mentioned in the report.

LIST OF COMPANIES AND ORGANIZATIONS
1. 3P Biopharmaceuticals
2. A2 Healthcare
3. Abramson Cancer Center
4. Adaptimmune
5. Adicet Bio
6. Advanced Manufacturing Technologies (AMTech)
7. Alberta Cell Therapy Manufacturing
8. Allele Biotechnology and Pharmaceuticals
9. Alliance for Regenerative Medicine
10. AlloSource
11. Altor BioScience
12. American Society of Gene and Cell Therapy
13. Americans for Cures
14. Amsterdam Biotherapeutics Unit (AmBTU)
15. Angiocrine Bioscience
16. Anterogen
17. apceth Biopharma
18. Argos Therapeutics
19. Asahi Glass
20. Asia-Pacific Economic Cooperation
21. Asterias Biotherapeutics
22. Asymptote
23. Athersys
24. Atlantic Bio GMP
25. ATMI Life Sciences
26. Australasian Gene and Cell Therapy Society
27. Austrian Network for Gene Therapy
28. AUSTRIANOVA
29. Autolus
30. Azellon Cell Therapeutics
31. Batavia Biosciences
32. Bavarian Nordic
33. Bellicum Pharmaceuticals
34. Bio Elpida
35. BioLife Solutions
36. Biological and Cellular GMP Manufacturing Facility, City of Hope
37. biologistex
38. Biomedical Research Centre (BRC)
39. Biosafe Group
40. bluebird bio
41. Bone Therapeutics
42. Brammer Bio
43. Bristol-Myers Squibb
44. British Society of Gene Therapy
45. California Institute of Regenerative Medicine
46. Cancer Research Technology
47. Cancer Research UK, Biotherapeutics Development Unit (BDU)
48. Capricor Therapeutics
49. CardioCell
50. Carina Biotech
51. Celgene Cell Therapy
52. Cell and Gene Therapy Catapult
53. Cell Medica
54. Cell Therapies
55. Cell Therapy and Regenerative Medicine, University of Utah
56. Cell Therapy Facility, University Medical Center (UMC), Utrecht
57. Cell Therapy Manufacturing Cooperative Research Center
58. Cell Therapy Suit (CTS), University of Birmingham
59. CellCAN
60. Cellectis
61. CELLforCURE
62. Cellin Technologies
63. Cells Cure Foundation
64. Cells for Sight, Stem Cell Therapy Research Unit, University College London
65. Cellular Biomedicine Group (CBMG)
66. Cellular Dynamics International (a FUJIFILM company)
67. Cellular Therapeutics
68. Cellular Therapy Integrated Services (CTIS), Case Western Reserve University
69. Celyad (formerly known as Cardio3 BioSciences)
70. Center for Biomedical Engineering and Advanced Manufacturing, McMaster University
71. Center for Cell and Gene Therapy, Baylor College of Medicine
72. Center for Commercialization of Regenerative Medicine (CCRM)
73. Center for Gene and Cell Processing (CGCP), Takara Bio
74. Center for Stem Cell Research (CSCR)
75. Centre for Cell Manufacturing Ireland (CCMI), NUI Galway
76. Centre Multidisciplinaire de Développement du Génie Tissulaire, Université Laval
77. Centre of Genomics and Policy, McGill University
78. Children's GMP / GMP Facility St. Jude Children's Research Hospital
79. China National Accreditation Service
80. CiMaas
81. Citizens Financial Accountability Oversight Committee (CFAOC)
82. Clinical Biomanufacturing Facility, University of Oxford
83. Clinical Cell and Vaccine Production Facility (CVPF), University of Pennsylvania
84. Clinical Research Facility, South London and Maudsley
85. Cognate Bioservices
86. Cook Myosite
87. Cryoport
88. Cryosite
89. CureCell
90. Cynata Therapeutics
91. Cytori Therapeutics
92. Dana-Farber / Harvard Cancer Center Cell Manipulation Core
93. DanDrit Biotech
94. Dendreon (acquired by Valeant Pharmaceuticals)
95. EMD Millipore
96. EUFETS
97. European Bank for induced pluripotent Stem Cells
98. European Society of Gene and Cell Therapy
99. Fibrocell
100. Finnish Gene Therapy Society
101. Fisher BioServices
102. Fondation de l’Hôpital Maisonneuve-Rosemont
103. Fondazione Telethon
104. Foundation for the Accreditation of Cellular Therapy
105. Foundation of Croatian Association for Regenerative Medicine and Stem Cell Therapy
106. Fraunhofer Institute for Cell Therapy and Immunology IZI
107. Fraunhofer Institute for Interfacial Engineering and Biotechnology
108. Fred Hutchinson Cancer Research Center
109. French Society of Cellular and Gene Therapy
110. Gates Biomanufactuirng Facility
111. GE Global Research
112. GE Healthcare
113. GE Ventures
114. Gene and Cell Therapy Lab, Institute of Translational Health Sciences
115. Gene Therapy and Radiation Research Foundation
116. Genenta Science
117. Georgia Institute of Technology
118. Georgia Research Alliance
119. German Gene Therapy Society
120. German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen (GRCBDS)
121. GlaxoSmithKline
122. Gradalis
123. Great Ormond Street Hospital (GOSH) Cellular Therapy Laboratories, University College London
124. Green Cross
125. Guy's and St Thomas' Facility
126. Health Industries South Australia
127. Health Sciences Authority, Singapore
128. Hielscher Ultrasonics
129. Histocell
130. Hitachi Chemicals
131. Hitachi PCT
132. Hospital of University of Pennsylvania
133. Houston Methodist Hospital
134. Houston Methodist Hospital Foundation
135. Houston Methodist Research Institute
136. Immatics Biotechnologies
137. ImmunoCellular Therapeutics
138. Immunocore
139. Immunovative Therapies
140. Innovate UK
141. Institute of Cellular Medicine
142. IntelliCell BioSciences
143. Intercytex
144. International Cellular Medicine Society
145. International Society for Cancer Gene Therapy
146. International Society for Cellular Therapy
147. International Society for Stem Cell Research
148. Invetech
149. iPS Academia Japan
150. Irish Society for Gene and Cell Therapy
151. Irish Stem Cell Foundation
152. Islet Sciences
153. Israeli Society for Gene and Cell Therapy
154. Janssen
155. Japan Society for Gene Therapy
156. Japan Tissue Engineering
157. JingYuan Bio
158. John Goldmann Centre for Cellular Therapy, Imperial College London
159. Juno Therapeutics
160. JW Biotechnology
161. JW CreaGene
162. KBI Biopharma
163. Kiadis Pharma
164. King’s College London
165. Kite Pharma
166. Korean Society of Gene and Cell Therapy
167. Kyoto University
168. Laboratory of Cell and Gene Medicine, Stanford University
169. Life Technologies
170. Lion Biotechnologies
171. Lonza
172. Loughborough University
173. Lummy HK
174. Marken
175. MassBio
176. MaSTherCell
177. Mayo Clinic
178. MED REBELS
179. MedCision
180. Medigene
181. Medinet
182. Medipost
183. Merix Bioscience
184. Mesoblast
185. Michael G Harris Cell Therapy and Cell Engineering Facility (CTCEF), Memorial Sloan Kettering Cancer Center
186. Michael Smith Laboratories, University of British Columbia
187. Milentyi Biotec
188. MNX Global Logistics
189. Molecular and Cellular Therapeutics, University of Minnesota
190. MolMed
191. MRC Centre for Regenerative Medicine, University of Edinburgh
192. Nantes University Hospital
193. National Cancer Institute (NCI)
194. National Cell Manufacturing Consortium
195. National Institute of Health Center of Regenerative Health
196. National Institute of Standards and Technologies
197. National Stem Cell Foundation
198. National Stem Cell Foundation of Australia
199. National University of Ireland (NUI), Galway
200. Netherlands Cancer Institute
201. Networks of Centres of Excellence (NCE) of Canada
202. Neuralstem
203. Newcastle Cellular Therapies Facility, Newcastle University
204. NewLink Genetics
205. NextCell
206. NHS Blood and Transplant
207. NHS Blood and Transplant Birmingham
208. Nikon
209. Nikon Cell and Gene Therapy Contract Manufacturing
210. North Carolina State University
211. Northwest Biotherapeutics
212. Novartis
213. Novo Nordisk Engineering (NNE)
214. NuVasive
215. Ocata Therapeutics
216. Octane
217. Oncobiomed
218. Ontario Institute of Regenerative Medicine
219. Orbsen Therapeutics
220. Orchard Therapeutics
221. Orthofix
222. Osiris Therapeutics
223. Ottawa Hospital Research Institute
224. Oxford BioMedica
225. Pall Corporation
226. PAREXEL
227. PCI Services (Biotec Services International)
228. PCT, a Caladrius Company
229. Peter Couche Foundation
230. Peter MacCallum Cancer Center
231. Pfizer
232. PharmaBio
233. PharmaCell
234. Pharmicell
235. Pharmstandard
236. Philip S Orsino Facility for Cell Therapy, Princess Margaret Hospital
237. Pluristem Therapeutics
238. PPF Group
239. Production Assistance for Cellular Therapies
240. Promethera Biosciences
241. Raymond G Perelman Center for Cellular and Molecular Therapeutics, The Children's Hospital of Philadelphia
242. Rayne's Cell Therapy Suite, King's College London
243. Regenerative Medicine Foundation
244. Regenerative Medicine Institute
245. Regeneus
246. Reinnervate
247. Reliance Life Sciences
248. ReNeuron
249. Research and Development Center for Cell Therapy, Foundation for Biomedical Research and Innovation
250. Riyadh Pharma
251. Robertson Clinical and Translational Cell Therapy, Duke University
252. Roche Diagnostics
253. Rockefeller University
254. RoosterBio
255. Roslin Cells
256. Roswell Park Cancer Institute
257. Royal Adelaide Hospital
258. Royal Free, CCGTT
259. Royal Prince Alfred Hospital
260. Royal Victoria Infirmary
261. Saint-Gobain
262. SAVSU Technologies
263. Science Foundation Ireland
264. Scottish Centre for Regenerative Medicine
265. Scottish National Blood Transfusion Service (SNBTS) Cellular Therapy
266. Seattle Children’s Research Institute
267. Servier
268. Sistemic
269. Smilow Translational Research Center
270. Smith & Nephew
271. SOTIO
272. South London and Maudsley Foundation Trust
273. Spanish Society of Gene and Cell Therapy
274. Stage Cell Therapeutics
275. Stem Cell Institute
276. StemCutis
277. Stemedica Cell Technologies
278. Stemedica International
279. StemedicaAsia
280. StemProtein
281. Swedish Society for Gene and Cell Therapy
282. Sydney Cell and Gene Therapy
283. Synpromics
284. TAP Biosystems
285. TargetAMD
286. TC Biopharma
287. Terumo BCT
288. Texas Children’s Hospital
289. The Canadian Gene Cure Foundation
290. The Houston Methodist Institute of Technology
291. The Netherlands Society of Gene and Cell Therapy
292. The New York Stem Cell Foundation
293. Therapeutic Cell Production Core (TCPC), Seattle Children's Hospital
294. TiGenix
295. Tmunity Therapeutics
296. TNK Therapeutics
297. Tokyo Electron
298. TrakCel
299. Turkish Society for Gene and Cell Therapy
300. TVAX Biomedical
301. TxCell
302. Tyne Hospitals NHS Foundation Trust
303. UC Davis GMP Laboratory
304. UCLA Human Gene and Cell Therapy
305. UK Stem Cell Foundation
306. University Hospital South Manchester NHS Foundation Trust (UHSM)
307. University of California
308. University of Cambridge
309. University of Leeds
310. University of Manchester
311. University of Texas
312. University of Wollongong
313. Upstate Stem Cell cGMP Facility, University of Rochester
314. Vaccinogen
315. Vecura, Karolinska University Hospital
316. Vericel
317. Vitruvian Networks
318. Vor Biopharma
319. Waisman Biomanufacturing
320. World Courier
321. WuXi AppTec
322. Xellbiogene
323. YposKesi


1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. CELL THERAPY MANUFACTURING: INTRODUCTION
3.1. Context and Background
3.2. Cell-based Therapies: Introduction
3.2.1. Cell-based Therapies: A Comparison with Biotechnology Products
3.2.2. Cell-based Therapies: Classification
3.2.3. Cell-based Therapies: Current Market Landscape
3.3. Cell Therapy Manufacturing: An Introduction
3.4. Cell-based Therapies Manufacturing: Key Challenges
3.5. Cell Therapy Manufacturing: Types of Manufacturers
3.6. Cell Therapy Manufacturing: Other Important Considerations
3.6.1. Characterization
3.6.2. Scale-up
3.6.3. Cost of Goods
3.7. Cell Therapy Manufacturing: Regulatory Landscape
3.7.1. Current Scenario
3.7.2. Existing Challenges
3.7.3. Guidelines for Different Development Phases
4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. Cell Therapy Manufacturing: Overall Market Landscape
4.2.1. Cell Therapy Manufacturing: Distribution by Location of Manufacturing Facility
4.2.2. Cell Therapy Manufacturing: Distribution by Type of Cells
4.2.3. Cell Therapy Manufacturing: Distribution by Purpose of Production
4.2.4. Cell Therapy Manufacturing: Distribution by Scale of Operation
4.2.5. Cell Therapy Manufacturing: Distribution by Source of Cells
4.3. Cell Therapy Manufacturing: Role of Logistic Service Providers
5. ROADMAPS: POTENTIAL STRATEGIES TO OVERCOME EXISTING CHALLENGES
5.1. Chapter Overview
5.2. Roadmap for the United States
5.2.1. Cell Processing
5.2.2. Cell Preservation, Distribution and Handling
5.2.3. Process Monitoring and Quality Control
5.2.4. Standardization and Regulatory Support
5.2.5. Workforce Development
5.3. Roadmaps for Other Geographies
5.3.1. Europe
5.3.2. Asia Pacific
6. CELL THERAPY MANUFACTURING: IN-HOUSE MANUFACTURERS
6.1. Chapter Overview
6.2. Argos Therapeutics
6.2.1. Company Overview
6.2.2. Financial Overview
6.2.3. Product Portfolio
6.2.4. Manufacturing Capabilities
6.2.5. Partnerships / Collaborations
6.3. Bavarian Nordic
6.3.1. Company Overview
6.3.2. Financial Overview
6.3.3. Product Portfolio
6.3.4. Manufacturing Capabilities
6.4. Cytori Therapeutics
6.4.1. Company Overview
6.4.2. Financial Overview
6.4.3. Product Portfolio
6.4.4. Manufacturing Capabilities
6.4.5. Partnerships / Collaborations
6.5. Juno Therapeutics
6.5.1. Company Overview
6.5.2. Financial Overview
6.5.3. Product Portfolio
6.5.4. Manufacturing Capabilities
6.5.5. Partnerships / Collaborations
6.6. MEDIPOST
6.6.1. Company Overview
6.6.2. Financial Overview
6.6.3. Product Portfolio
6.6.4. Manufacturing Capabilities
6.6.5. Partnerships / Collaborations
6.7. SOTIO (Acquired by PPF Group)
6.7.1. Company Overview
6.7.2. Financial Overview
6.7.3. Product Portfolio
6.7.4. Manufacturing Capabilities
6.7.5. Partnerships / Collaborations
6.8. Stemedica Cell Technologies
6.8.1. Chapter Overview
6.8.2. Product Portfolio
6.8.3. Manufacturing Capabilities
6.8.4. Partnerships / Collaborations
7. CELL THERAPY MANUFACTURING: INDUSTRY PLAYERS
7.1. Chapter Overview
7.2. Cell and Gene Therapy Catapult
7.2.1. Company Overview
7.2.2. Service Portfolio
7.2.3. Manufacturing Capabilities
7.2.4. Partnerships/ Collaborations
7.3. CELLforCURE
7.3.1. Company Overview
7.3.2. Service Portfolio
7.3.3. Manufacturing Capabilities
7.3.4. Partnerships/ Collaborations
7.4. Lonza
7.4.1. Company Overview
7.4.2. Service Portfolio
7.4.3. Manufacturing Capabilities
7.4.4. Partnerships/ Collaborations
7.5. PharmaCell
7.5.1. Company Overview
7.5.2. Service Portfolio
7.5.3. Manufacturing Capabilities
7.5.4. Partnerships/ Collaborations
7.6. PCT, a Caladrius Company
7.6.1. Company Overview
7.6.2. Service Portfolio
7.6.3. Manufacturing Capabilities
7.6.4. Partnerships/ Collaborations
7.7. Roslin Cell Therapies
7.7.1. Company Overview
7.7.2. Service Portfolio
7.7.3. Manufacturing Capabilities
7.7.4. Partnerships/ Collaborations
7.8. Waisman Biomanufacturing
7.8.1. Company Overview
7.8.2. Service Portfolio
7.8.3. Manufacturing Capabilities
7.8.4. Partnerships/ Collaborations
8. CELL THERAPY MANUFACTURING: NON-INDUSTRY PLAYERS
8.1. Chapter Overview
8.2. Center for Cell and Gene Therapy, Baylor College of Medicine, US
8.2.1. Overview
8.2.2. Operating Segments
8.2.3. Service Portfolio
8.2.4. Capabilities
8.3. Centre for Cell Manufacturing Ireland, National University of Ireland, Ireland
8.3.1. Overview
8.3.2. Service Portfolio
8.3.3. Capabilities
8.4. Clinical Cell and Vaccine Production Facility, University of Pennsylvania, US
8.4.1. Overview
8.4.2. Service Portfolio
8.4.3. Capabilities
8.5. Guy’s And St. Thomas’ GMP Facility, Guy’s Hospital, UK
8.5.1. Overview
8.5.2. Service Portfolio
8.5.3. Capabilities
8.6. Newcastle Cellular Therapies Facility, Newcastle University, UK
8.6.1. Overview
8.6.2. Service Portfolio
8.6.3. Capabilities
8.7. Rayne Cell Therapy Suite, King’s College London, UK
8.7.1. Overview
8.7.2. Capabilities
8.8. Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre of Regenerative Medicine, UK
8.8.1. Overview
8.8.2. Capabilities
8.9. Laboratory of Cell and Gene Medicine, Stanford University, US
8.9.1. Overview
8.9.2. Capabilities
9. ROLE OF NON-PROFIT ORGANIZATIONS
9.1. Chapter overview
9.2. Cell Therapy Manufacturing: List of Non-Profit Organizations
9.2.1. CellCAN
9.2.2. Cell Therapy Manufacturing Cooperative Research Center
9.2.3. National Cell Manufacturing Consortium
9.2.4. California Institute of Regenerative Medicine
9.3. Cell Therapy Manufacturing: International Societies
10. RECENT DEVELOPMENTS
10.1. Chapter Overview
10.2. Collaboration / Agreement Models
10.3. Cell Therapy Manufacturing: List of Collaborations
10.4. Cell Therapy Manufacturing: Partnership Analysis
11. MARKET SIZING AND FORECAST
11.1. Context and Background
11.2. Forecast Methodology
11.3. Cell Therapy Manufacturing Market, 2017-2027
11.3.1. Cell Therapy Manufacturing Market: Distribution by Type of Cell Therapy
11.3.2. Cell Therapy Manufacturing Market: Distribution by Source of Cells
11.3.3. Cell Therapy Manufacturing: Distribution by Purpose of Manufacturing
11.4. Cell Therapy Manufacturing Market: Regional View
12. SWOT ANALYSIS
12.1. Chapter Overview
12.2. Strengths
12.3. Weaknesses
12.4. Opportunities
12.5. Threats
13. CONCLUSION
13.1. A Growing Pipeline of Cell Therapy Products is Likely to Increase the Demand for Manufacturing of Cell-based Therapies
13.2. Stakeholders are Continuously Striving to Overcome Existing Challenges
13.3. Developed Economies have Emerged as Prominent Hubs for Cell Therapy Manufacturing
13.4. Both Industry and Academia have Jointly Led the Initiatives; The Trend is Likely to Persist in the Near Term
13.5. Partnerships / Collaborations have been Widespread and will Continue to act as Key Enablers
13.6. The Manufacturing of Cell-based Therapies is Likely to Become a Multi-billion Dollar Market in the Coming Decade
14. SURVEY ANALYSIS
14.1. Chapter Overview
14.2. Seniority Level of Respondents
14.3. Type of Cell Therapy
14.4. Scale of Operation
14.5. Source of Cells
14.6. Type of Cell Culture System
14.7. Fill / Finish Service
15. INTERVIEW TRANSCRIPTS
15.1. Chapter Overview
15.2. Tim Oldham, CEO, Cell Therapies
15.3. Brian Dattilo, Manager of Business Development, Waisman Biomanufacturing
15.4. Mathilde Girard, Department Leader, Cell Therapy Innovation and Development, YposKesi
15.5 Dr. Gerard MJ Bos, CEO, CiMaas
16. APPENDIX: TABULATED DATA
17. APPENDIX: LIST OF COMPANIES AND RESEARCH ORGANIZATIONS
LIST OF FIGURES
Figure 3.1 Classification of Advanced Therapy Medicinal Products
Figure 3.2 Cell Therapy Manufacturing: Key Steps
Figure 3.3 Cell Therapy: Challenges and Drivers
Figure 3.4 Cell Therapy Manufacturing: Types of Manufacturers
Figure 3.5 Cell-based Therapies: Potency as Critical Quality Attribute
Figure 4.1 Cell Therapy Manufacturing: Distribution by Location of Manufacturing Facility (Regions)
Figure 4.2 Cell Therapy Manufacturing: Distribution by Location of Manufacturing Facility (Countries)
Figure 4.3 Cell Therapy Manufacturing: Distribution by Type of Organization
Figure 4.4 Cell Therapy Manufacturing: Distribution by Location of Manufacturing Facility, World Map Representation
Figure 4.5 Cell Therapy Manufacturing: Distribution by Type of Cell Therapy
Figure 4.6 Cell Therapy Manufacturing: Distribution by Purpose of Production
Figure 4.7 Cell Therapy Manufacturing: Distribution by Scale of Operation
Figure 4.8 Cell Therapy Manufacturing: Distribution by Source of Cells
Figure 5.1 Cell Therapy Manufacturing: Roadmap for the US
Figure 5.2 Cell Therapy Manufacturing: Roadmap for the APEC
Figure 6.1 Argos Therapeutics: Revenues, 2012 – Q1-Q3 2016 (USD Million)
Figure 6.2 Argos Therapeutics: Funding Instances (USD Million)
Figure 6.3 Bavarian Nordic: Revenues, 2012- Q1-Q3 2016 (DKK Million)
Figure 6.4 Cytori Therapeutics: Revenues, 2012- Q1-Q3 2016 (USD Million)
Figure 6.5 Juno Therapeutics: Funding Instances (USD Million)
Figure 6.6 MEDIPOST: Revenues, 2012-2015 (KRW Billion)
Figure 6.7 MEDIPOST: Revenues, Distribution by Business Segments, 2015 (KRW Billion)
Figure 6.8 PPF Group: Revenues, 2011-2015 (EUR Billion)
Figure 7.1 Cell and Gene Therapy Catapult: Service Portfolio
Figure 7.2 CELLforCURE: Service Portfolio
Figure 7.3 Lonza: Historical Timeline
Figure 7.4 Lonza: Sub-Segments
Figure 7.5 Lonza Pharma and Biotech: Service Portfolio
Figure 7.6 Lonza: Biological Manufacturing Services
Figure 7.7 Lonza: Cellular Products
Figure 7.8 PharmaCell: Service Portfolio
Figure 7.9 PCT: Company Structure
Figure 7.10 PCT: Service Portfolio
Figure 7.11 Roslin Cell Therapies: Service Portfolio
Figure 7.12 Waisman Biomanufacturing: Service Portfolio
Figure 7.13 Waisman Biomanufacturing: Clinical Products Portfolio
Figure 7.14 Waisman Biomanufacturing: Quality Assurance and Control
Figure 7.15 Waisman Biomanufacturing: Manufacturing Suites
Figure 7.16 Waisman Biomanufacturing: Overview of Suite Services
Figure 8.1 Center for Cell and Gene Therapy: Operating Segments
Figure 8.2 Center for Cell and Gene Therapy: Service Portfolio
Figure 8.3 Center for Cell Manufacturing Ireland: Service Portfolio
Figure 8.4 Newcastle Cellular Therapies: Service Portfolio
Figure 10.1 Cell Therapy Manufacturing: Cumulative Trend of Collaborations (2011-2017)
Figure 10.2 Cell Therapy Manufacturing: Distribution by Type of Collaboration
Figure 10.3 Cell Therapy Manufacturing: Leading Players by Collaborations
Figure 11.1 Cell Therapy Manufacturing Market, 2017-2027 (USD Million)
Figure 11.2 Cell Therapy Manufacturing Market, 2017-2027: Distribution by Type of Cell Therapy (USD Million)
Figure 11.3 Cell Therapy Manufacturing Market: Distribution by Type of Cell Therapy, 2017, 2022 and 2027
Figure 11.4 Cell Therapy Manufacturing Market, 2017-2027: Distribution by Source of Cells (USD Million)
Figure 11.5 Cell Therapy Manufacturing Market, 2017-2027: Distribution by Purpose of Manufacturing
Figure 11.6 Cell Therapy Manufacturing Market, 2017-2027: Regional Distribution (USD Million)
Figure 11.7 Cell Therapy Manufacturing Market: Regional Distribution, 2017, 2022 and 2027
Figure 12.1 Number of Clinical Trials of Cell-based Therapies: Distribution by Cell Type
Figure 12.2 Number of Clinical Trials of Cell-based Therapies: Distribution by Phase of Development
Figure 13.1 Cell Therapy Manufacturing: Regional Distribution by Location of Manufacturing Facility, World Map Representation
Figure 13.2 Cell Therapy Manufacturing Market Forecast: Conservative, Base and Optimistic Scenarios, 2017-2027 (USD Million)
Figure 14.1 Survey Analysis: Distribution by Type of Organization
Figure 14.2 Survey Analysis: Distribution by Location of Manufacturing Facility
Figure 14.3 Survey Analysis: Distribution by Seniority Level of Respondents
Figure 14.4 Survey Analysis: Distribution by Type of Cell Therapy
Figure 14.5 Survey Analysis: Distribution by Scale of Manufacturing
Figure 14.6 Survey Analysis: Distribution by Source of Cells
Figure 14.7 Survey Analysis: Distribution by Cell Culture System
Figure 14.8 Survey Analysis: Distribution by Fill / Finish Service
LIST OF TABLES
Table 3.1 Cell-based Therapies: Applications
Table 3.2 Differences between Cell Therapy and Biotechnology Products
Table 3.3 Cell-based Therapies: Commercialized Products
Table 3.4 Cell Therapy Manufacturing: Assessment Strategies for Different Manufacturing Processes
Table 3.5 Cell-based Therapies: Regulatory Considerations
Table 4.1 Cell Therapy Manufacturing: List of Manufacturers
Table 4.2 Cell Therapy Manufacturers: Type of Cell Therapy
Table 4.3 Cell Therapy Manufacturers: Type of Organization and Purpose of Production
Table 4.4 Cell Therapy Manufacturers: Scale of Operation
Table 4.5 Cell Therapy Manufacturers: Source of Cells
Table 4.6 Logistic Service Providers for Cell-based Therapies
Table 5.1 Cell Processing: Challenges and Strategies
Table 5.2 Cell Preservation, Distribution and Handling: Challenges and Strategies
Table 5.3 Process Monitoring and Quality Control: Challenges and Strategies
Table 5.4 Standardization and Regulatory Support: Challenges and Strategies
Table 5.5 Workforce Development: Challenges and Strategies
Table 6.1 Argos Therapeutics: Company Overview
Table 6.2 Argos Therapeutics: Product Portfolio
Table 6.3 Bavarian Nordic: Company Overview
Table 6.4 Bavarian Nordic: Product Portfolio
Table 6.5 Cytori Therapeutics: Company Overview
Table 6.6 Cytori Therapeutics: Product Portfolio
Table 6.7 Juno Therapeutics: Company Overview
Table 6.8 Juno Therapeutics: Product Portfolio
Table 6.9 MEDIPOST: Company Overview
Table 6.10 MEDIPOST: Product Portfolio
Table 6.11 SOTIO: Company Overview
Table 6.12 SOTIO: Product Portfolio
Table 6.13 Stemedica Cell Technologies: Company Overview
Table 6.14 Stemedica Cell Technologies: Product Portfolio
Table 7.1 Cell and Gene Therapy Catapult: Company Overview
Table 7.2 Cell and Gene Therapy Catapult: Overview Manufacturing of Capabilities
Table 7.3 Cell and Gene Therapy Catapult: Partnerships
Table 7.4 CELLforCURE: Company Overview
Table 7.5 CELLforCURE: Overview Manufacturing of Capabilities
Table 7.6 CELLforCURE: Partnerships
Table 7.7 Lonza: Company Overview
Table 7.8 Lonza: Global Manufacturing Sites
Table 7.9 Lonza: Overview Manufacturing of Capabilities
Table 7.10 Lonza: Partnerships
Table 7.11 PharmaCell: Company Overview
Table 7.12 PharmaCell: Overview Manufacturing of Capabilities
Table 7.13 PharmaCell: Partnerships
Table 7.14 PCT: Company Overview
Table 7.15 PCT: Overview Manufacturing of Capabilities
Table 7.16 PCT: Partnerships
Table 7.17 Roslin Cell Therapies: Company Overview
Table 7.18 Roslin Cell Therapies: Overview Manufacturing of Capabilities
Table 7.19 Roslin Cell Therapies: Partnerships
Table 7.20 Waisman Biomanufacturing: Company Overview
Table 7.21 Waisman Biomanufacturing: Overview Manufacturing of Capabilities
Table 7.22 Waisman Biomanufacturing: Partnerships
Table 8.1 Center for Cell and Gene Therapy: Overview of Capabilities
Table 8.2 Center for Cell Manufacturing Ireland: Overview of Capabilities
Table 8.3 Clinical Cell and Vaccine Production Facility: Overview of Capabilities
Table 8.4 Guy’s and St Thomas: Overview of Capabilities
Table 8.5 Newcastle Cellular Therapies Facility: Overview of Capabilities
Table 8.6 Rayne Cell Therapy Suite: Overview of Capabilities
Table 8.7 Scottish National Blood Transfusion Services: Overview of Capabilities
Table 8.8 Laboratory of Cell and Gene Medicine: Overview of Capabilities
Table 9.1 Cell Therapy Manufacturing: List of Non-Profit Organizations
Table 9.2 CellCAN: Overview
Table 9.3 Cell Therapy Manufacturing Cooperative Research Center: Overview
Table 9.4 National Cell Manufacturing Consortium: Overview
Table 9.5 California Institute of Regenerative Medicine: Overview
Table 9.6 Cell Therapy Manufacturing: List of Gene and Cell Therapy Societies
Table 10.1 Cell Therapy Manufacturing: Collaborations,
Table 11.1 Cell Therapies: Market Evolution
Table 12.1 Cell Therapy Manufacturing: SWOT Analysis
Table 14.1 Survey Response: Overview of the Participating Companies / Organizations
Table 14.2 Survey Response: Seniority Level of Respondents
Table 14.3 Survey Response: Type of Cell Therapy
Table 14.4 Survey Response: Scale of Manufacturing
Table 14.5 Survey Response: Source of Cells
Table 14.6 Survey Response: Cell Culture System
Table 14.7 Survey Response: Fill / Finish Service
Table 16.1 Cell Therapy Manufacturing: Distribution by Location of Manufacturing Facility (Regions)
Table 16.2 Cell Therapy Manufacturing: Distribution by Location of Manufacturing Facility (Countries)
Table 16.3 Cell Therapy Manufacturing: Distribution by Type of Organization
Table 16.4 Cell Therapy Manufacturing: Distribution by Type of Cell Therapy
Table 16.5 Cell Therapy Manufacturing: Distribution by Purpose of Production
Table 16.6 Cell Therapy Manufacturing: Distribution by Scale of Operation
Table 16.7 Cell Therapy Manufacturing: Distribution by Source of Cells
Table 16.8 Argos Therapeutics: Revenues, 2012 – Q1-Q3 2016 (USD Million)
Table 16.9 Argos Therapeutics: Funding Instances (USD Million)
Table 16.10 Bavarian Nordic: Revenues, 2012- Q1-Q3 2016 (DKK Million)
Table 16.11 Cytori Therapeutics: Revenues, 2012- Q1-Q3 2016 (USD Million)
Table 16.12 Juno Therapeutics: Funding Instances (USD Million)
Table 16.13 MEDIPOST: Revenues, 2012-2015 (KRW Billion)
Table 16.14 MEDIPOST Revenues: Distribution by Business Segments, 2015 (KRW Billion)
Table 16.15 PPF Group: Revenues, 2011-2015 (EUR Billion)
Table 16.16 Cell Therapy Manufacturing: Cumulative Trend of Collaborations (2011-2017)
Table 16.17 Cell Therapy Manufacturing: Distribution by Type of Collaboration
Table 16.18 Cell Therapy Manufacturing: Leading Players by Collaborations
Table 16.19 Cell Therapy Manufacturing Market, 2017-2027 (USD Million)
Table 16.20 Cell Therapy Manufacturing Market, 2017-2027: Distribution by Type of Cell Therapy (USD Million)
Table 16.21 Cell Therapy Manufacturing Market: Distribution by Type of Cell Therapy, 2017, 2022 and 2027
Table 16.22 Cell Therapy Manufacturing Market, 2017-2027: Distribution by Source of Cell Therapy (USD Million)
Table 16.23 Cell Therapy Manufacturing Market, 2017-2027: Distribution by Purpose of Manufacturing (USD Million)
Table 16.24 Cell Therapy Manufacturing Market, 2017-2027: Regional Distribution (USD Million)
Table 16.25 Cell Therapy Manufacturing Market: Regional Distribution, 2017, 2022 and 2027
Table 16.26 Number of Clinical Trials of Cell-based Therapies Distribution by Cell Type
Table 16.27 Number of Clinical Trials of Cell-based Therapies: Distribution by Phase of Development
Table 16.28 Cell Therapy Manufacturing Market Forecast: Conservative, Base and Optimistic Scenarios, 2017-2027 (USD Million)
Table 16.29 Survey Analysis: Distribution by Type of Organization
Table 16.30 Survey Analysis: Distribution by Location of Manufacturing Facility
Table 16.31 Survey Analysis: Distribution by Seniority Level of Respondents
Table 16.32 Survey Analysis: Distribution by Type of Cell Therapy
Table 16.33 Survey Analysis: Distribution by Scale of Manufacturing-
Table 16.34 Survey Analysis: Distribution by Source of Cells
Table 16.35 Survey Analysis: Distribution by Cell Culture System
Table 16.36 Survey Analysis: Distribution by Fill / Finish Service

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