Peptide Therapeutics: Contract API Manufacturing Market (2nd Edition), 2022-2035 Distribution by [A] Scale of Operation (Preclinical / Clinical and Commercial) [B] Type of Synthesis Method Used [C] Company Size (Small, Mid-sized and Large), and [D] Key Ge

Peptide Therapeutics: Contract API Manufacturing Market (2nd Edition), 2022-2035 Distribution by [A] Scale of Operation (Preclinical / Clinical and Commercial) [B] Type of Synthesis Method Used [C] Company Size (Small, Mid-sized and Large), and [D] Key Geographical Regions (North America, Europe, Asia Pacific and Rest of the World): Industry Trends and Global Forecasts

Over the years, the popularity of biologics has led to an evident shift in the focus of pharmaceutical companies, from traditional interventions towards more complex and advanced pharmacological interventions, such as peptide therapeutics. Since the discovery of insulin, the peptide-based drugs market has evolved significantly. Presently, over 80 peptide-based drugs are available in the market for the treatment of an array of diseases, including cancer, chronic pain, diabetes, HIV infection, multiple sclerosis and osteoporosis. Further, since 2017, more than 10 peptide-based drugs have been approved by the USFDA. Of these, LupkynisTM and Zegalogue® were recently approved in 2021, while ImcivreeTM, Victoza®, LUPRON DEPOT®, Zoladex®, Sandostatin® and Somatuline® received approval in 2020. In this context, 1,000+ clinical trials have been / are being conducted to evaluate the therapeutic viability and future potential of novel peptides across various phases of development. The increasing popularity of this class of drugs can be attributed to their high specificity, affinity, less drug-drug interactions, diverse biological and chemical activity (enabling the enhancement of their half-lives), proven pharmacological value and favorable safety profiles. Considering the various advantages offered by such drugs, the demand for peptide-based therapeutics is increasing at a considerable pace.

It is worth highlighting that the peptide synthesis and purification domain is fraught with several challenges, including complexities associated with synthesis of complex, long chain macromolecules, which is known to affect the product yield and purity. In order to mitigate the aforementioned challenges, several players engaged in this domain prefer to outsource their operations to peptide contract manufacturers. Currently, more than 60 contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) claim to offer services for the development, design, manufacturing and purification of peptides. Owing to the fact that a large number of peptide therapeutic developers are outsourcing various aspects of their business processes, several CMOs / CDMOs have become one-stop-shops to cater to the diverse needs of peptide therapeutics developers. Considering the ongoing innovation in production technologies, purification techniques, evolving pipeline and increasing demand for peptide-based drug candidates, we believe that developer companies are likely to continue relying on contract manufacturing service providers and the market is inclined to witness a steady growth in the coming decade.

As pharma companies resume full-scale operation after the COVID-19 outbreak, the demand for large-scale peptide therapeutics contract API manufacturing is expected to increase significantly. It is worth highlighting that a number of peptide-based COVID-19 vaccines are being developed by pharmaceutical companies which further accelerate the high demand for peptide manufacturing service providers in order to scale-up production of these novel therapeutics post their approval, in order to meet the global demand.

SCOPE OF THE REPORT
The “Peptide Therapeutics: Contract API Manufacturing Market by Scale of Operation (Preclinical / Clinical and Commercial), Type of Synthesis Method Used (Chemical Synthesis Method and Non-Chemical Synthesis Method), Company Size (Small, Mid-sized and Large), and Key Geographical Regions (North America, Europe, Asia Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022-2035” report features an extensive study of the current market landscape and future opportunities associated with the contract manufacturing of therapeutic peptides, over the next decade. The report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. Amongst other elements, the report includes:
A detailed overview of the current market landscape of companies offering peptide contract manufacturing services, along with information on several relevant parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), geographical location of CMO, number and location of their respective facilities, type of peptide synthesis method used (chemical and non-chemical), types of peptide modification services offered, type of peptide purification technology used (HPLC / UPLC, Ion-Exchange Chromatography and Size-Exchange Chromatography) and regulatory accreditations / certifications received.
An insightful company competitiveness analysis of prominent peptide contract manufacturers, based on several relevant parameters, such as service strength (in terms of experience of the service provider), and capabilities related to contract manufacturing of peptides (such as type of product, type of service(s) offered, number of manufacturing facilities, scale of operation, type of synthesis method used, type of purification technique used, and type of peptide modification).
Elaborate profiles of key players (shortlisted on the basis of the company competitiveness analysis) engaged in this domain. Each profile features a brief overview of the company, along with information on year of establishment, number of employees, location of headquarters, key executives, details related to peptide contract manufacturing services offered, recent developments, and an informed future outlook.
An analysis on the recent developments within the peptide contract manufacturing industry, highlighting information on several partnerships and collaborations and facility expansions that have taken place in this domain, during the period 2016-2021.
An in-depth analysis of completed, ongoing, and planned clinical studies focused on peptide therapeutics, based on several relevant parameters, such as trial registration year, phase of development, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), study focus and key geographical regions.
A detailed analysis of peptide contract manufacturing service providers’ capabilities in different regions, based on several relevant parameters, such as number of CMOs, number of clinical sites, number of clinical trials, number of patients enrolled, number of peptide manufacturing facilities, type of product, number of clinical / commercial manufacturing CMOs, demand for peptide therapeutics and installed capacity.
Informed estimates of the annual commercial and clinical demand for peptide therapeutics, based on several relevant parameters, such as target patient population, dosing frequency and dose strength.
An estimate of the overall, installed capacity for manufacturing peptides, based on data reported by industry stakeholders in the public domain; the analysis takes into consideration the distribution of available peptide production capacity across companies of different sizes (small, mid-sized, large and very large firms), scale of operation (clinical and commercial), and key geographical regions (North America, Europe, Asia Pacific).
An analysis highlighting potential strategic partners segregated based on the likelihood of entering into collaboration with peptide therapeutics developers. These players have been shortlisted based on several relevant parameters, such as pipeline strength, pipeline maturity, year of establishment and company size.
A qualitative analysis highlighting the various factors that need to be taken into consideration by peptide drug developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
A region-wise, detailed analysis of the total cost of ownership for a peptide contract manufacturing service provider. It features an informed estimate of direct and indirect expenses taking into consideration 11 relevant parameters, over a span of 10 years.
A discussion on regulatory guidelines related to peptide manufacturing, highlighting the key differences across various geographies, including the US, Europe, Australia, China, India, Japan and South Korea. It also includes details related to the various challenges, related to regulatory scrutiny, faced by peptide manufacturers.
An insightful discussion on how the recent COVID-19 pandemic is likely to impact the peptide contract manufacturing market, along with information on the key initiatives undertaken by service providers to overcome the challenges faced due to the pandemic.
A discussion on industry affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the evolution of this field; it includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics.

One of the key objectives of the report was to estimate the existing market size and the future growth potential within the peptide contract manufacturing market, based on several relevant parameters, such as projected growth of overall peptide-based products market, cost of goods sold and direct manufacturing costs. We have developed an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, over the period 2022-2035. Additionally, the report features the likely distribution of the current and forecasted opportunity across [A] scale of operation (preclinical / clinical and commercial) [B] type of synthesis method used [C] company size (small, mid-sized and large), and [D] key geographical regions (North America, Europe, Asia Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s evolution.

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.

1.1. RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we have conducted interviews with experts in this domain (academia, industry, medical practice and other associations) in order to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market over the coming years, the report also provides our independent view on various emerging trends 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.

1.2. KEY QUESTIONS ANSWERED
Who are the key players engaged in offering contract manufacturing services for peptide therapeutics?
What are the different partnerships and expansion initiatives undertaken by peptide therapeutics contract manufacturers in the recent past?
Which regions represent the current key contract manufacturing hubs for peptide therapeutics?
What is the current, installed capacity for contract manufacturing of peptides therapeutics?
What is the current, global demand for peptide therapeutics? How is the demand for such candidates likely to evolve in the foreseen future?
What percentage of the peptide therapeutics manufacturing operations are presently outsourced?
What factors should be taken into consideration while deciding whether the manufacturing operations for peptide therapeutics should be kept in-house or outsourced?
How is the current and future opportunity likely to be distributed across key market segments?

1.3. CHAPTER OUTLINES
Chapter 2 is an executive summary of key insights captured in our research. It offers a high-level view on the current state of the peptide contract manufacturing market and its likely evolution in the short-mid-term and long term.

Chapter 3 provides a general introduction to peptides, including a brief overview of different peptide classes, popular methods used for peptide synthesis and modification. It also highlights the different peptide purification strategies that are available in the market. Further, it includes information on the various applications of peptides, along with a brief overview of contract manufacturing. It also provides a detailed discussion on the need for outsourcing peptide manufacturing operations and its key advantages.

Chapter 4 features a detailed discussion on the regulatory landscape related to peptide contract manufacturers across various geographies, such as the US, Europe, Australia, China, India, Japan and South Korea. It also includes details related to the various challenges, related to regulatory scrutiny, faced by peptide manufacturers.

Chapter 5 provides an overview of the current market landscape of companies offering peptide contract manufacturing services, along with information on several relevant parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), geographical location of CMO, number and location of their respective facilities, type of peptide synthesis method used (chemical and non-chemical), types of peptide modification services offered, type of peptide purification technology used (HPLC / UPLC, Ion-Exchange Chromatography and Size-Exchange Chromatography), and regulatory accreditations / certifications received.

Chapter 6 features an insightful company competitiveness analysis of prominent peptide contract manufacturers, based on several relevant parameters, such as service strength (in terms of experience of the service provider), and capabilities related to contract manufacturing of peptides (such as type of product, type of service(s) offered, number of manufacturing facilities, scale of operation, type of synthesis method used, type of purification technique used, and type of peptide modification).

Chapter 7 features profiles of key players (shortlisted on the basis of the company competitiveness analysis) engaged in this domain. Each profile features a brief overview of the company, along with information on year of establishment, number of employees, location of headquarters, key executives, details related to peptide contract manufacturing services offered, recent developments, and an informed future outlook.

Chapter 8 presents an analysis of the recent developments within the peptide contract manufacturing industry, highlighting information on several partnerships and collaborations and facility expansions that have taken place in this domain, during the period 2016-2021.

Chapter 9 presents an in-depth analysis of completed, ongoing, and planned clinical studies focused on peptide therapeutics, based on several relevant parameters, such as trial registration year, phase of development, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), study focus and key geographical regions.

Chapter 10 presents a detailed analysis of peptide contract manufacturing service providers’ capabilities in different regions, based on several relevant parameters, such as number of CMOs, number of clinical sites, number of clinical trials, number of patients enrolled, number of peptide manufacturing facilities, type of product, number of clinical / commercial manufacturing CMOs, demand for peptide therapeutics and installed capacity.

Chapter 11 features a detailed analysis of the annual commercial and clinical demand for peptide therapeutics, based on several relevant parameters, such as target patient population, dosing frequency and dose strength.

Chapter 12 features an analysis of the overall, installed capacity for manufacturing peptides, based on data reported by industry stakeholders in the public domain; the analysis takes into consideration the distribution of available peptide production capacity across companies of different sizes (small, mid-sized and large firms), scale of operation (clinical and commercial), and key geographical regions (North America, Europe, Asia Pacific).

Chapter 13 presents potential strategic partners segregated based on the likelihood of entering into collaboration with peptide therapeutics developers. These players have been shortlisted based on several relevant parameters, such as pipeline strength, pipeline maturity, year of establishment and company size.

Chapter 14 presents qualitative analysis highlighting the various factors that need to be taken into consideration by peptide drug developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO.

Chapter 15 features a detailed analysis of the total cost of ownership for a peptide contract manufacturing service provider. It features an informed estimate of direct and indirect expenses taking into consideration 11 relevant parameters, over a span of 10 years.

Chapter 16 presents a detailed market forecast analysis, highlighting the likely growth of the peptide contract manufacturing market till the year 2035. In order to provide details on the future opportunity, our projections have been segmented on the basis of [A] scale of operation (preclinical / clinical and commercial) [B] type of synthesis method used [C] company size (small, mid-sized and large), and [D] key geographical regions (North America, Europe, Asia Pacific and Rest of the World).

Chapter 17 presents an insightful discussion on how the recent COVID-19 pandemic is likely to impact the peptide contract manufacturing market, along with information on the key initiatives undertaken by service providers to overcome the challenges faced due to the pandemic.

Chapter 18 provides a detailed discussion on industry affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the evolution of this field; it includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics.

Chapter 19 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the peptide 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 peptide CMOs.

Chapter 20 presents the insights generated from a detailed survey, wherein we invited multiple stakeholders involved in the peptide therapeutics contract manufacturing market.

Chapter 21 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 22 is an appendix that provides the list of companies and organizations mentioned in the report.

LIST OF COMPANIES / LIST OF COMPANIES AND ORGANIZATIONS

The following companies and organizations have been mentioned in the report.
1. 13therapeutics
2. 9 Meters Biopharma
3. AAPPTec
4. Abbiotec
5. Abcepta
6. Abclonal
7. ABI Scientific
8. Abzena
9. ACES Pharma
10. Activotec
11. Adalvo
12. Adar Biotech
13. Advanced Accelerator Applications
14. Advanced ChemTech
15. Advanced Peptides
16. Aileron Therapeutics
17. Ajinomoto Bio-Pharma
18. Akashi Therapeutics
19. Albiochem
20. Allysta Pharmaceuticals
21. Almac
22. Alpha Diagnostic
23. AltaBioscience
24. Altimmune
25. AmbioPharm
26. American Peptide Company
27. Amgen
28. AminoPrimeCentral
29. Amolyt Pharma
30. Ampio Pharmaceuticals
31. Amunix
32. Amyndas Pharmaceuticals
33. Anaspec
34. AnGes
35. Anji Pharmaceuticals
36. Antagene
37. APAC Pharmaceutical
38. Apellis Pharmaceuticals
39. Apeptico
40. APIM Therapeutics
41. Apitope
42. APL
43. Aquestive Therapeutics
44. Arch Biopartners
45. Ardena
46. Ascendia
47. AsclepiX Therapeutics
48. Aspen Oss
49. AstraZeneca
50. Asymchem
51. Atlantic Peptides
52. Atox Bio
53. Aurigene Pharmaceutical Services
54. Aurinia Pharmaceuticals
55. Auspep
56. Austin Chemical
57. Averica
58. Avilex Pharma
59. Axon Neuroscience
60. Baccinex
61. Bachem
62. BAM Biotech
63. Bayer
64. BCN Peptides
65. Bicycle Therapeutics
66. Bioassay
67. BioConcept
68. BioLineRx
69. Biolingus
70. Biomarck Pharmaceuticals
71. BioMarin Pharmaceutical
72. Biomer Technology
73. Biopeptek Pharmaceuticals
74. BioServ
75. Bio-Synthesis
76. BioVectra
77. Boehringer Ingelheim
78. Boston Therapeutics
79. Burrard Pharmaceuticals
80. California Peptide
81. Cambridge Peptides
82. Cambridge Research Biochemicals
83. CanBas
84. CanPeptide
85. Capsugel
86. Cara Therapeutics
87. CARBOGEN AMCIS
88. Carmot Therapeutics
89. CASLO
90. CBL
91. Celtek Peptides
92. CEM
93. Cend Therapeutics
94. Centre for Process Systems Engineering (CPSE)
95. CHEMI
96. ChemPartner
97. ChemPep
98. Chiasma Pharma
99. ChinaTech Peptide
100. Chinese Peptide Company
101. Chondropeptix
102. Chrysalis BioTherapeutics
103. Clinuvel Pharmaceuticals
104. CohBar
105. Constant Therapeutics
106. CordenPharma
107. Corvid Pharmaceuticals
108. Covalab
109. CPC Scientific
110. Creative Peptides
111. CreoSalus
112. CSBio
113. CureDM
114. Curia
115. Curonz
116. Cytovation
117. Dalton Pharma
118. Deca Peptide
119. Designer Bioscience
120. Diabetology
121. Diapin Therapeutics
122. Dottikon ES
123. Eli Lilly
124. Entera Bio
125. Enteris BioPharma
126. Enzene Biosciences
127. Enzo Life Sciences
128. EOC Pharma
129. Esperance Pharmaceuticals
130. Eurogentec
131. Europe Pharmaceutical
132. F4 Pharma
133. Ferring Pharmaceuticals
134. FirstString Research
135. Follicum
136. Formac Pharmaceuticals
137. Frontier Biotechnologies
138. Genervon Biopharmaceuticals
139. Genosphere
140. Genpro Biotech
141. GenScript
142. Genus Oncology
143. Gila Therapeutics
144. GlaxoSmithKline
145. GlioCure
146. GLyPharma
147. GlyTech
148. GP Pharm
149. Grace
150. Green Chemistry and Enabling Technologies
151. IBMM Peptide
152. Grey Matter Research Foundation
153. GYRUS Pharma
154. HAMLET Pharma
155. Hemmo Pharmaceuticals
156. HighTide Therapeutics
157. Hybio Pharmaceutical
158. iBio
159. i-DNA Biotechnology
160. IDP Pharma
161. ILC Therapeutics
162. ILS (A subsidiary of Otsuka Chemical)
163. Imcyse
164. ImmuPharma
165. Innovagen
166. Inotrem
167. Intavis Peptide Services
168. Integrity Bio
169. InterK Peptide Therapeutics
170. Iris Biotech
171. Issar Pharmaceuticals
172. Jitsubo
173. JPT Peptide Technologies
174. Kaijie Peptide
175. Kalos Therapeutics
176. KareBayTM Biochem
177. KeyBioscience
178. Kinexus
179. KriSan Biotech
180. KYTHERA Biopharmaceuticals
181. La Jolla Pharmaceutical
182. Lassogen
183. LifeTein
184. Longevity Biotech
185. Lonza
186. Lyotex
187. MedImmune
188. MElkin Pharmaceuticals
189. MeSCue-Janusys
190. Mimotopes
191. MuseChem
192. Nanomerics
193. Nanos
194. Natco Pharma
195. National Cancer Institute
196. NervGen
197. Neuland Laboratories
198. Neuro-Bio
199. New England Peptide
200. NextPharma
201. NoNO
202. NovaCell Technology
203. Novavax
204. Novetide
205. Novo Nordisk
206. NSJ Prayog Life Sciences
207. NUMAFERM
208. ONL Therapeutics
209. OPKO Health
210. Oramed Pharmaceuticals
211. ORPEGEN Peptide Chemicals
212. Oryn Therapeutics
213. Ovoca Bio
214. Oxalo Therapeutics
215. Oxurion
216. Palatin Technologies
217. Pepceuticals
218. PEPDesign
219. Pepscan
220. PEP-Therapy
221. Peptide 2.0
222. Peptide Institute
223. Peptide Sciences
224. Peptide Synthetics
225. peptides&elephants
226. Peptilogics
227. PeptiStar
228. Peptron
229. Pfanstiehl
230. PharmaMar
231. Phoenix Pharmaceuticals
232. piCHEM
233. PIN Pharma
234. Piramal Pharma Solutions
235. PolyPeptide
236. Polyphor
237. PREVITALICA
238. Priavoid
239. PrimaPharma
240. Primm Biotech
241. Priveel peptides
242. ProImmune
243. ProLynx
244. Promore Pharma
245. ProNeurogen
246. Protagenic Therapeutics
247. Protagonist Therapeutics
248. Proteimax
249. Proteogenix
250. ProvePharm
251. Pulmotect
252. Quantum Hi-Tech (China) Biological
253. Radius Health
254. Rani Therapeutics
255. RegeneRx Biopharmaceuticals
256. Revolo Biotherapeutics
257. Rhythm Pharmaceuticals
258. rPeptide
259. RS Synthesis
260. Salix Pharmaceuticals
261. Sanofi
262. Santhera Pharmaceuticals
263. Sapience Therapeutics
264. SBS Genetech
265. Scancell
266. Schafer-N
267. Scilight-Peptide
268. ScinoPharm
269. Seachaid Pharmaceuticals
270. Sekisui Medical
271. Senn Chemicals
272. Serpin Pharma
273. Severn Biotech
274. Shengnuo Peptide
275. Shenzhen JYMed Technology
276. Sinopep
277. Soligenix
278. Soricimed Biopharma
279. Space Peptides
280. STA Pharmaceutical (A subsidiary of WuXi AppTec)
281. Stealth BioTherapeutics
282. Sussex Research
283. Symbiosis Pharmaceutical
284. Synex
285. SYNG Pharmaceuticals
286. EOC Pharma
287. Takeda
288. TCG
289. TearSolutions
290. TheraSource
291. Theratechnologies
292. Topas Therapeutics
293. Tufts University Core Facility
294. TwoToBiotech
295. UCB Pharma
296. Ulster University
297. UNC Lineberger Comprehensive Cancer Center
298. United Biosystems
299. US Biological
300. USV
301. Valliscor
302. Vault Pharma
303. Vaxeal
304. Viatem
305. Vivtide
306. Wilshire Technologies
307. Wuhan Jetide Biotech
308. Xaia Custom Peptides
309. Xigen
310. Zealand Pharma
311. Zhangzhou Sinobioway Peptide
312. Zhejiang Peptides Biotech
313. Zucara Therapeutics

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