Novel Drug Reconstitution Systems Market, 2021-2030 Distribution by Type of Container (Cartridge, Infusion Bag and Prefilled Syringe), Fabrication Material (Glass and Plastic), Physical State of Drug in Syringe and Cartridge (Liquid / Powder, Liquid / Liq

Novel Drug Reconstitution Systems Market, 2021-2030 Distribution by Type of Container (Cartridge, Infusion Bag and Prefilled Syringe), Fabrication Material (Glass and Plastic), Physical State of Drug in Syringe and Cartridge (Liquid / Powder, Liquid / Liquid), Physical State of Drug in Infusion Bag (Liquid Mixture, Frozen Mixture), Volume of Container (<1 mL, 1-2.5 mL, 2.5-5 mL, >5 mL for prefilled syringe and cartridge; <250 mL, 250-500 mL, 500-1,000 mL, >1,000 mL for infusion bag), Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World): Industry Trends and Global Forecasts, 2021-2030

Over the last few years, numerous biologics and small molecule drugs have made their way to the market. Most of these biologic products are not stable as liquid formulations, and tend to lose efficacy with alterations in their pharmacokinetic and pharmacodynamic properties, thereby, making it difficult to preserve them for longer period of time. In order to achieve longer shelf life, lyophilization has emerged as the preferred choice for making dry biopharmaceutical formulations. In fact, around 30% of the FDA approved parenteral drugs are in lyophilized form. Since 2014, the FDA had approved more than 20 applications for lyophilized new drugs. Evidently, this method of producing stabilized formulations has witnessed widespread adoption and the affiliated market opportunity is estimated to be USD 3 billion. The increased adoption of such drugs has led to the rise in demand for reconstitution systems that allow proper mixing of lyophilized drug with the diluent and administration of required dose. The traditional reconstitution methods involve manual extraction and transfer of diluent into the vials containing the lyophilized product, using syringe and transfer needle. Given the large number of steps involved and multiple containers, this method is associated with the risk of medication errors and needle-stick injuries. In addition, the complexity associated with these conventional systems restricts the injection of lyophilized drugs only by the healthcare workers within the confined area of healthcare facilities.

The existing challenges in the conventional reconstitution method have prompted the pharmaceutical industry to develop advanced reconstitution devices, which allow the patients and caregivers to administer drugs without healthcare provider’s intervention. These systems contain premeasured dose of drug and diluent, which essentially reduces the chances of dosing errors and needle-stick injuries. Moreover, these advanced systems enhance the portability, efficiency and optimum delivery of the lyophilized drugs and have the potential to reduce the number of steps significantly, which enable the dilution and reconstitution at the time of delivery. Owing to their multiple benefits, various pharmaceutical companies are considering these systems for lifecycle management of their drugs in order to enhance the provision of healthcare. Further, it is worth mentioning that over 1,800 patent applications have been filed / granted for reconstitution systems and affiliated technologies. We believe that such efforts are likely to drive growth in this market over the coming years.

The ‘Novel Drug Reconstitution Systems Market by Type of Container (Cartridge, Infusion Bag and Prefilled Syringe), Fabrication Material (Glass and Plastic), Physical State of Drug in Syringe and Cartridge (Liquid / Powder, Liquid / Liquid), Physical State of Drug in Infusion Bag (Liquid Mixture, Frozen Mixture), Volume of Container (<1 mL, 1-2.5 mL, 2.5-5 mL, >5 mL for prefilled syringe and cartridge; <250 mL, 250-500 mL, 500-1,000 mL, >1,000 mL for infusion bag), Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World): Industry Trends and Global Forecasts, 2021-2030’ report features an extensive study on the current and future potential of novel drug reconstitution systems, being developed in order to ease the storage and administration of lyophilized drugs, thereby maintaining stability and shelf-life. In addition, it features an elaborate discussion on the likely opportunity for the players engaged in this domain, over the next decade. Amongst other elements, the report includes:

A detailed assessment of the current market landscape of novel drug reconstitution systems, providing information on the type of device (prefilled syringe, cartridge, infusion bags), type of chamber (dual chamber, multi chamber), physical state of drug (lyophilized, liquid), container fabrication material (glass, plastic), device usability (single use, multi-use), and volume of container. In addition, the chapter includes details related to novel drug reconstitution system manufacturers, along with information on their year of establishment, company size, location of headquarters and key players (in terms of number of products manufactured).

A detailed landscape of the reconstitution devices and systems featuring information on type of container or device, volume of primary container, physical state of drug, device usability and provision for self-administration. In addition, the chapter includes details related to the manufacturers, along with information on their year of establishment, company size and location of headquarters.

Elaborate profiles of prominent players engaged in this domain. Each profile includes a brief overview of the company, details related to its financial information (if available), information on product portfolio, recent developments and an informed future outlook.

A detailed analysis on the trends in packaging of over 350 drug products (including both biologics and small molecule drugs) that were approved by the FDA between 2014 and H1 2021, featuring an assessment of the packaging requirements of various container-closure systems based on several parameters, such as year of approval of drug, type of molecule (small molecule, biologic), type of biologic (allogeneic cell therapy, autologous cell therapy, fusion proteins, hormones, interferons, monoclonal antibodies, recombinant enzymes, recombinant protein and viral cell therapy), type of primary packaging container used (vials, pouches / packets, bottles, IV / sealed bags, prefilled syringes / pen , tubes, cartridge, blister packaging, others), type of packaging material(s) used for manufacturing primary container, type of closure used (cap / needle shield, seal, plunger, stopper and others), type of packaging material(s) used for manufacturing closures, dosage form, route of administration, holding temperature. In addition, the chapter provides information on the developers of the aforementioned drugs and an analysis based on year of establishment, company size, location of headquarters and leading drug developers (in terms of number of drugs approved).

An insightful analysis of the patents filed / granted for novel drug reconstitution systems, since 2011, taking into consideration various relevant parameters, such as type of patent, publication year, geographical location, CPC symbols, emerging focus areas, leading players (in terms of number of patents granted / filed in the given time period), patent characteristics and geography. In addition, the chapter includes a detailed patent benchmarking and an insightful valuation analysis.

A competitiveness analysis of novel drug reconstitution system manufacturers based on various relevant parameters, such as supplier power (in terms of experience / expertise of the manufacturer) and key product specifications (number of systems, type of systems, type of drugs and number of chambers).

An in-depth analysis of recent events (summits / forums / conferences / annual meetings) that were organized for stakeholders in this domain, highlighting the evolution of discussion topics related to novel drug reconstitution systems. The analysis also provides details on type of event, regional distribution, emerging agendas, popular organizers, active industry and non-industry players, and a schematic mapping of upcoming events.

A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall novel drug reconstitution systems market.

An in-depth analysis to estimate the current and future demand for various novel drug reconstitution systems, including cartridges, infusion bags and prefilled syringes.

An elaborate discussion on emerging trends that are likely to have an impact on the future adoption of novel drug reconstitution systems. It presents a Harvey ball analysis, highlighting the relative effect of each trend on the adoption of novel drug reconstitution systems including dual chamber systems.

One of the key objectives of the report was to estimate the existing market size and the future opportunity for novel drug reconstitution systems, over the next decade. Based on various parameters, such as target consumer segments, likely adoption rates and expected prices of such products, we have provided informed estimates on the evolution of the market for the period 2021-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] type of reconstitution system (prefilled syringe / cartridge / infusion bag), [B] physical state of drug (liquid / powder, liquid / liquid for prefilled syringes and cartridges; liquid mixture and frozen mixture for infusion bags), [C] type of fabrication material (glass, plastic / type of plastic for infusion bags), [D] volume of container (<1 mL, 1-2.5 mL, 2.5-5 mL and >5 mL for prefilled syringes and cartridges; 0-250 mL, 250-500 mL, 500-1,000 mL and >1,000 mL for infusion bags), [E] key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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

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

While the focus has been on forecasting the market till 2030, the report also provides our independent views 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.

KEY QUESTIONS ANSWERED
Who are the key players engaged in the development of novel drug reconstitution systems?
What is the relative competitiveness of different novel drug reconstitution system manufacturers?
What is the packaging trend in terms of container and closure for the drugs approved since 2014?
Who are the leading players focused on the development of lyophilized drugs?
What is the focus area of various conferences conducted in this domain?
How has the intellectual property landscape in this domain evolved over the years?
What are the emerging trends related to pharmaceutical packaging?
What are the key agenda items being discussed in various global events / conferences held in this domain?
How is the current and future market opportunity, likely to be distributed across key market segments?

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

Chapter 3 provides a general introduction to novel drug reconstitution systems. In this chapter, we have briefly discussed the key considerations in reconstitution and the factors affecting reconstitution of drugs. The chapter also discusses the process of lyophilization of pharmaceuticals and need for reconstitution systems. In addition, it provides information on dual chamber systems and the benefits offered by these systems.

Chapter 4 presents an overview of the current market landscape of novel drug reconstitution systems, along with information on the type of device (prefilled syringe, cartridge, infusion bags), type of chamber (dual chamber, multi chamber), physical state of drug (lyophilized, liquid), container fabrication material (glass, plastic), device usability (single use, multi-use), and volume of container. It also includes a detailed analysis based on the year of establishment, company size (in terms of employee count), region and location of headquarters. In addition, the chapter provides information on the novel drug reconstitution system manufacturers, while highlighting the leading players in this domain.

Chapter 5 presents an overview of the current market landscape of other reconstitution devices and systems (one step reconstitution systems and conventional reconstitution devices), along with information on the type of primary container, volume of primary container, physical state of drug, device usability and provision for self-administration. The chapter also provides information on the manufacturers of other reconstitution systems, along with analysis based on their year of establishment, company size, location of headquarters and leading players (in terms of number of products manufactured).

Chapter 6 includes profiles of the key players engaged in the development of novel drug reconstitution systems (shortlisted on the basis of the company size and the number of products in the pipeline). Each profile features a brief overview of the company, its financial information (if available), details on its product portfolio, recent developments and an informed future outlook.

Chapter 7 provides a detailed review of the packaging trends of over 350 product candidates (biologics and small molecule drugs) that were approved by the FDA between 2014 and H1 2021, including an analysis of the packaging requirements based on several relevant parameters, such as approval year of drug, type of molecule (small molecule, biologic), type of biologic (allogeneic cell therapy, autologous cell therapy, fusion proteins, hormones, interferons, monoclonal antibodies, recombinant enzymes, recombinant protein and viral cell therapy), type of primary packaging container used (vials, pouches / packets, bottles, IV / sealed bags, prefilled syringes / pen , tubes, cartridge, blister packaging, others), most popular packaging material(s) used for primary containers, type of primary packaging closure used (cap / needle shield, seal, plunger, stopper and others), most popular packaging material(s) used for manufacturing closures, dosage form, route of administration, holding temperature. Further, the chapter provides information on the developers of the approved drugs, along with information on their year of establishment, company size, location of headquarters and most active players (in terms of number of small molecule drugs and number and type of biologics approved).

Chapter 8 features an in-depth analysis of the patents that have been filed / granted for the novel drug reconstitution systems, since 2011. The analysis also highlights the key trends associated with the patents, such as the type of patent (granted patent, patent application and others), publication year, application year, geographical location, CPC symbols, emerging focus areas of the patents, type of organization and leading players (in terms of number of patents granted / filed). In addition, it includes detailed patent benchmarking and valuation analysis based on patent characteristics.

Chapter 9 provides a competitiveness analysis of novel drug reconstitution system manufacturers that we came across during our research, based on supplier strength (in terms of experience / expertise of the manufacturer) and key product specifications (number of systems, type of systems, type of drugs and number of chambers).

Chapter 10 provides an analysis of recent events (summits / forums / conferences / workshops) related to novel drug reconstitution systems that were organized / planned. It features an analysis based on the year of occurrence of event, event platform, type of event, regional distribution, emerging agendas / key focus areas, most active event organizers, most active event speakers and geographical mapping of the upcoming events.

Chapter 11 provides information on the affiliated trends, key drivers and challenges associated with novel drug reconstitution systems, under a reliable SWOT framework. The chapter includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall novel drug reconstitution systems market.

Chapter 12 features a detailed analysis on the current and future demand for novel drug reconstitution systems. We have provided inputs on the likely demand for these systems across the type of reconstitution system (prefilled syringe / cartridge / infusion bag), physical state of drug (liquid / powder, liquid / liquid for prefilled syringes and cartridges; liquid mixture and frozen mixture for infusion bags), type of fabrication material (glass, plastic / type of plastic for infusion bags), volume of container (<1 mL, 1-2.5 mL, 2.5-5 mL and >5 mL for prefilled syringes and cartridges; 0-250 mL, 250-500 mL, 500-1,000 mL and >1,000 mL for infusion bags) geography (North America, Europe, Asia-Pacific, Latin America and Middle East and Africa) for the period, 2021-2030.

Chapter 13 features a detailed market forecast of the likely growth of novel drug reconstitution systems, till the year 2030. We have generated insights on the likely distribution of the current and forecasted opportunity across the type of reconstitution system (prefilled syringe / cartridge / infusion bag), physical state of drug (liquid / powder, liquid / liquid for prefilled syringes and cartridges; liquid mixture and frozen mixture for infusion bags), type of fabrication material (glass, plastic / type of plastic for infusion bags), volume of container (<1 mL, 1-2.5 mL, 2.5-5 mL and >5 mL for prefilled syringes and cartridges; 0-250 mL, 250-500 mL, 500-1,000 mL and >1,000 mL for infusion bags), and key geographical regions (North America, Europe, Asia-Pacific, Latin America and Middle East and Africa).

Chapter 14 provides information on the upcoming emerging trends (including preference for self-medication of drugs, shift towards more flexible packaging, focus on personalized therapies, integrating dual chamber systems with other platforms, and increase in the initiatives undertaken by industry stakeholders) that are likely to have an impact on the future adoption of novel drug reconstitution systems. It also presents a Harvey ball analysis, highlighting the relative impact of each trend on the adoption of novel drug reconstitution systems including dual chamber systems.

Chapter 15 is a summary of the overall report, presenting insights on the contemporary market trends and the likely evolution of the novel drug reconstitution systems market.

Chapter 16 is an appendix, that contains tabulated data and numbers for all the figures provided in the report.

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

LIST OF COMPANIES AND ORGANIZATIONS

The following companies / institutes / government bodies and organizations have been mentioned in this report.

1. 3M Innovative Properties
2. AbbVie
3. Ablynx
4. Acacia Pharma
5. Acadia Pharmaceuticals
6. AcelRx Pharmaceuticals
7. Achaogen
8. Acorda Therapeutics
9. Actelion Pharmaceuticals
10. ADC Therapeutics
11. ADIENNE
12. Advanced Accelerator Applications (AAA)
13. AdvoCare Medical
14. Aerie Pharmaceuticals
15. Agios Pharmaceuticals
16. Aguettant
17. AkaRx (acquired by Eisai)
18. Akcea Therapeutics (acquired by Ionis Pharmaceuticals)
19. Alcon Laboratories
20. Alexion Pharmaceuticals
21. Alkermes
22. Allergan
23. Almirall
24. Alnylam Pharmaceuticals
25. AMAG Pharmaceuticals (acquired by Covis Pharma)
26. Amgen
27. Amivas
28. Amphastar Pharmaceuticals
29. Amsino
30. Anacor Pharmaceuticals (acquired by Pfizer)
31. Antares Pharma
32. Apellis Pharmaceuticals
33. Aquestive Therapeutics
34. ARaymond
35. Ardelyx
36. ARIAD Pharmaceuticals (acquired by Takeda)
37. Array BioPharma (acquired by Takeda)
38. Arte
39. Astellas Pharma
40. AstraZeneca
41. Aurinia Pharmaceuticals
42. AVEO Pharmaceuticals
43. B. Braun
44. Bausch & Lomb
45. Bausch Health Companies (formerly Valeant Pharmaceuticals)
46. Baxter
47. Bayer Healthcare
48. Becton Dickinson (BD)
49. BeiGene
50. Biocorp
51. BioCryst Pharmaceuticals
52. Biogen
53. Biohaven Pharmaceuticals
54. BioMarin Pharmaceutical
55. Bioprojet Pharma
56. BloodWorks
57. Blue Earth
58. Blueprint Medicines
59. Boehringer Ingelheim
60. Bracco Diagnostics
61. Braintree Laboratories (acquired by Sebela Pharmaceuticals )
62. Bristol Myers Squibb
63. Cassiopea
64. Catalyst Pharmaceuticals
65. Celgene
66. Celltrion
67. Chelsea Therapeutics
68. Chemo Research
69. Chiesi USA
70. Cleveland Cord Blood Center (CCBC)
71. CLINUVEL
72. Clovis Oncology
73. Cosmo Pharmaceuticals
74. Credence Medsystems
75. Cubist Pharmaceuticals
76. Curium
77. Daiichi Sankyo
78. Debiotech
79. Deciphera Pharmaceuticals
80. Dr. Reddy's Laboratories
81. Duoject
82. Durata Therapeutics (acquired by Actavis)
83. Dutch Ophthalmic Research Center
84. Eiger BioPharmaceuticals
85. Eisai
86. Eli Lilly
87. Elusys Therapeutics
88. EMD Serono
89. Enable Injections
90. Epizyme
91. Equashield
92. Esperion Therapeutics
93. Evolus
94. ExEm Foam
95. EyePoint Pharmaceuticals
96. Ferrer
97. Fresenius Kabi
98. G1 Therapeutics
99. Galderma
100. Genentech
101. Gerresheimer
102. Gilead Sciences
103. GlaxoSmithKline
104. Global Blood Therapeutics
105. Greenwich Biosciences
106. Grifols
107. Haemopharm
108. Harmony Biosciences
109. Helapet
110. Helsinn Healthcare
111. Hemedis
112. Horizon Therapeutics
113. ICU Medical
114. IDEO
115. iHealthNet
116. Immunomedics (acquired by Gilead Sciences)
117. Incyte
118. Insmed
119. Integrity Bio
120. Intercept Pharmaceuticals
121. Intra-Cellular Therapies
122. Ionis Pharmaceuticals
123. Ironwood Pharmaceuticals
124. ITF Pharma
125. Janssen Pharmaceuticals
126. Jazz Pharmaceuticals
127. JW Chemi Town
128. KAI Pharmaceuticals (acquired by Amgen)
129. Kapsam
130. Karyopharm Therapeutics
131. KemPharm
132. Kite Pharma
133. Kyowa Kirin
134. Kythera Biopharma (acquired by Allergan)
135. La Jolla Pharmaceutical Company
136. Leadiant Biosciences
137. Lexicon Pharmaceuticals
138. Lundbeck
139. Lupin
140. MacroGenics
141. Maeda Industry
142. Mayne Pharma
143. MEDIPHARMAPLAN
144. Medicines Development for Global Health (MDGH)
145. MedXL
146. Melinta Therapeutics
147. Merck
148. Millennium Pharmaceuticals (acquired by Takeda)
149. Miltenyi Biotec
150. Mitsubishi Tanabe Pharma
151. MorphoSys
152. Myovant Sciences
153. Mystic Pharmaceuticals
154. Nabriva Therapeutics
155. Neurocrine Biosciences
156. Nipro
157. Novartis
158. Novimmune
159. Novo Nordisk
160. NPS Pharmaceuticals
161. NS Pharma
162. Nündel Kunststofftechnologie
163. Ocular Therapeutix
164. Oncopeptides
165. Organon International
166. Origin Biosciences
167. Ortho Dermatologics
168. Otsuka Pharmaceutical
169. Paladin
170. Paratek Pharmaceuticals
171. Pfizer
172. PHC Injection Device Technologies
173. Piramal Imaging
174. Portola Pharmaceuticals (acquired by Alexion Pharmaceuticals)
175. Progenics Pharmaceuticals
176. PTC Therapeutics
177. Puma Biotechnology
178. QED Therapeutics
179. Radius Health
180. Recon Therapeutics
181. Recordati Rare Diseases
182. Regeneron Pharmaceuticals
183. Relypsa
184. Rempex Pharmaceuticals
185. Travere Therapeutics (formerly Retrophin)
186. Rhythm Pharmaceuticals
187. Ridgeback Biotherapeutics
188. Rigel Pharmaceuticals
189. Roche
190. Sage Therapeutics
191. Sagentia Innovation
192. Sanofi
193. Sanofi Genzyme
194. Sarepta Therapeutics
195. SCHOTT
196. SCHOTT-KAISHA
197. SCYNEXIS
198. Seagen
199. Servier Pharmaceuticals
200. sfm medical devices
201. Shandong Pharmaceutical Glass
202. Shield Therapeutics
203. Shionogi
204. Shire Pharmaceuticals (acquired by Takeda)
205. SIGA Technologies
206. Simplivia
207. SIPPEX
208. SK Life Science
209. SKINSORB
210. Spark Therapeutics
211. Spectrum Pharmaceuticals
212. Sprout Pharmaceuticals
213. Stemline Therapeutics (acquired by Menarini)
214. Stevanato Group
215. Strongbridge Biopharma
216. Sun Pharma
217. Sun Pharma Advanced Research Company (SPARC)
218. Supernus Pharmaceuticals
219. SYMATESE DEVICE
220. Synergy Pharmaceuticals
221. Taian Youlyy Industrial
222. Taiho Oncology
223. TaiMed Biologics
224. Taisei Kako
225. Takeda Pharmaceuticals
226. Technoflex
227. Terumo
228. TESARO (acquired by GlaxoSmithKline)
229. Tetraphase Pharmaceuticals
230. Teva Pharmaceutical
231. TG Therapeutics
232. The Conference Forum
233. The Feinstein Institutes for Medical Research
234. The International Research Conference
235. The Medicines Company (acquired by Novartis)
236. The Metrix Company (formerly Riggs BioChemical)
237. TherapeuticsMD
238. Theravance Biopharma and Mylan
239. Trevena
240. Tyfill Pharmapack
241. U.S. Food and Drug Administration (USFDA)
242. UIHC – P E T Imaging Center
243. Ultragenyx Pharmaceutical
244. Unilife
245. UCB
246. United Therapeutics
247. Unitract Syringe
248. University of California, Los Angeles (UCLA)
249. Urovant Sciences
250. US WorldMeds
251. Valmed Pharma
252. VANDA Pharmaceuticals
253. Vanrx Pharmasystems
254. Verastem Oncology
255. Vericel
256. Vertex Pharmaceuticals
257. Vetter Pharma
258. Viela Bio (acquired by Horizon Therapeutics)
259. ViiV Healthcare
260. Vonlanthen
261. Vygon
262. Weibel CDS
263. Wellstat Therapeutics
264. West Pharmaceutical Services
265. Wyeth
266. Y-mAbs Therapeutics
267. Ypsomed
268. Yukon Medical
269. Zealand Pharma
270. Zionexa (acquired by GE Healthcare)

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