Roots Analysis Pvt. Ltd.

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1 Roots Analysis Pvt. Ltd. -v3981/ Publisher Sample Phone: (US) or or (Int'l) Hours: Monday - Thursday: 5:30am - 6:30pm EST Fridays: 5:30am - 5:30pm EST customerservice@marketresearch.com MarketResearch.com

2 4.3. COMPETITIVE ANALYSIS OF MARKETED SPRAY DRYERS During the course of our research, we identified the companies which manufacture spray dryers for pharmaceutical industry. The spray dryers can also be classified as aseptic or non-aseptic depending upon the product to be spray dried. From a customer s perspective, the spray dryer is chosen depending on the scale of operation (laboratory scale, pilot scale and industrial scale), the particle size distribution and whether sterile conditions are required or not. Table 4.1 presents the list of spray dryers currently available in the market along with their technical specifications. Table 4.1 Technical Specifications of Marketed Spray Dryers S.No. Company Model Max. Inlet Temp 1 2 Advanced Drying Systems Advanced Drying Systems Water Evaporation Rate Nozzle Type Report Particle Page Scale 27 Separation Technique LSD C 1.5Kg/hr Lab Size Unnamed Pilot Scale 3 Buchi Labortechnik B C 1.0 Kg/hr Lab Size 4 Buchi Labortechnik B C 0.2 Kg/hr Piezoelectric driven vibrating mesh Electrostatic particle collector Lab Size 5 GEA Niro ASD-Micro 220 C 1 Kg/hr Lab Size 6 GEA Niro PSD C 3-4 Kg/hr 7 GEA Niro PSD C <20 Kg/hr 8 GEA Niro PSD C Kg/hr 9 GEA Niro PSD C 70 Kg/hr 10 GEA Niro PSD C ~150 Kg/hr 11 GEA Niro PSD C >200 Kg/hr or Pressure Lab Size Pilot Scale Pilot Scale 12 GEA Niro SDMicro 200 C 1Kg/hr Lab Size 13 GEA Niro FSD GEA Niro FSD Kg/hr 15 GEA Niro FSD Kg/hr Continued on Pages 28, 29, 30 Rotary atomizer or 2-Fluid pressure Rotary atomizer or 2-Fluid pressure Rotary atomizer or 2-Fluid pressure - Pilot Scale Copyright 2014 Roots Analysis Private Limited Page 3

3 INTEREST OF CMOS Spray drying is being picked up by pharmaceutical companies because of its advantages which overweigh other available drying technologies. Table 5.2 shows a representative list of CMOs which provide spray drying technology on Nero s spray dryers. Report Page 44 Table 5.2 List of CMOs using Niro Spray Dryers S. No. CMOs Spray Dryer Used 1 Albion Niro -128 (3500 lbs/hr) 2 Bend Research Niro PSD-1, Niro PSD-2 3 Evonik Niro dryers 4 GEA Niro GEA Niro PSD1, GE Niro PSD4 5 Glaxo Smith Kline Niro PSD-3 6 Hovione Niro Mobile Minor, Niro Production Minor, Niro PSD3, Niro PSD4, Niro PSD5, Niro FSD IDI Farma GEA-Niro Mobile Minor 8 Microsphere-SA Niro Mobile Minor 2000, Niro QSD Norwich Pharmaceuticals Niro PSD-4 10 Nova Labs Niro ASD1, Niro PSD3 11 Pharma Spray Drying GEA Niro Mobile Minor 2000s 12 Seigfried Niro spray dryers 13 Spray Tek Niro Spray Dryers Similar lists available for other companies manufacturing spray dryers Figure 5.2 shows the percentage distribution of contract manufacturers on the basis of type of spray dryers used. Figure 5.2 CMO Landscape: Distribution by the Spray Dryer Used 8, 16.7% 13, 27.1% 10, 20.8% Niro Buchi NA Other Spray Dryers 17, 35.4% Note: A particular CMO may use more than one company s spray dryer; such instances have been counted separately Copyright 2014 Roots Analysis Private Limited Page 4

4 CMO: FILL/ FINISH CAPABILITY ANALYSIS Once spray dried, the powder can be either packaged in vials and distributed or can be further compressed into tablets, capsules, pellets, beads etc. Table 6.1 provides details of whether the CMOs have the fill/ finish capability or not. Table SAMPLE 6.1 CMO Capability Analysis PAGES S.No. CMO 1 Agere Pharmaceuticals Fill/ Finish Capability Notes Filling as powder-in-a-bottle, capsules, tablets, coated tablets (cosmetic and enteric), powder for inhalation, alternative dosage forms (solutions, suspensions) 2 Aizant Filling in tablets, capsules and powder in bottles 3 Almac Group Filling as tablets, capsules and powders 4 AMRI Global Filling in vials, syringes, tablets and capsules 5 Aptuit NA 6 Ascendia Pharma Filling in tablets and capsules 7 Astron Research Filling into capsule and rotary tablet 8 9 Bend Research, Inc. (BRI) Boehringer Ingelheim 10 Evonik Tablets and capsules Filling as Powder/pellet/mini tablet capsules Report Page 67 Capsule filling, hard capsules, powder, pellets and beads 11 Formex LLC Filling as tablets, capsules and powder 12 Formurex Filling as tablets, capsules and emulsions 13 Fuji Chemical Industry 14 GEA Niro Filling as powder 15 GlaxoSmithKline NA 16 Hovione Filling in capsules 17 Kuecept NA As orally Disintegrable Tablets, powder 18 Meggle Pharma Capsule and sachet filling 19 Metrics, Inc. Filling as powder and bead-based capsules and tablets 20 Micro-sphere SA Filling in capsules 21 Norwich Pharmaceuticals Filling in inhalable devices 22 Nova Laboratories Filling in vials, syringes, medical devices 23 Pantheon NA Pharmaceutics International Pharmatek Laboratories Filling in capsules, Tablets Capsule filling or compressed in a tablet Continued on Pages 68, 69 Copyright 2014 Roots Analysis Private Limited Page 5

6.4. REGIONAL ANALYSIS This section includes the geographical representation of the CMOs present globally on the basis of the scale of operation provided by these CMOs. 6.4.1.

5 6.4. REGIONAL ANALYSIS This section includes the geographical representation of the CMOs present globally on the basis of the scale of operation provided by these CMOs SAMPLE LABORATORY/ CLINICAL SCALE PAGES Figure 6.1 highlights the regional spread of the location of the CMOs across the globe which provides laboratory scale spray drying facility for pharmaceuticals industry. As can be observed from the figure, majority of the CMOs are located in the United States and Europe. It is important to Report Page 85 mention that, apart from the CMOs we studied for this exercise, there are a number of other contract manufacturers which are providing spray drying services to other industries. As the pharma spray drying industry matures, such CMOs will evaluate the possibility of expanding to the pharmaceutical domain; this increased competition is likely to benefit industry s overall evolution. Figure 6.1 Regional Presence of CMOs (Laboratory Scale) Similar distribution of CMOs for pilot scale and industrial scale services available on Pages 72, 73 Copyright 2014 Roots Analysis Private Limited Page 6

6 SPRAY DRYING TO IMPROVE THE SOLUBILITY & BIOAVAILABILITY OF THE DRUG Insolubility and reduced bioavailability are key challenges being faced by drug manufacturers. With reduced solubility, there is improper absorption of the drug within the body resulting in reduced efficacy. It has been estimated that 40% of the currently marketed drugs and 90% of the drugs in the development pipeline are poorly soluble. Techniques which can be employed to improve the solubility of drugs include micronization, Report Page 85 solubilization, complexation with polymers, salt formation, solid dispersion and addition of surfactants. Specifically, solid dispersion methods include hot melt extrusion, spray drying, freeze drying, solvent evaporation, electrostatic spinning and superficial fluid technology. These methods involve dispersion of active ingredients in a carrier membrane polymer followed by rapid solidification and entrapment of the drug within the carrier. Spray drying is one such solid dispersion method which has been widely used to improve the solubility of drugs. Table 7.1 gives the representative pipeline of drugs that have been spray dried to improve their solubility and bioavailability. Table 7.1 List of Spray Dried Drugs: To Improve Solubility and Bioavailability S. No. Drug Carrier 1 Nifedipine (Procardia) Eudragit excipients 2 Theophylline Kollidon, Chitosan 3 Albendazole Soluplus-Polymer, THF MeOH -SD solvent 4 Magestrol acetate Soluplus-Polymer, Acetone-SD solvent 5 Fenofibrate Soluplus-Polymer, Acetone-SD solvent 6 Itraconazole Soluplus-Polymer, Acetone-SD solvent 7 Indomethacin Soluplus-Polymer, Acetone, THF-SD solvent 8 Fenofibrate Poloxamer 188, TPGS 9 Ibuprofen Ethanol 10 Rizatriptan Chitosan 11 Naproxen CP, HPMC 12 Itraconazole Dextran or TPGS 1000 and PVPVA Pioglitazone Poloxamer 407, I2 Cyclodextrin 14 Torcetrapib HPMCAS 15 Etravirine HPMC Copyright 2014 Roots Analysis Private Limited Page 7

7 8.1 FUTURE MARKET OUTLOOK We have followed a top-down approach to review the overall market scenarios. We looked at the market under two categories: Currently Marketed Drugs: As mentioned earlier, we don t anticipate pharma companies to alter the existing manufacturing processes; any changes will warrant gaining approvals for the new processes before using them for commercial production. We believe that the spray drying market for existing marketed drugs is not likely to increase substantially; having said that, there will be opportunities which can be monetized when these drugs are nearing patent expiry. Pipeline Drugs: There are a number of drugs which are currently in the pipeline and are likely Report Page 94 to be made commercially available in the near future. As the industry realizes the benefits of spray drying vis-à-vis other drying technologies, the opportunity to investigate and implement will primarily arise from this pipeline. In fact, for obvious reasons, most of the growth in the spray drying market is visualized to come from drugs which are currently in pipeline. 1 Figure 8.1 Future Market Scenarios: Description Detailed results of each scenario (in terms of USD Million and % Growth) presented on Pages Discussion with Sam de Costa, Aseptic Spray Drying, Nova Laboratories Copyright 2014 Roots Analysis Private Limited Page 8

GEA pharmaceutical spray drying. Improve drug properties and production efficiency with spray drying

GEA pharmaceutical spray drying Improve drug properties and production efficiency with spray drying 2 PHARMA Industry-leading technology Spray drying is a technique preferred by a growing number of pharmaceutical