Manufacturing of Solid Dosage Forms - Transformation in Manufacturing Concepts and Expanding Contract Manufacturers’ Production Capacity May Force Regulatory Bodies to Re-Design Guidelines on Quality Standards

Manufacturing of Solid Dosage Forms - Transformation in Manufacturing Concepts and Expanding Contract Manufacturers’ Production Capacity May Force Regulatory Bodies to Re-Design Guidelines on Quality Standards

Summary

GBI Research's report, “Manufacturing of Solid Dosage Forms - Transformation in Manufacturing Concepts and Expanding Contract Manufacturers’ Production Capacity May Force Regulatory Bodies to Re-Design Guidelines on Quality Standards" Production Capacity May Force Regulatory Bodies to Re-Design Guidelines on Quality Standards”. The report provides the key market data on the Contract Manufacturing Organization (CMO) market size for solid dosage forms along with forecast from 2009-2016 for API and excipient market. The report also gives insight into challenges, unmet needs, and technology landscape and cGMP guidelines for manufacturing of solid dosage forms. The report also analyzes the strengths, weaknesses, opportunities, and threats leading players involved in manufacturing of solid dosage forms. The report is based on proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts to provide a comprehensive view of the manufacturing of solid dosage forms.

The proper design and formulation of a solid dosage form requires knowledge about the physical, chemical and biological distinctiveness of pharmaceutical ingredients (API and excipients) to be used in manufacturing process. GBI research estimates that the APIs market was will grow from $62.5 billion in 2009 to an estimated at a CAGR of 5.8% between 2009 and 2016 to reach $91.3 billion by 2016. Growth in generics and oncology market and rising focus on high potency API are driving the growth of API market. The excipient market will also show a growth rate4% between 2006-2016 to reach $536m by 2016.the trend of outsourcing of the manufacturing operation to the CMO has increased in recent years and GBI Research estimates that CMO market manufacturing of for solid dosage forms will grow at a rate of growth from $11.2 billion in 2009 to reach $24.5 billion by 2016 with a CAGR of11.8% between 2009–2016.

Scope

The scope of this report includes -
- Key emerging technologies in the manufacturing of solid dosage forms
- Market revenues and forecasts for API’s, excipeints and CMO market for manufacturing of solid dosage forms.
- Qualitative analysis of the market drivers, barriers, future outlook and challenges for the API, excipient and CMO market.
- Manufacturing trends and new technologies used for manufacturing of solid dosage forms.
- Challenges and unmet needs in manufacturing of solid dosage forms.
- Regulatory aspects related to the manufacturing of solid dosage form.
- Single use technology trends, benefits, and challenges in downstream bioprocess that shape the bio manufacturing industry
- Analysis and competitive assessment of leading and evolving players involved in manufacturing of solid dosage forms.

Reasons to buy

The report will enhance your decision making capability. It will allow you to -
- Formulate strategies to increase your company’s growth by understanding the new growth opportunities, market size and growth prospectus in market for manufacturing of solid dosage forms.
- Work around the technology hurdles by identifying the key trends shaping and driving the market for manufacturing of solid dosage forms.
- Device a more tailored country strategy through the understanding of key drivers and barriers to market for manufacturing of solid dosage forms.
- Differentiate yourself from competitors and develop new solutions for the manufacturing industry by understanding the existing competitive landscape and how it is evolving to meet the increasing demands.

1 Table of Contents
1 Table of Contents 6
1.1 List of Tables 9
1.2 List of Figures 9
2 Manufacturing of Solid Dosage Forms - Introduction 11
3 Manufacturing of Solid Dosage Forms - Overview 12
3.1 General Manufacturing Process for Solid Dosage Forms 12
3.1.1 Dispensing 12
3.1.2 Sizing 12
3.1.3 Powder Blending 13
3.1.4 Granulation 13
3.1.5 Drying 13
3.1.6 Tablet Compression 13
3.1.7 Packaging 13
3.2 Granulation 14
3.2.1 Dry Granulation 14
3.2.2 Wet Granulation 14
4 Manufacturing of Solid Dosage Forms - Market Overview 16
4.1 Overview of Drug Formulations Market 16
4.2 Solid Dosage Form Market 17
4.3 Drivers and Restraints in the Solid Dosage Market 18
4.3.1 Drivers 18
4.3.2 Restraints 19
4.4 Major Components of the Solid Dosage Forms Market 20
4.4.1 Active Pharmaceutical Ingredients (APIs) 20
4.4.2 API Drivers 21
4.4.3 API Market Constraints 22
4.4.4 Excipients 23
4.4.5 Excipients Drivers 26
4.4.6 Excipients Restraints 27
4.5 Outsourcing of Manufacturing 28
4.5.1 Global Pharmaceuticals CMO Market Overview 28
4.5.2 CMO Market Size for Solid Dosage Forms 30
4.5.3 Key Drivers 31
4.5.4 Key Restraints 32
5 Manufacturing of Solid Dosage Forms - Technology Lanscape 33
5.1 Manufacturing Trends Used for Solid Dosage Forms 33
5.2 Innovative Technologies for Solid Dosage Manufacturing 34
5.2.1 Fluidized Hot-Melt Granulation 34
5.2.2 Hot-Melt Extrusion (HME) 35
5.2.3 Dry Emulsions 35
5.2.4 Bohle Tablet Coater (BTC) 35
5.3 Batch versus Continuous Process 36
6 Manufacturing of Solid Dosage Forms - Challenges and Unmet Needs 38
6.1 Unmet Needs 38
6.1.1 Solid Dosage Products Based on High Active Compounds 38
6.1.2 Compliance with cGMP Guidelines 38
6.1.3 Redesigning Manufacturing Platforms 38
6.2 Challenges 39
6.2.1 Regulatory Hurdles for Continuous Process Facilities 39
6.2.2 Innovative and Efficient Excipients Required 39
7 Manufacturing of Solid Dosage Forms - Regulatory Landscape 40
7.1 cGMP Guidelines 40
7.2 For API cGMP Guidelines 41
7.3 Excipient Regulation 45
7.3.1 Comparison of the US, Europe and Japan 45
7.4 For Excipients cGMP Guidelines 46
7.4.1 The IPEC Excipient Guide 46
7.4.2 The IQA/PQG Guide 46
7.4.3 Application of the PQG standard 46
7.4.4 IPEC and PQG Standards Comparison 47
7.4.5 Regulatory Basis for Supplier Qualification 48
8 Manufacturing of Solid Dosage Forms - Competitive Landscape 49
8.1 Capsugel 49
8.1.1 Company Overview 49
8.1.2 SWOT Analysis 49
8.1.3 M&A, and Licensing Deals 50
8.2 Patheon 50
8.2.1 Company Overview 50
8.2.2 SWOT Analysis 50
8.2.3 M&A, and Licensing Deals 52
8.3 AAI Pharma 53
8.3.1 Company Overview 53
8.3.2 SWOT Analysis 53
8.3.3 M&A, and Licensing Deals 55
8.4 Famar 56
8.4.1 Company Overview 56
8.4.2 SWOT Analysis 56
8.4.3 M&A, and Licensing Deals 57
8.5 EGIS Pharmaceuticals PLC 58
8.5.1 Company Overview 58
8.5.2 SWOT Analysis 58
8.5.3 M&A and Licensing Deals 60
8.6 STADA’s Group 61
8.6.1 Company Overview 61
8.6.2 SWOT Analysis 61
8.6.3 M&A, and Licensing Deals 62
8.7 Mylan 64
8.7.1 Company Overview 64
8.7.2 SWOT Analysis 64
8.7.3 M&A, and licensing Deals 66
8.8 DSM Pharmaceutical 70
8.8.1 Company Overview 70
8.8.2 SWOT Analysis 71
8.8.3 M&A, and Licensing Deals 71
8.9 Teva Pharmaceutical Industries 72
8.9.1 Company Overview 72
8.9.2 SWOT Analysis 72
8.9.3 M&A and Licensing Deals 73
9 Manufacturing of Solid Dosage Forms - Emerging Companies 76
9.1 Catalent Pharma Solutions, Inc 76
9.1.1 Company Overview 76
9.1.2 Key Products and Services 76
9.1.3 Key features 76
9.1.4 Recent Updates Relating to Licensing Deals and Strategic Consolidations 76
9.2 Merrion Pharmaceuticals Plc 77
9.2.1 Company Overview 77
9.2.2 Service Portfolio and Offerings 77
9.2.3 Recent Updates Related to Licensing Deals and Strategic Consolidations 77
9.3 Emisphere Technologies, Inc. 77
9.3.1 Company Overview 77
9.3.2 Service Portfolio and Offerings 77
9.3.3 Recent Updates Related to Licensing Deals, Strategic Consolidations 78
9.4 Chiasma Ltd. 78
9.4.1 Company Overview 78
9.4.2 Service Portfolio and Offerings 78
9.4.3 Recent Updates Related to Licensing Deals and Strategic Consolidations 79
9.5 Oramed Pharmaceuticals 79
9.5.1 Company Overview 79
9.5.2 Service Portfolio and Offerings 79
9.5.3 Recent Updates Related to Licensing Deals and Strategic Consolidations 79
10 Manufacturing of Solid Dosage Forms - Appendix 80
10.1 Market Definitions 80
10.2 Abbreviations 80
10.3 Sources 81
10.4 Research Methodology 81
10.4.1 Coverage 81
10.4.2 Secondary Research 82
10.4.3 Primary Research 82
10.4.4 Expert Panel Validation 82
10.5 Contact Us 83
10.6 Disclaimer 83

1.1 List of Tables
Table 1: Manufacturing of Solid Dosage Forms, Global Pharmaceutical Market, ($bn), 2011-2018 16
Table 2: Manufacturing of Solid Dosage Forms, API Market, ($bn), 2011-2018 20
Table 3: Manufacturing of Solid Dosage Forms, Excipient Market, ($m) 2011-2018 23
Table 4: Manufacturing of Solid Dosage Forms, Global Pharmaceutical Contract Manufacturing Market, ($bn), 2011-2018 29
Table 5: Manufacturing of Solid Dosage Forms, CMO Market Size For The Solid Dosage Forms, ($bn), 2011-2018 30
Table 6: Manufacturing of Solid Dosage Forms, Regulatory Landscape, Comparison Among US, Europe and Japan, 2011 45
Table 7: Manufacturing of Solid Dosage Forms, Competitive Landscape, Deals, Capsugel, 2007- 2011 50
Table 8: Manufacturing of Solid Dosage Forms, Competitive Landscape, Deals, Patheon, 2004-2011 52
Table 9: Manufacturing of Solid Dosage Forms, Competitive Landscape, Deals, AAI Pharma, 2004-2011 55
Table 10: Manufacturing of Solid Dosage Forms, Competitive Landscape, Deals, FAMAR, 2004-2011 57
Table 11: Manufacturing of Solid Dosage Forms, Competitive Landscape, Deals, EGIS, 2004-2011 60
Table 12: Manufacturing of Solid Dosage Forms, Competitive Landscape, Deals, STADA, 2004-2011 62
Table 13: Manufacturing of Solid Dosage Forms, Competitive Landscape, Deals, Mylan, 2004-2011 66
Table 14: Manufacturing of Solid Dosage Forms, Competitive Landscape, Deals, DSM Pharmaceutical, 2004-2011 71
Table 15: Manufacturing of Solid Dosage Forms, Competitive Landscape, Deals, TEVA Pharmaceutical, 2004-2011 73

1.2 List of Figures
Figure 1: Manufacturing of Solid Dosage Forms, Types, 2011 11
Figure 2: Manufacturing of Solid Dosage Forms, General Process of Manufacturing, 2011 12
Figure 3: Manufacturing of Solid Dosage Forms, Wet and Dry Granulation Process, 2011 15
Figure 4: Manufacturing of Solid Dosage Forms, Global Pharmaceutical Market, ($bn), 2011-2018 16
Figure 5: Manufacturing of Solid Dosage Forms, Percentage Distribution of Various Dosage Forms Based on Number of Marketed Drugs, 2011 17
Figure 6: Manufacturing of Solid Dosage Forms, Percentage Distribution of Various Dosage Forms Based on Revenues, 2011 17
Figure 7: Manufacturing of Solid Dosage Forms, Drivers and Restraints, 2011 19
Figure 8: Manufacturing of Solid Dosage Forms, API Market, ($bn), 2011-2018 20
Figure 9: Manufacturing of Solid Dosage Forms, Market Drivers and Restraints, 2011 22
Figure 10: Manufacturing of Solid Dosage Forms, Excipient Market, ($m), 2011-2018 23
Figure 11: Manufacturing of Solid Dosage Forms, Excipient Types, 2011 24
Figure 12: Manufacturing of Solid Dosage Forms, Excipient Types Used in Pharmaceutical Manufacturing, 2011 24
Figure 13: Manufacturing of Solid Dosage Forms, Excipient Drivers and Restraints, 2011 25
Figure 14: Manufacturing of Solid Dosage Forms, CMO Industry Structure, 2011 28
Figure 15: Manufacturing of Solid Dosage Forms, Global Pharmaceutical Contract Manufacturing Market, ($bn), 2011-2018 29
Figure 16: Manufacturing of Solid Dosage Forms, CMO Market Size For The Solid Dosage Forms, ($bn), 2011-2018 30
Figure 17: Manufacturing of Solid Dosage Forms, CMO Market Drivers and Restraints, 2011 31
Figure 18: Manufacturing of Solid Dosage Forms, Technology Trends, 1960-2011 33
Figure 19: Manufacturing of Solid Dosage Forms, Innovative Technology, 2011 34
Figure 20: Manufacturing of Solid Dosage Forms, Batch and Continuous Manufacturing Comparison, 2011 37
Figure 21: Manufacturing of Solid Dosage Forms, Unmet Needs and Challenges, 2011 39
Figure 22: Manufacturing of Solid Dosage Forms, cGMP Guidelines, 2011 40
Figure 23: Manufacturing of Solid Dosage Forms, cGMP Guidelines for APIs, 2011 41
Figure 24: Manufacturing of Solid Dosage Forms, Regulatory Landscape, cGMP Guidelines for Excipients, 2011 48
Figure 25: Manufacturing of Solid Dosage Forms, Competitive Landscape, SWOT Analysis, CAPSUGEL, 2011 49
Figure 26: Manufacturing of Solid Dosage Forms, Competitive Landscape, SWOT Analysis, Patheon, 2011 51
Figure 27: Manufacturing of Solid Dosage Forms, Competitive Landscape, SWOT Analysis, AAI Pharma, 2011 53
Figure 28: Manufacturing of Solid Dosage Forms, Competitive Landscape, SWOT Analysis, FAMAR, 2011 56
Figure 29: Manufacturing of Solid Dosage Forms, Competitive Landscape, SWOT Analysis, EGIS, 2011 59
Figure 30: Manufacturing of Solid Dosage Forms, Competitive Landscape, SWOT Analysis, STADA, 2011 61
Figure 31: Manufacturing of Solid Dosage Forms, Competitive Landscape, SWOT Analysis, Mylan, 2011 64
Figure 32: Manufacturing of Solid Dosage Forms, Competitive Landscape, SWOT Analysis, DSM Pharmaceuticals, 2011 71
Figure 33: Manufacturing of Solid Dosage Forms, Competitive Landscape, SWOT Analysis, TEVA, 2011 72