; Contract Manufacturing Organizations to 2018 - Cost Advantages and Improving Quality Standards Build Confidence and Encourage Foreign Investment in Asian CMOs
Documents
Resources
Learning Center
Upload
Plans & pricing Sign in
Sign Out
Your Federal Quarterly Tax Payments are due April 15th Get Help Now >>

Contract Manufacturing Organizations to 2018 - Cost Advantages and Improving Quality Standards Build Confidence and Encourage Foreign Investment in Asian CMOs

VIEWS: 9 PAGES: 84

The report which provides key data, information and analysis of the Contract Manufacturing Organization (CMO) industry. The report provides a comprehensive insight into the size of the CMO market, and includes forecasts, key reasons for outsourcing, the geographical landscape of CMO’s, profiles of top CMOs, regulatory frameworks, drivers and restraints and deals analysis.

More Info
  • pg 1
									        Contract Manufacturing Organizations to 2018 - Cost
         Advantages and Improving Quality Standards Build
       Confidence and Encourage Foreign Investment in Asian
                              CMOs
 Reference Code: GBIHC206MR                                                                                             Publication Date: April 2012


  The global CMO market is          Global CMO Market is Poised for Impressive Growth
  forecast to reach
  approximate revenues of           GBI Research suggests that the global Contract Manufacturing Organizations (CMO) market will
  $59.9 billion by 2018             grow steadily because the outsourcing of pharmaceutical production by the Western
  growing at a CAGR of              pharmaceutical companies has increased a lot to the Asian countries. The market value of global
  11% between 2010 and              CMO market was approximately at $26 billion in 2010. This global CMO market grew at a
  2018.                             Compound Annual Growth Rate (CAGR) of 10.7% over 2008, when the market was approximately
                                    $21.2 billion. Increase in the biologics and generic manufacturing is the main factor which is driving
                                    the market. The market is forecast to reach approximately with a value of $59.9 billion by 2018. The
                                    global CMO market will grow approximately at a CAGR of 11% between 2010 and 2018.

                                     CMO Market, Global, Revenue Forecasts ($bn), 2008-2018

                                                        70
                                                                                                  CAGR (2010-2018) : 11.0%


                                                        60



                                                        50
                                        Revenue ($bn)




                                                        40

                                                             CAGR (2008-2010) : 10.7%

                                                        30



                                                        20



                                                        10



                                                         0
                                                                   2008                            2010                            2018


                                     Source: GBI Research, WHO, FDA, Contract Pharma




Contract Manufacturing Organizations to 2018 - Cost                                                                  GBIHC206MR / Published APR 2012
Advantages and Improving Quality Standards Build Confidence                                                                                        Page 1
and Encourage Foreign Investment in Asian CMOs                                  © GBI Research. This report is a licensed product and is not to be copied,
                                                                                                                reproduced, shared or resold in any form
                                    Cost Advantages and Improving Quality Standards Encourage Foreign Investment in Asian
                                    CMOs
                                    There is increasing demand for CMO services globally. The fastest growing countries in this sector
                                    – namely, India and China – have witnessed drastic changes in their government and regulatory
                                    policies to favor pharmaceutical outsourcing. Accordingly, these governments have also started
                                    introducing sanctions favoring CMOs in order to increase business and attract foreign clients. For
                                    example, in 2005 the Indian Biotechnology Policy issued a lot easier process for regulatory
                                    clearance (single window clearances) along with the exemptions from import duties and service
                                    taxes, which is encouraging the foreign investments within the country. Also in January 2005, the
                                    introduction of the new patent rule in India encouraged many multinational pharmaceutical
                                    companies to outsource their manufacturing units here protected by Intellectual Property Rights
                                    (IPRs). The amendment of the Schedule Y article allows parallel phase clinical trials to be
                                    conducted along with reduced custom duties on the samples of clinical trials, which are being
                                    imported. In China the State Food and Drug Administration (SFDA) has clearly stated contract
                                    manufacturing as a long-term goal for the country’s economic growth. In early 2001, Article 13 of
                                    the new edition of the “Drug Administration Law” was issued. According to this a drug
                                    manufacturer, authorized by the drug regulatory department which is under the State Council, may
                                    produce drugs only after getting approval of the drug regulatory department. The availability of
                                    adequate numbers of current good manufacturing practices (cGMP)-compliant manufacturing sites
                                    in the Asian region make India and China popular outsourcing destinations of choice for CMOs.
                                    Eastern Europe Offers Better IPR Protection Compared to Other Emerging CMO
                                    Destinations
                                    GBI Research finds that most of the countries in Eastern Europe offer superior IPR protection
                                    compared to other emerging CMO markets. The Eastern European nations have strong Intellectual
                                    Property (IP) protection and enforcement frameworks and witness fewer instances of IPR violation,
                                    unlike their Asian counterparts which lack a proper IPR protection and enforcement framework and
                                    witness more instances of IPR violation. Better IPR protection and enforcement frameworks in
                                    Eastern Europe are one of the key drivers for outsourcing to Eastern Europe.




Contract Manufacturing Organizations to 2018 - Cost                                                       GBIHC206MR / Published APR 2012
Advantages and Improving Quality Standards Build Confidence                                                                             Page 2
and Encourage Foreign Investment in Asian CMOs                       © GBI Research. This report is a licensed product and is not to be copied,
                                                                                                     reproduced, shared or resold in any form
                                    1         Table of Contents
                                    1   Table of Contents ........................................................................................................................ 3
                                        1.1    List of Tables..................................................................................................................... 5
                                        1.2    List of Figures ................................................................................................................... 6
                                    2   Contract Manufacturing Organizations to 2018 - Introduction ..................................................... 7
                                        2.1    GBI Research Guide ......................................................................................................... 7
                                    3   Contract Manufacturing Organizations to 2018 - Industry Overview............................................ 8
                                        3.1    Current Status of Pharmaceutical Industry ....................................................................... 8
                                        3.2    Cost Optimization Steps for the Pharmaceutical Companies ............................................ 8
                                           3.2.1    Reduction in Physical Assets..................................................................................... 9
                                           3.2.2    Downsizing Manufacturing ........................................................................................ 9
                                           3.2.3    Reduction in R&D Spending .................................................................................... 10
                                        3.3    What CMOs are and Reasons for Outsourcing to Them ................................................. 12
                                           3.3.1    Different Types of CMOs and the Range of Services Provided by Them ................ 12
                                           3.3.2    How Does Outsourcing to CMOs Take Place? ........................................................ 14
                                           3.3.3    Key Outsourcing Models ......................................................................................... 16
                                           3.3.4    Key Benefits of Outsourcing .................................................................................... 18
                                    4   Contract Manufacturing Organizations to 2018 - Market Characterization ................................ 21
                                        4.1    Market Forecasts ............................................................................................................ 21
                                    5   Contract Manufacturing Organizations to 2018 - Geographical Landscape .............................. 23
                                        5.1    Introduction ..................................................................................................................... 23
                                        5.2    Established Markets ........................................................................................................ 24
                                           5.2.1    The US CMO Market ............................................................................................... 24
                                           5.2.2    The Eastern European CMO Market ....................................................................... 25
                                        5.3    Emerging Markets ........................................................................................................... 27
                                           5.3.1    The Indian CMO Market .......................................................................................... 27
                                           5.3.2    The Chinese CMO Market ....................................................................................... 29
                                    6   Contract Manufacturing Organizations to 2018 - Market Drivers and Restraints ....................... 32
                                        6.1    Global CMO Market Drivers ............................................................................................ 33
                                           6.1.1    Availability of Low-cost Skilled Manpower ............................................................... 33
                                           6.1.2    Increasing Government Sanctions are Favoring CMOs .......................................... 34
                                           6.1.3    Increased Consumption of Generics ....................................................................... 35
                                           6.1.4    Better Intellectual Property Rights Protection .......................................................... 40
                                           6.1.5    Increasing Uptake of Biologics and Entry of Biosimilars into Market ....................... 41
                                        6.2    Global CMO Market Restraints ....................................................................................... 42
                                           6.2.1    Capacity Utilization Issues Affecting the Profitability of CMOs ................................ 42
                                           6.2.2    Reduced Number of New Drug Approvals ............................................................... 42
                                           6.2.3    Complex Cost Structures in Outsourcing................................................................. 45
                                    7   Contract Manufacturing Organizations to 2018 - Regulatory Framework .................................. 46
                                        7.1    Overview ......................................................................................................................... 46
                                        7.2    FDA Guidelines ............................................................................................................... 46
                                           7.2.1    Organization and Personnel .................................................................................... 46
                                           7.2.2    Building and Facilities .............................................................................................. 47
                                           7.2.3    Process Equipment ................................................................................................. 47
                                           7.2.4    Control of Raw Materials ......................................................................................... 47
                                           7.2.5    Production and Process Controls ............................................................................ 47
                                           7.2.6    Packaging and Labeling .......................................................................................... 47
                                           7.2.7    Holding and Distribution .......................................................................................... 48
                                           7.2.8    Key Changes in FDA Guidelines ............................................................................. 48
                                        7.3    EMA Guidelines .............................................................................................................. 49
                                           7.3.1    Quality Management ............................................................................................... 50
                                           7.3.2    Production Activities ................................................................................................ 51
                                           7.3.3    Buildings and Facilities ............................................................................................ 51
                                           7.3.4    Process Equipment ................................................................................................. 52


Contract Manufacturing Organizations to 2018 - Cost                                                                      GBIHC206MR / Published APR 2012
Advantages and Improving Quality Standards Build Confidence                                                                                            Page 3
and Encourage Foreign Investment in Asian CMOs                                      © GBI Research. This report is a licensed product and is not to be copied,
                                                                                                                    reproduced, shared or resold in any form
                                          7.3.5    Materials Management ............................................................................................ 52
                                          7.3.6    Packaging and Labeling .......................................................................................... 52
                                          7.3.7    Key Changes in EMA Guidelines............................................................................. 53
                                       7.4    PIC/S .............................................................................................................................. 53
                                    8 Contract Manufacturing Organizations to 2018 - Key Aspects of the Upstream and Downstream
                                       Processing CMO Industry .......................................................................................................... 55
                                       8.1    Comparison of Upstream Processing and Downstream Processing ............................... 55
                                          8.1.1    CMO Market Size for Upstream Processing ............................................................ 56
                                          8.1.2    CMO Market Size for Downstream Processing ....................................................... 57
                                    9 Contract Manufacturing Organizations to 2018 - Key CMO Participants ................................... 58
                                       9.1    Catalent Pharma Solutions, Inc....................................................................................... 58
                                       9.2    Lonza Group AG ............................................................................................................. 60
                                       9.3    Royal DSM N.V. .............................................................................................................. 62
                                       9.4    Piramal Healthcare Ltd. .................................................................................................. 64
                                       9.5    Jubilant Life Sciences ..................................................................................................... 65
                                       9.6    Evonik Industries AG ...................................................................................................... 67
                                       9.7    Patheon Inc. .................................................................................................................... 68
                                       9.8    Fareva Holding................................................................................................................ 69
                                       9.9    Cambrex ......................................................................................................................... 70
                                       9.10 Boehringer Ingelheim ...................................................................................................... 71
                                    10 Contract Manufacturing Organizations to 2018 - Strategic Consolidations within the Global
                                       CMO Market .............................................................................................................................. 72
                                       10.1 Mergers and Acquisitions ................................................................................................ 72
                                          10.1.1 Summary of Mergers and Acquisitions .................................................................... 72
                                       10.2 Co-development Deals ................................................................................................... 73
                                          10.2.1 Summary of Co-development Deals ........................................................................ 74
                                       10.3 Licensing Deals............................................................................................................... 76
                                          10.3.1 Summary of Licensing Deals ................................................................................... 77
                                    11 Contract Manufacturing Organizations to 2018 - Appendix ....................................................... 80
                                       11.1 Market Definitions ........................................................................................................... 80
                                       11.2 Abbreviations .................................................................................................................. 80
                                       11.3 Research Methodology ................................................................................................... 81
                                          11.3.1 Coverage ................................................................................................................. 82
                                          11.3.2 Secondary Research ............................................................................................... 82
                                          11.3.3 Primary Research .................................................................................................... 82
                                          11.3.4 Expert Panel Validation ........................................................................................... 83
                                       11.4 Contact Us ...................................................................................................................... 83
                                       11.5 Disclaimer ....................................................................................................................... 83
                                       11.6 Sources ........................................................................................................................... 83




Contract Manufacturing Organizations to 2018 - Cost                                                                      GBIHC206MR / Published APR 2012
Advantages and Improving Quality Standards Build Confidence                                                                                            Page 4
and Encourage Foreign Investment in Asian CMOs                                      © GBI Research. This report is a licensed product and is not to be copied,
                                                                                                                    reproduced, shared or resold in any form
                                    1.1    List of Tables
                                    Table 1:    CMO Market, Global, Revenue ($bn), 2008-2010 .......................................................... 21
                                    Table 2:    CMO Market, Global, Revenue Forecasts ($bn), 2010-2018 ......................................... 21
                                    Table 3:    CMO Market, The US, Revenue ($bn), 2008-2010 ........................................................ 24
                                    Table 4:    CMO Market, The US, Revenue Forecasts ($bn), 2010-2018 ....................................... 25
                                    Table 5:    CMO Market, The Central and Eastern Europe, Revenue ($bn), 2008-2010................. 26
                                    Table 6:    CMO Market, The Central and Eastern Europe, Revenue Forecasts ($bn), 2010-2018 26
                                    Table 7:    CMO Market, India, Revenue ($bn), 2008-2010 ............................................................ 27
                                    Table 8:    CMO Market, India, Revenue Forecasts ($bn), 2010-2018............................................ 27
                                    Table 9:    CMO Market, China, Revenue ($bn), 2008-2010 ........................................................... 29
                                    Table 10:   CMO Market, China, Revenue Forecasts ($bn), 2010-2018 .......................................... 29
                                    Table 11:   CMO Market, Global, Market Drivers, All Employees: Index of Hourly Compensation
                                                Costs (United States = 100) ........................................................................................... 33
                                    Table 12:   CMO Market, Global, Market Drivers, Major Drug Patent Expirations, 2012-2018......... 36
                                    Table 13:   CMO Market, Global, Market Restraints, Reduction in Drug Approval Rates by FDA,
                                                1996-2010 ...................................................................................................................... 43
                                    Table 14:   CMO Market, Global, Market Restraints, Opportunities Lost by CMOs Due to Reduced
                                                Approval Rates by FDA.................................................................................................. 44
                                    Table 15:   CMO Market, Global, PIC/S Members from Eastern Europe ......................................... 53
                                    Table 16:   CMO Market, Global, Upstream Processing in Biopharmaceuticals, Comparison of
                                                Upstream and Downstream Process.............................................................................. 55
                                    Table 17:   CMO Market, Upstream Processing in Biopharmaceuticals, Revenue Forecast,($bn),
                                                2009-2018 ...................................................................................................................... 56
                                    Table 18:   CMO Market, Downstream Processing in Biopharmaceuticals, Revenue Forecast ($bn),
                                                2009-2018 ...................................................................................................................... 57
                                    Table 19:   CMO Market, Global, M&A, 2009-2011.......................................................................... 72
                                    Table 20:   CMO Market, Global, Co-development Deals, 2009-2011 ............................................. 73
                                    Table 21:   CMO Market, Global, Licensing Deals, 2009-2011 ........................................................ 76




Contract Manufacturing Organizations to 2018 - Cost                                                                   GBIHC206MR / Published APR 2012
Advantages and Improving Quality Standards Build Confidence                                                                                         Page 5
and Encourage Foreign Investment in Asian CMOs                                   © GBI Research. This report is a licensed product and is not to be copied,
                                                                                                                 reproduced, shared or resold in any form
                                    1.2       List of Figures
                                    Figure 1:  CMO Market, Global, Cost Optimization Steps in the Pharmaceutical Industry ............. 10
                                    Figure 2:  CMO Market, Global, Impact Analysis of Various Cost Optimization Methods .............. 11
                                    Figure 3:  CMO Market, Global, Industry Structure ....................................................................... 12
                                    Figure 4:  CMO Market, Global, Process for Selection of CMO and Management of Outsourcing
                                               Project ............................................................................................................................ 14
                                    Figure 5: CMO Market, Global, Key Benefits of Outsourcing to CMOs ......................................... 18
                                    Figure 6: CMO Market, Global, Revenue Forecasts ($bn), 2008-2018 ......................................... 21
                                    Figure 7: CMO Market, Global, Market Share by Services Provided %, 2010 .............................. 22
                                    Figure 8: CMO Market, Global, Revenue Split of Global CMO Market by Geography %, 2010 .... 23
                                    Figure 9: CMO Market, The US, Revenue Forecasts ($bn), 2008-2018 ....................................... 24
                                    Figure 10: CMO Market, The Top Five European Countries Vs The Central and Eastern Europe
                                               Countries (%), 2010 ....................................................................................................... 25
                                    Figure 11: CMO Market, The Central and Eastern Europe, Revenue Forecasts ($bn), 2008-2018 26
                                    Figure 12: CMO Market, India, Revenue Forecasts ($bn), 2008-2018............................................ 27
                                    Figure 13: CMO Market, China, Revenue Forecasts ($bn), 2008-2018 .......................................... 29
                                    Figure 14: CMO Market, Global, Contract Manufacturing Organizations, Global Market Driver and
                                               Restraints ....................................................................................................................... 32
                                    Figure 15: CMO Market, Global, Market Drivers, Difference in Hourly Wage Costs in Euro Area 
								
To top
;