gbihc264mr seasonal influenza vaccine market in … › product › sample-7503566.pdfseasonal...

Seasonal Influenza Vaccine Market in Asia-Pacific to 2018 Positive Impact of Government Support Offset by Limited Production Capacity, High Investment and Strict Regulations as Barriers to New Entrants

GBI Research Report Guidance

© GBI Research. This is a licensed product and is not to be photocopied GBIHC264MR / Published APR 2013

GBI Research Report Guidance

The chapter begins an executive summary, which draws out the key points that are driving the seasonal influenza vaccine market in the APAC region.

Chapter two is the introduction and includes the report guidance.

Chapter three gives an overview of the seasonal influenza vaccine market.

Chapter four gives detailed forecasts for the seasonal influenza vaccine market in Australia, comprising vaccination coverage, total number of doses administered, price per dose, market size, and drivers and restraints.

Chapter five gives detailed forecasts for the seasonal influenza vaccine market in China, comprising vaccination coverage, total number of doses administered, price per dose, market size, and drivers and restraints.

Chapter six gives detailed forecasts for the seasonal influenza vaccine market in Hong Kong, comprising vaccination coverage, total number of doses administered, price per dose, market size, and drivers and restraints.

Chapter seven gives detailed forecasts for the seasonal influenza vaccine market in India, comprising vaccination coverage, total number of doses administered, price per dose, market size, and drivers and restraints.

Chapter eight gives detailed forecasts for the seasonal influenza vaccine market in Japan, comprising vaccination coverage, total number of doses administered, price per dose, market size, and drivers and restraints.

Chapter nine gives detailed forecasts for the seasonal influenza vaccine market in Malaysia, comprising vaccination coverage, total number of doses administered, price per dose, market size, and drivers and restraints.

Chapter 10 gives detailed forecasts for the seasonal influenza vaccine market in New Zealand, comprising vaccination coverage, total number of doses administered, price per dose, market size, and drivers and restraints.

Chapter 11 gives detailed forecasts for the seasonal influenza vaccine market in Philippines, comprising vaccination coverage, total number of doses administered, price per dose, market size, and drivers and restraints.

Chapter 12 gives detailed forecasts for the seasonal influenza vaccine market in Singapore, comprising vaccination coverage, total number of doses administered, price per dose, market size, and drivers and restraints.

Chapter 13 gives detailed forecasts for the seasonal influenza vaccine market in Taiwan, comprising vaccination coverage, total number of doses administered, price per dose, market size, and drivers and restraints.

Chapter 14 lists promising vaccine candidates in various companies’ pipelines and provides detailed description of marketed vaccines and promising molecules.

Chapter 15 profiles the major companies active in the market.

Chapter 16 highlights key M&A deals that took place in the seasonal influenza vaccine market between 2007 and mid-2012 and lists the major R&D licensing agreements and co-development deals.


Executive Summary

Executive Summary

Seasonal Influenza Vaccine Market in Asia-Pacific is Set to Grow at a CAGR of XX% during the 2011–2018 Forecast Period

Seasonal Influenza Vaccine Market, APAC Region, Revenue Forecast ($bn), 2011–2018

2011 2012 2013 2014 2015 2016 2017 2018

Rev

enue

s ($

bn)

Australia China Hong Kong India Japan Malaysia New Zealand Philippines Singapore Taiwan

Source: GBI Research Proprietary Market Size Database [accessed on January 10, 2013]

GBI Research forecasts the market for seasonal influenza vaccines in the Asia-Pacific (APAC) region to grow at a Compound Annual Growth Rate (CAGR) of XX% during the 2011–2018 period from $XX billion to $XX billion driven by increasing disease awareness, wider vaccination coverage and rising government support for immunization against seasonal influenza. However, limited production capacity, a high level of required investment, and strict regulations present barriers to new entrants.

The seasonal influenza vaccines market in the Philippines is forecast to grow from $XXm in 2011 to $XXm in 2018 at an impressive CAGR of XX%. In 2011, the largest market in the APAC region was Japan with a XX% share, although this is forecast to decrease to XX% in 2018. Other attractive markets in terms of growth rate are India, Malaysia and Singapore, which are forecast to grow at CAGRs of XX%, XX% and XX% respectively. Australia also has a large market, forecast to grow at a CAGR of XX%. It currently accounts for around XX% of the overall APAC market. The seasonal influenza vaccines markets in Hong Kong, New Zealand and Taiwan are forecast to exhibit moderate growth during the forecast period, and the markets in China and India are forecast to grow at CAGRs of XX%.

Seasonal influenza vaccines in APAC to grow at a CAGR of XX% from $XX billion in 2011 to $XX billion in 2018


Page 5

Table of Contents

1 Table of Contents

1 Table of Contents ................................................................................................................................. 5 1.1 List of Tables ............................................................................................................................10 1.2 List of Figures...........................................................................................................................12

2 Introduction........................................................................................................................................14 3 Seasonal Influenza Vaccine Market in Asia-Pacific – Market Overview ..................................................15

3.1 Market Characterization and Forecasts.....................................................................................15 3.2 Revenue by Geographical Segmentation...................................................................................16

4 Seasonal Influenza Vaccine Market in Asia-Pacific – Australia ...............................................................18 4.1 Registration Process and Regulations .......................................................................................18 4.2 Market Characterization and Forecasts.....................................................................................21 4.3 Cost of Vaccination ..................................................................................................................22 4.4 Vaccination Pattern .................................................................................................................23

4.4.1 Population .......................................................................................................................23 4.4.2 Vaccinated Population Contribution..................................................................................24 4.4.3 Vaccination Coverage .......................................................................................................25 4.4.4 Number of Doses per Person .............................................................................................25 4.4.5 Total Number of Doses .....................................................................................................26 4.4.6 Dose Contribution ............................................................................................................26

4.5 Drivers and Barriers .................................................................................................................27 4.5.1 Drivers .............................................................................................................................27 4.5.2 Restraints ........................................................................................................................27

5 Seasonal Influenza Vaccine Market in Asia-Pacific – China ....................................................................28 5.1 Registration Process and Regulations .......................................................................................28 5.2 Market Characterization and Forecasts.....................................................................................30 5.3 Cost of Vaccination ..................................................................................................................31 5.4 Vaccination Pattern .................................................................................................................32


5.5 Competitive Landscape ............................................................................................................36 5.6 Drivers and Barriers .................................................................................................................36

5.6.1 Drivers .............................................................................................................................36 5.6.2 Barriers ............................................................................................................................36

6 Seasonal Influenza Vaccine Market in Asia-Pacific – Hong Kong ............................................................37 6.1 Registration Process and Regulations .......................................................................................37 6.2 Market Characterization and Forecasts.....................................................................................39 6.3 Cost of Vaccination ..................................................................................................................40 6.4 Vaccination Pattern .................................................................................................................41



6.6.1 Drivers .............................................................................................................................46


Page 6

Table of Contents

6.6.2 Restraints ........................................................................................................................46 7 Seasonal Influenza Vaccine Market in Asia-Pacific – India .....................................................................47

7.1 Registration Process and Regulations .......................................................................................47 7.2 Market Characterization and Forecasts.....................................................................................50 7.3 Cost of Vaccination ..................................................................................................................51 7.4 Drivers and Barriers .................................................................................................................52


8 Seasonal Influenza Vaccine Market in Asia-Pacific – Japan ....................................................................53 8.1 Registration Process and Regulations .......................................................................................53 8.2 Market Characterization and Forecasts.....................................................................................55 8.3 Cost of Vaccination ..................................................................................................................56 8.4 Vaccinated Population .............................................................................................................57

8.4.1 Population .......................................................................................................................57 8.4.2 Vaccinated Population Contribution..................................................................................58 8.4.3 Vaccination Coverage .......................................................................................................59

8.5 Drivers and Restraints ..............................................................................................................61 8.5.1 Drivers .............................................................................................................................61 8.5.2 Barriers ............................................................................................................................62

9 Seasonal Influenza Vaccine Market in Asia-Pacific – Malaysia ...............................................................63 9.1 Registration Process and Regulations .......................................................................................63 9.2 Market Characterization and Forecasts.....................................................................................65 9.3 Cost of Vaccination ..................................................................................................................66 9.4 Vaccination Pattern .................................................................................................................67




10 Seasonal Influenza Vaccine Market in Asia-Pacific – New Zealand.........................................................73 10.1 Registration Process and Regulations .......................................................................................73 10.2 Market Characterization and Forecasts.....................................................................................75 10.3 Cost of Vaccination ..................................................................................................................76 10.4 Vaccination Pattern .................................................................................................................77




11 Seasonal Influenza Vaccine Market in Asia-Pacific – Philippines ............................................................83 11.1 Registration Process and Regulations .......................................................................................83 11.2 Market Characterization and Forecasts.....................................................................................85


Page 7

Table of Contents

11.3 Cost of Vaccination ..................................................................................................................86 11.4 Vaccination Pattern .................................................................................................................87



11.6.1 Drivers .............................................................................................................................92 11.6.2 Restraints ........................................................................................................................92

12 Seasonal Influenza Vaccine Market in Asia-Pacific – Singapore .............................................................93 12.1 Registration Process and Regulations .......................................................................................93 12.2 Market Characterization and Forecasts.....................................................................................94 12.3 Cost of Vaccination ..................................................................................................................95 12.4 Vaccination Pattern .................................................................................................................96


12.5 Competitive Landscape .......................................................................................................... 100 12.6 Drivers and Barriers ............................................................................................................... 101

12.6.1 Drivers ........................................................................................................................... 101 12.6.2 Barriers .......................................................................................................................... 101

13 Seasonal Influenza Vaccine Market in Asia-Pacific – Taiwan ............................................................... 102 13.1 Registration Process and Regulations ..................................................................................... 102 13.2 Market Characterization and Forecasts................................................................................... 104 13.3 Cost of Vaccination ................................................................................................................ 105 13.4 Vaccination Pattern ............................................................................................................... 106

13.4.1 Population ..................................................................................................................... 106 13.4.2 Vaccinated Population Contribution................................................................................ 107 13.4.3 Vaccination Coverage ..................................................................................................... 108 13.4.4 Number of Doses per Person ........................................................................................... 108 13.4.5 Total Number of Doses ................................................................................................... 109 13.4.6 Dose Contribution .......................................................................................................... 109

13.5 Competitive Landscape .......................................................................................................... 110 13.6 Drivers and Barriers ............................................................................................................... 111

13.6.1 Drivers ........................................................................................................................... 111 13.6.2 Restraints ...................................................................................................................... 111

14 Seasonal Influenza Vaccine Market in Asia-Pacific - Pipeline Analysis .................................................. 112 14.1 Pipeline Analysis by Phase ...................................................................................................... 112 14.2 Product Profiles of Promising Molecules ................................................................................. 117

14.2.1 Optaflu .......................................................................................................................... 118 14.2.2 GSK2186877A ................................................................................................................ 118 14.2.3 Intanza/Flu-ID ................................................................................................................ 119 14.2.4 Fluad Pediatric ............................................................................................................... 120 14.2.5 FluBlok ........................................................................................................................... 120

14.3 Product Profiles of Marketed Products ................................................................................... 121 14.3.1 Fluarix ........................................................................................................................... 121


Page 8

Table of Contents

14.3.2 Vaxigrip ......................................................................................................................... 121 14.3.3 Influvac .......................................................................................................................... 121 14.3.4 Fluvax ............................................................................................................................ 121 14.3.5 Agrippal ......................................................................................................................... 121

15 Seasonal Influenza Vaccine Market in Asia-Pacific – Competitive Landscape ....................................... 122 15.1 Sanofi Pasteur........................................................................................................................ 122 15.2 GlaxoSmithKline Biologicals .................................................................................................... 122 15.3 Abbott Laboratories (Solvay Pharmaceuticals) ........................................................................ 122 15.4 CSL Biotherapies .................................................................................................................... 122 15.5 Novartis Vaccines................................................................................................................... 123 15.6 Crucell N.V. (Berna Biotech) ................................................................................................... 123

16 Seasonal Influenza Vaccine Market in Asia-Pacific – Strategic Consolidations ...................................... 124 16.1 Overview ............................................................................................................................... 124 16.2 Major Merger and Acquisition Deals, 2007–2012 .................................................................... 124

16.2.1 AstraZeneca Acquires Medimmune ................................................................................. 125 16.2.2 Sanofi-Aventis (now Sanofi) Acquires Acambis ................................................................ 125 16.2.3 Mymetics Acquires Virosome Biologicals ......................................................................... 125 16.2.4 Simcere Pharmaceutical Acquires a Majority Stake in Jiangsu Yanshen Biological Technology

Stock.............................................................................................................................. 125 16.2.5 Novartis Completes Acquisition of 85% Stake in Zhejiang Tianyuan .................................. 126 16.2.6 Abbott Laboratories Acquires Solvay Pharmaceuticals ..................................................... 126 16.2.7 Nutri Pharma Acquires a Majority Stake in Bionor Immuno ............................................. 126 16.2.8 Johnson & Johnson Acquires Crucell ................................................................................ 126 16.2.9 GlaxoSmithKline to Acquire Remaining Interest in Shenzhen GSK-Neptunus Biologicals .... 126

16.3 M&A Deals by Geography ...................................................................................................... 127 16.4 Major Licensing Agreements, 2007–2012 ............................................................................... 128

16.4.1 Crucell Enters into License Agreement with Adimmune Corporation ................................. 128 16.4.2 MedImmune Enters into Licensing Agreement with Sanofi Pasteur .................................. 128 16.4.3 Vivalis Enters into Licensing Agreement with GlaxoSmithKline ......................................... 128 16.4.4 Vivalis Enters into Licensing Agreement with Nobilon International ................................. 128 16.4.5 MedImmune Enters into Licensing Agreement with GlaxoSmithKline ............................... 128 16.4.6 Hemispherx Biopharma Enters into Licensing Agreement with Biken ................................ 129 16.4.7 MedImmune Enters into Licensing Agreement with Biken ................................................ 129 16.4.8 MedImmune Enters into Licensing Agreement with Omninvest ........................................ 129 16.4.9 OPKO Health Enters into Licensing Agreement with Academia Sinica ............................... 129 16.4.10 Altravax Enters into Licensing Agreement with Maxygen ................................................. 129 16.4.11 Protein Sciences Expands its Licensing Agreement with UMN Pharma for FluBlok and

PanBlok ......................................................................................................................... 129 16.4.12 NasVax Extends its Research Agreement with Novartis ................................................... 130 16.4.13 iBio Enters into Licensing Agreement with G-Con............................................................. 130

16.5 Licensing Deals by Geography ................................................................................................ 131 17 Seasonal Influenza Vaccine Market in Asia-Pacific – Appendix ............................................................ 132

17.1 Market Definitions ................................................................................................................. 132 17.2 Abbreviations ........................................................................................................................ 132 17.3 Bibliography .......................................................................................................................... 133 17.4 Research Methodology .......................................................................................................... 134

17.4.1 Coverage ....................................................................................................................... 134 17.4.2 Secondary Research ....................................................................................................... 135 17.4.3 Primary Research ........................................................................................................... 135

17.5 Therapeutic Landscape .......................................................................................................... 136 17.5.2 Market Size by Geography .............................................................................................. 137

17.6 Geographical Landscape ........................................................................................................ 138


Page 9

Table of Contents

17.7 Pipeline Analysis .................................................................................................................... 138 17.8 Competitive Landscape .......................................................................................................... 138

17.8.1 Expert Panel Validation .................................................................................................. 138 17.9 Contact Us ............................................................................................................................. 138 17.10 Disclaimer.............................................................................................................................. 138


Page 10

Table of Contents

1.1 List of Tables

Table 1: Seasonal Influenza Vaccine Market, APAC Region, Revenue Forecast ($bn), 2011–2018............15 Table 2: Seasonal Influenza Vaccine Market, APAC Region, Revenue Forecast by Geography ($m), 2011–

2018 .......................................................................................................................................16 Table 3: Seasonal Influenza Vaccine Market, Australia, Revenue Forecast ($m), 2011–2018 ...................21 Table 4: Seasonal Influenza Vaccine Market, Australia, Vaccination Cost Forecast ($), 2011–2018..........22 Table 5: Seasonal Influenza Vaccine Market, Australia, Population Forecast by Age Group (million), 2011–

2018 .......................................................................................................................................23 Table 6: Seasonal Influenza Vaccine Market, Australia, Vaccinated Population Forecast by Age Group (%),

2011–2018 .............................................................................................................................24 Table 7: Seasonal Influenza Vaccine Market, Australia, Vaccination Coverage Forecast by Age Group

(million), 2011–2018 ...............................................................................................................25 Table 8: Seasonal Influenza Vaccine Market, Australia, Number of Doses Forecast by Age Group (million),

2011–2018 .............................................................................................................................26 Table 9: Seasonal Influenza Vaccine Market, China, Revenue Forecast ($m), 2011–2018 .......................30 Table 10: Seasonal Influenza Vaccine Market, China, Vaccination Cost Forecast ($), 2011–2018 ..............31 Table 11: Seasonal Influenza Vaccine Market, China, Population Forecast by Age Group (million), 2011–

2018 .......................................................................................................................................32 Table 12: Seasonal Influenza Vaccine Market, China, Vaccinated Population Forecast (%), 2011–2018 .....33 Table 13: Seasonal Influenza Vaccine Market, China, Vaccination Coverage Forecast (million), 2011–2018

...............................................................................................................................................34 Table 14: Seasonal Influenza Vaccine Market, China, Number of Doses Forecast (million), 2011–2018 .....35 Table 15: Seasonal Influenza Vaccine Market, Hong Kong, Revenue Forecast ($m), 2011–2018................39 Table 16: Seasonal Influenza Vaccine Market, Hong Kong, Vaccination Cost Forecast ($), 2011–2018.......40 Table 17: Seasonal Influenza Vaccine Market, Hong Kong, Population Forecast by Age Group, (million),

2011–2018 .............................................................................................................................41 Table 18: Seasonal Influenza Vaccine Market, Hong Kong, Vaccinated Population Forecast by Age Group

(%), 2011–2018 .......................................................................................................................42 Table 19: Seasonal Influenza Vaccine Market, Hong Kong, Vaccination Coverage Forecast (‘000), 2011–

2018 .......................................................................................................................................43 Table 20: Seasonal Influenza Vaccine Market, Hong Kong, Number of Doses Forecast by Age Group (‘000),

2011–2018 .............................................................................................................................44 Table 21: Seasonal Influenza Vaccine Market, India, Revenue Forecast ($m), 2011–2018.........................50 Table 22: Seasonal Influenza Vaccine Market, India, Vaccination Cost Forecast ($), 2011–2018................51 Table 23: Seasonal Influenza Vaccine Market, Japan, Revenue Forecast ($m), 2011–2018 .......................55 Table 24: Seasonal Influenza Vaccine Market, Japan, Vaccine Cost ($), 2011–2018 ..................................56 Table 25: Seasonal Influenza Vaccine Market, Japan, Population Forecast by Age Group (million), 2011–

2018 .......................................................................................................................................57 Table 26: Seasonal Influenza Vaccine Market, Japan, Vaccination Coverage Forecast by Age Group (%),

2011–2018 .............................................................................................................................58 Table 27: Seasonal Influenza Vaccine Market, Japan, Overall Vaccination Coverage (million), 2011–2018 59 Table 28: Seasonal Influenza Vaccine Market, Japan, Vaccination Coverage by Age Group (million), 2011–

2018 .......................................................................................................................................59 Table 29: Seasonal Influenza Vaccine Market, Japan, Number of Doses Forecast (million), 2011–2018 .....59 Table 30: Seasonal Influenza Vaccine Market, Japan, Number of Doses Forecast by Age Group (million),

2011–2018 .............................................................................................................................60 Table 31: Seasonal Influenza Vaccine Market, Malaysia, Revenue Forecast ($m), 2011–2018 ...................65 Table 32: Seasonal Influenza Vaccine Market, Malaysia, Vaccination Cost Forecast ($), 2011–2018..........66 Table 33: Seasonal Influenza Vaccine Market, Malaysia, Population Forecast by Age Group (million), 2011–

2018 .......................................................................................................................................67 Table 34: Seasonal Influenza Vaccine Market, Malaysia, Vaccinated Population Forecast by Age Group (%),

2011–2018 .............................................................................................................................68 Table 35: Seasonal Influenza Vaccine Market, Malaysia, Vaccination Coverage Forecast by Age Group

(‘000), 2011–2018 ...................................................................................................................69 Table 36: Seasonal Influenza Vaccine Market, Malaysia, Number of Doses Forecast by Age Group (‘000),

2011–2018 .............................................................................................................................70 Table 37: Seasonal Influenza Vaccine Market, New Zealand, Revenue Forecast ($m), 2011–2018 ............75 Table 38: Seasonal Influenza Vaccine Market, New Zealand, Vaccination Cost Forecast (%), 2011–2018 ..76


Page 11

Table of Contents

Table 39: Seasonal Influenza Vaccine Market, New Zealand, Population by Age Group Forecast (million), 2011–2018 .............................................................................................................................77

Table 40: Seasonal Influenza Vaccine Market, New Zealand, Vaccinated Population Forecast (%), 2011–2018 .......................................................................................................................................78

Table 41: Seasonal Influenza Vaccine Market, New Zealand, Vaccination Coverage Forecast (‘000), 2011–2018 .......................................................................................................................................79

Table 42: Seasonal Influenza Vaccine Market, New Zealand, Number of Doses Forecasts (‘000), 2011–2018...............................................................................................................................................80

Table 43: Seasonal Influenza Vaccine Market, Philippines, Revenue Forecast ($m), 2011–2018 ...............85 Table 44: Seasonal Influenza Vaccine Market, Philippines, Vaccination Cost Forecast ($), 2011–2018 ......86 Table 45: Seasonal Influenza Vaccine Market, Philippines, Population Forecast (million), 2011–2018 .......87 Table 46: Seasonal Influenza Vaccine Market, Philippines, Vaccinated Population Forecast (%), 2011–2018

...............................................................................................................................................88 Table 47: Seasonal Influenza Vaccine Market, Philippines, Vaccination Coverage Forecast (million), 2011–

2018 .......................................................................................................................................89 Table 48: Seasonal Influenza Vaccine Market, Philippines, Number of Doses Forecast (million), 2011–2018

...............................................................................................................................................90 Table 49: Seasonal Influenza Vaccine Market, Singapore, Revenue Forecast ($m), 2011–2018 .................94 Table 50: Seasonal Influenza Vaccine Market, Singapore, Vaccination Cost Forecast ($), 2011–2018 ........95 Table 51: Seasonal Influenza Vaccine Market, Singapore, Population Forecast by Age Group (million),

2011–2018 .............................................................................................................................96 Table 52: Seasonal Influenza Vaccine Market, Singapore, Vaccinated Population Forecast by Age Group

(%), 2011–2018 .......................................................................................................................97 Table 53: Seasonal Influenza Vaccine Market, Singapore, Vaccination Coverage Forecast (‘000), 2011–

2018 .......................................................................................................................................98 Table 54: Seasonal Influenza Vaccine Market, Singapore, Number of Doses Forecast by Age Group (‘000),

2011–2018 .............................................................................................................................99 Table 55: Seasonal Influenza Vaccine Market, Taiwan, Revenue Forecast ($m), 2011–2018 ................... 104 Table 56: Seasonal Influenza Vaccine Market, Taiwan, Vaccination Cost Forecast ($), 2011–2018 .......... 105 Table 57: Seasonal Influenza Vaccine Market, Taiwan, Population Forecast by Age Group (million), 2011–

2018 ..................................................................................................................................... 106 Table 58: Seasonal Influenza Vaccine Market, Taiwan, Vaccinated Population Forecast by Age Group (%),

2011–2018 ........................................................................................................................... 107 Table 59: Seasonal Influenza Vaccine Market, Taiwan, Vaccination Coverage Forecast by Age Group

(million), 2011–2018 ............................................................................................................. 108 Table 60: Seasonal Influenza Vaccine Market, Taiwan, Number of Doses Forecast by Age Group (million),

2011–2018 ........................................................................................................................... 109 Table 61: Seasonal Influenza Vaccine Market, APAC Region, Pipeline, Filed, 2012 .................................. 113 Table 62: Seasonal Influenza Vaccine Market, APAC Region, Pipeline, Phase III, 2012 ............................ 113 Table 63: Seasonal Influenza Vaccine Market, APAC Region, Pipeline, Phase II, 2012 ............................. 114 Table 64: Seasonal Influenza Vaccine Market, APAC Region, Pipeline, Phase I, 2012 .............................. 115 Table 65: Seasonal Influenza Vaccine Market, APAC Region, Pipeline, Preclinical, 2012 .......................... 116 Table 66: Seasonal Influenza Vaccine Market, APAC Region, Pipeline, Discovery Phase, 2012 ................ 116 Table 67: Seasonal Influenza Vaccine Market, APAC Region, Most Promising Vaccines in Clinical

Development, 2012............................................................................................................... 117 Table 68: Seasonal Influenza Vaccine Market, APAC Region, Major M&A Deals, 2007–2012................... 124


Page 12

Table of Contents

1.2 List of Figures

Figure 1: Seasonal Influenza Vaccine Market, APAC Region, Revenue Forecast ($m), 2011–2018.............15 Figure 2: Seasonal Influenza Vaccine Market, APAC Region, Revenue Forecast by Geography ($bn), 2011–

2018 .......................................................................................................................................16 Figure 3: Seasonal Influenza Vaccine Market, Australia, Regulatory Authorities, 2012 .............................18 Figure 4: Seasonal Influenza Vaccine Market, Australia, Drug Approval Process, 2011 .............................19 Figure 5: Seasonal Influenza Vaccine Market, Australia, Revenue Forecast ($m), 2011–2018 ...................21 Figure 6: Seasonal Influenza Vaccine Market, Australia, Vaccination Cost Forecast ($), 2011–2018..........22 Figure 7: Seasonal Influenza Vaccine Market, Australia, Population Forecast by Age Group (million), 2011–

2018 .......................................................................................................................................23 Figure 8: Seasonal Influenza Vaccine Market, Australia, Vaccinated Population Forecast by Age Group (%),

2011–2018 .............................................................................................................................24 Figure 9: Seasonal Influenza Vaccine Market, Australia, Number of Doses Forecast by Age Group (million),

2011–2018 .............................................................................................................................26 Figure 10: Seasonal Influenza Vaccine Market, Australia, Drivers and Barriers, 2012 .................................27 Figure 11: Seasonal Influenza Vaccine Market, China, Regulatory Authorities, 2011 ..................................28 Figure 12: Seasonal Influenza Vaccine Market, China, New Drug Registration Process, 2011 .....................29 Figure 13: Seasonal Influenza Vaccine Market, China, Revenue Forecast ($m), 2011–2018 .......................30 Figure 14: Seasonal Influenza Vaccine Market, China, Vaccination Cost Forecast ($), 2011–2018 ..............31 Figure 15: Seasonal Influenza Vaccine Market, China, Population Forecast by Age Group (million), 2011–

2018 .......................................................................................................................................32 Figure 16: Seasonal Influenza Vaccine Market, China, Vaccinated Population Forecast (%), 2011–2018 .....33 Figure 17: Seasonal Influenza Vaccine Market, China, Number of Doses Forecast (million), 2011–2018 .....35 Figure 18: Seasonal Influenza Vaccine Market, China, Drivers and Barriers, 2012 ......................................36 Figure 19: Seasonal Influenza Vaccine Market, Hong Kong, Regulatory Authorities, 2011 ..........................37 Figure 20: Seasonal Influenza Vaccine Market, Hong Kong, Drug Approval Process, 2011 ..........................38 Figure 21: Seasonal Influenza Vaccine Market, Hong Kong, Revenue Forecast ($m), 2011–2018................39 Figure 22: Seasonal Influenza Vaccine Market, Hong Kong, Vaccination Cost Forecast ($), 2011–2018.......40 Figure 23: Seasonal Influenza Vaccine Market, Hong Kong, Population Forecast by Age Group (million),

2011–2018 .............................................................................................................................41 Figure 24: Seasonal Influenza Vaccine Market, Hong Kong, Vaccinated Population Forecast by Age Group

(%), 2011–2018 .......................................................................................................................42 Figure 25: Seasonal Influenza Vaccine Market, Hong Kong, Number of Doses Forecast by Age Group (‘000),

2011–2018 .............................................................................................................................44 Figure 26: Seasonal Influenza Vaccine Market, Hong Kong, Market Share by Company (%), 2012 ..............45 Figure 27: Seasonal Influenza Vaccine Market, Hong Kong, Drivers and Barriers, 2012 ..............................46 Figure 28: Seasonal Influenza Vaccine Market, India, Regulatory Authority, 2011 .....................................47 Figure 29: Seasonal Influenza Vaccine Market, India, Common Technical Document Application, 2011 .....48 Figure 30: Seasonal Influenza Vaccine Market, India, Drug Approval Process, 2011 ...................................49 Figure 31: Seasonal Influenza Vaccine Market, India, Revenue Forecast ($m), 2011–2018.........................50 Figure 32: Seasonal Influenza Vaccine Market, India, Vaccination Cost Forecast ($), 2011–2018................51 Figure 33: Seasonal Influenza Vaccine Market, India, Drivers and Barriers, 2012 .......................................52 Figure 34: Seasonal Influenza Vaccine Market, Japan, Regulatory Authorities, 2012 ..................................53 Figure 35: Seasonal Influenza Vaccine Market, Japan, Drug Approval Process, 2012..................................54 Figure 36: Seasonal Influenza Vaccine Market, Japan, Revenue Forecast ($m), 2011–2018 .......................55 Figure 37: Seasonal Influenza Vaccine Market, Japan, Population Forecast by Age Group (million), 2011–

2018 .......................................................................................................................................57 Figure 38: Seasonal Influenza Vaccine Market, Japan, Vaccination Coverage Forecast by Age Group (%),

2011–2018 .............................................................................................................................58 Figure 39: Seasonal Influenza Vaccine Market, Japan, Number of Doses Forecast by Age Group (million),

2011–2018 .............................................................................................................................60 Figure 40: Seasonal Influenza Vaccine Market, Japan, Drivers and Barriers, 2012 ......................................61 Figure 41: Seasonal Influenza Vaccine Market, Malaysia, Regulatory Authorities, 2011 .............................63 Figure 42: Seasonal Influenza Vaccine Market, Malaysia, Drug Approval Process, 2011 .............................64 Figure 43: Seasonal Influenza Vaccine Market, Malaysia, Revenue Forecast ($m), 2011–2018 ...................65 Figure 44: Seasonal Influenza Vaccine Market, Malaysia, Vaccination Cost Forecast ($), 2011–2018..........66 Figure 45: Seasonal Influenza Vaccine Market, Malaysia, Population Forecast by Age Group (million), 2011–

2018 .......................................................................................................................................67


Page 13

Table of Contents

Figure 46: Seasonal Influenza Vaccine Market, Malaysia, Vaccinated Population Forecast by Age Group (%), 2011–2018 .............................................................................................................................68

Figure 47: Seasonal Influenza Vaccine Market, Malaysia, Number of Doses Forecast by Age Group (‘000), 2011–2018 .............................................................................................................................70

Figure 48: Seasonal Influenza Vaccine Market, Malaysia, Market Share by Company (%), 2012 .................71 Figure 49: Seasonal Influenza Vaccine Market, Malaysia, Drivers and Barriers, 2012 .................................72 Figure 50: Seasonal Influenza Vaccine Market, New Zealand, Regulatory Authorities, 2011 ......................73 Figure 51: Seasonal Influenza Vaccine Market, New Zealand, Drug Approval Process, 2011.......................74 Figure 52: Seasonal Influenza Vaccine Market, New Zealand, Revenue Forecast ($m), 2011–2018 ............75 Figure 53: Seasonal Influenza Vaccine Market, New Zealand, Vaccination Cost Forecast ($), 2011–2018 ...76 Figure 54: Seasonal Influenza Vaccine Market, New Zealand, Population by Age Group Forecast (million),

2011–2018 .............................................................................................................................77 Figure 55: Seasonal Influenza Vaccine Market, New Zealand, Vaccinated Population Forecast (%), 2011–

2018 .......................................................................................................................................78 Figure 56: Seasonal Influenza Vaccine Market, New Zealand, Number of Doses Forecast (‘000), 2011–2018

...............................................................................................................................................80 Figure 57: Seasonal Influenza Vaccine Market, New Zealand, Market Share by Company (%), 2012 ...........81 Figure 58: Seasonal Influenza Vaccine Market, New Zealand, Drivers and Barriers, 2012 ...........................82 Figure 59: Seasonal Influenza Vaccine Market, Philippines, Regulatory Authorities, 2011 ..........................83 Figure 60: Seasonal Influenza Vaccine Market, Philippines, Drug Approval Process, 2011 ..........................84 Figure 61: Seasonal Influenza Vaccine Market, Philippines, Revenue Forecast ($m), 2011–2018 ...............85 Figure 62: Seasonal Influenza Vaccine Market, Philippines, Vaccination Cost Forecast ($m), 2011–2018 ...86 Figure 63: Seasonal Influenza Vaccine Market, Philippines, Population Forecast (million), 2011–2018 .......87 Figure 64: Seasonal Influenza Vaccine Market, Philippines, Vaccinated Population Forecast (%), 2011–2018

...............................................................................................................................................88 Figure 65: Seasonal Influenza Vaccine Market, Philippines, Number of Doses Forecast (million), 2011–2018

...............................................................................................................................................90 Figure 66: Seasonal Influenza Vaccine Market, Philippines, Market Share by Company (%), 2012 ..............91 Figure 67: Seasonal Influenza Vaccine Market, Philippines, Drivers and Barriers, 2012 ..............................92 Figure 68: Seasonal Influenza Vaccine Market, Singapore, Regulatory Authorities, 2011 ...........................93 Figure 69: Seasonal Influenza Vaccine Market, Singapore, Drug Approval Process, 2011 ...........................93 Figure 70: Seasonal Influenza Vaccine Market, Singapore, Revenue Forecast ($m), 2011–2018 .................94 Figure 71: Seasonal Influenza Vaccine Market, Singapore, Vaccination Cost Forecast ($), 2011–2018 ........95 Figure 72: Seasonal Influenza Vaccine Market, Singapore, Population Forecast by Age Group (million),

2011–2018 .............................................................................................................................96 Figure 73: Seasonal Influenza Vaccine Market, Singapore, Vaccinated Population Forecast by Age Group

(%), 2011–2018 .......................................................................................................................97 Figure 74: Seasonal Influenza Vaccine Market, Singapore, Number of Doses Forecast by Age Group (‘000),

2011–2018 .............................................................................................................................99 Figure 75: Seasonal Influenza Vaccine Market, Singapore, Market Share by Company (%), 2012 ............. 100 Figure 76: Seasonal Influenza Vaccine Market, Singapore, Drivers and Barriers, 2012 ............................. 101 Figure 77: Seasonal Influenza Vaccine Market, Taiwan, Regulatory Authorities, 2011 ............................. 102 Figure 78: Seasonal Influenza Vaccine Market, Taiwan, Drug Approval Process, 2011 ............................. 103 Figure 79: Seasonal Influenza Vaccine Market, Taiwan, Revenue Forecast ($m), 2011–2018 ................... 104 Figure 80: Seasonal Influenza Vaccine Market, Taiwan, Vaccination Cost Forecast ($), 2011–2018 .......... 105 Figure 81: Seasonal Influenza Vaccine Market, Taiwan, Population Forecast by Age Group (million), 2011–

2018 ..................................................................................................................................... 106 Figure 82: Seasonal Influenza Vaccine Market, Taiwan, Vaccinated Population Forecast by Age Group (%),

2011–2018 ........................................................................................................................... 107 Figure 83: Seasonal Influenza Vaccine Market, Taiwan, Number of Doses Forecast by Age Group (million),

2011–2018 ........................................................................................................................... 109 Figure 84: Seasonal Influenza Vaccine Market, Taiwan, Market Share by Company (%), 2012.................. 110 Figure 85: Seasonal Influenza Vaccine Market, Taiwan, Drivers and Barriers, 2012.................................. 111 Figure 86: Seasonal Influenza Vaccine Market, APAC Region, Pipeline by Phase (%), 2012 ....................... 112 Figure 87: Seasonal Influenza Vaccine Market, APAC Region, M&A Deals by Geography (%), 2007–2012 . 127 Figure 88: Seasonal Influenza Vaccine Market, APAC Region, Licensing Agreements by Geography, (%),

2007–2012 ........................................................................................................................... 131 Figure 89: GBI Research Market Forecasting Model ............................................................................... 137


Page 14

Introduction

2 Introduction

Influenza (flu) is caused by a contagious Ribonucleic Acid (RNA) virus of the orthomyxoviridae family, which mostly infects the upper respiratory tract. Seasonal influenza is more severe than other respiratory infections, such as the common cold. Typical symptoms include fever, and respiratory symptoms such as sore throat, cough, runny or stuffy nose, headache, muscle ache, and fatigue. Additional symptoms in children include diarrhea, vomiting and nausea. Patients tend to recover in one to two weeks but in certain cases it can develop into pneumonia, a complicated and life-threatening disease. The elderly population is most susceptible to seasonal influenza-related complications due to low immunity.

Influenza causes a loss of productivity and can also increase healthcare costs, leading to an increased economic burden. The cost of influenza epidemics to the US economy stands at $XX–XX billion per year. Upper respiratory tract infections occur in XX–XX% of the population during annual influenza epidemics. These annual epidemics are estimated to result in three to five million cases of severe illness and XX–XX deaths every year globally (WHO, 2003).

Based on epidemiology, influenza is categorized as seasonal or pandemic. Seasonal influenza usually occurs in the temperate regions of the world during winter and fall. Seasonal influenza can also occur in tropical countries throughout the year but is more prominent during the rainy season. Unlike seasonal influenza, pandemic influenza outbreaks are irregular and unpredictable. Pandemic influenza is caused by a new type of influenza strain, transmitted into humans from animals. It spreads very rapidly and thus poses a greater threat than seasonal influenza.

Influenza viruses that cause disease in humans are divided into groups A and B. Type A influenza viruses are the most virulent and affect a number of species alongside humans, such as birds and pigs. They mutate quite fast and have the potential to cause a pandemic. Type B influenza viruses almost exclusively infect humans and are less common than influenza A viruses. Type B influenza viruses mutate at a slower rate than type A viruses and lack the potential to cause a pandemic. Antigens, spike-like features with hemagglutinin (H) and neuraminidase (N) components, present on the surface of the virus are used to determine its classification.

An annual seasonal influenza vaccine is used to protect against the highly variable seasonal influenza virus. Frequent genetic changes mean that it must be reformulated annually. The World Health Organization (WHO) is responsible for gathering this information and uses it to make recommendations for the composition of the seasonal influenza vaccine every year.

Each seasonal influenza vaccine targets three influenza viruses: one A (H3N2) virus, one regular seasonal A (H1N1) virus and one B virus. Protection against the influenza strains develops about two weeks after receiving the vaccine.

Seasonal influenza is more severe than other respiratory infections, such as the common cold


Page 15

Seasonal Influenza Vaccine Market in Asia-Pacific – Market Overview

3 Seasonal Influenza Vaccine Market in Asia-Pacific – Market Overview

3.1 Market Characterization and Forecasts

Figure 1: Seasonal Influenza Vaccine Market, APAC Region, Revenue Forecast ($m), 2011–2018

2011 2012 2013 2014 2015 2016 2017 2018

Rev

enue

s ($

m)

CAGR (2011–2018): XX%


Table 1: Seasonal Influenza Vaccine Market, APAC Region, Revenue Forecast ($bn), 2011–2018

Year 2011 2012 2013 2014 2015 2016 2017 2018 CAGR (%)

Revenues


The seasonal influenza vaccine market in the Asia-Pacific (APAC) region is expected to grow to $XX billion by 2018, indicating a Compound Annual Growth Rate (CAGR) of XX% from $XX billion in 2011.


Page 112

Seasonal Influenza Vaccine Market in Asia-Pacific - Pipeline Analysis

14 Seasonal Influenza Vaccine Market in Asia-Pacific - Pipeline Analysis

14.1 Pipeline Analysis by Phase

A total of XX R&D programs are being conducted for seasonal influenza vaccines, with the pipeline fairly evenly divided between all stages of development. R&D activity is dominated by programs in Phase XX (XX%), followed by the Preclinical Phase (XX%), Phase XX (XX%) and Phase XX (XX%). Filed programs, Phase XX and Phase XX collectively account for XX%, indicating a strong pipeline.

Figure 86: Seasonal Influenza Vaccine Market, APAC Region, Pipeline by Phase (%), 2012

Phase III

Phase II

Phase I

Preclinical

DiscoveryFiled

N=XX

Source: GBI Research Proprietary Companies Database [accessed on January 10, 2013]

A number of vaccines in the pipeline are cell culture-based, produced using mammalian cell culture instead of the conventional egg-based method. They can be produced quickly, which reduces the production cycle time and increases the manufacturer’s ability to cope with demand.

Also featured in the pipeline are adjuvanted vaccines. Adjuvanted vaccines consist of a pharmacological or immunological agent called an adjuvant, which differs from the antigen and increases the immunogenicity of the antigen in the recipient. By using an adjuvant, the immune response is increased while keeping the injected antigen at low quantities in the recipient.

Most of the seasonal influenza vaccines being developed are based on novel technologies such as cell culture-based production, the addition of adjuvants to the vaccines, and new modes of vaccine delivery. Some vaccines are first-in-class, such as Universal Influenza Vaccine, which will target all strains of the influenza virus.

Filed programs, Phase XX and Phase XX collectively account for XX%, indicating a strong pipeline


Page 132

Seasonal Influenza Vaccine Market in Asia-Pacific – Appendix

17 Seasonal Influenza Vaccine Market in Asia-Pacific – Appendix

17.1 Market Definitions

Seasonal influenza vaccine market in the APAC region covers the seasonal influenza vaccine markets in Australia, China, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Singapore and Taiwan.

Vaccination coverage refers to the population that has been vaccinated against seasonal influenza.

Vaccinated population contribution or coverage rate refers to the proportion of the total population that has been vaccinated against seasonal influenza.

17.2 Abbreviations

ADEC: Australian Drug Evaluation Committee

APAC: Asia-Pacific

ARTG: Australian Register of Therapeutic Goods

BFAD: Bureau of Food and Drugs

CAGR: Compound Annual Growth Rate

CARM: Centre for Adverse Reactions Monitoring

CDSCO: Central Drugs Standard Control Organization

CDA: Center for Drug Administration

CDC: Centers for Disease Control

CDE: Center for Drug Evaluation

CTD: Common Technical Document

DCA: Drug Control Authority

DCGI: Drug Controller General of India

DoH: Department of Health

EMA: European Medicines Agency

FDA: Food and Drug Administration

GCP: Good Clinical Practice

GMP: Good Manufacturing Practice

GSK: GlaxoSmithKline

HSA: Health Science Authority

MADRAC: Malaysian Adverse Drug Reaction Advisory Committee

NICPBP: National Institute for the Control of Pharmaceutical and Biological Products

NMA: New Medicine Application

NPCB: National Pharmaceutical Control Bureau

PBS: Pharmaceutical Benefit Scheme

PDAA: Provincial Drug Administration Authority

PHARMAC: Pharmaceutical Management Agency

PMDA: Pharmaceuticals and Medical Devices Agency

RNA: Ribonucleic Acid

SFDA: State Food and Drug Administration


Page 133


TFDA: Taiwan Food and Drug Administration

TGA: Therapeutic Goods Administration

TPD: Therapeutic Products Division

WHO: World Health Organization

17.3 Bibliography

Center for Drug Evaluation, Taiwan (2012). Drug Review and Registration Guideline. Center for Drug Evaluation, Taiwan. Available from: http://www1.cde.org.tw/eng/Regulations/regulations3.html. [Accessed November 06, 2012]

Central Drugs Standard Control Organization (2010). Guidelines On Common Technical Document (CTD). Central Drugs Standard Control Organization. Available from: http://cdsco.nic.in/ctd_guidance%20-final.pdf.

Central Drugs Standard Control Organization (2012). Drugs Control Administration. Central Drugs Standard Control Organization. Available from: http://cdsco.nic.in/html/Drugs_ContAd.html. [Accessed October 29, 2012].

Department of Health (2012a). Hong Kong the Facts. Available From http://www.gov.hk/en/about/abouthk/factsheets/docs/health_department.pdf.

Department of Health (2012b). Introduction to Drug Regulatory System in Hong Kong. Available from: http://www.drugoffice.gov.hk/eps/root/en/consumer/news_informations/drug_regulatory_system.html. [Accessed October 29, 2012].

European Medicines Agency (2012). Annex 1: Summary of Product Characteristics. European Medicines Agency. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000758/WC500046957.pdf.

GlaxoSmithKline (2012). Result Summary for 106372_ Observer-blind superior efficacy trial with GlaxoSmithKline Biologicals’ influenza vaccine GSK2186877A in elderly subjects. GlaxoSmithKline. Available from: http://www.gsk-clinicalstudyregister.com/result_detail.jsp?protocolId=106372_&studyId=ED868874-90DA-4EB7-8EF8-BAE391468699&compound=GSK2186877A [Accessed November 5, 2012]

Health Sciences Authority (2011). Regulatory Guidance. Available from: http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/western_medicines/files_guidelines.Par.22361.File.dat/Guidance%20on%20Medicinal%20Product%20Registration%20in%20Singapore%202011%20(COMPLETE).pdf.

Health Sciences Authority (2012). About us. Available from: http://www.hsa.gov.sg/publish/hsaportal/en/about_us.html [Accessed November 1, 2012].

Japan Pharmaceuticals Manufacturers Association (2012). Pharmaceutical Administration and Regulations in Japan. Available from: http://www.jpma.or.jp/english/parj/pdf/2012.pdf.

Medsafe (2012). Medsafe’s evaluation and approval process. Available from: http://www.medsafe.govt.nz/consumers/Safety-of-Medicines/Medsafe-Evaluation-Process.asp. [Accessed October 29, 2012].

National Pharmaceutical Control Bureau (2012). About NPCB. Available from: http://portal.bpfk.gov.my/index.cfm?&menuid=160. [Accessed October 29, 2012].

Republic of Philippines, Department of Health (2012). Food and Drug Administration. Available from: http://www.doh.gov.ph/bfad/orgchart.html [Accessed October 31, 2012].

State Food and Drug Administration (2012a). Drug Administration Law of the People's Republic of China. Available from: http://www.sfda.com/drug-administration-law-of-the-peoples-republic-of-china.html [Accessed October 30, 2012].

State Food and Drug Administration (2012b). SFDA of China. Available from: http://www.sfda.com/ [Accessed October 29, 2012].


Page 134


Taiwan Food and Drug Administration (2012). About FDA. Taiwan Food and Drug Administration. Available From: http://www.fda.gov.tw:8080/eng/about_fda.aspx?aboutfdasn=15 [Accessed November 20, 2012]

Therapeutic Goods Administration (2012a). About the TGA. Therapeutic Goods Administration. Available from: http://www.tga.gov.au/about/index.htm. [Accessed October 29, 2012].

Therapeutic Goods Administration (2012b). Industry Basics. Therapeutic Goods Administration. Available from: http://www.tga.gov.au/industry/basics.htm. [Accessed October 29, 2012].

World Health Organization (2003). Influenza. Available from: http://www.who.int/mediacentre/factsheets/2003/fs211/en/ [Accessed November 1, 2012].

World Health Organization (2012). Philippines Pharmaceutical Country Profile. World Health Organization. Available from: http://www.who.int/medicines/areas/coordination/Philippines_PSCPBNarrativeQuestionnaireEndorsement_13062012.pdf [Accessed November 6, 2012].

17.4 Research Methodology

GBI Research’s dedicated research and analysis teams consist of experienced professionals with a pedigree in marketing, market research, consulting backgrounds in the pharmaceutical industry, and advanced statistical expertise.

GBI Research adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the Strategic and Competitive Intelligence Professionals (www.scip.org).

All GBI Research databases are continuously updated and revised.

17.4.1 Coverage

The objective of updating GBI Research’s coverage is to ensure that it represents the most up-to-date vision of the industry possible.

Changes to the industry taxonomy are decided on the basis of extensive research of company, association and competitor sources.

Company coverage is based on three key factors: market capitalization, revenues, and media attention/innovation/market potential.

An exhaustive search of 56 member exchanges is conducted, and companies are prioritized on the basis of their market capitalization;

The estimated revenues of all major companies, including private and governmental, are gathered and used to prioritize coverage; and,

Companies which are making the news, or which are of particular interest due to their innovative approach, are prioritized.

GBI Research aims to cover all major news events and deals in the medical industry, with its databases updated on a daily basis.

The coverage is further streamlined and strengthened with additional inputs from GBI Research’s expert panel (see below).


Page 135


17.4.2 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and US Securities and Exchanges Commission (SEC) filings.

Industry trade journals, scientific journals and other technical literature.

Internal and external proprietary databases.

Relevant patent and regulatory databases.

National government documents, statistical databases and market reports.

Procedure registries.

News articles, press releases and webcasts specific to the companies operating in the market.

17.4.3 Primary Research

GBI Research conducts hundreds of primary interviews each year with industry participants and commentators, in order to validate its data and analysis. A typical research interview fulfills the following functions:

It provides first-hand information on the market size, market trends, growth trends, competitive landscape, future outlook, etc.

Helps in validating and strengthening the secondary research findings; and

Further develops the analysis team’s expertise and market understanding.

Primary research involves email interactions, telephone interviews, and face-to-face interviews for each market, category, segment and sub-segment across geographies.

The participants who typically take part in such a process include, but are not limited to:

Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers.

Hospital stores, laboratories, pharmacies, distributors and paramedics.

Outside experts: Investment bankers, valuation experts, research analysts specializing in specific medical equipment markets; and

Key Opinion Leaders: Physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of medical equipment.

The report consists of the following four major sections:

Geographic Landscape

Therapeutic Landscape

Pipeline Analysis

Competitive Analysis


Page 136


17.5 Therapeutic Landscape

The revenues for each indication, by geography, are arrived at by utilizing the GBI Research market forecasting model. The global revenues for each indication are a summarized value of the revenues of all four countries. Only company sponsored molecules which are in late stages of clinical development and are anticipated to launch in the forecast period are considered for market estimation. The data for market estimation was based on extensive primary and secondary research and also from company websites, press releases and GBI Research’s proprietary databases.

The annual cost of therapy for each indication is arrived at by considering the cost of the drugs, dosage of the drugs, and the duration of the therapy.

The marketed drugs section contains an overview of the drugs, their mechanism of action, efficacy and safety issues related to the drugs. The drugs profiled in this section are chosen based on estimated revenues and their mechanism of action.

GBI Research uses the epidemiology-based treatment flow model to forecast the market size for therapeutic indications.

17.5.1.1 Epidemiology-based Forecasting

The forecasting model used at GBI Research makes use of epidemiology data gathered from research publications and primary interviews with physicians to represent the treatment flow patterns for individual diseases and therapies. The market for any disease segment is directly proportional to the volume of units sold and the price per unit.

Sales = Volume of units sold X Price per unit

The volume of units sold is calculated based on the average dosage regimen for that disease, the duration of treatment, and the number of patients who are prescribed drug treatment (the prescription population). The prescription population is calculated as a percentage of the population diagnosed with a disease (the diagnosis population). The diagnosis population is the population diagnosed with a disease expressed as a percentage of the population that is seeking treatment (the treatment seeking population). The prevalence of a disease (diseased population) is the percentage of the total population who suffer from a disease/condition.

Data on treatment seeking rate, diagnosis rate and prescription rate, if unavailable from research publications, are gathered from interviews with physicians and are used to estimate the patient volumes for the disease under consideration. Therapy uptake and compliance data are fitted in the forecasting model to account for patient switching and compliance behavior.

To account for differences in patient affordability of drugs across various geographies, macroeconomic data such as inflation and GDP, and healthcare indicators such as healthcare spending, insurance coverage and average income per individual, are used.

Annual cost of treatment is calculated using product purchase frequency and the average price of the therapy. Product purchase frequency is calculated from the dosage data available for the therapies, and drug prices are gathered from public sources.

The epidemiology-based forecasting model uses a bottom-up methodology, and makes use of estimations in the absence of data from research publications. Such estimations may result in a final market value that is different from the actual value. To correct this ‘gap’, the forecasting model uses triangulation, with the help of base year sales data (from company annual reports, internal and external databases) and sales estimations.

Analogous Forecasting Methodology

The analogous forecasting methodology is used to account for the introduction of new products, patent expiries of branded products, and the subsequent introduction of generics. Historic data for new product launches and generics penetration are used to arrive at robust forecasts. The increase or decrease of prevalence rates, treatment seeking rate, diagnosis rate and prescription rate are fitted into the forecasting model to estimate the market growth rate.


Page 137


The proprietary model enables GBI Research to account for the impact of individual drivers and restraints in the growth of the market. The year of impact and the extent of impact are quantified in the forecasting model to provide close-to-accurate data sets.

17.5.2 Market Size by Geography

The treatment usage pattern and annual cost of treatment in each country has been factored in while deriving the individual country market size.

Forecasting Model for Therapeutic Areas

Figure 89: GBI Research Market Forecasting Model

D is e ase P opu lati onGener al Po pu lation 743 ,535,048

Q ualifying c onditio n 1 (Age/S ex/O c c upation e tc )Q ualifying c onditio n 2 (Age/S ex/O c c upation e tc )

Preval ence t issu e valve disease 0.2% 1,784,484 Q ualifying c onditio n (c om plic ation , s everity)D IS EA SE D P OPU LA T IO N 1,784,484

T r eatm en t Flow P attern sTreatm e nt S e eki ng R at e (Sy m ptom s/ Dis A warene ss) 89 % 1,588,191 Diagn os is Ra t e ( C lin ical a nd D ia gn ostic Te st s) 75 % 1,191,143

Prescr iption R ate ( Phys ician P ercep t io n, Tr eatm ent E ffectiv e n ess)Tis s ue V alve 70 % 833,800 O th er T reatm ents for Va lve (Sur g /M ed/N one) -

Fulfi llm en tA vailab i lit y NAW illingne ss to U s e (Patient Perc eptions) NAR eady to U se (S urgery e lig ib i lity , R eus e etc ) NA

Affo rd abil it y at PriceH E as % of G D P s pen dA vera ge Inc om e (per ind ivid ua l)P at ient O ut-o f -poc ket Budget (A nnual)

Bud get a lloc ation to on e-t ime s urgeryBud get a lloc ation to o the r h ealth n eed s

A vera ge Pay or C overageP at ient L iab il ityTarget Pr ic e ( @ 20% p at liab)A SP for C o s t o f Therapy

T O TA L P AT IEN T V OLU M E S

Pro du ct P urch ase Fr e quen c y 1 T OT A L U N IT VO LU M ES

Pr ic ing per Un it 18,00 0$ In f lat ionP rice D ec reas e due to c om pet it ion

M a r ket Valu e

G B I R esea r ch M ar ket S iz ing M o del

Source: GBI Research

The above figure represents a typical forecasting model constructed by GBI Research. As discussed previously, the model is built on the treatment flow patterns. The model starts with the general population, then diseased population as a percentage of general population, and then follows the treatment seeking population as a percentage of the diseased population, and the diagnosed population as a percentage of the treatment seeking population. Finally, the total volume of units sold is calculated by multiplying the treated population by the average dosage per year per patient.


Page 138


17.6 Geographical Landscape

GBI Research analyzes the seasonal influenza vaccine market in Australia, China, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Singapore and Taiwan. The total market size for each country is provided, which is the summarized value of the market sizes of all the indications for that particular country.

17.7 Pipeline Analysis

This section provides a list of molecules at different stages in the pipeline for various indications. The list is sourced from internal databases and validated for the accuracy of phase and mechanism of action at clinicaltrials.gov and company websites. The section also includes a list of promising molecules, which is narrowed down based on the results of the clinical trials at various stages and the novelty of the mechanism of action.

17.8 Competitive Landscape

Profiles of leading players are provided, along with an overview of key products marketed by the companies for various indications. An analysis of strengths, weaknesses, opportunities and threats of each company with respect to various indications is also listed.

GBI Research aims to cover all major M&A, licensing deals and co-development deals related to the market. This section is sourced from the companies’ websites and internal databases.

17.8.1 Expert Panel Validation

GBI Research uses a panel of experts to cross-verify its databases and forecasts.

GBI Research’s expert panel comprises marketing managers, product specialists, international sales managers from pharmaceutical companies, academics from research universities, and key opinion leaders from hospitals.

Historic data and forecasts are relayed to GBI Research’s expert panel for feedback and adjusted in accordance with their feedback.

17.10 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GBI Research.

gbihc264mr seasonal influenza vaccine market in … › product › sample-7503566.pdfseasonal...

Documents