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Introduction
 
The protein therapeutic market is forecast to grow rapidly at a CAGR of 10.5% from 2003 to 2010, to almost double in value. The increased use, development and discovery of protein therapeutics will lead to increasing opportunities for drug delivery companies. Pharma companies need to utilize these technologies to gain a competitive edge in an increasingly crowded therapeutic protein market.
 

 
Scope
 
Analysis of the protein therapeutics portfolio and pipeline for 50 leading pharma and biotech companies
 
Benchmarking of the current and future protein drug delivery market by technology and therapeutic focus
 
Evaluation of the key drivers and resistors of the protein drug delivery market
 
Assessment of the strategic aims of pharmaceutical companies in utilizing protein drug delivery technologies
 
Highlights
 
The protein therapeutic market is largely immediate release, but there is a trend moving towards increased sustained release formulations. Datamonitor believes that pharmaceutical companies in the protein therapeutic market should look to in-license suitable technologies to improve the qualities and potential of their products.
 

 
The protein therapeutic market is primarily an injectable arena, but drug delivery companies are striving to develop non-injectable solutions to the delivery of protein therapeutics.
 

 
While the majority of protein therapeutics on the market do not have devices available, this is a growing segment of the market and Datamonitor expects the growth to accelerate. Datamonitor believes that companies should explore the use of devices to maximize the potential of their products and differentiate them from competitors.
 

 
Reasons to Purchase
 
Identify the opportunities provided by current and future protein drug delivery technologies to effectively plan your product development
 
Understand trends across technological and therapeutic fields to target resources effectively and recognize pipeline opportunities
 
Optimize market penetration through improved knowledge of the growth drivers and corporate dynamics of the protein drug delivery market
 

TABLE OF CONTENTS
 
CHAPTER 1 EXECUTIVE SUMMARY 3
 
Scope 3
 
Datamonitor’s opinion on the current and future protein drug delivery market 3
 
The protein therapeutic market is largely immediate release, but there is a trend moving towards increased sustained release formulations. Datamonitor believes that pharmaceutical companies in the protein therapeutic market should look to in-license suitable technologies to improve the qualities and potential of their products. Drug delivery companies should consider the frequency of dosing when developing their technologies, since this will influence a resultant products uptake. 4
 
The protein therapeutic market is primarily an injectable market, but drug delivery companies are striving to develop non-injectable solutions to the delivery of protein therapeutics. Datamonitor believes that companies should invest in alternative or novel delivery solutions which will improve patient compliance and expand a products potential. In doing so, this will also expand the opportunities for the protein market as a whole. Drug delivery companies should look to capitalise from this growth. 5
 
While the majority of protein therapeutics on the market do not have devices available, this is a growing segment of the market and Datamonitor expects the growth to accelerate. Datamonitor believes that companies should explore the use of devices to maximise the potential of their products and differentiate from competitors. Drug delivery companies can develop technologies to out-license of apply the technology to products directly. 7
 
CHAPTER 2 INTRODUCTION TO PROTEIN DRUG DELIVERY 16
 
Key Findings 16
 
Protein therapeutics 17
 
The protein therapeutic market size and therapy area exposure 17
 
Drug delivery of proteins 22
 
Reformulation of protein therapeutics 27
 
Delivery devices for protein therapeutics 37
 
CHAPTER 3 DYNAMICS OF PROTEIN DRUG DELIVERY MARKET 46
 
Key findings 46
 
Development of protein drug delivery market 47
 
Changing dynamics of drug delivery market 47
 
Protein drug delivery technologies are primarily developed by specialists 48
 
Strategic issues for protein drug delivery companies 49
 
Drivers to the protein drug delivery market 49
 
Limitations to protein reformulation and drug delivery technologies 51
 
Key factors defining winners and losers 58
 
Strategic issues for pharmaceutical companies using protein drug delivery technologies 58
 
General strategic objectives of drug reformulation and the application of drug delivery technologies 58
 
Aims for the use of protein drug delivery technologies 60
 
Concerns for pharmaceutical companies when implementing product drug delivery technologies 106
 
Key factors defining winners and losers 107
 
CHAPTER 4 APPENDIX 108
 
Datamonitor’s in-house proprietary protein database 108
 
LIST OF TABLES
 
Table 1: The protein therapeutic market is estimated to grow by 10.5% between 2003 and 2010 18
 
Table 2: Non-injectable drug delivery routes are expected to show the greatest growth in the protein therapeutic market, however, this growth is from small starting sales 23
 
Table 3: Sustained release formulations are expected to report greater growth as a percentage, but the actual increase of immediate release formulations will be greater 28
 
Table 4: Protein therapeutics with the availability of a device are expected to show greater growth than that of products without a device available 38
 

 
LIST OF FIGURES
 
Figure 1: Oncology is the largest therapy area of the protein therapeutic market by sales 19
 
Figure 2: Oncology is the largest therapy area of the protein therapeutic market by sales 20
 
Figure 3: Survey respondents recognized oncology, AIID and diabetes and endocrinology as the key protein therapeutic markets 21
 
Figure 4: Subcutaneous injection is the primary route of protein therapeutics delivery 22
 
Figure 5: Subcutaneous injection will remain the primary route of protein delivery, but its share of the market will decrease 24
 
Figure 6: AIID is expected to show high growth in protein therapeutic sales between 2003 and 2010 25
 
Figure 7: Most protein therapeutics are immediate release formulations 27
 
Figure 8: There are four key therapy areas with sustained release protein therapeutics 29
 
Figure 9: The majority of sustained release formulations are delivered by subcutaneous injection 31
 
Figure 10: In 2010, most of the sales from sustained release products will come from products launched in the late 1990’s and early 2000’s 32
 
Figure 11: Convenient but regular dosing regimes appear to be the primary market for sustained release technologies 34
 
Figure 12: The proportion of sales originating from sustained release products is expected to increase in certain dosing categories, including once a day 35
 
Figure 13: Some therapy areas are associated with key dosing regimens 36
 
Figure 14: Most protein therapeutic sales relate to products without devices available 37
 
Figure 15: Protein therapeutics in most therapy areas use devices 39
 
Figure 16: Most devices are used with protein therapeutics administered by subcutaneous delivery 41
 
Figure 17: A higher proportion of sustained release protein therapeutics have devices available 43
 
Figure 18: In 2010, most of the sales from protein therapeutics with a device available will have launched over recent years 45
 
Figure 19: The protein drug delivery market is driven by specialist companies developing technologies for use by pharmaceutical companies 48
 
Figure 20: There are different factors which can be considered inhibitors to the use of protein drug delivery technologies 51
 
Figure 21: Four classes of strategic objectives for drug reformulation 60
 
Figure 22: Several factors are considered key drivers to the protein drug delivery market 61
 
Figure 23: Prescription volumes of Intron, PEG-Intron and Pegasys in the US, 1999–2003: PEG-Intron saw a rapid uptake following its launch, cannibalising Intron’s prescription volumes, but prescription volumes have declined heavily since the launch of Pegasys 66
 
Figure 24: Prescription volumes of Intron, PEG-Intron and Pegasys in Europe, 1999–2003; PEG-Intron heavily cannibalized Intron’s prescription volume following its launch 67
 
Figure 25: Sales of Intron, PEG-Intron and Pegasys in the US, 1999–2003: Intron’s sales have been static, while PEG-Intron’s sales grew rapidly following its launch, but has been declining heavily since 2003 68
 
Figure 26: Sales of Intron, PEG-Intron and Pegasys in Europe, 1999–2003: PEG-Intron’s sales are greater than Intron 69
 
Figure 27: Price of Intron, PEG-Intron and Pegasys per week in the US, 1999–2003: Pegasys is more expensive than PEG-Intron 70
 
Figure 28: Price of Intron, PEG-Intron and Pegasys per week in Europe, 1999–2003: While PEG-Intron and Pegasys have had similar price points, Intron price has been far higher since 2002 71
 
Figure 29: Prescription volumes of Remicade, Enbrel and Humira in the US, 1999–2003: Enbrel has dominated the rheumatoid arthritis over the last five years 76
 
Figure 30: Standardized volumes by patient number for Remicade, Enbrel and Humira in the US, 1999–2003: Remicades less frequewnt 77
 
Figure 31: Sales of Remicade, Enbrel and Humira in the US, 1999–2003: Remicade and Enbrel have achieved similar levels of sales 78
 
Figure 32: Price of Remicade, Enbrel and Humira per week in the US, 1999–2003: Humira is the most expensive treatment 79
 
Figure 33: Prescription volumes of Humalog, Humulin and NovoLog/NovoRapid in the US, 1999–2003: switching from human insulin to insulin analogues 81
 
Figure 34: Prescription volumes of Humalog, Humulin and NovoLog/NovoRapid in the US, 1999–2003: insulin analogues dominate the market 82
 
Figure 35: Sales of Humalog, Humulin and NovoLog/NovoRapid in the US, 1999–2003: Humulin’s sales decline as patient’s switch to insulin analogues 83
 
Figure 36: Sales of Humalog, Humulin and NovoLog/NovoRapid in Europe, 1999–2003: Humalog has the highest sales 84
 
Figure 37: Price of Humalog, Humulin and NovoLog/NovoRapid per unit in the US, 1999–2003: Humulog’s price has quadrupled over the last five years 85
 
Figure 38: Price of Humalog, Humulin and NovoLog/NovoRapid per unit in Europe, 1999–2003; since 2001, the drugs have a similar price point 86
 
Figure 39: Prescription volumes of Avonex, Betaseron and Rebif in the US, 1999–2003: Betaseron has dominated the market since 2000 88
 
Figure 40: Prescription volumes of Avonex, Betaseron and Rebif in Europe, 1999–2003: Betaseron has been the market leader over the last five years 89
 
Figure 41: Sales of Avonex, Betaseron and Rebif in the US, 1999–2003: Avonex has had higher sales than Betaseron and Rebif 90
 
Figure 42: Sales of Avonex, Betaseron and Rebif in Europe, 1999–2003: the drugs have seen similar level of sales since 2001 91
 
Figure 43: Price of Avonex, Betaseron and Rebif per week in the US, 1999–2003; Rebif has been the most expensive treatment 92
 
Figure 44: Price of Avonex, Betaseron and Rebif per week in Europe, 1999–2003; Rebif remains the most expensive treatment 93
 
Figure 45: Marketing product mix of Sanofi Aventis’s diabetes and endocrinology franchise 95
 
Figure 46: Prescription volumes of Neupogen and Neulasta in the US, 1999–2003: Neupogen sales have fallen since the launch of Neulasta in 2002 96
 
Figure 47: Sales of Neupogen and Neulasta in the US, 1999–2003: Neulasta’s sales were greater than Neupogen a year after its launch 97
 
Figure 48: Price of Neupogen and Neulasta per day in the US, 1999–2003: the drugs have a similar price point on a daily basis 98
 
Figure 49: Prescription volumes of Epogen, Procrit and Aranesp in the US, 1999–2003: Epogen prescription volume has continued to grow after the launch of its follow-on product Aranesp 100
 
Figure 50: Prescription volumes of Eprex versus Aranesp in Europe, 1999–2003: the prescription volume of Eprex has declined following the launch of Aranesp 101
 
Figure 51: Sales of Epogen, Procrit and Aranesp in the US, 1999–2003: Sales of Amgen’s Epogen has continued to grow at a similar rate despite the launch of its follow-up product Aranesp 102
 
Figure 52: Sales of Eprex versus Aranesp in Europe, 1999–2003: sales of Eprex have grown steadily, despite the launch of Aranesp 103
 
Figure 53: Price of Epogen, Procrit and Aranesp per unit in the US,1999–2003: Aranesp entered the market at a higher price than its predecessor Epogen and by 2003, the price had more doubled 104
 
Figure 54: Price of Eprex and Aranesp per unit in Europe, 1999–2003: since Aranesp’s launch at a higher price point, Exprex unit price has been steadily increasing 105