Protein Drug Delivery: Penetrating a Growth Market

SUMMARY

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 willlead to increasing opportunities for drug delivery companies. Pharma companies need to utilize thesetechnologies 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 biotechcompanies
• Benchmarking of the current and future protein drug delivery market by technology andtherapeutic focus
• Evaluates the key drivers and resistors of the protein drug delivery market
• Assesses the strategic aims of pharmaceutical companies in utilizing protein drug deliverytechnologies

Report Highlights

The protein therapeutic market is largely immediate release, but there is a trend moving towardsincreased sustained release formulations. Datamonitor believes that pharmaceutical companies in theprotein therapeutic market should look to in-license suitable technologies to improve the qualitiesand potential of their products.

The protein therapeutic market is primarily an injectable arena, but drug delivery companies arestriving 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 agrowing segment of the market and Datamonitor expects the growth to accelerate. Datamonitor believesthat companies should explore the use of devices to maximise the potential of their products anddifferentiate them from competitors.

Reasons to Purchase

• Understand trends across technological and therapeutic fields to target resources effectivelyand recognise pipeline opportunities.
• Identify the opportunities provided by current and future protein drug delivery technologies toeffectively plan your product development.
• Optimise your market penetration through improved knowledge of the growth drivers and corporatedynamics of the protein drug delivery market.

TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY

• Scope
• Datamonitors opinion on the current and future protein drug delivery market

The protein therapeutic market is largely immediate release, but there is a trend moving towardsincreased sustained release formulations. Datamonitor believes that pharmaceutical companies in theprotein therapeutic market should look to in-license suitable technologies to improve the qualitiesand potential of their products. Drug delivery companies should consider the frequency of dosingwhen developing their technologies, since this will influence a resultant products uptake.

The protein therapeutic market is primarily an injectable market, but drug delivery companies arestriving to develop non-injectable solutions to the delivery of protein therapeutics. Datamonitorbelieves that companies should invest in alternative or novel delivery solutions which will improvepatient compliance and expand a products potential. In doing so, this will also expand theopportunities for the protein market as a whole. Drug delivery companies should look to capitalisefrom this growth.

While the majority of protein therapeutics on the market do not have devices available, this is agrowing segment of the market and Datamonitor expects the growth to accelerate. Datamonitor believesthat companies should explore the use of devices to maximise the potential of their products anddifferentiate from competitors. Drug delivery companies can develop technologies to out-license ofapply the technology to products directly.

CHAPTER 2 INTRODUCTION TO PROTEIN DRUG DELIVERY

• Key Findings
• Protein therapeutics
• The protein therapeutic market size and therapy area exposure
• Drug delivery of proteins
• Drug delivery by therapy area
• Reformulation of protein therapeutics
• Drug formulation by therapy area
• Drug formulation by drug delivery method
• Drug formulation by drug launch year
• Drug formulation by dosing frequency
• Delivery devices for protein therapeutics
• Use of devices by therapy area
• Use of devices by drug delivery method
• Use of devices by drug formulation
• Use of devices by drug launch year

CHAPTER 3 DYNAMICS OF PROTEIN DRUG DELIVERY MARKET

• Key findings
• Development of protein drug delivery market
• Changing dynamics of drug delivery market
• Protein drug delivery technologies are primarily developed by specialists
• Strategic issues for protein drug delivery companies
• Drivers to the protein drug delivery market
• Growth of biotechnology and protein products creates significant market potential
• Implications and recommendations
• Limitations to protein reformulation and drug delivery technologies
• Cost of investment
• Limits to technology application
• Delivery profile of protein therapeutics
• Barriers to entry for new companies/technologies
• Implications and recommendations
• Key factors defining winners and losers
• Strategic issues for pharmaceutical companies using protein drug delivery technologies
• General strategic objectives of drug reformulation and the application of drug deliverytechnologies
• Aims for the use of protein drug delivery technologies
• Maintain market presence
• Gaining competitive edge and differentiation
• Expand therapeutic use
• Concerns for pharmaceutical companies when implementing product drug delivery technologies
• Pricing and royalties
• Implications and recommendations
• Key factors defining winners and losers

CHAPTER 4 APPENDIX

• Datamonitors in-house proprietary protein database
• List of Tables
• Table 1: The protein therapeutic market is estimated to grow by 10.5% between 2003 and 2010
• Table 2: Non-injectable drug delivery routes are expected to show the greatest growth in theprotein therapeutic market, however, this growth is from small starting sales
• 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
• Table 4: Protein therapeutics with the availability of a device are expected to show greatergrowth than that of products without a device available
• List of Figures
• Figure 1: Oncology is the largest therapy area of the protein therapeutic market by sales
• Figure 2: Oncology is the largest therapy area of the protein therapeutic market by sales
• Figure 3: Survey respondents recognized oncology, AIID and diabetes and endocrinology as the keyprotein therapeutic markets
• Figure 4: Subcutaneous injection is the primary route of protein therapeutics delivery
• Figure 5: Subcutaneous injection will remain the primary route of protein delivery, but itsshare of the market will decrease
• Figure 6: AIID is expected to show high growth in protein therapeutic sales between 2003 and2010
• Figure 7: Most protein therapeutics are immediate release formulations
• Figure 8: There are four key therapy areas with sustained release protein therapeutics
• Figure 9: The majority of sustained release formulations are delivered by subcutaneous injection
• Figure 10: In 2010, most of the sales from sustained release products will come from productslaunched in the late 1990s and early 2000s
• Figure 11: Convenient but regular dosing regimes appear to be the primary market for sustainedrelease technologies
• Figure 12: The proportion of sales originating from sustained release products is expected toincrease in certain dosing categories, including once a day
• Figure 13: Some therapy areas are associated with key dosing regimens
• Figure 14: Most protein therapeutic sales relate to products without devices available
• Figure 15: Protein therapeutics in most therapy areas use devices
• Figure 16: Most devices are used with protein therapeutics administered by subcutaneous delivery
• Figure 17: A higher proportion of sustained release protein therapeutics have devices available
• Figure 18: In 2010, most of the sales from protein therapeutics with a device available willhave launched over recent years
• Figure 19: The protein drug delivery market is driven by specialist companies developingtechnologies for use by pharmaceutical companies
• Figure 20: There are different factors which can be considered inhibitors to the use of proteindrug delivery technologies
• Figure 21: Four classes of strategic objectives for drug reformulation
• Figure 22: Several factors are considered key drivers to the protein drug delivery market
• Figure 23: Prescription volumes of Intron, PEG-Intron and Pegasys in the US, 1999-2003: PEG-Intronsaw a rapid uptake following its launch, cannibalising Introns prescription volumes, butprescription volumes have declined heavily since the launch of Pegasys
• Figure 24: Prescription volumes of Intron, PEG-Intron and Pegasys in Europe, 1999-2003; PEG-Intronheavily cannibalized Introns prescription volume following its launch
• Figure 25: Sales of Intron, PEG-Intron and Pegasys in the US, 1999-2003: Introns sales havebeen static, while PEG-Introns sales grew rapidly following its launch, but has been decliningheavily since 2003
• Figure 26: Sales of Intron, PEG-Intron and Pegasys in Europe, 1999-2003: PEG-Introns sales aregreater than Intron
• Figure 27: Price of Intron, PEG-Intron and Pegasys per week in the US, 1999-2003: Pegasys ismore expensive than PEG-Intron
• Figure 28: Price of Intron, PEG-Intron and Pegasys per week in Europe, 1999-2003: While PEG-Intronand Pegasys have had similar price points, Intron price has been far higher since 2002
• Figure 29: Prescription volumes of Remicade, Enbrel and Humira in the US, 1999-2003: Enbrel hasdominated the rheumatoid arthritis over the last five years
• Figure 30: Standardized volumes by patient number for Remicade, Enbrel and Humira in the US,1999-2003: Remicades less frequent
• Figure 31: Sales of Remicade, Enbrel and Humira in the US, 1999-2003: Remicade and Enbrel haveachieved similar levels of sales
• Figure 32: Price of Remicade, Enbrel and Humira per week in the US, 1999-2003: Humira is themost expensive treatment
• Figure 33: Prescription volumes of Humalog, Humulin and NovoLog/NovoRapid in the US, 1999-2003:switching from human insulin to insulin analogues
• Figure 34: Prescription volumes of Humalog, Humulin and NovoLog/NovoRapid in the US, 1999-2003:insulin analogues dominate the market
• Figure 35: Sales of Humalog, Humulin and NovoLog/NovoRapid in the US, 1999-2003: Humulins salesdecline as patients switch to insulin analogues
• Figure 36: Sales of Humalog, Humulin and NovoLog/NovoRapid in Europe, 1999-2003: Humalog has thehighest sales
• Figure 37: Price of Humalog, Humulin and NovoLog/NovoRapid per unit in the US, 1999-2003:Humulogs price has quadrupled over the last five years
• Figure 38: Price of Humalog, Humulin and NovoLog/NovoRapid per unit in Europe, 1999-2003; since2001, the drugs have a similar price point
• Figure 39: Prescription volumes of Avonex, Betaseron and Rebif in the US, 1999-2003: Betaseronhas dominated the market since 2000
• Figure 40: Prescription volumes of Avonex, Betaseron and Rebif in Europe, 1999-2003: Betaseronhas been the market leader over the last five years
• Figure 41: Sales of Avonex, Betaseron and Rebif in the US, 1999-2003: Avonex has had highersales than Betaseron and Rebif
• Figure 42: Sales of Avonex, Betaseron and Rebif in Europe, 1999-2003: the drugs have seensimilar level of sales since 2001
• Figure 43: Price of Avonex, Betaseron and Rebif per week in the US, 1999-2003; Rebif has beenthe most expensive treatment
• Figure 44: Price of Avonex, Betaseron and Rebif per week in Europe, 1999-2003; Rebif remains themost expensive treatment
• Figure 45: Marketing product mix of Sanofi Aventiss diabetes and endocrinology franchise
• Figure 46: Prescription volumes of Neupogen and Neulasta in the US, 1999-2003: Neupogen saleshave fallen since the launch of Neulasta in 2002
• Figure 47: Sales of Neupogen and Neulasta in the US, 1999-2003: Neulastas sales were greaterthan Neupogen a year after its launch
• Figure 48: Price of Neupogen and Neulasta per day in the US, 1999-2003: the drugs have a similarprice point on a daily basis
• Figure 49: Prescription volumes of Epogen, Procrit and Aranesp in the US, 1999-2003: Epogenprescription volume has continued to grow after the launch of its follow-on product Aranesp
• Figure 50: Prescription volumes of Eprex versus Aranesp in Europe, 1999-2003: the prescriptionvolume of Eprex has declined following the launch of Aranesp
• Figure 51: Sales of Epogen, Procrit and Aranesp in the US, 1999-2003: Sales of Amgens Epogenhas continued to grow at a similar rate despite the launch of its follow-up product Aranesp
• Figure 52: Sales of Eprex versus Aranesp in Europe, 1999-2003: sales of Eprex have grownsteadily, despite the launch of Aranesp
• Figure 53: Price of Epogen, Procrit and Aranesp per unit in the US,1999-2003: Aranesp enteredthe market at a higher price than its predecessor Epogen and by 2003, the price had more doubled
• Figure 54: Price of Eprex and Aranesp per unit in Europe, 1999-2003: since Aranesps launch at ahigher price point, Eprex unit price has been steadily increasing