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Controlled-release: Players, products & prospects to 2018 (Volume I)

Espicom Business Intelligence Ltd, June 2009, Pages: 126


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Controlled-release Delivery

The controlled-release market was worth nearly US$21 billion globally in 2008. The sector is dominated by the launch of oral controlled-release formulations in key therapeutic areas such as the central nervous system, cardiovascular, metabolic and respiratory diseases. The growth of controlled-release delivery continues to be fuelled by line extensions helping to offset the impact of generic erosion. We estimate there are around 60 approved controlled-release products which will generate global sales of over US$21.5 billion in 2009, peaking at around US$29.5 billion in 2017 as products mature and face patent expiration leading to a decline in mature product sales to US$28.9 billion by 2018. In addition, we forecast that controlled-release products in development from 17 key companies could generate additional sales of over US$5.1 billion by 2018.

Impact on product lifecycles
Controlled-release technologies, possibly more than any other approved delivery systems, have been an important tool for pharmaceutical companies to protect their branded franchises from the ever increasing and competitive generic market. These formulations play a critical role in establishing a balanced portfolio of solid dosage products and may lead to enhanced efficacy and improved patient compliance. This leads to reductions in patient costs and extending product life-cycle management for both branded and generic pharmaceuticals.

In the past, pharmaceutical companies have tended to develop controlled-release formulations as immediate-release counterparts near patent expiration. This trend is reversing and companies are developing controlled-release formulations earlier in the product life-cycle and often launching multiple formulations (immediate release, controlled release/
modified release, and delayed release) in parallel to expand the potential addressable patient population and gain a significant share of competitive market places.

This report answers key questions...
Who will have launched novel products by 2018 and what technologies could they be using?
Can market leaders such as ALZA and Elan maintain their status in controlled release in the face of growing competition?
What obstacles must companies overcome to achieve full market potential?
What strategies are proving most productive and for which companies?
What will the product/company landscape look like in 2018?

This report is part of a major new 4-volume strategic analysis

Drug Delivery Technologies:
Players, Products & Prospects to 2018

Focusing on the sectors that are driving growth

VOLUME I
CONTROLLED- RELEASE

VOLUME II
NANOTECHNOLOGY

VOLUME III
NUCLEIC ACID DELIVERY

VOLUME IV
TARGETED DELIVERY

Click here for details of the full report >>

CONTENTS
EXECUTIVE SUMMARY & INTRODUCTION
- Overview of controlled-release delivery: past, present & future
- Controlled delivery profiles
- Controlled-release delivery: motivators & resistors
- Controlled-release delivery: impact on product lifecycles
CONTROLLED-RELEASE DELIVERY
- Types of controlled-release delivery used
Activated controlled-release delivery
Degradation controlled-release delivery
Diffusion controlled-release delivery
- Current therapeutic application of controlled-release in drug delivery
- Leading brands that utilise controlled-release delivery
- Future commercial applications & opportunities
STRATEGIES OF DRUG DELIVERY COMPANIES
- Leading controlled-release drug delivery companies
- Partnerships & acquisitions
- Intellectual Property
THE CONTROLLED-RELEASE MARKET
- Now 2009: Approved controlled-release product sales
- Future 2018: Global controlled-release product sales and novel controlled-release product sales
COMPETITOR ANALYSIS
Detailed analysis of leading companies covering:
- Proprietary delivery technology
- Applications in the pharma industry
- Management/technical expertise
- Competition within the delivery technology sector
- Products in development/approved utilising the delivery technology
- Sales forecasts of products utilising the delivery technology
- Competitor ratio analysis
Companies analysed:
- AlphaRx Corporation
- ALZA Corporation
- Antares Pharma, Inc.
- Biovail Corporation
- Camurus AB
- Cerulean Pharma, Inc
- Cipher Pharmaceuticals, Inc.
- Debiopharm Group
- DelSite Biotechnologies, Inc.
- Depomed, Inc.
- Durect Corporation
- Elan Corporation
- Elite Pharmaceuticals, Inc.
- Endo Pharmaceuticals, Inc.
- Ethypharm SA
- Eurand N.V.
- Flamel Technologies, Inc.
- Glycologic, Ltd
- KV Pharmaceuticals, Inc
- Labopharm, Inc.
- Lavipharm SA
- Nano Interface Technology
- OctoPlus N.V.
- Penwest Pharmaceuticals, Inc.
- SCOLR Pharma, Inc.
- Shire, Plc.
- Skinvisible, Inc.
- SkyePharma, Inc.
- Spherics Pharmaceuticals, Inc.
- Watson Pharmaceuticals, Inc.
APPENDICIES
- Global controlled release approved drug sales 2008-2018
- Global controlled release development drug sales 2008-2018
- Key controlled release delivery companies by 2015

Unique company & technology evaluation
It is vital that management information is reliable, current and insightful. Today, product and company assessment must be seen in a wider competitive and market environment.

In this report we present a précis on each of the leading delivery specialists and potential new delivery platforms and have identified their key attributes, based on a number of criteria including:

Proprietary delivery technology
Applications of the delivery technology within the pharmaceutical industry
Management/technical expertise of the delivery specialist
Competition within the delivery technology sector
Products in development/approved utilising the delivery technology

We have established a competitor ratio analysis based on each of the criteria mentioned above. Each criterion attracts an award of up to 10 points, with a maximum score of 50, thus enabling the establishment of an Espicom “ranking table” in each segment of the market, dependent on their relative attributes.

Multi-point evaluation and scoring assessment
Pharma drugs that utilise drug delivery systems have been evaluated based on a number of parameters, including:

The technology
Comparison of delivery platforms within each area including: activated, degradation or diffusion for controlled-release systems; nano-engineered (nanocrystals, nanoparticle, nanosuspension) or nanocarriers (carbon/ceramic, dendrimer, liposome, micelle, polymeric nanoparticles) for nano-enabled delivery; viral or non-viral platforms for nucleic acid delivery and active or passive platforms for targeted delivery systems
The application of the technology within a number of therapy areas
Route of delivery (oral, parenteral, transdermal, implantable), delivery of small molecules/macromolecules and vaccines, additional features such as bioerodible materials etc
The current status of the technology in clinical development or following approval
Number of approved and marketed products, clinical or preclinical development candidates, single or multiple products.
Competition within the technology arena
Alternative drug delivery systems to technologies under evaluation, advantages and disadvantages over competitors.
The drug delivery specialist’s expertise
Number of drug delivery systems in development, strategic alliances, financial position, marketing presence.
The product portfolio
Drug delivery systems under evaluation, products in development, commercialisation/development partnerships.
Potential drug sales
Based on key events such as market, competition, patent expiry, time of entry into the market.

About the Author
Dr Cheryl Barton is a highly regarded independent consultant with over 16 years research and business analysis experience. Following her senior research positions in academia and seven years with Merck, in which she was responsible for research projects ranging from Alzheimer’s disease to schizophrenia. Dr Barton subsequently joined Dutch investment bank ABN Amro NV as a senior equity analyst where she was lead analyst on major pharmaceutical companies such as Roche and Sanofi-Synthélabo, and assessed the potential impact of new drug development on European Stocks.

In 2002, Dr Barton founded a consulting business (www.Pharmavision.co.uk) to provide independent, tailor-made, pharmaceutical thematic research to investment houses and pharmaceutical companies. The research reports combine independent scientific analysis with patient-based models to forecast the potential sales growth of key drugs in clinical development.




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