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

Publication Date	June 2009
Publisher	Espicom
Product Type	Report
Pages	126
ISBN Number	978-1-85822-353-7
Product Code	ESP00616

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Summary

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

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 pr?(C)cis 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-Synth?(C)labo, 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.

Content

Executive Summary
Introduction
- Overview of controlled-release delivery: past, present & future
  - Leading controlled-release technology platforms & characteristics
- Controlled delivery profiles
  - Drug release profiles
- Controlled-release delivery: motivators & resistors
  - Motivators
    - Controlled-Release technology motivators
  - Resistors
    - Controlled-Release technology resistors
- Controlled-release delivery: impact on product lifecycles
  - Impact of reformulation on product life-cycle
Controlled-Release Delivery
- Types of controlled-release delivery used by pharma industry
  - Activated controlled-release delivery
    - Activated controlled-release delivery - ALZA's OROS systems
  - Degradation controlled-release delivery
    - Degradation controlled-release delivery - SkyePharma's GEOMATRIX
  - Diffusion controlled-release delivery
    - Monolithic diffusion controlled-release delivery - LaboPharm's Contramid
    - Reservoir diffusion controlled-release delivery - Impax' CMDS
    - Combined controlled-release delivery - Flamel's Micropump
    - Advantages and disadvantages of controlled-release platforms
- Current therapeutic application of controlled-release in drug delivery
- Leading brands that utilise controlled-release delivery
  - Leading controlled-release approved drugs
- Future commercial applications & opportunities
Strategies of Drug Delivery Companies
- Leading controlled-release drug delivery companies
  - Leading controlled-release drug delivery companies
- Partnerships & acquisitions
  - Strategic developmental & commercialisation partnerships
  - Merger & acquisitions
    - Recent partnerships & acquisitions in the controlled-release field
- Intellectual Property
  - Controlled-Release patents
The Controlled-Release Market
- Now 2009
  - Approved controlled-release product sales
- Future 2018
  - Global controlled-release product sales
  - Novel controlled-release product sales
Competitor Analysis
- Movers & Shakers: Cutting edge or losing their grip
  - Movers & shakers in controlled-release drug delivery systems
- COMPANY PROFILES
  - AlphaRx Corporation (www alpharx com)
  - Proprietary delivery technology
    - Drug Delivery Technologies: Controlled-Release
  - Applications in the pharma industry
  - Management/technical expertise
  - Competition within the delivery technology sector
  - Products in development/approved utilising the delivery technology
    - AlphaRx' product pipeline
  - Sales forecasts of products utilising the delivery technology
    - AlphaRx' drug delivery sales
  - Competitor Ratio Analysis
  - ALZA Corporation (www alza com)
  - 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
    - ALZA's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - ALZA's drug delivery sales
  - Competitor Ratio Analysis
  - Antares Pharma, Inc. (www antarespharma com)
  - 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
    - Antares' product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Antares' drug delivery sales
  - Competitor Ratio Analysis
  - Biovail Corporation (www Biovail com)
  - 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
    - Biovail's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Biovail's drug delivery sales
  - Competitor Ratio Analysis
  - Camurus AB (www camurus se)
  - Proprietary delivery technology
    - Camurus' FluidCrystal CR technology
  - Applications in the pharma industry
  - Management/technical expertise
  - Competition within the delivery technology sector
  - Products in development/approved utilising the delivery technology
    - Camurus AB's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Camurus AB's drug delivery sales
  - Competitor Ratio Analysis
  - Cerulean Pharma Inc (www ceruleanrx com)
  - Proprietary delivery technology
    - Drug Delivery Technologies: Controlled-Release
  - Applications in the pharma industry
  - Management/technical expertise
  - Competition within the delivery technology sector
  - Products in development/approved utilising the delivery technology
    - Cerulean's product pipeline
  - Sales forecasts of products utilising the delivery technology
  - Competitor Ratio Analysis
  - Cipher Pharmaceuticals, Inc. (www cipherpharma com)
  - 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
    - Cipher's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Cipher's drug delivery sales
  - Competitor Ratio Analysis
  - Debiopharm Group (www debio com)
  - 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
    - Debiopharm's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - DebioPharm's drug delivery sales
  - Competitor Ratio Analysis
  - DelSite Biotechnologies, Inc. (www delsite com)
  - 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
    - DelSite's product pipeline
  - Sales forecasts of products utilising the delivery technology
  - Competitor Ratio Analysis
  - Depomed, Inc. (www depomedinc com)
  - 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
    - Depomed's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Depomed's product sales
  - Competitor Ratio Analysis
  - Durect Corporation (www Durect com)
  - Proprietary delivery technology
  - Applications in the pharma industry
  - Management/technical expertise
  - Competition within the delivery technology sector
    - Drug Delivery Technologies: Controlled-Release
  - Products in development/approved utilising the delivery technology
    - Durect's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Durect's product sales
  - Competitor Ratio Analysis
  - Elan Corporation (www elan com)
  - 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
    - Elan's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Elan's drug delivery sales
  - Competitor Ratio Analysis
  - Elite Pharmaceuticals, Inc. (www elitepharma com)
  - Proprietary delivery technology
  - Applications in the pharma industry
  - Management/technical expertise
  - Competition within the delivery technology sector
    - Elite's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Elite's product sales
  - Competitor Ratio Analysis
  - Endo Pharmaceuticals, Inc. (www endo com)
  - 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
    - Endo's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Endo's product sales
  - Competitor Ratio Analysis
  - Ethypharm SA (www ethypharm com)
  - 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
    - Ethypharm's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Ethypharm's product sales
  - Competitor Ratio Analysis
  - Eurand (www eurand com)
  - 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
    - Eurand's product pipeline
    - Drug Delivery Technologies: Controlled-Release
  - Sales forecasts of products utilising the delivery technology
    - Eurand's product sales
  - Competitor Ratio Analysis
  - Flamel Technologies, Inc. (www flamel com)
  - Proprietary delivery technology
    - Flamel's Medusa technology
    - Flamel's Micropump technology
  - Applications in the pharma industry
  - Management/technical expertise
  - Competition within the delivery technology sector
  - Products in development/approved utilising the delivery technology
    - Flamel's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Flamel's product sales
  - Competitor Ratio Analysis
  - Glycologic, Ltd (www glycologic co UK)
  - 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
    - Glycologic's product pipeline
  - Sales forecasts of products utilising the delivery technology
  - Competitor Ratio Analysis
  - KV Pharmaceuticals, Inc (www kvpharmaceutical com)
  - 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
    - KV's product pipeline
  - Sales forecasts of products utilising the delivery technology
  - Competitor Ratio Analysis
  - Labopharm, Inc. (www labopharm com)
  - 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
    - Labopharm's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Labopharm's product sales
  - Competitor Ratio Analysis
  - Lavipharm SA (www lavipharm com)
  - 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
    - Lavipharm's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Drug Delivery Technologies: Controlled-Release
  - Competitor Ratio Analysis
  - Nano Interface Technology (www nanointerfacetech com)
  - 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
    - NITI's product pipeline
  - Sales forecasts of products utilising the delivery technology
  - Competitor Ratio Analysis
  - OctoPlus N V. (www octoplus nl)
  - 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
    - OctoPlus' product pipeline
  - Sales forecasts of products utilising the delivery technology
    - OctoPlus' product sales
  - Competitor Ratio Analysis
  - Penwest Pharmaceuticals (www penw com)
  - 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
    - Penwest's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Penwest's product sales
  - Competitor Ratio Analysis
  - SCOLR Pharma, Inc. (www scolr com)
  - 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
    - SCOLR's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - SCOLR's drug delivery sales
  - Competitor Ratio Analysis
  - Shire, Plc (www shire com)
  - 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
    - Shire's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Shire's leading drug delivery product sales
  - Competitor Ratio Analysis
  - Skinvisible, Inc. (www skinvisible com)
    - Drug Delivery Technologies: Controlled-Release
  - 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
    - Skinvisible's product pipeline
  - Sales forecasts of products utilising the delivery technology
  - Competitor Ratio Analysis
  - SkyePharma (www skyepharma com)
  - 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
    - SkyePharma's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - SkyePharma's product sales
  - Competitor Ratio Analysis
  - Spherics (www spherics com)
  - 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
    - Spheric's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Spheric's product sales
  - Competitor Ratio Analysis
  - Watson Pharmaceuticals (www watson com)
  - 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
    - Watson's product pipeline
  - Sales forecasts of products utilising the delivery technology
    - Watson' drug delivery sales
  - Competitor Ratio Analysis
Appendix
- Global controlled-release approved drugs sales 2008-2018 (US$million)
Appendix
- Global controlled-release developmental drugs sales 2008-2018 (US$million)
Appendix
- Competitor Ratio Analysis Criteria
  - Key Controlled-release delivery companies by 2015
Bibliography
Glossary
Acronyms
Endnotes