Drug Delivery Technologies: Controlled-release

Published Date: 26/06/2009
Category: Drug Delivery & Devices

Research Report Decription

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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.

Key Questions Answered:

• 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?

Companies Mentioned:

AlphaRx Corporation, ALZA Corporation, Antares Pharma, Biovail Corporation, Camurus AB, Cerulean Pharma, Cipher Pharmaceuticals, Debiopharm Group, DelSite Biotechnologies, Depomed, Durect Corporation, Elan Corporation, Elite Pharmaceuticals, Endo Pharmaceuticals, Ethypharm SA, Eurand N.V., Flamel Technologies, Glycologic, KV Pharmaceuticals, Labopharm, Lavipharm SA, Nano Interface Technology, OctoPlus N.V., Penwest Pharmaceuticals, SCOLR Pharma, Shire, Skinvisible, SkyePharma, Spherics Pharmaceuticals, Watson Pharmaceuticals

Paper Highlights:

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 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 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:

• What proprietary delivery technologies are under evaluation?
• Which delivery technologies are being applied by the pharmaceutical industry?
• Who are the leading delivery specialists within the sector?
• What are the key competitors within the delivery technology sector?
• Which products are under development or approved utilising these novel delivery technologies?

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 approva: lNumber 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.