June 26th 2009
£595 / $1040 / €745
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...
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
NUCLEIC ACID DELIVERY
Click here for details of the full report >>
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:
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:
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
Route of delivery (oral, parenteral, transdermal, implantable), delivery of small molecules/macromolecules and vaccines, additional features such as bioerodible materials etc
Number of approved and marketed products, clinical or preclinical development candidates, single or multiple products.
Alternative drug delivery systems to technologies under evaluation, advantages and disadvantages over competitors.
Number of drug delivery systems in development, strategic alliances, financial position, marketing presence.
Drug delivery systems under evaluation, products in development, commercialisation/development partnerships.
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.