June 26th 2009
£1795 / $3140 / €2245
Critical analyses and competitive ratings for major specialist developers
Unique sales forecasts to 2018 for key current and new products utilising drug delivery technologies
A comprehensive examination of the 4 major and compelling drug delivery sectors
While pharmaceutical sales have risen steadily over the last five years generating over US$720 billion in 2008, analysts are forecasting sales growth will slow over the next five years due to an unprecedented level of patent expiration compounded by the downturn in the global economy. At the same time, the global drug delivery market has undergone rapid growth from an estimated US$26 billion in 2000 to approximately US$74 billion in 2008.
This market has been driven by a number of factors:
Within this market there are areas of advanced drug delivery which have attracted the attention of the pharmaceutical industry and the investment community.
Focusing on the sectors that are driving growth!
NUCLEIC ACID DELIVERY
Drug Delivery Technology: Assessing its potential
The time when advanced drug delivery was merely a means for profitable product life extension has gone. Drug delivery is now a major component of the pharmaceutical industry’s future and critical to bringing novel therapies to market.
Indeed, without the ability to effectively deliver targeted drugs in therapeutically significant quantities, many of the gene-based agents in research would not be viable. Despite the importance of the sector, the pharmaceutical industry has not always been quick to embrace the full range of potential technologies and opportunities on offer.
With so many companies pursuing a wide range of research strategies, it is difficult for industry and commercial executives to get a balanced and independent overview of the competitive landscape.
That is why this major new 4-volume report, Drug Delivery Technologies: Players, Products and Prospects to 2018, is essential reading for everyone in the field, from niche technology specialists through to the investment community and the pharmaceutical industry itself.
'' By 2018 sales of products using the novel drug delivery technology assessed in this report could exceed US$58 billion ''
This report provides a detailed insight into the current and future market for drug delivery technology and...
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...
Nucleic Acid Delivery
The nucleic acid delivery market is maturing with over 1,450 clinical trials underway worldwide. The majority of these are in early clinical development (approximately 60%) with just over 3% in Phase III trials. Our analysis indicates that up to 35 novel nucleic acid products could reach the market within our forecasting period (2008-2018). However the harsh economic environment may force companies to place promising drugs on hold as they focus on lead projects rather than multiple programmes. To date, only a handful of nucleic acid-based products have been approved for human prescription and these products rely on delivery technologies in one shape or form. We estimate the nucleic acid market was worth just over US$80 million globally in 2008.
By 2018 we anticipate the nucleic acid technology market will have matured as many of the late-stage clinical programmes come to fruition and drug delivery companies continue to overcome issues surrounding its safety and efficiency. The development of nucleic acid delivery systems will help to improve specificity whilst the development of novel polymers and lipopolymer complexes will help to carry larger DNA payloads in order to target cells and make multigene targeting a reality. We forecast that nucleic acid products in development from 11 key companies could generate additional sales of nearly US$2.3 billion by 2018. These products utilise a range of delivery platforms including viral to non-viral delivery systems, and cover gene therapies, gene agents and DNA vaccines for a variety of targets including cancer, cardiovascular and infectious diseases.
Catalysts for change
Which companies and products will dominate?
This volume will tell you!
The true value of nanotechnology lies in its potential to improve the solubility and enhance the efficiency of product delivery. It has been successfully applied to the commercialisation of more than 30 drugs. Regulators have published numerous white papers on the topic and established Task Forces to monitor the progress and application of this technology although there are presently no regulations specific to nanomedicine or nano-enabled medical devices.
As the field of nanotechnology gains momentum and nano-enabled platforms emerge to address the industry’s need for therapeutic, bioavailable and less toxic products, this market is expected to grow significantly over the next decade. Proof of concept data with novel compounds is accumulating and new formulations of old chemotherapeutic drugs offer the promise to revolutionise cancer therapies.
The potential of future applications:
By 2018, the market could exceed US$13 billion
By 2018 the established nanotechnology product market will be US$10.2 billion. The market will mature as the number of marketed nano-enabled products doubles and second generation nanomedicines begin to emerge. These agents will address areas of high unmet clinical need and result in the formulation of approved and novel drugs which are safer, less toxic and more efficacious than first generation products.
By 2018 these second generation nanomedicines could generate sales of nearly US$2.9 billion and establish nanotechnology as an important tool in the industry’s delivery armoury. A range of proprietary delivery platforms will utilise CaP technologies, FluidCrystals, micelles and polymeric nanoparticles to target a number of therapy areas such as CNS disorders, oncology and infectious diseases.
By 2018, over 30 new products will be launched resulting in a global market for advanced targeted delivery products worth over US$8.5 billion.
Despite considerable advances in drug delivery technologies, there continues to be a high unmet clinical need for safer and better-tolerated drugs. Sub-optimal compliance and failure to persist with drug treatments are important determinants of therapeutic non-response and are of significant cost to healthcare providers. Advanced targeted drug delivery technologies will help to overcome some of these issues by improving pharmacokinetics, increasing tolerability and reducing dose-limiting off-target effects.
The need for targeted delivery platforms is increasing as patients and drug regulators seek to meet these challenges.
Current and future applications
Whilst the majority of targeted delivery systems under evaluation incorporate passive carrier systems, there will be a shift towards the use of actively targeted carriers to increase the therapeutic index of existing and new products. There are significant opportunities for future commercial developments within the pharmaceutical industry. These include:
A new generation of targeted delivery systems is under development to meet these needs which should provide greater control over the selective targeting of tissue, either with active moieties or inactive moieties which may be activated within the tissue by biological (enzymes), chemical (pH) or physical means (light, ultrasound) in order to release the active agent. The multitude of delivery platforms will lend themselves to the delivery of both small molecules and macromolecules and to a variety of target sites and delivery routes.
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:
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.