The increasing number of new biological products, and the emergence of a biosimilars market has focused the industry’s attention on the development of novel and advanced drug delivery technologies which can deliver these new targeted products. However, oral and parenteral drug administration still dominates the market, and technical innovation is ensuring these tried and tested routes of administration continue to offer more compelling and effective methods of drug delivery.
The global pharmaceutical industry generated revenues of over US$800 billion in 2009, growing at around 7% per annum.
Oral formulations accounted for almost 60% of prescriptions, with the top 10 oral products accounting for nearly 10% of total global pharmaceutical sales. The global market for oral drug delivery enhanced products (DDEPs) was estimated to be worth around US$51 billion in 2009, accounting for nearly 60% of the market share of the entire DDEP market; sustained-release formulations represented over 95% of all oral DDEPs.
Parenteral drug delivery is the second largest segment of the market accounting for nearly 30% of the market share. It is presently valued at US$27 billion and is expected to reach US$51 billion by 2015 driven primarily by the launch of new biologics; the uptake of novel delivery platforms and the utilisation of controlled-release systems.
This report provides a detailed insight into the current and future market for oral and parenteral drug delivery technology, and...
Oral Delivery Technology
During the last 30 years, considerable advances have been made in drug delivery technologies, particularly in the field of controlled-release delivery. However, there is an unremitting demand for products that achieve continuous release of therapeutic agents over extended time periods. This has led to the development of a multitude of drug delivery platforms mainly involving either multi-particulate dosage forms (e.g. pellets contained in gelatine capsules) or single-unit dosage forms (e.g. bilayer or multilayer tablets), and a variety of release profiles.
Currently-marketed oral DDEPs encompass several therapeutic categories including cancer, cardiovascular, central nervous system, musculoskeletal, metabolic diseases (diabetes) and respiratory conditions. Oral disintegrating tablets (ODTs) or melts have evolved as an important delivery system for drugs that treat medical conditions vulnerable to a sudden onset of symptoms such as allergies, migraine, reflux disease and schizophrenia. In addition, oral DDEP platforms have been utilised to reduce the abuse-resistance of opioids and to prevent alcohol “dose dumping.”
Oral DDEPs are widely used across the globe as patients migrate towards convenient dosage formulations. Controlled-release tablets and capsules remain the main formulation platform although orally disintegrating, nanoparticle and combined technology formulations are expected to broaden applications in the future.
Oral DDEPs use a variety of mechanisms to modify the controlled delivery of the molecule (drug) including: osmotic-driven drug release, degradation-driven release, diffusion-controlled release or through a combination of delivery platforms. Advanced oral DDEPs can be used to target release within specific regions of the GI tract such as Alizyme’s Colal delivery system and Cosmo’s MMX technology. In addition, companies have developed pulsatile-release platforms that allow drug release to more closely follow circadian rhythms, such as BTG’s Pulsincap.
A vigorous research environment
Over 800 companies are currently involved in the development of oral drug delivery technologies from large pharma to specialty delivering technologists. This report identifies 29 of the top movers and shakers in the oral delivery industry.
This report answer key questions
Parenteral Delivery Technology
Over the last 50 years, considerable technological advances have been made in the area of parenteral drug delivery to overcome the many limitations associated with this route of delivery. This has led to the development of sophisticated systems that allow drug targeting and the sustained or controlled release of parenteral medicines. Over the next ten years more than 30 new targeted-delivery products are expected to be commercially released and more than 35 nano-enabled nucleic acid products could reach the market.
Improvements in parenteral delivery devices such as pre-filled syringes, pens, auto-injectors and needle-free devices continue to alleviate the burden of self-administration and improve patient compliance. Meanwhile the explosion of biological therapies provides additional challenges for drug delivery specialists seeking to develop ways of improving on standard injections for these products.
Widening therapeutic uses for parenteral delivery
The development of new and approved agents for oncology, infectious disease, endocrinology and inflammatory and immune-related diseases continues to fuel the growth of injectable DDEPs. This market will be driven by the identification of novel drug targets and the development of innovative immunotherapeutics that address areas of high unmet clinical need, a segment that has been historically poorly treated with oral therapeutics. Parenteral DDEPs are widely used across the globe, but tend to be priced at a premium due to the sophisticated delivery devices which often require administration from a healthcare professional.
Innovation from a vigorous research-based sector
Parenteral DDEPs apply to a variety of formulations and devices in which to modify the delivery of small and large molecule drugs. Self-injection devices include pen injectors, auto-injectors, needle-free injectors and nasal spray devices while formulation-based technologies range from liposomes and emulsions, PEGylation, microparticles and nanoparticles and dendrimers, either used alone or in combination to optimise delivery and minimise off-target toxicities. Over 250 companies are currently involved in the development of parenteral drug delivery technologies from large pharma to specialty delivery technologists, and this report analyses 24 of the leading players.
This report answers key questions
What trends are driving the parenteral delivery sector to double digit growth?
Which sector of the market is expected to grow by a CAGR of 15% to 2015?
Which companies are developing technologies for the delivery of poorly-soluble drugs?
What clinical benefits are there in the subcutaneous delivery of monoclonal antibodies?
What is the current state of play for auto injectors and insulin pumps for the treatment of diabetes?
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 (Pharmavision) 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.