There are more than 1400 sustained or controlled release drugs approved all
over the world. Revenues within the global generics market reached an estimated
value of $265 b in 2012, showing a growth of 9.3% throughout the year. The
contribution of generics is approximately 20% of the overall international
pharmaceutical market. Utilization of generic in terms of volume is higher in
the US and lower in Japan, 89% and 24% respectively.
The oral drug delivery market remains the largest slice of the overall drug
delivery market, with more than 52% of market share. It is presently valued at
$49 billion and is expected to reach over $90 billion by 2016, at a CAGR of 11%.
The growth in the oral drug delivery market shall be driven primarily by newer
technologies enabling controlled release formulations of oral drugs and oral
formulations of injectable only drugs. Global injectable drug delivery market is
expected to be worth $29b by 2015.
Novel drug delivery systems (NDDS) offer many more advantages, which include
improved therapy by increasing the efficacy and duration of drug activity,
increased patient compliance through decreased dosing frequency and convenient
routes of administration, and improved targeting for a specific site to reduce
unwanted side effects. The challenge for both drug and drug delivery companies
is to deliver both existing and emerging drug technologies in a manner that
improves the current benefits enjoyed by the patients.
The generic market with reference to innovative molecule (NCE) has become very
competitive as several companies have already filed ANDA's for potential generic
drugs in the near term. The study of the novel drug delivery companies and their
formulation technologies will provide the potential value added opportunity in
the generic field in terms of patient’s compliance or bioavailability
enhancement. It will also provide an enhanced life cycle for drugs under patent
coverage (life cycle extension).
This comprehensive report on novel drug delivery system focuses mainly on the
oral and injectable formulations of pharmaceuticals and specialty companies.
This report enumerates the various formulation technologies involved in making
value added formulations, pharmaceutical applications and advantages of specific
technologies. Wherever possible, marketed drugs using a similar technology have
been discussed as proof of validation along with the status of additional
pipeline. The discussed proprietary formulation technologies includes Colal,
Glide SDI, Arestat, GeoClock, GeoMatrix, FlashTab, Lock Tab, Medusa, Eligen,
Oradur, EnteriCare and Saber.
This report will be helpful for those pharma companies who are exploring novel
opportunities for their growth by in-licensing formulation technology or value
added pipeline drugs available/being studied in the market.
Innovative Drug Delivery System: Potential Product and Formulation Technology
1. Global Generic Business – Present Status and Future Opportunities
2. Therapeutic focus and Trends in Advanced drug Delivery System based on recent
3. Patent expiry impact and generic companies strategies –Super generics
4. The relationship between solubility and permeability in formulations
5. Formulation approach for water –insoluble drugs and oral peptide delivery
6. FDA guidelines for 505 (b)(2) applications and advantage of development
7. Types of changes allowed in 505 (b)(2) development and its advantage
8. Regulatory challenges in clinical data requirement in 505(b)(2) development
and safety studies
9. Analysis, Application and Advantages of formulations technologies for more
than 75 pharma companies with over 100 formulation technologies in oral and
injectable formulations discussed
10. Late stage pipeline development for discussed specialty and major Pharma
11. The discussed formulations proprietary technologies includes Colal, Glide
SDI, Arestat, GeoClock, GeoMatrix, FlashTab, Lock Tab, Medusa, Eligen,
Oradur,EnteriCare and Saber