Research Overview
Regulatory and Patent Uncertainties Constrain Development of Generic and
Biogeneric Drugs in Developed Countries
With end users of prescription drugs seeking to pay less for medication,
generic and biogeneric products are poised for strong growth, especially in the
developing nations. However, this may not be the case in developed regions ?
especially in the United States and Europe - where market growth is likely to be
restricted due to concerns over patent infringements and lack of clear-cut
regulatory processes for approval of generic and biogeneric drugs. Currently,
regulations pertaining to introduction of generics apply only to small molecule
drugs while the regulatory process for large molecule, protein-based biotech
products is yet to be defined. Even a minor change in the manufacturing process
is likely to trigger major changes in biological activity that are distinctly
different from original products and this mandates the use of clinical testing
of biogeneric drugs prior to their approval.
Frost & Sullivan�fs recent study analyzes the worldwide market for
generic and biogeneric products. It focuses on the United States, European,
Asian, and the Rest-of-the-World (ROW) markets. The research provides a
comprehensive snapshot of the competitive landscape, revenue and prescription
forecasts, technology trends, and challenges.
Weak Patent Laws Aid Market Growth of Generic Drugs in Developing Nations
Generic drug manufacturers in developing nations, aided by weak patent laws,
are focusing on producing blockbuster drugs that are still under patent
protection. "In India, for example, drug manufacturers may patent a process
but not a compound, thus, generic drug makers are able to synthesize the
compound through another process and may legally introduce another version of
the drug," explains the research analyst of this study. "In this
manner, they can benefit from the original manufacturer�fs ongoing advertising
and promotion of the drug while eliminating the need to depend on the American
and European generics producers."
In an endeavor to avoid the stringent patent processes, generic manufacturers
may lose some quality in the process of reengineering drugs. Several Asian and
ROW generics producers have faced similar difficulties and one recent example is
the removal of two generic HIV drugs produced by a prominent Indian
pharmaceutical company from the WHO list of approved medications meant
specifically for patients in Africa.
Consumer Belief in Branded Products Restricts Use of Generics
Though generics and biogeneric drugs are emerging as strong contenders to
branded medications, a number of consumers in developed nations have a
perception that branded products are more effective than unbranded ones.
"Certain patient populations tend to view healthcare benefits as
entitlements rather than privileges and resist shifting from more expensive to
less expensive options," says the analyst. Even when they are compelled to
switch drugs, they shift from one brand to another ? Popularly known as a
�ebrand name shift�f ? Despite the availability of low-cost generics. This is
one challenge that generic drug manufacturers are likely to find hard to
overcome in their quest to extend market reach.
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To maximize the potential for growth within a firm�fs internal and external
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1 EXECUTIVE SUMMARY
2 TOTAL MARKET
- Overview
- Introduction
- Research Scope and Segmentation
- Market Overview
- Market Dynamics
- Industry Issues
- Industry Challenges
- Market Engineering Analysis
- Market Forecasts
- Prescription and Revenues Forecasts
- Cost Savings
- Competitive Landscape
- Product Analysis
- Market Share Analysis
- Challenges and Opportunities in Biogenerics
- Overview
- Challenges in Biogenerics
- Opportunities in Biogenerics
- Frost & Sullivan Awards
- Product Differentiation Award
- Product Distribution Innovation Award
- Industry Innovation and Advancement Award
- Product Development Leadership Award
3 U.S. GENERICS AND BIOGENERICS MARKETS
- Overview
- Introduction
- Market Overview
- Market Dynamics
- Segment Issues
- Market Drivers
- Market Restraints
- Market Engineering Analysis
- Market Forecasts
- Prescription and Revenue Forecasts
- Cost Savings
- Competitive Landscape
- Regulatory Overview
- Pipeline Analysis
- Competitive Analysis
- Market Share Analysis
- Challenges and Opportunities in Biogenerics
- Overview
- Challenges in Biogenerics
- Opportunities in Biogenerics
4 EUROPEAN GENERICS AND BIOGENERICS MARKETS
- Overview
- Introduction
- Market Overview
- Market Dynamics
- Segment Issues
- Market Drivers
- Market Restraints
- Market Engineering Analysis
- Market Forecasts
- Prescription and Revenue Forecasts
- Cost Savings
- Competitive Landscape
- Regulatory Overview
- Pipeline Analysis
- Competitive Analysis
- Market Share Analysis
- Challenges and Opportunities in Biogenerics
- Overview
- Challenges in Biogenerics
- Opportunities in Biogenerics
5 ASIAN GENERICS AND BIOGENERICS MARKETS
- Overview
- Introduction
- Market Overview
- Market Dynamics
- Segment Issues
- Market Drivers
- Market Restraints
- Market Engineering Analysis
- Market Forecasts
- Prescriptions and Revenue Forecasts
- Cost Savings
- Competitive Landscape
- Regulatory Overview
- Pipeline Analysis
- Competitive Analysis
- Market Share Analysis
- Challenges and Opportunities in Biogenerics
- Overview
- Challenges in Biogenerics
- Opportunities in Biogenerics
6 REST-OF-WORLD GENERICS AND BIOGENERICS MARKETS
- Overview
- Introduction
- Market Overview
- Market Dynamics
- Segment Issues
- Market Drivers
- Market Restraints
- Market Engineering Analysis
- Market Forecasts
- Prescription and Revenue Forecasts
- Cost Savings
- Competitive Landscape
- Regulatory Overview
- Pipeline Analysis
- Competitive Analysis
- Market Share Analysis
- Challenges and Opportunities in Biogenerics
- Overview
- Challenges in Biogenerics
- Opportunities in Biogenerics
7 APPENDIX
- Decision Support Databases
- Biotechnology Companies
- Government Healthcare Expenditure
- Percentage of R&D Expenditure
- Private Investment in Biotechnology
- Government R&D Investment in Biotechnology
