Market Access Pricing and Reimbursement

Generic drug must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamics properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use The FDA's use of the word "identical" is very much a legal interpretation, and is not literal. In most cases, generic products are available once the patent protections afforded to the original developer have expired. Generic drugs  are in general less effective than the original formulation due to a weaker placebo effect and a stronger placebo effect. When generic products  become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In most countries of the world, patents give 20 years of protection. However, many countries/regions, e.g. the European Union and the USA may grant up to 5 years of additional protection for drugs ("patent term restoration") if manufactures meet specific goals such as conducting clinical studies for paediatric patients. Manufacturers, wholesalers, insurers, and drugstores can each increase prices at various stages of production and distribution.

 

The "Generic Drugs Market: 2015 - 2030 - Opportunities, Challenges, Strategies & Forecasts" report presents an in-depth assessment of the generic drugs ecosystem including technology, economics, key trends, market drivers, challenges, investment potential, regulatory landscape, leading therapies, opportunities, future roadmap, value chain, ecosystem player profiles and strategies. The report also presents market size forecasts for generic drugs from 2015 through to 2030. The forecasts are segmented for over 10 therapeutic areas, 3 brand classifications, 5 regions and 25 leading countries.

A recently proposed Food and Drug Administration (FDA) regulation affecting generic drug labelling would introduce product liability, increasing the overall costs for generic manufacturers. Should the rule be finalized, it would increase spending on generic drugs by $4 billion per year. Pricing and margins in the industry have a tendency to decline as a result of fierce competition in the generic drug industry and increased government pricing pressure. The biggest driver is global medicine spending trend towards generics. With most governments in the world to seeking ways to control healthcare budgets, we are positive about generic drug’s growth rate compared with its branded counterparts. Also, the continued patent cliff creates growing pipelines opportunities for the generic firms. Growth in both overall population and aging demographics prove to be beneficial for the overall healthcare sector including generic drug makers. Healthcare reform in US and fast growth in emerging market are other important drivers for the industry.

  • Generic Market and Business Opportunities
  • US Generic Market
  • Europe Generic Market
  • Asia Generic Market
  • Marketing of Generic Drugs

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