GBI Research, the leading business intelligence provider, has released its latest research “Generic Growth Strategies – Manufacturers to Increase Focus on Super Generics and Biosimilars to Drive Revenues”. It provides a comprehensive overview of the generic drugs market, analysis of upcoming noteworthy patent expirations, and trends and issues facing the generics market. The report delves into much detail on the current landscape; changes that have structured the generic drugs market in the last 30 years; and the reason behind the players’ urgency in developing and implementing generic growth strategies. The report also contains impact analysis of the regulatory landscape in the major geographies pertaining to the generic drugs market. Major strategies adopted by the leading companies in the generic drugs market have been analyzed in much detail, along with an elaborate company portfolio and strategic analysis of leading generic players. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.
The pharmaceutical industry is going to experience major patent expiries during 2011-2014. Although generic drug companies are expected to experience lucrative opportunities due to the impending patent expiries, they are gearing up to face competition from entities such as innovator companies vying for a share of the generic drugs market, and intense competition from other generic companies.
GBI Research has found that the pharmaceutical industry in general and the generics sector in particular have turned out to be highly competitive of late. There is rampant consolidation; novel business models are developing such as hybrid models between generic and innovator companies; and generics companies partnering with third-party sales to increase growth. Such joint ventures and co-operations are being adapted to leverage each partner’s strengths. The benefits from these partnerships are wide ranging for the generics companies, from higher access to research and development (R&D) capabilities and innovator drugs access to wider penetration in new markets.
Patent Expiries in Near Future Will Drive Generics’ Growth
The pharmaceutical industry is going to experience major patent expiries during 2010-2014, of which 2010 to 2012 are expected to be the peak years, with the loss of patents for drugs whose sales were worth more than $60 billion during 2009. In 2010, major drugs like Lipitor (atorvastatin), Cozaar (losartan), Advair (fluticasone/salmeterol), Arimidex (anastrozole), Flomax (tamsulosin)and Gemzar (gemcitabine), which together had sales of more than $24 billion, are facing generic competition. In 2011, several blockbusters are facing impending patent expiry and thus present opportunities for generics proliferation.
Source: GBI Research, Company Reports
The US generic industry has grown considerably ever since the enactment of the Hatch-Waxman Act, in 1984 which provided substantial power to generic companies to challenge drug patents and avail the benefit of a 180-day exclusivity period given to the first-to-file generic company. Since then, generic companies have used this Act to challenge the patents of branded drugs. Moreover, healthcare providers are under pressure from rising healthcare costs and prescription drug spending in particular. With increasing prices for the prescription drugs, healthcare providers such as federal and state-funded programs, employers, insurance companies, and even end-consumers under the co-pay agreements, are feeling the economic pressure. In such an environment, generic drugs provide several advantages over prescription drugs.
Available data from the Center for Drug Evaluation and Research (CDER) and U.S Food and Drug Administration (FDA) shows that since 2005 there had been 588 first-time generic drug approvals by 2010 in the US. First-time generics are defined as those drug products that are being approved for the first time as generic drug products and are therefore novel generic products to the market. The year 2009 saw the most first-time generic drug approvals since 2005, with 112 generic dug products approvals. There were 93 generic drug approvals in 2010. On average, there have been 98 first-time generic drug products approvals each year between 2005 and 2010.
Pharmaceutical products are not protected by only one patent, but by many. Sometimes a molecule is protected twice, once in a racemic form and once as an enantiomer; a specific salt may also be protected as well as a crystalline form (or lack of) for that salt. Each drug is guarded with more than one patent application, which in turn helps in extending patent life.
Molecules including omeprazole, citalopram and loratidine have been replaced by esomeprazole, escitalopram and desloratidine, respectively though such replacement hardly offers any advantages over the original formulations. Often supported by elaborate advertising and promotional expenditure, it leads to physicians prescribing the new product. For instance Servier, the pharmaceutical firm, introduced Coversyl Novum, a therapeutically identical version of their antihypertensive product Coversyl.
Generic companies traditionally offer large discounts; however, these companies are now undertaking portfolio-management strategies by offering drug products that have high barriers to entry and are as a result available at higher prices. These are called super generics, which are developed as value-added reformulations of off-patent drugs that require New Drug Application (NDA) submissions. This category of products offers a means of differentiation in the industry. The other attractive opportunity area for generic companies is in biosimilars, which are generic versions of biologics.
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