Ranbaxy Set to Enter the U.S. Market with Valsartan, Diovan

The U.S. Food and Drug Administration (FDA) has granted approval to Ranbaxy Laboratories to launch the generic version of Diovan, blood pressure pill by Swiss drug maker Novartis AG. This long-awaited decision will make Ranbaxy the first rival drug maker to launch a copy of Diovan in the United States. FDA had earlier banned a number of Ranbaxy India facilities due to reports of poor production quality.

The total annual market sale of Diovan is estimated to be $2.19 billion. Its generic version, whose chemical name is Valsartan, will be manufactured and marketed in the U.S. market for the treatment of high blood pressure and heart failure. Ranbaxy is entitled to six-month exclusivity to sell it before other drugmakers become eligible to gain FDA approval and introduce their versions. Valsartan will be available in 40 mg, 80 mg, 160 mg, and 320 mg tablets.

According to BCC Research’s report, Global Markets for Generic Drugs, the global generics sector reached $269.8 billion in 2009. This is expected to reach $300.9 billion in 2013 and $ 518.5 billion in 2018, registering a compound annual growth rate (CAGR) of 11.5%.

Use this report for, but not limited to, the following reasons:

• Gain an overview of the global market for generic drugs, including coverage of therapeutics such as antibacterials, antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs, and drugs for respiratory conditions
• Analyze global market trends, with data from 2012, estimates for 2013, and projections of CAGRs through 2018
• Examine strategies employed by companies specializing in generics to meet the challenges of this highly competitive market, and also summarizing strategies employed by “originator” companies to forestall generic competition
• Assess important trends by product categories and major country markets, acknowledging Brazil, China, India, Mexico, and Russia as among the rising markets for generic activity

To Order your copy of this report (or any of its chapters) or to download the Complimentary Introduction chapter, click here.

Global generic drugs market to reach $518.5 billion by 2018

This is a time of growth and change for the generic pharmaceutical sector. With several blockbuster brands coming off patent, demand for generic replacements is increasing steadily, resulting in reduced profit margins and an intense M&A environment. Indeed, the rise of so-called super-generics and mounting pressures to reduce healthcare costs globally are pushing drug prices even lower. Further, a whole new market field -- biogenerics -- is opening up, for those generics companies prepared to buy in. However, not all traditional companies are well-suited for these conditions.

BCC Research provides an in-depth analysis of the global market for generic drugs through its report Global Markets for Generic Drugs. According to the report, this market was valued at nearly $270 billion in 2012 and is estimated at nearly $301 billion for 2013. BCC Research projects the market to grow to $518.5 billion by 2018, and register a five-year compound annual growth rate of 11.5% from 2013 to 2018.

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Use this report to:

• Gain an overview of the global market for generic drugs, including coverage of therapeutics such as antibacterials, antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs, and drugs for respiratory conditions.
• Analyze global market trends, with data from 2012, estimates for 2013, and projections of CAGRs through 2018.
• Examine strategies employed by companies specializing in generics to meet the challenges of this highly competitive market, while also summarizing strategies employed by “originator” companies to forestall generic competition.
• Assess important trends by product categories and major country markets, acknowledging that Brazil, China, India, Mexico, and Russia are among the rising markets for generic activity.
• Review comprehensive company profiles of major players in the industry.

SAMPLE FIGURE

MAJOR NATIONAL GENERIC MARKETS, THROUGH 2018

($ BILLIONS)

To order your copy of this report (or any of its chapters) or to download the complimentary introduction chapter, click here.

Generic Drugs: The Global Market

According to a technical market research report, Generic Drugs: The Global Market from BCC Research (PHM009E) (www.bccresearch.com), the global market for generic drugs was worth $84 billion in 2009, a figure that is expected to reach $129.3 billion in 2014, for a compound annual growth rate (CAGR) of 9% over the 5-year forecast period.


The generic market came of age during the 1990s and the generic industry consolidated its position during the first years of the new millennium. Starting as a patchwork of national marketplaces, the generic world now rivals the traditional pharmaceutical universe.

However, this is a volatile time for the generic pharmaceutical sector. The demand for generics is increasing steadily because of pressure to control healthcare costs. At the same time, fierce price competition is resulting in slashed profit margins for participating companies. A major growth driver for the generics sector is that several blockbuster pharmaceutical brands are coming off-patent and are therefore open to generic competition. And the international landscape is changing for generics as for all pharmaceuticals. China, India, Eastern European countries and Brazil are among rising centers of generic activity.

This report, Generic Drugs: The Global Market, values the current global generics market in developed countries at an estimated $59 billion. Of the latter figure, the five major European national markets account for 23%, the U.S. for 42%, and Japan for 6%.

Generic penetration varies widely from country to country; in Europe, for example, generics account for almost 18% of the German pharmaceutical market but only 11% of the pharma market in France. The European average share is 15%; this compares with 10% of the U.S. pharmaceutical market, but only 6% of the market in Japan.

In terms of growth, generics have outstripped “regular” pharmaceuticals and seem certain to grow more quickly during the next decade, driven by:

• Aging populations, especially in developed countries, driving up the costs of healthcare including drugs

• Problems faced by payers (governments, HMOs, individuals) in attempting to pay for expensive branded pharmaceuticals

• General economic downturn exacerbating the above problems

• Emergence of new national markets for pharmaceuticals among developing economies, needing to install affordable healthcare systems

• Wider access to information about pharmaceuticals via the internet, leading to fuller appreciation of the value of generics in the public domain

• Increasing involvement of “big pharma” in the generics arena, improving the public perception and acceptance of generics

• Loss of patent protection by a succession of blockbuster products, creating new opportunities for generics.

Although the worldwide economic downturn which began to take hold in 2008 led to slower growth for pharmaceuticals overall, the negative effect was less marked in the generic sector, and in the medium to long term it is expected that generic markets will continue to show positive growth, and at a faster rate than mainstream pharma.