The discovery of antibiotics in the 1930s fundamentally transformed the way physicians care for patients, shifting their approach from a focus on diagnoses without means to intervene to a treatment-focused approach that saves lives. Seven decades of medical advances enabled by antibiotics are now seriously threatened by the convergence of relentlessly rising antibiotic resistance and the alarming and ongoing withdrawal of most major pharmaceutical companies from the antibiotic market. Without effective antibiotics, diverse fields of medicine will be severely hampered, including surgery, the care of premature infants, cancer chemotherapy, care of the critically ill, and transplantation medicine, all of which are feasible. Many public health experts and officials consider the emergence and spread of antibiotic resistance as one of, if not the, paramount public health threat of the 21st century. While not a new phenomenon, the emergence and spread of antibiotic-resistant bacteria has reached a state of crisis unlike anything modern healthcare has ever contended with. While most resistant microbes continue to emerge in the hospital setting, physicians and epidemiologists are finding more resistance outside of the hospital environment among people who have never had any previous healthcare contact. In the hospital setting, the number of patients who are dying from untreatable bacterial infections continues to grow. The antibiotic market has seen only 2 new classes of antibiotics over the past 30 years:

• The oxazolidinones: Pfizer’s Zyvox (linezolid) was the first of this new class of synthetic antibiotic compounds. Approved by the FDA in 2000, growth in the use of Zyvox is among the fastest in the market, second only to Cubicin. Sales totaled about $944 million in 2007, a 21% increase over 2006.
• The cyclic lipopeptides: Cubist’s Cubicin (daptomycin) is the first of the cyclic lipopeptides, a natural class of compounds. Approved by the FDA in 2003, use of Cubicin is growing at afaster rate than any other antibiotic. Net sales totaled $290.4 million in 2007, representing a 53% year-over-year increase.

Antibiotics are short-course therapies intended for acute or semi-acute conditions, not life-long chronic conditions, which translate to limited returns on investment (relative to other therapeutic areas). Added to this is the fact that most new antibiotics almost immediately become drivers of the evolution, or development, of resistance as soon as they become introduced to medical care and the marketplace. Knowing this, and for good reason, efforts continue to be directed toward imposing restrictions on antibiotic usage. However, this also has the unfortunate effect of reducing the potential earnings—a strong disincentive for companies relying on the blockbuster model of pharmaceutical development to become involved with antibiotic R&D.

The global anti-infective market is currently valued at US$66.5 billion with antibacterial agents accounting for over 50% of sales. The antibacterial market is set to grow to over US$45.0 billion by 2012, driven by the uptake of newer antibacterial agents such as glycopeptides and carbapenems which demonstrate resistance to methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE) as well as other emerging strains.

Pharmaceutical companies continue to develop a new generation of antibacterial agents such as cephalosporins, macrolides and quinolones to overcome the major issue of drug resistance. In addition, a number of new drug classes such as Hydramicins are under evaluation which are effective in multi drug resistant organisms.

This report examines each of the antibacterial classes in turn, assessing the market potential and application in hospital and community-acquired infections. The report assesses the overall antibacterial market, key classes and the drivers and resistors influencing their prescription. The report provides an overview of key products in each category, summarizing their clinical efficacy and marketing position. The overview of the current market is given in terms of segmentation and by leading players and their products and analyzes market trends.

Combating resistance will require a multi-pronged approach: one focused on prevention and the more judicious use of antibiotics, but one also focused on the discovery and development of not just new antibiotics, but new antibiotics with novel potential to inhibit bacterial growth, reproduction, and resistance—either through novel mechanisms of action or through the inhibition of new targets. Several companies featured in this report are pursuing the discovery and development of new antibiotic compounds. However, far too many of the new compounds are simply improved analogues of already existing compounds, which means that they probably won’t be presenting much of a challenge to the bacterial world with respect to combating resistance.

Global Outlook of Antibacterial Market

Published : September 2012                                    No. of Pages : 70

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