INTRODUCTION
STUDY GOAL AND OBJECTIVES
The world is in the midst of an emerging crisis of antibiotic resistance to microbial pathogens. Numerous pathogens that have become resistant to commonly used antibiotics have been described in various contexts, including drug-resistant methycillin-resistant Staphylococcus aureus (MRSA), Streptococcus pneumoneae, and Mycobacterium tuberculosis. Considering the breadth of effect and significant impact on morbidity and mortality, multi-drug-resistant (MDR) pathogens are a substantial threat to public health. Although this problem calls for the development of new antibiotics with new mechanisms of action, the pharmaceutical industry has abandoned the sector as less lucrative for their investments. The number of new antibiotics approved by the U.S. Food and Drug Administration (FDA) declined dramatically during the past 2 decades.
During the past 5 years, there has been a revival in the antibiotics sector. Although some companies are developing analogues of existing antibiotic classes and putting them into clinical trials, other start-up and biotechnology companies have come up with molecules that adopt new approaches in tackling microbial infections. Although the number of such new molecules in the approval stages is still low, research and development (R&D) pipelines are promising, and several novel classes of antibiotics are in their early stages of development. The main goal of this report is to identify the trends in the antibiotics sector in terms of the emerging trends to handle the resistance problem worldwide. Most of the recent antibiotic clinical trials address the issue of antibiotic resistance. Hence, the market forecast based on conventional antibiotic classes will have a significant impact on both the newly approved drugs and the drugs in advanced stages of development targeting antibiotic resistance during the forecast period.
This report includes detailed analysis of the regulatory trends in various parts of the world. New legislation targeting antibiotic resistance issues are being considered by several governments. Impact of these trends can be significant in terms of the market forecast. The report also analyzes the nature, geographic spread, and mechanisms of various microbial infections. Various conventional and emerging antibiotic classes are analyzed in detail, and the mechanisms of action of these antibiotic classes are discussed. Mechanisms of resistance adopted by various bacteria are presented, along with the mechanisms chosen by scientists to counter the resistance mechanisms while designing new antibiotics. Emerging technology trends in the antibiotic sector are included as well. A detailed analysis of U.S. patents filed between 1976 and 2009 is conducted to identify the antibiotic classes that are gaining maximum attention by the research community and the key players investing in antibiotic R&D. Finally, the global antibiotic market size and its potential growth are estimated for the next 5 years. Because the market growth is mainly for the antibiotics tackling the resistance problem, the compound average growth rate (CAGR) indicates the growth of antibiotic resistance markets.
REASONS FOR DOING THE STUDY
There is a renewed interest in the antibiotic sector, which is evident from the most recent patents and investments. Bacterial vaccines and new antibiotic classes are gaining a tremendous amount of attention with several product candidates in clinical development. These new products are expected to change the outlook of the antibiotic sector to a large extent over the next 5 years. Several reports focus on anti-infective markets in general. This report, however, focuses exclusively on antibacterials, with a particular emphasis on the emerging problem of antibiotic resistance. It also includes a detailed analysis of the emerging technology trends, which give a clear picture of the future of the sector. This helps to provide regulatory authorities and industry strategists a better perspective on which to base their decisions. BCC Research published a report on this topic in 2002. Since then, the market has witnessed dramatic changes in terms of technology, investment, and regulatory trends, which are captured in this report.
INTENDED AUDIENCE
This report reviews the global antibiotic markets, including discussions on the market development and growth potential over the next 5 years. It also analyzes key factors that are driving the market growth. It describes the trends in detail with respect to various antibiotic classes, including the novel classes that are emerging and their technological basis. It includes in-depth discussions of the industry structure and the regulatory environment. It is valuable reading for investors, policymakers, and industry participants. Profiles of leading players in the industry are also included.
Such involved analyses have been conducted to help strategy developers and decision makers within pharmaceutical companies and government bodies. The detailed analyses of the regulatory factors that play major roles in deciding the industry trends are especially useful for legislators involved in government policy development programs. Technology trend and patent analyses give an overview of the new trends with respect to innovation within the sector.
SCOPE OF REPORT
The scope of this report includes current antibiotic markets as well as the emerging antibiotic market, with an exclusive focus on antibiotic resistance. It technically encompasses antibacterials that include antibiotics, bacterial vaccines, and other emerging antibacterials that are not necessarily classified as antibiotics. Prevention of bacterial infections using bacterial vaccines is within the scope of the study. Antiviral and antifungal products are excluded from the market definition, and vaccines targeting viral diseases are outside the scope of this study. In short, this report contains:
- Overview of antibiotic market
- Classification of bacteria
- Classification of antibiotics
- Mechanisms of resistance by bacteria
- Resistance trends and geographic analysis
- Antibiotics targeted to counter the resistance mechanisms
- Emerging regulatory trends
- Technology trends in combating resistance
- Patent analysis
- Current antibiotic market and future growth trends
- Emerging new approaches and product candidates in antibiotic resistance
- Analysis of leading companies and their strategies
- Sales projections through 2014 for antibiotic resistance markets
The base year of this study is 2009. Market figures are based on the revenues at the supplier levels, which are projected in 2009 constant dollars (i.e., inflation is not computed into the projection figures). The revenue figures are derived from the revenues of the key players in a particular year. Revenues of generic products are outside the scope of this study. Projections for the antibiotic resistance market are based on the assumption that the new and emerging products combat the antibiotic resistance issue in one way or another. Hence, forecasts are for the antibiotic resistance markets and are based mainly on the projections of the marketers.
INFORMATION SOURCES AND METHODOLOGY
Both primary and secondary research methods were used in this market research study. The information and analysis presented in this report are based on an extensive survey of the antibacterial sector as well as a detailed examination of published literature and reports obtained from regulatory authorities, research institutions, trade associations, and national and international healthcare organizations. Key information from the literature was used to obtain expert opinion on commercial potential and market sizes from industry professionals. Data to prepare this study were derived from regulatory agencies, annual reports of companies, scientific associations, public healthcare authority websites, and industry related databases. In addition, discussion with researchers and sales personnel of drug companies, academic researchers, and government agency spokespersons have been conducted to gain insight into the emerging market trends.
ANANLYST’S CREDENTIALS
Syamala Ariyanchira is a bench scientist who transferred to industry analysis. She combines her technical background with business sector issues and is involved in various activities, including technology assessment, strategic planning, competitor analysis, due diligence, and market analysis. Her clients include investment firms, government agencies, and chemical and pharmaceutical companies. She holds a PhD from Indian Institute of Science, Bangalore, India, and has authored three recent reports for BCC Research.
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DISCLAIMER
The information developed in this report is intended to be as reliable as possible at the time of publication and of a professional nature. This information does not constitute managerial, legal, or accounting advice; nor should it serve as a corporate policy guide, laboratory manual, or an endorsement of any product, as much of the information is speculative in nature. The author assumes no responsibility for any loss or damage that might result from reliance on the reported information or its use.
Report Code: PHM025B, Published: November 2009, Analyst: Syamala Ariyanchira
