The U. S. Microbiome Therapeutic Market Analysis

There are multiple health concerns worldwide and more and more drugs are needed every day. Many drugs however, are extremely expensive to develop, test, and produce. According to the Tufts Center for the Study of Drug Development (2002), it costs up to $802 million to bring a new drug to the market. In 2002, pharmaceutical companies spent $34 billion in research and development (Center-Watch, 2003). In addition to the costs, the overall time from the discovery to approve and market the drug can take up to 15 years.

Second Genome was founded in 2009 by leading experts in microbial research and drug discovery. Second Genome is developing a proprietary, first-in-class microbiome drug discovery platform to develop novel therapeutics in a range of diseases. They employ novel technologies for identifying, screening, and scientifically validating products through a comprehensive understanding of host-microbe interaction and the resulting implications in driving disease.

Before, biologists assumed all microbes are bad for the human body (automatically thought of pathogens), caused many diseases and harm our body fundamental systems. In addition, the biologists think that our body is already built which had all the functions required to maintain our health. However, the attitude has changed over the last decade. The biologists characterized the most prevalent species of microbes in the body, and found out that these collective microbes do not threaten us, and they also are important part of human bodies.

EXECUTIVE SUMMARYSilicon Valley Medical Technologies (SIVMED) was founded as a research and development firm. In the beginning, SIVMED performed its own basic research, obtained patents on promising technologies, and then either sold or licensed the technologies to other firms which marketed the products. The firm has since then grown and is now contracted to perform research and testing for larger genetic engineering firms, biotechnology firms, the US government, and is now widely recognized as the leader in an emerging growth industry. SIVMED's founders were relatively wealthy individuals when they started company, and they committed a great deal of their own funds to the venture. Their personal funds, however, were soon exhausted by the

These companies are abandoning their research because it is harder to find new drugs to kill Gram-negative bacteria. These companies also worry about not getting return on the investment of their research for new antibiotics. The new drugs require expensive clinical trial tests and smaller pharmaceutical companies don’t have the financial ability to take the trails.

MedImmune is dedicated to helping patients live better lives through advances in science and medicine. Hundreds of thousands of patients have benefited from their products, which are designed to treat or prevent infectious diseases, cancer and inflammatory diseases (Wikipedia, 2012). Their extensive research and development efforts are focused on these same areas.

Achieve a median composite eight-year product development cycle by 2010. Deliver two new molecular entity (NME) launches on average per year from 2010. In order to achieve the above objective, ensure that we have 10 or more NMEs in Phase III development by 2010. Development cycle times and quality for small molecules and biologics. Number of NME launches per year. Attrition rates. Number of development projects by phase. Number of in-licensing deals, alliances and acquisitions. R&D investment levels. Improving R&D quality and speed through leading-edge science, effective risk management and decision-making and overall business efficiency. Maximising the value of our biologics business and continuing to build a major presence in this fast-growing sector. Investing in external opportunities to enhance our internal innovation through in-licensing, alliances and acquisitions. 2008 target exceeded for small molecule development cycle times. NME and life-cycle management progressions

When we speak of the word “bacteria” some individuals may not recognize how large of a role these tiny organisms play in our everyday lives. Some may jump to the conclusion that bacteria are related to the spread of germs or sickness among the human population. Most microbes are harmless or beneficial (Matthews, 2015) and a large majority of these tiny microbes are extremely important in order to maintain the balance of living organisms and chemicals in our environment (Tortora, Funke, & Case, 2013).

Hospitals in the United States do not have to report outbreaks to the government. However, according to the documentary the Centers of Disease Control and Prevention estimated that two million Americans are infected with resistance bacteria, which can result in about 23,000 Americans death each year. This is a hidden and silent epidemic with KPC found in hospitals in 44 states in the United States. In addition, there have been 32 confirmed cases this documentary in 14 countries with NDM-1 gene. The documentary should have explored what the U.S., India and other countries do differently or similarly in treating the superbug NDM-1. The US had in recent years signed a deal with GlaxoSmithKline worth $200 million on development and research of drug resistance antibiotics (Hirschler). GlaxoSmithKline is a “global healthcare group, which is engaged in the creation and discovery, development, manufacture and marketing of

As we are growing up, we are exposed to more microbiota from the environment and the food we eat. When we consider the microbiome in our gut as invasive species, like any other invasive species we can see that their chance of surviving in our body depends on niche and resources. The environment conditions such as temperature, pH, and aerobic/anaerobic will determine if a species occupy that space will thrive or not. “By viewing pathogens as invasive species, we see that the contexts in which they are able to cause disease are the same as those required for any other species that invades and proliferates in a community (Costello et al.,

The human microbiome is the genetic material of the microbes that live inside and on the human body. Microbes are microscopic organisms such as bacteria, fungi, protozoa and viruses. One’s diet and environmental factors can affect the composition of the microbiome. There is a high concentration of microbes in the gut, particularly inside the large intestine. The microbiome does many different things. It helps to digest our food, regulate our immune system, produce vitamins, protect against bad bacteria, and is essential for human development. Recent studies suggest that the microbiome also has an impact on the brain and emotional behavior. Interactions between the host and its microbiome are complex and bidirectional.

There are several rewards to consider with expansion of Biocon. Currently in India, there is a growing market for contract research organization and the growth of Biocon falls right within this opportunity. The growth is expected to last for more than few years with a rate that looks promising. Clinigene is expected to reap revenues much higher than the current Biocon and Syngene combined (Kalegaonkar A., Nov 4, 2008). It will take clinical studies to a higher level with better options in terms of drug manufacturing. With other countries ready to outsource the service of clinical studies, Clinigene’s future looks bright.

According the World Health Organization (WHO), antibiotic resistance is one of the world’s greatest health threats to date (Haddox, 2013). In the article, The Health Threat of Antibiotic Resistance, Gail Haddox (2013) discusses the danger antibiotic resistance poses in today’s society and strategies to prevent the expansion of antibiotic resistance. In Europe alone, an estimated 25,000 deaths have been attributed to multi-resistant infections (Haddox, 2013). Common infections are now harder to treat due to the increased resistance to antibiotics across the world, in fact some are becoming untreatable. Antibiotics should be treated like oil, a non-renewable resource (Haddox, 2013).

Comparing these potential market size, we can easily observe that Oxyglobin is roughly two times as profitable as Hemopure. Accordingly, Biopure should take these data into account to evaluate whether or not to launch Oxyglobin immediately. On the other hand, this revenue expectation is not so realistic. In fact, it is almost impossible that the company will capture the whole potential markets because of its small production capacity. This latter represents the main obstacle to a potential success of Biopure in both animal and human