Health The Great Market.
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With the increase in global welfare level, medical care became widespread and a further essential need. Countries economical efforts grew but they did so at such a pace that there is a growing pressure for this heavy burden to be significantly reduced, on the consumers side many are complaining about the excessively high prices and demand that the current level of healthcare prices to be reduced.
As marketing exclusivity periods for first in-class drugs decline, drug developers are facing incresing pressure to improve productivity in their drug development activities to help bolster return on investment.
R&D strategies that strive to attain a best in-class status for new drugs or, at the least, clear advantages over existing therapies with patient subgroups or particular indications will dominate.
They are also suffering growing pressures to contain costs from managed care organizations and pricing and reimbursement.
Authorities are increasing pressure on firms to get new drugs to market sooner, preferably with clear advantages in safety, efficacy, or economic value.
The health market makes millions and many more as expected as more and more people have access to medical care. Also the population aging in developed countries, with the many health implications it has, causes that a new set of needs arise. As more elderly people demand for attention and preventive care the market will continue to grow. The world goes on with its globalization trend and diseases stop being local or regional to become wide spreading at a world level. The transmission of diseases also becomes more and more quickly.
Despite the economic downturn, the pharmaceutical industry has grown 7% globally with an estimated value of $390 billion. The US market alone is valued at $189 billion. Several factors have contributed to this growth and the increased revenues. The price of drugs has increased 4%. A growing baby boomer population has led to an increased demand for medicines, and the number of medications being prescribed for treating a disease has also increased in recent years.
There have been significant changes in the pharmaceutical business environment with several mergers and acquisitions in the past few years, which has resulted in a consolidated, fiercely competitive market with fewer players. The biggest change to come over the next 4 years is that the industry in the US alone stands to lose more than $36 billion in sales when several branded drugs come off patent. This is a formidable challenge for the pharmaceutical industry and boosts the opportunities for manufacturers of generics.
Another factor that has changed the business environment is the patent life (years that offer a market exclusivity to the manufacturer sell the drug) for drugs, which has been decreasing. The patent life, which symbolizes the period when companies usually recover their R&D costs and generate profits is currently about 12 years and is expected to drop to 10 years within the next decade. Hence, with the shrinking patent life, the companies are under more pressure to curtail costs and increase R&D efficiencies. With the entry of “me-too” drugs, companies also have to increase their marketing budgets to better differentiate their products.
Companies looking for synergies and for developing healthy pipelines account for several mergers that have occurred in recent years. Several factors can be attributed to this scenario. The drug development time has increased from 8 years during the 1960s to about 14 years. The obvious opportunities in well-characterized disease areas have already been exploited and scientists now have to explore diseases that are not so well understood to come up with superior and innovative drugs. The R&D involved in this process is very challenging and time-intensive. Hence, R&D costs have gone up about 213% in the last decade. It is estimated that it now costs almost $800 million to bring a new drug to market. The payoffs generated by the genomics revolution have been slow and have not met expectations.
The profiles of the diseases being targeted have evolved over the years along with the changing population dynamics. A decade ago, infectious diseases and development of antibiotics were a large R&D focus. Today with the aging population, the fastest growing and highest selling market is the one for statins - the cholesterol lowering drugs. What was once considered a niche and small disease market is now offering a large undiagnosed patient population with a large unmet medical need and a huge commercial opportunity. Although this changing disease profile has not been sudden, it still presents a formidable challenge because not all companies have aligned their business model to address this issue. Statins for lowering cholesterol, glitazones for diabetes, monoclonal antibodies for cancer, and COX-2 inhibitors for pain management are targeting some of these new markets.
Companies are investing billions in developing immunotherapy drugs, designed to selectively and optimally use the body’s own immune system to prevent or fight disease. Among these immunotherapies are monoclonal antibodies and therapeutic vaccines. The development of therapeutic vaccines for the treatment of HIV/AIDS, cancer, and other major diseases holds tremendous promise as adjunctive therapies to conventional treatments.
The increasing healthcare expenditure, shrinking healthcare funding and the growing consumer outcry has resulted in mounting pressure on drug companies to lower drug prices. The rising healthcare expenditure on prescription drugs can be attributed to the pharmaceutical companies endeavor to shift the patients to newer, more expensive products, as older products mature and give way to generic competition. The increase in the use of drugs in chronic diseases, such as cardiovascular, diabetes, gastrointestinal, and CNS has also contributed to this increase. Due to the presence of multiple products within the same class, there is a pressure to lower costs. The industry is also under fire for the high drug inflation rate, which over the past five years has far exceeded the average rate of inflation. The average cost of prescription drugs has increased by 4% every year during the past several years. Escalating product development costs and a shorter market exclusivity period on one hand, and the increasing pressure to curtail costs on the other, puts the pharmaceutical manufacturers in a tight spot. In addition, the consistent pressure from the managed-care organizations also counteracts the premium pricing strategies employed in the marketplace.
The longest documented human life span is 122 years. Though a life span that long is rare, improvements in medicine, science and technology over the last century have helped more people live longer, healthier lives. If you were born in the early 1900s in the United States, your life expectancy was only about 50 years. Today it's around 77. The aging boom is upon us. Since 1900, the number of Americans age 65 and older has increased 10-fold. The oldest-old, people age 85 and older, constitute the fastest growing segment of the U.S. population. By 2050, this population, currently about 4 million people, could top 19 million. Living to 100 likely will become more commonplace. In 1950, only about 3,000 Americans were centenarians; by 2050, there could be nearly one million. This remarkable burst of longevity, unprecedented in human history, has been possible because of equally remarkable improvements in sanitation, health care, and lifestyle. Some gerontologists suspect an average life expectancy of 85 years or more may be possible in the near future.
Worldwide population ageing is a public health challenge affecting many aspects of human life and societies in developed and developing nations alike. Population ageing has a great impact on individuals health and social needs, family structures, health systems and overall socioeconomic development.The birth rate has been decreasing compared to the elders increase so that we face a future society of fewer children and more elderly persons. In the very near future this will give way to a “super-aged society”. As a result, in looking at “health” on a national basis, the health of the elderly persons, their medical treatment, welfare, and care, are among the most pressing issues the world faces.
The percentage of the population who are in the older age groups (>65 years) will increase in all countries in the next few decades. This process of population ageing will take place more rapidly in developing countries than it did in developed countries. Ageing of the population will present two major challenges. First, health care systems must reorient themselves to preventing and treating the conditions, such as increased chronic diseases and functional impairments that characterize an older population and second, countries must mobilize the additional resources that will be required to meet the increase in needs.
As Europe’s population grows older and demands for healthcare provision increase, the developed world is facing a nightmare scenario of rapidly increasing healthcare costs.
According to studies from the EU Economic Policy Committee, on the “Budgetary challenges posed by ageing populations”, due to the growing number of elderly people amongst Europe’s population, the number of working age citizens contributing to social service funds is rapidly diminishing, while conversely, the number of elderly citizens is rising. It is estimated that by 2050 there will be only two working age citizens for each elderly person in the EU, instead of the current four.
One readily available solution to these problems is to be found, in part, in increasing the use of generic medicines. These competitively priced therapeutic equivalents to patent expired originator pharmaceuticals have demonstrated they possess the same quality, safety, and efficacy as their originator products, and they go through the same regulatory procedures. The only difference is their price, which is typically 20% to 80% below that of brand-name originator pharmaceuticals.
Cardiovascular system High blood pressure (hypertension)
Bones, muscles and joints Osteoporosis
Digestive system Healthy digestion
Kidneys, bladder and urinary tract Urinary incontinence
Prostate gland enlargement
Brain and nervous system How to keep your mind sharp
Eyes Dry eyes
Ears Hearing loss
Teeth Dry mouth
Oral and throat cancer
Skin, nails and hair Skin cancer
Sleep Sleep and seniors
Weight Menopause and weight gain
Food & Exercise Exercise regularly
Eat nutritious food
Over time, the heart muscle becomes a less efficient pump, working harder to pump the same amount of blood through the body. In addition, blood vessels become less elastic. Hardened fatty deposits may form on the walls of the arteries (atherosclerosis), narrowing the passageway through the vessels. The natural loss of elasticity, in combination with atherosclerosis, makes arteries stiffer, causing the heart to work even harder to pump blood through them. This can lead to high blood pressure (hypertension).
High blood pressure (hypertension) is often called a silent killer because people can have it for years without knowing it. Blood pressure is determined by the amount of blood the heart pumps and the amount of resistance to blood flow in the arteries. Blood pressure normally varies during the day. It can even vary slightly with each beat of the heart. It increases during activity and decreases with rest. Many people may not view high blood pressure as life-threatening. But uncontrolled high blood pressure can increase the risk of serious health problems.
Bones reach their maximum mass between ages 25 and 35. As people age, their bones shrink in size and density. One consequence is that they might become shorter. Gradual loss of density weakens the bones and makes them more susceptible to fracture. Muscles, tendons and joints generally lose some strength and flexibility as people age.
Osteoporosis, which means "porous bones," causes bones to become weak and brittle - so brittle that even mild stresses like bending over, lifting a vacuum cleaner or coughing can cause a fracture. In most cases, bones weaken when people have low levels of calcium, phosphorus and other minerals in their bones. Osteoporosis can also accompany endocrine disorders or result from excessive use of drugs such as corticosteroids.
Although it is often thought of as a women's disease, osteoporosis affects many men as well. Even children are not immune.
Swallowing and the motions that automatically move digested food through the intestines slow down as people get older. The amount of surface area within the intestines diminishes slightly. The flow of secretions from the stomach, liver, pancreas and small intestine may decrease. These changes generally do not disrupt the digestive process but constipation conditions are more frequent.
The digestive system can adjust to a wide variety of foods, tolerate an astonishing amount of emotional stress and put up with hurried meals of questionable nutritional value. But over time a poor diet, bad eating habits and other unsavory lifestyle habits can take their toll. The possible results? Distressing bouts of heartburn, nausea, cramps, diarrhea or constipation.
With age, kidneys become less efficient in removing waste from the bloodstream. Chronic conditions, such as diabetes or high blood pressure, and some medications can damage kidneys further.
About 30 percent of people age 65 and older experience urinary incontinence. Incontinence can be caused by a number of health problems, such as obesity, frequent constipation and chronic cough. Women are more likely than men to have incontinence. Women who have been through menopause might experience stress incontinence as the muscles around the opening of the bladder lose strength and bladder reflexes change. Pelvic muscles become weaker, reducing bladder support. In older men, incontinence is sometimes caused by an enlarged prostate, which can block the urethra. This makes it difficult to empty the bladder and can cause small amounts of urine to leak. Urinary incontinence is an all too common, often embarrassing and frustrating problem for millions of people.
Prostate enlargement affects about half of men in their 60s and up to 90 percent of men in their 70s and 80s.
The number of cells (neurons) in brain decreases with age, and memory becomes less efficient. However, in some areas of the brain, the number of connections between the cells increases, perhaps helping to compensate for the aging neurons and maintain brain function. Reflexes tend to become slower. There is also a tendency to become less coordinated. To try to slow down or even revert this process occupational therapies are advised so as to stimulate their intelect to remain active.
With age, eyes are less able to produce tears, your retinas thin and lenses gradually turn yellow and become less clear. During the 40s, focusing on objects that are close up may become more difficult. Later, the irises stiffen, making pupils less responsive. This can make it more difficult to adapt to different levels of light. Other changes to lenses can make people sensitive to glare, which presents a problem when driving at night. Cataracts, glaucoma and macular degeneration are the most common problems of aging eyes.
Healthy eyes are continuously covered by a tear film - a constant layer of fluid designed to remain stable between blinks. A stable tear film prevents irritation of the nerves of the cornea, the clear front surface of eyes, and allows the eye to maintain clear, comfortable vision. The tear film protects the eyes and lubricates them. It also reduces the risk of eye infection and, with each blink of the eyelids, helps clear eyes of any debris. When the eyes become irritated from dust or are bothered by wind, smoke or fumes, extra tears form to help wash away the foreign material. Decreased production of fluids from tear glands can destabilize the tear film, allowing it to break down rapidly and creating dry spots on the cornea that cause irritation and diminished vision. An imbalance in the substances that make up the tear film also can make eyes become dry. For most people who have dry eyes, it's a chronic condition.
A cataract is a clouding of the normally clear lens of eyes. Clouded vision can make it more difficult to read, drive a car or see the expression on a friend's face. Cataracts commonly affect distance vision and cause problems with glare. They generally do not cause pain, double vision with both eyes open or abnormal tearing. Clouding of the lens is a normal part of getting older. About half of people older than 65 have some degree of clouding of the lens. After age 75, as many as 70 percent have cataracts that are significant enough to impair their vision. Most cataracts develop slowly and do not disturb eyesight early on. But as the clouding progresses, the cataract eventually interferes with vision. In the early stages, stronger lighting and eyeglasses can help to deal with the vision problems. But at some point, if impaired vision jeopardizes normal lifestyle, it might need surgery.
Glaucoma is sometimes called the silent thief because it can slowly steal your sight before people realize anything's wrong. The most common form of glaucoma, primary open-angle glaucoma, develops gradually, giving no warning signs. Many people are not even aware they have an eye problem until their vision is extensively compromised. Glaucoma is the second most common cause of vision loss in the United States as it affects approximately 3 million Americans. Glaucoma is not just one disease, but a group of them. The common feature of these diseases is damage to the optic nerve that usually is accompanied by an abnormally high pressure inside the eyeball. If left untreated, glaucoma may lead to blindness in both eyes.
Age-related macular degeneration is a chronic eye disease that occurs when tissue in the macula, deteriorates. Degeneration of the macula causes blurred central vision or a blind spot in the center of your visual field. The first sign of macular degeneration may be a need for more light when doing close-up work. Fine newsprint may become harder to read and street signs more difficult to recognize. Eventually people may notice that when they are looking at a grid, some of the straight lines appear distorted or crooked. Gray or blank spots may mask the center of the visual field. The condition usually develops gradually, but may sometimes progress rapidly, leading to severe vision loss in one or both eyes. Macular degeneration is the leading cause of severe vision loss in people age 60 and older.
Presbyopia is the gradual loss of the eye's ability to focus actively on nearby objects. It is a natural part of aging that usually begins to affect people after age 40. For most people, presbyopia becomes apparent when they need to hold print at arm's length in order to read it.
Hearing loss is one of the most common conditions affecting adults who are middle-aged and older. One in three people older than 60 and half of all people older than 85 have significant hearing loss. Over the years, sounds and noise can damage the hair cells of the inner ears. In addition, the walls of the auditory canals thin, and eardrums thicken. People may have difficulty hearing high frequencies. Some people find it difficult to follow a conversation in a crowded room. Changes in the inner ear or in the nerves attached to it, earwax buildup and various diseases can all impact hearing.
The gradual hearing loss that occurs as people age (presbycusis) is a common condition. An estimated one-third of the peolple older than age 60 and one-half of those older than age 85 have some degree of hearing loss. Over time, the wear and tear on ears from noise contributes to hearing loss by damaging the cochlea, a part of your inner ear. It is believed that heredity and chronic exposure to loud noises are the main factors that contribute to hearing loss. Other factors, such as earwax blockage, can prevent ears from conducting sounds as well as they should.
How teeth and gums respond to age depends on how well people cared for them over the years. But even if they were meticulous about brushing and flossing, may notice that their mouth feels drier and gums have receded. Teeth may darken slightly and become more brittle and easier to break. Most adults can keep their natural teeth all of their lives. But with less saliva to wash away bacteria, teeth and gums become slightly more vulnerable to decay and infection.
Some older adults experience dry mouth (xerostomia), which can lead to tooth decay and infection. Dry mouth can also make speaking, swallowing and tasting difficult. Oral cancer is more common among older adults. Lack of saliva is a common problem that may seem little more than a nuisance, but it can affect both enjoyment of food and the health of teeth.
Missing teeth can make it difficult to eat and can cause discomfort in social situations. Implants or dentures may help people once again to chew, talk and smile with teeth that look and feel like their own.
The American Cancer Society estimates more than 28,000 new cases of oral and throat (oropharyngeal) cancer occur annually in the United States an estimated more than 7,000 Americans die of these cancers annually. The worldwide market for implant-based dental reconstruction products will approach nearly $3.5 billion by 2010.
With age, skin thins and becomes less elastic and more fragile. It is also likely to bruise more easily. Decreased production of natural oils may make skin drier and more wrinkled. Age spots can occur, and skin tags are more common. Nails grow at about half the pace they once did. Hair may gray and thin. In addition, older people are likely to perspire less, making it harder to stay cool in high temperatures and putting them at increased risk of heat exhaustion and heat stroke. Skin cancer is also a concern as people age. There is a 40 % to 50 % chance of getting skin cancer at least once by the time people reach 65.
Skin cancer is the most common form of cancer diagnosed. Doctors diagnose skin cancer in approximately 1 million Americans each year, and about 9,800 Americans die annually of skin cancer. Fair-skinned people who live in areas that get a lot of sunshine are at greatest risk. But anyone can develop skin cancer, which is most commonly caused by overexposure to ultraviolet (UV) radiation from the sun.
Baldness typically refers to excessive hair loss from your scalp and can be the result of heredity, certain medications or an underlying medical condition. Anyone - men, women and children - can experience hair loss. The most common type is pattern baldness (androgenetic alopecia). It accounts for about 95 percent of hair loss from the scalp. It's typically permanent and can be attributed to heredity. Another type of alopecia, alopecia areata, can be temporary.
Hair typically turns gray as a result of aging. Pigment in the hair shaft comes from special cells at the root (base) of the hair. These cells are genetically programmed to make a certain amount of pigment (melanin) at specific ages. At some point in the aging process, these cells make less and less pigment until the hair has very little pigment. White hair has no pigment, and gray hair has some but not as much as a red, black or brown hair.
Vertical nail ridges, which run from the cuticle to the tip of the nail, are fairly common. They do not indicate serious illness and typically increase with age.
Skin tags are small, soft, flesh-colored growths that protrude from your skin. They most often occur in fold areas of the body, such as on the sides of the neck, armpit or groin. Skin tags typically appear in middle age.
Sleep needs change little throughout adulthood. However, as people age, they will likely find that they sleep less soundly, meaning they will need to spend more time in bed to get the same amount of sleep. By age 75, some people find that they are waking up several times each night. Having difficulty getting to sleep and staying asleep is common as people age. But that does not mean insomnia cannot be avoided. Some medicines and therapies can help reduce or even eliminate these conditions.
As people age, maintaining a healthy weight - or losing weight if they are overweight - may be more difficult. This because metabolism generally slows, meaning that their body burns fewer calories. Calories that were once used to meet the daily energy needs instead are stored as fat. Also the level of activity may decrease, resulting in unwanted weight gain. There is also the tendency that the weight gain tends to accumulate around the stomach, rather than hips and thighs.
With age, sexual needs, patterns and performance may change. Impotence becomes more common in men as they age. By the time they are 65, up to 25 percent of men have difficulty getting or keeping an erection about one in every four times they have sex. In others, it may take longer to get an erection, and it may not be as firm as it used to be.
The demand for medical products related to cardiovascular, bones, muscles, joints, digestive system, kidneys, brain, eyes, teeth, skin, nails, hair sleeping disorders, overweight or sexual problems are meant to rise as the population requiring them is meant to increase. The previous conditions that we saw before are just some of the new opportunities that derive from the population ageing. These conditions will represent a greater share of the diseases affecting mankind. They have, therefore, a great potential for the health industry and should be regarded with special attention as they represent a potential market of million consumers. Therefore the development or generic production of medicines related to these conditions represent a very important niche that should be regarded as a strategically one.
Stem cells can be derived from an embryo or an adult. Unlike most cells in the body, such as skin or heart cells, which are dedicated to perform a specific function, stem cells are not specialists. But under certain circumstances, they can differentiate into specialized cells. Another unique characteristic of stem cells is their ability to replicate for indefinite periods without becoming senescent. It is not clear, however, if adult stem cells can fully match embryonic stem cells’ capacity to differentiate into vast arrays of replacement cells and tissues. In animal studies, certain adult stem cells have shown some potential to develop into multiple cell types, suggesting that both embryonic and adult stem cells could have therapeutic applications. Still, the discovery of human stem cells is an important scientific breakthrough that clearly has the potential to improve the quality and length of life.
As the senior will be a significant part of the population and they demand specific treatment, geriatric care will be a area of greater importance and with a growing demand. Additionally this segment of the population will posses a considerable income, due to the social welfare, to spend in this kind of care. Therefore geriatric care services will meet a great expansion and some of the retirees will move to countries where the cost of living is lesser than in their own to enjoy their retirement.
There are basically two forms of drug - proprietary (or 'brand-named') drugs that are developed and produced by large multinational pharmaceutical companies, and generic drugs that are either copies, or the basic form of a proprietary drug. Paracetamol for example is the generic form of Panadol or Tylenol. The companies that make these brand-names may spend thousands on marketing and inventing new formulations, but the basic active ingredient in their tablets is just standard paracetamol which can be bought without the label for far less money. Paracetamol can be made generically because there is no longer a patent on it. However, drugs that are in patent can also be copied under certain conditions, and are also known as generics.
A generic medicine is an equivalent of an originator pharmaceutical product. It contains the same active substance as, is “essentially similar” to, and is therefore interchangeable with, the originator product.
A generic medicine is marketed in compliance with international patent law. It is identified either by its internationally approved non-proprietary scientific name (INN) or by its own brand name. Generic medicines are widely used in many EU countries in cost-effective treatment programmes, and are increasingly prescribed by doctors as effective alternatives to higher-priced originator pharmaceuticals.
Also governments, as the number of retired people starts to get too close to the number of workers, will try to find cheaper ways to supply the surging medical with the minimum possible costs. This effort will lead them to incentive the increase usage of such type of medicines as they are significantly cheaper and provide the same results.
Increasing patient access to generic medicines generates four main public health benefits. It:
2. Stimulates Competition
3. Creates Budget Headroom for Innovation.
4. Encourages new pharmaceutical companies.
In the end of 2004, 35% of top selling pharmaceuticals were patent expired, creating a major opportunity over the next few years for increasing the purchase of generic medicines, both in community prescription and in hospital sectors. This poses good perspectives for the generics industry as the increasing trend is supposed to continue with more and more applications for generic patents being made.
Areas like the North America and Europe are reconsidering their previous position on tropical diseases as their range is moving up north and south and are threatening to hit those areas. They are doing so by filling their stocks with supplies of available medicines to fight those diseases to prevent possible epidemics. Global warming will cause a significant increase in human mortality due to extreme weather and infectious disease. No country, even industrialized nations will escape these impacts. Scientists project that as warmer temperatures spread north and south from the tropics, and to higher elevations, malaria-carrying mosquitoes will spread with them. They conclude that global warming will likely put as much as 65% of the world's population at risk of infection and that means an increase of 20%. Spreading infectious disease, longer and hotter heat waves, and extreme weather will all claim thousands of additional lives nationwide each year. Doctors and scientists around the world are becoming increasingly alarmed over global warning’s impact on human health. Abnormal and extreme weather, which scientists have long predicted would be an early effect of global warming, have claimed hundreds of lives across the world in recent years. Our warming climate is also creating the ideal conditions for the spread of infectious disease, putting millions of people at risk.
Malaria, generally does not afflict regions with annual average temperatures below 16°C, because lower temperatures inhibit the parasite. As minimum temperatures climb, the disease could spread into previously malaria free regions. Yet the predicted consequences of global warming would fall most heavily on tropical regions, where malaria could spread in both latitude and altitude. A relatively small increase in winter (minimum) temperature would likely facilitate the spread of malaria into large urban highland populations that are currently malaria free and immunologically naive, such as Nairobi, Kenya, and Harare, Zimbabwe.
Future trouble will also come from the seas as the global warming should make the oceans a more hospitable home for cholera and harmful algal blooms.
New diseases will show up in areas previously safe not only because of the global warming effects but also as new strains of virus and bacteria’s will emerge. With the growing population density of cities and villages and the sometimes poor sanitation conditions, diseases thrive and evolve. Also the irresponsible usage of current drugs is helping mutations – in the antibiotics situation the scenario is alarming as many are ceasing to be effective and stronger ones are being put to general use. This creates many problems as current available drugs, unlike diseases, are ceasing to be effective and deaths are more frequent. Also previous deaths whose causes were unexplained may on the future have their causes met what will enable new research fields.
This presents itself as an opportunity for pharmaceuticals, as diseases that were under control will no longer be and drugs that previously were controlling the market will cease to, as they will need to be replaced by new, more effective ones.
All diseases have a genetic component, whether inherited or resulting from the body's response to environmental stresses like viruses or toxins. The successes of the human genome project have even enabled researchers to pinpoint errors in genes - the smallest units of heredity - that cause or contribute to disease.
The ultimate goal is to use this information to develop new ways to treat, cure, or even prevent the thousands of diseases that afflict humankind. But the road from gene identification to effective treatments is long and fraught with challenges. In the meantime, biotechnology companies are racing ahead with commercialization by designing diagnostic tests to detect errant genes in people suspected of having particular diseases or of being at risk for developing them.
An increasing number of gene tests are becoming available commercially, although the scientific community continues to debate the best way to deliver them to the public and medical communities that are often unaware of their scientific and social implications. While some of these tests have greatly improved and even saved lives, scientists remain unsure of how to interpret many of them.
Explorations into the function of each human gene - a major challenge extending far into the 21st century - will shed light on how faulty genes play a role in disease causation. With this knowledge, commercial efforts are shifting away from diagnostics and toward developing a new generation of therapeutics based on genes. Drug design is being revolutionized as researchers create new classes of medicines based on a reasoned approach to the use of information on gene sequence and protein structure function rather than the traditional trial-and-error method. Drugs targeted to specific sites in the body promise to have fewer side effects than many of today's medicines.
The potential for using genes themselves to treat disease - gene therapy - is the most exciting application of DNA science. This rapidly developing field holds great potential for treating or even curing genetic and acquired diseases, using normal genes to replace or supplement a defective gene or to bolster immunity to disease.
Rapid progress in genome science and a glimpse into its potential applications have spurred observers to predict that biology will be the foremost science of the 21st century. Technology and resources generated by the Human Genome Project and other genomics research are already having a major impact on research across the life sciences. The potential for commercial development of genomics research presents the health industry with a wealth of opportunities, and sales of DNA-based products and technologies in the biotechnology industry are projected to exceed $45 billion by 2009. Those opportunities can derive from:
predispositions to disease
systems for drugs
Demand for anti-aging products is expected to reach $30 billion in 2009, propelled by a stream of new and improved products offering health maintenance and appearance enhancing benefits to a largely untapped customer base of middle-aged and elderly consumers. The value of chemicals used to manufacture these products will reach $3.8 billion. New product introductions and the passage of the relatively affluent baby boomer generation through middle age (when age related changes become more apparent) will stimulate demand for formulated appearance anti-aging products. Strong growth will arise from various products that reduce the visibility of wrinkles and age spots, such as wrinkle removal injections and age-defying lotions. However, gains will be limited by fierce price competition among the large number of over-the counter brands continuing to emerge. Hair growth stimulants will also record robust gains.
Chemicals expected to benefit from rapid gains in anti-aging products include memory-enhancing neurological and ophthalmic agents; botulinum toxin for wrinkle-reducing applications; and a host of small volume herbal extracts, including lutein, lycopene and black cohosh, used in both dietary supplements and cosmeceuticals.
Tobacco addiction is widespread and its prejudice is also widely known. As governments from the developed countries start to tax at a higher rate these products the incentives for a change of habits are bigger. The economical and health advantages of quitting to smoke will be greater and people will be willing to spend a greater amount of money in recovering from their condition.
Cigarette smoking is a major preventable cause of disease worldwide, and it is the major cause of premature death in North America. The important causes of mortality are atherosclerotic vascular disease, cancer, and chronic obstructive pulmonary disease (COPD). Smoking also can contribute to other diseases, eg, histiocytosis X, respiratory bronchiolitis, obstructive sleep apnea, idiopathic pneumothorax, low birth weight, and perinatal mortality.
Factors influencing smoking initiation differ from those of smoking behavior maintenance. Nicotine dependence, genetic factors, and psychosocial factors influence maintenance of smoking behavior.
Nicotine meets the criteria of a highly addictive drug. Nicotine is a potent psychoactive drug that induces euphoria, serves as a reinforcer of its use, and leads to nicotine withdrawal syndrome when it is absent. Nicotine in cigarette smoke affects mood and performance and is the source of addiction to tobacco. Smoking may begin as a voluntary habit, but eventually it becomes an addiction.
One in every eight deaths worldwide is due to cancer, which claims twice as many lives as AIDS. By 2020, three out of every five new cancer cases will be found in the developing world. In these countries, 80% to 90% of cancer patients already suffer from advanced and incurable cancers at the time of diagnosis.Also in 2020, regions with traditionally low numbers of cancer deaths could see alarming increases in mortality rates. Regions including Northern Africa and Western Asia, South America, the Caribbean, and South East Asia could face sharp increases of over 75% in the number of cancer deaths in 2020 as compared to 2000.
The knowledge about prevention and treatment of cancer is increasing, yet the number of new cases grows every year. If current trends continue, 15 million people will discover they have cancer in 2020, two-thirds of them in newly-industrialized and developing countries.
The AIDS epidemic caught scientists off guard. The medical community has been unable to find ways to cure or even vaccinate against infection. AIDS is an acronym that stands for acquired immunodeficiency syndrome and is an infectious disease in which the immune system collapses. This disease is caused by the human immunodeficiency virus (HIV). Most HIV infections are sexually transmitted; however, another cluster of infections has come from IV-drug users sharing needles. HIV infections are atypical of other viral infections in several ways: HIV typically kills its host around a decade after infection yet is virtually asymptomatic during the first several years; the viral infection is not, by itself, the cause of death; the virus specifically infects key cells of the immune system and thereby ultimately destroys the immune response; the virus can "hide-out" inside cells for years and then emerge long after any treatment has stopped.
The number of cases grew rapidly in just a few years. From blood samples and autopsy reports, the first case dates to the 1950s. But it was not until nearly 1980 that it became common enough to be noticed. Today, 30 million people are infected worldwide. A huge fraction of Africa's population in some countries is infected, the epidemic is spreading exponentially in Asia. (Five years ago, it was estimated that 10% of Thailand's military was infected.) Drugs are available that prolong the life of infected individuals, but the regimen is rigorous (daily doses of several drugs), and the virus has been able to evolve resistance to every drug tried.
Recent surveys discovered that over 69% of women are concerned with the visible signs of aging, including fine lines, wrinkles, and dryness. 47% want to improve the look of the skin around their eyes, and 18% want to improve the look of the area around their mouths.
Strains of flu virus differ from one another largely in the genes that code for surface molecules called glycoproteins, which are the primary targets of the body's immune system in defending against flu viruses. Evolutionary changes in immune response against such “antigen” molecules are the reason that new vaccines must be developed against emerging strains of virus. Vaccines remain the mainstays in our armamentarium against influenza but they must be constantly updated to meet with the new strain of virous that are constantly appearing.
Severe acute respiratory syndrome (SARS) is a viral respiratory illness caused by a coronavirus, called SARS-associated coronavirus (SARS-CoV). SARS was first reported in Asia in February 2003. Over the next few months, the illness spread to more than two dozen countries in North America, South America, Europe, and Asia before the SARS global outbreak of 2003 was contained. According to the World Health Organization (WHO), a total of 8,098 people worldwide became sick with SARS during the 2003 outbreak. Of these, 774 died.
The main way that SARS seems to spread is by close person-to-person contact. The virus that causes SARS is thought to be transmitted most readily by respiratory droplets (droplet spread) produced when an infected person coughs or sneezes. Droplet spread can happen when droplets from the cough or sneeze of an infected person are propelled a short distance (generally up to 3 feet) through the air and deposited on the mucous membranes of the mouth, nose, or eyes of persons who are nearby. The virus also can spread when a person touches a surface or object contaminated with infectious droplets and then touches his or her mouth, nose, or eye(s).
Drug addiction is a complex illness. It is characterized by compulsive, at times uncontrollable drug craving, seeking, and use that persist even in the face of extremely negative consequences. For many people, drug addiction becomes chronic, with relapses possible even after long periods of abstinence.
The compulsion to use drugs can take over the individual's life. Addiction often involves not only compulsive drug taking but also a wide range of dysfunctional behaviors that can interfere with normal functioning in the family, the workplace, and the broader community. Addiction also can place people at increased risk for a wide variety of other illnesses. These illnesses can be brought on by behaviors, such as poor living and health habits, that often accompany life as an addict, or because of toxic effects of the drugs themselves. Because addiction has so many dimensions and disrupts so many aspects of an individual's life, treatment for this illness is never simple.
Effective drug abuse and addiction treatment programs typically incorporate many components, each directed to a particular aspect of the illness and its consequences Three decades of scientific research and clinical practice have yielded a variety of effective approaches to drug addiction treatment.
Medications, such as antidepressants, mood stabilizers, or neuroleptics, may be critical for treatment success when patients have co-occurring mental disorders, such as depression, anxiety disorder, bipolar disorder, or psychosis.
Blood is an essential body fluid. It is responsible for the transport of oxygen to body tissues, and for carrying away wastes such as carbon dioxide. It performs important functions such as clotting to stop bleeding. It is the major vehicle for transport of nutrients and antibodies. Blood is literally a river of life. Blood is one of the world's most vital medical commodities: The liquid and its derivatives save millions of lives every year. Yet blood is a complex resource not completely understood, easily contaminated, and bearing more than its share of cultural baggage. Physicians and scientists alike recognized that a blood substitute would bypass the risk of a blood-borne pathogen being passed to a patient during transfusion. Further advantages to using a blood substitute in place of normal blood include an increased shelf life, the elimination of the need to crossmatch blood types from donor to recipient, and the ability to transfuse in an ambulance. The estimated market for a blood substitute is now between 2 and 12 billion dollars. the world market for blood and its derivatives probably does not exceed $18.5 billion per year. About 4.5 million units of human blood are transfused every year, at a price of $200 to $350 a pint, a market of $8 billion to $10 billion. Unlike human blood, the synthetic stuff doesn’t have a limited shelf life, and is free of viruses such as HIV and hepatitis that can be present in human blood.
Diabetes mellitus is a group of diseases characterized by high levels of blood glucose resulting from defects in insulin production, insulin action, or both. Diabetes can be associated with serious complications and premature death, but people with diabetes can take steps to control the disease and lower the risk of complications.
Type 1 diabetes was previously called insulin-dependent diabetes mellitus (IDDM) or juvenile-onset diabetes. Type 1 diabetes develops when the body's immune system destroys pancreatic beta cells, the only cells in the body that make the hormone insulin that regulates blood glucose.
Type 2 diabetes was previously called non-insulin-dependent diabetes mellitus (NIDDM) or adult-onset diabetes. Type 2 diabetes may account for about 90% to 95% of all diagnosed cases of diabetes. It usually begins as insulin resistance, a disorder in which the cells do not use insulin properly. Type 2 diabetes is associated with older age, obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity, and race/ethnicity. Type 2 diabetes is increasingly being diagnosed in children and adolescents.
With this new tendency to be obese our society is becoming more prone to diabetes. This cronical disease is growing every day and not only adults and elders are struck by its effects. Nowadays children due to their habits are more prone to be diabetic.
Diabetes can affect many parts of the body and can lead to serious complications such as blindness, kidney damage, and lower-limb amputations.
In the US alone about 210,000 people under 20 years of age have diabetes. This represents 0.26% of all people in this age group. Approximately one in every 400 to 500 children and adolescents has type 1 diabetes. Over the age of 20 years old: 18.0 million; 8.7% of all people in this age group have diabetes. Over 60 years old: 8.6 million; 18.3% of all people in this age group have diabetes.
As people get older the preoccupation with their physical welfare increases and their life is most of the times planned around this need. This means that holidays that can help them take care of their body as well as their spirit are welcomed. Izmir has a fine example in the usage of fish to help cure psoriasis condition.
In a further reflection of consumers' growing inclination to choose products that are good for their health, travel packages that combine medical checkups or treatment with fun and relaxing activities are enjoying a steady growth in popularity. A typical package of this sort involves the traveler being given an extensive medical checkup at a hospital before enjoying a relaxing and therapeutic stay at a hot spring resort. Witnessing a particular boom in popularity are medical travel package tours offering positron emission tomography (PET) scans, a technology that is being used increasingly in the detection of cancer, with hotel accommodation included. These packages, which also include hotel accommodation, are the result of alliances between travel agencies and medical institutions in cities throughout Japan. Such packages offer benefits not only for consumers - it is well known that early detection is vital in the treatment of many diseases - but also for medical institutions and the travel industry. Hospitals and clinics are also able to use the expensive medical equipment they own to derive commercial revenue, while travel agencies are able to tap a new and expanding market. More and more medical travel packages are expected to appear in the years ahead. Many industry analysts predict that medical tourism will be an increasingly important element of the travel industry, because people's awareness of the importance of preventative health and their willingness to spend time and money on it are likely to continue to grow.
With the development of new areas of the genetic field new sorts of test as well as the accuracy of the current ones increase. Also people become more confident in the reliability of the results. New applications of these techniques arise. Not only for police research purposes, even though that will happen at a higher rate, but also university laboratories and other medical laboratories that can not afford or do not have the skills or machines to do these tests.
Despite still being in its infancy, the genetic testing market has the potential for strong growth in the future, genetic testing generated revenues totaling $319.9 million in 2000 and is estimated to reach $877.2 million by 2006 at a compound annual growth rate of 20.4%. Tests that were uncommon, if not unheard of, a short while ago are now routinely performed at genomic testing labs all over the world.
The use of genetic tests to measure a person’s predisposition to blood clots, for example, is increasing at a rate of 150% per year. Gynecologists are expected to recommend that many couples planning to have a child be tested for the cystic fibrosis gene. While the prenatal-screening area is projected to increase at an annual rate of 8%, the cancer and predisposition testing markets are expected to grow at rates of 30% and 29.8%, respectively. Analysts attribute such high growth rates in the cancer and predisposition testing segments to continuing developments in genetic research.
The market for pre-hospital emergency and trauma equipment is really healthy, and is expected to remain that way well through century. Nevertheless the hospital market for emergency equipment is in a downturn. That segment of the market is considered saturated, with revenues derived primarily from replacement sales. Understandably, manufacturers have targeted pre-hospital prospects. As pre-hospital emergency and trauma equipment becomes increasingly automated, accurate and user-friendly, it is being put into the hands of an expanding end-user base of pre-hospital lay persons and minimally trained practitioners. That expanded user base, plus the rapid development and deployment of new, cost-effective equipment, gives the pre-hospital emergency market tremendous growth potential. Manufacturers and marketers are scrambling for position in the cost-conscious, highly competitive industry. As prices fall, products become more accessible, leading to increasing end-user demand creating a new hot prospects market.
The culture of the body is increasing, as people get more conscious that their body is a machine that requires maintenance to work properly. They also care more about their looks and fitness and the way how other people see them. This new concept has driven people to the gym and to buy devices that enable them to pursue these two goals, “Looking good and being good”.
Of course this option has opened a new branch of the health industry that’s the production of such devices that can help people exercising. This already significant and growing market presents a great opportunity for high margins goods.
The rising obesity epidemic reflects the profound changes in society and in the behavioral patterns of communities over the last 20 - 30 years. Individuals may become obese, partly because they have a genetic predisposition to gain weight readily when they are exposed to unhealthy diets and lifestyles. Nevertheless, the fundamental cause of the obesity epidemic is the change in behaviors and lifestyles, especially with regard to diet and physical activity patterns. Furthermore, for childhood obesity, there is increasing evidence from a range of studies indicating the important role of early life environment in the later risk of obesity. Intrauterine life, infancy, and the pre-school period, have all been considered as possible critical periods during which the regulation of energy balance may be programmed for the long term. Obesity is a complex, multi-factorial disorder and coherent and comprehensive strategies are needed for its effective and sustainable prevention and management.
Obesity is now well recognized as a disease in its own right, one, which is largely preventable through changes in lifestyle, especially diet and physical activity. Obesity is a major risk factor associated with increased morbidity and mortality from chronic noncommunicable diseases. In many parts of the world, obesity rates are doubling every 5 to 10 years and increasing the financial burden of providing medical care due to resulting health problems. World Health Statistics 2005 published last month indicated that the prevalence of obesity in adults is 10 to 25% in most countries of both Western and Eastern Europe, 20 to 30% in many countries in the Eastern Mediterranean region as well as in some countries in the Americas, and up to 70 to 80% in some Pacific nations. In Japan, the prevalence of adult overweight is relatively low, i.e. approximately 2 - 3 %; however, it is increasing rapidly as many of other Asian countries.
Biotech is transforming the landscape of the pharmaceutical industry with gene-based techniques to attack and diagnose disease. The sector had already passed a milestone in 2003 when it gained more drug approvals than big pharmaceutical firms. In 2005, biotech firms might contribute as many as 20 of the 35 new drug products expected to win FDA approval, with sales potential of at least $150 million each.
A deep field of drugs in development holds out the potential for rising revenues. Biotech research has produced 230 therapeutic products already on the market, 55 under FDA review and about 365 in Phase III clinical trials - the last stage before they are submitted for regulatory approval.
The research and development of a new pharmaceutical usually takes 12 years and costs an average of USD 800 million. High R&D expenditures over the past few years have made it possible to launch the record number of 35 new molecular entities in Germany’s market alone in 2004.
In 2001, an average of USD 800 million was required for the development of a new molecular entity. More than half of these expenditures are spent on clinical development, especially the logistically expensive, multinational phase III studies. The requirements with regard to proven safety and efficacy during the marketing authorization process have increased steadily. Another reason for the strong cost increase is the growing complexity of the diseases to be treated.
The research and development of new pharmaceutical substances is highly cost- and labor-intensive. In 2001, the R&D intensity of the pharmaceutical industry, measured by the share of R&D employees compared to the overall number of employees and the share of R&D expenditures compared to sales, topped all other industries in Germany.
From 1999 to 2003, the R&D expenditures of the pharmaceutical companies in Europe, Japan and the United States were up 36 percent to USD 58 billion. The share of the United States keeps increasing. During the same period, R&D expenditures (calculated in the respective national currencies) were on the rise: 48 percent in the USA, 28 percent in Japan and 21 percent in Europe. In 2003, almost half of all R&D spending was made in the USA.
As seen before the advantages of research and development in the medicines area are reducing and are profitable to only a small industry players that can cope with the enormous amounts needed in research and that can distribute and protect their results. As for small and medium companies researching innovative products is and will be more so in the future, a very hazardous task.
An era of personalized medicines, in which patients are prescribed treatments based on their genetic make-up, will not be with us for at least another 15 to 20 years. Personalized medicines also known as pharmacogenetics have a promising future. However, it will be another 15 to 20 years before their use is widespread because of the many gaps in our understanding of how genetics relates to the causes of disease. Current examples of what the future might hold are the approaches used in the treatment of some cancers and the use of a genetic test with a drug so it is only given to patients with the right genes for it to be effective. With the human genome sequenced, some people are expecting personalized medicines within a few years, but the reality is still many years away. There are some examples around today, but the complex multiple causes of diseases mean it will be at least 15 to 20 years before a patients genetic make-up is a major factor in determining which drugs they are prescribed. There is a need to invest in gathering data on how genes influence drug response in the patient population. This is to try and reduce the risk of adverse reactions and to target drugs so they are only given to the patients for whom they will be most effective. Pharmacogenetics may prove valuable in the fight against the big killers worldwide, such as malaria, tuberculosis and HIV. Research is needed to establish the cost-effectiveness and clinical value of this approach.
Diseases are a constant in human life. It is hard that a healthy human being never had had a single year when he had not been hill. In fact the human body is constantly being “attacked” by all sort of organisms that require him to take care of. Nevertheless there are times when he is not as well prepared and those organisms take advantage of it and the initially harmless condition can turn into something more relevant. These human immunitary system “distractions” are more frequent as the body gets older. This means that a medical condition that previously did not required any more treatment than time to be dealt with may now need a specific approach to prevent it from becoming far too serious. Also those conditions that previously demanded medical attention may now need a faster and stronger approach to be effective. As the number of elder people increase so will do the medical needs. Also the population density in urban areas and their sometimes poor sanitary conditions to assist those populations help diseases to thrive and easily spread to other people. The globalization of the world that is characterized by the relatively easiness in which someone travels from on extreme of the hearth to the other can help “transporting” diseases from one point of the globe to nearly everywhere. This may help making local diseases outbreaks become global epidemics.
The specific conditions of the climate change - the general increase in the temperatures level - also help the natural range of some diseases to increase and expand their borders. The European continent that thought that was safe from tropical diseases are reviewing their orientation to on the subject. Additionally situations that where once considered as unimportant and even sometimes encouraged - for instance the overweight problem - are now seen as medical problems that must be treated otherwise can degenerate into more serious health problems.
These situations enhance the importance of the medical industry in human life. They also pose new health sector has many potentialities and presents a great number of advantages. Nevertheless the amount of investment to return is very high and risky, also the ability to implement the prices with the needed margins to recover from it are being shortened due to the generics and social pressures. This increases the role of generics in the pharmaceutics industry. These medicines are to take the leading role in the supply of the most common conditions and only the most specific ones will remain in the hands of big companies with enough funds and that have the conditions to enforce their products to the markets. The generics business is expected to continue to grow steadily as people get more and more aware of their advantages and old fears are tackled.