DRAFT

DRAFT

09.16.11 | By Amiee Adasczik

Biotechnology medicines are developed through biological processes using living cells or organisms, rather than the traditional chemical synthesis approach. The biotechnology medicines in the new report "Biotechnology Medicines in Development," are targeting autoimmune diseases, cancer, cardiovascular diseases, diabetes, HIV/AIDS and other infectious diseases, psoriasis, Alzheimer's disease, Parkinson's disease, asthma, chronic obstructive pulmonary disease; hemophilia, glaucoma and many genetic disorders.

Below are selected facts about the diseases targeted by some of the new ways America's biopharmaceutical research companies are attacking disease through bio-technology.
Autoimmune Diseases
  • Autoimmunity is the underlying cause of more than 100 serious, chronic illnesses, targeting women 75 percent of the time.
  • Taken together, autoimmune diseases strike women three times more than men. Of the 50 million Americans living with autoimmunity, an estimated 30 million people are women.
  • Autoimmune diseases have been cited in the top 10 leading causes of all deaths among U.S. women age 65 and younger, representing the fourth largest cause of disability among women in the United States.
  • Nine out of 10 people who have lupus are women. African American, Hispanic, Asian and Native American women are two to three times more likely to develop lupus than Caucasian women.
  • The NIH estimates that the annual direct health care costs for autoimmune diseases to be in the range of $100 billion.
Blood Disorders
  • Hemophilia affects 1 in 5,000 male births. About 400 babies are born with hemophilia each year. Currently, the number of people with hemophilia in the United States is estimated to be about 20,000, based on expected births and deaths since 1994.
  • Sickle cell disease is an inherited disease that affects more than 80,000 people in the United States, 98 percent of whom are of African descent.
  • Von Willebrand disease, the most common inherited bleeding condition, affects males and females about equally and is present in up to 1 percent of the U.S. population.
Cancer
  • This year nearly 1.6 million new cancer cases will be diagnosed.
  • Men have a little less than a 1 in 2 lifetime risk of developing cancer, and for women, the risk is a little more than 1 in 3.
  • About 78 percent of all cancers are diagnosed in people ages 55 and older.
  • Cancer is the second leading cause of death by disease in the United States-1 of every 4 deaths-exceeded only by heart disease.
  • This year, more than 570,000 are expected to die of cancer, more than 1,500 people a day.
  • The National Institutes of Health estimates overall costs for cancer in 2010 at $263.8 billion: $102.8 billion for direct medical costs (total of all health expenditures); $20.9 billion for indirect morbidity costs (e.g., cost of lost productivity due to illness); and $140.1 billion for indirect mortality costs (cost of lost productivity due to premature death).
Cardiovascular Diseases (CVD)
  • More than 82 million American adults-greater than one in three-had one or more types of CVD. Of that total, 40.4 million were estimated to be age 60 and older.
  • CVD (as the underlying cause of death) accounted for 33.6 percent of all 2,423,712 deaths, or 1 of every 3 deaths, in 2007. CVD total mention deaths accounted for about 55.4 percent of all deaths in 2007.
  • Nearly 2,200 Americans die of CVD each day, an average of one death every 39 seconds. CVD claims more lives each year than cancer, chronic lower respiratory diseases, and accidents combined.
  • More than 150,000 Americans killed by CVD in 2007 were under age 65.
  • Coronary heart disease killed 406,351 people-about 1 of every 6 deaths--in the United States in 2007. Each year, an estimated 785,000 Americans will have a new heart attack, and about 470,000 will have a recurrent attack. An additional estimated 195,000 silent first myocardial infarctions occur each year.
  • Approximately every 25 seconds, an American will have a coronary event, and approximately every minute, someone will die of one.
  • Each year, some 795,000 people experience a new or recurrent stroke. Approximately 610,000 of these are first attacks, and 185,000 are recurrent attacks. In 2007, stroke accounted for about 1 of every 18 deaths in the United States. On average, every 40 seconds, someone in the United States has a stroke.
  • The total direct and indirect cost of CVD and stroke in the United States for 2007 was estimated to be $286 billion.
Diabetes
  • In the United States, 25.8 million people, or 8.3 percent of the population, have diabetes. An estimated 18.8 million have been diagnosed, but 7 million people are not aware that they have the disease. Another 79 million have pre-diabetes.
  • Diabetes is the seventh leading cause of death in the United States. In 2007, diabetes was listed as the underlying cause on 71,382 death certificates and was listed as a contributing factor on an additional 160,022 death certificates. That means diabetes contributed to a total of 231,404 deaths that year. Overall, the risk for death among people with diabetes is about twice that of people of similar age but without diabetes.
  • The total annual economic cost of diabetes in 2007 was estimated to be $174 billion. Medical expenses for people with diabetes are more than two times higher than for people without diabetes.
Digestive Disorders
  • Digestive disorders are estimated to affect up to 70 million people in the United States.
  • About 500,000 people in the United States have Crohn's disease, which anyone can get. It is not yet known what causes Crohn's disease.
  • The incidence of ulcerative colitis in North America is 10-12 cases per 100,000 per year, with peak incidence occurring between the ages of 15 and 25. A second peak in incidence occurs in the 6th decade of life. Ulcerative colitis affects females more than males.
Eye Conditions
  • Age-related macular degeneration (AMD) is the leading cause of severe vision loss in adults over age 50. An estimated 1.8 million people have AMD and another 7.3 million are at substantial risk for vision loss from AMD.
  • Glaucoma is the second leading cause of blindness in the world (after cataracts) and the leading cause of blindness among African Americans.
  • An estimated 2.8 million people had open-angle glaucoma in the United States in 2010, and that number will increase to 3.4 million by 2020.
Genetic Disorders
  • There are more than 6,000 known genetic disorders. Approximately 4 million babies are born each year, and about 3 percent-4 percent will be born with a genetic disease or major birth defect.
  • More than 20 percent of infant deaths are caused by birth defects or genetic conditions (e.g., congenital heart defects, abnormalities of the nervous system, or chromosomal abnormalities).
  • Approximately 10 percent of all adults and 30 percent of children in hospitals are there due to genetically-related problems.
Growth Disorders
  • Estimates for the number of growth hormone deficiency (GHD) cases vary. Some countries have reported one in 10,000 children with GHD, while others have reported one in 3,500 children.
  • For adult-onset GHD, indirect estimates based on the incidence of pituitary gland tumors suggest an incidence of 10 cases per 1 million people annually. In the United States, the exact prevalence of GHD is unknown. About 35,000 adults have GHD, with about 6,000 newly diagnosed each year.
HIV/AIDS - Worldwide
  • The number of people living with HIV worldwide continued to grow in 2008, reaching an estimated 33.4 million. (The total number of people living with the virus in 2008 was more than 20 percent higher than the number in 2000, and the prevalence was roughly threefold higher than in 1990.)
  • Worldwide in 2008, an estimated 2.7 million new HIV infections occurred, and some 2 million deaths resulted due to AIDS-related illnesses. (The latest data indicate that globally the spread of HIV appears to have peaked in 1996, when 3.5 million new HIV infections occurred. In 2008, the estimated number of new HIV infections was approximately 30 percent lower than at the epidemic's peak 12 years earlier.)
HIV/AIDS - United States
  • In 2008, the Centers for Disease Control and Prevention (CDC) estimated that approximately 56,300 people were newly infected with HIV in 2006 (the most recent year that data are available).
  • At the end of 2007, the estimated number of people living with a diagnosis of HIV infection (in the 37 states and five U.S. dependent areas with confidential name-based HIV infection reporting) was 599,819. In the 37 states only, that total included 577,452 adults and adolescents, and 2,919 children under the age of 13. (Data include people with a diagnosis of HIV infection regardless of the stage of disease at diagnosis.)
  • In 2008, the estimated number of people diagnosed with AIDS in the United States and dependent areas was 37,991. (Of these, 37,151 were diagnosed in the 50 states and the District of Columbia and 840 were diagnosed in the dependent areas.) In the 50 states and the District of Columbia, 27,543 AIDS diagnoses were among adult and adolescent males, 9,567 were among adult and adolescent females, and 41 diagnoses were among children under the age of 13.
  • In 2007, the estimated number of deaths of people with an AIDS diagnosis in the United States and dependent areas was 18,089. In the 50 states and the District of Columbia, this included 17,613 adults and adolescents and six children under the age of 13.
  • The cumulative estimated number of deaths of people with an AIDS diagnosis in the United States and dependent areas, through 2007, was 597,499. In those areas, that total included 571,453 adults and adolescents and 4,931 children under the age of 13.
  • Note: Cumulative totals include people of unknown race/ethnicity. Because totals for the estimated numbers were calculated independently of the values for the subpopulations, the subpopulation values may not equal the totals.
Infectious Diseases
  • More than 9.5 million people die each year due to infectious diseases-nearly all live in developing countries. Children are particularly vulnerable to infectious diseases.
  • Pneumonia, diarrhea and malaria are leading causes of death among children under age 5.
  • Three infectious diseases alone-malaria, tuberculosis, and AIDS-account for about 1 out of every 13 deaths, mostly among children and young adults.
  • For all its familiarity, influenza is a serious virus. It sickens 5 percent to 15 percent of the U.S. population and hospitalizes up to 250,000 people each year. Some 30,000 to 40,000 people die after becoming infected. Influenza costs the economy more than $10 billion a year in an average season.
  • The estimated economic impact of pandemic influenza would cost this country $71.3 billion to $166.5 billion, excluding disruptions to commerce and society.
Neurologic Disorders
  • Alzheimer's disease, the most common type of dementia, accounts for an estimated 60 percent to 80 percent of cases.
  • More women than men have Alzheimer's disease and other dementias. Almost two-thirds of all Americans living with Alzheimer's are women. Of the 5.2 million people over age 65 with Alzheimer's in the United States, 3.4 million are women and 1.8 million are men.
  • In 2000, there were an estimated 411,000 new cases of Alzheimer's disease. For 2010, that number was estimated to be 454,000 (a 10 percent increase); by 2030, it is projected to be 615,000 (50 percent increase from 2000); and by 2050, 959,000 (130 percent increase from 2000).
  • In 2008, Alzheimer's was reported as the underlying cause of death for 82,476 people.
  • For people with Alzheimer's disease and other dementias, aggregate payments for health care, long-term care, and hospice are projected to increase from $183 billion in 2011 to $1.1 trillion in 2050 (in 2011 dollars).
  • A little more than 5,600 people in the United States are diagnosed with amyotrophic lateral sclerosis (ALS), often referred to as "Lou Gehrig's disease," each year. (That's 15 new cases a day.) An estimated 30,000 Americans have the disease at any given time.20
  • According to the ALS CARE Database, 60 percent of the people with ALS in the Database are men, and 93 percent of patients in the Database are Caucasian.
  • Most people who develop ALS are between the ages of 40 and 70, with an average age of 55 at the time of diagnosis.
  • Duchenne muscular dystrophy, an inherited disorder, occurs in approximately 1 out of every 3,600 male infants.
  • Nearly 1 million people in the United States are living with Parkinson's disease. The cause is unknown, and there is presently no cure.
  • Parkinson's disease has been reported to affect approximately 1 percent of Americans over age 50, but unrecognized early symptoms of the disease may be present in as many as 10 percent of those over age 60. Parkinson's disease is more prevalent in men than in women (approximate ratio: 3:2).
  • Approximately 60,000 Americans are diagnosed with Parkinson's disease each year.
  • The combined direct and indirect cost of Parkinson's disease, including treatment, Social Security payments and lost income from inability to work, is estimated to be nearly $25 billion per year in the United States alone.
  • Medication costs for an individual person with Parkinson's average $2,500 a year, and therapeutic surgery can cost up to $100,000 per individual.
Respiratory Diseases
  • An estimated 39.9 million Americans have been diagnosed with asthma by a health professional within their lifetime.
  • Approximately 24.6 million Americans (including 7.1 million children) had asthma in 2009.
  • Females traditionally have consistently higher rates of asthma than males. In 2009, females were about 11.1 percent more likely than males to ever have been diagnosed with asthma.
  • African Americans are also more likely to be diagnosed with asthma over their lifetime. In 2009, the prevalence rate in blacks was 27.9 percent higher than the rate in whites.
  • In 2009, an estimated 12.8 million Americans (including 4.1 million children under age 18) had an asthma attack, representing almost half of all the people who currently have asthma.
  • Females tend to have consistently higher asthma attack prevalence rates than males. In 2009, 7.6 million females had an asthma attack compared to 5.2 million males.
  • The asthma attack prevalence rate in African Americans was 40 percent higher than the rate in whites.
  • From 2002 to 2007, the annual economic cost of asthma in the United States was $56 billion.
  • In 2008, asthma accounted for an estimated 14.4 million lost school days in children and 14.2 million lost work days in adults.
  • In 2008, 12.1 million U.S. adults ages18 and older were estimated to have chronic obstructive pulmonary disease (COPD).
  • In 2006, 120,970 people died of COPD, compared to 127,049 in 2005; 52.1 percent of deaths were in women. That was the seventh consecutive year in which the number of deaths due to COPD was higher among women than men.24
  • The national projected annual cost for COPD in 2010 was $49.9 billion. This includes $29.5 billion in direct health care expenditures, $8.0 billion in indirect morbidity costs and $12.4 billion in indirect mortality costs.
  • There is a lack of newly published data to demonstrate an accurate estimate for the incidence of idiopathic pulmonary fibrosis (IPF) in the United States. The most recent estimates indicate that approximately 128,000 Americans have IPF, although there are published estimates that suggest the number may be as high as 200,000.
Skin Diseases
  • More than 100 million Americans-one-third of the U.S. population-are afflicted with skin diseases.
Transplantation
  • More than 100,000 men, women, and children currently need life-saving organ transplants.
  • Every 10 minutes another name is added to the national organ transplant waiting list.
  • An average of 18 people die each day from the lack of available organs for transplant.
  • In 2009, there were 8,021 deceased organ donors and 6,610 living organ donors resulting in 28,465 organ transplants.
  • Acute graft-versus-host disease (GVHD) usually happens within the first 3 months after a transplantation. Chronic GVHD usually starts more than 3 months after a transplant and can last a lifetime.
  • Rates of GVHD vary from between 30 percent to 40 percent among related donors and recipients to 60 percent to 80 percent between unrelated donors and recipients. The greater the mismatch between donor and recipient, the greater the risk of GVHD.

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