Vaccine Market White Paper

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Vaccine Market White Paper

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Revenues earned by manufacturers of vaccines worldwide reached $27.6 billion in 2015, up from $24.7 billion in 2014 as sales in all segments expanded. Kalorama finds that sales of pediatric vaccines constitute the larger market according to a recent report, accounting for 57.6% of the total vaccines market.. In 2015, global sales of pediatric vaccines were boosted by rising sales of Prevnar pneumococcal vaccine. World sales of adult vaccines were up 6.2% from the prior year.

A vaccine is a preparation used to prevent

contraction of a particular disease by



al triggering an immune response to that


disease. Because of the large number of

deadly diseases that have been eliminated through the proliferation of effective vaccines, vaccination is generally viewed as one of the greatest public health achievements during the 20th century. However, risks are

associated with using all immunobiologics, and no vaccine is 100% safe or effective.
Vaccines function by stimulating the immune system to create antibodies, which induces resistance to specific

antigens. Vaccines cause long-lasting effects (months or even years) against viral diseases by stimulating the immune response to form antibodies against the disease. They usually require 2 to 10 days for full protection to be achieved, but the immune response may be stimulated by repeated doses administered years later. There are more than two dozen vaccine-preventable diseases for which vaccines have been formulated.

Key issues in the global vaccine market today include product safety and refusal to immunize, obesity, pricing pressure, supply shortages, increasing vaccine development efficiency, and innovations in vaccine delivery systems and production.

In recent years, some segments of the public have become increasingly concerned about the risks associated with vaccines, which has lead to some parents choosing not to vaccinate their children. Since vaccination is such a common and memorable event, any illness following immunization may be attributed to the vaccine. While some of these reactions may be caused by the vaccine, many of them are unrelated events that occur after vaccination by coincidence. News and

reports of vaccine-related illness tend to exacerbate the public’s fears and result in higher rates of non-immunization. In response, the American Academy of Pediatrics launched a Refusal to Vaccinate form in 2013 designed to educate parents about the impact of refusing to vaccinate their children and to document such refusals. Nonetheless, data from the National Foundation for Infectious Diseases (NFID) indicates that 50,000 Americans continue to die each year from vaccine-preventable diseases.

Aside from being associated with a broad range of serious co-morbidities
including arthritis, asthma, cancer, cardiovascular disease, diabetes,
gastrointestinal disease, hypertension, kidney disease, pain and sleeping disorders,
obesity has recently been linked to reduced effectiveness of vaccines. In a recent
study of 22 obese teenagers conducted at Baylor College of Medicine in Texas,
researchers found that the standard one-inch injection needle spurred only a weak
response to hepatitis B vaccine while a 1.5 inch needle provided a higher antibody
count. As longer needles are not routinely used for vaccinations and many
healthcare professionals are not aware of the limitations of shorter needles, this
presents a potentially significant public health risk due to the likelihood of similar limitations with other vaccines and rising rates of obesity.

Pricing pressure on vaccines continues to rise with the introduction of new, higher priced vaccines and other pharmaceutical products. Recent research suggests that about three quarters of Americans think that rising drug prices are a pressing issue, and legislative or other action is needed to keep prices affordable. These and other initiatives are expected to exert downward pricing pressure on vaccines, particularly in the developing world markets. In response, manufacturers are seeking ways to lower production costs.

Vaccine shortages and delays have plagued the U.S. and other countries for years, and continue to do so. Such shortages can occur for many reasons including a limited number of manufacturers in the vaccine market, manufacturing or production problems, insufficient stockpiles, and (in the developing nations) greater medical need than ability to pay for vaccines.

Vaccine development is a complex, expensive and time consuming process, typically costing $500 million or more and spanning several years. Some projects take considerably longer; Sanofi Pasteur, for example, reportedly spent $1.5 billion and 20 years developing Dengvaxia for Dengue fever. Furthermore, many worthwhile projects are terminated for reasons related to commercial viability. In order to shorten development times and bring much-needed new products to market more quickly and effectively, several leading companies have established novel collaborations. Sanofi Pasteur, the Bill & Melinda Gates Foundation and the Infectious Disease Research Institute (IDRI) partnered to create the Global Health Vaccine Center of Innovation. GHVCI’s mission is to create a new, cheaper model for vaccines development.

The challenge to develop needle-free vaccines has been taken up by researchers worldwide and it is likely that within the forecast period of this report, at least one new delivery system will be introduced commercially. Edible vaccines, mucosally delivered vaccines, intranasal vaccines, vaccine patches and vaccine chips are all under development, with the latter expected to be commercialized within the next several years. Chips are a novel method of vaccine administration, having been pioneered by scientists at several universities.

Production techniques are an important but overlooked area of vaccine development, as improvements in production methods can significantly impact both speed to market and cost. Tobacco plants, insects and nanoparticle systems all offer a means to produce vaccines more quickly and cost effectively than using chicken eggs. Of these, tobacco plants offer the greatest immediate potential, with production scale up expected within the forecast period of this report.

Vaccine clinical development follows the same general pathway as drugs and other biologics, with developers submitting an Investigational New Drug (IND) application to the FDA then conducting progressively more comprehensive clinical studies. The successful completion of Phase III testing is typically followed by the submission of a Biologics License Application (BLA). The FDA’s Vaccines and Related Biological Products Advisory

Based on information from Kalorama Information’s report: Vaccines 2016:World Market


http://www.kaloramainformation.c om/Vaccines‐9944129/

Committee (VRBPAC) provides advice to the agency regarding the safety and efficacy of the vaccine for the proposed indication. Vaccine approval also requires the provision of adequate product labeling to allow healthcare providers to understand the vaccine’s proper use, including its potential benefits and risks, in order to communicate with patients and parents and to safely deliver the vaccine to the public. Although extensive studies are required for licensure, post-marketing research and surveillance are also necessary to identify safety issues which may only arise or be detected following vaccination of a much larger population. Similar

vaccine approval procedures are employed by other regulatory authorities in Europe, Asia, Latin America and other regions.

Despite ongoing improvements in pediatric vaccination, it is estimated that at least two million children die each year from diseases that could have been prevented by already existing vaccines. This problem is most significant in low income countries, with the health disparity between rich and poor countries resulting in average life spans of about 77 and 52 years, respectively. In addition to this high death toll, millions more suffer disability and illness because they have not been immunized.

There have been and will continue to be challenges to the vaccine delivery system in terms of the science, economics, and social impact of immunization; these challenges may increase as new vaccines are developed. For xample, shortages of specific vaccines continue to occur, in both the developed and developing nations, and have resulted in significant disruption to childhood immunizations. Another significant challenge to immunization delivery is the increasing concern within a segment of the general public about the safety and potential adverse effects of childhood immunizations.

Each year, the CDC’s Advisory Committee on Immunization Practices (ACIP) reviews the recommended childhood immunization schedule to ensure it remains current with changes in manufacturer’s vaccine formations, revised recommendations for the use of licensed vaccines, and recommendations for newly licensed vaccines. It is recommended that all children be routinely immunized against measles; mumps; rubella (German measles); diphtheria; tetanus; pertussis (whooping cough); poliomyelitis; pneumococcal infection; chicken pox; hepatitis B; and Haemophilus influenzae type B (Hib), which is a cause of meningitis. Based on information from

A wide variety of vaccine products are currently recommended to immunize children against disease.

Immunizations by public providers are generally paid for through federal and state government funding under public health programs. These programs are intended to reduce barriers to immunization and to improve immunization rates by providing free vaccines to qualifying infants and children.

Adult immunization is an important, but frequently overlooked, part of patient care. Vaccination programs typically focus on children, yet adults in industrialized countries are more likely to die as a result of vaccine- preventable diseases than are children. Vaccination protects not only individuals, but also entire communities from diseases spread by person-to-person transmission.

For example, vaccination can prevent about 50% of deaths from pneumococcal disease and 80% of deaths from influenza-related complications in the elderly. Pharmacoeconomic studies have demonstrated the value of influenza and pneumococcal vaccines; however, immunization rates for these diseases continue to be low in the elderly populations.

The CDC recommends that individuals traveling outside the U.S. have up-to-date immunizations, especially for poliomyelitis and tetanus. Diphtheria, hepatitis A, hepatitis B, measles-mumps-rubella, and varicella vaccines may also be needed, depending on a traveler’s itinerary, vaccination record and level of risk. Some countries now require an International Certificate of Vaccination against yellow fever as a condition for entry.