Growth Opportunities In Global Vaccines Market

The market size of the Global Vaccines market is estimated to be USD 36.45 Billion in 2018 and is expected to record CAGR growth rate of 6.7% and is expected to reach a market size of USD 57.39 Billion in 2025.

Definition / Scope
Market Overview
Market Risks
Top Market Opportunities
Market Trends
Industry Challenges
Technology Trends
Other Key Market Trends
Market Size and Forecast
Market Outlook
Technology Roadmap
Distribution Chain Analysis
Competitive Landscape
Competitive Factors
Key Market Players
Strategic Conclusion
References
Appendix

Definition / Scope

The global vaccine market is growing significantly due increasing initiatives by non-government organizations to provide immunization and improvement in production technique of vaccine in the industry.

Various programs and campaigns are organized, such as Immunization Week by World Health Organization, to create awareness among the population all over the world. Massive unexplored market in vaccine industry of developing economies are creating ample opportunities for the vaccine market to grow at a considerable rate in the coming years.

Moreover, the advanced research and development facilities, and new and innovative product developments by the companies are propelling the growth of the vaccine industry.

Increasing prevalence of cancer and infectious diseases is fuelling the growth of the vaccine market. Infectious diseases are the major contributor to the human mortality and morbidity.

According to World Health Organization, approximately 129,064 cases were reported in 2013. Vaccination has rescued millions of lives to provide secure and better life.

The vaccine market is categorized on the basis of type, technology, disease indication and end users. On the basis of type of vaccine, the vaccine market can be categorized as preventive vaccine and therapeutic vaccine.

Preventive vaccine leads the vaccine market due to increasing prevalence of infectious disease and increasing investment by government and non-government organizations.

On the basis of technology, the vaccine market is categorized as synthetic vaccine, recombinant vaccine, subunit vaccine, toxoid vaccine, inactivated vaccine, live attenuated vaccine, dendritic cell vaccines, and conjugated vaccines.

The subunit vaccines lead the market due to increasing research activity for the development of safe and effective vaccine. Based on disease indication, the market can be segmented as infectious diseases, cancer, allergies, and others.

The infectious disease leads the market due to increasing government initiates to improve immunization program worldwide; whereas, the cancer vaccines market are expected to grow with the fastest rate in the coming years, due to increasing number of cancer cases every year. Moreover, on the basis of end users, the vaccine market is segmented into paediatrics and adults.

Market Overview

The market size of the Global Vaccines market is estimated to be USD 40.1 Billion in 2017 and is expected to grow at a CAGR of 11.2% over the forecast period.

The inactivated vaccine type segment was estimated to have over 12.5% market share in 2018 owing to the related advantages including easy storage and transport due to the highly stable nature of these vaccines. In December 2018, Sanofi Pasteur, Inc. launched a new trivalent, inactivated polio vaccine in India.

The DNA vaccine segment is presumed to be the fastest growing type over the forecast period owing to the ease of production compared to the cell-based vaccines and the promising, targeted immunization outcomes coupled with the continual developments in the biotechnology area.

Other advantages associated are ease of production, long lasting immunogenicity, and no risk of reversion.

The cancer application segment is expected to witness the fastest growth with a CAGR of over 11.8% in the vaccinations market majorly attributable to the need for immunization against cancer coupled with the increasing prevalence of various types of cancer, such as cervical and colorectal cancers.

North America is the most developed region, and is expected to generate estimated revenue of over USD 27 billion by 2024. The rising government support for vaccine development and the numerous company investments deployed for research and development are the key drivers accentuating the market growth in this region. Moreover, the established healthcare infrastructure and facilities present in this region are crucial factors supporting the emergence of this vertical.

The Asia Pacific region is expected to witness the fastest growth over the forecast period, attributed by the growing target population base with high-unmet clinical needs. Furthermore, the increasing disposable income level and the rising awareness regarding the merits of vaccination in emerging economies of the Asia Pacific region is further expected to foster the market growth.

Market Risks

Capital Intensive Procedure

Vaccine development is a capital-intensive procedure. The development process (from in vitro research to marketing) takes 10–15 years and an investment of USD 800 million–USD 1 billion. Moreover, as the success rate of vaccine development is very low, manufacturers find it challenging to obtain initial investments and manage operational costs.

High Cost of Vaccine Development and Storage

The storage and distribution cost of vaccines is higher than any other pharmaceutical product, as it requires specialized equipment and monitoring devices. The lack of proper storage and distribution facilities can deteriorate vaccine quality. Thus, the high cost of vaccine development and storage is a major risk.The complexity and high fixed costs of vaccine manufacturing limit potential profit.

Top Market Opportunities

High Growth Prospects in Emerging Markets

The global pharmaceutical industry is in transition: growth in high income markets has slowed, while growth in emerging economies such as Brazil, Thailand, Indonesia, India and China is in the double digits.

While many programs have focused on access to new drugs and vaccines in the least developed countries, rapidly growing countries at higher income levels – home to more than 70% of the world’s poor – have historically been ignored by both companies and donors.

Although the countries are too wealthy to qualify for much development assistance, entrenched inequality and substandard delivery systems have prevented healthcare and medicines from reaching the entire population.

At the same time, economic development has increased the demand for new health products, and the concurrent increase in the burden of non-communicable disease has led to a greater degree of overlap with the products currently available in high-income markets.

The economic driver of the relative wealth of emerging market countries can provide an incentive for pharmaceutical companies to contribute to expanded access to health-related products and services that will benefit the poorest populations at the “bottom of the pyramid.”

Focus on therapeutic vaccines

Therapeutic cancer vaccines differ from traditional vaccines in that they are only given to patients who already have cancer, with the goal of decreasing the spread of the disease and prolonging survival. Such vaccines are designed to stimulate the immune system to selectively kill tumor cells.

While therapeutic prostate cancer vaccines have not yet received FDA approval, many have shown promising activity in clinical trials. Over the last decade, significant progress has been made in the diagnosis and treatment of prostate cancer.

Today, prostate cancer can be detected earlier with the use of routine prostate-specific antigen (PSA) screenings. As a result, curative modalities offer better success rates. Treatment options for advanced disease are also better; hormonal therapy is commonly initiated earlier in the course of the disease, and more effective chemotherapeutic regimens that prolong survival are now being used.

According to the American Cancer Society (ACS), these factors have contributed to a decrease in the mortality rate of prostate cancer of 3.5% annually in recent years. Recent advances in understanding the pathophysiology of prostate cancer have led to the discovery of numerous potential therapeutic prostate cancer vaccines.

Use of adjuvants in vaccines

An adjuvant is an ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine. In other words, adjuvants help vaccines work better. Some vaccines that are made from weakened or killed germs contain naturally occurring adjuvants and help the body produce a strong protective immune response.

However, most vaccines developed today include just small components of germs, such as their proteins, rather than the entire virus or bacteria.

Adjuvants help the body to produce an immune response strong enough to protect the person from the disease he or she is being vaccinated against. Adjuvanted vaccines can cause more local reactions (such as redness, swelling, and pain at the injection site) and more systemic reactions (such as fever, chills and body aches) than non-adjuvanted vaccines.

Needle-free Vaccine Delivery

The search for methods of vaccine delivery not requiring a needle and syringe has been accelerated by recent concerns regarding pandemic disease, bioterrorism, and disease eradication campaigns.

Needle-free vaccine delivery could aid in these mass vaccinations by increasing ease and speed of delivery, and by offering improved safety and compliance, decreasing costs, and reducing pain associated with vaccinations.

Jet injectors are needle-free devices that deliver liquid vaccine through a nozzle orifice and penetrate the skin with a high-speed narrow stream. They generate improved or equivalent immune responses compared with needle and syringe.

Powder injection, a form of jet injection using vaccines in powder form, may obviate the need for the “cold chain.” Transcutaneous immunization involves applying vaccine antigen and adjuvant to the skin, using a patch or “microneedles,” and can induce both systemic and mucosal immunity.

Respiratory Syncytial Virus Vaccines

RSV is a virus that can cause serious respiratory infections (infections of the lungs and airways), such as pneumonia and bronchiolitis (inflammation of the airways). RSV infection occurs throughout life. In infants, RSV is the main cause of bronchiolitis. Most cases of bronchiolitis are mild and can be managed at home, but about 3% of cases will need hospital care.

Worldwide, RSV is the second largest cause of death in children under one year of age (second only to malaria). In 2017 the World Health Organization (WHO) estimated that RSV causes around 33 million serious respiratory infections a year.

This results in more than 3 million hospitalisations and nearly 60,000 deaths in children under 5 years of age every year. Nearly half of these hospitalisations and deaths are in children under 6 months of age. A vaccine to prevent RSV infection might be a cost-effective way of reducing the burden of severe RSV disease.

Hospital treatment for babies with RSV costs the NHS millions of pounds every year. There is currently no licensed RSV vaccine, but a number of vaccines are now in the later stages of development and are expected to be licensed.

Market Trends

High prevalence of infectious diseases

The high prevalence of diseases, such as cholera, tuberculosis, hepatitis, and malaria will ensure strong demand for associated vaccines as well as R&D into more effective products for better adult and pediatric immunization. Currently, vaccines have been developed for 25 diseases, as against 70 types of deadly infectious agents.

The US FDA has licensed several vaccines to prevent infections, such as BioThrax (Emergent BioSolutions Inc., US) for the prevention of anthrax; Diphtheria & Tetanus Toxoids Adsorbed (Sanofi Pasteur Ltd., France); KINRIX (GlaxoSmithKline plc., UK) for immunization against diphtheria, tetanus, pertussis, and poliomyelitis; PedvaxHIB (Merck & Co., US) for diseases caused by Haemophilus influenza type B; and Afluria (CSL Limited, Australia) for the prevention of influenza.

Vaccines for diseases, such as cancer, Ebola, HIV, and malaria are currently in clinical trials to ensure their safety and efficacy.

Rising Research and Development Activities

The rising prevalence of infectious diseases and the growing focus on the immunization programs are considered as the major factors that are projected to enhance the growth of the global vaccines market in the next few years.

In addition to this, the rising company initiatives to enhance the vaccines research and development and the growing government support for vaccine development are projected to accelerate the growth of the global vaccines market in the next few years.

The rising number of prospects from the developing economies is predicted to enhance the growth of the overall market in the near future

Increase in Government Focus on Immunization Programs

The broad coalition of governments, worldwide, working to promote the awareness of vaccination benefits through immunization programs with the objective of containing the propagation of communicable diseases that are associated with high morbidity and mortality is expected to stimulate the market growth.

For instance, the ‘Immunize Australia Program’ sponsors the immunization of individuals, which acts as a preventative action in preventing disease occurrence and checks rampant disease transmission thus protecting millions of Australians from severe diseases.

Another program that has been involved in achieving extensive immunization coverage on the Indian continent is the National Immunization Program, a government program that has focused on taking strong preventive measures to offset vaccine-preventable diseases, particularly in children.

The involvement of government and non-government organizations gaining prominence in this field is expected to provide the vertical with an impactful boost.

The UNICEF and the WHO have published guidelines on developing a national immunization plan, the comprehensive Multi-Year Plan (cMYP) for all nations across the globe, which intends to ensure equitable access to vaccination facilities for all individuals and increase stakeholder participation in attaining vaccination coverage targets through the designing and implementation of feasible financial strategies to assess current and future program costs that increase the accountability of the respective participants.

Worldwide immunization coverage, 2014

The percentage coverage of worldwide immunization is presented above. The steadily rising global immunization coverage has led to a lucrative growth of the market. For instance, in 2014, 115 million infants across the world received the Diphtheria, Pertussis, and Tetanus (DPT3) vaccine and around 129 countries globally have achieved nearly 90% vaccination coverage for DPT3.

New Vaccines

There has been promising headway in the development and use of new clinical trial designs, which includes the use of biomarkers, backed by real-world evidence, which can in turn enable the innovation and development of new vaccines.

Increasing company initiatives to enhance vaccine R&D

The resurgence of interest in vaccine research has also been underpinned by the rapidly expanding body of knowledge in the fields of microbial pathogenesis and immunology , which in turn has advanced the ability of researchers and developers to create both preventive and therapeutic vaccines, or target new diseases, not thought possible before.

In addition to these scientific advances, the recent growth observed in the global vaccine market and the ability to achieve “blockbuster” status through robust sales revenues have provided a strong impetus for vaccine manufacturers to renew and/or expand research efforts, i.e. with a view toward increasing public health impact while achieving commercial success.

Overall, current industry estimates suggest there are approximately 150-200 candidates in the vaccine pipeline worldwide (in various stages of clinical development), and intensified interest in vaccine R&D is anticipated to generate a three-fold increase in available vaccines over the next few decades thereby driving the growth of the market.

Inadequate Reimbursement Coverage

Preferred provider organizations (PPOs) and indemnity insurance have more limited immunization benefits. Given the more limited range of immunization benefits within PPOs relative to HMOs and point-of-service plans, immunization rates are likely to decline should these trends continue, if only because of the change in the relative market share of insurance plan types.

The rates of private insurance coverage somewhat overstate the level of private coverage as a source of payment for immunization because they omit patient cost sharing in the form of deductibles and copayments.

These costs are difficult to estimate, but indications are that they represent a significant portion of immunization payments. For example, a recent National Immunization Survey found that 79 percent of privately insured children had some sort of payment associated with their last immunization visit.

In a public survey, 19 percent of physicians cited inadequate insurance as the principal reason for the lack of immunization among patients. A lack of insurance was cited by 16 percent of parents; 11 percent specifically cited underinsurance.

Longer timelines required for Vaccine Production

Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement. The time is needed because the process of producing a new vaccine involves many sequential steps, and each of these steps requires a certain amount of time to complete. The vaccine development process from start (obtaining a virus sample) to end (availability of vaccine for use) are all complex and time-consuming.

Stringent Government Regulations for the Approval of Products

The standard for testing and monitoring of vaccines is higher than it is for most other medicines, because they are one of the few medical treatments given to healthy people (mainly healthy children).

This means that the level of acceptable risk is much lower than it might be for a cancer treatment, for example. It can take many years for a vaccine to pass through all the stages described below. In the case of the MenB vaccine, for example, it took nearly 20 years from the first idea to the vaccine being licensed for use.

These are some of the stages a vaccine will have gone through before use:

Literature review: looking at what has been done before.
Theoretical development or innovation: coming up with a new idea, or a variation on an existing idea.
Laboratory testing and development. This involves ‘in vitro’ testing using individual cells and ‘in vivo’ testing, often using mice. The vaccine has to pass rigorous safety tests at this stage, and demonstrate that it works in animals.
Phase I study – an initial trial involving a small group of adult participants (up to 100 people). This is carried out to make sure that the vaccine does not have major safety concerns in humans, and also to work out the most effective dose.
Phase II study – a trial in a larger group of participants (several hundred people). Phase II trials check that the vaccine works consistently, and look at whether it generates an immune response. Researchers also start looking for potential side effects.
Phase III study – a trial in a much larger group of people (usually several thousand). Phase III trials gather statistically significant data on the vaccine’s safety and efficacy (how well it works). This means looking at whether the vaccine generates a level of immunity that would prevent disease, and provides evidence that the vaccine can actually reduce the number of cases. It also gives a better chance of identifying rarer side effects not seen in the phase II study.
Licensing – expert review of all trial data by the UK government (through the Medicines and Healthcare products Regulatory Agency – MHRA) or European regulator (European Medicines Agency – EMA). At this stage the regulators check that the trials show that the product meets the necessary efficacy and safety levels. They also make sure that, for most people, the product’s advantages far outweigh the disadvantages.
Phase IV studies – post-marketing surveillance to monitor the effects of the vaccine after it has been used in the population. These may be requested by a regulatory body, or carried out by the pharmaceutical industry.

Industry Challenges

Inadequate access to vaccines

Inadequate access to vaccines in low and middle income countries results in more than two million deaths each year. Two thirds of these deaths occur in children under the age of 5.

Hepatitis B virus and Haemophilus influenzae type b (Hib) vaccines are now starting to be used in low and middle income countries, but they were licensed for use in the industrialised world more than two decades ago.

Our difficulty in disseminating well established vaccines casts doubt on our ability to promote widespread use of new ones, such as those for diarrhoea associated with rotavirus infection and for human papillomavirus (a causative agent of cervical cancer).

Currently, over 99% of the 440,000 annual deaths from rotavirus associated diarrhoea and 93% of the 260,000 annual deaths from cervical cancer occur outside the 60 wealthiest countries.

Three arguments have historically dominated discussions about the cause of unequal access to vaccines in poorer countries: the primacy of healthcare infrastructure; constraints imposed by insufficient funding; and the belief that vaccine approval in high income countries is a precondition for discussing access in other settings.

Product recalls

There have been only a few vaccine recalls or withdrawals due to concerns about either how well the vaccine was working or about its safety. Several vaccine lots have been recalled in recent years because of a possible safety concern before anyone reported any injury. Rather, the manufacturer’s quality testing noticed some irregularity in some vaccine vials.

In these cases, the safety of these vaccines was monitored continuously before and after they were in use. CDC analyzed reports to the Vaccine Adverse Event Reporting System (VAERS) to search for any side effects that might have been caused by the irregularity, and found none.

Any time such an irregularity is found in a vaccine lot which could make it unsafe, the manufacturer, in collaboration with the U.S. Food and Drug Administration (FDA), will recall it immediately.

Technology Trends

Simulating immune systems

Using human blood cells, plasma, immune cells and other components, researchers have created the human tissue construct, an “immune system in a test tube” that can accurately simulate human immunity.

Developed by Levy and fellow Boston Children’s researcher Guzman Sanchez-Schmitz, the tissue construct makes it possible to model human immune systems for different age groups, which other cellular and animal methods are unable to do.

Infections are most common in the very young and the very old .Using age-specific tissue constructs, we can compare vaccine formulations to learn which may be most effective with respect to immune cells in different age groups.

Researchers are developing a next-generation tissue construct system called the immune system unit(ISU) that will even more faithfully reproduce the human immune system and accelerate the testing of new vaccines.

Increasing vaccine stability

Research is under way to develop vaccines that can better withstand hot and cold temperatures and be transported globally without losing their potency. For example, polyphosphazenes, adjuvant molecules that stabilize vaccine antigens, can be added to vaccines and dried onto micro-needles for intradermal delivery.

Levy’s team recently characterized polyphosphazenes’ ability to activate human newborn white blood cells, suggesting these agents may someday have utility in early-life vaccines. Another example is the use of silk to stabilize vaccines.

Other Key Market Trends

Focussed offering of Solutions

To succeed in this oligopolistic market, companies will need to carve out a niche for themselves. This can be achieved by offering successful solutions either for long-standing challenges in HIV and malaria or by focusing on new therapeutic areas like Alzheimer’s and Diabetes.

The measles outbreak of 2019, with a registered 300% rise in a number of cases globally and a 25year high in the USA, highlight the need for vaccines for adults and travellers now more than ever.

Market Size and Forecast

North America

The North America vaccines market is expected to reach US$ 24,510.0 Mn in 2027 from US$ 14,566.0 Mn in 2018. The market is estimated to grow with a CAGR of 6.0% from 2019-2027.

The growth of the vaccines market is primarily attributed due to the compulsion or mandate vaccination and dropping vaccination rates. However, low awareness about the benefits of vaccines are likely to hinder the growth of the market during the forecast period.

Additionally the growth of the North America vaccines market is contributed due to the factors such as investments made by the key players for various research and development activities as well as launch of new products in the US.

USA Vaccines Market Size

USD 15.9 Billion – The estimated market size of the US Vaccines Market in 2018
4.3% – The CAGR growth rate of the US Vaccines market in the forecast period 2018 to 2025
USD 21.35 Billion- The expected market size of the US Vaccines Market in 2025

Canada Vaccines Market Size

USD 4.77 Billion – The estimated market size of the Canadian Vaccines Market in 2018
5.2% – The CAGR growth rate of the Canadian Vaccines market in the forecast period 2018 to 2025
USD 6.8 Billion- The expected market size of the Canadian Vaccines Market in 2025

Mexico Vaccines Market Size

USD 1.9 Billion – The estimated market size of the Mexican Vaccines Market in 2018
5.6% – The CAGR growth rate of the Mexican Vaccines market size in the forecast period 2018 to 2025
USD 2.78 Billion- The expected market size of the Mexican Vaccines Market in 2025

South America

South America Vaccine Market is being led by Brazil with it occupying more than 50% of Market Share.The South American Vaccines Market accounts for 12% of the global market share by holding a market size of USD 4.37 Billion in 2018

Brazil Vaccines Market Size

USD 2.18 Billion – The estimated market size of the Brazilian Vaccines Market in 2018
6% – The CAGR growth rate of the Brazilian Vaccines market in the forecast period 2018 to 2025
USD 3.28 Billion- The expected market size of the Brazilian Vaccines Market in 2025

Argentina Vaccines Market Size

USD 1.09 Billion – The estimated market size of the Argentinian Vaccines Market in 2018
6.2% – The CAGR growth rate of the Argentinian Vaccines market in the forecast period 2018 to 2025
USD 1.66 Billion- The expected market size of the Argentinian Vaccines Market in 2025

Asia-Pacific

Asia Pacific is expected to grow rapidly over the forecast period owing to increasing demands of a vaccine in the countries like India and China coupled with rising awareness about the usage of vaccines.

China Vaccines Market Size

USD 4 Billion – The estimated market size of the Chinese Vaccines Market in 2018
6.5% – The CAGR growth rate of the Chinese Vaccines market in the forecast period 2018 to 2025
USD 6.22 Billion- The expected market size of the Chinese Vaccines Market in 2025

India Vaccines Market Size

USD 1.2 Billion – The estimated market size of the Indian Vaccines Market in 2018
6.7% – The CAGR growth rate of the Indian Vaccines market size in the forecast period 2018 to 2025
USD 1.89 Billion- The expected market size of the Indian Vaccines Market in 2025

Japan Vaccines Market Size

USD 600 Million – The estimated market size of the Japanese Vaccines Market in 2018
6.9% – The CAGR growth rate of the Japanese Vaccines market in the forecast period 2018 to 2025
USD 957.18 Million- The expected market size of the Japanese Vaccines Market in 2025

Europe

The Europe Vaccines market size was valued at USD 7 Billion in 2018 and is anticipated to register a CAGR of 6.9% over the forecast period to reach a market size of USD 11.17 Billion in 2025.

UK Vaccines Market Size

USD 2.8 Billion – The estimated market size of the UK Vaccines Market in 2018
6.9% – The CAGR growth rate of the UK Vaccines market size in the forecast period 2018 to 2025
USD 4.47 Billion- The expected market size of the UK Vaccines Market in 2025

Germany Vaccines Market Size

USD 1.4 Billion – The estimated market size of the German Vaccines Market in 2018
7.0% – The CAGR growth rate of the German Vaccines market in the forecast period 2018 to 2025
USD 2.25 Billion- The expected market size of the German Vaccines Market in 2025

France Vaccines Market Size

USD 980 Million – The estimated market size of the French Vaccines Market in 2018
7.2% – The CAGR growth rate of the French Vaccines market in the forecast period 2018 to 2025
USD 1.59 Billion- The expected market size of the French Vaccines Market in 2025

Middle East and Africa

Middle East and Africa Vaccines market is slow compared to other regions of the world. Yet, there are decent market opportunity for Vaccine manufacturers, especially in countries such as UAE and South Africa.

Saudi Arabia Vaccines Market Size

USD 452 Million – The estimated market size of the Saudi Arabian Vaccines Market in 2018
5.8% – The CAGR growth rate of the Saudi Arabian Vaccines market in the forecast period 2018 to 2025
USD 670.72 Million- The expected market size of the Saudi Arabian Vaccines Market in 2025

UAE Vaccines Market Size

USD 271.2 Million – The estimated market size of the UAE Vaccines Market in 2018
6.6% – The CAGR growth rate of the UAE Vaccines market in the forecast period 2018 to 2025
USD 424.22 Million- The expected market size of the UAE Vaccines Market in 2025

South Africa Vaccines Market Size

USD 316.4 Million – The estimated market size of the South African Vaccines Market in 2018
6.5% – The CAGR growth rate of the South African Vaccines market in the forecast period 2018 to 2025
USD 491.68 Million- The expected market size of the South African Vaccines Market in 2025

Market Outlook

The market size of the Global Vaccines market is estimated to be USD 36.45 Billion in 2018 and is expected to grow at a CAGR of 6.7% to reach a market size of USD 57.39 Billion in 2025.

Moreover, the established healthcare infrastructure and facilities present in this region are crucial factors supporting the emergence of this vertical.

Technology Roadmap

Nanoparticle-based vaccines

The use of nanoparticle-based vaccines has received a great attention to improve vaccine efficacy, immunization strategies, and targeted delivery to achieve desired immune responses at the cellular level.

To improve vaccine efficacy, these nanocarriers should protect the antigens from premature proteolytic degradation, facilitate antigen uptake and processing by antigen presenting cells, control release, and should be safe for human use. Nanocarriers composed of lipids, proteins, metals or polymers have already been used to attain some of these attributes.

DNA Vaccination

DNA vaccination is a technique for protecting against disease by injection with genetically engineered DNA so cells directly produce an antigen, producing a protective immunological response.

DNA vaccines have potential advantages over conventional vaccines, including the ability to induce a wider range of immune response types. DNA vaccines are third generation vaccines. They contain DNA that codes for specific proteins (antigens) from a pathogen.

The DNA is injected into the body and taken up by cells, whose normal metabolic processes synthesize proteins based on the genetic code in the plasmid that they have taken up.

Because these proteins contain regions of amino acid sequences that are characteristic of bacteria or viruses, they are recognized as foreign and when they are processed by the host cells and displayed on their surface, the immune system is alerted, which then triggers immune responses.

Alternatively, the DNA may be encapsulated in protein to facilitate cell entry. If this capsid protein is included in the DNA, the resulting vaccine can combine the potency of a live vaccine without reversion risks.

In 1983, Enzo Paoletti and Dennis Panicali at the New York Department of Health devised a strategy to produce recombinant DNA vaccines by using genetic engineering to transform ordinary smallpox vaccine into vaccines that may be able to prevent other diseases.

They altered the DNA of cowpox virus by inserting a gene from other viruses (namely Herpes simplex virus, hepatitis B and influenza).

Distribution Chain Analysis

Vaccine supply chains are characterised by two main parts, one being the manufacturing process and the other being the distribution process. The first two steps (suppliers and manufacture) may be included in the manufacturing process, whereas the three other steps may be included in the delivery process.

For the sake of simplicity, and if one considers clustering customers, one can consider customers and consumers to be in the same step of the supply chain.

Vaccine manufacturing involves several steps and each one can be performed in different sites located in different countries. However, only one step is considered, and vaccines leave factories as final products.

All of these steps can take up to 24 months to complete, approximately, which represents a huge lead time in the delivery of vaccines from factories to warehouses After manufacturing, vaccines are shipped for distribution.

In the distribution process vaccines go through international shipping and finally arrive to warehouses where they are stored. To store vaccines, it is necessary to consider the available storage space and capacity, as well as the electricity supply. The last step encompasses delivering vaccines to final markets as countries.

Inside the industry, the preferred mechanism to overcome the productivity crises has been to increase investment, primarily, in the two extreme ends of the supply chain, R&D and sales. However, supply chain optimisation is an excellent way to increase profit margins and is becoming current practice

Competitive Landscape

The global market for vaccines is highly competitive in nature with a high level of fragmentation, owing to the presence of a large number of local and global players operating worldwide. To maintain a leading position in the market, the key players are making notable investments in the research and development activities, which is projected to enhance the competitive environment of the market in the next few years.

In addition to this, the rising emphasis on the development of new products is projected to support the growth of the overall market in the next few years. The rise in the number of mergers and acquisitions and strategic collaborations are estimated to offer lucrative opportunities for the market players in the next few years.

Product approvals and collaborations were observed as the most adopted strategy in global vaccines industry. Few of the recent product key developments are listed below:

2019: Merck, known as MSD outside of the United States and Canada, announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD). The Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of drugs intended for serious or life-threatening conditions.
2018: The European Commission has granted marketing authorization for Dengvaxia, Sanofi’s dengue vaccine. The marketing authorization follows the October 18, 2018, recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to approve use of the dengue vaccine in European endemic areas.
2018: Pfizer entered into a multi-year research and development (R&D) collaboration with BioNTech AG to develop mRNA-based vaccines

Competitive Factors

Competitive Pricing

Competitive pricing is the process of selecting strategic price points to best take advantage of a product or service based market relative to competition. This pricing method is used more often by businesses selling similar products, since services can vary from business to business, while the attributes of a product remain similar.

This type of pricing strategy is generally used once a price for a product or service has reached a level of equilibrium, which occurs when a product has been on the market for a long time and there are many substitutes for the product.

Quality

Competitive advantage denotes a firm’s ability to achieve market superiority over its competitors. In the long run, a sustainable competitive advantage provides above-average performance. The characteristics relate to quality, quality can be an important means of gaining competitive advantage.

Innovation

The market dynamics are affected by many factors – from consumers’ socioeconomic conditions to a firm’s capacity to show an innovative product for consumption. Thus, innovation is becoming the companies’ main competitive factor to increase and keep their operating area.

Key Market Players

Merck & Co., Inc. provides healthcare solutions worldwide. It operates through four segments: Pharmaceutical, Animal Health, Healthcare Services, and Alliances. The company offers therapeutic and preventive agents to treat cardiovascular, type 2 diabetes, chronic hepatitis C virus, HIV-1 infection, intra-abdominal, fungal infection, insomnia, and inflammatory diseases. It also provides neuromuscular blocking agents; cholesterol modifying medicines; and anti-bacterial and vaginal contraceptive products.

CSL Limited researches, develops, manufactures, markets, and distributes biopharmaceutical and allied products in Australia, the United States, Germany, the United Kingdom, Switzerland, China, and internationally. The company operates through two segments, CSL Behring and Seqirus. The CSL Behring segment offers plasma therapies for the treatment of immunodeficiency, bleeding disorders, hereditary angioedema, Alpha-1 antitrypsin deficiency, and neurological disorders. The Seqirus segment manufactures and distributes non-plasma biotherapeutic products; and developsinfluenza vaccines. CSL Limited was founded in 1916 and is headquartered in Parkville, Australia.

GlaxoSmithKline plc engages in the creation, discovery, development, manufacture, and marketing of pharmaceutical products, vaccines, over-the-counter medicines, and health-related consumer products in the United Kingdom, the United States, and internationally. It operates through four segments: Pharmaceuticals, Pharmaceuticals R&D, Vaccines, and Consumer Healthcare. The company offers pharmaceutical products comprising medicines in the therapeutic areas, such as respiratory, HIV, immuno-inflammation, anti-virals, central nervous system, cardiovascular and urogenital, metabolic, anti-bacterials, and dermatology.

Janssen Pharmaceuticals, Inc. manufactures and markets prescription pharmaceutical products. It provides medicines for health concerns in various therapeutic areas, including attention deficit hyperactivity disorder, pain management, acid reflux and infectious diseases, women’s health, and mental health (bipolar I disorder and schizophrenia); neurologics, including Alzheimer’s disease, epilepsy, and migraine prevention and treatment; SYMTUZATM, a darunavir-based single-tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.

Pfizer Inc. discovers, develops, manufactures, and sells healthcare products worldwide. It offers medicines and vaccines in various therapeutic areas, including internal medicine, vaccines, oncology, inflammation and immunology, and rare diseases under the Lyrica, Chantix/Champix, Eliquis, Ibrance, Sutent, Xalkori, Inlyta, Xtandi, Enbrel, Xeljanz, Eucrisa, BeneFix, Genotropin, and Refacto AF/Xyntha brands.

The company also provides consumer healthcare products that comprise over-the-counter medicines, including dietary supplement products under the Centrum, Caltrate, and Emergen-C names; pain management products under the Advil and ThermaCare names; gastrointestinal products under the Nexium 24HR/Nexium Control and Preparation H names; and respiratory and personal care products under the Robitussin, Advil Cold & Sinus, and ChapStick names.

Sanofi Pasteur SA manufactures and distributes human vaccines. The company offers vaccines for various bacterial diseases, including cholera, diphtheria, haemophilus influenzae Type B infections, meningococcal infections, pertussis, pneumococcal infections, tetanus, tuberculosis, and typhoid fever. It also provides vaccines for various viral diseases, such as hepatitis A, hepatitis B, influenza, Japanese encephalitis, measles, mumps, poliomyelitis, rabies, rubella, yellow fever, and smallpox; and seasonal and pandemic influenza vaccines, inactivated poliomyelitis vaccines, meningococcal vaccines, and pediatric combination vaccines.

Mitsubishi Tanabe Pharma Corporation manufactures and sells pharmaceuticals in Japan, Europe, North America, other Asian countries, and internationally. The company offers drugs for autoimmune, diabetes, kidney, central nervous system, and other disease treatment; and vaccines, as well as sells generic drugs and over-the-counter (OTC) products. It offers Remicade for treatment of rheumatoid arthritis (RA), Crohn’s, Bechet’s, psoriasis, ankylosing spondylitis, and ulcerative colitis diseases; Simponi for the treatment of RA; Kremezin for the treatment of chronic renal failure; and Tenelia for type II diabetes mellitus.

Serum Institute of India Pvt. Ltd., a biotechnology company, develops and manufactures vaccines for diphtheria, tetanus, pertussis, Hib, BCG, r-hepatitis B, measles, mumps, and rubella diseases. The company offers bacterial, recombinant and combination, viral, and meningococcal A conjugate vaccines; anti-sera and other products; gonadotrophins and other pharma products; and polysaccharide conjugate, influenza, and rotavirus vaccines, as well as uro-oncology drugs. It supplies its products in India and internationally.

Emergent BioSolutions Inc. develops, manufactures, and commercializes immunobiotics such as vaccines and immune globulins that assist the body’s immune system. The company’s biodefense segment develops, manufactures, and commercializes drugs such as BioThrax, a vaccine for the prevention of anthrax, for use against biological agents. Other products in preclinical development include drugs for the treatment of patients after they are exposed to anthrax and botulinum toxin.

Novavax AB operates as a clinical-stage biotechnology company, manufactures vaccines to prevent a broad range of infectious diseases. The company manufactures vaccine to enhance the amplitude of the immune response and qualitatively change it, enhance its specificity to provide protection against related microorganisms, as well as allows immunization with much lower doses of antigen. The company was founded in 1997 and is based in Uppsala, Sweden. Novavax AB operates as a subsidiary of Novavax, Inc.

Strategic Conclusion

The major challenges pricking the growth of the Global Vaccines market includes inadequate access to vaccines and Product recalls

The growth of the market is restrained by factors such as Inadequate Reimbursement Coverage, Longer timelines required for Vaccine Production and Stringent Government Regulations for the Approval of Products

The growth of the Global Vaccines market is augmented by Opportunities such as High Growth Prospects in Emerging Markets, Focus on therapeutic vaccines, Use of adjuvants in vaccines, Needle-free Vaccine Delivery and Respiratory Syncytial Virus Vaccines

Appendix

FDA – U.S. Food and Drug Administration
ACS – American Cancer Society
RSV – Respiratory Syncytial Virus
WHO – World Health Organization
R&D – Research and Development
cMYP – Multi-Year Plan
UNICEF – United Nations International Children’s Emergency Fund
DPT3 – Diphtheria, Pertussis, and Tetanus
PPO – Preferred provider organizations
MHRA – Medicines and Healthcare products Regulatory Agency
EMA – European Medicines Agency
Hib – Haemophilus influenzae type b
VAERS – Vaccine Adverse Event Reporting System
ISU – immune System Unit
IPD – invasive pneumococcal disease
CHMP – Committee for Medicinal Products for Human Use