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The global recombinant vaccines market size was USD 8.97 billion in 2018 and is projected to reach USD 21.00 billion by 2026, exhibiting a CAGR of 11.3% during the forecast period.
Development of vaccine initially was on an empirical basis, relying mostly on attenuation or inactivation of pathogens. The emergence of genetic engineering, genomics, and recombinant DNA technology revolutionized the vaccine development lately by introducing recombinant vaccines in the market. Recombinant vaccines are genetically engineered in the laboratory by eliminating the risk of infectious viral antigen, ensuring vaccine effectiveness and safety. Researchers at pharmaceutical companies are taking advantage of genetic engineering and are developing therapeutically effective vaccines.
The need for reducing the high prevalence of viral infections such as human papillomavirus infection, hepatitis B, rotavirus infections, and others are imposing a higher demand for recombinant vaccines worldwide. According to the HPV Information Center, annual incidence cases in 2018 for HPV were highest among the emerging countries such as China and India. Also, the World Health Organization (WHO) states that China has the world’s largest burden of hepatitis B virus infections leading to the demand for vaccine doses and vaccination camps. Governments from all the countries worldwide are keenly focused on implementing vaccination programs and policies to help eradicate the burden of these diseases. Owing to stringent government regulations, the vaccination supply has increased and is expected to increase at a faster rate during the forecast period. This is anticipated to drive the global market value of recombinant vaccines.
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Additionally, higher R&D investments, increasing burden of population, continuous vaccine supply for immunization in every part of the globe, the launch of novel recombinant vaccines, and higher procurement volume by international organizations are likely to boost the genetically modified vaccines market during the forecast period 2019-2026.
“Advantages of Recombinant Vaccines to Increase the Sales of Genetically Modified Vaccines”
One of the most crucial and significant drivers for the recombinant vaccines market growth is the full-fledged advantages of recombinant vaccines in development, effectiveness as well as with the safety of the patient getting immunized. Recombinant vaccines can be produced quickly and in larger quantities, which eliminates the risk of a vaccine shortage. These vaccines are also free from infectious viral particles, thus reducing the risk of infection and can be safely given to immunosuppressed people. Owing to the advantages of recombinant vaccines manufacturers are deliberately focused on developing novel vaccines against viral diseases through advanced DNA technology, genomics, and other biotechnology techniques.
Moreover, increasing prevalence of viral diseases worldwide is anticipated to increase the sales of the recombinant vaccines, thus marking a stellar market growth in the near future. For example, Merck’s Gardasil sales grew from USD 1.7 billion in 2014 to USD 3.2 billion in 2018. Government surveillance and policies in securing every individual against infectious diseases are likely to increase the vaccine volume doses required on an annual basis, thus contributing to the rise in the market share of the recombinant vaccines in the global recombinant pharmaceuticals. According to the Hepatitis B Foundation, every year 30 million people are infected by the hepatitis B virus. This huge number is likely to increase the sales of the hepatitis B vaccines annually, thus contributing positively to the market growth. The above-mentioned factors, coupled with a growing population and stringent regulations for infant immunization is expected to drive the global recombinant vaccines market during the forecast period.
“Robust R&D with Strong Pipeline Candidates to Drive the Market Growth”
Another critical driving factor is the technological advancements in the field of recombinant DNA technology, genetics, and proteomics which is boosting the research & development of recombinant vaccines. Subsequently, the product R&D is leading to an increase in clinical trials. Owing to several advantages of recombinant vaccines production, pharmaceutical companies are interested in developing recombinant vaccines for different and complex viral diseases. Also, strong government backup through higher funding is boosting their interest in research. Several recombinant candidates are undergoing clinical trials for the faster introduction of effective recombinant vaccines. Companies such as GSK, Merck, and others are tremendously investing in R&D for genetically modified vaccines. Currently, GSK has pipeline candidates for hepatitis B, meningococcal B, papillomavirus, respiratory syncytial virus infection, rotavirus, and many more infections. Other market players are also focused on the introduction of novel and effective vaccines thus responsible for driving the global recombinant vaccines market growth with a greater CAGR in the forecast period.
“Subunit Segment to Dominate the Recombinant Vaccines Market”
On the basis of type, the recombinant vaccines market can be segmented into subunit and live attenuated.
Recombinant subunit vaccines contain only the recombinant protein, excluding the infectious virus, thus protecting against the risk of viral diseases. The introduction of recombinant subunit vaccines has opened new perspectives for the manufacturers to stand against the viral antigens. Due to its effectiveness subunit vaccines sales have reached no bound across the world against diseases of HPV, hepatitis B and others. On the other hand, strong R&D for the development of subunit vaccines has marked the highest CAGR during the forecast period.
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Moreover, vaccines against rotavirus, ebola, dengue, and others fall in the live attenuated segment of the vaccines. Challenges faced in the development of live attenuated vaccines are anticipated to hinder the growth of the live attenuated vaccines segment. Despite the challenges faced, in May 2019, Sanofi received USFDA approval for Dengvaxia, a live attenuated dengue vaccine.
“Growing Efficacy of Parenteral Vaccines to Exhibit the Highest CAGR During the Forecast Period”
On the basis of route of administration, the global market can be segmented into parenteral and oral. Parenteral vaccines recorded a higher market share and is expected to maintain its position throughout the forecast period. Parenteral immunization is one of the most common and traditional modes of vaccinations wherein vaccine dose is directly injected in the blood, tissue or underneath the skin. Parenteral vaccination has always proved its effectiveness and ease of accessibility during immunization and are thus the most preferable mode of delivery of vaccines.
Moreover, vaccines are induced into our body to get faster immunization and recovery which is obtained only through parenteral mode. Therefore, higher sales and new product launches would increase the market size of the parenteral vaccines in the foreseeable period. For example, the world’s first Ebola vaccine Ervebo that recently received USFDA approval is a parenteral mode of vaccine delivery.
Although oral vaccines are much cheaper and easy to consume, they are the least preferred mode for vaccine delivery. But, Rotateq and Rotarix vaccines indicated against rotavirus are the only recombinant oral vaccines currently available in the market. Rotavirus vaccine has proved its efficacy and thus are in higher demand worldwide to immunize infants against rotavirus. The introduction of lesser recombinant oral vaccines is likely to affect the growth of the oral vaccines segment during the forecast period.
“Human Papillomavirus to Hold a Leading Position in the Recombinant Vaccines Market in Terms of Revenue Generation”
On the basis of disease indication, the global market can be segmented into human papillomavirus (HPV), hepatitis B (Hep B), rotavirus, herpes zoster, meningococcal B, and others. HPV vaccines in the disease indication segment accounts for the highest market share in 2018. It is also likely to emerge as the fastest growing segment during the forecast period. The dominance is attributable to the higher sales of the vaccines worldwide owing to its higher demand and procurement volume as well as effectiveness in protection against human papillomavirus disease. Also, novel pipeline candidates for HPV vaccines are likely to increase the market value in the coming years.
Hepatitis B and rotavirus vaccines also positively contribute to the market growth owing to the growing prevalence of hepatitis B in emerging and underdeveloped countries and the launch of effective hepatitis B vaccines. For example, Sanofi and MSD received USFDA approval for its VAXELIS vaccine indicated against hepatitis B. Implementation of immunization policies against the hepatitis B vaccine for young ones is also expected to increase the demand and sales of hepatitis B vaccines worldwide.
Despite lesser revenues and a lower CAGR, the herpes zoster, meningococcal B and other vaccine segment are anticipated to see numerous R&D initiatives in the forecast period due to increasing trials with advanced recombinant techniques and resources. Currently, GSK’s has a pipeline candidate in phase 3 of the clinical trial for reducing the risk of herpes zoster in the population. Furthermore, increased awareness among individuals about immunization benefits will increase the sales of the recombinant vaccines during the forecast period.
“Hospitals & Retail Pharmacies to Lead the Distribution Channel Segment”
On the basis of the distribution channel, the genetically engineered vaccines market can be segmented into hospitals & retail pharmacies, government suppliers, and others. The hospitals & retail pharmacies are anticipated to have the dominant revenue share in the forecast period. The dominance is attributable to doctors or surgeons' preference to conduct vaccination in the hospitals due to the availability of necessary resources and facilities at the hospitals. Also, patients generally prefer having vaccination at a smaller and nearby institutions. Hospitals & retail pharmacies are also likely to emerge as the fastest-growing segment during the forecast period.
On the flip side, government suppliers also contribute to the growth of the market by procuring high volume doses of recombinant vaccines from the manufacturers and supplying them at a lower cost. Government suppliers such as GAVI/PAHO/UNICEF/WHO have vaccination surveillance systems to meet the shortage and demand across the world. According to GAVI, more than 3.9 million girls have received human papillomavirus immunization throughout the world through GAVI support.
North America generated a revenue of USD 4.12 billion in 2018 and is anticipated to emerge dominant in the global market during the forecast period. Continuous R&D investments by key players and the rapid adoption of efficient recombinant vaccines across the region are expected to drive the market growth of North America. Moreover, the availability of advanced molecular & genetic engineering instruments in the region is the major factor responsible to boost the R&D leading to the introduction of novel recombinant vaccines. Also, implementation of marketing, distribution, and launching strategies by the key players ensuring higher vaccine sales has led to the dominance of North America in the global genetically engineered vaccines market.
North America Recombinant Vaccines Market Size, 2018
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Asia Pacific is expected to witness the highest growth rate in the market. Immunization by governments has increased the demand for effective vaccines in the region. Coupled with growing incidence rates of human papillomavirus disease, hepatitis B is contributing to the rising demand for vaccine supply across the Asia Pacific region. According to the HPV Information Center in 2019, 106,430 annual incidences of human papillomavirus was recorded in China alone. Likewise, India, Southeast Asia, and other countries have also recorded higher annual incidence rates in 2019. This would drive the recombinant vaccine market growth across the region.
On the other hand, Europe is projected to witness significant growth in the market due to the lower prevalence of disease indications and lesser adoption of immunization policies in under-developed Europe. The high growth countries, including UK, France, and Germany, would contribute to the growth of the European market owing to government support for vaccination. International organizations such as GAVI, PAHO and UNICEF are also focused on providing vaccines to the needy by procuring high volume doses from major manufacturers. The Latin American market for recombinant vaccines is anticipated to undergo a slower growth due to lack of R&D resources required for carrying recombinant techniques. The Middle East and Africa would have restricted growth in the market value compared to the other key regions owing to lack of awareness about application of recombinant DNA technology in the development of vaccines.
“GlaxoSmithKline plc and Merck & Co., Inc Lead the Market Owing To Effective Recombinant Vaccines”
The recombinant vaccines market is dominated by GlaxoSmithKline plc and Merck Co., Inc due to their strong vaccine portfolio and implementation of key distribution strategy in the developed as well as developing nations. GSK has a strong portfolio of recombinant vaccines against human papillomavirus, hepatitis B, rotavirus, and others. GSK’s Shingrix vaccine indicated against herpes zoster is currently leading as the company’s top-selling vaccine. Likewise, Merck Co., Inc also has an effective recombinant vaccine portfolio in competition to GSK’s portfolio. The company’s top-selling recombinant vaccines Gardasil and Gardasil 9 are contributing to the leading position of Merck.
Moreover, the company is focused on launching novel vaccines in the market against complex viral diseases. Recently, Merck received USFDA approval for its Ervebo vaccine indicated against the ebola virus. Ervebo is also the world’s first ebola virus vaccine. The rising competitive tension between key players, coupled with challenges in launching effective recombinant vaccines, will boost the market players to introduce novel vaccines.
Advances in the molecular biology, genomics, and proteomics techniques have added new perspective in the development of genetically modified vaccines against complex disorders. This advancement has helped scientists worldwide in putting strategic efforts in fighting viral diseases. Broad range of application in the field of recombinant DNA technology, coupled with increasing competition between key players to launch effective vaccines, is expected to drive the recombinant vaccines market during the forecast period.
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Along with this, the report provides a detailed analysis of the recombinant vaccines market and focuses on the key aspects such as leading companies, product types, and leading applications of the product. Besides, the report offers insights into the market trends and highlights key industry developments. In addition to the features above, the report encompasses several factors that have contributed to the growth of the market over the recent years. Furthermore, it offers a detailed analysis and information as per market segments, helping our readers to get a comprehensive overview of the global market.
Value (USD billion)
By Route of Administration
By Disease Indication
By Distribution Channel
Fortune Business Insights says that the recombinant vaccines market is projected to reach USD 21.00 billion by 2026.
In 2018, the market was valued at USD 8.97 billion.
Growing at a CAGR of 11.3%, the market will exhibit faster growth in the forecast period (2019-2026)
Subunit recombinant vaccines is expected to be the leading segment in the market during the forecast period.
Advantages provided by recombinant vaccines driving higher sales coupled with robust R&D and strong pipeline candidates is the key factor driving the market.
GlaxoSmithKline plc and Merck Co. Inc are the top players in the recombinant vaccines market.
North America is expected to hold the highest market share in the market.
Effectiveness of recombinant vaccines in reducing the risk of complex viral infections and government backing in spreading awareness for immunization is likely to drive the adoption of recombinant vaccines market.
Introduction of novel DNA-technology systems, advanced molecular biology & genetic engineering techniques, as well as growing financing mechanisms for the development of effective recombinant vaccines, are the hyper-market trends of recombinant vaccines market.
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