Recombinant Vaccines Market Size, Share & COVID-19 Impact Analysis, By Type (Subunit and Live Attenuated), By Route of Administration (Parenteral and Oral), By Disease Indication (Human Papillomavirus (HPV), Hepatitis B, Rotavirus, Herpes Zoster, Meningococcal B, and Others), By Distribution Channel (Hospital & Retail Pharmacies, Government Suppliers and Others) and Geography Forecast, 2020-2027

The global recombinant vaccines market size was valued at USD 10.82 billion in 2019 and is projected to reach USD 25.32 billion by 2027, exhibiting a CAGR of 11.3% during the forecast period. North America dominated the global market with a share of 45.93% in 2019.

The development of vaccines 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 vaccine development lately by introducing vaccines in the market. These vaccines are genetically engineered in the laboratory by eliminating the risk of infectious viral antigen, ensuring vaccine effectiveness and safety.

The need for reducing the high prevalence of viral infections such as human papillomavirus infection, hepatitis B, COVID-19, and others are imposing a higher demand for 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 growing 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. This is anticipated to drive the global market during the projected period.

COVID-19 Outbreak Impact on the Global Market

The COVID-19 outbreak has immensely affected the countries worldwide exerting an economic burden on the population. According to UNICEF in May 2020, 99 countries reported the termination of the immunization campaigns for measles/rubella, polio, HPV, DTP, and many other antigens. However, there has been a rise in the demand for vaccines worldwide due to its effectiveness against deadly infections. As per the 2020 first-quarter report of Pfizer Inc., the company did not witness any disruptions in the supply chain activities of the vaccine. Moreover, increased R&D leading to the development of potential recombinant COVID-19 vaccine is anticipated to raise the market potential in forecasted years. For instance, Novavax has a pipeline candidate NVX-CoV2373 in the phase-1 clinical study against COVID-19 impact. Thus, the market is anticipated to witness positive growth during the forecast period owing to the launch of pipeline candidates.

LATEST TRENDS

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Growing Vaccines Supply by UNICEF, WHO, PAHO Owing to Need for Rapid Immunization

The growing prevalence of infectious diseases in the countries worldwide has raised an alarming situation demanding for rapid supply of effective vaccines. Additionally, increasing susceptibility of geriatric and children population towards deadly disease has led to the need for rapid immunization globally. The international bodies such as UNICEF, PAHO have been a helping hand by supplying millions of vaccine doses to the countries in need. This led to vaccination of 65% of the elderly population in the U.S against flu. Large amounts of vaccine dose procurement by these organizations have led to a decrease in the prevalence rate of many diseases and increasing the immunity of the population against the diseases.

DRIVING FACTORS

Advantage of Recombinant Properties to Increase the Sales of Genetically Modified Vaccines

One of the most crucial and significant drivers for the market growth is the full-fledged advantage of recombinant properties in providing effectiveness and safety to the patient getting immunized.  The vaccines can be produced quickly and in larger quantities, which eliminates the risk of vaccine shortages. These products 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 vaccines, manufacturers are deliberately focused on developing novel products against viral diseases through advanced DNA technology, genomics, and other biotechnology techniques.

Additionally, the increasing prevalence of viral diseases in countries, worldwide, is anticipated to increase the sales of the products, thus marking a stellar market growth in the near future. For example, Merck’s Gardasil sales grew from US$ 1.7 billion in 2014 to US$ 3.7 billion in 2019. Also, 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 the growing population and stringent regulations for infant immunization is expected to drive the global market during the projected timeframe.

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 R&D of vaccines. Subsequently, this is leading to an increase in clinical trials. Big pharma companies are developing recombinant vaccines due to its superior advantages for different and complex viral diseases such as COVID-19, etc. 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 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 market growth with a higher CAGR during the analysis period.

RESTRAINING FACTOR

 High Cost Associated with the Per Dose of the Vaccine to Limit Adoption

Despite, higher prevalence of chronic and infectious diseases, certain factors are limiting the adoption of products. Among them is the high cost associated with the per dose vaccine volume. Though international organizations are playing their best part in supplying millions of volume doses to every corner of the country, still there are many parts to receive vaccination amid their high cost. According to the CDC updated vaccine price list for 2020, the private sector cost of Gardasil 9 per dose is around USD 227.93. Additionally, the adult vaccine Bexsero cost around USD 170.75. Therefore, the high cost of vaccines becomes difficult for the middle-income population to afford vaccination and thus limit the adoption.

SEGMENTATION

By Type Analysis

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Effectiveness Offered by the Subunit Products to Contribute for a Leading Position

Based on type, the global market can be classified 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. 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 expected 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.

By Route of Administration Analysis

Growing Efficacy of Parenteral Vaccines to Exhibit the Highest CAGR During the Forecast Period

Based on the route of administration, the global market can be segmented into parenteral and oral. Parenteral vaccines recorded a higher recombinant vaccines market share and are 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. 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.

By Disease Indication Analysis

Higher Sales for HPV Vaccines to Hold a Leading Position in the Global Market

Based on 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 account for the highest market share in 2019. It is also likely to emerge as the fastest-growing segment during the projected timeframe. The dominance is attributable to the higher sales of the vaccines worldwide owing to its higher demand and procurement volume. 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 due 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 revenue generation 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 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 vaccines during the forecast period.

By Distribution Channel Analysis

Increased Immunization Rates Responsible for Dominance of the Hospitals & Retail Pharmacies

Based on the distribution channel, the genetically engineered vaccines market can be segmented into hospitals & retail pharmacies, government suppliers, and others. The hospitals & retail pharmacies segment is anticipated to have a higher 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 institution. 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 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.

REGIONAL INSIGHTS

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North America generated a revenue of USD 4.97 billion in 2019 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 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 vaccines. Asia Pacific is expected to witness the highest growth rate in the market. The emendation in immunization programs by governments has increased the demand for effective vaccines in Asia Pacific. 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. These aforementioned factors together are expected to drive market growth in the regions

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 f is anticipated to undergo a slower growth due to the 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 the lack of awareness about the application of recombinant DNA technology in the development of vaccines.

KEY INDUSTRY PLAYERS

Higher Revenue Generation for Recombinant Vaccine Portfolio of GlaxoSmithKline Plc to Lead Dominance

The 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 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 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 vaccines, will boost the market players to introduce novel vaccines.

LIST OF KEY COMPANIES PROFILED:

• GlaxoSmithKline plc. (U.K, Europe)


• Merck & Co., Inc (New Jersey, U.S)


• Dynavax Technologies (California, U.S)


• Pfizer Inc (New York, U.S)


• Sanofi S.A (France, Europe)


• Serum Institute of India Pvt. Ltd (India, Asia Pacific)


• Novartis AG (Switzerland, Europe)


• Other Prominent Players

KEY INDUSTRY DEVELOPMENT:

• December 2019 - Merck received USFDA green signal to launch the first Ebola vaccine ERVEBO. Ervebo is a recombinant viral vaccine indicated against the Zaire Ebola virus.


• December 2018 - Sanofi and MSD received USFDA approval for VAXELIS, a combination vaccine indicated against DTP, Haemophilus B, and hepatitis B. Vaxelis is a recombinant vaccine for hepatitis B.

REPORT COVERAGE

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The Recombinant Vaccines market report provides a detailed analysis of the global 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 recent years. Furthermore, it offers a detailed depth analysis and information as per market segments, helping our readers to get a comprehensive overview of the global market. 

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