The global recombinant vaccines market size was estimated to be USD 10.14 billion in 2023 and is expected to reach at USD 34.18 billion by 2034 with a CAGR of 11.68% during the forecast period 2024-2034. Growing prevalence of infectious & zoonotic diseases, increasing research & development activities by market players, rising investments for the development of new vaccines, rapid growth in novel technologies, surge in awareness regarding the vaccination among population, growing clinical trial procedures, increasing launch of innovative vaccines, rising demand for vaccinations, and surge in number of product approvals by regulatory authorities are some of the key factors boosting the market growth.
Surge in number of product approvals by regulatory authorities is predicted to boost the market growth during the forecast period. Recombinant vaccines, which are proteins or DNA constructs created through expression in bacterial or yeast systems, function by being introduced into host cells, which recognize them as foreign substances, leading to the initiation of an immune response. One key benefit of recombinant vaccines is their suitability for individuals with compromised immune systems. Moreover, recombinant proteins offer the advantage of not integrating into the host's genome, eliminating the risk of genomic integration. Consequently, in response to the growing demand for recombinant vaccines, industry stakeholders are emphasizing the development of innovative vaccine solutions. For instance, in May 2023, GSK plc has revealed that the US Food and Drug Administration (FDA) granted approval for Arexvy (respiratory syncytial virus vaccine, adjuvanted) to prevent lower respiratory tract disease (LRTD) attributed to respiratory syncytial virus (RSV) in individuals aged 60 and above. Notably, this marks the world's inaugural approval of an RSV vaccine intended for older adults.
By type, subunit recombinant vaccines was the highest revenue-grossing segment in the global recombinant vaccines market in 2023 owing to the increasing utilization of recombinant subunit vaccines includes the use of recombinant proteins and rising focus on the development of novel vaccines. For instance, in February 2023, Pfizer Inc. has reported that the U.S. Food and Drug Administration (FDA) is now reviewing a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316, also known as RSVpreF. This vaccine aims to prevent medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI triggered by RSV in infants from birth to six months of age through active immunization of pregnant individuals. Additionally, attenuated recombinant vaccines is predicted to grow at fastest CAGR during the forecast period owing to the increasing research & development activities, surge in efforts for the formulation of novel vaccines, and rising regulatory approvals.
By disease, hepatitis B was the highest revenue-grossing segment in the global recombinant vaccines market in 2023 owing to the surge in prevalence of hepatitis B and rising launch of effective hepatitis B vaccines. For instance, in June 2023, VBI Vaccines Inc., a biopharmaceutical firm dedicated to leveraging immunology for the effective prevention and treatment of diseases, has revealed the availability of PreHevbri (Hepatitis B vaccine, recombinant, adsorbed) in the United Kingdom. This vaccine is designed for active immunization against infection caused by all identified subtypes of the hepatitis B virus (HBV) in adults. Additionally, cancer is predicted to grow at fastest CAGR during the forecast period owing to the growing burden of cancer, rising prevalence of human papillomavirus-related diseases and surge in healthcare expenditure.
By distribution channel, hospitals was the highest revenue-grossing segment in the global recombinant vaccines market in 2023 owing to the growing number of hospitals providing vaccination services, increasing research & development activities of recombinant vaccines development, and rising funding by the government organizations. Additionally, vaccination centers is predicted to grow at fastest CAGR during the forecast period owing to the increasing initiatives by major market players, surge in investment by private & government organizations, growing awareness regarding vaccinations among population, and rising approvals by regulatory bodies. For instance, in April 2023, The University of Oxford-developed R21/Matrix-M malaria vaccine, which incorporates adjuvant technology from Novavax and is manufactured and scaled up by the SIIPL, has received complete national approval for utilization in Ghana from the country's Food and Drugs Authority (FDA Ghana).
By end-user, adult was the highest revenue-grossing segment in the global recombinant vaccines market in 2023 owing to the growing number of adult patients suffering from infectious diseases, rising production to fulfill the unmet demand for recombinant vaccines, and enhancing the efficacy of recombinant vaccines employed for the prevention of a range of diseases. Additionally, pediatric is predicted to grow at fastest CAGR during the forecast period owing to the increasing prevalence of chronic & infectious diseases and surge in approvals by regulatory authorities. For instance, in June 2022, Tonix Pharmaceuticals Holding Corp., a clinical-stage biopharmaceutical company, has announced the issuance of U.S. Patent No. 11,345,896 by the United States Patent and Trademark Office (USPTO) on May 31, 2022. This patent, titled 'Synthetic Chimeric Poxviruses,' encompasses claims related to synthetic horsepox virus, which serves as the foundation for the company's TNX-8011 vaccine currently under development for protection against monkeypox and smallpox. It also covers the company's recombinant pox virus (RPV) platform designed for safeguarding against various pathogens, including SARS-CoV-2.
North America region is anticipated for the highest revenue share during the forecast period owing to the growing adoption of efficient vaccines, the availability of advanced molecular & genetic engineering instruments, and rising investments by key players. For instance, in June 2023, Wellcome and the Bill & Melinda Gates Foundation have jointly provided funding to support the progression of a tuberculosis (TB) vaccine candidate, M72/AS01E (M72), into a Phase III clinical trial. Should this vaccine prove to be effective, it has the potential to be the first new vaccine in over a century aimed at preventing pulmonary TB, a type of active TB. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the increasing approvals by regulatory bodies, growing research & development activities, and rising launch of novel vaccines. For instance, in April 2023, GlaxoSmithKline Pharmaceuticals Ltd. has introduced Shingrix (Zoster Vaccine Recombinant, Adjuvanted) in India. This vaccine is intended for adults aged 50 years and above to prevent shingles (herpes zoster) and post-herpetic neuralgia. Shingrix stands out as the world's first non-live, recombinant subunit vaccine administered via intramuscular injection in two doses.
Surge in number of product approvals by regulatory authorities is predicted to boost the market growth during the forecast period. Recombinant vaccines, which are proteins or DNA constructs created through expression in bacterial or yeast systems, function by being introduced into host cells, which recognize them as foreign substances, leading to the initiation of an immune response. One key benefit of recombinant vaccines is their suitability for individuals with compromised immune systems. Moreover, recombinant proteins offer the advantage of not integrating into the host's genome, eliminating the risk of genomic integration. Consequently, in response to the growing demand for recombinant vaccines, industry stakeholders are emphasizing the development of innovative vaccine solutions. For instance, in May 2023, GSK plc has revealed that the US Food and Drug Administration (FDA) granted approval for Arexvy (respiratory syncytial virus vaccine, adjuvanted) to prevent lower respiratory tract disease (LRTD) attributed to respiratory syncytial virus (RSV) in individuals aged 60 and above. Notably, this marks the world's inaugural approval of an RSV vaccine intended for older adults.
By type, subunit recombinant vaccines was the highest revenue-grossing segment in the global recombinant vaccines market in 2023 owing to the increasing utilization of recombinant subunit vaccines includes the use of recombinant proteins and rising focus on the development of novel vaccines. For instance, in February 2023, Pfizer Inc. has reported that the U.S. Food and Drug Administration (FDA) is now reviewing a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316, also known as RSVpreF. This vaccine aims to prevent medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI triggered by RSV in infants from birth to six months of age through active immunization of pregnant individuals. Additionally, attenuated recombinant vaccines is predicted to grow at fastest CAGR during the forecast period owing to the increasing research & development activities, surge in efforts for the formulation of novel vaccines, and rising regulatory approvals.
By disease, hepatitis B was the highest revenue-grossing segment in the global recombinant vaccines market in 2023 owing to the surge in prevalence of hepatitis B and rising launch of effective hepatitis B vaccines. For instance, in June 2023, VBI Vaccines Inc., a biopharmaceutical firm dedicated to leveraging immunology for the effective prevention and treatment of diseases, has revealed the availability of PreHevbri (Hepatitis B vaccine, recombinant, adsorbed) in the United Kingdom. This vaccine is designed for active immunization against infection caused by all identified subtypes of the hepatitis B virus (HBV) in adults. Additionally, cancer is predicted to grow at fastest CAGR during the forecast period owing to the growing burden of cancer, rising prevalence of human papillomavirus-related diseases and surge in healthcare expenditure.
By distribution channel, hospitals was the highest revenue-grossing segment in the global recombinant vaccines market in 2023 owing to the growing number of hospitals providing vaccination services, increasing research & development activities of recombinant vaccines development, and rising funding by the government organizations. Additionally, vaccination centers is predicted to grow at fastest CAGR during the forecast period owing to the increasing initiatives by major market players, surge in investment by private & government organizations, growing awareness regarding vaccinations among population, and rising approvals by regulatory bodies. For instance, in April 2023, The University of Oxford-developed R21/Matrix-M malaria vaccine, which incorporates adjuvant technology from Novavax and is manufactured and scaled up by the SIIPL, has received complete national approval for utilization in Ghana from the country's Food and Drugs Authority (FDA Ghana).
By end-user, adult was the highest revenue-grossing segment in the global recombinant vaccines market in 2023 owing to the growing number of adult patients suffering from infectious diseases, rising production to fulfill the unmet demand for recombinant vaccines, and enhancing the efficacy of recombinant vaccines employed for the prevention of a range of diseases. Additionally, pediatric is predicted to grow at fastest CAGR during the forecast period owing to the increasing prevalence of chronic & infectious diseases and surge in approvals by regulatory authorities. For instance, in June 2022, Tonix Pharmaceuticals Holding Corp., a clinical-stage biopharmaceutical company, has announced the issuance of U.S. Patent No. 11,345,896 by the United States Patent and Trademark Office (USPTO) on May 31, 2022. This patent, titled 'Synthetic Chimeric Poxviruses,' encompasses claims related to synthetic horsepox virus, which serves as the foundation for the company's TNX-8011 vaccine currently under development for protection against monkeypox and smallpox. It also covers the company's recombinant pox virus (RPV) platform designed for safeguarding against various pathogens, including SARS-CoV-2.
North America region is anticipated for the highest revenue share during the forecast period owing to the growing adoption of efficient vaccines, the availability of advanced molecular & genetic engineering instruments, and rising investments by key players. For instance, in June 2023, Wellcome and the Bill & Melinda Gates Foundation have jointly provided funding to support the progression of a tuberculosis (TB) vaccine candidate, M72/AS01E (M72), into a Phase III clinical trial. Should this vaccine prove to be effective, it has the potential to be the first new vaccine in over a century aimed at preventing pulmonary TB, a type of active TB. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the increasing approvals by regulatory bodies, growing research & development activities, and rising launch of novel vaccines. For instance, in April 2023, GlaxoSmithKline Pharmaceuticals Ltd. has introduced Shingrix (Zoster Vaccine Recombinant, Adjuvanted) in India. This vaccine is intended for adults aged 50 years and above to prevent shingles (herpes zoster) and post-herpetic neuralgia. Shingrix stands out as the world's first non-live, recombinant subunit vaccine administered via intramuscular injection in two doses.
Segmentation: Recombinant Vaccines Market Report 2023 - 2034
Recombinant Vaccines Market Analysis & Forecast by Type 2023 - 2034 (Revenue USD Bn)
- Attenuated Recombinant Vaccines
- Vector Recombinant Vaccines
- Subunit Recombinant Vaccines
Recombinant Vaccines Market Analysis & Forecast by Disease 2023 - 2034 (Revenue USD Bn)
- Cancer
- Hepatitis B
- Sexually Transmitted Diseases
- Others
Recombinant Vaccines Market Analysis & Forecast by Distribution Channel 2023 - 2034 (Revenue USD Bn)
- Vaccination Centers
- Hospitals
Recombinant Vaccines Market Analysis & Forecast by End-user 2023 - 2034 (Revenue USD Bn)
- Pediatric
- Adult
Recombinant Vaccines Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Recombinant Vaccines Market: Type Estimates & Trend Analysis
8. Recombinant Vaccines Market: Disease Estimates & Trend Analysis
9. Recombinant Vaccines Market: Distribution Channel Estimates & Trend Analysis
10. Recombinant Vaccines Market: End-user Estimates & Trend Analysis
11. Regional Market Analysis
12. North America Recombinant Vaccines Market
13. Europe Global Recombinant Vaccines Market
14. Asia Pacific Global Recombinant Vaccines Market
15. Latin America Global Recombinant Vaccines Market
16. MEA Global Recombinant Vaccines Market
17. Competitor Analysis
18. Company Profiles
Companies Mentioned
- AstraZeneca Plc.
- Merck & Co. Inc.
- Dynavax Technologies Corporation
- Emergent BioSolutions Inc.
- Novartis AG
- GlaxoSmithKline Plc.
- Pfizer Inc.
- Novavax Inc.
- Sanofi
- Bayer AG
- GC Biopharma
- Serum Institute of India Pvt. Ltd.
- Bharat Biotech
- Johnson & Johnson Services Inc.
- Bio Farma
- Sartorius AG
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | January 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 10.14 Billion |
| Forecasted Market Value ( USD | $ 34.18 Billion |
| Compound Annual Growth Rate | 11.6% |
| Regions Covered | Global |
| No. of Companies Mentioned | 16 |
