PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1933317
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1933317
The global recombinant vaccines market is poised for robust growth owing to increasing prevalence of infectious diseases, rising demand for safe and effective vaccines, and strategic investments by leading pharmaceutical companies. The market was valued at USD 41.59 billion in 2025, expected to reach USD 44.86 billion in 2026, and projected to grow to USD 109.06 billion by 2034, reflecting a CAGR of 10.62% during the forecast period.
Recombinant vaccines are genetically engineered vaccines that target specific genes or proteins to elicit a focused immune response. These vaccines offer high specificity, scalability, and safety advantages compared to traditional vaccines. For example, in May 2023, GSK received U.S. FDA approval for Arexvy, a recombinant vaccine for preventing lower respiratory tract disease caused by RSV in adults aged 60 years and older.
The market is dominated by key players such as Bavarian Nordic, GSK plc, Pfizer Inc., and Merck & Co., Inc., whose strong product portfolios and global distribution networks contribute to their leading positions.
Market Dynamics
Market Drivers
One of the major growth drivers is the rising investment in research and development. Recombinant vaccines can be developed without using the entire pathogen, reducing the risk of infection and adverse events. Companies are heavily investing in developing these vaccines to meet growing demand. For instance, in September 2024, the U.S. International Development Finance Corporation (DFC) provided a loan of up to USD 20 million to Panacea Biotec Limited for developing an IPV-based recombinant polio vaccine, EasySix.
Market Restraints
The high cost of vaccine development and risk of clinical trial failures restrict market growth. Production involves advanced cell culture systems, purification processes, and expensive bioreactors, increasing capital expenditure. For example, in August 2023, GSK plc invested USD 270.6 million to expand recombinant vaccine capacity in Belgium. Similarly, in August 2025, the U.S. HHS terminated mRNA vaccine development activities under BARDA due to ineffective protection against certain infections.
Market Opportunities
The development of therapeutic vaccines offers significant opportunities for market expansion. Recombinant vaccines for cancer or viral infections provide targeted therapeutic benefits. In March 2025, ImmunityBio, Inc. partnered with U.S. Urology Partners to expand access for recombinant BCG (rBCG) immunotherapy for bladder cancer. Likewise, in June 2024, Moderna and Merck reported positive Phase 2 data for a personalized recombinant mRNA cancer vaccine in melanoma patients.
Market Challenges
Cold chain logistics and supply challenges remain critical barriers. Recombinant vaccines are temperature-sensitive, requiring strict cold storage to maintain efficacy. Low- and middle-income countries often face infrastructure challenges, restricting vaccine accessibility. For example, in September 2021, the WHO delivered 350 ultra-cold chain freezers to over 45 countries to address these limitations.
Market Trends
A prominent trend is the development of combination vaccines that provide protection against multiple diseases in a single shot, improving compliance and reducing storage challenges. In December 2024, Sanofi received Fast Track designation for combination vaccines targeting influenza and COVID-19 in adults above 50 years.
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Competitive Landscape
The market is semi-consolidated, dominated by Bavarian Nordic, GSK plc, Pfizer Inc., and Merck & Co., Inc.. Other players include Mitsubishi Chemical, AstraZeneca, Sanofi, EMERGENT, and BIKEN, focusing on product innovation, strategic partnerships, and geographic expansion.
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Conclusion
The global recombinant vaccines market is projected to grow from USD 41.59 billion in 2025 to USD 109.06 billion by 2034, at a CAGR of 10.62%. Growth is driven by rising infectious disease prevalence, investments in R&D, development of subunit and combination vaccines, and expansion of therapeutic applications. Despite challenges such as high manufacturing costs and cold chain logistics, opportunities in HPV, hepatitis B, and therapeutic cancer vaccines, along with strategic collaborations, will continue to propel market expansion globally.
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