RECOMBINANT VACCINE MARKET ANALYSIS

Recombinant Vaccine Market Size and Trends

The Global Recombinant Vaccine Market is estimated to be valued at USD 11.21 Bn in 2024 and is expected to reach USD 24.10 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 11.5% from 2024 to 2031.

Key Takeaways of the Recombinant Vaccine Market:

• The attenuated recombinant vaccines segment is expected to contribute the highest share of the market with 43.1% in 2024.
• The Human Papillomavirus (HPV) segment is expected to contribute the highest share with 23.1% in 2024 under the indication segment.
• The pediatric segment is expected to contribute the highest share under the end user segment with a share of 35.2% in 2024.
• North America is expected to top the global market with 35.3% share, followed by Asia Pacific with 27.7% share in 2024.

Market Overview:

Factors such as rising prevalence of infectious diseases and increasing R&D investments are driving the demand for recombinant vaccines. Recombinant vaccine technology allows high yield and mass production of vaccines at low cost. This has led to significant growth in sales of recombinant vaccines for diseases such as influenza, hepatitis B, and HPV. Moreover, ongoing research for the development of recombinant vaccines for emerging and re-emerging diseases will provide new opportunities for market players. Continued government support for immunization programs is further expected to aid market expansion during the forecast period.

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Key Developments:

• In July 2024, BioNet Europe, a subsidiary of BioNet, a vaccine manufacturer has submitted a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its monovalent Recombinant Pertussis Vaccine (RPV). The stand-alone vaccine targets the rising cases of whooping cough in Europe and is designed for individuals needing a pertussis-only booster while up-to-date on diphtheria and tetanus immunizations.
• In May 2024, ImmunityBio, a biotechnology company, partnered exclusively with the Serum Institute of India, a vaccine manufacturer, to secure the Bacillus Calmette-Guerin (BCG) supply. The agreement includes manufacturing standard BCG (sBCG) and next-generation recombinant BCG (iBCG) for use with ImmunityBio's ANKTIVA in current and future indications, pending regulatory approval. This collaboration aims to address BCG shortages impacting bladder cancer patients globally.
• In November 2023, GC Biopharma, a biopharmaceutical company, applied for marketing approval of "GC1109," a recombinant anthrax vaccine, to the Korean Ministry of Food and Drug Safety (MFDS). Jointly developed with the Korea Disease Control and Prevention Agency (KDCA), GC1109 demonstrated strong immunogenicity and safety in Phase II trials. The vaccine targets anthrax, a lethal Class 1 infectious disease, and aims to enhance preparedness against bioterrorism. If approved, it will be the world's first recombinant anthrax vaccine.
• In December 2020, Sanofi and GSK, healthcare companies, announced a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults. While Phase 1/2 results showed a strong immune response in adults aged 18-49, the response in older adults was insufficient. An improved antigen formulation demonstrated protection against lung pathology and rapid viral clearance in non-human primates, boosting confidence in the vaccine's potential for all adults.

Top Strategies Followed by Global Recombinant Vaccine Market Players

• Established Players: Leading companies are forming alliances to enhance their market presence.
  • For instance, in May 2024, Novavax and Sanofi entered a co-exclusive licensing agreement to co-commercialize a COVID-19 vaccine and develop novel COVID-19-influenza combination vaccines. This collaboration combines Novavax's proprietary recombinant protein and nanoparticle technologies with Sanofi's expertise in vaccine commercialization, aiming to broaden access to vaccines globally.
• Mid-Level Players: Mid-sized companies are engaging in partnerships to boost technology and production capabilities.
  • In November 2022, Pfizer-BioNTech received the USFDA approval for their updated bivalent COVID-19 booster vaccine targeting both the original strain and the Omicron BA.5 variant, showcasing successful collaboration in vaccine development.
• Small-Scale Players: Smaller companies are focusing on niche markets with unique products. For example, Vaxcyte, a biotech startup, is developing VAX-31, an experimental pneumococcal disease vaccine. In September 2024, early-stage trials showed that VAX-31 elicited an immune response equal to or better than existing vaccines, positioning Vaxcyte as a potential competitor in the market.

Emerging Startups - Recombinant Vaccine Industry Ecosystem

• Innovative Technologies: Several startups are developing advanced technologies to transform the industry. For instance, companies like Immunomic Therapeutics are utilizing nanoparticle-based platforms to enhance vaccine stability and thermostability without refrigeration. Others are working on DNA or mRNA-based personalized vaccine approaches facilitated by technologies like Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR). Such innovations have the potential to revolutionize disease prevention and spur significant market changes.
• Sustainable Solutions: Many startups focus on sustainability to differentiate themselves. Examples include companies creating eco-friendly disposable vaccine delivery mechanisms from renewable resources. There are also startups leveraging waste biomass to produce recombinant vaccine ingredients through fermentation. Their contributions help lower industry carbon footprint and production costs, bolstering their market presence.
• Market Contribution: Startups are crucial in meeting unique demands through innovative niche solutions. Many collaborate with research institutions to create vaccines targeting rare or pediatric diseases, while others partner with large corporations to accelerate the development and commercialization of cutting-edge technologies. These efforts enhance the product portfolios of major companies while driving clinical advancements and fostering sustainable progress in the industry.