Recombinant Vaccine Market Analysis & Forecast 2025-2032

Recombinant Vaccine Market Size and Forecast – 2024 to 2031

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.

Segmental Insights

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Type Insights - Superior Safety and Efficacy Drive Dominance of Attenuated Recombinant Vaccines

The attenuated recombinant vaccines segment is expected to contribute the highest share of the market with 43.1% in 2024 owing to its ability to induce strong and long-lasting immune responses while maintaining a high safety profile. Attenuated recombinant vaccines contains live-attenuated viral or bacterial agents which have been genetically engineered to be less virulent/nonvirulent but still able to induce strong and long-lasting immune responses. Compared to subunit recombinant vaccines which only contains isolated protein antigens of the pathogen, attenuated recombinant vaccines present the antigens to the immune system in a more similar context as during natural infection. This elicits a balanced and coordinated humoral and cellular immune response mimicking natural immunity more closely.

Indication Insights - Comprehensive HPV Protection Fuels Market Leadership

The Human Papillomavirus (HPV) segment is expected to contribute the highest share with 23.1% in 2024 under the indication segment owing to the comprehensive protection it provides against Human Papillomavirus infections. HPV is the most common sexually transmitted infection worldwide. Certain high-risk HPV types can cause cancer including cervical, anal, penile, vulvar, and oropharyngeal cancers. Low-risk types can cause genital warts. The three currently approved HPV vaccines, Gardasil, Gardasil 9, and Cervarix, which are all recombinant vaccines, provide immunity against the high-risk HPV 16 and 18 viral types responsible for approximately 70% of cervical cancers and precancerous cervical lesions. Gardasil 9 further protects against 5 additional high-risk types.

End User Insights - Pediatric Immunization Leads with Lifelong Protection

The pediatric segment is expected to contribute the highest share under the end user segment with a share of 35.2% in 2024 as immunizing at a young age confers life-long protection and avoids disease susceptibility during the peak infectious years. Childhood is a highly vulnerable period for exposure to various dangerous viral and bacterial infections. Immature immune systems of infants and young children may be overwhelmed by some pathogens, increasing disease severity risk. Establishing protective immunity as early as possible mitigates this vulnerability. Recombinant protein-based vaccines are ideally suited for early life immunization due to enhanced safety and ability to induce long-lasting immune memory from an early age onwards.

Regional Insights

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North America Recombinant Vaccine Market Trends

North America’s dominance in the global recombinant vaccine market with a share of 35.3% in 2024 can be attributed to factors like the well-established healthcare infrastructure, favorable government policies supporting vaccine research, and the presence of major players like Pfizer. The region houses top innovators which helped accelerate the development and adoption of novel vaccine technologies.

Asia Pacific Recombinant Vaccine Market Trends

The Asia Pacific region exhibits the fastest growth in the recombinant vaccine market with a share of 27.7% in 2024. This can be largely attributed to rising healthcare spending, growing focus on preventive healthcare among its vastly populated emerging countries, and strategic initiatives by regional governments to broaden immunization programs.

Recombinant Vaccine Market Outlook for Key Countries

U.S. Recombinant Vaccine Market Trends

The U.S. is a leader in the recombinant vaccine market, driven by significant investments in R&D and a robust healthcare infrastructure. In February 2023, Pfizer Inc. announced that the U.S. FDA has accepted a Biologics License Application (BLA) for RSVpreF (PF-06928316), its respiratory syncytial virus (RSV) vaccine candidate. The vaccine aims to prevent medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI in infants up to six months old through active immunization of pregnant individuals.

Germany Recombinant Vaccine Market Trends

Germany's strong pharmaceutical sector supports the recombinant vaccine market, with a focus on advanced manufacturing technologies. The Germany government has increased funding for vaccine research, with a notable investment of USD 750 million announced in March 2021 to enhance vaccine production capabilities.

India Recombinant Vaccine Market Trends

India is emerging as a key player in the recombinant vaccine market, driven by its large population and increasing vaccination rates. The Serum Institute of India, the world's largest vaccine manufacturer, has ramped up the production of recombinant vaccines, contributing to the country's goal of universal immunization.

China Recombinant Vaccine Market Trends

China recombinant vaccine market is expanding rapidly due to government initiatives aimed at improving public health. In April 2021, the Chinese government launched a national vaccination campaign like the National Cervical Cancer Prevention and Control Program, targeting Human Papillomavirus, significantly increasing the demand for recombinant vaccines.

Market Players, Key Devlopment, and Competitive Intelligence

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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.

Market Report Scope

Market Dynamics

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Market Driver - Increase in research and development activities for recombinant vaccines

The global recombinant vaccine market is expected to witness significant growth over the forecast period owing to the increasing research and development activities carried out by various pharmaceutical and biotechnology companies. These companies are investing heavily in developing advanced and more effective recombinant vaccines to curb the rising burden of infectious diseases worldwide. Recombinant technology is considered a breakthrough in vaccine development as it allows the production of large amounts of specific and purified vaccine antigens in a relatively short duration of time. Various recombinant vaccines are currently under development or clinical trials against major diseases like hepatitis B, HIV, cervical cancer, influenza, and malaria. For instance, in March 2022, VBI Vaccines Inc. introduced PreHevbrio, a recombinant hepatitis B vaccine, in the United States. This vaccine is designed to prevent infections caused by all known subtypes of the hepatitis B virus (HBV) in adults aged 18 and older.

Market Challenge - Prolonged period for the introduction of new vaccines

The global recombinant vaccine market faces significant challenges in terms of the prolonged period required for the introduction of new vaccines. Developing a new vaccine is an expensive and time-consuming process that requires several stages of research and testing spanning over a decade or more. First, potential antigens must be identified through extensive research. This is followed by pre-clinical testing on animal models to test for safety, immunogenicity and efficacy. If successful, vaccines enter clinical trials with human subjects comprising three phases to further evaluate these parameters along with appropriate dosages. Only then regulatory approvals are sought from bodies like the FDA which involves submission of vast documentation. The entire process from target identification to market launch of a novel vaccine can take 10-15 years. This deters investments as returns may take a long time to realize. Stringent regulations also increase compliance costs for manufacturers.

Market Opportunity - High growth potential in untapped emerging economies

The global recombinant vaccine market possesses high growth opportunities in several untapped emerging economies. Countries in regions like Asia Pacific, Latin America, the Middle East, and Africa currently account for a relatively smaller share of the overall market. However, with improving economic conditions and rising healthcare expenditures, the demand for vaccines is set to surge rapidly in these developing nations over the coming years. Initiatives by governments and international organizations to strengthen immunization programs will also boost uptake. As living standards and life expectancy increase, people in these regions will seek access to sophisticated biologics like recombinant vaccines to protect against diseases. This presents lucrative opportunities for manufacturers to enter new markets and capture a share of the growing demand. Efforts must be made to price products affordably and educate about the need for preventive healthcare.

Analyst Opinion (Expert Opinion)

• The recombinant vaccine market holds significant growth potential over the next decade driven by rising immunization programs worldwide and technological advancements in vaccine production. Recombinant technology allows for higher vaccine yields and more targeted protection compared to traditional production methods. Additional drivers include growing awareness about the benefits of vaccination and global efforts to eradicate diseases. The market for vaccines against influenza, Hepatitis B, and human papillomavirus is projected to rise substantially.
• Stringent regulatory norms governing vaccine approval delays market entry for new players. High R&D costs associated with clinical trials and ensuring vaccine safety also act as barriers. Moreover, vaccine hesitancy in some regions continues to hamper immunization rates. Players must overcome these challenges to maximize opportunities in the market.
• North America presently dominates due to rapid uptake of new vaccines while Asia Pacific is likely to witness the fastest gains. Presence of major manufacturers and favorable reimbursement policies stimulate demand in developed economies. On the other hand, improving access through public-private partnerships and vaccine procurement programs could spur adoption across developing Asian countries. Overall, with its distinct advantages, recombinant technology will play a crucial role in fighting infectious diseases globally. Continuous innovations to develop more effective and affordable vaccines will define success in this landscape.

Market Segmentation

• By Type Insights (Revenue, USD Bn, 2019 - 2031)
  • Attenuated Recombinant Vaccines
  • Vector Recombinant Vaccines
  • Subunit Recombinant Vaccines
• By Indication Insights (Revenue, USD Bn, 2019 - 2031)
  • Human Papillomavirus (HPV)
  • Meningococcal
  • Hepatitis B
  • Influenza
  • Rotavirus
  • Herpes Zoster
  • Others
• By End User Insights (Revenue, USD Bn, 2019 - 2031)
  • Pediatric
  • Adult
  • Geriatric
• By Distribution Channel Insights (Revenue, USD Bn, 2019 - 2031)
  • Hospital & Retail Pharmacies
  • Government Suppliers
  • Vaccination Centers
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Merck & Co., Inc.
  • Sanofi S.A.
  • Pfizer Inc.
  • GlaxoSmithKline Plc.
  • Johnson & Johnson
  • Novavax, Inc.
  • AstraZeneca Plc.
  • Dynavax Technologies Corporation
  • Serum Institute of India Pvt. Ltd.
  • Emergent BioSolutions Inc.
  • Bharat Biotech
  • Protein Sciences Corporation
  • VBI Vaccines Inc.
  • Inovio Pharmaceuticals, Inc.