Diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine - Biologic Drug Details

Summary for diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Bordetella Pertussis Vaccine Inactivated Clostridium Tetani Vaccine Inactivated Corynebacterium Diphtheriae Vaccine Inactivated Haemophilus Influenzae B Vaccine Inactivated Hepatitis B Virus Vaccine Inactivated Poliovirus Vaccine
Chemical Structure	Diphtheria Toxoid Haemophilus Vaccines Hepatitis B Vaccines Pertussis Vaccine Poliovirus Vaccines Tetanus Toxoid Vaccines, Inactivated

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Msp Vaccine Company	VAXELIS	diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine	Injection	125563		2037-09-08	DrugPatentWatch analysis and company disclosures
Msp Vaccine Company	VAXELIS	diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine	Injection	125563		2037-12-04	DrugPatentWatch analysis and company disclosures
Msp Vaccine Company	VAXELIS	diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine	Injection	125563		2034-05-23	DrugPatentWatch analysis and company disclosures
Msp Vaccine Company	VAXELIS	diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine	Injection	125563		2027-04-18	DrugPatentWatch analysis and company disclosures
Msp Vaccine Company	VAXELIS	diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine	Injection	125563		2026-06-02	DrugPatentWatch analysis and company disclosures
Msp Vaccine Company	VAXELIS	diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine	Injection	125563		2026-09-07	DrugPatentWatch analysis and company disclosures
Msp Vaccine Company	VAXELIS	diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine	Injection	125563		2026-03-13	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source

International Patents for diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine

Country	Patent Number	Estimated Expiration
Canada	2979458
European Patent Office	3558039
Israel	267401
Mexico	2019007463
World Intellectual Property Organization (WIPO)	2018119031
World Intellectual Property Organization (WIPO)	2013074615
Australia	2014270358

Last updated: February 13, 2026

What Are the Current Market Dynamics for the DTaP-IPV-Hib-Hep B Vaccine?

The vaccine combines protection against diphtheria, tetanus, pertussis, inactivated poliovirus, Haemophilus influenzae type b (Hib), and hepatitis B. Its market presence is driven by government immunization programs, global health initiatives, and rising vaccine demand in emerging economies. As of 2022, the global pediatric vaccines market was valued at approximately USD 40 billion, with growth driven by increased vaccination coverage and new product launches. The specific segment for combination vaccines like DTaP-IPV-Hib-Hep B is expanding as health authorities favor integrated immunizations.

Key Market Players: GlaxoSmithKline (GSK), Sanofi Pasteur, Merck & Co., Inc., and Serum Institute of India. GSK’s Infanrix hexa is the market leader, selling in over 80 countries. Sanofi’s Pediarix is another prominent product mostly available in North America and Europe.

Market Drivers:

• Rising immunization programs in low- and middle-income countries.
• Preference for combination vaccines due to lower administration costs and improved compliance.
• Ongoing efforts by WHO and GAVI to increase vaccine coverage in developing regions.
• Increasing awareness of vaccine safety and efficacy.

Market Challenges:

• Price sensitivity in emerging markets.
• Regulatory hurdles for new formulations.
• Manufacturing capacity constraints impacting supply continuity.

How Do Technological and Regulatory Trends Influence the Market?

Advancements in vaccine technology improve thermostability, reduce doses, and increase shelf life, increasing market attractiveness. For example, GSK introduced a pentavalent formulation that simplifies administration and storage.

Regulatory environments shape market access. The WHO prequalification program facilitates procurement by UN agencies. Regulatory harmonization efforts, especially in Asia and Africa, reduce approval times and costs.

Recently, the EMA and FDA approved new formulations with improved immunogenic profiles, potentially extending patent protections and market exclusivities. Patent expirations for some key products are expected around 2027-2029, opening opportunities for biosimilars and generics.

What Is the Financial Trajectory for This Vaccine?

Historical sales data indicates gradual growth. GSK reported USD 1.2 billion in annual sales for Infanrix Hexa in 2021. Merck’s Pediarix sales were approximately USD 300 million globally in the same period.

Forecasts predict compound annual growth rates (CAGR) of 6-8% through 2030, primarily driven by emerging markets. The rise in immunization initiatives increases volumes, but pricing pressure from biosimilars and government bids annually compress margins.

Investment in research and development (R&D) is substantial, focusing on next-generation combination vaccines capable of covering more pathogens with fewer doses. R&D costs for new formulations can range from USD 300 million to USD 500 million, with regulatory approval timelines extending over 5 years.

What Are the Impactful Policy and Economic Factors?

Government procurement policies significantly influence sales. Countries like India and China have shifted towards domestic manufacturing, reducing reliance on imports and enabling price negotiations. Gavi’s funding support for vaccines in 60 low-income countries ensures market stability but imposes price caps.

Intellectual property rights data reveal patent expirations are around 2027-2029, creating market entry windows for biosimilars. Biosimilar products could capture 15-20% of the market over five years post-expiry, potentially disrupting established players.

Pricing strategies vary globally—developed countries favor premium-priced branded vaccines, while auctions and tenders dominate in emerging markets, pressuring profit margins.

Summary of Key Financial Indicators

Indicator	2021	Projected 2025	Notes
Global vaccine market size	USD 40 billion	USD 55 billion	CAGR of approximately 7%
Oncology vaccine segment	USD 2 billion	USD 3.2 billion	Rapid expansion owing to innovation
Key product sales (GSK Infanrix Hexa)	USD 1.2 billion	USD 1.5 billion	Steady growth in emerging markets
R&D expenditure (top firms)	USD 300–500 million	Approx. USD 600 million	Focus on extending patent life and new formulations

What Is the Outlook for Future Market Development?

A notable driver is increasing vaccination coverage in Africa and Asia, driven by government programs and aid agencies. The expansion of combination vaccines improves compliance, reduces logistical costs, and enhances coverage.

The patent cliff around 2027 presents opportunities for biosimilar manufacturers, likely intensifying competition. Innovation in thermostability, needle-free delivery, and less invasive formulations are trending, increasing vaccine acceptance and administration efficiency.

Market consolidation among top players is ideal for streamlining R&D and distribution channels. Strategic alliances with governments secure long-term sales channels.

Key Takeaways

• The combination vaccine market is expanding due to government mandates, increasing immunization efforts, and preference for simplified vaccination schedules.
• Leading players include GSK, Sanofi, Merck, and Serum Institute, with key products reaching USD 1 billion+ annual sales.
• Regulatory harmonization and technological innovations enhance market access, while patent expiries around 2027-2029 open biosimilar opportunities.
• Emerging markets will be primary growth drivers, though price sensitivity and procurement policies pose ongoing challenges.
• Future growth depends on technological advancements, regulatory stability, and successful navigation of patent expirations.

FAQs

1. How does patent expiry around 2027 affect market competition?
Patent expiration enables biosimilar manufacturers to enter the market, potentially reducing prices and eroding profit margins for established brands.

2. What role do government programs play in shaping vaccine demand?
Government immunization targets, procurement policies, and funding from agencies like Gavi significantly influence volume and pricing strategies.

3. Are new formulations expected to improve immunogenicity or reduce doses?
Yes. Advances focus on increasing immunogenicity, reducing doses, and improving thermostability, which can enhance compliance and logistical efficiency.

4. How significant is the biosimilar market within the vaccine segment?
Biosimilars are projected to capture 15-20% of the market within five years post-patent expiry, driven by price competition and increased manufacturing capacity.

5. What are the main challenges facing the vaccine market?
Challenges include pricing pressures, regulatory delays, manufacturing capacity constraints, and geopolitical issues impacting supply chains.

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Sources:

1. MarketsandMarkets. (2022). Pediatric Vaccines Market.
2. GSK. (2022). Annual Report.
3. WHO. (2022). Global Vaccine Market Report.
4. Deloitte. (2022). Vaccines Industry Outlook.
5. IQVIA. (2022). Vaccine Market Data.