ENGERIX-B Drug Profile

Summary for Tradename: ENGERIX-B

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ENGERIX-B

Recent Clinical Trials for ENGERIX-B

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sheffield Teaching Hospitals NHS Foundation Trust	Phase 2/Phase 3
Chang Gung Memorial Hospital	Phase 4
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2

See all ENGERIX-B clinical trials

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. General 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 ENGERIX-B Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ENGERIX-B Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ENGERIX-B 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
Glaxosmithkline Biologicals	ENGERIX-B	hepatitis b vaccine (recombinant)	Injection	103239		2035-03-19	Patent claims search
Glaxosmithkline Biologicals	ENGERIX-B	hepatitis b vaccine (recombinant)	Injection	103239		2033-11-14	Patent claims search
Glaxosmithkline Biologicals	ENGERIX-B	hepatitis b vaccine (recombinant)	Injection	103239		2034-01-16	Patent claims search
Glaxosmithkline Biologicals	ENGERIX-B	hepatitis b vaccine (recombinant)	Injection	103239		2034-01-16	Patent claims search
Glaxosmithkline Biologicals	ENGERIX-B	hepatitis b vaccine (recombinant)	Injection	103239		2034-01-16	Patent claims search
Glaxosmithkline Biologicals	ENGERIX-B	hepatitis b vaccine (recombinant)	Injection	103239		2034-12-30	Patent claims search
Glaxosmithkline Biologicals	ENGERIX-B	hepatitis b vaccine (recombinant)	Injection	103239		2034-12-30	Patent claims search

ENGERIX-B Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: ENGERIX-B

Introduction to ENGERIX-B

ENGERIX-B is a hepatitis B vaccine produced by GlaxoSmithKline (GSK), designed to protect against the hepatitis B virus (HBV). This vaccine has been a cornerstone in the prevention of hepatitis B, a severe public health concern globally.

Market Size and Growth

The hepatitis B vaccine market, which includes ENGERIX-B, has been experiencing significant growth. As of 2023, the global hepatitis B vaccine market was valued at USD 8.38 billion and is projected to grow to USD 13.31 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 5.2% during the forecast period[3].

Key Drivers of Market Growth

Rising Prevalence of Hepatitis B

The increasing prevalence of hepatitis B infections, particularly through prenatal transmission and contact with infected body fluids, has driven the demand for vaccines like ENGERIX-B. This trend is expected to continue, fueling market growth[3].

Advancements in Vaccine Technology

Technological advancements in vaccine design and administration are gaining momentum. The use of AI in vaccine and drug design, as well as improvements in vaccine delivery systems, are enhancing the efficacy and accessibility of vaccines like ENGERIX-B[5].

Government Initiatives and Public Health Policies

Favorable government initiatives and public health policies aimed at reducing the burden of HBV infections are crucial drivers. For instance, Public Health England's efforts to track HBV infection burdens and estimate vaccination cost-effectiveness are supportive of market growth[5].

Combination Vaccines

The combination vaccines segment, which includes vaccines like Twinrix that protect against both hepatitis B and hepatitis A, is anticipated to grow at the fastest rate. This segment reduces the cost of packaging individual vaccines, contributing to its market growth[5].

Financial Trajectory

Revenue Contribution

ENGERIX-B, as part of GSK's vaccine portfolio, contributes significantly to the company's revenue. GSK's vaccines segment, including ENGERIX-B, has seen strong performance, with sales from new products launched since 2017 contributing over £11 billion in 2023[2].

Market Share and Competition

The global hepatitis B vaccine market is moderately concentrated, with key players like GSK, Sanofi, and Merck & Co., Inc. dominating the market. ENGERIX-B competes in this landscape, benefiting from GSK's strong market presence and distribution networks[3].

Regional Performance

North America, particularly the United States, has been a significant market for ENGERIX-B, with the region accounting for a substantial share of the global market. The European Union and the UK are also expected to expand significantly due to improved healthcare infrastructure and active government initiatives[3][5].

Challenges and Opportunities

High Cost of Vaccine Development

One of the challenges facing the market is the high cost associated with vaccine development. However, this is offset by the increasing healthcare expenditure and the growing recognition of the economic benefits of vaccination programs[5].

Inequitable Access to Vaccines

Inequitable access to vaccines remains a challenge, particularly in developing regions. However, regional partnerships and distribution agreements are being pursued to address this issue[5].

Technological Advancements

Technological advancements in vaccine administration and the use of AI in vaccine design present opportunities for enhancing the efficacy and accessibility of ENGERIX-B. These advancements are expected to drive future growth[5].

GSK's Strategic Focus

Pipeline Strengthening

GSK has been focusing on strengthening its pipeline, including potential new vaccines and treatments. The company's R&D efforts have led to several major product approvals, and it plans for at least 12 major product launches from 2025, which could further bolster its market position[2].

Operational Efficiency

GSK's focus on cost discipline and improving operating margins is expected to enhance the financial performance of its vaccine segment, including ENGERIX-B. The company's demerger of Haleon in 2022 has also strengthened its balance sheet, enabling further investments in R&D and product launches[2].

Illustrative Statistics

• The global hepatitis B vaccine market is projected to grow from USD 8.85 billion in 2024 to USD 13.31 billion by 2032, with a CAGR of 5.2%[3].
• North America dominated the global market with a share of 33.89% in 2023[3].
• GSK's vaccines segment, including ENGERIX-B, contributed significantly to the company's revenue, with sales from new products launched since 2017 exceeding £11 billion in 2023[2].

Expert Insights

"The exceptional launch of new vaccines and the strong performance of our existing portfolio have been key drivers of our growth. We continue to invest in R&D and strategic partnerships to maintain our leadership in the vaccines market," - GSK Executive[2].

Key Takeaways

• The hepatitis B vaccine market, including ENGERIX-B, is expected to grow significantly due to rising prevalence, technological advancements, and favorable government policies.
• GSK's strong market presence, pipeline strengthening, and operational efficiency are crucial for the financial trajectory of ENGERIX-B.
• Challenges such as high development costs and inequitable access are being addressed through regional partnerships and technological innovations.

FAQs

Q: What is the current market size of the hepatitis B vaccine market? A: As of 2023, the global hepatitis B vaccine market was valued at USD 8.38 billion[3].

Q: What is the projected growth rate of the hepatitis B vaccine market? A: The market is expected to grow at a CAGR of 5.2% from 2024 to 2032[3].

Q: Which region dominates the global hepatitis B vaccine market? A: North America dominated the global market with a share of 33.89% in 2023[3].

Q: What are the key drivers of the hepatitis B vaccine market growth? A: Key drivers include the rising prevalence of hepatitis B, technological advancements, and favorable government initiatives[3][5].

Q: Who are the major players in the global hepatitis B vaccine market? A: Major players include GSK, Sanofi, and Merck & Co., Inc.[3].

Cited Sources

1. Biospace: Hepatitis B Market Estimated to Reach USD 4.9 Billion by 2034...
2. GSK: Annual Report 2023
3. Fortune Business Insights: Hepatitis B Vaccine Market Size, Share, Growth | Trends [2032]
4. GSK: GSK Investor Presentation
5. GlobeNewswire: Global Hepatitis B Virus (HBV) Vaccine Market Report 2023-2027