HAVRIX Drug Profile

Summary for Tradename: HAVRIX

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for HAVRIX

Recent Clinical Trials for HAVRIX

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
GlaxoSmithKline	Phase 3
Ensemble contre le SIDA	Phase 3

See all HAVRIX clinical trials

Pharmacology for HAVRIX

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Hepatitis A Virus Vaccine
Chemical Structure	Hepatitis A Vaccines 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. 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 HAVRIX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for HAVRIX Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for HAVRIX 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	HAVRIX	hepatitis a vaccine	Injection	103475		2033-03-11	Patent claims search
Glaxosmithkline Biologicals	HAVRIX	hepatitis a vaccine	Injection	103475		2029-05-13	Patent claims search
Glaxosmithkline Biologicals	HAVRIX	hepatitis a vaccine	Injection	103475		2035-08-19	Patent claims search
Glaxosmithkline Biologicals	HAVRIX	hepatitis a vaccine	Injection	103475		2038-07-09	Patent claims search
Glaxosmithkline Biologicals	HAVRIX	hepatitis a vaccine	Injection	103475			Patent claims search
Glaxosmithkline Biologicals	HAVRIX	hepatitis a vaccine	Injection	103475		2040-03-04	Patent claims search

HAVRIX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Biologic Drugs: Focus on HAVRIX and the Biologics Market

Introduction to Biologic Drugs

Biologic drugs, including vaccines like HAVRIX, are revolutionizing the healthcare industry with their targeted and often more effective treatments compared to traditional pharmaceuticals. Here, we will delve into the market dynamics and financial trajectory of the biologics market, with a specific focus on HAVRIX and similar biologic products.

Global Biologics Market Overview

The global biologics market is experiencing rapid growth, driven by several key factors. As of 2024, the market size was valued at USD 511.04 billion and is projected to reach approximately USD 1,374.51 billion by 2033, growing at a CAGR of 10.4% during the forecast period[1].

Key Drivers of the Biologics Market

• Increasing Burden of Chronic Diseases: The rising prevalence of cancer, neurological diseases, genetic diseases, and autoimmune diseases is a significant driver. Biologics offer innovative treatments for these conditions, such as gene therapy, RNAi therapeutics, and antibody-drug conjugates[1].
• Technological Advancements: Continuous advancements in drug delivery systems and the development of targeted therapies are enhancing the efficacy and safety of biologic treatments[4].
• Approval of Novel Biologics: The approval of new biologic drugs, including gene therapies and antisense/RNAi therapeutics, is propelling market growth. For instance, approvals for treatments like Hemgenix for hemophilia B and ROCTAVIAN for hemophilia A are significant milestones[1].

Regional Market Dynamics

• North America: This region held the largest revenue share of 46% in 2023, driven by the high prevalence of chronic diseases, the presence of leading biopharmaceutical companies, favorable reimbursement policies, and significant investments in R&D[1].
• Asia Pacific: This region is projected to expand at a CAGR of 11.2% during the forecast period, driven by increasing healthcare access and investments in healthcare infrastructure[1].

Disease Category and Source Segmentation

• Oncology Segment: Dominated the biologics industry with a share of 29.40% in 2023. The oncology segment is a major driver due to the high incidence of cancer and the development of targeted cancer therapies[1].
• Hematological Disorders: Expected to expand at the fastest CAGR of 11.8% during the forecast period, driven by approvals of gene therapies for rare blood disorders like hemophilia[1].
• Microbial Segment: Dominated the biologics industry with a share of 59.23% in 2023, but mammalian expression systems are expected to grow significantly in the coming years[1].

Manufacturing and Product Segmentation

• In-House Manufacturing: Held an 85.87% market share in 2023, but the outsourcing segment is projected to expand at a CAGR of 10.8% during the forecast period[1].
• Monoclonal Antibodies: Accounted for a significant share of 68% in 2023. However, the antisense and RNAi therapeutics segment is anticipated to expand at a CAGR of 20.7% during the forecast period[1].

HAVRIX and the Hepatitis A Vaccine Market

HAVRIX, a hepatitis A vaccine developed by GSK, operates within the broader biologics market. Here are some key points related to HAVRIX and the hepatitis A vaccine market:

• Market Focus: The hepatitis A vaccine market is largely focused on pediatric use, which represents over 80% of the total market[5].
• Global Demand: An increase in demand in low- and middle-income countries (LMICs and UMICs) could impact pricing, though no major price changes are expected currently[5].
• Competitive Landscape: Companies like GSK, which developed HAVRIX, play a significant role in the vaccine market. GSK's strong performance in vaccines, including the launch of Arexvy for RSV, highlights the company's commitment to vaccine development and its impact on market dynamics[3].

Financial Performance and Outlook

• GSK's Financials: GSK's performance in 2023 was strong, with sales excluding COVID-19 solutions growing at double-digit levels. The company's vaccine segment, including HAVRIX, contributed significantly to this growth. GSK's adjusted operating profit grew by 12% at constant exchange rates (CER), and the company expects continued growth driven by new product launches and pipeline advancements[3].
• Market Growth Projections: The biologics market, including vaccines like HAVRIX, is expected to continue its robust growth. The increasing adoption of advanced drug delivery systems, growing awareness of biologic therapies, and strong pipeline of biologic drugs are key factors driving this growth[4].

Challenges and Opportunities

• Regulatory Approvals: The approval process for biologic drugs is stringent and time-consuming. However, the recent approvals of novel biologics indicate a favorable regulatory environment, which is an opportunity for growth[1].
• Technological Innovations: Continuous technological advancements offer opportunities for the development of more targeted and effective biologic treatments. This includes innovations in gene therapy, RNAi therapeutics, and antibody-drug conjugates[1].

Key Takeaways

• The global biologics market is projected to grow significantly, driven by the increasing burden of chronic diseases and technological advancements.
• HAVRIX and other hepatitis A vaccines are part of a larger vaccine market that is focused primarily on pediatric use.
• Companies like GSK are driving growth through strong R&D investments and successful product launches.
• The market is expected to be influenced by regional dynamics, with North America and the Asia Pacific region playing key roles.

FAQs

1. What is the projected growth rate of the global biologics market?

   • The global biologics market is projected to grow at a CAGR of 10.4% from 2024 to 2033[1].

2. Which region dominates the biologics market?

   • North America held the largest revenue share of 46% in 2023[1].

3. What are the key drivers of the biologics market?

   • Key drivers include the increasing burden of chronic diseases, technological advancements, and the approval of novel biologic drugs[1].

4. How significant is the hepatitis A vaccine market?

   • The hepatitis A vaccine market is largely focused on pediatric use, representing over 80% of the total market[5].

5. Which company developed HAVRIX?

   • HAVRIX was developed by GSK[5].

Cited Sources:

1. Nova One Advisor - Biologics Market Size to Hit Around USD 1.37 Trillion By 2033[1].
2. IMARC Group - Viral Hepatitis Market Estimated to Reach a CAGR of 2.69% during 2024-2034[2].
3. GSK - Strategic report 2023[3].
4. Biospace - Biologics Market Size to Reach USD 699.5 Billion by 2032[4].
5. World Health Organization - Global Market Study Hepatitis A[5].