Hepatitis b vaccine (recombinant), adjuvanted - Biologic Drug Details

Summary for hepatitis b vaccine (recombinant), adjuvanted

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	2

Pharmacology for hepatitis b vaccine (recombinant), adjuvanted

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Hepatitis B Virus Vaccine
Chemical Structure	Hepatitis B Vaccines Vaccines, Inactivated

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1. Brand-side disclosures in response to biosimilar applications

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1) High Certainty: US Patents for hepatitis b vaccine (recombinant), adjuvanted Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for hepatitis b vaccine (recombinant), adjuvanted Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for hepatitis b vaccine (recombinant), adjuvanted Derived from Patent Text Search

No patents found based on company disclosures

Hepatitis b vaccine (recombinant), adjuvanted Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Hepatitis B Vaccine (Recombinant, Adjuvanted)

Introduction

The hepatitis B vaccine market, particularly for recombinant and adjuvanted versions, is experiencing significant growth driven by increasing global awareness, advancing vaccine technologies, and robust market demand. Here, we delve into the market dynamics and financial trajectory of this critical biologic drug.

Global Market Size and Growth

The global hepatitis B vaccine market is substantial and growing. As of 2022, the market size was valued at approximately USD 3.3 billion and is projected to reach USD 5.7 billion by 2032, growing at a CAGR of 5.1%[2].

By 2030, the market is expected to reach USD 9.5 billion, with a CAGR of over 5.6% from 2023 to 2030[3]. Another forecast indicates the market will grow to USD 11.84 billion by 2031, with a CAGR of 4.6% from 2024 to 2031[5].

Key Market Drivers

Increasing Prevalence of Hepatitis B

The growing prevalence of chronic hepatitis B infection, liver cirrhosis, and liver cancer drives the demand for effective preventive vaccines. According to the World Health Organization (WHO), 296 million people were living with chronic hepatitis B infection in 2019, with 1.5 million new infection cases registered each year[2].

Expanded Vaccination Recommendations

The Advisory Committee on Immunization Practices (ACIP) has expanded its recommendations for adult hepatitis B vaccination, which is expected to significantly increase the market size. For instance, Dynavax believes that the expanded ACIP recommendation could expand the market to over $800 million by 2027, with HEPLISAV-B well-positioned to achieve a majority market share[1].

Government Initiatives and Public Awareness

Government initiatives and increasing public awareness about the importance of immunization and preventive healthcare practices are fueling market growth. North America, in particular, is expected to see considerable growth due to these factors[2].

Advances in Vaccine Technology

The development of more effective vaccines, such as the recombinant hepatitis B vaccine, and the use of adjuvants like CpG 1018, enhance vaccine efficacy and reduce the number of doses required. This technological advancement is a significant driver of market growth[3].

Financial Performance of Key Players

Dynavax Technologies Corporation

Dynavax, a key player in the hepatitis B vaccine market, reported significant financial growth in 2022. The HEPLISAV-B vaccine, which is the first and only adult hepatitis B vaccine approved in the U.S. and EU that enables series completion with only two doses in one month, achieved record annual net product revenue of $125.9 million, representing a 104% growth compared to 2021[1].

For 2023, Dynavax anticipates HEPLISAV-B net product revenue to be between $165 million and $185 million, representing a year-over-year revenue growth of approximately 30-47%[1].

CpG 1018 Adjuvant

The CpG 1018 adjuvant, used in COVID-19 vaccines and other vaccine platforms, generated significant revenue for Dynavax in 2022, with net product revenue of $587.7 million. However, due to the successful execution of pandemic-related commercial supply agreements and the resulting stockpile, Dynavax expects minimal to zero CpG 1018 adjuvant net product revenues in 2023[1].

Market Segmentation

Regional Market

North America accounts for a significant share of the hepatitis B vaccine market, with over 40.6% of the business share in 2022. This region is expected to grow at a considerable rate due to increasing prevalence of hepatitis B infections and growing awareness about immunization[2].

Product Types

The market includes various types of hepatitis B vaccines, such as recombinant vaccines, vaccines derived from plasma, and combination vaccines. Recombinant vaccines are the most frequently used type and are expected to drive market growth[5].

Competitive Landscape

The hepatitis B vaccine market is competitive, with several major players including GlaxoSmithKline, Gilead Sciences Inc., Merck & Co., Inc., Shenzhen Kangtai Biological Products Co., Ltd., Serum Institute of India Pvt., Dynavax Technologies Corporation, Sanofi, VBI Vaccines Inc., and others. These companies are adopting strategies such as mergers and acquisitions, partnerships, and product launches to reinforce their market share[5].

Cost-Effectiveness and Health Benefits

Studies have shown that universal hepatitis B vaccination among adults can be highly cost-effective. A study by the CDC found that universal hepatitis B screening and vaccination for adults aged 18-69 could save significant healthcare costs and improve health outcomes. The 2-dose strategy, in particular, reduced acute hepatitis B cases by 24.6% and deaths by 22.2%, with a cost per quality-adjusted life year gained similar to the 3-dose strategy[4].

Future Outlook

The future of the hepatitis B vaccine market looks promising, driven by increasing demand, technological advancements, and expanded vaccination recommendations. As global awareness and public health initiatives continue to grow, the market is expected to see sustained growth over the next decade.

Key Takeaways

• The global hepatitis B vaccine market is projected to grow significantly, reaching USD 9.5 billion by 2030.
• Dynavax's HEPLISAV-B vaccine has seen record revenue growth and is expected to continue growing.
• The use of adjuvants like CpG 1018 enhances vaccine efficacy and market potential.
• North America is a key region driving market growth due to high prevalence and awareness.
• Universal hepatitis B vaccination is cost-effective and improves health outcomes.

FAQs

What is the current market size of the hepatitis B vaccine market?

The current market size of the hepatitis B vaccine market was valued at approximately USD 3.3 billion in 2022 and is estimated to grow significantly over the next decade[2].

Which regions are driving the growth of the hepatitis B vaccine market?

North America is a significant driver of the market, accounting for over 40.6% of the business share in 2022. The region is expected to continue growing due to increasing prevalence and awareness[2].

What are the key drivers of the hepatitis B vaccine market?

Key drivers include the growing prevalence of hepatitis B infections, expanded vaccination recommendations, government initiatives, public awareness, and advances in vaccine technology[2][3].

How cost-effective is universal hepatitis B vaccination?

Universal hepatitis B vaccination among adults is highly cost-effective, reducing acute cases and deaths while providing significant healthcare cost savings[4].

Who are the major players in the hepatitis B vaccine market?

Major players include GlaxoSmithKline, Gilead Sciences Inc., Merck & Co., Inc., Dynavax Technologies Corporation, Sanofi, VBI Vaccines Inc., and others[5].

Sources

1. Dynavax Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Full Year 2023 Financial Guidance - Dynavax Investors
2. Hepatitis B Vaccine Market Size – Trends Analysis, 2032 - Global Market Insights
3. Hepatitis B Vaccine (Recombinant) Market Size, Market Share, Data Analysis and Forecasts 2023-2030 - GlobeNewswire
4. Success Story: Costs and Effectiveness of Hepatitis B Screening and Vaccination - CDC
5. Hepatitis B Vaccine Market Size, Share & Growth Analysis - SNS Insider