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Last Updated: December 25, 2024

RECOMBIVAX, RECOMBIVAX HB Drug Profile


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Summary for Tradename: RECOMBIVAX, RECOMBIVAX HB
High Confidence Patents:0
Applicants:1
BLAs:1
Pharmacology for RECOMBIVAX, RECOMBIVAX HB
Physiological EffectActively Acquired Immunity
Established Pharmacologic ClassInactivated Hepatitis B Virus Vaccine
Chemical StructureHepatitis B 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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 RECOMBIVAX, RECOMBIVAX HB Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for RECOMBIVAX, RECOMBIVAX HB Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for RECOMBIVAX, RECOMBIVAX HB Derived from Patent Text Search

These patents were obtained by searching patent claims

RECOMBIVAX, RECOMBIVAX HB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Recombivax and Recombivax HB

Introduction to Recombivax and Recombivax HB

Recombinax and Recombivax HB are recombinant vaccines developed to protect against hepatitis B, a serious and sometimes fatal viral infection of the liver. These vaccines contain a harmless portion of the hepatitis B virus (HBV) surface antigen, which stimulates the immune system to produce antibodies against the virus.

Market Size and Growth

The global market for recombinant vaccines, including those for hepatitis B, is experiencing significant growth. By 2031, the global recombinant vaccines market is estimated to reach USD 24.7 billion, growing at a CAGR of 11.4% from 2022 to 2031[1].

Hepatitis B Vaccine Market Specifics

The hepatitis B vaccine (recombinant) market, specifically, is valued at US$ 6.5 billion in 2023 and is expected to grow to US$ 9.5 billion by 2030, with a CAGR of over 5.6% during the forecast period of 2023-2030[4].

Regional Market Dynamics

North America is the dominant region for the recombinant vaccines market, including hepatitis B vaccines, due to high prevalence rates of chronic diseases and increased vaccination rates. However, the Asia-Pacific region is expected to witness the highest CAGR during the forecast period, driven by the large population and increasing prevalence of infectious diseases in countries like India and China[1].

Key Market Drivers

Several factors are driving the growth of the recombinant vaccines market:

  • Increasing Incidence of Infectious Diseases: The rise in infectious diseases, including zoonotic diseases, is a significant driver.
  • Emerging Technologies: Advances in vaccine development technologies are enhancing the efficacy and safety of recombinant vaccines.
  • Product Approvals: Recent approvals of new vaccines, such as the six-in-one pediatric combination vaccine by Merck and Sanofi, contribute to market growth[1].

Financial Performance of Key Players

Companies like Merck & Co., Inc., and GlaxoSmithKline Plc., which produce Recombivax and similar vaccines, report varied financial performances:

  • Merck & Co., Inc.: As a major player, Merck's financials are influenced by the sales of its vaccines. The company's overall revenue and profitability can be impacted by the success of its vaccine portfolio, including Recombivax[1].

  • GlaxoSmithKline Plc.: GSK's financial results show fluctuations due to various factors such as stock build and international tenders. However, the company remains confident in its vaccine business, including hepatitis B vaccines like Recombivax HB. For instance, the re-entry of Recombivax into the market has contributed to the company's vaccine sales[5].

Product-Specific Financials

While detailed financials for Recombivax and Recombivax HB are not separately disclosed, the overall performance of these vaccines can be inferred from the broader vaccine market trends:

  • Revenue Contribution: These vaccines contribute to the overall revenue of the companies. For example, the launch of new vaccines and the re-entry of existing ones like Recombivax can boost sales figures[5].

  • Research and Development: Significant investments in research and development are crucial for maintaining and improving vaccine efficacy. Companies like VBI Vaccines, which also focuses on hepatitis B vaccines, spend substantial amounts on R&D, which can impact their financial performance. For instance, VBI Vaccines reported R&D expenses of $15.5 million in 2022, offset by government grants and funding arrangements[3].

Distribution and Access

The distribution and access to these vaccines are critical for their market success:

  • Distribution Channels: Product access agreements with retail pharmacy chains and reimbursement coverage are essential. For example, VBI Vaccines has put in place product access agreements with several retail pharmacy chains, ensuring broader access to their hepatitis B vaccine, PreHevbrio[3].

  • Reimbursement Coverage: Reimbursement coverage is a key factor in vaccine adoption. As of 2023, reimbursement coverage for PreHevbrio, a similar hepatitis B vaccine, is estimated to be in place for 75% of Medicare-insured lives, 75% of commercially insured lives, and more than 60% of lives under state Medicaid plans[3].

Challenges and Opportunities

Despite the growth potential, there are challenges and opportunities in the market:

  • Prolonged Introduction Period: The prolonged period required for the introduction of new vaccines can hinder market growth. However, this also presents opportunities for continuous research and development to improve vaccine efficacy and safety[1].

  • Emerging Economies: The high growth potential in untapped emerging economies offers lucrative opportunities for market expansion. Companies can leverage these markets to increase their global footprint and revenue[1].

Key Takeaways

  • The global recombinant vaccines market, including hepatitis B vaccines like Recombivax and Recombivax HB, is expected to grow significantly.
  • North America is the dominant region, but the Asia-Pacific region is expected to witness the highest CAGR.
  • Increasing incidence of infectious diseases, emerging technologies, and product approvals drive market growth.
  • Financial performance is influenced by sales, R&D investments, and distribution strategies.
  • Reimbursement coverage and access agreements are crucial for market success.

Frequently Asked Questions (FAQs)

Q: What is the projected market size for the global recombinant vaccines market by 2031? A: The global recombinant vaccines market is estimated to reach USD 24.7 billion by 2031[1].

Q: Which region is expected to witness the highest CAGR for recombinant vaccines? A: The Asia-Pacific region is expected to witness the highest CAGR during the forecast period[1].

Q: What are the key drivers of the recombinant vaccines market? A: Key drivers include the increasing incidence of infectious diseases, emerging technologies, and recent product approvals[1].

Q: How does reimbursement coverage impact the adoption of hepatitis B vaccines? A: Reimbursement coverage significantly impacts adoption by making the vaccines more accessible to a broader population[3].

Q: What challenges do companies face in introducing new recombinant vaccines? A: Companies face challenges such as the prolonged period required for the introduction of new vaccines, which can hinder market growth[1].

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