Covid-19 vaccine, mrna - Biologic Drug Details

Summary for covid-19 vaccine, mrna

Tradenames:	2
High Confidence Patents:	0
Applicants:	2
BLAs:	2
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for covid-19 vaccine, mrna

Recent Clinical Trials for covid-19 vaccine, mrna

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
KEMRI United States Army Medical Research Directorate-Kenya	Phase 1
Naval Medical Research Center	Phase 1
Johns Hopkins University	Phase 1

See all covid-19 vaccine, mrna 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 covid-19 vaccine, mrna Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for covid-19 vaccine, mrna Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for covid-19 vaccine, mrna Derived from Patent Text Search

No patents found based on company disclosures

Covid-19 vaccine, mrna Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of mRNA COVID-19 Vaccines

Introduction

The mRNA COVID-19 vaccines have revolutionized the healthcare industry, particularly in the wake of the COVID-19 pandemic. This article delves into the market dynamics and financial trajectory of these vaccines, highlighting key drivers, challenges, and future outlook.

Market Size and Growth

The mRNA vaccine market has experienced significant growth, driven largely by the demand for COVID-19 vaccines. As of 2022, the mRNA vaccine market size was valued at USD 11.3 billion and is projected to grow at a CAGR of 9.6% to reach USD 27.7 billion by 2032[1].

Key Drivers of Market Growth

Rising Prevalence of Infectious Diseases

The increasing prevalence of infectious diseases, coupled with the evolution of viral and microbial variants, has fueled the demand for effective vaccines. The COVID-19 pandemic, which resulted in over 4.5 million deaths in 2020, underscored the need for rapid vaccine development and deployment[1].

Government Initiatives and R&D

Government initiatives and substantial investments in research and development (R&D) have been crucial in driving the market. For instance, the US government invested at least $337 million in pre-pandemic research and $31.6 billion during the pandemic to support vaccine development, production, and purchase[2].

Efficacy and Potential of mRNA Vaccines

mRNA vaccines have demonstrated high efficacy rates and the ability to stimulate robust immune responses. This has led to increased adoption and trust in these vaccines, further boosting market growth[1].

Regional Market Dynamics

North America

North America accounted for over 42.4% of the mRNA vaccine market revenue in 2022 and is expected to continue growing at a considerable rate. The presence of well-established healthcare infrastructure, key market players, and ongoing research activities are significant factors contributing to this growth[1].

Europe and Rest of the World

In Europe, despite a decline in revenues due to market saturation and lower vaccination rates, new pipeline products are showing promise. For example, the EU has expressed interest in purchasing up to 36 million doses of a new mRNA COVID-19 vaccine per year for four years[3].

The Rest of the World region generated significant revenues, primarily from COVID-19 vaccine sales, with $3.6 billion in 2023. However, this region also faces challenges related to vaccine demand and distribution[3].

Financial Performance of Key Players

Moderna

Moderna, a leading player in the mRNA vaccine market, saw its total product sales drop to around $6.6 billion in 2023, a decline of over 64% from 2022. This decline is attributed to market saturation and reduced demand for COVID-19 vaccines. Despite this, Moderna is heavily reinvesting its pandemic gains into R&D, with promising pipeline products such as the RSV vaccine expected to launch in 2024[3].

BioNTech

BioNTech reported strong financial results for 2023, with revenues of €3.8 billion and a net profit of €0.9 billion. The company delivered over 400 million COVID-19 vaccine doses worldwide in 2023 and has progressed several infectious disease vaccine candidates into clinical evaluation. BioNTech's financial position remains strong, with €17.7 billion in cash, cash equivalents, and security investments as of the end of 2023[5].

Challenges and Risks

Overreliance on COVID-19 Vaccine Sales

Both Moderna and BioNTech face significant risks due to their overreliance on COVID-19 vaccine sales. For Moderna, approximately 97% of its total revenue in 2023 was tied to its COVID-19 vaccine, Spikevax. This overreliance poses a substantial risk if new products do not successfully launch or if the COVID-19 vaccine market continues to decline[3].

Pricing and Value Extraction

The pricing strategy of mRNA vaccine manufacturers has been a subject of debate. Despite the low manufacturing cost of around $1-3 per dose, companies like Moderna and Pfizer-BioNTech have announced plans to charge significantly higher prices, highlighting issues of value extraction and the privatization of public investment[2].

Future Outlook

Pipeline Products and Diversification

The future growth of the mRNA vaccine market is heavily dependent on the successful launch of pipeline products. Companies like Moderna and BioNTech are investing heavily in R&D to develop vaccines for various genetic disorders, autoimmune diseases, and types of cancer. The launch of vaccines such as Moderna's RSV vaccine in 2024 is expected to yield significant revenues and diversify their product portfolios[3][5].

Clinical Trials and Regulatory Approvals

The progression of clinical trials and the granting of regulatory approvals will be critical for the future success of mRNA vaccines. The increasing number of clinical trials for various infectious diseases and the growing use of stem cell therapies are expected to drive market expansion[4].

Government Contracts and Preparedness

Government contracts and pandemic preparedness initiatives will continue to play a significant role in the market. For instance, BioNTech's contract with the German government for pandemic preparedness is expected to contribute to its revenue in 2024[5].

Key Takeaways

• The mRNA vaccine market is projected to grow significantly, driven by the rising prevalence of infectious diseases and government initiatives.
• Key players like Moderna and BioNTech are heavily investing in R&D to diversify their product portfolios.
• Overreliance on COVID-19 vaccine sales poses a significant risk for these companies.
• Pricing strategies and value extraction remain critical issues in the market.
• Future growth is dependent on the successful launch of pipeline products and ongoing clinical trials.

FAQs

Q: What is the projected market size of the mRNA vaccine market by 2032?

A: The mRNA vaccine market is estimated to reach USD 27.7 billion by 2032, growing at a CAGR of 9.6% from 2022[1].

Q: How much did the US government invest in mRNA COVID-19 vaccine development and purchase during the pandemic?

A: The US government invested at least $337 million in pre-pandemic research and $31.6 billion during the pandemic to support vaccine development, production, and purchase[2].

Q: What is the main challenge faced by companies like Moderna and BioNTech in the mRNA vaccine market?

A: The main challenge is the overreliance on COVID-19 vaccine sales, which poses a significant risk if new products do not successfully launch or if the COVID-19 vaccine market continues to decline[3].

Q: Which region accounted for the largest revenue share in the mRNA vaccine market in 2022?

A: North America accounted for over 42.4% of the mRNA vaccine market revenue in 2022[1].

Q: What is the expected revenue range for BioNTech in 2024?

A: BioNTech expects its group revenue for the full 2024 financial year to be in the range of €2.5 billion to €3.1 billion[5].

Sources

1. Global Market Insights: mRNA Vaccine Market Size & Share Report, 2032.
2. The BMJ: Financing covid-19 mRNA vaccines.
3. University of Iowa Tippie College of Business: Krause Fund Research - Current Students.
4. Grand View Research: mRNA Therapeutics Market Size And Share Report, 2030.
5. BioNTech: BioNTech Announces Fourth Quarter and Full Year 2023 Financial Results.