Cholera vaccine live oral - Biologic Drug Details

Summary for cholera vaccine live oral

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

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. DrugPatentWatch analysis and 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 cholera vaccine live oral Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for cholera vaccine live oral Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Bavarian Nordic A/s	VAXCHORA	cholera vaccine live oral	Suspension	125597		2027-05-14	DrugPatentWatch analysis and company disclosures
Bavarian Nordic A/s	VAXCHORA	cholera vaccine live oral	Suspension	125597		2024-02-23	DrugPatentWatch analysis and company disclosures
Bavarian Nordic A/s	VAXCHORA	cholera vaccine live oral	Suspension	125597		2029-02-26	DrugPatentWatch analysis and company disclosures
Bavarian Nordic A/s	VAXCHORA	cholera vaccine live oral	Suspension	125597		2031-01-18	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for cholera vaccine live oral 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

International Patents for cholera vaccine live oral

Country	Patent Number	Estimated Expiration
South Korea	20040108809
Australia	2003242540
Norway	20044940
World Intellectual Property Organization (WIPO)	03097846

Market Dynamics and Financial Trajectory for Live Oral Cholera Vaccines

Last updated: February 24, 2026

What Is the Current Market Size for Oral Cholera Vaccines?

The global cholera vaccine market was valued at approximately USD 322 million in 2022, with a compound annual growth rate (CAGR) of 8.2% projected through 2027. The increase reflects expanding demand driven by outbreak response and endemic control efforts.

Key Market Drivers

• Increasing cholera outbreaks in Asia, Africa, and Latin America.
• World Health Organization (WHO) endorsement of oral cholera vaccines (OCVs) for outbreak control.
• Growing investment from governments and NGOs in vaccination campaigns.
• Improved vaccine stability and coverage, especially in resource-limited settings.

Market Segmentation

Segment	Market Share (2022)	Notes
Oral Cholera Vaccines	85%	Dominates the cholera vaccine market
Injectable Cholera Vaccines	15%	Declining due to availability of oral options

Which Companies Are Leading in the Live Oral Cholera Vaccine Market?

Two primary vaccines predominate:

• Dukoral (Crucell/Bilthoven); WHO prequalified.
• Shanchol (Euvichol); produced by Eubiologics and licensed to multiple manufacturers.

These vaccines represent 60% of the market as of 2022. Other players include:

• Euvichol-Plus, a reformulation of Shanchol with improved stability.
• Several regional manufacturers developing lower-cost vaccines.

What Is the Financial Trajectory for Live Oral Cholera Vaccines?

Revenue Growth

The market experienced steady growth from 2017-2022, with an average CAGR of 8.2%. Projected to reach USD 520 million by 2027.

Cost Dynamics

• Manufacturing costs reduced by roughly 12% over five years due to scale-up and process improvements.
• Average price per dose ranges from USD 1.50 to USD 3.50, depending on procurement volume and region.
• Public procurement accounts for 75% of sales, favoring lower prices.

Investment Trends

• Increased R&D investment, USD 30 million in 2022, to develop longer-lasting formulations.
• Governments of endemic regions, such as Bangladesh and Nigeria, allocate USD 20-30 million annually for vaccination programs.
• Notable rise in funding from the Global Alliance for Vaccines and Immunization (GAVI), which supported over 120 million doses in 2022.

What Are the Regulatory and Policy Factors?

• WHO prequalification enables procurement by UN agencies.
• Regulatory approvals in regions like Africa, Southeast Asia, and Latin America facilitate market expansion.
• Recent WHO emergency use listing (EUL) for Shanchol-Plus enhances market confidence.
• Policies favor oral vaccines for ease of deployment during outbreaks, supporting market growth.

What Challenges Affect the Market?

• Limited duration of immunity (typically 2-3 years), requiring booster doses.
• Manufacturing capacity constraints in low-income countries.
• Cold chain logistics and vaccine storage challenges.
• Competition from injectable vaccines and non-vaccine interventions (e.g., water sanitation).

How Will Future Market Trends Evolve?

• Advances in live oral vaccine formulations promising longer immunity durations (up to 5 years).
• Increasing use of combination vaccines integrating cholera with other enteric diseases.
• Expansion into outbreak-specific stockpiles driven by WHO and UNICEF.
• Growth in private sector access, mainly in middle-income countries.

Key Takeaways

• The live oral cholera vaccine market is expanding at an 8.2% CAGR, projected to reach USD 520 million by 2027.
• Dominated by a few large manufacturers, with increased efforts to develop longer-lasting formulations.
• Public procurement and WHO support drive growth, though logistical and manufacturing challenges persist.
• Regional policies favor oral vaccines, with expanding acceptance in new markets.
• Innovation focuses on improving duration of immunity and vaccine stability.

FAQs

1. What are the main manufacturers of live oral cholera vaccines?
Dukoral (Crucell/Bilthoven) and Shanchol (Euvichol) are the leading products, with regional manufacturers strengthening the market.

2. How does vaccine cost impact market growth?
Lower prices facilitate broader distribution, especially in low-income regions. Public procurement typically secures volumes at USD 1.50–3.50 per dose.

3. What are key regulatory hurdles?
WHO prequalification is crucial for UN procurement. Regulatory approvals vary by country, affecting regional market access.

4. What innovations are expected to influence market dynamics?
Longer-lasting formulations, combination vaccines, and improved cold chain logistics are the primary areas of innovation.

5. How has global health policy influenced market trajectories?
WHO recommendations for outbreak control and support from organizations like GAVI have accelerated vaccine adoption and funding.

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References

[1] MarketWatch. (2023). Cholera Vaccine Market Size and Trends.
[2] World Health Organization. (2022). Cholera vaccines: WHO position paper.
[3] Global Alliance for Vaccines and Immunization. (2022). Annual Report.
[4] Research and Markets. (2022). Global Cholera Vaccines Market.
[5] GAVI. (2023). Supporting endemic cholera vaccination programs.