Pembrolizumab - Biologic Drug Details

Summary for pembrolizumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for pembrolizumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pembrolizumab

Recent Clinical Trials for pembrolizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Regeneron Pharmaceuticals	Phase 2/Phase 3
Dartmouth-Hitchcock Medical Center	Phase 1/Phase 2
James Isaacs, MD	Phase 1

See all pembrolizumab clinical trials

Recent Litigation for pembrolizumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.	2022-03-17

See all pembrolizumab litigation

PTAB Litigation

Petitioner	Date
Genome & Company	2018-10-02

See all pembrolizumab litigation

Pharmacology for pembrolizumab

Mechanism of Action	Programmed Death Receptor-1-directed Antibody Interactions
Established Pharmacologic Class	Programmed Death Receptor-1 Blocking Antibody

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 pembrolizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2027-06-18	Company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2028-06-13	Company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2032-12-19	Company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2034-12-19	Company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	Injection	125514		2027-06-18	Company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	Injection	125514		2028-06-13	Company disclosures

3) Low Certainty: US Patents for pembrolizumab 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
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2035-06-26	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2034-02-06	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2034-10-30	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2034-06-17	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2035-05-04	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2034-11-05	Patent claims search

Market Dynamics and Financial Trajectory for Pembrolizumab

Introduction

Pembrolizumab, marketed under the brand name Keytruda, is a revolutionary biologic drug that has transformed the landscape of cancer treatment. As an immune checkpoint inhibitor targeting the PD-1 receptor, it enables the body's immune system to identify and eliminate cancer cells. Here, we delve into the market dynamics and financial trajectory of pembrolizumab.

Market Size and Forecast

The pembrolizumab market is poised for significant growth. As of 2023, the market size was valued at USD 19.5 billion and is projected to reach USD 32.5 billion by 2031, growing at a CAGR of 6.5% during the forecast period of 2024-2031[1].

Key Drivers of Market Growth

Several factors are driving the growth of the pembrolizumab market:

Combination Therapies

The exploration of pembrolizumab in combination with other therapies, such as chemotherapy, targeted therapy, or other immunotherapies, has the potential to enhance its effectiveness and marketability[1].

Increased Investment in Oncology

Pharmaceutical companies, research institutions, and investors are increasingly focusing on oncology, leading to innovations and expanded clinical trials that often include pembrolizumab[1].

Patient Awareness and Advocacy

Increased awareness of cancer treatments due to patient advocacy groups and educational programs encourages patients to seek out advanced treatments, boosting demand for pembrolizumab[1].

Health Insurance Coverage

The extent of insurance coverage and reimbursement policies for pembrolizumab significantly influences market access and patient uptake, thus impacting overall market growth[1].

Expansion into Emerging Markets

As healthcare systems in emerging markets improve and access to cancer treatments increases, pembrolizumab's availability in these regions can significantly expand its market[1].

Distribution Channels

The pembrolizumab market is segmented by distribution channels, including:

Hospital Pharmacies

Hospital pharmacies play a vital role in acute care settings where pembrolizumab is often administered as part of comprehensive cancer treatment plans within hospital facilities[1].

Retail Pharmacies

Retail pharmacies provide another avenue for the distribution of pembrolizumab, although they may not offer the same level of specialized care as hospital pharmacies[1].

Online Pharmacies

Online pharmacies are becoming increasingly relevant, offering convenience and accessibility, although they may face regulatory and logistical challenges[1].

Geographic Market Segmentation

The pembrolizumab market can be analyzed through various geographic regions:

North America

North America is a crucial market, characterized by a highly developed healthcare infrastructure, strong research and development activities, and a large patient pool benefiting from pembrolizumab's applications in oncology. Favorable reimbursement policies in the U.S. further support market growth[1].

Europe

Europe follows closely, with robust regulatory frameworks and increasing investments in cancer immunotherapy driving the adoption of pembrolizumab across multiple countries. Countries like Germany, France, and the UK are notable for their contributions[1].

Asia-Pacific

The Asia-Pacific region holds immense potential for growth, fueled by rising cancer incidences and improving healthcare systems that prioritize innovative treatments. Countries like Japan, China, and India are witnessing a surge in pembrolizumab utilization due to increased clinical trial activity and government initiatives[1].

Middle East and Africa

While currently smaller in scale, the Middle East and Africa are gradually emerging with potential due to increasing cancer prevalence and developing healthcare infrastructures. Investments in health systems and improving patient access to cutting-edge treatments can lead to further market growth in this region[1].

Financial Considerations

Cost and Pricing

The cost of pembrolizumab can vary significantly. Yearly cumulative cost-based prices range from €52 to €885 per vial, with prices higher in initial years or for specific indications and decreasing over time as more indications are approved[2].

Cost-Effectiveness Analysis

Economic analyses have shown that pembrolizumab, when compared to other treatments like ipilimumab, dabrafenib, and vemurafenib, has varying cost-effectiveness ratios. For instance, the incremental cost-effectiveness ratio of pembrolizumab compared to ipilimumab can range from $28,749 per life year gained (LYG) to $52,829 per quality-adjusted life year (QALY)[5].

Reimbursement and Insurance

In the U.S., the financial burden of Keytruda is alleviated for Medicare beneficiaries, as Medicare Part B covers a substantial 80% of outpatient treatment costs. This robust Medicare coverage, along with various assistance programs, supports the market's growth[3].

Market Trends

Rising Adoption of Immunotherapy

The increasing adoption of immunotherapy in cancer treatment is a significant trend driving the growth of the pembrolizumab market. As more patients and healthcare providers recognize the benefits of immunotherapy, the demand for pembrolizumab is expected to rise[3].

Technological Advancements

Technological advancements in treatment therapies and the specificity and effectiveness of cancer immunotherapy are contributing factors to the market's growth. These advancements include better diagnostic tools and more targeted treatment approaches[4].

New Product Launches

The market is also expected to flourish with new product launches and expanded indications for pembrolizumab. These new launches can further enhance the drug's marketability and patient reach[4].

Challenges and Limitations

Side Effects

Despite its efficacy, pembrolizumab is associated with several side effects, such as musculoskeletal pain, fever, cough, and difficulty in breathing. These side effects can hamper the growth of the market[4].

High Costs

The high cost of pembrolizumab is a significant barrier to access. The estimated annual patient cost can exceed USD 150,000, which raises concerns about affordability and accessibility, especially in regions with limited healthcare resources[3].

Conclusion

Pembrolizumab is a cornerstone in modern cancer immunotherapy, with a market that is expected to grow substantially in the coming years. Driven by factors such as combination therapies, increased investment in oncology, patient awareness, and expansion into emerging markets, the pembrolizumab market is poised for significant expansion.

Key Takeaways

• The pembrolizumab market is projected to reach USD 32.5 billion by 2031, growing at a CAGR of 6.5% from 2024 to 2031.
• Combination therapies and increased investment in oncology are key drivers of market growth.
• Patient awareness and advocacy, along with favorable health insurance coverage, play crucial roles in market expansion.
• The Asia-Pacific region holds immense potential for growth due to rising cancer incidences and improving healthcare systems.
• High costs and side effects are significant challenges that need to be addressed.

FAQs

Q: What is pembrolizumab, and how does it work?

Pembrolizumab, marketed as Keytruda, is an immune checkpoint inhibitor that targets the PD-1 receptor, enabling the body's immune system to identify and eliminate cancer cells.

Q: What are the primary drivers of the pembrolizumab market growth?

The primary drivers include combination therapies, increased investment in oncology, patient awareness and advocacy, health insurance coverage, and expansion into emerging markets.

Q: How is the pembrolizumab market segmented geographically?

The market is segmented into North America, Europe, Asia-Pacific, and the Middle East and Africa, with North America and Europe being the leading regions due to their developed healthcare infrastructures.

Q: What are the financial considerations for pembrolizumab?

The cost of pembrolizumab can range from €52 to €885 per vial, with significant variations based on indications and regions. Reimbursement policies, especially in the U.S., play a crucial role in making the treatment accessible.

Q: What are the challenges associated with pembrolizumab?

The high cost of the drug and associated side effects such as musculoskeletal pain, fever, and difficulty in breathing are significant challenges that need to be addressed.

Sources

1. Verified Market Research - Pembrolizumab Market Size, Scope, Growth, Trends And Forecast.
2. PLOS ONE - A case study for pembrolizumab and daratumumab.
3. Mordor Intelligence - Keytruda Market Size & Share Analysis - Growth Trends.
4. Allied Market Research - Pembrolizumab Market Size and Industry Growth By 2030.
5. Pan-Canadian Oncology Drug Review - Final Economic Guidance Report - Pembrolizumab (Keytruda) for Metastatic Melanoma.