Pancrelipase - Biologic Drug Details

Summary for pancrelipase

Tradenames:	6
High Confidence Patents:	14
Applicants:	6
BLAs:	6
Suppliers: see list	5
Recent Clinical Trials:	See clinical trials for pancrelipase

Recent Clinical Trials for pancrelipase

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Memorial Sloan Kettering Cancer Center	Phase 1/Phase 2
Andrew Hendifar, MD	Phase 2
VIVUS, Inc.	Phase 2

See all pancrelipase 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 pancrelipase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,260,074	2040-03-30	Company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,302,400	2040-03-30	Company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,324,514	2012-06-22	Company disclosures

3) Low Certainty: US Patents for pancrelipase 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
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	COTAZYM	pancrelipase	Capsule, Delayed Release	020580	10,029,015	2024-07-05	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	COTAZYM	pancrelipase	Capsule, Delayed Release	020580	10,040,783	2031-06-20	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	COTAZYM	pancrelipase	Capsule, Delayed Release	020580	10,087,493	2040-03-30	Patent claims search

International Patents for pancrelipase

Country	Patent Number	Estimated Expiration
Australia	4132993
China	101686943
Chile	2008000517

Pancrelipase Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pancrelipase

Introduction to Pancrelipase

Pancrelipase is a prescription medication used to treat individuals who cannot digest food normally due to a deficiency in pancreatic enzymes. It is commonly used for conditions such as chronic pancreatitis, cystic fibrosis, and pancreatic cancer. Here, we delve into the market dynamics and financial trajectory of pancrelipase.

Market Size and Growth

The global pancrelipase market is projected to experience significant growth over the next decade. By 2030, the market is expected to reach approximately $2.6 billion, growing at a Compound Annual Growth Rate (CAGR) of 4.7% during the forecast period[1][3].

Historical Context

In 2021, the global pancrelipase market was valued at around $1.8 billion. This figure is anticipated to rise to $2.7 billion by 2031, with a CAGR of 4.3% from 2022 to 2031[3].

Drivers of Growth

Increasing Incidence of Chronic Conditions

The rise in the incidence of chronic pancreatitis, cystic fibrosis, and pancreatic cancer is a major driver of the pancrelipase market. These conditions necessitate the use of pancreatic enzyme replacement therapy, thereby increasing the demand for pancrelipase[3].

Growing Awareness and Emphasis on Digestive Health

There is a growing awareness and emphasis on managing digestive health, which contributes to the increased demand for pancrelipase. This awareness among both patients and healthcare providers drives the market forward[1].

Technological and Collaborative Advancements

Collaborations between pharmaceutical companies, research institutions, and healthcare organizations are fostering innovation in the development and distribution of pancrelipase. This is particularly evident in the Asia Pacific region, which is expected to acquire a significant share of the market by 2030[1].

Market Segmentation

By Application

• Chronic Pancreatitis: This segment accounted for the highest share in 2021 and is expected to continue dominating the market with the fastest CAGR of 4.6% during the forecast period. The high prevalence of chronic pancreatitis among individuals, particularly due to increased alcohol consumption, drives this segment's growth[3].
• Cystic Fibrosis: Patients with cystic fibrosis also require pancrelipase, and this segment has unique needs that are addressed through specialized support programs like CFCareForward[2].
• Other Conditions: This includes pancreatic cancer and other digestive disorders that require pancreatic enzyme replacement therapy.

By Age

• Adults and Geriatrics: This segment held the major share in 2021, accounting for around four-fifths of the global pancrelipase market revenue. The high incidence of pancreatic cancer and digestive disorders among adults and the geriatric population propels the growth of this segment[3].
• Children: While this segment is smaller, it is still significant due to the need for pancreatic enzyme replacement therapy in children with conditions like cystic fibrosis.

By Distribution Channel

• Drug Store and Retail Pharmacies: This segment held the highest share in 2021, accounting for more than three-fifths of the global pancrelipase market revenue. The convenience and accessibility of these channels contribute to their dominance[3].
• Online Pharmacies: This segment is expected to grow at the fastest CAGR of 6.0% from 2022 to 2031 due to the high convenience and cost-effectiveness of purchasing prescription drugs online[3].

Regional Outlook

North America

North America holds a significant share of the pancrelipase market, driven by the high prevalence of chronic pancreatitis and cystic fibrosis in this region[3].

Europe

Europe dominated the market in 2022 with a 43% share, driven by the increased prevalence of pancreatitis and changing lifestyles in this region[4].

Asia Pacific

The Asia Pacific region is expected to witness significant growth at a CAGR of 4.1% during the forecast period, driven by the increasing population and indigestion problems due to unhealthy diets[4].

Financial Assistance and Patient Support

CREON Support Programs

• CREON Complete: This program is designed for patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis, pancreatectomy, or other conditions. It offers financial assistance, tools to track symptoms, and multivitamins at no cost[2].
• CFCareForward: This program is specifically for patients with EPI due to cystic fibrosis. It provides potential savings on medication, nutritional supplements, and educational materials[2].

Cost Savings

Eligible patients can pay as little as $5 or $0 for a 30- or 90-day prescription through the CREON Support programs. These programs also offer co-pay assistance, multivitamins, and other resources to make the medication more affordable[2][5].

Challenges and Limitations

Production Costs

The employment of expensive and specialized equipment, technologies, and numerous clinical trials contributes to high production costs, which can impede market growth to some extent[3].

COVID-19 Impact

The COVID-19 pandemic had a negative impact on the pancrelipase market as patients managed their conditions through self-medication or non-medically approved strategies. However, the market has been recovering as global situations returned to normalcy[3].

Future Outlook

The pancrelipase market is poised for significant growth driven by increasing awareness of digestive health, rising incidence of chronic conditions, and advancements in technology and distribution. The Asia Pacific region is expected to play a crucial role in this growth, along with the expanding online pharmacy segment.

Key Takeaways

• The global pancrelipase market is projected to reach $2.6 billion by 2030, growing at a CAGR of 4.7%.
• The market is driven by the increasing incidence of chronic pancreatitis, cystic fibrosis, and pancreatic cancer.
• The adults and geriatrics segment dominates the market due to high incidence rates of digestive disorders.
• Drug store and retail pharmacies are the primary distribution channels, but online pharmacies are growing rapidly.
• Financial assistance programs like CREON Complete and CFCareForward make the medication more affordable for patients.

FAQs

What is the projected market size of the pancrelipase market by 2030?

The global pancrelipase market is expected to reach approximately $2.6 billion by 2030[1].

What are the main drivers of the pancrelipase market?

The main drivers include the increasing incidence of chronic pancreatitis, cystic fibrosis, and pancreatic cancer, along with growing awareness and emphasis on digestive health[1][3].

Which segment dominates the pancrelipase market by application?

The chronic pancreatitis segment dominates the market and is expected to continue growing with the fastest CAGR during the forecast period[3].

How do patient support programs like CREON Complete and CFCareForward help patients?

These programs offer financial assistance, tools to track symptoms, multivitamins at no cost, and other resources to make the medication more affordable and manageable for patients[2].

What was the impact of the COVID-19 pandemic on the pancrelipase market?

The pandemic had a negative impact as patients managed their conditions through self-medication or non-medically approved strategies, but the market has been recovering as global situations returned to normalcy[3].

Which region is expected to witness significant growth in the pancrelipase market?

The Asia Pacific region is expected to witness significant growth at a CAGR of 4.1% during the forecast period[4].

Sources

1. KBV Research: Global Pancrelipase Market Size, Share & Industry Growth to 2030.
2. CREON Patient Support: Patient Support - CREON® (pancrelipase).
3. PR Newswire: Pancrelipase Market to Reach USD 2.7 Billion, Globally, by 2031 at 4.3% CAGR: Allied Market Research.
4. Maximize Market Research: Pancrelipase Market: Global Industry Analysis and Forecast (2023 - 2029).
5. CREON Patient Support: Save on CREON.