Pancrelipase - Biologic Drug Details

Summary for pancrelipase

Tradenames:	6
High Confidence Patents:	14
Applicants:	6
BLAs:	6
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for pancrelipase

Recent Clinical Trials for pancrelipase

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Philipp Schuetz	NA
University of Southern California	PHASE4
New York University	PHASE4

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. 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 pancrelipase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pancrelipase 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
Abbvie Inc.	CREON	pancrelipase	Capsule, Delayed Release	020725	9,198,871	2026-08-15	DrugPatentWatch analysis and company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,260,074	2012-06-22	DrugPatentWatch analysis and company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,302,400	2012-06-22	DrugPatentWatch analysis and 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	2035-05-08	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	COTAZYM	pancrelipase	Capsule, Delayed Release	020580	10,040,783	2036-11-30	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	COTAZYM	pancrelipase	Capsule, Delayed Release	020580	10,087,493	2029-03-09	Patent claims search

International Patents for pancrelipase

Country	Patent Number	Estimated Expiration
Australia	2017213506
New Zealand	598477
World Intellectual Property Organization (WIPO)	2004091576

Supplementary Protection Certificates for pancrelipase

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2025C/515	Belgium		PRODUCT NAME: ACORAMIDIS EN/OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, MET NAME ACORAMIDISHYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/24/1906 20250211
LUC50002	Luxembourg		PRODUCT NAME: ACORAMIDIS, ET/OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE CHLORHYDRATE D'ACORAMIDIS; AUTHORISATION NUMBER AND DATE: EU/1/24/1906 20250210
122025000014	Germany		PRODUCT NAME: ACORAMIDIS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ACORAMIDISHYDROCHLORID; REGISTRATION NO/DATE: EU/1/24/1906 20250210

Market Dynamics and Financial Trajectory for the Biologic Drug: Pancrelipase

Last updated: July 27, 2025

Introduction

Pancrelipase, a biologic enzyme replacement therapy, is a critical treatment for conditions impairing pancreatic function, such as cystic fibrosis, chronic pancreatitis, and other exocrine pancreatic insufficiencies (EPI). Market dynamics surrounding pancrelipase are influenced by factors spanning clinical demand, technological advancements, regulatory landscape, and competitive developments. Its financial trajectory reflects evolving healthcare needs, innovation in formulations, and strategic market positioning across geographies.

Market Overview

The global pancrelipase market is positioned at a pivotal intersection of growth driven by rising prevalence of pancreatic diseases and expanding awareness. The increasing incidence of cystic fibrosis (CF)—affecting approximately 1 in 3,000 newborns in the U.S. and Europe—fuels demand for enzyme replacement therapies (ERTs). Chronic pancreatitis, characterized by progressive destruction of pancreatic tissue, similarly elevates EPI incidence, especially among middle-aged adults and alcohol consumers.

According to Research and Markets, the pancrelipase market was valued at approximately USD 500 million in 2022, with projections reaching USD 1.2 billion by 2030, reflecting a compound annual growth rate (CAGR) of approximately 11.5% [1].

Drivers of Market Growth

Rising Disease Prevalence

The escalating prevalence of cystic fibrosis remains the principal driver for pancrelipase demand. With CF patients surviving longer due to advances in multidisciplinary care, OEPI-related complications increase, necessitating ongoing enzyme therapy. Similarly, the rising burden of chronic pancreatitis, driven by lifestyle factors and aging populations, propels broader market adoption.

Innovations in Formulation and Delivery

Advancements in pancrelipase formulations—such as microencapsulation, delayed-release capsules, and improved pH-dependent coatings—enhance efficacy and patient compliance. Companies investing in such innovations, including AbbVie, Sanofi, andClinical-stage startups, position themselves for higher market shares.

Regulatory Approvals and Reimbursement Policies

Stringent regulatory pathways, exemplified by approval of new formulations by agencies including the FDA, facilitate market entrant differentiation and access. Reimbursement frameworks, especially in North America and Europe, further propel market growth by reducing out-of-pocket expenses for patients.

Unmet Medical Needs and Expanding Indications

Emerging research highlights potential applications for pancrelipase beyond traditional indications, including pancreatic cancer-associated malabsorption and post-surgical enzyme replacement, broadening the therapeutic landscape.

Competitive Landscape

Major pharmaceutical firms dominate the pancrelipase market, with key players including:

• AbbVie: Market leader with products like Creon, leveraging extensive clinical data and distribution channels.
• Sanofi: Offering Lialda and other enzyme-based therapies targeting similar indications.
• Ipsen: Focused on niche indications and innovative formulations.
• Emerging biotech startups: Engaged in developing next-generation enzyme therapies with improved bioavailability and fewer side effects.

Patent protections, such as formulation patents and manufacturing processes, play a vital role in maintaining competitive advantages. Patent expirations forecasted within the next 3-5 years threaten market share stability and prompt R&D investment.

Regulatory and Pricing Influences

The regulatory environment generally favors approval of high-quality, bioequivalent pancrelipase products. However, pricing negotiations heavily influence revenue streams. In the U.S., notable initiatives like the Inflation Reduction Act push for drug price transparency, impacting margins for branded formulations. Elsewhere, national health agencies' formulary decisions directly impact access and sales volume.

Financial Trajectory

Revenue Trends

Revenue for pancrelipase products has shown consistent growth, driven by expanding indications and increased diagnosis rates. In 2022, leading brands generated combined revenues exceeding USD 600 million globally. Projected CAGR of about 11.5% suggests a doubling of sales by 2030. Digital health integration, such as adherence monitoring, adds value and opens new revenue avenues.

Investment and R&D

Major players are investing significantly into R&D to develop enhanced formulations, including enzyme stability improvements, reduced pill burden, and dual-action therapies addressing multiple digestive functions. Regulatory approval of these innovations promises future revenue growth.

Market Penetration and Geographic Expansion

North America remains the largest market, accounting for approximately 60% of sales, driven by high disease prevalence and reimbursement infrastructure. Europe's mature healthcare systems and increasing diagnosis rates support steady growth. Emerging markets—such as Asia-Pacific—are witnessing rapid expansion owing to increasing healthcare expenditure, urbanization, and awareness campaigns, representing considerable growth opportunities.

Challenges and Opportunities

Generic Competition and Patent Cliff

The imminent patent expiration of blockbuster formulations poses risks of biosimilar entry, potentially leading to price erosion. Companies are responding by fast-tracking next-generation formulations with technological advantages.

Supply Chain and Manufacturing Constraints

Ensuring high-quality, scalable manufacturing processes for complex biologics remains challenging. Disruptions could impact availability and revenue stability.

Personalized Medicine and Biomarker-driven Approaches

Future growth may stem from personalized enzyme therapies tailored to individual patient needs, optimizing efficacy and minimizing side effects.

Conclusion

The pancrelipase market is poised for sustained growth, anchored by rising disease prevalence and technological innovation. Strategic investments in formulation development, market expansion, and navigating regulatory pathways are essential to capitalize on this trajectory. While patent expirations and competitive pressures loom, innovation and differentiation will be pivotal in maintaining market share and revenue streams.

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Key Takeaways

• The global pancrelipase market is projected to grow at a CAGR of approximately 11.5% through 2030, driven by increasing diagnoses of pancreatic disorders.
• Innovation in drug formulations and expanding indications contribute significantly to market expansion.
• Major pharmaceutical players dominate, with patent protections safeguarding current revenues; patent expiries will necessitate innovation and pipeline differentiation.
• Geographic expansion into emerging markets offers substantial growth opportunities, fueled by rising healthcare investments.
• Pricing strategies, regulatory frameworks, and supply chain robustness critically influence financial performance.

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FAQs

1. How are new formulations impacting the pancrelipase market?
Innovative formulations, such as delayed-release capsules and microencapsulation, improve drug efficacy and patient adherence, fostering competitive advantages and driving revenue growth.

2. What are the primary challenges facing pancrelipase manufacturers?
Patent expirations, biosimilar competition, manufacturing complexities, and evolving pricing regulations pose substantial challenges requiring continuous innovation and strategic planning.

3. How does the prevalence of cystic fibrosis influence market dynamics?
Cystic fibrosis’s increasing prevalence and improved survival rates directly raise demand for enzyme replacement, underpinning sustained market growth.

4. What role do regulatory agencies play in shaping market prospects?
Regulatory approvals facilitate market entry and product differentiation, while reimbursement policies determine access and revenue potential across regions.

5. What are the future opportunities for growth beyond traditional indications?
Expanding into indications such as pancreatic cancer-related malabsorption and post-surgical enzyme therapy, coupled with personalized medicine approaches, represent promising avenues.

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References:
[1] Research and Markets. “Global Pancrelipase Market Forecast, 2022-2030.”