North America Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market Share, Trends, Key Drivers, Demand, Opportunities and Competitive Outlook

North America Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market research report is useful in collecting information on consumers from structured distribution research and helps in making marketing customer oriented. By using promotional research to study media mix, advertising effectiveness, and integrated communication tools the report has been generated. Such market insights help in promoting effectively a company’s product in the market. North America Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market research report involves major parameters namely market analysis, market definition, market segmention, key developments in the market, competitive analysis, and research methodology.

Data Bridge Market Research analyzes that the North America exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is expected to reach the value of USD 6,797.66 million by 2030, at a CAGR of 7.3% during the forecast period.

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The North America exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is expected to grow in the forecast year due to the rise in market players and the availability of advanced services. Along with this, manufacturers are engaged in the developmental activity for launching novel services in the market. The increasing development in advanced healthcare techniques is further boosting the market growth. However, difficulties such as the stringent regulations to hamper the exocrine pancreatic insufficiency (EPI) therapeutic and diagnostic sector, the side effects and religious hurdles associated with pancreatic enzyme replacement therapy (PERT) might hamper the growth of the North America exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market in the forecast period.

Market report helps to comprehend the demands of customers, detect more business opportunities, plan the perfect marketing campaign, minimize losses, and keep track of the competition. North America Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market report allows organizations to classify their objectives while following the current trends and take advantage by reaching out to their target audience.

Fundamental Aim of this Market Report

• Factors influencing This Market Size and growth rate.
• Major alterations to this market in the near future.
• Notable Market rivals around the world.
• Future Scope and Product Outlook
• Future-promising emerging markets.
• The Market Presents Difficult Challenges and Threats.

Market Overview:

Exocrine pancreatic insufficiency (EPI) is a medical condition where the pancreas fails to produce enough digestive enzymes to digest fats, proteins, and carbohydrates in the intestine. EPI can be caused by various conditions, such as chronic pancreatitis, cystic fibrosis, and pancreatic cancer. Therapeutics for EPI involve using pancreatic enzyme replacement therapy (PERT), which provides the necessary digestive enzymes that the pancreas is not producing. PERT is usually taken with meals and snacks to help break down food and absorb nutrients properly; several PERT products are available, such as pancrelipase, pancreatin, and lipase.

Diagnostics for EPI may involve blood tests to measure the levels of digestive enzymes in the blood, fecal elastase test to check the level of pancreatic elastase in the stool, and imaging tests, such as CT scans, MRI, or endoscopic ultrasound to visualize the pancreas and detect any abnormalities. Additionally, breath tests can measure the levels of hydrogen and methane in the breath, indicating EPI.

Drivers

• Increasing prevalence of exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis and cystic fibrosis

Exocrine pancreatic insufficiency (EPI) is a condition caused when the pancreas fails to make sufficient amounts of digestive enzymes to help digestion and absorption of nutrients. Chronic pancreatitis is the main cause of EPI in adults. Pancreatitis causes inflammation and swelling of the pancreas. Over time, it can damage the pancreatic cells that make digestive enzymes. Similarly, cystic fibrosis is one of the main causes of EPI in children. It is inherited from parents and causes thick mucus to build up in the lungs, creating difficulty breathing. Mucus also accumulates in the pancreas and prevents digestive enzymes from reaching the small intestine. People with EPI can’t absorb enough fats, proteins, and carbohydrates from foods which is called malabsorption.

Therefore, the increasing prevalence of EPI due to chronic pancreatitis and cystic fibrosis is driving the growth of the market in the forecast period.

•   Rising technological advancements in the diagnosis and treatment of EPI

There is a lack of consensus regarding the best diagnostic approach, and experts have noted the non-reliability and non-specificity of available diagnostic tests. Available diagnostic tests for EPI include fecal fat quantification, the fecal elastase-1 test, and the C-mixed triglyceride breath test. Developing a machine learning model that identifies patients in a commercial medical claims database who likely have EPI but are undiagnosed is one of the recent objectives to advance the diagnosis and treatment framework of EPI.

Therefore, the rising technological advancements in the diagnosis and treatment of EPI is driving the market’s growth in the forecast period.

Restraint

• Stringent regulations to hamper the exocrine pancreatic insufficiency (EPI) therapeutic and diagnostic sector

The use of therapies and medications for EPI disorders across the globe is rapidly increasing, with the growth of the aged population and several chronic diseases which are preventable by early diagnosis. At the same time, the players of the EPI disorders products manufacturers in the market must follow certain regulations to get approval from the upper authorities for launching the product in the market. These stringent guidelines need to be followed and this is one of the most difficult tasks of all the steps. The U.S. Food and Drug Administration (FDA) regulates the U.S. and the European Union (EU) regulates Europe. However, the rapid development of privacy policies and regulations is being made in the Asia-Pacific and EMEA, including India, Russia, China, South Korea, Singapore, Hong Kong, and Australia. Some drug regulatory agencies, including the U.S. Food and Drug Administration (FDA), have instructed that manufacturers obtain regulatory approvals before marketing their products because of possible adverse effects and inadequate effectiveness. These stringent FDA regulations have made approval of pancrelipase products difficult.

Hence, from the above instances, concluded that stringent regulations may restrain the growth of the exocrine therapeutic insufficiency therapeutics and diagnostics market in the forecast period.

Recent Developments

• In August 2021, AzurRx announced that it had engaged in the development of yeast-derived lipase, MS1819, which has been engineered to have superior enzymatic activity as compared to current treatments.
• In February 2023, Codexis, Inc. and Nestlé Health Science announced the interim findings from a Phase 1 trial examining the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of CDX-7108. A lipase variation called CDX-7108 was created expressly to get around the drawbacks of the current pancreatic enzyme replacement treatment (PERT). This has aided the business in marketing the product.

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Some of the major players operating in the North America exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market are EagleBio, AbbVie. Nordmark Arzneimittel GmbH & Co., Digestive Care, Inc., Cilian AG, Alcresta Therapeutics, Inc., ChiRhoClin, Abbott, Bioserv Diagnostics, Laboratory Corporation of America, Organon group of companies Metagenics LLC, Janssen, Nestlé., VIVUS LLC., and ScheBo Biotech AG, among others.

North America Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market Scope

Diagnosis

• Imaging Tests
• Pancreatic Function Test

On the basis of diagnosis, the North America exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is segmented into imaging test and pancreatic function test.

Treatment

• Nutritional Management
• Pancreatic Enzyme Replacement Therapy (PERT)

On the basis of treatment, the North America exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is segmented into nutritional management and pancreatic enzyme replacement therapy (PERT).

Drug Type

• Generic
• Branded

On the basis of drug type, the North America exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is segmented into generic and branded.

End User

• Hospitals
• Specialty Clinics
• Homecare
• Diagnostic Centre
• Research and Academic Institutes
• Others

On the basis of end user, the North America exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is segmented into Hospitals, Specialty Clinics, Homecare, Diagnostic Centers, Research and Academic Institute, and others.

Distribution Channel

• Direct Tender
• Retail Pharmacy
• Third-Party Distributor
• Others

Key highlights of this Market report:

• Growth rate
• Remuneration prediction
• Consumption graph
• Market concentration ratio
• Secondary industry competitors
• Competitive structure
• Major restraints
• Market drivers
• Regional bifurcation
• Competitive hierarchy
• Current market tendencies
• Market concentration analysis

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• Latest industry influencing trends and development scenario
• Open up New Markets
• To Seize powerful market opportunities
• Key decision in planning and to further expand market share
• Identify Key Business Segments, Market proposition & Gap Analysis
• Assisting in allocating marketing investments

Table of Contents:

1. Introduction
2. Market Segmentation
3. Executive Summary
4. Premium Insights
5. Market Regulations
6. Market Overview

Continued…

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