The leading Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market report puts across the idea of high level analysis of major market segments and identification of opportunities. Market analysis and market segmentation has been carried out in terms of markets, geographic scope, years considered for the study, currency and pricing, research methodology, primary interviews with key opinion leaders, DBMR market position grid, DBMR market challenge matrix, secondary sources, and assumptions. This market document accomplishes comprehensive analysis of profiles of key market players that provides a competitive landscape. The persuasive Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market report displays important product developments and tracks recent acquisitions, mergers and research in the HEALTHCARE industry by the key players.
The global 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 global exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market in the forecast period.
Increasing healthcare expenditure on advancement and development is expected to give opportunities to the market. However, the high cost associated with EPI diagnosis and treatment may challenge the market growth.
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Data Bridge Market Research analyzes that the global exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is expected to reach a value of USD 13,385.56 million by 2030, at a CAGR of 7.2% during the forecast period.
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
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.
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
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.
Some of the major players operating in the global 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.
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Recent Developments
The global exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is categorized into five notable segments such as diagnosis, treatment, drug type, end user, and distribution channel. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.
Diagnosis
On the basis of diagnosis, the global exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is segmented into imaging test and pancreatic function test.
Treatment
On the basis of treatment, the global exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is segmented into nutritional management and pancreatic enzyme replacement therapy (PERT).
Drug Type
On the basis of drug type, the global exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is segmented into generic and branded.
End User
On the basis of end user, the global 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
On the basis of distribution channel, the global exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is segmented into direct tender, retail pharmacy, third party distributor, and others.
The report provides insights on the following pointers:
Critical Insights Related to This Market Included in the Report:
TOC:
1 INTRODUCTION
1.1 OBJECTIVES OF THE STUDY
1.2 MARKET DEFINITION
1.3 OVERVIEW OF GLOBAL EXOCRINE PANCREATIC INSUFFICIENCY (EPI) THERAPEUTICS AND DIAGNOSTICS MARKET
1.4 LIMITATIONS
1.5 MARKETS COVERED
2 MARKET SEGMENTATION
2.1 MARKETS COVERED
2.2 GEOGRAPHICAL SCOPE
2.3 YEARS CONSIDERED FOR THE STUDY
2.4 CURRENCY AND PRICING
2.5 DBMR TRIPOD DATA VALIDATION MODEL
2.6 MULTIVARIATE MODELLING
2.7 PRODUCT TYPE LIFELINE CURVE
2.8 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS
2.9 DBMR MARKET POSITION GRID
2.1 MARKET TESTING TYPE COVERAGE GRID
2.11 VENDOR SHARE ANALYSIS
2.12 SECONDARY SOURCES
2.13 ASSUMPTIONS
3 EXECUTIVE SUMMARY
4 PREMIUM INSIGHTS
4.1 PESTEL ANALYSIS
4.2 PORTER ANALYSIS
5 INDUSTRY INSIGHTS
6 REGULATORY FRAMEWORK
7 MARKET OVERVIEW
7.1 DRIVERS
7.1.1 INCREASING PREVALENCE OF EXOCRINE PANCREATIC INSUFFICIENCY (EPI) DUE TO CHRONIC PANCREATITIS AND CYSTIC FIBROSIS
7.1.2 RISING TECHNOLOGICAL ADVANCEMENTS IN DIAGNOSIS AND TREATMENT OF EPI
7.1.3 STRATEGIC INITIATIVES BY THE KEY MARKET PLAYERS
7.1.4 SEDENTARY LIFESTYLES AND UNHEALTHY DIETS
7.2 RESTRAINTS
7.2.1 STRINGENT REGULATIONS TO HAMPER THE EXOCRINE PANCREATIC INSUFFICIENCY(EPI) THERAPEUTIC AND DIAGNOSTIC SECTOR
7.2.2 SIDE EFFECTS AND RELIGIOUS HURDLES ASSOCIATED WITH PANCREATIC ENZYME REPLACEMENT THERAPY (PERT)
7.3 OPPORTUNITIES
7.3.1 INCREASING PREVALENCE OF PANCREATIC DISORDERS AND ASSOCIATED CONDITION
7.3.2 RISING AWARENESS ABOUT THE BENEFITS OF EARLY DIAGNOSIS AND TREATMENT OF EPI
7.3.3 GROWING DEMAND FOR COMBINATION THERAPIES AND PERSONALIZED MEDICINE
7.4 CHALLENGES
7.4.1 HIGH COST ASSOCIATED WITH EPI DIAGNOSIS AND TREATMENT
7.4.2 LIMITED AVAILABILITY OF EPI THERAPEUTICS AND DIAGNOSTICS
8 GLOBAL EXOCRINE PANCREATIC INSUFFICIENCY (EPI) THERAPEUTICS AND DIAGNOSTICS MARKET, BY TREATMENT
Continued…
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