North America Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market Size to Reach USD 6,797.66 Million by 2030
A wide ranging 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. Depending on client’s requirements, massive business, product and market related information is brought together via this report that eventually helps businesses create better strategies. The report has across-the-board and comprehensive market insights which are based on business intelligence. No stone is left unturned while researching and analysing data to prepare market research report like this one and the others. The persuasive North America Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market report helps unearth the general market conditions, existing trends and tendencies.
The increasing awareness of advanced diagnostic technology North America has enhanced the demand for the market. The rising healthcare expenditure for better health services also contributes to the market’s growth. The major market players focus on various service launches and approvals during this crucial period. In addition, the increase in improved advancement of processes and techniques also contributes to the rising demand for exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics.
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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.
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.
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.
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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- Identify Key Business Segments, Market proposition & Gap Analysis
- Assisting in allocating marketing investments
Table of Contents:
- Introduction
- Market Segmentation
- Executive Summary
- Premium Insights
- Market Regulations
- Market Overview
Continued…
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Key Benefits of the Report:
- This study presents the analytical depiction of this industry along with the current trends and future estimations to determine the imminent investment pockets.
- The report presents information related to key drivers, restraints, and opportunities along with a detailed analysis of this market share.
- The current market is quantitatively analyzed to highlight the market growth scenario.
- Porter’s five forces analysis illustrates the potency of buyers & suppliers in the market.
- The report provides a detailed this industry analysis based on competitive intensity and how the competition will take shape in the coming years.
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