North America Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market – Industry Trends and Forecast to 2030

North America Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market, By Diagnosis (Imaging Tests and Pancreatic Function Test), Treatment  (Nutritional Management, Pancreatic Enzyme Replacement Therapy (PERT), Drug Type (Generic and Branded), End User (Hospitals, Specialty Clinics, Homecare,  Diagnostic Centers, Research and Academic Institute, and Others), Distribution Channel (Direct Tender, Retail Pharmacy, Third Party Distributors, and Others) - Industry Trends and Forecast to 2030.

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

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.

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.

Market Definition

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. 

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

This section deals with understanding the market drivers, opportunities, restraints, and challenges. All of this is discussed in detail below:     

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.

Opportunity

• Increasing prevalence of pancreatic disorders and associated condition

EPI is a prominent side effect of pancreatic diseases like cancer, cystic fibrosis, and chronic pancreatitis. These ailments can harm the pancreas, impairing its capacity to generate digestive enzymes and result in EPI. The rising prevalence of pancreatic diseases and related ailments worldwide is driving the demand for EPI therapies and diagnostics. These conditions can cause damage to the pancreas, leading to a reduced ability to produce digestive enzymes, which can result in EPI. Cystic fibrosis's damage to the pancreas makes it another disorder that can result in EPI. The genetic disease known as cystic fibrosis impacts the reproductive, digestive, and respiratory systems. Cystic fibrosis is more common in Caucasians, particularly those with a Northern European ancestry, than worldwide. As the incidence of these conditions continues to increase, the demand for EPI therapeutics and diagnostics is also expected to grow. This presents a significant opportunity for pharmaceutical companies and manufacturers to develop new and effective treatments and diagnostic tests for EPI.

Thus, the increasing prevalence of pancreatic disorders and associated conditions is expected to act as an opportunity for market growth.

Challenge

• High cost associated with EPI diagnosis and treatment

The complexity of the illness and the requirement for specialized tests make the diagnosis of EPI expensive. Faecal elastase testing, secretin-stimulated pancreatic function testing, and imaging tests like magnetic resonance imaging (MRI) and endoscopic ultrasonography (EUS) are the most frequently used diagnostic procedures for EPI. These tests can be pricey, and not all medical professionals can access the tools and training needed to carry them out.  The high expense of identifying EPI can also delay a diagnosis, which can exacerbate symptoms and raise healthcare costs over time. Untreated EPI can cause continuing digestive problems, nutrient malabsorption, and weight loss in patients, all of which can increase medical expenses and difficulties.

Thus, the high cost associated with EPI diagnosis and treatment is expected to act as a challenge in the market growth.

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.

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

The North America 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

• 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

On the basis of distribution channel, the North America exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market is segmented into direct tender, retail pharmacy, third party distributor, and others.

North America Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market Regional Analysis/Insights

The North America 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 countries covered in this market report are the U.S., Canada, and Mexico.

The U.S. is dominating due to the presence of key market players in the largest consumer market with high GDP.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impact the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts, and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, the presence and availability of North America brands and their challenges faced due to large or scarce competition from local and domestic brands, and impact of sales channels are considered while providing forecast analysis of the country data.

Competitive Landscape and North America Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market Share Analysis

The North America exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in R&D, new market initiatives, production sites and facilities, company strengths and weaknesses, product launch, product approvals, product width and breath, application dominance, and product type lifeline curve. The above data points provided are only related to the company’s focus on the North America nurse call systems market.

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.