In January 2023, as per the NCBI article pancreatic insufficiency, about 85% of cystic fibrosis patients have EPI, usually acquired soon after birth. EPI is prevalent in about 60% to 90% of patients diagnosed with chronic pancreatitis within 10 to 12 years of diagnosis. Chronic pancreatitis occurs in about 42 to 73 per 100,000 of the population in the United States. It is considered the most common pancreatic disorder associated with pancreatic insufficiency, and this could be compared to 36 to 125 per 100,000 of the population in Japan, China, and India.
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Data Bridge Market Research analyzes that the Global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market is expected to grow at a CAGR of 7.2% in the forecast period of 2023 to 2030 and is expected to reach USD 13,385.56 million by 2030. The pancreatic replacement therapy (PERT) segment is projected to propel the market growth as they are widely used for the diagnosis of pancreatic disorders in various regions and more due to the availability of more advanced technologies. Especially these therapies have a broad range of applications for research and clinical purposes among others.
Key Findings of the Study
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 in breathing. Mucus also accumulates in the pancreas, preventing digestive enzymes from reaching the small intestine. People with EPI can’t absorb enough fats, proteins, and carbohydrates from foods which is called malabsorption.
According to various research studies, chronic pancreatitis and cystic fibrosis are the top causes of EPI in many people worldwide. The rising cases of exocrine pancreatic insufficiency have propelled the use of various EPI therapeutics and diagnostics among the population, thereby driving the market growth.
Report Scope and Market Segmentation
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Report Metric
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Details
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Forecast Period
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2023 to 2030
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Base Year
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2022
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Historic Years
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2021 (Customizable to 2015-2020)
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Quantitative Units
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Revenue in Million, Volumes in Units, and Pricing in USD
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Segments Covered
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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)
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Countries Covered
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U.S., Canada, Mexico, Germany, France, U.K, Italy, Spain, Netherlands, Russia, Switzerland, Turkey, Belgium, Denmark, Finland, Norway, Sweden, Poland, and Rest of Europe, China, Japan, India, South Korea, Australia, New Zealand, Singapore, Thailand, Malaysia, Indonesia, Philippines, Vietnam, Taiwan, and Rest of Asia-Pacific, Brazil, Argentina, and Rest of South America, South Africa, Saudi Arabia, Bahrain, Kuwait, Qatar, Oman, U.A.E., Egypt, Israel, and Rest of Middle East and Africa
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Market Players Covered
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VIVUS LLC (U.S.), Metagenics LLC (U.S.), Janssen Global Services, LLC (Belgium), Nestle (Switzerland), Laboratory Corporation of America Holdings ((U.S.), ChiRhoClin (U.S.), Bioserv Diagnostics GmbH (Germany), Alcresta Therapeutics, Inc. (U.S.), Cilian AG (Germany), ScheBo Biotech AG (U.S.), Organon group of companies (U.S.), AbbVie Inc.(U.S.), EagleBio (U.S.), Nordmark (Germany), Digestive Care, Inc.(U.S.), Abbott (U.S.)
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Data Points Covered in the Report
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In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework
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Segment Analysis
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.
- Based on the treatment, the market is segmented into nutritional management and pancreatic enzyme replacement therapy (PERT).
In 2023, the pancreatic enzyme replacement therapy (PERT) segment of the treatment segment is expected to dominate the market
In 2023, the pancreatic enzyme replacement therapy (PERT) segment is expected to dominate the market as this type of treatment is widely popular. This segment is expected to reach the highest CAGR of 7.9% in the forecast period of 2023 to 2030.
- Based on diagnosis, the market is segmented into imaging test and pancreatic function test. In 2023, the pancreatic function test segment is expected to dominate the market with a market share of 65.16% as these products are utilized in various regions, and more advanced technologies are available.
In 2023, the branded segment of the drug type segment is expected to dominate the market
- Based on drug type, the market is segmented into generic and branded. In 2023, the branded segment is expected to dominate the market with a market share of 77.02%, as this type of drug type is widely used and shows good results.
- Based on end user, the market is segmented into hospitals, specialty clinics, homecare, diagnostic center, research & academic institute, and others. In 2023, the hospitals segment is expected to dominate the market with a market share of 34.60% due to increased government funding and increased R&D activities.
- Based on distribution channel, the market is segmented into direct tender, retail pharmacy, third party distributor, and others. In 2023, the direct tender segment is expected to dominate the market with a market share of 64.29% due to increasing awareness regarding pancreatic diseases globally.
Major Players
Data Bridge Market Research recognizes the following companies as the major Exocrine Pancreatic Insufficiency (EPI) market players in the global Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics market that include VIVUS LLC (U.S.), Metagenics LLC (U.S.), Janssen Global Services, LLC (Belgium), Nestle (Switzerland), Laboratory Corporation of America Holdings ((U.S.), ChiRhoClin (U.S.), Bioserv Diagnostics GmbH (Germany), Alcresta Therapeutics, Inc. (U.S.), Cilian AG (Germany), ScheBo Biotech AG (U.S.), Organon group of companies (U.S.), AbbVie Inc.(U.S.), and EagleBio (U.S.) among others.
Market Development
- 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.
- In December 2022, AbbVie (NYSE: ABBV) and HotSpot Therapeutics, Inc., a biotechnology company, announced a collaboration and option to license agreement for HotSpot's discovery-stage IRF5 program for the treatment of autoimmune diseases. This collaboration has helped the company in expanding its research and product portfolio.
- In April 2022, Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products has announced promotion of RELiZORB which is the only enzyme product cleared by the FDA for use in enteral feeding. This is one of its milestone achievement which has helped the company to generate more revenue and establish globally.
- In February 2020, VIVUS LLC announced that it has received the authorization by the U.S. Food and Drug Administration (FDA), the supplemental New Drug Application (sNDA) for an improved formulation of PANCREAZE (pancrelipase) Delayed Release Capsules, which increases the shelf life of all PANCREAZE dosages to 36 months. According to the provisions of the modified contract manufacturing agreement announced in June 2019, VIVUS closely collaborated with Nordmark Arzneimittel GmbH & Co. KG, its manufacturing partner for PANCREAZE, on the FDA approval. Exocrine pancreatic insufficiency (EPI) brought on by cystic fibrosis or other disorders is treated with PANCREAZE. This has aided the business in getting the goods on the market.
- In January 2020, Nestle Health Science announced the acquisition of the gastrointestinal drug Zenpep from Allergan in an asset. With this transaction, the company hopes to increase its medical nutrition business and round out its line of therapeutic items. For those whose pancreas is unable to produce enough digestive enzymes to adequately break down fat, protein, and carbohydrates, Zenpep is a drug that is available in the United States. Following the transaction's completion, Nestlé will acquire ownership of Zenpep with the seller providing the standard transition assistance.
Regional Analysis
Geographically, the countries covered in the global exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market report are the U.S., Canada, Mexico, Germany, France, U.K, Italy, Spain, Netherlands, Russia, Switzerland, Turkey, Belgium, Denmark, Finland, Norway, Sweden, Poland, and Rest of Europe, China, Japan, India, South Korea, Australia, New Zealand, Singapore, Thailand, Malaysia, Indonesia, Philippines, Vietnam, Taiwan, and Rest of Asia-Pacific, Brazil, Argentina, and Rest of South America, South Africa, Saudi Arabia, Bahrain, Kuwait, Qatar, Oman, U.A.E., Egypt, Israel, and Rest of Middle East and Africa.
As per Data Bridge Market Research analysis:
North America is the dominant region in the global exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market during the forecast period of 2023 to 2030
In 2023, North America is expected to dominate the market owing to the higher level of investments by U.S. manufacturers and the increasing prevalence of pancreatic and digestive diseases in the U.S. North America will continue to dominate the market in terms of market share and market revenue and will continue to flourish its dominance during the forecast period. This is due to the growing adoption of advanced technology and the launch of new products in this region. Additionally, the rising geriatric population are expected further to enhance the market growth rate in this region.
Asia-Pacific is estimated to be the fastest-growing region in the global exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market during the forecast period of 2023 to 2030
Asia-Pacific is expected to grow during the forecast period due to the rapid development of medical facilities in emerging economies in this region. In addition to this, the rising level of healthcare expenditure and increasing per-capita income are expected to propel the market growth in this region.
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