Exocrine Pancreatic Insufficiency (EPI) Therapeutics and Diagnostics Market Report 2025

This report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.

The exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market size has grown strongly in recent years. It will grow from $5.69 billion in 2024 to $6.17 billion in 2025 at a compound annual growth rate (CAGR) of 8.4%. The growth in the historic period can be attributed to increased prevalence of underlying conditions, advancements in diagnostic tools, pharmaceutical developments, rising global healthcare access.

The exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market size is expected to see strong growth in the next few years. It will grow to $8.32 billion in 2029 at a compound annual growth rate (CAGR) of 7.8%. The growth in the forecast period can be attributed to telemedicine and remote monitoring, data analytics and ai, patient education and support, regulatory changes and reimbursement policies. Major trends in the forecast period include personalized treatment approaches, development of novel therapies, minimally invasive diagnostics, collaborative care models.

The growing prevalence of diabetes is anticipated to drive the expansion of the exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market in the future. Diabetes is a chronic condition characterized by elevated blood sugar levels (hyperglycemia), resulting from the body's inability to produce sufficient insulin or use the insulin effectively. EPI treatment, including pancreatic enzyme replacement therapy (PERT), can enhance nutrient absorption and support better glycemic control in individuals with both diabetes and EPI. For example, in June 2024, the National Health Service (NHS England) reported that the number of people diagnosed with pre-diabetes in 2023 increased to 3,615,330, an 18% rise from 3,065,825 in 2022. Among those under 40, pre-diabetes cases rose nearly 25%, from 173,166 in 2022 to 216,440 in 2023. This growing diabetic population is fueling the demand for EPI therapeutics and diagnostics.

The surge in cases of gastrointestinal disorders is projected to drive the expansion of the exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market in the foreseeable future. Gastrointestinal disorders encompass a range of medical conditions affecting the digestive tract, including the organs responsible for digestion. Managing gastrointestinal diseases relies significantly on exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics, which rectify enzyme deficiencies and promote effective nutrient digestion. For instance, as of June 2023, Crohn's and Colitis Canada, a non-profit organization based in Canada, estimated that over 322,600 Canadians were living with inflammatory bowel diseases (IBD) in 2023, constituting about 0.82% of the population. With the prevalence of IBD projected to persist, it is anticipated that approximately 470,000 Canadians will have IBD by 2035, roughly 1.1% of the population, or about 1 in every 91 individuals in the country. Consequently, the escalating incidence of gastrointestinal disorders is anticipated to be a driving force behind the growth of the exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market.

Key players in the exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market are increasingly forming strategic partnerships to integrate advanced technologies and broaden their market presence. A strategic partnership involves collaboration between two or more organizations, combining their resources, expertise, and efforts to reach shared objectives. For example, in February 2023, Codexis, Inc., a protein engineering firm based in the US, partnered with Nestlé Health Science, a Swiss nutrition company, to announce the interim results of their Phase 1 clinical trial of CDX-7108, an investigational therapy for EPI. These promising results from the trial open the door for further research that could lead to improved treatment options for individuals affected by EPI.

In October 2022, DiaSorin SpA, an Italian biotechnology firm, acquired Luminex Corporation for $1.8 billion. This acquisition allows DiaSorin to bolster its presence in the U.S. market, expand its product portfolio, and establish long-term collaborations with biopharmaceutical companies. Luminex Corporation, based in the U.S., specializes in biological testing technologies, including those related to exocrine pancreatic insufficiency (EPI).

Major companies operating in the exocrine pancreatic insufficiency (epi) therapeutics and diagnostics market are Pfizer Inc., Merck & Co. Inc., Janssen Pharmaceuticals Inc., AbbVie Inc., Novartis AG, Sanofi S.A., AstraZeneca PLC, Abott Laboratories, Medtronic PLC, Solvay S.A., Laboratory Corporation of America Holdings (Labcorp), Organon group of companies Metagenics LLC, Allergan PLC, Chiesi Farmaceutici S.p.A., Codexis Inc., Nordmark Arzneimittel GmbH & Co. KG, ChiRhoClin Inc., Digestive Care Inc., Alcresta Therapeutics Inc., Vivus Inc., Cilian AG, Bioserv Diagnostics Gmbh, Anthera Pharmaceuticals Inc., Aptalis Pharma Inc., First Wave BioPharma Inc., EagleBiosciences Inc., ScheBo Biotech AG.

North America was the largest region in the exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market in 2024. The regions covered in exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market consists of revenues earned by entities by providing dietary interventions and bile acid replacement therapy (BAR). The market value includes the value of related goods sold by the service provider or included within the service offering. The exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market also includes sales of Creon, Zenpep and Ultresa. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

Exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics pertain to the treatment of a condition where the pancreas fails to produce adequate digestive enzymes necessary for the effective breakdown and absorption of nutrients from food within the small intestine. The role of EPI diagnostics and therapeutics is pivotal in the identification and management of exocrine pancreatic insufficiency, facilitating individuals with EPI in attaining improved nutrient absorption and overall well-being.

The primary forms of treatments encompassed within exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics comprise nutritional management, pancreatic enzyme replacement therapy (PERT), and lifestyle adjustments. Nutritional management is a specialized healthcare approach utilizing nutrition and diet to address various medical and health conditions. Diverse diagnostic techniques are employed, including blood tests, magnetic resonance imaging (MRI), endoscopic ultrasonography (EUS), and computerized tomography (CT) scanning. Various types of medications, both generic and branded, are utilized, and these are distributed through a range of channels such as direct tender, retail pharmacy, third-party distributor, and others. These are availed by a diverse array of end users including hospitals, specialty clinics, homecare, diagnostic centers, research and academic institutes, among others.

The exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market research report is one of a series of new reports that provides exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market statistics, including exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics industry global market size, regional shares, competitors with a exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market share, detailed exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market segments, market trends and opportunities and any further data you may need to thrive in the exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics industry. This exocrine pancreatic insufficiency (EPI) therapeutics and diagnostics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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