The U.S. colonoscopy bowel preparation drugs market size was USD 483.02 Million in 2021 and is expected to register a revenue CAGR of 3.0% during the forecast period. Rising prevalence of colon cancer and increasing Research & Development (R&D) activities are major factors driving market revenue growth. For instance, according to the Global Cancer (GLOBOCAN) statistics published in January 2020, in the U.S., annually, around 147,950 new cases of large bowel cancer are diagnosed, of which around 104,610 cases are of colon cancer and the remaining are rectal cancer.
In addition, rising adoption of strategies, such as collaborations and acquisitions by the market players, is driving market revenue growth over the forecast period. For instance, on 12th February 2020, Norgine B.V. entered into an exclusive license and distribution agreement with Aspen Pharmacare, a South African pharmaceutical holding company, for distribution and commercialization of PLENVU in the Republic of Southern Africa, Lesotho, Eswatini, Botswana, and Namibia. Moreover, on 1st May 2018, Sebela Pharmaceuticals, a specialty pharmaceutical company, acquired Braintree Laboratories Inc., a prescription pharmaceuticals manufacturing company, for expanding its gastroenterology product portfolio.
Furthermore, rising product launches by market players is also driving market revenue growth over the forecast period. For instance, on 5th January 2021, Sebela Pharmaceuticals announced that SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, the first tablet colonoscopy preparation to receive approval from U.S. Food and Drug Administration (FDA) in over 10 years, is now available in the U.S. SUTAB is a sulfate-based tablet colonoscopy preparation that is taken orally in a split-dose administration starting the evening before a colonoscopy. These tablets offer a safe and effective alternative to liquid colonoscopy preparations, which traditionally require consuming large volumes of poor-tasting solution and can often be a barrier to patients’ willingness to undergo colonoscopy screening for colorectal cancer. However, alternative colonoscopy preparations, such as SUTAB, can play an important role in encouraging more patients to get screened for colorectal cancer, thus creating enormous opportunities for market growth. In addition, on 16th February 2018, Ferring Pharmaceuticals launched Clenpiq, the first ready-to-drink colonoscopy preparation. Clenpiq contains stimulant laxative sodium picosulfate and magnesium oxide and anhydrous citric acid, which forms osmotic laxative magnesium citrate.
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Conversely, occurrence of side effects like abdominal pain, abdominal swelling, nausea, and vomiting are challenging factors hindering colonoscopy bowel preparation market growth.
Driver: Rising Research & Development (R&D) activities
The colonoscopy bowel preparation drugs market is expected to witness a significant growth, owing to rising research & development activities for development of innovative bowel preparation drugs, to offer better products in the market. For instance, in December 2019, ColonaryConcepts LLC., a biotechnological company engaged in the development of colon preparation products, announced Phase III clinical trial of its Edible Colonoscopy (EC) preparation used for bowel cleansing.
Restraint: Increasing incidence of adverse side effects, such as stomach discomfort, abdominal swelling, nausea, and vomiting
As clinical studies are conducted under widely varying conditions, adverse reaction rates are observed in clinical studies of a drug. For example, comparing SUPREP Bowel Prep Kit with a bowel prep containing polyethylene glycol and electrolytes (PEG + E) causes adverse reactions. The most common adverse reactions after administration of SUPREP Bowel Prep Kit were overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache. Thus, increasing incidence of adverse side effects could hamper market growth to a certain extent.
Drug Class Outlook:
Based on drug class, the colonoscopy bowel preparation drugs market has been segmented into laxatives, macrolides, and aminoglycosides. The laxatives segment is expected to account for 75% market share and is the most common bowel preparation drugs. In addition, owing to minimal adverse effects and complications, a large number of companies offer laxatives under their gastroenterological product portfolio. Examples of laxative bowel preparation drugs include miralax, clenpiq, gavilyte, gialax, and glycolax.
The Macrolides segment is expected to account for 22% market share in the bowel preparation drugs market. Macrolides are antibiotics, such as erythromycin, which are used for bowel preparation prior to colonoscopy procedures. However, use of macrolides is plagued with serious disadvantages including allergic reactions and cholestatic hepatitis.
Mechanism of Action Outlook:
Based on mechanism of action, the colonoscopy bowel preparation drugs market has been segmented into isosmotic, hyperosmotic, and stimulant preparations. Isosmotic drugs are high-volume, non-absorbable, and non-fermentable electrolyte solutions that are osmotically balanced. Mechanical impact of large-volume lavage cleans colon with minimum water and electrolyte changes and provides evacuation. In addition, majority of laxatives are isosmotic preparations and account for maximum share of 52% in this market.
The stimulant preparations segment is expected to account for 11% share in the market which is projected to reduce to 9% by 2030, primarily due to side effects of such drugs operating as stimulant preparations.
Based on prescription, the colonoscopy bowel preparation drugs market has been segmented into Rx and OTC. The Rx segment is expected to account for 68% primarily because majority of bowel preparation drugs being developed by pharmaceutical companies are prescription drugs. Over the last three years, U.S. FDA has approved over 100 prescription drugs, owing to which the market share of such drugs is comparatively higher.
The OTC segment is projected to witness to grow to USD 410.5 Billion growing at a CAGR of 8.2%. This can be attributed to ongoing conversion of prescription drugs to OTC by regulatory bodies. In addition, over 700 prescription drugs have been converted to OTC in the last three decades.
Distribution Channel Outlook:
Based on distribution channel, the colonoscopy bowel preparation drugs market has been segmented into hospital pharmacy, retail pharmacy, and online pharmacy. Increase in market share of hospital pharmacy can be attributed to the fact that over 60% of population in 2020, opted for colonoscopy procedure in hospital settings. Higher number of individuals are anticipated to adopt colonoscopies primarily due to its efficiency in cancer screening and detection and rising prevalence of colorectal cancer.
The U.S. colonoscopy bowel preparation drugs market is competitive in nature. Key players are engaged in product development and strategic alliances to expand their respective product portfolio and gain a robust footing in the global market.
Some major players operating in the market report include Sebela Pharmaceuticals, Norgine B.V., Ferring Pharmaceuticals, Salix Pharmaceuticals, and Bayer AG, among others.
- On 7 January 2021, a new colonoscopy prep tablet was approved by FDA. The first tablet colonoscopy preparation to receive approval from FCA in over 10 years is now available in the U.S. SUTAB is a sulfate-based tablet colonoscopy preparation that is taken orally in a split-dose administration starting the evening before a colonoscopy. According to its maker, Sebela Pharmaceuticals, the tablets offer a safe and effective alternative to liquid colonoscopy preparations.
- On 7 July 2021, Treos Bio Limited announced a clinical collaboration with Roche. Treos evaluated combination of PolyPEPI1018 and atezolizumab in patients with late-stage microsatellite stable metastatic colorectal cancer.
- On 10 September 2021, Cardiff Oncology announced a new data from its lead clinical program evaluating onvansertib in combination with Standard-Of-Care (SOC) FOLFIRI/bevacizumab for second-line treatment of patients with KRAS-mutated metastatic Colorectal Cancer (mCRC).
- On 18 June 2020, Hutchison China MediTech Limited (“Chi-Med”) announced that the U.S. FDA had granted Fast Track Designation for fruquintinib development for treatment of metastatic colorectal cancer patients who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-Vascular Endothelial Growth Factor (VEGF) biological therapy, and if RAS wild-type, an anti-Epidermal Growth Factor Receptor (EGFR) therapy.
Segments Covered in the report
This report offers historical data and forecasts revenue growth at a global, regional, and country level, and provides analysis of the market trends in each of the sub-segments from 2019 to 2030. For the purpose of this report, Reports and Data has segmented the U.S. colonoscopy bowel preparation drugs market based on drug class, mechanism of action, prescription, distribution channel, and region:
Drug Class Outlook (Revenue, USD Million; 2019-2030)
Mechanism of Action Outlook (Revenue, USD Million; 2019-2030)
- Stimulant Preparations
Prescription Outlook (Revenue, USD Million; 2019-2030)
Distribution Channel Industry Outlook (Revenue, USD Million; 2019-2030)
- Hospital Pharmacy
- Retail Pharmacy
- Online Pharmacy
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