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Crohn's Disease

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Published Date : Sep 2023
Category : Autoimmune Diseases
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Discovering the Hidden Opportunities for Crohn’s Disease with DiseaseLandscape Insights

"Decoding the Crohn’s Disease Industry Inventions Using Data-Driven Analysis"

Crohn's Disease (CD) is a chronic condition that has a significant impact on quality of life and economic performance. Crohn’s Disease also known as Inflammatory Bowel Disease affects the digestive tract of the patients. Approximately, 25% of people with Crohn’s Disease show joint complications, and 15% of people show skin complications. Researchers are working on the diagnostic as well as treatment domain of Crohn’s Disease to improve the health of patients.

However, the prevalence of Crohn’s Disease differs from region to region. Research conducted by Crohn’s and Colitis Foundation UK in 2022 states that 1 in every 123 people in the UK have Crohn’s Disease. The prevalence of CD in North America is 400,000 to 600,000. Around 27-48 per 100.000 people are suffering from CD.

Crohn’s Disease affects any portion of the gastrointestinal area from the mouth to the anus. Symptoms of CD include abdominal pain, watery feces, colitis, and in severe cases more than 20 bowel movements per day. However, CD affects at any age but onset of CD happens in the age group of 15 to 30 years and 40 to 60 years old.

Moreover, patients suffering from Crohn’s Disease die more likely due to non-malignant gastrointestinal infection. According to NIH, the percentage of the death rate of Crohn’s Disease is nearly ranges from 25% to 40%. Due to innovations and technology life expectancy of patients has increased. Males have a 75.5-year average life expectancy compared to 78.4 years for females.

The following is the classification of Crohn’s Disease based on the area of the digestive tract it affects and the percentage of cases for a particular type:

As shown in the above pie chart, Crohn’s Disease is divided into Ileocolic Crohn’s Disease in which the large intestine and ileum are affected and measure 50% of cases. Whereas Crohn’s ileitis affects only the ileum part of the body and imparts 30% of cases. Crohn’s colitis affects the large intestine only and accounts for 20%.

Discovery in the preventive, diagnostic, and treatment fields has been identified as an important element of expanding the marketplace on a global scale for industry players. As a result, it contributes to the globalization of developing products.

DiseaseLandscape Insights assists the stakeholders by providing data related to the Crohn’s Disease marketplace, knowledgeable choices in healthcare equipment, therapies, and diagnostic techniques where various new technologies and innovations are impacting the market of disease and driving higher expansion.

Crohn’s Disease is spreading throughout the world creating a drastic shift in an individual’s standard of life. The present condition of Crohn’s Disease would propel the industries in the appropriate direction and provide emerging opportunities for a variety of market leaders in the domain of DiseaseLandscape Insights.

Crohn’s Disease Diagnostic Analysis-

“To Persist Healthy: It is Superior to Discover Crohn’s Disease Before It Causes Pain”

Diagnosis of Crohn’s Disease is performed by various combination tests. By considering the physical evaluation and medical history of the patient the diagnostic test is used. The following techniques are used to detect Crohn’s Disease.

Diagnosis of Crohn’s Disease is performed by various combination tests. By considering the physical evaluation and medical history of the patient the diagnostic test is used. The following techniques are used to detect Crohn’s Disease.

1.   Blood Tests-

Blood tests are performed to check the count of red blood cells and white blood tests. It also helps to measure the level of C-reactive protein. All these biomarkers assist clinicians to check the presence of inflammation and also to rule out the chances of other diseases.

2.   Imaging Tests-

An imaging test is the other important method to diagnose the disease and accurately helps in understanding the level of inflammation present in the body, following are the brief classifications of imaging tests.

·       Computational Tomography- Computational tomography is used to create images of body parts by using X-ray and computer technology. Wall thickening at the right side of the colon, fat proliferation on the colon, and other affected organs are the findings of the CT scan.

·       Magnetic Resonance Imaging- Magnetic resonance imaging captures photos of internal organs and soft tissue without using X-rays. MRI helps to analyze inflammation caused by Crohn’s Disease. Instead of CT scan MRI is used more frequently because it involves less harmful radiation, and it can be used for adults and children equally.

3.   Colonoscopy-

A colonoscopy is used to look into the small and large intestines of the patient by inserting the thin tube attached to a camera. Based on the Annals of Internal Medicine, colonoscopy is highly accurate for diagnosing Crohn’s Disease and it is accurate in 90% of cases, because of the high sensitivity and specificity of the CT instrument.

Furthermore, as per NIH study, Colonoscopy is around 70% effective for the diagnosis of Crohn’s Disease. The side effects of this test are the use of sedatives which are harmful, there is the chance of bleeding from where abnormal tissue was removed and there is a chance of perforation of the wall of the organ.

The below table provides names of the market competitors who are transforming healthcare with advanced diagnostic breakthroughs, are listed below

                                                                                           Diagnostic Market Players

Colonoscopy

Blood Tests

Imaging Tests

Pro Scope Systems

Cipla Limited

Radiance Imaging System

FUJIFILM Holdings America Corporation

Metropolis Healthcare Ltd.

DiagnoTech Corporation

KARL STORZ SE & Co. KG

Sun Pharmaceuticals Industries Ltd

Gastro Diagnostics.Ltd

STERIS Plc

Apollo Diagnostics

Siemens Healthineers

Olympus America

Fortis Healthcare

Med Imaging Solutions

HUGER Medical Instrument Co., Ltd

Dr. Reddy’s Laboratory

UltraScan diagnostics

GI View Ltd

SRL Diagnostics

 

 

                                                                                          Diagnosis Products

Colonoscopy

Blood Tests

Imaging Tests

Welch Allyn’s Disposable

Allegro

MAGNETOM Sola

Welch Allyn’s Fiberoptic

StarStrip®

PreXion 3D Excelsior CBCT Scanner

 

Epoc®

CX CT Scanner

 

LiquiColor®

Row CT Scanner

 

Crohn’s Disease Treatment Analysis-

There are many treatment options for Crohn’s Disease available in the market. By analyzing the type of disease and other factors of individual patients the treatment is given to the patient. The following are the treatment options available to manage the Crohn’s Disease-

Medications- Medications like anti-inflammatory drugs and antibiotics cure small intestinal bacterial overgrowth, inhibit the immune system, and reduce inflammation. Corticosteroids and Amino salicylates are also used to treat Crohn’s Disease.

Immunomodulators- Immunomodulators play a substantial role in the treatment of Crohn’s Disease. Immunomodulators alone are used or they are used with a combination of other agents to work appropriately.

Biologics- In biologics, there are mainly 2 biologics used which are pro-inflammatory cytokine inhibitors and integrin antagonists  TNF- and IL-12/23, pro-inflammatory cytokines, which are crucial in the pathophysiology of Crohn's disease.

Surgery- In severe cases surgery is a must. Surgery is required to treat fistulas, abscesses, and perianal disease. Medically resistant illness, perforation, blockage, strictures, uncontrolled bleeding, dysplasia, and cancer are other indications that need to be treated by surgery.

However, According to the Crohn’s Colitis Foundation, 70% of Crohn’s Disease patient requires surgery at least once in their lifetime. In addition to that, 30% of patients who had surgery develop the recurrent symptoms of Crohn’s disease within 3 years.

The below chart gives information about a class of drugs, the names of drugs, their dosage, and side effects associated with a drug -

Class of Drug

Drug

Dosage

Side Effect

Corticosteroids

Prednisone

40 to 60 mg per day

Orally

Hypertension, high glucose level, osteoporosis, mood disorder.

 

Budesonide

9 mg every morning for 8 weeks

Orally

Diarrhea, nausea, headache, arthralgias, sinusitis.

Immunomodulators

Azathioprine

50 mg daily

Orally

Gastritis, pancreatitis, lymphoma, thrombocytopenia.

 

6- mercaptopurine

50 mg per day

Orally

Myelosuppresion, hepatic toxicity and encephalopathy, lymphoma.

 

Methotrexate

25 mg per week

Subcutaneously or IV

Alopecia, photosensitivity, stomatitis, lung fibrosis, renal failure.

Biologics

Adalimumab

Initially 160 mg per week then 80 mg then 40 mg every two weeks

IV

Erythema, lymphoma, malignancies, hemorrhage.

 

Certolizumab

Initially 400 mg in 2 weeks then 400 mg in 4 weeks

IV or subcutaneously

Injection site reaction, upper respiratory tract infection, hypertension.

 

Infliximab

5 mg per kg once a week

IV

Infusion-related reactions, hypotension, myalgia, skin ulceration.

 

Vedulizumab

300 mg once at weeks 0, 2, 4, and then every 8 weeks thereafter.

Nasophyringitis, hypersensitivity reactions, anaphylaxis, pyrexia.

 

Natalizumab

300 mg every 4 weeks

IV

Headaches, depression, nausea, lower respiratory infections arthralgia.

 

Ustekinumab

Weight based dosing

Upto 55 kg- 260 mg

55 kg to 85 kg- 390 mg

>85 kg- 520 mg

Vomiting, Nasophyringitis, injection site erythema pruritus, infections.

 

The below table shows the key market player who are redefining the treatment industry and their product names-

Market Player

Products

Anant Pharmaceuticals Pvt. Ltd.

Jubilant Cadista Pharmaceuticals Inc.

Prednisone

Prometheus Laboratories Inc.

Aegis Pharmaceuticals

Azathioprine (Imuran)

McNeil Pharmaceutical

Salvavidas Pharmaceutical Pvt. Ltd

Loperamide (Imodium A-D®)

Janssen Biotech, Inc.

Mitsubishi Tanabe Pharma

Lexicare Pharma Pvt. Ltd.

Infliximab (Remicade)

UCB

Certolizumab pegol (Cimzia)

AbbVie Inc.

Zydus Group

Adalimumab (Humira)

Biogen Idec Inc.

Elan Corporation, plc.

Natalizumab (Tysabri)

Janssen Pharmaceuticals

CuraTeQ Biologics

Ustekinumab (Stelara)

Pfizer

Manus Aktteva Biopharma LLP

Metronidazole (Flagyl)

 

Recent Developments-

One novel biologic, Risankizumab-Rzaa (Skyrizi), is a cytokine inhibitor that suppresses the inflammatory molecule interleukin 23 (IL-23). It was licensed to treat Crohn's disease in June 2022 by FDA regulatory authority. Furthermore, Skyrizi (risankizumab-rzaa), a humanized immunoglobulin G1 (IgG1) monoclonal antibody, is an interleukin-23 antagonist. It binds to the p19 component of human interleukin 23 (IL-23), inhibiting its interaction with the IL-23 receptor. Advancement and evolution in the treatment field have increased the life expectancy of the patient.

Regulatory Framework for Crohn’s Disease-

“Exploring the Regulatory Network for Better Business Choice”

The DiseaseLandscape Insights considers the regulatory ecosystem of different countries for Crohn’s Disease. DLI provides data about risk assessment laws, import/export rules, and surveillance to the industry player. DLI offers data related to global organizations, their schemes, and rules for a better understanding of the Crohn’s Disease domain.

However, the US Food and Drug Administration (FDA) released draft guideline documents on Crohn's disease medication development in 2022 that included recommendations for clinical trial design. This guideline suggests that there should be an induction trial first and then a randomized trial should be conducted for particular drugs which have the potential to cure Crohn’s Disease.

To make people aware of the impact of Crohn’s Disease European Federation of Crohn’s and Ulcerative Colitis Associations started a campaign in 2022. People with age above 60 years are also affected by Crohn’s Disease. This program was an initiative to spread knowledge about Crohn’s Disease, its causes, symptoms, and preventive measures.

Competitive Analysis-

“Understanding the Business Tactics of Competitors to Acquire the Best Route for Business”

Several worldwide industries are concentrating on developing new products and enhancing the use of technology for the improvement of existing techniques to boost their competitive position. To broaden their selection of products, industries are also working on growth initiatives, which principally involve regulatory approval for medication research, acquisition partnerships, and a focus on cooperation.

However, one of the pharmaceutical companies AbbVie has submitted the regulatory applications to the FDA and EMA for Upadacitinib (RINVOQ®) in Crohn's Disease. After approval of this product, AbbVie will generate a huge amount of revenue. These innovations also inspire other researchers and set the upper standard for the existing market players.

Moreover, in the BOOM-IBD Clinical Trial, researchers are examining whether nerve stimulation, a treatment that has received FDA approval for the management of various illnesses, can be successful in the management of inflammatory bowel disease, such as Crohn's disease.

Market Trends-

“Reviewing Market Dynamics to Accelerate the Business”

The market is rising and growing continuously due to developments and innovations in the treatment field of Crohn’s Disease. The launching of new medications and the discovery of various drugs from many sources are now trending in the market. New market players and existing market players are working on various new technologies to evolve the diagnostic and treatment domain of Crohn’s Disease.

However, an innovation in biologics for the treatment of Crohn’s disease has changed the market dynamics. Biologics like Ustekinumab (Stelara) have been launched into the market and generated immense awareness as well as revenue in the market. Manufacturer has built a large business in the treatment landscape of Crohn’s Disease.

Furthermore, many researchers are working on the use of gut bacteria in combination to treat the Crohn’s Disease. Key players have various ways like finding new bacterial classes, searching for genetic modification techniques in the gut microbiota, and understanding the mechanism of action of bacteria on the body of patients to enter into and establish a profitable business.

Crohn’s Disease affects every age group but there is no clinical data available for patients 60 years old. There is only observational data available for the treatment options. So, there is a need for specific knowledge for the treatment of Crohn’s Disease in older age groups. Market players have a huge opportunity in this field to expand their businesses.

All in all, the key players have numerous opportunities in the treatment and diagnosis field. The existing players have generated tremendous income from the Crohn’s Disease business. Such developments have increased the scope and economy of the Crohn’s Disease market globally.

Clinical Trial Data Assessment-

The crucial role of clinical trials in the practice of evidence-based medicine and health care reform is highlighted by the government's increasing concentration on comparing the effectiveness of studies. One of the main goals of reforming healthcare is achieved by the market participants accurately examining medical therapy with the use of clinical data. 

The table below includes the study names of the ongoing clinical trials as well as the stages at which they are taking place.

Phase I

Phase II

Phase III

Phase IV

Study to Evaluate Safety, Tolerability, and Early Efficacy of Oral E-B-FAHF-2 in Subjects With Mild-To-Moderate Crohn's Disease

Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's Disease

A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

A Phase 4 Study Evaluating Real-World Use of CDPATH™, a Crohn's Disease Risk Prediction Tool

An Open-Label, Proof of proof-of-concept study of Vorinostat for the Treatment of Moderate-to-Severe Crohn's Disease and Maintenance Therapy With Ustekinumab

Personalized AZithromycin/metronidAZole, in Combination With Standard Induction Therapy, to Achieve a Fecal Microbiome Community Structure and Metagenome Changes Associated With Sustained Remission in Pediatric Crohn's Disease (CD): a Pilot Study

A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

A Phase 4, Single Arm, Open-Label, 52-Week, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab (STELARA), an Anti-Interleukin-12/23 Monoclonal Antibody, in Chinese Participants With Moderately to Severely Active Crohn's Disease

Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's Disease

A Phase 2a, Randomized, Placebo-controlled, Double-blind Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AGMB-129 in Patients With Fibrostenotic Crohn's Disease

Randomized Trial for Unstable Pediatric Crohn's Disease Patients Comparing the Use of Crohn's Disease Exclusion Diet (CDED) on Top of Standard Therapy Versus Standard Therapy Alone.

Does the Microbiome Change With Flagyl Treatment After Ileocolic Resection for Crohn's Disease

A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in Subjects with Crohn's Disease

A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RVT-3101 for the Treatment of Subjects with Moderate to Severe Active Crohn's Disease

A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease

Conditions

Induction Optimization With Stelara for Crohn's Disease

Extracorporeal Photopheresis of Patients with Crohn's Disease Using 5-aminolevulinic Acid

Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric Crohn's Disease

Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal

USTekinumab in Fistulising Perianal Crohn's Disease (CD): The USTAP CD Study

A Phase 1, Multicentre, 2-part, Randomised, Parallel-arm, Placebo-controlled, Partially Double-blind Study to Evaluate the Safety and Target Engagement of EXL01 in the Maintenance of Steroid-induced Clinical Response or Remission in Participants with Mild to Moderate Crohn's Disease

Phase 2a Randomised Double-blind Placebo-controlled Trial to Assess Safety and efficacy of Artesunate and curcumin in Crohn's Disease Patients, Who Continue to Have Mild to Moderate Disease Activity on an Adequate Dose of Azathioprine

A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Efficacy and Safety of Selective Intensive Induction Therapy Based on Ustekinumab Clinical Decision-making Tools in Patients With Crohn's Disease: A Multicenter, Prospective, Randomized, Controlled Study(SIIT-CD Study)

 

Conclusion-

DiseaseLandscape Insights (DLI) assists manufacturers in developing and implementing viable remedies to interrupt and manage Crohn’s Disease outbreaks. Furthermore, there is an increasing need for diagnostic tools, clinical evaluations, and innovative therapies as a result of greater awareness and estimated epidemics.

DiseaseLandscape Insights offers essential knowledge and expertise to major stakeholders involved in the manufacture of therapeutic goods. DiseaseLandscape Insights' support makes it easier for market participants to organize and carry out clinical trials for innovative medicines and pharmaceuticals, patient recruiting tactics, and regulatory compliance.

All in all, this encourages the leaders to perform qualitative research, explore the manufacturing organizations, and learn about raw material suppliers. DiseaseLandscape Insights assists all industry players to stay one step ahead and obtain a stronger foothold in the Crohn’s Disease Domain.

SUMMARY
VishalSawant
Vishal SawantBusiness Development
vishal@diseaselandscape.com

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