Industry Detail

Market Overview:

The Global In-vitro Inflammatory Bowel Disease Diagnostic & Treatment market is expected to offer an $ opportunity value of USD 7,540.33 Million.

The In-vitro Inflammatory Bowel Disease Diagnostic & Treatment market size was estimated to grow from USD 17,432.9 Million in 2019 to USD 24,973.2 Million by 2028, with a compound annual growth rate (CAGR) of approximately 5.44% between 2023 and 2028. 

Global Market Size, Forecast, and Trend Over the Analysis Period, 2019 - 2028

Market Definition:

Inflammatory Bowel Disease refers to inflammation or chronic swelling of the intestines. General forms of IBD include Crohn’s disease (CD) and ulcerative colitis (UC). Both cause chronic inflammation in the GI tract. These conditions can cause rectal bleeding and diarrhea, bloating, abdominal cramping, pain, reduced appetite, unintended weight loss and fatigue.

Both the ulcerative colitis and Crohn’s disease markets are quite large and anticipated to experience significant growth. Multiple new mechanisms in the treatment of IBD are being developed and many are showing promising results in both ulcerative colitis and Crohn’s disease patients.

Disease Outlook:

Prevalence of Ulcerative Colitis is more than CD, Though the proportion of prevalence and incidences varies across the markets. The Approval and launches of new novel medications for the treatment of Ulcerative Colitis is the main growth driver in the expected increase in sales, whereas CD drug sales expected to increase by approximately 52.4%.

Similarities between UC and CD include immunopathology and clinical signs and symptoms (abdominal pain, diarrhea, fever, anemia, weight loss), whereas the differences between UC and CD UC are limited to colon; CD patchy through-out colon and small intestine UC more responsive to medical treatment CD requires surgery more often.

Disease Epidemiology Overview:

As per NCBI studies it is estimated that in 2015, an estimated 1.35% of US adults (~3.2 million) reported being diagnosed with IBD (either Crohn’s disease or ulcerative colitis). Prevalence differed by several sociodemographic characteristics, including age, race/ethnicity, education, and poverty.

• Ulcerative Colitis Prevalent Pool: According to the recent statistics, there are around 13 million prevalent cases of UC globally in 2022, which should grow to about 13.87 million by 2027. The 2022 numbers include 2.1 million patients in North America, 3.81 million in Europe and 5.42 million in Asia.
• Crohn’s Disease Prevalent Pool: On the other hand, CD estimated to be about half the size of the UC market at 6.3 million cases worldwide in 2022, growing to 6.5 million in 2027. In CD, there are nearly 2.1 million patients in North America, 2.43 million in Europe and 1.41 million in Asia in 2022.

According to the Crohn’s and Colitis Foundation (CCFA), approximately 70,000 new cases of inflammatory bowel disease are diagnosed in the U.S. annually. As per the CCFA report of 2019, about 1.63 million people were living with IBD in the U.S. Furthermore, as per the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA), there were around 3.41 million people in Europe living with any form of IBD in 2020. An increasing number of people are being affected by IBD thereby increasing the demand for effective treatment options.

Currently, the highest annual incidence of IBD in Europe was 24.3 per 100,000 person-years for UC, and 12.7 per 100,000 person-years for CD, that in North America was 19.2 per 100,000 person-years for UC and 20.2 per 100,000 person-years for CD and that in Asia and Middle East was 6.3 per 100,000 person-years for UC and 5.0 per 100,000 person-years for CD. The highest prevalence for UC was 505 per 100,000 persons in Europe, and 249 per 100,000 persons in North America. The annual prevalence of CD was 322 per 100,000 persons in Europe, and 319 per 100,000 persons in North America.

Treatment Landscape: Explores Current Treatment Options, Market Response, gap in Treatment, Experts Opinions among others

• Treatments for IBD
  • Ulcerative Colitis
    • Mild disease: sulfasalazines; 5-ASAs (mesalamine)
    • Moderate: steroids (budesonide; prednisone); azathioprine; 6-mercaptopurine; methotrexate
    • Severe: Anti-TNF; Entyvio (vedolizumab); Xeljanz (tofacitinib); Stelara (ustekinumab)
  • Crohn’s Disease
    • Mild/Moderate: steroids
    • Moderate/Severe: Anti-TNF; Entyvio; Stelara; Tysabri (natalizumab)

Inflammatory bowel disease is an increasingly crowded market with an influx of novel therapies recently launched or nearing approvals. The mainstay of treatment of IBD is immunosuppressive
and immune-modulating agents. The ulcerative colitis and Crohn’s disease landscapes may shift soon but new drugs will compete with entrenched blockbusters, including Humira, Stelara and Entyvio, with biosimilars on the way.

• Ulcerative colitis treatment usually begins with oral anti-inflammatory drugs, including corticosteroids, such as budesonide; 5-aminosalicylic acid (5-ASAs) drugs, such as mesalamine; and thiopurines.
  • When UC patients move from conventional therapies to advanced therapies, they typically initiate biologic therapies, starting with an anti-TNF antibody, such as Humira or Remicade, but sometimes the IL-12/IL-23 inhibitor Stelara (ustekinumab) and or integrin inhibitor Entyvio (vedolizumab).
• In Crohn’s disease, biologic therapies are typically used after corticosteroids, 5-ASAs, antibiotics and immunomodulatory agents.
  • In addition to TNF inhibitors, Stelara and Entyvio, biologics labeled for CD include the integrin inhibitor Tysabri and IL-23 inhibitor Skyrizi (risankizumab).

Inflammatory Bowel Disease Pipeline Snapshot:

The presence of robust pipeline assets for the treatment of IBD is going to significantly influence the market growth. The late-stage pipeline for ulcerative colitis includes mainly IL-23 and JAK/TYK inhibitors, microbiome drugs and cell therapies; whereas for Crohn’s disease its AbbVie’s Rinvoq (upadacitinib), as well as Lilly’s mirikizumab (LY3074828) and Takeda’s Alofisel (darvadstrocel). Pipeline insights would help in understanding the upcoming therapy assessment and market events shaping the overall market.

Among companies with active phase II and III programs and approved (not generic) ulcerative colitis and Crohn’s disease drugs, AbbVie, Inc. leads with five assets, followed by Johnson & Johnson, Pfizer, Inc. and Bausch Health Companies, Inc.

Novel Drugs Currently in Late-Phase Development:

• Etrolizumab (anti-integrin, β7 subunit)
• SHP-647 (PF-00547659, anti-MAdCAM-1)
• Risankizumab
• Brazikumab
• Mirikizumab
• Guselkumab (anti-IL-23)
• Briakinumab (anti-IL-12/IL-23)
• Filgotinib, upadacitinib (JAK1 inhibitor)
• Mongersen (SMAD7 antisense oligonucleotide)
• Many others

Report has covered the late stage pipeline molecules and their recent developments, estimated launch dates for most promising molecules along with comprehensive clinical mapping.

Regional Synopsis:

Currently North America and Europe is occupying larger share of pie and dominating the global market. As the most of the market leaders have presence in these regions and conducting clinical activities at a larger scale. Countries such as United States, India, Japan and China are offering numerous opportunities for existing and potential market leaders. As patients are aspiring for new treatment options to deal with existing IBD issues.

The Asia-Pacific Market is expected to be the most attractive market over the projected period for companies and investors. The underdiagnoses, inaccessibility in healthcare services and curing the diseases is kind of hampering the market revenue. Report has investigated the competitive structure encompasses financial health, strategies, pipeline, new product launches and collaboration among others.

Market Drivers and Challenges:

In-Vitro Inflammatory Bowel Disease Market Dynamics:

• Growing Prevalent Pool of Chronic Disorders: Surge in the number of people suffering from Crohn’s disorder and other bowel diseases requires medical diagnosis, treatment and management therapies which in turn are driving the demand.
• Proliferation of Clinical Trials Activities
• Thrust for Novel Treatment Options

Challenges:

• Underdiagnosis in Underdeveloped Regions
• Differences in the Therapeutic Outcomes
• Lack of Skilled Professionals

Strategic Moves Covered in the Report:

• Nanoparticle-Mediated Treatment of Inflammatory Bowel Diseases could revolutionize the treatment landscape
• 3D hydrogel co-culture model addresses the IBD challenges
• Teva Pharmaceuticals  and Sanofi have collaborated to co-develop and co-commercialise a novel anti-TL1A therapy for inflammatory bowel disease's (IBD) ulcerative colitis and Crohn's disease.

There are varieties of treatment options addressing the wide market unmet need. Report has covered in-depth analysis around this.

Market Segmentation:

Our in-depth analysis of the Global In-vitro Inflammatory Bowel Disease Diagnostic & Treatment Market includes the following segments: