The Crohn’s disease therapeutics market is expected to grow at a CAGR of 10.35% from 2022 to 2027 and is expected to reach USD 23.14 billion by 2027 from USD 12.82 Billion in 2021. Crohn's disease is an inflammatory bowel disease (IBD) that causes digestive tract inflammation, leading to abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The inflammatory bowel disease treatment market can be segmented into two types, i.e., Crohn's Disease and Ulcerative Colitis. Among these, Crohn's Disease dominates the global market.
According to Arizton estimates, the prevalence of Crohn's Disease was high in the United States, followed by the UK and China, in 2020. The increasing prevalence of Crohn's Disease is driving the growth of the Crohn's Disease drugs market. According to estimates, one million people were affected with Crohn's Disease in the US in 2019.
Crohn's Disease Therapeutics: Pipeline Scenario
The Crohn's Disease portfolio contains a total of 100+ assets that are in various phases of development. Most industry-sponsored drugs in active clinical development for Crohn's Disease are in the Phase II stage. Anti-interleukin and integrin antibodies are dominating the Crohn’s Disease drug pipeline.
Crohn's Disease Therapeutics: Clinical Trials Scenario
The clinical trial portfolio contains 150+ trials in various development phases. Most industry-sponsored drugs in active clinical development for Crohn's Disease are in the Phase II stage. The distribution of clinical trials across Phase I-IV indicates that the vast majority of trials for Crohn's Disease have been in the early and mid-phases of development, with 75-80% of trials in Phase I-II and only 16% in Phase III-IV. The US has a substantial lead in the number of global Crohn's Disease clinical trials.
Adoption of Biologics: Biological therapies such as anti-tumor necrosis factor (TNF), anti-interleukin & integrin antibodies are widely used for various inflammatory diseases such as Crohn’s disease (CD). These are considered generally satisfactory in treating patients who are not adequately controlled by steroids and aminosalicylates. Still, some patients can experience a loss of response to these therapies, particularly anti-TNFs. With Stelara (ustekinumab) being the last biologic approved for Crohn’s disease in 2016, there is a demand for therapies with novel MOAs that are less immunogenic than current offerings and many new classes of therapies are looking to enter the industry over the next few years. The biologics such as anti-integrin and interleukin inhibitors are making inroads into the Crohn’s Disease market owing to better clinical profile and convenient patient dosing.
Increasing Prevalence of Crohn's Disease: The market studied has been witnessing considerable growth, which can be associated with the increasing prevalence of Crohn's Disease worldwide. As per estimates, the prevalence of Crohn's Disease patients was 18,30,704 in the 8MM in 2020. This number is expected to reach 21,91,344 from 2021 to 2027.
The Emergence of Microbiome Therapeutics: microbiome-based therapeutics with novel mechanisms are emerging for treating Crohn’s Disease. Major players in the industry are developing novel products and spending significantly on research and development, along with major acquisitions and collaborations.
For example, Takeda has entered into a global licensing, co-development, and co-promotion agreement with Enterome S.A. Enterome, BiomX, Synlogics, 4D Pharma, Vedanta Bioscience, and many others are focusing on microbiome-based therapeutics for the treatment of the disease. These players adopt organic and inorganic growth strategies to strengthen their product portfolio.
Successive Launch of New Therapies: There are already several biologics indicated for the treatment of moderate-to-severe Crohn’s disease, including anti-TNFs Humira (adalimumab), Remicade (infliximab), and Cimzia (certolizumab pegol), the anti-integrins Entyvio (vedolizumab), and Tysabri (Natalizumab), and the interleukin (IL) 12 and 23 inhibitors Stelara (ustekinumab) and Skyrizi (Risankizumab-rzaa). Presently, five major companies have approved branded drugs in the Crohn’s Disease treatment market—Johnson & Johnson (J&J), AbbVie, Takeda, UCB, and Biogen.
Drug Class: Among the drug class, TNF-Alpha inhibitors are expected to account for a significant share of the global Crohn's disease therapeutics market. However, the other drugs are expected to be the fastest growing segment during the forecast period. Recently approved biologics such as Skyrizi (risankizumab-rzaa) are expected to drive the global Crohn's Disease treatment market during the forecast period. The Crohn’s disease market has historically relied on anti-tumor necrosis factor (anti-TNF) therapies that have been available for over a decade. Still, recent developments have led to research on novel mechanisms of action (MOAs) to combat the high numbers of patients experiencing treatment non-response. The Crohn’s disease market will experience significant growth due mainly to the launch of new drugs, most of which are expected to launch between 2023–2025, targeting the moderate-to-severe patient population. The biologics such as anti-integrin and interleukin inhibitors are making inroads into the Crohn’s Disease market owing to better clinical profile and convenient patient dosing.
Gender type: Among the gender type, Women were expected to account for a significant share of the global Crohn's disease therapeutics market; this is because of slight women's predominance over men.
Disease type: Among the disease type, the small/large intestinal type is expected to account for a significant share of the global Crohn's Disease treatment market. However, the small intestinal type is expected to be the fastest growing segment during the forecast period.
Age Group: Among the Age group, People of age 49 yrs & below are expected to account for a significant share of the global Crohn’s Disease therapeutics market. The disease can occur at any age, but Crohn’s Disease is most often diagnosed in adolescents and adults between the ages of 20 and 30.
The U.S. dominates Crohn’s disease therapeutics market by geography due to the rise in affordable healthcare, knowledge, and awareness amongst the people, and technological advancement in this region. However, the UK is expected to grow faster with a high CAGR in Crohn's Disease drug market due to the rise in access and quality of healthcare, increased awareness about disease management, and rising healthcare expenditure in this region. The trend of biosimilars in emerging markets, such as China and Japan, could potentially alter the therapeutic landscape in this region.
The Crohn's disease treatment market is dominated by many companies offering generic drugs and selective pharma/biotech companies offering patented/commercial drugs for treating Crohn's Disease. The U.S. Food and Drug Administration (FDA) approved the TNF-Alpha agent Humira (Adalimumab) for treating Crohn's Disease in 2012. Following this, the FDA approved Stelara (ustekinumab) in 2016 and Skyrizi (risankizumab-rzaa) in 2022 for treating Crohn's Disease. Although generic products continue to capture significant industry share, the arrival of biologics and other targeted therapies indicates a paradigm shift in this therapeutic space through the forecast period.
The prominent players offering drugs in the Crohn's Disease treatment market include Takeda, Abbvie, Janssen Pharmaceuticals, Pfizer, Bristol-Myers-Squibb, Gilead Bioscience, Celltrion, RedHill Biopharma, Landos Biopharma, ReiStone Biopharma, Eli Lilly and Company, and many others.
Key Mergers & Acquisitions:
- In Mar 2022, Pfizer Inc. announced the completion of its acquisition of Arena Pharmaceuticals. Under the terms of the agreement, Pfizer has completed its acquisition of all outstanding shares, options, and restricted stock units of Arena.
- In Jun 2021, Synlogic, Inc announced that it had entered into a research collaboration agreement with Roche to discover a novel Synthetic Biotic medicine for the treatment of inflammatory bowel disease (IBD). Under the terms of the deal, Synlogic and Roche will collaborate to develop a Synthetic Biotic drug addressing an undisclosed novel target in IBD.
- In May 2021, Landos Biopharma, Inc and LianBio entered an exclusive collaboration and license agreement for the development and commercialization of omilancor and NX-13 in Greater China (mainland China, Hong Kong, Taiwan, and Macau) and selected Asian markets. Under the terms of the collaboration, LianBio will receive exclusive rights to develop and commercialize omilancor and NX-13 in Greater China, South Korea, Singapore, Thailand, Vietnam, Myanmar, Cambodia, Indonesia, and the Philippines.
- In June 2022, AbbVie announced that the U.S. Food and Drug Administration (FDA) had approved SKYRIZI (risankizumab-rzaa) as the first and only specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease (CD). The approval was based on The ADVANCE and MOTIVATE studies designed to evaluate the efficacy and safety of two doses of risankizumab, 600 mg and 1200 mg, in adults with moderately to severely active Crohn's disease compared to placebo.
- In May 2022, AbbVie announced positive topline results from U-ENDURE, its Phase 3 maintenance study evaluating upadacitinib in adult patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to conventional or biologic therapy. The results showed that more patients treated with either dose of upadacitinib (15 mg or 30 mg once daily) achieved the co-primary endpoints of endoscopic response and clinical remission, as well as the secondary endpoint of endoscopic remission, at one year (week 52) compared to placebo.
- In March 2022, Ossium Health, Inc. announced that the U.S. Food and Drug Administration (FDA) had accepted its Investigational New Drug (IND) application for OSSM-001, a mesenchymal stem cell (MSC) product, for the treatment of refractory perianal fistulas in patients with Crohn’s disease. Ossium plans to initiate patient screening and enrollment in a multi-center Phase 1 clinical trial evaluating OSSM-001 by the end of 2022.
- Detailed overview of Crohn's Disease, including disease definition, classification, diagnosis, and treatment pattern
- Overview of the global trends of Crohn's Disease therapeutics market in the eight major markets (8MM)
- Historical, current, and projected patient pool of Crohn's Disease for the 2018 – 2027 period
- Gender type, Disease Type, Age Group, Drug Class, and Geography type segmentation of Crohn's Disease
- Historical, current, and projected size of Crohn's Disease treatment market for the 2018 – 2027 period
- In-depth analysis of the segments, which includes products, treatment, and competitor analysis
- Market share of the key players, company profiles, product specifications, and competitive landscape
- Comprehensive data on emerging trends, drivers, growth opportunities, and restraints
- Detailed overview of marketed drugs with key coverage of developmental activities, including sponsor name, approved indication, territory, collaborations, licensing, mergers and acquisitions, regulatory designations, and other product-related activities.
- Detailed overview of therapeutic pipeline activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and MOA type for Crohn's Disease across the complete product development cycle, including all clinical and non-clinical stages
- Detailed overview of clinical trial activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and Geography type for Crohn's Disease across all clinical stages
- Coverage of dormant and discontinued pipeline projects along with the reasons across Crohn's Disease treatment market
- Coverage of major milestones (product approvals/launches timelines, clinical trial result publications, regulatory designations, licensing & collaborations, research & development progress of pipeline assets) in the Crohn's Disease space.