Inflammatory Bowel Disease (IBD) Drugs Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Drug Class (TNF Inhibitors, Corticosteroids, Amino Salicylates, Immunomodulators, Others), By Disease Indication (Ulcerative Colitis, Crohn’s Disease), By Route of Administration (Oral, Injectable), By Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy), By Region and Competition, 2019-2029F

Market Overview

Global Inflammatory Bowel Disease (IBD) Drugs Market was valued at USD 21.73 Billion in 2023 and is anticipated to project impressive growth in the forecast period with a CAGR of 5.41% through 2029. The market is rapidly growing, driven by various factors such as the increasing prevalence of the disease, a growing aging population, and advances in drug research and development. The incidence of IBD is increasing globally, and the disease is often chronic, requiring long-term treatment. The introduction of biological therapies has revolutionized the treatment of IBD, but the high cost of treatment has been a barrier to access for many patients. However, the development of biosimilars has led to increased competition in the IBD drugs market, resulting in lower prices and improved access to treatment. The aging population is expected to increase in the coming years, leading to a rise in the number of patients with IBD. The increasing prevalence of ulcerative colitis and Crohn's disease is driving the growth of the global market for inflammatory bowel disease drugs. The growing awareness of the disease worldwide is one of the factors fueling the market growth for inflammatory bowel disease treatments. Additionally, the availability of medications such as infliximab, adalimumab, golimumab, and certolizumab for the treatment of inflammatory bowel disease is driving market expansion.

Key Market Drivers

Increasing Incidence of Inflammatory Bowel Disease Around the World

Inflammatory Bowel Disease (IBD) patients have a death rate that is 1.5–5 times higher than the general population. Crohn's disease patients have the highest morbidity and mortality rates. Infections and disease progression, as well as surgical complications, are among the leading causes of death. More significantly, colorectal cancer is frequently diagnosed in individuals with IBD. The likelihood of developing colon cancer within 20 years is highest in patients with pancolitis. Therefore, screening colonoscopies are advised every one to two years. These individuals not only have the condition but are also treated with strong drugs like steroids and biological agents, which have a variety of side effects.

In North America, the incidence of inflammatory bowel disease (IBD) varies from 2.2 to 19.2 cases per 100,000 person-years for ulcerative colitis and from 3.1 to 20.2 cases per 200,000 person-years for CD, according to a paper published by the National Institutes of Health (NIH). Adult ulcerative colitis is prevalent in the United States at 238 per 100,000 people and 201 per 100,000 people. IBD is far more common in Europe and North America than in Asia or Africa. Up to 25% of patients will develop IBD by adolescence, despite the fact that the majority of IBD cases affect adults between the ages of 15 and 30.

Although females are significantly more likely than males to get Crohn's disease, both sexes seem to experience ulcerative colitis equally. IBD typically affects developed nations and regions with colder climates, which is also expected to increase the demand for IBD drugs as cases of Inflammatory Bowel Disease rise.

Surging Approval of Biosimilars

The rising demand and approvals for biosimilars for the treatment of various inflammatory conditions are high-impact factors for the market. For instance, in December 2022, the U.S. FDA approved Idacio as the eighth adalimumab biosimilar in the U.S. The newly approved biosimilar is a citrate-free low-concentration preparation intended for the treatment of several inflammatory conditions, including Crohn’s Disease in adults and children aged 6 years or older. In addition, in October 2021, the U.S. FDA approved Cyltezo for the management of moderate to severe Crohn’s Disease and Ulcerative Colitis.

Additionally, government agencies are working to encourage the use of biosimilars by ensuring their safety. For instance, the government body of Saskatchewan (Canada) started a biosimilar program in October 2022 to make high-quality treatments more affordable for its citizens. Similarly, to encourage the adoption of biosimilar candidates, Canadian governments like Ontario and Quebec are extending their biosimilar programs. Moreover, the increasing introduction of biosimilars is expected to boost the adoption of biological products for the treatment of IBD in developing economies.

Increasing Mergers and Acquisitions

For the treatment of immune-mediated illnesses like Crohn's disease, ulcerative colitis, and other autoimmune ailments, Prometheus is creating PRA023. The PRA023 study, ARTEMIS-UC, a Phase 2 placebo-controlled study evaluating safety and efficacy in patients with moderate to severely active Ulcerative Colitis, and APOLLO-CD, a Phase 2A open-label study evaluating safety and efficacy in patients with moderate to severely active Crohn’s Disease, have produced positive results in December 2022 according to the recent presentations of the findings that took place at the ECCO's (18th) Congress. The company's flagship candidate, PRA023, is a humanized monoclonal antibody (mAb) directed against TL1A, a target linked to both intestinal fibrosis and inflammation. PRA023 is a unique, late-stage candidate for Crohn's disease, ulcerative colitis, and other autoimmune diseases.

A cooperative development agreement was initiated in 2020 between Intract Pharma and Celltrion Inc., Celltrion Healthcare Co., Ltd., and the Celltrion Group for the development of the first oral antibody therapy for the treatment of inflammatory bowel disease. The oral medication, along with Remsima IV and Remsima SC's intravenous and subcutaneous preparations, is anticipated to maintain Celltrion's dominant position in the TNF-inhibitor market. Intract Pharma will be responsible for developing the product through clinical validation, with assistance from the Celltrion Group, including the provision of drug material for the production of the oral product. After the conclusion of Phase 2 clinical trials, Celltrion Group retains the right to complete the clinical development of the product and launch it on the market. The oral infliximab medication has been given the all-clear by the UK regulatory agency (MHRA) to proceed to Phase 1b/2a clinical trials in IBD patients during the second half of 2021, without the need for additional preclinical investigation or a clinical safety assessment. The focus of the development of the oral drug is to maintain its stability at room temperature, making it easy for patients to distribute, store, and administer at home.

The joint development is focused on introducing the first orally administered antibody that targets inflammatory bowel disease (IBD), which is expected to have an impact not only on the market for infliximab but also on the therapy market for IBD more broadly. In terms of technological platforms that reliably deliver antibodies to the intestine, Intract Pharma is at the forefront of the sector. Collaboration between the two parties is anticipated to pave the way for the creation of more novel oral antibodies for application in patients, which is expected to increase the market growth of inflammatory bowel disease drugs globally.

Growing Pipeline of Investigational Drugs

The expanding pipeline of investigational drugs for Inflammatory Bowel Disease (IBD) is another key driver boosting the market for IBD drugs. Pharmaceutical companies are actively engaged in the development of new drug candidates targeting various pathways involved in the pathogenesis of IBD, including immune modulation, cytokine inhibition, and mucosal healing. These investigational drugs encompass a diverse range of therapeutic modalities, including small molecules, biologics, and cell-based therapies, offering a comprehensive approach to managing IBD and addressing unmet medical needs. As promising candidates progress through clinical trials and regulatory approval processes, the availability of new treatment options for patients with IBD is expected to increase, driving market growth and expansion in the coming years.

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Key Market Challenges

Adverse Effects & Safety Concerns

The occurrence of adverse effects and safety concerns associated with existing treatment modalities. While medications such as biologic therapies, immunomodulators, and corticosteroids can effectively manage disease activity and induce remission in many patients with IBD, they may also be associated with a range of adverse effects and safety risks that impact patient tolerability, adherence, and long-term outcomes.

Adverse effects of IBD drugs can vary widely and may include infusion reactions, infections, gastrointestinal symptoms, dermatological reactions, hepatotoxicity, hematological abnormalities, and increased risk of malignancies. Additionally, certain medications may have long-term safety concerns, such as immunosuppressants' increased susceptibility to infections or corticosteroids' potential for bone density loss and metabolic complications. These safety concerns can limit the utility of existing IBD drugs, particularly in patients with comorbidities or specific risk factors, and may necessitate treatment modifications or discontinuation, leading to suboptimal disease management and poor patient outcomes.

Limited Treatment Options for Pediatric Patients

A significant challenge in the market for Global Inflammatory Bowel Disease (IBD) drugs is the limited availability of safe and effective treatment options for pediatric patients with IBD. While IBD predominantly affects adults, a substantial proportion of patients are diagnosed during childhood or adolescence, presenting unique challenges in disease management and treatment decision-making for pediatric populations.

Children and adolescents with IBD may experience distinct disease phenotypes, disease trajectories, and treatment responses compared to adults, necessitating tailored approaches to diagnosis and therapy. However, the evidence base for pediatric IBD treatments is limited, as clinical trials often exclude pediatric populations or have small sample sizes, leading to gaps in knowledge regarding treatment efficacy, safety, and long-term outcomes in children and adolescents with IBD.

Furthermore, pediatric patients may face challenges in accessing specialized care, multidisciplinary support, and age-appropriate treatment options for IBD, particularly in regions with limited pediatric gastroenterology expertise or healthcare resources. This lack of access to comprehensive care and evidence-based treatments may result in delayed diagnosis, suboptimal disease management, and poorer outcomes for pediatric patients with IBD.

Key Market Trends

Emergence of Oral Small Molecule Inhibitors

A notable trend in the Global Inflammatory Bowel Disease (IBD) drugs market is the emergence of oral small molecule inhibitors as a promising class of therapeutics for the treatment of IBD. Unlike biologic therapies, which are administered via injections or infusions, small molecule inhibitors are orally administered drugs that target intracellular signaling pathways involved in the inflammatory cascade. These medications offer several advantages, including convenience of administration, improved patient compliance, and potential cost savings compared to biologics.

Small molecule inhibitors act by inhibiting key enzymes or receptors involved in inflammatory signaling pathways, such as Janus kinase (JAK) inhibitors, sphingosine-1-phosphate receptor modulators, and phosphodiesterase inhibitors. These agents modulate immune responses, reduce inflammation, and restore mucosal barrier function in patients with IBD, thereby providing an alternative treatment option for individuals who may not respond to or tolerate biologic therapies.

Furthermore, the development of oral small molecule inhibitors represents a significant advancement in personalized medicine for IBD, as these agents offer the potential for targeted therapy based on individual disease characteristics and treatment responses. Unlike biologics, which are often associated with immunogenicity and loss of response over time, small molecule inhibitors may offer a more durable treatment effect and greater flexibility in dosing regimens, enhancing treatment optimization and patient outcomes.

Focus on Personalized Medicine and Precision Therapy

A significant trend driving innovation in the Global Inflammatory Bowel Disease (IBD) drugs market is the shift towards personalized medicine and precision therapy approaches tailored to individual patient characteristics, disease phenotypes, and treatment responses. IBD is a heterogeneous condition with diverse clinical presentations and underlying pathogenic mechanisms, requiring personalized treatment strategies that address the unique needs and preferences of each patient.

Personalized medicine in IBD involves the use of biomarkers, genetic testing, and other molecular diagnostics to identify patient subgroups that may benefit from specific therapies or treatment modalities. Biomarkers such as fecal calprotectin, C-reactive protein, and genetic variants associated with IBD susceptibility can help guide treatment decisions, predict disease progression, and monitor treatment response in patients with IBD. Additionally, advances in genomic profiling and molecular imaging techniques offer insights into disease activity, mucosal healing, and therapeutic targets, enabling more precise and individualized treatment approaches.

Segmental Insights

Drug Class Insights

Based on the drug class, TNF inhibitors are currently dominating the Global Inflammatory Bowel Disease (IBD) Drugs Market. TNF inhibitors, also known as anti-TNF agents, are a class of biologic therapies that target Tumor necrosis factor-alpha (TNF-α), a pro-inflammatory cytokine implicated in the pathogenesis of IBD. These medications work by binding to soluble and membrane-bound TNF-α, thereby neutralizing its activity and reducing inflammation in the gastrointestinal tract.

TNF inhibitors have revolutionized the treatment landscape for IBD, offering effective therapeutic options for patients with moderate to severe disease who have failed to respond to conventional therapies. Medications such as infliximab, adalimumab, and certolizumab pegol have demonstrated efficacy in inducing and maintaining remission, improving mucosal healing, and reducing disease activity in patients with Crohn's disease and ulcerative colitis.

Disease Indication Insights

Based on the Disease Indication segment, In the Global Inflammatory Bowel Disease (IBD) drugs market, both ulcerative colitis and Crohn's disease are significant indications, but Crohn's disease currently dominates the market. Crohn's disease and ulcerative colitis are the two primary forms of IBD, characterized by chronic inflammation of the gastrointestinal tract, but they differ in terms of their location, pattern of inflammation, and clinical manifestations.

Crohn's disease is a chronic inflammatory condition that can affect any part of the digestive tract, from the mouth to the anus, but it most commonly involves the small intestine and the colon. It is characterized by transmural inflammation, meaning inflammation that extends through the entire thickness of the intestinal wall, and can lead to complications such as strictures, fistulas, and abscesses. Crohn's disease often presents with symptoms such as abdominal pain, diarrhea, fatigue, weight loss, and malnutrition, and it can have a significant impact on quality of life and long-term health outcomes.

Ulcerative colitis, on the other hand, is a chronic inflammatory condition that primarily affects the colon and rectum. It is characterized by inflammation and ulceration of the mucosal lining of the colon, typically starting in the rectum and extending proximally in a continuous fashion. Ulcerative colitis often presents with symptoms such as bloody diarrhoea, abdominal pain, urgency, and tenesmus. While ulcerative colitis is typically less severe than Crohn's disease and tends to have fewer extraintestinal manifestations, it can still cause significant morbidity and impairment of quality of life.

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Regional Insights

North America is currently dominating the global Inflammatory Bowel Disease (IBD) drugs market. This region's dominance can be attributed to several key factors that collectively contribute to its significant market share and influence in the IBD pharmaceutical sector. North America boasts a robust healthcare infrastructure with well-established medical institutions, advanced research facilities, and a high level of healthcare spending. This infrastructure supports comprehensive diagnostic capabilities, specialized treatment centers, and access to cutting-edge therapies for patients with IBD. Consequently, patients in North America have greater access to innovative IBD drugs, clinical trials, and multidisciplinary care, driving market growth and adoption of novel therapies.

North America is home to a large patient population affected by Inflammatory Bowel Disease, including Crohn's disease and ulcerative colitis. The prevalence of IBD in North America is among the highest globally, with millions of individuals diagnosed with the condition. This sizable patient population creates a significant market opportunity for pharmaceutical companies developing IBD drugs, driving demand for effective treatments and driving market expansion.  

Recent Developments

• In 2023, Merck & Co., Inc. strengthened its immunology pipeline with the acquisition of Prometheus Biosciences, Inc., a clinical-stage biotech firm specializing in precision medicine for immune-mediated diseases. Their lead candidate, PRA023, is a humanized monoclonal antibody targeting TNF-like ligand 1A (TL1A), associated with intestinal inflammation and fibrosis. This strategic move enhances Merck's capabilities in developing novel therapeutic and companion diagnostic products for immune-related conditions.

Key Market Players

• Takeda Pharmaceutical Company Limited
• AbbVie Inc.
• Pfizer Inc.
• UCB S.A.
• Johnson & Johnson
• Novartis AG
• Bristol Myers Squibb Co.
• Merck & Co., Inc.
• Celltrion, Inc.

Report Scope:

In this report, the Global Inflammatory Bowel Disease (IBD) Drugs Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Inflammatory Bowel Disease (IBD) Drugs Market, By Drug Class:

o   TNF Inhibitors

o   Corticosteroids

o   Amino salicylates

o   Immunomodulators

o   Others

• Inflammatory Bowel Disease (IBD) Drugs Market, By Disease Indication:

o   Ulcerative Colitis

o   Crohn’s Disease

• Inflammatory Bowel Disease (IBD) Drugs, By Route of Administration:

o   Oral

o   Injectable

• Inflammatory Bowel Disease (IBD) Drugs Market, By Distribution Channel:

o   Hospital Pharmacy

o   Retail Pharmacy

o   Online Pharmacy

• Inflammatory Bowel Disease (IBD) Drugs Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Inflammatory Bowel Disease (IBD) Drugs Market.

Available Customizations:

Global Inflammatory Bowel Disease (IBD) Drugs market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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