Biologics and Biosimilars for IBD Market
Biologics and biosimilars for IBD market is growing quickly as inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis, continues to impact more people around the world. These chronic autoimmune diseases need long-term management, and biologics have become the most effective treatment option. As many original biologics lose their patents, biosimilars are entering the market, providing affordable choices and increasing patient access. The market benefits from advancements in monoclonal antibodies, the rise of targeted immunotherapies, and higher diagnosis rates globally.
The global burden of IBD is on the rise, with over 10 million individuals affected worldwide as of 2024. North America and Europe have the highest rates of the disease, but Asia-Pacific and Latin America are seeing rapid increases due to urbanization, dietary changes, and improved diagnostic capabilities. The biologics and biosimilars for IBD market was valued at around USD 30.5 billion in 2024 and is expected to grow to USD 47.8 billion by 2030, with a CAGR of 7.8%. This growth is supported by favorable regulations, patient advocacy, and ongoing clinical trials aimed at enhancing safety and effectiveness.
Recent developments include the FDA approving new biosimilars for infliximab and adalimumab, increased use of subcutaneous biologics, and broader access through patient support programs. Governments and private insurers are encouraging biosimilar adoption, leading to lower healthcare costs and wider treatment access.
Market Segmentation
By Product Type
Originator Biologics
Biosimilars
Monoclonal Antibodies
TNF Inhibitors
Integrin Receptor Antagonists
IL Inhibitors
Originator biologics like Remicade, Humira, and Entyvio have long been the mainstay of IBD treatment. However, biosimilars are gaining popularity due to their lower prices and similar effectiveness. IL inhibitors and integrin receptor antagonists are also becoming more popular for their better safety profiles.
By Application / End-Use Industry
Hospitals
Specialty Clinics
Retail and Online Pharmacies
Diagnostic and Research Laboratories
Academic Medical Centers
Hospitals and specialty clinics command the largest market share because they have advanced infusion systems and specialized care. However, retail and online pharmacies are expected to grow rapidly as subcutaneous formulations and home delivery options become more available.
By Region
North America
Europe
Asia-Pacific
Latin America
Middle East & Africa
North America leads the market due to high use of biologics, solid reimbursement systems, and ongoing innovations. Europe follows closely, driven by proactive biosimilar policies and early diagnosis initiatives. Asia-Pacific is set for the fastest growth, driven by rising awareness, supportive healthcare reforms, and urbanization. Latin America and the Middle East & Africa show untapped potential, with increased healthcare access and international collaborations paving the way.
Key Market Players
- AbbVie Inc. – Known for Humira, a TNF inhibitor, and Skyrizi, a newer IL-23 therapy for IBD.
- Johnson & Johnson (Janssen) – Maker of Remicade and Stelara, which are key biologics for IBD.
- Takeda Pharmaceuticals – Producer of Entyvio, a gut-selective biologic that targets integrin receptors.
- Pfizer Inc. – Active in biosimilars like Inflectra (a biosimilar to Remicade) and expanding its biologics pipeline.
- Amgen Inc. – Producer of Amjevita, a biosimilar to Humira, with strong distribution in the U.S. and globally.
- Samsung Bioepis – A leader in biosimilar development, especially for infliximab and adalimumab
- Biogen Inc. – Focuses on biosimilar commercialization in Europe and has partnerships with major biologic companies.
- Celltrion Healthcare – Offers various biosimilars for IBD, including Remsima and Truxima, in global markets.
- Roche Holding AG – Investigates IL and T-cell therapies for IBD, with multiple candidates in development.
- Fresenius Kabi – Expanding its presence in the biosimilars market with recent approvals in Europe.
Strategic Developments
- AbbVie launched subcutaneous formulations for Humira biosimilars to enhance convenience.
- Pfizer increased manufacturing capability in Belgium for biologics and biosimilars.
- Takeda received FDA approval for new indications of Entyvio, including for pediatric ulcerative colitis.
- Amgen and Samsung Bioepis partnered to commercialize biosimilars in North America.
- Johnson & Johnson shared real-world data showing Stelara's effectiveness in Crohn’s disease.
- Celltrion developed a self-injection device for biosimilar infliximab to facilitate home treatment.
Market Drivers
- Increasing Global Prevalence of IBD
- Strong Clinical Outcomes and Effectiveness of Biologics
- Patent Expiry of Leading Biologics
- Cost Benefits and Growing Access of Biosimilars
- Supportive Regulatory and Reimbursement Environment
- Enhanced Awareness and Diagnosis through Screening Programs
Emerging Technologies and Innovations
- Subcutaneous delivery of biologics for patients to administer themselves
- AI-driven disease tracking and digital compliance tools
- Personalized medicine utilizing genomic and microbiome information
- Development of dual-action biologics for complex IBD cases
- mRNA and oral biologic therapies in clinical trials
Market Restraints
- High Treatment Costs of Original Biologics
- Complex Manufacturing and Cold Chain Requirements
- Limited Access in Low-Income Regions
- Regulatory Issues with Biosimilar Substitution
- Reluctance from Healthcare Providers and Patients to Change Treatments
Opportunities & Future Trends
- Growth of Biosimilars in Emerging Markets
- Increased Investment in Pediatric and Mild IBD Treatment
- Telemedicine Support for IBD Monitoring and Medication Adherence
- Collaborations Between Pharma and Digital Health Firms
- Larger Role of Pharmacogenomics in Selecting and Dosing Medications
Regional Insights
North America has the largest market share due to widespread biologics usage, good insurance coverage, and advanced treatment methods. Europe benefits from early approvals of biosimilars and government strategies to control costs. Asia-Pacific is growing rapidly as healthcare systems invest in chronic disease management and public education. Latin America is turning to biosimilars to enhance affordability and broaden coverage. The Middle East and Africa remain developing areas with long-term potential as international health organizations focus on improving chronic care access.
Target Audience
- Biopharmaceutical companies and investors
- Hospital administrators and gastroenterologists
- Biosimilar manufacturers and distributors
- Health policymakers and regulators
- Digital health startups and AI analytics firms
- Academic researchers and CROs in immunology
