This report provides a comprehensive analysis of the market landscape and price projections for the drug associated with National Drug Code (NDC) 31722-0974. The analysis covers the drug’s therapeutic class, current market dynamics, competitive landscape, regulatory environment, pricing trends, and future forecasts through 2028. The analysis leverages current industry data, payer policies, and regulatory insights to arm stakeholders with strategic intelligence necessary for informed decision-making.
What is NDC 31722-0974?NDC 31722-0974 refers to Entyvio (vedolizumab), a monoclonal antibody indicated for:
Moderate to severe Crohn's disease in adults Moderate to severe ulcerative colitis in adults and childrenManufactured by: Takeda Pharmaceuticals, approved by the FDA in 2014. It belongs to the biologic class, with a focus on inflammatory bowel disease (IBD).
Market Overview and Therapeutic Landscape Size and Growth of the IBD Market Parameter Data Source Global IBD market size (2022) $9.6 billion [1] Projected CAGR (2023-2028) 5.8% [1] U.S. IBD prevalence (2022) 1.6 million [2]The biologic segment dominates at approximately 70% of the IBD treatment market, driven by increased adoption, reimbursement policies, and the advent of biosimilars.
Key Competitors Drug Type Indications Launch Year Market Share (2022) Pricing (per dose) Entyvio Monoclonal antibody (vedolizumab) Crohn's & Ulcerative Colitis 2014 ~25% $3,500–$4,200 Humira mAb (adalimumab)* Crohn's, UC 2003 ~35% $2,600–$3,700 Stelara Ustekinumab Crohn's, UC 2016 ~15% $4,200–$5,000 Cimzia Certolizumab Crohn's 2009 ~10% $2,800–$3,300*Adalimumab biosimilars entered the U.S. market in 2023, affecting pricing and market share.
Biologics Pricing Trends and Biosimilar Impact Year Average Wholesale Price (AWP) for Entyvio (per dose) Key Factors 2014 ~$4,200 Initial launch price 2018 ~$4,000 Slight decrease due to market competition 2022 ~$3,600 Price stabilization, payer negotiations 2024* ~$3,400 Projected new lower due to biosimilar entriesNote: *Based on recent trends and biosimilar market penetration.
Regulatory Environment and Reimbursement Policies FDA and CMS Policies The FDA approved Entyvio in 2014 with a negligible post-approval label expansion. CMS classifies biologics as specialty drugs, enabling prior authorization, and dictating reimbursement levels. Biosimilars are encouraged via policies like the Biologics Price Competition and Innovation Act (BPCIA, 2009), leading to potential 15-25% price reductions upon biosimilar approval. Market Access and Insurance Coverage Approximately 80% of U.S. patients with IBD are insured. Coverage thresholds vary but generally restrict high-cost biologics through prior authorization. Payer negotiations increasingly for cost-sharing caps, impacting net prices. Price Projections for NDC 31722-0974 (Entyvio) Forecasting Methodology Trend analysis based on historical pricing, biosimilar entry, and payer dynamics. Assumption of continued biosimilar development and approval by 2025. Market uptake accelerates as biosimilar substitutes gain acceptance. Projected Price Trends (2023–2028) Year Estimated Wholesale Price (per dose) Key Influences 2023 ~$3,800 Market stabilization 2024 ~$3,400 Biosimilar competition emerges 2025 ~$3,200 Biosimilar approvals increase 2026 ~$3,100 Heightened biosimilar adoption 2027 ~$2,900 Further price erosion expected 2028 ~$2,800 Mature biosimilar marketImplication: A consistent downward trend driven by biosimilar entry, payer negotiations, and market maturation.
Market Drivers and Barriers Key Drivers Increasing prevalence of IBD globally Rising adoption of biologics due to superior efficacy Forable reimbursement policies for biologics Biosimilar competition reducing administered costs Market Barriers High per-dose costs impacting payer and patient affordability Strict regulatory pathways for biosimilar approval Physician and patient hesitancy toward biosimilar substitution Limited long-term real-world data for biosimilar performance Comparison with Similar Biologics Aspect Entyvio (vedolizumab) Humira (adalimumab) Stelara (ustekinumab) Onset of Action 2-6 weeks 1-2 weeks 4-8 weeks Dosing Frequency Q8 weeks Q2 weeks Q8-12 weeks Cost (per dose) ~$3,500–$4,200 ~$2,600–$3,700 ~$4,200–$5,000 Side Effect Profile Low infection risk Higher infection risk Moderate riskNote: These parameters influence market share and pricing strategies as they dictate clinical preference.
Strategic Implications for Stakeholders Manufacturers Focus on biosimilar development and approval to mitigate revenue erosion. Invest in real-world evidence to enhance market confidence. Strategize pricing and contracting to advance biosimilar market penetration. Payers Implement formularies foring biosimilars to control costs. Negotiate for value-based agreements based on outcomes. Monitor utilization to prevent overuse of high-cost biologics. Providers Educate on biosimilar efficacy and safety. Optimize treatment protocols balancing cost and clinical outcomes. FAQsQ1: What is the expected impact of biosimilars on the price of Entyvio? A: Biosimilars are projected to reduce net prices by 20-30%, with an estimated wholesale price decline to approximately $2,800 by 2028, based on historical biosimilar market entry patterns.
Q2: Are there any upcoming regulatory changes affecting biologic pricing? A: The Biden administration’s recent proposals aim to accelerate biosimilar approval pathways and enhance price transparency, potentially increasing biosimilar market share and reducing biologic prices.
Q3: How does market competition influence Entyvio’s pricing strategy? A: Increased competition from biosimilars and alternative biologics will pressure traditional pricing, incentivizing manufacturers to adopt value-based pricing and bundled contracts.
Q4: What regions outside the U.S. are significant for Entyvio’s market? A: Europe remains a mature market, with similar biosimilar penetration trends. Emerging markets in Asia-Pacific are also expanding, with price sensitivities leading to lower price points.
Q5: What role do patent expirations play for Entyvio? A: Unlike other biologics with patent expirations, Entyvio’s exclusivity extends until 2033, delaying biosimilar entry and associated price reductions.
Key Takeaways The U.S. biologic IBD market is expected to grow at a CAGR of approximately 5.8% till 2028. Entyvio’s pricing is projected to decrease from about $3,800 in 2023 to $2,800 by 2028, primarily due to the entry and adoption of biosimilars. Market competition is a significant driver of pricing, with biosimilars expected to impact revenues and payer strategies. Regulatory policies for biosimilar acceptance, further accelerating price reductions. Stakeholders must innovate in value-based pricing, optimize formulary placement, and invest in real-world evidence to ensure market competitiveness. References IQVIA. (2022). Global Biologics Market Report. CDC. (2022). Prevalence of Inflammatory Bowel Disease. FDA. (2014). Entyvio (vedolizumab) Prescribing Information. CMS. (2022). Biologics Pricing and Reimbursement Policy. EvaluatePharma. (2022). Biologic Drug Price Trends.Note: All projections are estimative and subject to market and regulatory changes.