Last updated: July 30, 2025
Introduction
Drug NDC 52268-0100, marketed under the label Jivi, is a recombinant human coagulation factor used primarily in the treatment and prophylaxis of bleeding episodes in patients with hemophilia A. As a long-acting factor VIII Product, Jivi has gained prominence due to its extended half-life, reducing the frequency of infusions compared to traditional factor VIII products. The following analysis evaluates the current market landscape, competitive positioning, pricing trends, and future price projections for this pharmaceutical.
Market Overview
Therapeutic Context
Hemophilia A is a hereditary bleeding disorder resulting from factor VIII deficiency. The condition affects roughly 1 in 5,000 male births globally. Treatment involves replacing the missing clotting factor, traditionally via plasma-derived or recombinant products. The advent of long-acting therapies like Jivi has transformed management by improving patient adherence, reducing infusion frequency, and enhancing quality of life.
Market Size and Growth
The global hemophilia treatment market is valued at approximately USD 10-12 billion as of 2023, projected to grow at a CAGR of 5-7% over the next five years [1]. The growth is driven by increased diagnosis, expanded access in developing regions, and the advent of new, long-acting agents. Jivi, with its extended half-life, occupies a significant niche, especially among prophylactic therapies.
Regulatory Status
Jivi has received approvals in multiple markets, including the U.S. FDA, EU EMA, and Japan's PMDA. Its approval is based on clinical studies demonstrating bioequivalence and safety, solidifying its position in the long-acting clotting factor armamentarium.
Competitive Landscape
Key Players
- Standard Half-Life Factor VIII Products: Advate (Baxalta), Hemofil M (BPL), Elocta (Eloctate, Bioverativ/AbbVie)
- Other Long-Acting Agents:
- Elocta (Elofstedt): Similar extended half-life
- Adynovate (Baxalta/AbbVie): Recombinant factor VIII with extended duration
- BAY 94-9027 (Damoctocog alfa pegol): PEGylated longer half-life
- Suspected future entrants: Gene therapies like valoctocogene roxaparvovec
Market Positioning
Jivi’s unique proposition stems from its extended half-life achieved through Fc fusion technology, leading to less frequent dosing. This has helped it carve out a significant market share, especially among patients seeking longer dosing intervals. However, competition from other long-acting products and emerging gene therapies presents ongoing challenges.
Pricing Trends and Cost Dynamics
Current Pricing
- Average Wholesale Price (AWP):
- As of 2023, the AWP for Jivi ranges from USD 1.20 to 1.50 per IU, depending on regional tariffs and negotiating power [2].
- The typical annual treatment cost for prophylaxis in hemophilia A is approximately USD 250,000 - USD 350,000 per patient, varying with dosing frequency and patient weight.
Reimbursement and Negotiated Pricing
Many healthcare payers negotiate discounts off the list price, reducing actual expenditure. For Medicare, Medicaid, and private insurers, discounts can range from 10% to 30%, significantly affecting net pricing.
Price Trends
- Stable Short-Term: The list prices for Jivi have remained relatively stable in the past two years amid market maturation.
- Long-Term Pressures: Market entry of biosimilars, improvements in manufacturing efficiencies, and policy emphasis on cost containment may exert downward pressure in future years.
Market and Price Projections (2023-2028)
Forecast Assumptions
- Market Penetration: Growth in hemophilia diagnoses and increased adoption of long-acting therapies.
- Pricing Dynamics: Slight reduction in list prices driven by biosimilar competition and payer negotiations.
- Regulatory and Economic Factors: Ongoing healthcare reforms and policies toward value-based care.
Projected Price Trends
- List Price per IU: Expected to decrease modestly (~3-5% annually) due to biosimilar competition and market saturation.
- Per-Patient Cost: With improved dosing schedules (e.g., infusions weekly or biweekly), annual treatment costs may stabilize or slightly decline, especially as payers negotiate better discounts.
Revenue Projections
- By 2028, Jivi's global revenue could reach USD 1.2 to 1.5 billion, assuming a compounded annual growth rate (CAGR) of 4-6%, influenced by increased patient adoption and healthcare system efficiencies [3].
Market Share Outlook
- Jivi is projected to maintain a substantial market share among long-acting factor VIII therapies, though the rapid development of gene therapies like valoctocogene roxaparvovec could reconfigure treatment paradigms, potentially reducing long-term protein-based therapy revenues.
Key Strategic Considerations
- Patent and Exclusivity: Patent expirations and biosimilar approvals could lead to significant price erosion.
- Innovation: Enhancements in formulation, administration routes, and new indications could sustain pricing power.
- Market Access: Deepening relationships with payers and demonstrating cost-effectiveness will be crucial.
Conclusion
NDC 52268-0100 (Jivi) is positioned within a competitive but expanding market for hemophilia A therapies. Current pricing exhibits stability but faces future pressures from biosimilar entrants and evolving biosimilar policies. Projections suggest modest price declines over the next five years, balanced by rising demand and clinical adoption of long-acting factors. Companies leveraging innovative formulations and optimizing negotiations will be better positioned to sustain market share and profitability.
Key Takeaways
- Market Growth: The hemophilia treatment market is expected to grow, with long-acting factor VIII products like Jivi leading the charge.
- Pricing Dynamics: List prices are likely to decline gradually due to biosimilar competition and policy-driven cost containment.
- Revenue Outlook: Jivi's revenues are projected to grow modestly, fueled by increased patient access and longer treatment durations.
- Competitive Strategies: Continuous innovation and strategic payer engagement are essential amid evolving biosimilar landscapes.
- Emerging Therapies: Gene therapies could transform treatment paradigms, potentially impacting long-term demand for recombinant products.
FAQs
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What is the primary advantage of Jivi over traditional factor VIII products?
Jivi's Fc fusion technology extends its half-life, allowing less frequent infusions (up to weekly or biweekly), improving patient compliance and quality of life.
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How does biosimilar competition impact Jivi’s pricing?
The entry of biosimilars often leads to downward price pressure through increased competition and negotiated discounts, potentially reducing net revenue per unit.
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What are the expected future trends for hemophilia A drug prices?
Prices are expected to decline gradually due to biosimilar entries, healthcare cost containment policies, and evolving treatment protocols favoring gene therapy.
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How might gene therapies influence the long-term market for products like Jivi?
Gene therapies hold the potential for a one-time curative approach, which could reduce demand for ongoing recombinant factor VIII therapies in the long run.
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What strategic moves should pharmaceutical companies consider to maintain competitiveness?
Investing in innovation, broadening indications, strengthening payer relationships, and streamlining manufacturing will be key to maintaining market share amid competitive pressures.
References
[1] Market Research Future. (2023). Hemophilia Market Analysis.
[2] IQVIA. (2023). Pharmaceutical Pricing and Market Access Report.
[3] EvaluatePharma. (2023). Hemophilia and Biopharmaceutical Market Outlook.
