Bioabsorbable Stents Market Trends

Growth Drivers

• Technological innovation and FDA acceptances: The aspect of advancement is readily accelerating the market adoption internationally. For instance, as per the 2024 FDA report, the organization has approved ultra-thin PLLA stents of 85µm, which tend to improve deliverability in complicated lesions. Besides, the EU has made an investment of €155 million for magnesium-specific stents through Horizon Europe. At present, the tactical priority remains in terms of R&D funding in rapid absorbable materials, along with smart stents, thus denoting a positive impact on the market.
• Sudden transition towards ambulatory and outpatient care: The aspect of the ongoing shift towards the integration of care facilities is an effective factor for the market. For instance, an estimated 67.5% of the U.S. PCIs currently take place in outpatient settings, which tends to diminish expenses by almost USD 8,200 per procedure. Besides, cardiac centers in Germany have reported that approximately 45% of short recovery times are associated with bioabsorbable stents. However, manufacturers need to redesign stents to ensure ASC compatibility and collaborate with outpatient clinics to accelerate the adoption.

Manufacturer Strategies Shaping Bioabsorbable Stents Market Expansion

Leading manufacturers in the market are implementing regulatory advancements, strategic partnerships, and product innovation to expand their respective market positions. For instance, Abbott Laboratories has enhanced its U.S. market share by almost 18.5% as of 2023 by implementing next-generation Absorb GT1 stents and further optimizing complicated lesions. Meanwhile, Boston Scientific went into a partnership with more than 45 hospitals in the U.S., which bolstered its revenue by USD 225 million through bundled procurement deals, thereby creating an optimistic outlook for the overall market.

Revenue Potential for Bioabsorbable Stent Manufacturers (2023-2025)

Feasible Expansion Models Shaping the Future of the Bioabsorbable Stents Market

Manufacturers in the market are readily adopting regulatory-driven market accessibility, value-based partnerships, and localized production procedures to ensure global expansion. For instance, suppliers in India are effectively collaborating with local hospitals under the PLI scheme, which has diminished stent expenses by almost 28% and enhanced revenue by 12.8% between 2022 and 2024. Likewise, Germany’s G-BA has incentivized bundled payments for PCI procedures, which, in turn, bolstered the bioabsorbable stents adoption by 17% as of 2023, thus suitable for propelling the market across different nations.

Feasibility Models for Market Expansion

Challenges

• Reimbursement and pricing gaps: The bioabsorbable stents market is facing significant obstacles, owing to reimbursement and pricing risks. For instance, Medicaid, in the U.S., covers only 36.5% of eligible patients, since the expenses of these stents is USD 2,550 per unit, which is more than 2.5 times conventional drug-eluting stents (DES). Europe-based markets, such as Germany, have effectively imposed stringent price caps and have forced manufacturers to reduce prices by almost 22% as of 2023. To this, payers have argued that long-lasting cost savings are not completely quantified, thus resulting in strict coverage policies.
• Delays in administrative trends: The presence of strict regulatory demands has slowed down entries into the bioabsorbable stents market globally. In this regard, a backlog in the FDA has resulted in postponing more than 2 major stent launches as of 2024. Therefore, these delays effectively increase the delay in revenue generation, along with R&D expenses. However, to overcome this challenge, organizations, such as Abbott, have engaged in conducting early regulatory consultations to streamline product and service approvals.