How much is small business insurance for life sciences?

Small CDMO ($1M-$5M revenue): $30,000 to $65,000 annually. Drivers: sponsor MSA insurance schedule demands, product class (oral solid dose runs lower than sterile injectable), cGMP property exposure.

Small CRO ($1M-$5M revenue): $20,000 to $45,000 annually. Drivers: number of active CTAs, patient PHI volume under management, sponsor cyber demands.

Pre-IND biotech ($1M-$5M revenue): $15,000 to $40,000 annually. Drivers: D&O at VC-backed clinical-stage governance, clinical trial liability if active studies, IP and tech E&O.

Small 503A compounding pharmacy ($1M-$5M revenue): $25,000 to $55,000 annually. Drivers: sterile vs non-sterile mix, USP 797/800 compliance posture, druggist professional liability volume.

Small 503B outsourcing facility ($2M-$10M revenue): $45,000 to $120,000 annually. Drivers: hospital purchase contract schedule demands, recall coverage, cGMP property.

Small medical device manufacturer ($1M-$5M revenue, Class I or II): $20,000 to $55,000 annually. Drivers: device class, distribution scale, GPO supplier insurance demands. Class III is materially higher.

Small diagnostic lab ($1M-$5M revenue): $18,000 to $42,000 annually. Drivers: test menu, CLIA category, cyber and HIPAA exposure.

Sponsor MSA insurance schedule demands. The single largest premium driver for any contract supplier in life sciences. A small CDMO with a $5M products demand can pay 40 to 60 percent less than one with a $10M demand at the same revenue.

Product class. Sterile injectable, biologic, Class III medical device, controlled substance handling, and oncology drug work all price materially higher than oral solid dose, Class I or II device, or non-controlled small molecule.

Prior loss history. A clean three-year loss run typically produces 10 to 25 percent premium credit; a ransomware or sponsor-related claim in last 36 months can add 30 to 100 percent to renewal pricing.

Compliance maturity. SOC 2, ISO 27001, clean FDA inspection history, USP 797/800 attestation, and documented quality management systems each produce premium credits in the 5 to 15 percent range.

Generic small-business insurance products (the BOP or middle-market manufacturers package commonly sold to general manufacturing) typically do not satisfy sponsor MSA insurance schedules on a strict reading. The products and completed operations sublimit, additional-insured wording, primary and non-contributory provisions, and recall extension are the most common gaps.

Small life sciences operators reviewing their existing coverage against a sponsor MSA should expect to find at least one material gap per coverage line; a full specialty rebuild is the norm rather than the exception.