Insight · · Updated
The SBIR/STTR funding landscape for life-science companies
Reviewed by the founder of Noradelis
Life-science PhD · NIH-funded PI · U.S. and European grant-review experience
NIH SBIR/STTR success rates fell from 21.9% in FY2019 to 10.4% in FY2025. Applications increased 47% from FY2023 while awards fell 19%. In this more competitive market, agency and mechanism selection deserve attention before proposal development: the available budget, research partnership, and time to funding differ materially across programs.
Federal agency comparison
The Department of War (DoW, formerly referred to as DoD) has the largest program in the SBIR.gov directory. HHS, principally through NIH, has the broadest relevance to biomedical companies. Other agencies support narrower applications of biotechnology.
| Agency | Directory budget figure | Fit for human biomedical companies |
|---|---|---|
| DoW | $2.3B | High for defined defense needs; limited otherwise |
| HHS—including NIH | $1.2B | Highest: broad biomedical scope |
| DOE | $349M | Low: specialized industrial biotechnology and biomanufacturing |
| NSF | $174M | High for enabling platforms and tools; no clinical trials |
| NASA | $174M | Low: specialized space-health applications |
| USDA | $42M | Low for human medicine; high for agriculture, food, and animal health |
| DHS | $15M | Low outside defined biodefense and detection needs |
| EPA | $5M | Low: environmental technologies; no general biomedical R&D |
Need help with your next funding decision? Assess funding fit and readiness.
Source: SBIR.gov participating agencies.
These directory figures describe program scale and should not be read as verified FY2026 appropriations or NIH-only award totals. Fit ratings are editorial assessments for human biomedical companies, not agency eligibility determinations. EPA’s funding page, updated September 24, 2026, lists a Phase I solicitation open through November 8, 2026, at 11:59 p.m. ET, with environmental technology topics.
What are the NIH SBIR Phase I and Phase II budget limits?
NIH’s general budget guidelines are $323,090 for Phase I and $2,153,927 for Phase II. Under approved SBA waivers, some institutes allow higher requests. The SBIR parent announcement, PA-27-100, lists institute-specific limits; eligibility depends on the institute and approved topic. These limits are not typical award amounts.
| Institute | Phase I | Phase II |
|---|---|---|
| NCI | $700,000 | $2.5M |
| NIA, NIAID, NIGMS, NIMH, NINDS | $700,000 | $3M |
| NCCIH | $700,000 | SBA guideline |
These are limits, not typical award amounts. A larger request still needs a justified work plan and must meet the institute’s waiver-topic requirements. NIH’s Commercialization Readiness Pilot has a separate general guideline of $4,191,495, but participating institutes may impose lower limits; Phase IIB limits depend on the opportunity.
Sources: NIH program basics (checked October 9, 2026) and PA-27-100.
How do NIH SBIR and STTR research requirements differ?
NIH SBIR normally requires the company to perform at least 67% of Phase I research and 50% of Phase II research. NIH STTR requires at least 40% from the company and at least 30% from one eligible nonprofit research partner. The principal investigator’s primary employment requirements also differ.
| Requirement | SBIR | STTR |
|---|---|---|
| Company research share | At least 67% in Phase I; 50% in Phase II, normally | At least 40% in both phases |
| Research institution | Optional subcontractor | One eligible nonprofit partner performs at least 30% |
| Principal investigator’s primary employment | Normally the company, at award and during the project | Company or partnering institution; formal company appointment or commitment required |
| Direct Phase II | Available where offered | Included in current NIH PA-27-102 |
For NIH STTR, each principal investigator must commit at least 10% effort to the project. For NIH SBIR applications with multiple principal investigators, at least one must meet the company primary-employment requirement. These are NIH requirements; agency rules can differ. NSF, for example, requires the principal investigator to be primarily employed by the company even for STTR. A university partnership is therefore a substantive operating decision, with implications for staffing, intellectual property, and where the funded work takes place.
Under NIH SBIR Phase I, third-party scientific and technical work normally cannot exceed 33% of total requested costs, including direct costs, indirect costs, and fee. On a $700,000 request, that is $231,000 across the relevant contracts and consultants. It is a limit on outsourced research, not a reserved advisory budget.
Sources: NIH SBIR parent announcement, NIH STTR parent announcement, NSF solicitation.
What were the NIH SBIR and STTR success rates in FY2025?
NIH SBIR and STTR had a combined success rate of 10.4% in FY2025: 931 awards from 8,915 competing applications reviewed. SBIR Phase I had a 7.8% rate, compared with 12.6% for STTR Phase I. These figures describe program results, not an individual company’s chance of funding.
| Fiscal year | Applications | Awards | Success rate |
|---|---|---|---|
| 2019 | 6,086 | 1,330 | 21.9% |
| 2022 | 6,084 | 1,125 | 18.5% |
| 2023 | 6,067 | 1,153 | 19.0% |
| 2024 | 7,447 | 981 | 13.2% |
| 2025 | 8,915 | 931 | 10.4% |
These figures count competing applications reviewed and awards made, rather than all awards supported during the fiscal year. NIH’s FY2025 data also show substantial differences across mechanisms.
| Mechanism | Applications | Awards | Success rate |
|---|---|---|---|
| SBIR Phase I | 4,468 | 349 | 7.8% |
| SBIR regular Phase II | 408 | 90 | 22.1% |
| SBIR Direct Phase II | 1,344 | 154 | 11.5% |
| SBIR Fast Track | 763 | 62 | 8.1% |
| SBIR Phase IIB | 123 | 30 | 24.4% |
| SBIR Commercialization Readiness Pilot | 147 | 24 | 16.3% |
| STTR Phase I | 1,390 | 175 | 12.6% |
| STTR regular Phase II | 103 | 29 | 28.2% |
| STTR Fast Track | 169 | 18 | 10.7% |
Source: NIH RePORT—Table 215, SBIR/STTR success rates. Percentages are shown to one decimal place. The rows total 8,915 applications and 931 awards, or 10.4%.
STTR Phase I’s 12.6% success rate was approximately 1.6 times SBIR Phase I’s 7.8%. For a company with a suitable research partner, this is a meaningful reason to assess STTR before defaulting to SBIR. It does not establish that changing mechanisms alone would produce that improvement: the applicant and project mix also differs.
STTR regular Phase II had the highest rate in the table, at 28.2%, but Phase II serves a different development stage and applicant population. Its rate is not an alternative probability available to a Phase I applicant.
Timing and commercialization support
The NIH SBIR parent announcement, PA-27-100, places the September 2026 submission cycle’s earliest start in April 2027—approximately seven months later. It accepts no late applications. NSF adds an earlier gate: a Project Pitch invitation is required before a Phase I or Fast Track proposal. Companies should budget for these steps before treating an award ceiling as available development capital.
Sources: NIH submission timetable, NSF Project Pitch requirements.
What is SBIR TABA, and how much does NIH allow?
Technical and Business Assistance (TABA) supports eligible commercialization activities for NIH SBIR/STTR recipients. NIH allows up to $6,500 for Phase I and $50,000 for Phase II across the project period, rather than per year. Under the April 2026 policy, funding can be requested in the application or through a post-award administrative supplement. Requests need a justification and vendor identification where applicable. NIH may decline a supplement request. Commercialization Readiness Pilot awards are excluded.
Source: NIH TABA policy.
Related non-dilutive funding pathways
The broader landscape includes federal and state programs outside conventional NIH SBIR/STTR. Some agencies also operate their own SBIR/STTR programs.
| Pathway | Fit | Individual award limit | Program-wide allocation |
|---|---|---|---|
| ARPA-H SBIR/STTR | Health technologies | $600K Phase I; $3.5M Phase II | — |
| BARDA DRIVe standard EZ-BAA | Medical countermeasures and health security | Below $750K in government funding | — |
| DoW / CDMRP | Disease-specific biomedical research | Mechanism-specific | $1.27B across 34 FY2026 programs |
| CPRIT Seed Company Awards | Texas oncology companies | $3M | — |
| CIRM Preclinical Development (PDEV) | California stem cell-based and genetic therapies | Up to $13M across up to five years | — |
Sources: ARPA-H small-business program page (undated; checked October 9, 2026); BARDA DRIVe, EZ-BAA-22-100-SOL-00003 (undated overview; checked October 9, 2026); CDMRP FY2026 release (February 4, 2026; updated August 12, 2026); CPRIT FY2027 SEED RFA (released March 26, 2026; revised May 12, 2026); CIRM PDEV announcement (August 26, 2026).
Award limits do not establish that applications are currently open. The listed ARPA-H submission deadlines have passed; BARDA’s overview lists no open EZ-BAA Areas of Interest; and CIRM’s latest PDEV application window closed October 8, 2026. BARDA’s separate + Phase pathway can support larger awards and is not represented by the standard EZ-BAA limit above. Check the funder’s current solicitation before planning an application.
Smaller programs can change the funding plan
USDA’s FY2025 Phase II announcement planned to fund approximately 45% of applications in each topic area. That was a funding target, not an observed award rate or evidence of the “best odds” across agencies. For an eligible agricultural biotechnology company, it nevertheless warrants attention alongside much larger programs. USDA FY2025 Phase II announcement.
For Houston and other Texas oncology companies, CPRIT merits a separate assessment alongside SBIR. Its Seed Company Award can provide up to $3 million. The FY2027 solicitation generally requires $1 in matching funds per $2 of CPRIT funding while cumulative CPRIT awards remain at or below $20 million; higher cumulative awards carry higher matching ratios. Companies based outside Texas may apply but must meet the specified Texas-presence criteria within one year of initial disbursement. Revenue-sharing terms also apply.
A combined CPRIT and SBIR plan should assign distinct costs and milestones to each award and establish an eligible source of matching funds. Neither overlapping reimbursement nor using federal funds as the match should be assumed. CPRIT FY2027 Seed Company Award solicitation.
Implications for funding strategy
Scientific fit and eligibility come first: a large agency budget or favorable historical rate has little value if the project cannot satisfy the program’s mission and research structure. Among eligible opportunities, however, competition is decision-relevant. NIH’s Phase I comparison makes STTR worth evaluating for companies with an appropriate institutional partner.
The next comparison is operational: how much work the award can fund, where that work must occur, and when funding could begin. A $700,000 ceiling, a seven-month minimum lead time, and an outsourcing limit affect different parts of the same development plan. Mechanism selection should precede proposal writing; the data do not quantify its value relative to proposal quality.
Need help applying this to your project? Explore SBIR/STTR readiness and funding strategy services.