NAICS 325414 Quarterly Industry Report
Biological Product (except Diagnostic) Manufacturing
Comprehensive industry research for valuation professionals, business owners, buyers, and lenders
NAICS Code: 325414Sector: 32Updated: Q1 2026
About This Report
This Fair Market Value industry report for NAICS 325414 provides business owners, acquirers, and financial advisors with data-driven valuation insights for the biological product manufacturing sector, drawing on data from the U.S. Census Bureau[5] and FDA[7] biologics manufacturing statistics. Additional data is drawn from Bureau of Labor Statistics[9].. The report aggregates transaction multiples, financial benchmarks, and market trends specific to NAICS 325414 establishments, supporting buy-sell agreements, succession planning, SBA-financed acquisitions, and litigation support engagements.
Industry Snapshot
Key metrics for the biological product (except diagnostic) manufacturing industry.
Industry Definition & Overview
Biological Product (except Diagnostic) Manufacturing (NAICS 325414) encompasses establishments primarily engaged in manufacturing vaccines, toxoids, blood fractions, culture media of plant or animal origin, and other biological products not classified as diagnostics, including therapeutic proteins, monoclonal antibodies, gene therapy vectors, and cell-based therapies. According to the U.S. Census Bureau[5], approximately 288 companies operate across 409 establishments, employing over 65,000 workers in biologics manufacturing facilities that use fermentation, cell culture, purification, and aseptic filling technologies to produce some of the most complex pharmaceutical products manufactured today.
The industry has experienced rapid growth driven by the expansion of biologic drug approvals, biosimilar competition for off-patent biologics, and pandemic-era investment in vaccine manufacturing capacity. Product categories include influenza and childhood vaccines, plasma-derived immunoglobulins and clotting factors, recombinant therapeutic proteins, and emerging advanced therapies including CAR-T cell therapies and gene therapy vectors. The Bureau of Labor Statistics[6] identifies production roles including cell culture technicians managing bioreactor systems, purification specialists operating chromatography and filtration systems, aseptic filling operators working in classified clean rooms, quality control analysts performing potency and safety testing, and regulatory affairs professionals managing Biologics License Application submissions to the FDA[7].
Per the SBA Office of Advocacy[8], the industry spans large multinational biopharmaceutical companies with global biologics manufacturing networks to contract development and manufacturing organizations serving biotech startups, smaller plasma fractionators, and specialty biological product producers. The capital-intensive nature of biologics manufacturing, with single production lines costing $200 million or more, creates barriers to entry that sustain competitive advantages for established manufacturers.
What's Included in This Industry
- Valuation multiples benchmarked to biological product manufacturing operations
- Revenue and EBITDA trends for domestic biologics and vaccine production facilities
- SBA lending data and financing terms for NAICS 325414 businesses
- Comparable transaction data from recent biologics manufacturer and CDMO acquisitions
- Industry risk factors including FDA compliance, product complexity, and cold chain requirements
- Workforce composition and labor cost benchmarks for biologics manufacturing operations
- Regional market analysis covering biologics manufacturing clusters nationwide
- Capital expenditure benchmarks for bioreactor systems and aseptic filling equipment
- Growth projections tied to biosimilar development and cell and gene therapy expansion
- Owner compensation and discretionary earnings benchmarks
NAICS Classification Hierarchy
| Level | Description | Code |
|---|---|---|
| Subsector | Chemical Manufacturing | 325 |
| Industry Group | Pharmaceutical and Medicine Manufacturing | 3254 |
| NAICS Industry | Pharmaceutical and Medicine Manufacturing | 32541 |
| National Industry | Biological Product (except Diagnostic) Manufacturing | 325414 |
Related NAICS Codes
| Code | Description | Relationship |
|---|---|---|
| 325412 | Pharmaceutical Preparation Manufacturing | Pharmaceutical preparation manufacturers producing complementary small-molecule drug products alongside biological therapies within integrated pharmaceutical company portfolios |
| 325411 | Medicinal and Botanical Manufacturing | Medicinal chemical manufacturers producing cell culture media components, purification reagents, and raw materials consumed in biological product manufacturing processes |
| 325413 | In-Vitro Diagnostic Substance Manufacturing | In-vitro diagnostic substance manufacturers sharing monoclonal antibody production capabilities and biological manufacturing infrastructure with therapeutic biologic producers |
| 541714 | Research and Development in Biotechnology (except Nanobiotechnology) | Biotechnology research organizations developing novel biologic drug candidates that generate manufacturing demand for biologics production capacity and contract services |
| 621511 | Medical Laboratories | Medical laboratories performing potency testing, sterility testing, and quality control analyses supporting biological product release and stability monitoring |
| 424210 | Drugs and Druggists' Sundries Merchant Wholesalers | Drug wholesalers distributing vaccines, plasma products, and biological therapies from manufacturers to hospitals, clinics, and specialty pharmacy distribution channels |
Geographic Concentration
Top states by share of national establishments.
| # | State | % Est. | Total Est. |
|---|---|---|---|
| 1 | California | 16.5% | 67 |
| 2 | Massachusetts | 8.6% | 35 |
| 3 | Pennsylvania | 8.1% | 33 |
| 4 | Texas | 5.7% | 23 |
| 5 | North Carolina | 4.9% | 20 |
| 6 | New Jersey | 4.7% | 19 |
| 7 | Iowa | 3.9% | 16 |
| 8 | Florida | 3.7% | 15 |
| 9 | Wisconsin | 3.7% | 15 |
| 10 | Illinois | 2.7% | 11 |
% Of Establishments
0%
17%
Source: County Business Patterns, U.S. Census Bureau[3]
SBA Lending Summary
16
Total SBA Loans
$1.6M
Total Loan Volume
$97K
Average Loan Size
9 yrs
Average Loan Term
9.00%
Average Interest Rate
32
Jobs Supported
Source: SBA 7(a) Program Data, U.S. Small Business Administration — FY 2025[4]
Key Insight: Biological product manufacturers evaluating SBA financing face challenging qualification given the capital-intensive nature of biologics production under the SBA size standards[10] for NAICS 325414, which set the threshold at 1,250 employees for small business classification. The SBA 7(a) loan program[11] may support smaller contract biologics manufacturers, plasma collection operations, and specialty biological product producers, while the CDC/504 loan program[12] could finance clean room buildouts, bioreactor installations, and cold storage infrastructure. Lenders evaluate FDA Biologics License approval status, manufacturing process validation records, and customer pipeline visibility when assessing biologics manufacturing loan applications.
Top SBA Lenders
| # | Lender | Loans | Volume | Avg Loan |
|---|---|---|---|---|
| 1 | Rockland Trust Company | 8 | $1.2M | $155K |
| 2 | Manufacturers and Traders Trust Company | 8 | $320K | $40K |
Frequently Asked Questions
Common questions about this industry.
What is the typical valuation multiple for a biologics manufacturer?
Biological product manufacturers typically command 12x to 20x or higher EBITDA multiples, reflecting the high barriers to entry and recurring revenue nature of the biologics manufacturing business. Per U.S. Census Bureau[5] data, the industry's 288 firms vary from large integrated biopharmaceutical companies to smaller CDMOs valued on capacity, regulatory standing, and pipeline visibility.
What SBA loan options are available for biologics businesses?
The SBA[10] sets the small business threshold at 1,250 employees for NAICS 325414. SBA financing may support smaller contract manufacturers, plasma processors, and specialty biologics producers, with 504 loans financing facility and equipment investments.
What FDA requirements affect biological product manufacturers?
The FDA[7] regulates biological products under the Public Health Service Act, requiring Biologics License Applications for marketing approval, compliance with cGMP regulations, lot-release testing, annual product reviews, and periodic facility inspections with particular focus on aseptic processing validation.
How is biosimilar competition affecting the biologics industry?
Patent expirations on blockbuster biologic drugs are creating market opportunities for biosimilar manufacturers filing abbreviated approval pathways with the FDA[7]. Biosimilar approvals have increased competition while also driving investment in biologics manufacturing capacity to meet growing production demand.
What are the growth drivers for biological product manufacturing?
Biologic drug approvals, cell and gene therapy pipeline expansion, pandemic preparedness investment, and biosimilar development drive industry growth. Per the FDA[7], biologics represent a growing share of new drug approvals, with advanced therapies including CAR-T and gene therapies creating new manufacturing capacity demand.
How does manufacturing complexity affect biologics valuations?
Biological product manufacturing requires specialized facilities costing hundreds of millions to build, validated processes that take years to develop, and trained workforces with expertise in cell culture and aseptic processing. Per the FDA[7], this complexity creates high barriers to entry that sustain premium valuations for established producers.
What workforce challenges do biologics manufacturers face?
The Bureau of Labor Statistics[6] reports intense competition for cell culture technicians, purification scientists, aseptic processing operators, and quality assurance professionals across the biologics sector. Rapid industry expansion has created workforce shortages in specialized manufacturing roles.
How do cold chain requirements affect biological product distribution?
Most biological products require temperature-controlled storage and distribution, with vaccines, plasma products, and cell therapies requiring -20°C to -80°C storage in some cases. Per the FDA[7], cold chain integrity requirements create distribution complexity that affects manufacturing facility design and logistics cost structures.
Sources & References
Government datasets and editorial sources used in this report.
- [1]U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages bls.gov
- [2]U.S. Census Bureau, Economic Census census.gov
- [3]U.S. Census Bureau, County Business Patterns census.gov
- [4]U.S. Small Business Administration, SBA 7(a) Loan Program Data data.sba.gov
- [5]U.S. Census Bureau census.gov
- [6]Bureau of Labor Statistics bls.gov
- [7]FDA fda.gov
- [8]SBA Office of Advocacy advocacy.sba.gov
- [9]Bureau of Labor Statistics bls.gov
- [10]SBA size standards sba.gov
- [11]SBA 7(a) loan program sba.gov
- [12]CDC/504 loan program sba.gov
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