NowenThe American Society of Mechanical Engineers Unclaimed
New York, NY, United States
ASME is a not-for-profit professional organization advancing engineering worldwide through standards, education, and professional development.
ASME is a not-for-profit professional organization that serves a global engineering community through quality learning, the development of codes and standards, certifications, research, conferences and publications, government relations, and other forms of outreach. Founded in 1880 as the American Society of Mechanical Engineers, ASME enables collaboration, knowledge sharing, and skill development across all engineering disciplines, while promoting the vital role of the engineer in society. Codes and standards, publications, conferences, continuing education, and professional development programs provide a foundation for advancing technical knowledge and a safer world.
ASME's mission is to advance engineering for the benefit of humanity.
What we offer
Bioprocessing Equipment Certification
Enhances quality, safety, and regulatory compliance for bioprocessing equipment manufacturers.
www.asme.org/certification-accreditation/bioprocessing-equipment-certificationMarket segments
Market size by segment
Growth potential (CAGR)
Bioprocessing equipment certification
Certification programs that verify design, manufacture, and quality system conformance of bioprocessing components to ASME BPE and related standards to support regulatory compliance and product purity.
Hygienic design and sanitary equipment standards
Standards and guidance for hygienic design, materials, surface finish, and construction of equipment used in pharmaceutical, biologics, and food processing to reduce contamination risk.
Regulated industry compliance (life sciences, medical devices, manufacturing)
Industry-focused regulatory mapping and controls alignment for sectors with specific requirements (GxP, FDA/EU medical device rules, CMMC/NIST), enabling tailored frameworks, multi-site coordination, and lifecycle compliance.
Supplier certification and traceability for life sciences supply chains
Programs that certify supplier capabilities, enable certification marks and component stamping, and provide documented traceability to support qualified supplier lists and procurement in regulated supply chains.
More information about our offering
Bioprocessing Equipment Certification
Certification program for ASME Bioprocessing Equipment (BPE) that verifies the quality management system of organizations manufacturing bioprocessing components and equipment under the BPE standard. The program reflects ASME’s leadership in standardizing hygienic equipment design and construction, and certifiable practices can support regulatory compliance while promoting product purity and safety.
- Ensures ComplianceVerifies that equipment adheres to rigorous design and manufacturing standards, crucial for maintaining safety and quality in bioprocessing.
- Validates Quality SystemsConfirms that the organization's processes meet ASME BPE requirements, enhancing overall operational efficiency and product safety.
- Grants Stamping RightsEnables companies to enhance product credibility by stamping components, indicating compliance with ASME BPE standards.
- Promotes Market TrustIndicates compliance with global standards, promoting trust among customers and regulatory bodies.
References
Methodology and sourcing behind the figures shown above.
Bioprocessing equipment certification
Estimated certification market derived from published bioprocessing equipment and single-use market sizes. Using Datamintelligence's ~US$58.1B 2024 bioprocessing equipment market as the primary base, I assumed certification/testing/audit services represent ~1% of equipment market (typical professional services share for equipment markets), yielding ~US$0.58B (rounded to US$0.6B). Growth potential tied to overall equipment and single-use subsector growth (Datamintelligence CAGR ~9.9%; MarketsandMarkets and Nova One report single-use CAGRs 13–16%), so a conservative CAGR of 9.0% was selected reflecting alignment with the broader equipment market while acknowledging regulatory and single-use adoption tailwinds.
- The global bioprocessing equipment market size reached US$ 58.14billion ... expected to reach US$ 147.55billion by 2033, growing at a CAGR of 9.9%.
- USD 33.67 BN MARKET SIZE 2030 CAGR 13.3% (2025-2030).
- the global single-use bioprocessing market size was estimated at USD 28.45 billion in 2023 and ... projected to increase USD 128.24 billion by 2033 with a CAGR of 16.25%.
- Industry Size (2025):USD 550.4 Mn ... Forecast (2035):USD 838.5 Mn ... CAGR (2025 to 2035): 4.3%.
Hygienic design and sanitary equipment standards
Primary estimate uses Future Market Insights’ global valuation for hygienic easy-to-clean food processing equipment (USD 56.6B in 2025) and its 7.0% CAGR (2025–2035). A smaller, narrower MRFR estimate (USD 4.48B; 4.23% CAGR) reflects a different scope/timeframe and supports the existence of subsegment estimates. A U.S. market datapoint (~USD 2.5B, ~6% CAGR) aligns as a national subset. Chosen figures reflect the broader global equipment market implied by FMI while acknowledging narrower estimates for specific niches or regional markets.
Regulated industry compliance (life sciences, medical devices, manufacturing)
Estimate based on specific submarket figures and broader market growth signals in the provided results. i-Pharm reports the Medical Device Regulatory Affairs market at $6.97B in 2021, reaching $12.25B by 2031 (5.8% CAGR); that implies ~ $8.2B by 2024 for the device-RA subsegment. MediTechInsights cites ~11% CAGR for the broader life‑sciences regulatory & compliance market. Broader MedTech and life‑sciences market sizes (IQVIA, BusinessResearchInsights) and related high-growth service segments (contract manufacturing reports from MarketsandMarkets and Credence) indicate sizeable adjacent spend on compliance, consulting and software. Aggregating an approximate global compliance market across medical devices, pharmaceuticals/biologics, and regulated manufacturing (software + consulting + managed services) yields a conservative 2024 estimate ~ $18B and a growth potential in line with reported sector CAGRs (~11%).
- Global Medical Device RA Market was valued at $6,969.7 million in 2021 and is expected to grow at a CAGR of 5.8% from 2022 to 2031.
- The life sciences regulatory and compliance market is projected to grow at a CAGR of approximately 11% over the forecast period.
- Market projected to reach USD 140.84 billion in 2030 from USD 83.77 billion in 2025, at a CAGR of 10.9% (2025-2030).
- U.S. Medical Device Contract Manufacturing Market Size 2024 USD 19,860.60 million; CAGR 11.69%; Size 2032 USD 48,090.95 million.
- Global MedTech market revenue for 2017 was $438 billion USD; with a CAGR of 6% to an estimated $585 billion USD by 2022.
- Life Sciences Market expected to be valued at USD 110.08 Billion in 2026; forecast to USD 299.17 Billion by 2035, CAGR 11.75% (2026-2035).
Supplier certification and traceability for life sciences supply chains
Estimation uses two market anchors from the search results: (1) the broader biotech supply chain market (USD 23.50B in 2025, CAGR 7.51%) and (2) the supply-chain traceability market (USD 3.8B in 2025, CAGR 11.6%), with pharmaceutical traceability ~22.4% of that traceability market (~USD 0.85B). Supplier certification and traceability for life sciences is a narrower intersection of pharma traceability and procurement/supplier-management services within the biotech supply-chain market. I used the traceability-as-baseline (~USD 0.85B) and added a conservatively estimated supplier-certification services share (≈USD 0.6B) drawn from a plausible portion of procurement & supplier-management spend in the USD 23.5B biotech supply-chain market to arrive at ~USD 1.5B. Growth CAGR is set near the midpoint but weighted toward faster software/services traceability growth (between 7.5% and 11.6%), rounded to 10.0%.