Quick answer: A pharma LCA (pharmaceutical life cycle assessment) measures the environmental impact of a medicine across its whole life, from raw materials and API synthesis through formulation, device, packaging, distribution, patient use and disposal. Since November 2025, pharma LCAs have a common rulebook: PAS 2090:2025, the BSI product category rules (PCR) for pharmaceutical products, which make results consistent and comparable across companies. Pharma companies can run PAS 2090 LCAs with consultants, with guided single-product tools such as PharmaLCA, or with AI-powered LCA software such as CarbonBright that scales across a full product portfolio.
Pharmaceutical companies face growing requests for product-level environmental data from health systems, procurers and investors. Until recently, every company calculated those footprints differently. PAS 2090 changes that. This guide explains the pharma LCA method, the PAS 2090 standard behind it, the software options, and which pharma products need an assessment.
Pharma LCA methodology
A pharma LCA measures the environmental impact of a medicine across every stage of its life, from raw material extraction to disposal. ISO 14040 and ISO 14044 define the method in four phases; PAS 2090 tells you how to apply each phase to a medicine.
- Goal and scope definition. State why the study is being done and who will use it. Set the functional unit and system boundary.
- Life cycle inventory (LCI). Collect inputs and outputs for each process: materials, solvents, energy, water, waste, transport and emissions. Use primary data where you control the process, and secondary databases (such as ecoinvent) elsewhere.
- Life cycle impact assessment (LCIA). Convert the inventory into impact indicators, such as climate change (kg CO2e), water use, resource depletion and ecotoxicity.
- Interpretation. Identify hotspots, test sensitivity to key assumptions, check data quality and report conclusions within the study’s limits.
PAS 2090 is not the only pharma method in use. Earlier studies relied on the GHG Protocol’s pharmaceutical sector guidance or on national methods such as France’s medicines carbon footprint methodology, developed by Ecovamed with the French government. PAS 2090 is the first to set harmonized international rules, building on ISO 14040, ISO 14044 and ISO 14067.
Key terms for pharma LCAs
| Term | What it means in pharma |
|---|---|
| Functional unit | The reference the results are expressed per, such as one dose, one pack, one daily dose or one full course of treatment |
| Cradle-to-gate | Raw materials through API synthesis, formulation and packaging, up to the factory gate |
| Cradle-to-grave | Cradle-to-gate plus distribution, patient use and end of life, including unused medicine |
| Product carbon footprint (PCF) | A single-impact LCA covering greenhouse gases only, aligned with ISO 14067 |
| Process mass intensity (PMI) | Total mass of materials used per kg of API; a common green chemistry metric that often tracks API footprint |
| Allocation | How impacts are split between co-products, such as multiple APIs made at one site |
| Hotspot | A life cycle stage or input that drives a large share of total impact |
Pharma product carbon footprints
A pharma product carbon footprint (PCF) is an LCA limited to one impact: greenhouse gas emissions, reported in kg CO2e and calculated under ISO 14067. Most of the product-level data pharma companies are asked for today is a PCF, not a full LCA. The NHS’s planned 2028 supplier requirement is for product carbon footprints, and brand owners are asking API, excipient and CDMO suppliers for PCFs to replace spend-based Scope 3 estimates.
PAS 2090 covers both: the same rules for functional unit, system boundary, allocation and data quality apply whether you report one impact or many. Pharma PCFs are typically expressed per dose, per pack or per daily dose. France’s methodology, for example, requires a footprint for each pack presentation of a medicine, also reported per unit and per Defined Daily Dose. Suppliers usually report cradle-to-gate, while finished medicines are increasingly footprinted cradle-to-grave.
Because a PCF is a subset of a full LCA, building the model once lets you report both, and product PCFs roll up directly into a Scope 3 Category 1 inventory. See how CarbonBright automates pharma product carbon footprints.
Where the impact usually sits
For small-molecule medicines, multi-step API synthesis is often the largest contributor, driven by solvents, reagents and energy-intensive purification. For biologics, cleanroom HVAC, single-use systems and cold chain loom larger. For inhalers, the propellant released during patient use can dominate. Packaging and transport are usually smaller but easier to change. A PAS 2090 LCA makes these patterns visible for a specific product rather than relying on rules of thumb.
What is PAS 2090?
PAS 2090:2025 is the first international standard for conducting product-level environmental LCAs of pharmaceutical products. Its full title is Pharmaceutical products – Product category rules for environmental life cycle assessments – Specification. The British Standards Institution (BSI) published it on 30 November 2025 (EFPIA).
A PAS (Publicly Available Specification) is a fast-track BSI standard built by consensus. PAS 2090 works as a product category rule (PCR): it sits on top of the general LCA standards (ISO 14040/14044 and ISO 14067 for carbon footprints) and adds the pharma-specific choices those standards leave open.
Who developed it
- Sponsors: NHS England, the UK Office for Life Sciences (OLS) and the Pharmaceutical LCA Consortium, working with the Sustainable Markets Initiative (SMI) Health Systems Task Force and the Pharmaceutical Environment Group (PEG) (BSI).
- Consortium members: AstraZeneca, GSK, Johnson & Johnson Innovative Medicine, Merck KGaA, MSD, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi and Takeda (Quantis).
- Technical author: Quantis drafted the standard on behalf of BSI.
- Consultation: more than 475 stakeholders across 35 countries took part, and the June 2025 public consultation drew over 400 comments (BSI).
What PAS 2090 covers
The standard applies to medicines for human use. It covers the drug substance, formulation, any administration device, packaging, distribution, patient use and end of life, with both cradle-to-gate and cradle-to-grave scopes (BSI Knowledge). It can be used for a full multi-impact LCA or for a carbon-only product carbon footprint (PCF).
Key features
- Harmonized rules for functional units, system boundaries, allocation, data quality and reporting, so footprints from different companies can be compared on a like-for-like basis.
- Built for every data maturity level. It does not require primary data for activities outside a company’s operational control, which makes it usable by innovators, generics manufacturers and suppliers alike (BSI).
- Hotspot focus. A core goal is to identify the life cycle stages that drive the most impact, so companies can prioritize reduction efforts.
- Voluntary. No law requires PAS 2090 today. Its weight comes from buyers, especially health systems such as the NHS, asking for consistent product data.
Supporting resources
To speed adoption, the Pharma LCA Consortium is producing a technical guidance document, a PAS 2090-compliant life cycle inventory (LCI) database with ecoinvent and Boehringer Ingelheim (first release of 180+ regionalized datasets), and a PAS 2090-compliant LCA tool, now known as PharmaLCA.
Why pharma LCAs matter
LCAs matter in pharma because buyers are starting to ask for product-level footprints, and most of a medicine’s impact sits upstream in the supply chain. Without an LCA, a company cannot answer those requests or see where to cut emissions.
Medicines are a large share of health system emissions
In England, the manufacture and supply of medicines (excluding inhalers and anaesthetic gases) makes up 17% of the NHS Carbon Footprint Plus, or 4.7 MtCO2e (NHS England). Inhalers and anaesthetic gases add a further 20% of the narrower NHS Carbon Footprint. Health systems cannot hit net zero without reducing medicine emissions, so they are turning to suppliers for data.
Procurement is starting to require product footprints
The NHS Net Zero Supplier Roadmap sets escalating requirements for suppliers (NHS England):
| Date | NHS supplier requirement |
|---|---|
| April 2022 | Minimum 10% net zero and social value weighting in all procurements |
| April 2023 | Carbon Reduction Plan for new contracts above £5m a year |
| April 2027 | Public reporting of targets, emissions and a Carbon Reduction Plan covering global Scope 1, 2 and 3 |
| 2028 | Planned requirements for carbon footprints of individual products |
| 2030 | Only suppliers showing progress can qualify for NHS contracts |
The 2028 product-footprint milestone is where PAS 2090 becomes practical. NHS England co-sponsored the standard, and it gives suppliers a consistent method to produce those footprints.
Other reasons pharma companies run LCAs
- Scope 3 reporting. Purchased goods (APIs, excipients, solvents, packaging) dominate most pharma carbon inventories. Product LCAs turn spend-based estimates into activity-based data for CSRD, CDP and SBTi reporting.
- Ecodesign in R&D. Route selection, solvent choice and process mass intensity are fixed early. LCA during development shows which choices lock in impact.
- Market access and HTA. Health technology assessment bodies are exploring how environmental evidence could enter appraisals, with PAS 2090 cited as a candidate framework (3BL).
- Supplier and CDMO requests. Brand owners now ask CDMOs and API suppliers for PAS 2090-aligned data on the intermediates and services they buy.
- Investor and customer questions. Product data backs up net zero claims and answers ESG due diligence.
Pharma LCA software
Pharma LCA software turns a medicine’s bill of materials, process data and supply chain into a calculated footprint, using background databases for inputs you don’t measure directly. The right option depends on how many products you need to assess, how often the numbers must be refreshed, and whether results need to feed reporting beyond a single study.
| Option | Examples | Strengths | Limitations |
|---|---|---|---|
| General-purpose expert LCA tools | SimaPro, Sphera LCA for Experts (formerly GaBi), openLCA | Maximum modeling flexibility for LCA specialists | Steep learning curve; PAS 2090 rules applied by hand; slow across a portfolio |
| Guided single-product tools | PharmaLCA | Step-by-step PAS 2090 workflows; free starter tier | Products modeled one at a time with manual data entry; paid tier priced per user; no Scope 3 roll-up advertised |
| AI-powered LCA platforms | CarbonBright | AI builds product models from BOMs and supplier data; scales to full portfolios; supplier portal; feeds Scope 3, CDP and CSRD reporting | Highest-quality results still benefit from primary process data |
| LCA consultancies | Quantis, Tunley Environmental and others | Deep expertise; third-party critical review | Cost and lead time per study; results go stale as products change |
PharmaLCA is a PAS 2090 tool developed with the Pharma LCA Consortium, with commercial launch planned for October 2026. Its Starter tier is free for a single user; the Professional tier adds curated ecoinvent data and collaboration at €8,000 per user per year (published pricing, as of October 2026).
What to look for in PAS 2090 LCA software
- PAS 2090 alignment: functional units, system boundaries, allocation, data quality ratings and reporting templates that match the standard.
- Pharma-relevant background data: chemical and solvent datasets, plus access to the consortium’s pharma LCI database via ecoinvent.
- API route modeling: multi-step syntheses, solvent recovery, yields and process mass intensity.
- Scale: the ability to assess hundreds of SKUs, strengths and pack sizes, not just one flagship product.
- Supplier collaboration: a way to request and use primary data from API suppliers, CDMOs and packaging vendors.
- Outputs: PAS 2090 reports, ISO 14067 PCFs, Scope 3 Category 1 roll-ups, and data ready for NHS Evergreen and CDP.
- Security: SOC 2 or ISO 27001, data isolation and role-based access for confidential process data.
How does CarbonBright compare?
CarbonBright and PharmaLCA solve different parts of the same problem. PharmaLCA is the consortium’s guided tool for building PAS 2090 assessments one product at a time. CarbonBright is an AI-powered LCA platform built to footprint an entire portfolio, from API synthesis to packaged dose, and connect those results to Scope 3, supplier requests and reporting (CarbonBright).
| Capability | CarbonBright | PharmaLCA | Expert LCA tools |
|---|---|---|---|
| PAS 2090 methodology | Supported: PAS 2090 rules for functional unit, system boundary, data quality and reporting applied as a configurable PCR | Built in via guided workflows | Applied manually by the practitioner |
| Data entry | AI turns BOMs, materials and supplier data into a product model and fills data gaps | Guided manual entry per product | Manual modeling |
| Portfolio scale | Built for every API, excipient and finished dosage form across a portfolio | Unlimited models; built per product | Practical for a few products at a time |
| Supplier engagement | Secure supplier portal for submitting and reviewing data | Collaboration in paid tier | Not included |
| Scope 3 roll-up | Product PCFs aggregate into a GHG Protocol Category 1 inventory with CDP-ready exports | Not a core feature | Not included |
| Other outputs | ISO 14040 LCAs, ISO 14067 PCFs, EPDs, product compliance | PAS 2090 LCA results | Custom reports |
| Ecodesign scenarios | Compare materials, routes, suppliers and packaging | Supported | Supported |
| Expertise needed | Low; AI co-pilot and CarbonBright LCA experts | Low to medium | High |
| Security | SOC 2 | ISO 27001 | Varies |
When CarbonBright is the better fit
- You need footprints for dozens or hundreds of products, strengths or pack sizes, not a single study.
- You are an API, excipient or CDMO supplier fielding PCF requests from multiple brand-owner customers.
- You want product LCAs to feed Scope 3, CDP and CSRD reporting without rebuilding the data.
- Your R&D team wants fast scenario comparisons on route, solvent, supplier or packaging choices.
Choosing the right fit
For a one-off assessment of a single product, a guided tool or a consultant can do the job. Once the requirement grows to a whole portfolio, recurring customer requests and Scope 3 reporting, rebuilding each model by hand becomes the bottleneck. That is the problem CarbonBright is built to solve.
Types of pharma products that need an LCA
PAS 2090 applies to any medicine for human use, but the hotspots and modeling choices differ by product type. Here is what an LCA typically focuses on for each.
LCA for active pharmaceutical ingredients (APIs)
API synthesis is often the largest share of a small-molecule medicine’s footprint. Multi-step routes, solvent use and recovery, reagents, yields and energy-intensive purification all drive impact. API makers increasingly receive PCF requests from brand owners, so cradle-to-gate API footprints are a common starting point.
LCA for tablets and capsules (oral solid dose)
For oral solid dose, the API share per dose, excipients, granulation and coating energy, and blister or bottle packaging are the main inputs. The functional unit is usually per dose or per daily dose, which makes strength and dosing frequency important.
LCA for biologics and monoclonal antibodies
Biologics shift the hotspots toward cell culture media, cleanroom HVAC, water for injection, single-use bioprocessing systems and cold-chain distribution. Facility energy and utilization rates matter more than in small-molecule manufacturing.
LCA for injectables, prefilled syringes and autoinjectors
Drug-device combination products, such as pens for GLP-1 and insulin therapies, add device materials, electronics in some cases, sterilization and end-of-life disposal. PAS 2090 covers the administration device as part of the product system.
LCA for inhalers
For pressurized metered-dose inhalers, the propellant released during patient use can dominate the footprint. LCAs compare propellant options and dry-powder alternatives, and are central to NHS efforts on inhaler emissions.
LCA for vaccines
Vaccine LCAs focus on bioproduction, multi-dose versus single-dose presentation, cold-chain storage and transport, and wastage from opened vials.
LCA for generics and biosimilars
Generics manufacturers face the same NHS procurement requirements as innovators but often with less primary data. PAS 2090’s tolerance for secondary data outside a company’s control makes it workable for generics and biosimilar portfolios.
LCA for OTC and consumer health products
OTC products share hotspots with oral solid dose, plus retail packaging and distribution. They also face consumer-facing green claims rules, so robust LCA data protects marketing claims.
LCA for excipients, intermediates and packaging components
Suppliers of excipients, intermediates, solvents, glass vials, blister films and cartons are being asked for PCFs by pharma customers. Cradle-to-gate footprints aligned with PAS 2090 let these suppliers answer once and reuse the data across customers.
LCA for CDMO and CMO services
Contract manufacturers need site- and product-level footprints to allocate emissions to each customer’s product. Clear allocation rules under PAS 2090 make those numbers defensible.
Pharma LCA examples
Published pharma LCAs show how much footprints vary by product type, and which design choices move the numbers most. The examples below predate PAS 2090 or used other methods (ISO 14040/44, the GHG Protocol pharma sector guidance, hybrid input-output models), so their results are not directly comparable. That inconsistency is exactly the gap PAS 2090 was written to close.
| Example | Product type | Scope | Key finding |
|---|---|---|---|
| Propellant switch in a triple-therapy inhaler (AstraZeneca) | Pressurized metered-dose inhaler | Cradle-to-grave | Replacing HFA-134a with HFO-1234ze cut the inhaler’s footprint by about 92%, bringing it close to a dry powder inhaler |
| Insulin and GLP-1 pen footprints (Novo Nordisk) | Drug-device combination | One year of treatment | Insulin in a prefilled pen: 8–24 kg CO2e per patient per year; a weekly GLP-1: 3–6 kg CO2e per year |
| Reusable insulin pen device (Novo Nordisk) | Reusable injector | Full life cycle, per device | 538 g CO2e in Europe, 953 g in the US and 482 g in Japan; the spread came mainly from distribution distance |
| Reusable vs disposable insulin pens (NHS analysis) | Drug-device combination | Annual treatment | Switching to reusable cartridge pens cut carbon footprint by 40% for the products assessed, and often lowered cost |
| 20 anaesthetic APIs (Parvatker et al., 2019) | Small-molecule API | Cradle-to-gate, per kg API | From 11 kg CO2e/kg (succinylcholine) to 3,000 kg CO2e/kg (dexmedetomidine); impact rose with the number of synthesis steps |
| 12,316 oral medicines (French pharmacopeia study) | Tablets and capsules | Cradle-to-pharmacy gate | API production was on average 28.5% of the footprint and medicine manufacturing 25.5% |
| 103 monoclonal antibodies (hybrid LCA) | Biologics | Cradle-to-pharmacy gate | Mean of about 170 kg CO2e per vial or prefilled syringe, and about 371 kg CO2e per month of treatment |
| Six severe-asthma biologics | Biologics | Cradle-to-gate, per preparation | 139 g to 6,996 g CO2e per preparation, a 50-fold range driven by API per dose and the manufacturer’s energy mix |
| IV vs subcutaneous pertuzumab/trastuzumab | Biologic, two administration routes | Manufacturing through hospital use and waste | Subcutaneous was slightly higher (47.2 vs 45.9 kg CO2e per loading dose) because of the higher dose; antibody production dominated both |
What these examples show
- Design choices dominate. Propellant, device reusability and synthesis route each changed results by 40% or more.
- Use phase can matter as much as manufacturing. For inhalers, propellant released by the patient drives the footprint; for biologics, hospital administration adds a measurable share.
- The functional unit changes the story. Per kg of API, per dose, per device and per year of treatment give very different pictures of the same product.
- Comparisons need a common method. Each study made its own boundary and data choices. PAS 2090 sets those rules once, so a health system can compare suppliers’ footprints like for like.
- Portfolio coverage is the next hurdle. Most published examples cover one product or one therapeutic class. Meeting product-level procurement requirements means footprinting every SKU, which is where AI-powered LCA platforms such as CarbonBright save the most time.
Sources
- BSI press release: first global standard for the environmental impact of pharmaceuticals
- BSI Knowledge: PAS 2090:2025 product page
- EFPIA: standardisation of pharmaceutical product carbon footprints
- Quantis: what PAS 2090 means for sustainable pharma
- PEG Hub: Pharma LCA Consortium resources
- NHS England: Net Zero Supplier Roadmap
- NHS England: five years of a greener NHS
- Ecovamed / French Directorate General for Enterprises: medicines carbon footprint assessment methodology (consultation version)
- 3BL: why LCAs matter for the pharmaceutical industry
- CarbonBright: Pharmaceuticals & Life Sciences
