Official Statistics

Bioscience and health technology sector statistics 2021: background quality and user guide

Updated 14 June 2023

1. Introduction

This background quality and user guide accompanies the Bioscience and health technology sector statistics (BaHTSS) 2021 release. The BaHTSS publication series contains analysis of trends in the UK life sciences industry, covering the biopharmaceutical and medical technology principal sectors. This accompanying background quality and user guide gives further details on how these statistics are derived and the underlying quality associated with the data and analysis used in the publication.

Any feedback or questions are welcome on these statistics, please email [email protected]

2. Statistical presentation

2.1 Definition of the UK life sciences industry

This report contains analysis of trends in the UK life sciences industry, covering the biopharmaceutical and medical technology principal sectors. The three main measures of economic contribution and industry structure included in this report are:

• employment - the number of people employed by life sciences businesses
• turnover - the amount of money taken by businesses within scope of life sciences sector activities
• number of businesses – the number of life sciences businesses and their sites registered in the UK

The term ‘business’ is used to describe an entity that is the legal owner of a group of trading addresses or sites and legal entities. A business may consist of more than one site or registered company. The UK life sciences industry consists of businesses operating in the following 4 sectors focusing on human health (veterinary and industrial biotechnology businesses are not in scope):

• Core biopharmaceutical: includes all businesses involved in developing and/or producing their own pharmaceutical products - from small, research and development (R&D) focused biotechs to multinational Big Pharma
• Biopharmaceutical service and supply: comprises businesses that offer goods and services to core biopharmaceutical businesses including, for example, contract research and manufacturing organisations (CRMOs), and suppliers of consumables and reagents for research and development (R&D) facilities
• Core medical technology: includes all businesses whose primary business involves developing and producing medical technology products, ranging from single-use consumables to complex hospital equipment, including digital health products
• Medical technology service and supply chain: comprises businesses that offer services to core medical technology businesses including, for example, CRMOs, and suppliers of consumables and reagents for R&D facilities

2.2 Classification of site activity

The data used in the BaHTSS publication provides information on businesses and individual sites operating in the UK life sciences sector. This data is structured at the site level, with each site’s data presented in an individual record, or row, in the accompanying dataset. Site level data can be aggregated up to company level to enable analysis of businesses operating in the UK life sciences sector. The activity carried out at each site is examined to allocate it a sector and a more detailed sub-category of that sector (referred to as a ‘segment’).

A small proportion of businesses in the database have more than one site. As activity is classified at the site level, it is possible for sites belonging to the same business to be allocated different segments or sectors to each other (meaning that turnover and employment figures for a single business may be split between multiple segments or sectors).

Assigning sites to sectors

Each individual site belonging to a life sciences business is assigned to one of 4 sectors depending on the main type of final medicinal product or device produced at that location. Sites that produce products that are directly used in healthcare are classified as “core” sites to distinguish them from sites that are active only in the service and supply chain.

Assigning sites to segments

Each site in the publication data is allocated a segment based on the activity carried out there. Where a company engages in activity that falls into more than one segment, only the segment that represents the majority of the site activity is used in the analysis.

The categories used in this segmentation are outlined section 11. Sector and segmentation classification scheme.

Genomics activity coding

Businesses in the dataset are additionally classified by whether their business is substantially involved in the field of genomics. In this analysis, sites with genomics activity are assigned a level 1 and level 2 genomics classification, these categories are outlined in section 11. Sector and segmentation classification scheme. Genomics is an interdisciplinary field of science and technology focused on the study of genomes. In this analysis the focus is on the study of the human genome and the application of the resulting knowledge to human health.

Companies are only coded as undertaking genomics activity if genomics is their principal activity, or if genomics contributes to a substantial level of their activity. Companies that use genomics to inform processes such as drug discovery would not be classed as undertaking genomics activity.

This classification is derived entirely separately from the sector/segment descriptions. This genomics classification is applied at the business level, whereas the sector/segment classification is applied at the site level. By comparing these classifications it is possible to analyse which sectors of the life sciences industry have the greatest concentration of genomics activity.

Business activity coding

Business activity codes are assigned on a site level and they are given a level 1 and level 2 business activity classification. These codes are outlined in section 11.Sector and segmentation classification scheme. Business activity codes are allocated by analysing public domain information relating to the company or site, including information from a company’s website and analysis of job roles within the business. These codes help to identify the role of a site and may be different for each site within a multi-site business. This helps to differentiate, for example, a head office/sales office location from a manufacturing site. The business activity codes are used to analyse the proportion of UK like sciences engaged in research and development, manufacturing, sales and distribution and after sales support.

2.3 Coverage

In order for a business to be classified as in-scope and its data to be included, it is assessed against the following criteria:

• has a legal entity in the UK, not including any crown dependencies;
• is a private limited company (this excludes universities, publicly owned institutions, NHS activities, and charities); and
• has a minimum of 20% of its total UK turnover derived from one or more of the segments shown in the 11. Sector and segmentation classification scheme section.

Analysis in this report is additionally conducted by geographical breakdowns of the UK. This includes regions and local authority districts. More information on these geographies can be found on the Office for National Statistics (ONS) page on Administrative geography.

2.4 Time period

The BaHTSS publication covers activity relating to the period from 2009 up to and including 2021.

2.5 Alignment with Standard Industry Classification (SIC) codes

Standard Industry Classification (SIC) codes are used to classify businesses by industry in administrative statistics. These codes were last updated in 2008. This classification system has categories for businesses whose primary activity is the manufacture of pharmaceuticals, manufacture of types of medical equipment, and those whose primary activity is biotechnology R&D.

However, the categories within the SIC system do not align with the full breadth of the life sciences industry, meaning that it is not possible to achieve complete data coverage of the life sciences industry using SIC codes. For this publication, a bespoke industry segmentation was designed with the assistance of data partners to enable better classification of activity within the life sciences industry. These categories are outlined in the 11. Sector and segmentation classification scheme section of this document.

The additional benefit of the segmentation approach used in the life sciences database is the ability to make a more granular assessment of the sector, including growth rates and trends within specific fields of life sciences. For example, this is the only source of definitive information that shows employment and growth rates in digital health, or allows us to understand the growth of advanced therapy medicinal products.

3.Data collection and processing

3.1 Data collection

To produce the BaHTSS dataset, information on businesses operating in the life sciences sector is collated from several sources. These sources are then compiled into a database that informs the analysis in the publication’s main reports.

Data on businesses operating in the life sciences sector is sourced from a range of data partners (who are listed in the ‘data partner acknowledgement’ section of this document). These data partners regularly provide information on these businesses from their internal databases, including information on new businesses forming, businesses ceasing operations and on mergers and acquisitions that have taken place on an annual basis.

This data is also supplemented by searches of publicly available data and subscription databases. This includes website analysis, detailed reviews of published articles including gender pay gap reports, quarterly and annual reviews, as well as company specific and national news sources. Business information, including employment, turnover, small and medium-sized enterprise (SME) status and company ownership is supplemented from the Dun & Bradstreet (D&B) Limited database and the FAME database from Bureau van Dijk Electronic Publishing.

The construction of this database is compiled by a consortium led by Kepier & Company Ltd. Further processing of the database and production of the analysis that feeds into the BaHTSS publication is then conducted by the Office for Life Sciences (OLS).

3.2 Data segmentation

The information from data partners and other information sources is cleansed and duplicate records are removed. Each site is then assigned a label within a hierarchical classification system (see section on 11. Sector and segmentation classification scheme) - a process referred to as ‘segmentation’ in the context of this report.

Segmentation assigns each new site to a sector and segment. As segmentation is carried out at the site level, it is possible for sites belonging to the same business to be allocated different segments and sectors to each other. For example, some large multi-national businesses produce both pharmaceutical and medical devices. If, based on the information available, a business cannot be assigned to a sector and segment, it is deemed to be not-in-scope (NIS). NIS information is retained but is not included in the data set used to analyse the industry.

Sites proposed for inclusion or identified through a search of new incorporations are checked for “proof of life”, which involves searching for signs of economic activity such as employees, turnover, award of funding, or an active website with contact details. Sites which fail this test but appear to be in scope are reviewed again in the next project cycle.

3.3 Matching against external datasets

Once the cleansed data set is prepared, it is used to source data on turnover and employment from reliable external data sources, and from examination of published company reports or data. Matching between datasets is achieved using the company name, company registration number and the postcode for the site. The turnover figures include turnover generated from the sale of products wholly or partially manufactured outside the UK. The external databases used are Dun & Bradstreet’s (D&B) database and Bureau van Dijk’s FAME database.

3.4 Data validation

The data returns from D&B and FAME are carefully checked to ensure a correct match with the business location. Further detailed validation of the data is then carried out by examining changes in the employment and turnover data. These changes are investigated to detect any anomalies through verification against other sources.

For example, large changes in employment at a business site are scrutinised to see if information is available from press releases or other information in the public domain to verify the change. From 2018 onwards, Gender Pay Gap reporting was used both to detect potential anomalies by using the compulsory employment band data, and to verify or update our data using more detailed information provided by businesses within their own reports. The data for individual sites under one business is examined to ensure that there is no double-counting of employment or turnover data.

3.5 Data adjustments

Turnover is reported in constant prices, based on the final year of activity associated with each addition to the series, using GDP deflators to take account of inflation across the years.

Businesses are assessed to determine whether all of their activity comes under the scope of life sciences. If it is considered a business conducts activity outside of life sciences, a scaling factor is applied to their turnover value and employment counts so that only the proportion that is directly related to life sciences activity is considered in the BaHTSS dataset.

3.6 Data partner acknowledgement

OLS gratefully acknowledge the contribution of the following regional and national organisations in the compilation of the Bioscience and Health Technology Sector Statistics database over the past thirteen years. These data partners are listed below:

• Association of British Healthcare Industries (ABHI)
• Association of the British Pharmaceutical Industry (ABPI)
• AXREM
• BioIndustry Association (BIA)
• BioNow
• BioPartner UK
• Biosciences Knowledge Transfer Network (KTN)
• British Healthcare Trade Association (BHTA)
• British In Vitro Diagnostics Association (BIVDA)
• HealthTech and Medicines Knowledge Transfer Network (KTN)
• Innovate UK
• Invest Northern Ireland
• MedCity
• Medicines Discovery Catapult
• Medilink East Midlands
• Medilink North of England
• Medilink South West
• Medilink West Midlands
• MediWales
• Medicines and Healthcare products Regulatory Agency (MHRA)
• OBN
• One Nucleus
• Scottish Enterprise
• South East Health Technologies Alliance (SEHTA)
• TechUK
• Welsh Government

3.7 Rounding and disclosure control

Outputs for the publication are assessed to ensure there is no disclosure of employment or turnover values for individual businesses. When aggregations of turnover or employment are derived from 5 businesses or fewer, these figures are suppressed. Totals are also rounded appropriately when individual values could be revealed.

The BaHTSS reports apply rounding to quoted numbers to ensure coherence and that the main results of the findings can be interpreted easily.

4.Data quality

These statistics are badged as official statistics and are produced in line with the Government Statistical Service (GSS) Code of Practice for Statistics. The OLS regularly assess the BaHTSS publication to ensure the statistics remain relevant and useful to user needs. OLS are planning to conduct further work in 2023 to ensure the segmentation of the life sciences sector is kept up to date with changes in the sector, and that the publication continues to meet our users’ needs.

Further work will also be conducted in 2023 to establish how the classification and segmentation of businesses can go through comprehensive quality assurance processes to ensure it is providing an accurate and timely view of the composition of the sector.

4.1 Quality

Q1: Suitable data sources - The sources used for this publication are regularly assessed as part of the technical specification and contract tendering process. The methodology for producing the final data sourced is outlined in the 3. Data collection and processing section.

Q2: Sound methods - The methods used to compile these statistics are further outlined in the methodology section and are similarly evaluated on an annual basis to ensure the processes are in line with the required standard for user needs.

Q3: Assured quality - The BaHTSS publication is assessed annually to ensure that the quality of the statistics is of the required standard for user needs and that this is conveyed to users.

An outline of the BaHTSS quality assurance process is provided below, with further details on how the BaHTSS publication meets the standard of quality as set out in the European Statistical System’s (ESS) Dimensions of Quality.

Overview of QA process:

• Data supplied by data partners on companies operating in the sector is additionally validated by Kepier & Co to ensure they are considered in scope as per the definition of life sciences used in this publication
• Regular communication is conducted with Kepier & Co and the data partners to ensure the dataset can be kept up to date with recent changes in the sector.
• Systematic validation checks are conducted by Kepier & Co on the dataset to check for accuracy of data supplied and uniformity of the classifications of businesses and sites within the dataset
• OLS conduct further validation checks on the dataset, including checking for implausible values and missing data
• The accompanying data tables used as the basis of this report are all produced using the statistical package R. This reduces the likelihood of computation errors and all outputs are quality assured by a second analyst.
• The report is compiled and assured by multiple analysts to check statements are accurate and objective

4.2 Value

V1: Relevance to users – The content of the publication is reviewed each year to consider how user needs are being met. This feeds into the data collection and segmentation processes conducted at the start of each annual publication cycle.

V2: Accessibility – The BaHTSS publication is published on gov.uk and all documents can be found on the BaHTSS collection page. The aggregated figures behind the charts and the commentary in the report are published in spreadsheets each year, along with an accompanying background quality and user guide that assures users of the methods and quality used in this publication

V3: Clarity and insight – Commentary on the current size and shape of the life sciences sector is objective, focussing on impartial statistical messages. Charts and maps are used to illustrate these. Key statistical messages are highlighted at the beginning of each report section. The database itself is created through collaboration with a range of industry experts, including region-specific and sector-specific representation through trade bodies and other network organisations.

V4: Innovation and improvement – The content, presentation and methodology are reviewed each year based on user needs. Past development has primarily been related to scope and how to identify new and emerging segments of the life sciences sector, such as digital health and genomics. Each new approach to scope is explored and tested with data partners, and the statistical impact is fully considered before implementation. Other developments have included expanding the list of data fields that are made publicly available.

V5: Efficiency and proportionality – Where possible, the database draws on existing information using third party sources, such as the Dun & Bradstreet and Bureau Van Dijk FAME datasets and company accounts. All data partners are voluntary contributors. The need for this report and underlying database arises from the difficulties encountered in achieving good coverage of the life sciences sector using existing data categorisation systems in other sources already in the publication domain.

4.3 Trustworthiness

T1: Honesty and integrity – These statistics are produced and published with the aim of ensuring that an accurate and objective view of the life sciences sector in the UK can be conveyed to the public. All material is produced in line with principles in the code of practice on impartiality.

T2: Independent decision making and leadership – Decisions on how these statistics are compiled and presented are made by analysts in OLS in line with guidance from the GSS.

T3: Orderly release – Access to the BaHTSS publication ahead of release is restricted to those involved in the production of these statistics. The circulation of the statistics 24 hours ahead of their release is restricted to the minimum necessary number of eligible recipients. The job titles of these individuals are outlined in the pre-release access list, which can be found on the BEIS statistics website.

T4: Transparent processes and management – substantial resources are employed to enable this data collection and effective quality assurance. Each year, a proportion of this resource is dedicated to further development of the report in light of new user requirements, potential improvements to methodology, or new data collection methods. The process for compiling these statistics is published within the accompanying document for users.

T5: Professional capability – Data is collected, processed and quality assured by a contractor with their specification outlined by OLS on an annual basis. Each individual working for the contractor has appropriate analytical capabilities, data protection awareness and industry-specific expertise. Those involved in the production of the statistics within OLS are all professional analysts and ensure the statistics remain in line with the code of practice.

T6: Data governance – All professionals involved in the creation, publication and storage of this dataset are well-versed in data protection and operate in compliance with data protection legislation. The maximum amount of data available without contravening third-party licence agreements, utilising GSS best practice for statistical disclosure control.

5. Relevance

These statistics are produced due to the need for a comprehensive view of the life sciences industry in the UK that is not provided by other published data sources. Standard Industry Classification (SIC) codes are used to classify businesses by industry in other official statistics. This classification system has categories for businesses whose primary activity is the manufacture of pharmaceuticals, manufacture of types of medical equipment, and those whose primary activity is biotechnology R&D.

However, these categories do not capture the full breadth of activities carried out by businesses operating in the life sciences sector, as demonstrated by the fact that only 28% of sites identified in the BaHTSS database in 2021 were classified within these four SIC codes. The more bespoke methods used in this publication to identify and classify UK life sciences businesses therefore mean that these statistics fulfil a previously unmet need in providing accurate, granular data on the life sciences sector.

6. Accuracy and reliability

6.1 Accuracy

Data on businesses operating in the UK life sciences sector is compiled based on information provided by data partners (listed in section 3. Data collection and processing). Regular communication is kept between Kepier & Co and OLS to ensure the list of businesses operating can be kept up to date and provides the most comprehensive view of the industry. Validation and enrichment of information provided by data partners is conducted by Kepier & Co.

This method provides high coverage of the sector due to the fact that a wide range of organisations representing different areas of the sector take part in providing data. This includes organisations representing each sector of industry, large businesses and small and medium-sized enterprises (SMEs).

All records provided by data partners are systematically checked by Kepier & Co to ensure they meet the scope of this series.

Information such as employment, turnover, SME status and company ownership is matched onto data supplied by data partners. This is drawn from both the FAME and D&B databases and data is cross-matched between the sources to validate the information and identify and resolve any conflicting data.

The segmentation in this report was derived after user engagement with stakeholders. This has been reviewed regularly to ensure it is still an accurate reflection of the industry and some major revisions have included:

• The addition of the pharmaceuticals sector
• Splitting the two primary sectors into “core” and “supply chain”
• The addition of the digital health sub segments
• The addition of genomics
• The removal of healthcare providers

In 2023, OLS will conduct further user engagement on this segmentation to ensure any recent changes in the life sciences environment can be factored into the classification system used in this report.

6.2 Revision policy

Each publication in this series backdates past published data with the most up to date information. Each edition revises the turnover figures for all years using the latest GDP deflators to account of inflation. It is recommended to always use the most up to date publication in the series. A summary of changes to each publication and revisions to the 2021 publication is included in the accompanying Bioscience and Health Technology Sector Statistics 2021 report and the revision notice for 2021 is additionally highlighted below.

An error was spotted relating to the turnover timeseries for past reports for the years 2009 to 2018. The timeseries is revised each year, but the corrections made to resolve this error have meant that the turnover timeseries has been revised by more than usual in this year’s publication (a decrease of up to 8% in each year between 2009 and 2018). This change in turnover can be seen in the biopharmaceutical core and service and supply sectors. Any revisions outside of this will be in line with the BEIS’s Statistics revision policy and highlighted clearly in the reports.

7. Timeliness and punctuality

This publication is released on an annual basis, covering activity relating up to and including the relevant year being published (with a one-year time lag). This publication schedule has been set in accordance with user needs balanced against the time and resource required to compile new information into the dataset. Company trading status, financial and employment data in the publication are aligned with the financial year end for that year.

Each annual publication is pre-announced via the gov.uk publication calendar at least 4 weeks in advance, in line with the principles outlined in the GSS code of practice for statistics.

8. Coherence and comparability

Each release of this publication backdates the timeseries of data available with the most recent methodology, where possible. In certain circumstances this has not been possible, including for:

• Business ownership: Improvements have been made in this publication to the coverage of the business ownership classification in the dataset. This work has been applied to the ownership status for businesses for data relating to 2021 only. It is anticipated that this work will be applied to earlier years in the dataset in future publications. The work has focussed on improving the analysis of the global ultimate owner of the business by combining and moderating information from both the D&B and FAME data sources.
• SME status: Improvements have been made to the coverage and accuracy of business size classification in this publication. This work has been applied to the SME status for businesses for data relating to 2021 only. It is anticipated that this work will be applied to earlier years in the dataset in future publications.

The accompanying report summarises any changes to methodology or process from the previous year. For the 2021 report this can be found in the ‘Publication updates’ section and is also summarised below:

8.1 New additions

This report publishes data on employment and turnover from life sciences businesses operating in the UK at local authority district level for the first time. An overview of this data can be found in the ‘Variation in employment and turnover’ section and further data can be found in the accompanying data tables.

8.2 Methodology changes

Several changes have been made to the methodology behind the statistics this year, including:

• Further research was conducted this year to identify businesses which have substantial levels of activity in the field of genomics. This has resulted in more businesses being tagged with the genomics classification codes. All figures in this report include a backdated timeseries to cover these businesses.
• Additional work has been undertaken in the 2021 edition to improve the accuracy of both the business size classification, which labels businesses as either SME or non-SME, and the business ownership classification, which identifies businesses with UK or overseas ownership. This work has been applied to the 2021 only, and as a result data for previous years is not available within this report.
• This publication only includes life sciences sites operating in the UK and excludes any operating in the UK’s crown dependencies. Previous publications in the BaHTSS series includes sites in the crown dependencies. The timeseries in this report has been backdated retrospectively.

9. Accessibility and clarity

All publications in the BaHTSS series are published on the gov.uk collection page and are freely available. These are published by OLS on an annual basis with a report summarising the main trends, accompanying data tables and background quality and user guide.

The reports in this series are published in HTML format from 2020 and the associated spreadsheets are published in OpenDocument Spreadsheet (ODS) format from 2021 to ensure accessibility. The ODS file also meets the requirements of the Government Analytical Function guidance on releasing statistics in spreadsheets.

Each release also has an accompanying site level dataset for the most recent year of activity. This has been subject to disclosure control methods to ensure no financial or employment information for individual businesses is disclosed.

10. Cost and burden

Data is submitted from the list of data providers in section “3.6 Data partner acknowledgment” on companies entering and leaving the industry on an annual basis. Data providers keep a record of these changes as part of their usual business cycle and provide a summary as part of the BaHTSS data collection each year. The collaborative approach to data provision recognises that data providers vary in their capacity to provide data to the project each year. This flexibility ensures that data providers can continue to contribute to the project each year despite variations in their capacity. The subsequent processing and enhancement of the submitted data by the project delivery team has been refined over the years to accommodate these variations whilst maintaining the quality of the resulting dataset.

11. Sector and segmentation classification scheme

This section outlines the classifications used in this report and their definitions.

11.1 Sectors

• Core biopharmaceutical: includes all businesses involved in developing and/or producing their own pharmaceutical products - from small, research and development (R&D) focused biotechs to multinational Big Pharma
• Biopharmaceutical service and supply: comprises businesses that offer goods and services to core biopharmaceutical businesses including, for example, contract research and manufacturing organisations (CRMOs), and suppliers of consumables and reagents for research and development (R&D) facilities
• Core medical technology: includes all businesses whose primary business involves developing and producing medical technology products, ranging from single-use consumables to complex hospital equipment, including digital health products
• Medical technology service and supply chain: comprises businesses that offer services to core medical technology businesses including, for example, CRMOs, and suppliers of consumables and reagents for R&D facilities

11.2 Segmentation

The 4 sectors are then disaggregated into categories that describe the individual product or service groups within a sector (listed in the tables below).

Biopharmaceutical core segments:

Segment description	Definition
Antibodies	Proteins made by plasma cells in response to an antigen. This segment includes companies involved in the research and/or manufacture of polyclonal and monoclonal antibodies as well as antibody fragments.
Therapeutic proteins	A protein-based drug including recombinant, non-recombinant, blood factors and peptides.
Advanced therapy medicinal products (ATMPs)	Advanced therapy medicinal products (ATMPs) contain cell therapies, tissue engineered products (TEPs), combination products and gene therapies, as defined in Regulation (EC) No 1394/2007 on advanced therapy medicinal products.
Vaccines	A substance which is used to stimulate the production of antibodies and provide immunity against one or several diseases. This includes viral, DNA, native cell, recombinant protein and cellular vaccines.
Small molecules	An organic compound with low molecular weight, they often can be administered orally and they can pass through cell membranes to reach intracellular targets.
Blood and tissue products	Human cells or tissue products intended for implantation, transplantation, infusion or transfer into a human.

Medical technology core segments:

Segment description	Definition
Wound care and management	Including but not limited to dressings, bandages, skin ulcer treatments and pressure relief devices.
In vitro diagnostic technology	Devices which test or measure biological samples to deduce the status of a person’s health.
Radiotherapy equipment	Equipment which uses radiation in the form of x-rays, gamma rays, neutrons, protons or other sources to kill cancer cells.
Medical imaging/ultrasound Equipment	Technologies which are used to view the human body in order to diagnose, monitor or treat medical conditions.
Anaesthetic and respiratory technology	Technology designed to aid the anaesthesia (loss of sensation) of a patient and/or aiding respiration.
Orthopaedic devices	Devices which aid or support bones or muscles. This includes orthopaedic prosthetics, orthotics and fracture repair devices.
Cardiovascular and vascular devices	Devices which aid the functioning of the heart and/or circulatory system, including artificial hearts and cardiac output monitors.
Neurology	Devices which aid the diagnosis and treatment of conditions and disease involving the brain, spinal cord and peripheral nerves.
Ophthalmic devices/equipment	Relating to the treatment of the eye and diseases of the eye. Includes implants and ophthalmic monitors.
Dental and maxillofacial technology	Primarily dentistry tools, crowns, implants and bridges. Also includes laser treatment, dental prosthetic manufacture and implants for reconstructive surgery
Drug delivery	Technologies that carry drugs into or throughout the body such as infusion systems and transdermal devices. Excludes drugs in tablet form.
Infection control	Includes a range of devices which minimise or reduce the chance of infection or contamination. Includes special surfaces and environmental controls as well as the more common sterilisation and disinfection devices.
Surgical instruments (reusable)	Includes enteral feed devices, endoscopy and laparoscopy devices and other surgical kits (including drapes). Also includes surgical staplers, retractors, scalpels and sizers. All devices in this category must be reusable and not single use.
Single use technology	Technologies which can only be used once. Includes syringes, needles, stoma and continence products, dialysis tubing and disposable theatre drapes and wipes. Can also include contraceptives and other single use kits.
Re-usable diagnostic or analytic equipment	Equipment which can be used repeatedly to help diagnose and analyse the patient’s condition. This includes point-of-care monitoring, ear nose and throat devices as well as nephrology and urology.
Implantable devices	A specialist category of implantable sensors, electrical stimulation and contraceptive devices.
Assistive technology	Includes wheelchairs, walking and hearing aids, prosthetics (not orthotic), rehabilitation products, seating and positioning.
Mobility access	Distributors and manufacturers of mobility vehicles, stairlifts and access equipment. Does not include wheelchairs but does include mobility vehicles.
Hospital hardware including ambulatory	Includes a range of hospital hardware such as hospital beds, support surfaces, lights, patient transfer trolleys and incubators. Also includes mortuary and organ storage and hospital specific non-disposable textiles.
Digital health	A fast moving and diverse segment which includes mobile health, health information technology and some wearable devices. Telehealth and telemedicine are also included alongside training simulators and robotics specialised for the life sciences sector.

Biopharmaceuticals and medical technology service and supply segments:

Segment description	Definition
Clinical research organisation	Companies that support drug manufacturers to discover and approve drugs on a subcontract basis. Activities include: data research, project management, tests, trial delivery (post approval, pre-clinical and clinical).
Contract manufacturing organisation	Companies that serve other companies in the pharmaceutical industry on a subcontract basis to provide comprehensive services from drug development through drug manufacturing.
Contract formulation manufacturing	Companies that develop alternative drug formulation and delivery methods (e.g. liquid medicines rather than tablets) and/or different dosages for specific groups of patients.
Assay developer	Companies that develop tests (assays) and test kits used in drug development. Includes toxicity testing and test systems which evaluate the effects of chemical compounds on cellular, molecular or biochemical processes of interest.
Analytical services	Companies that provide analytical services to the life sciences industry. A broad range of services including but not limited to: native mass spectrometry, genotyping, chromatographic. Also includes special measurement facilities such as 3D measurement of tooth implants and artificial joints.
Formulation/drug delivery specialist	Formulation development for oral, inhaled and parenteral routes of drug delivery.
Reagent, equipment and consumables supplier	Specialist suppliers to the pharmaceutical and medical technology industry as well as lab equipment and consumables suppliers for life sciences.
Regulatory expertise	Includes: regulatory affairs, CE marking, 510(K) clearance, PMA/PDP approval, ISO 13485 and ISO 14971 quality systems, pharmacovigilance, Post Marketing Drug Safety. Includes Qualified Persons (QP) and other expertise.
Patent and legal specialist	Patents, Intellectual Property concentrated on life sciences or having at least 20% of its business in the sector.
Logistics and packaging	Primary packaging, standard and custom designed packaging solutions, temperature-controlled courier services, specialist storage, fulfilment and distribution services.
Information systems specialists	Companies which focus on integrating ICT systems within the life sciences setting. Companies in this segment will provide expertise but if they provide a product, (such has a hospital information system) they will be categorised in the digital health segment instead.
Tissue and biomass	Procurement and supply of biological materials including serum, plasma, fresh blood products, tissues, organs, glands, urine, milk and amniotic fluids.
Market analysis/specialist consultants	A diverse segment which includes consultants on marketing, strategic planning, interim management services, process planning, R&D, process validation, cGMP manufacturing operations.
Contract design	Product design, process design and engineering, design, engineering and construction services. Can include design of clean rooms and cGMP facilities, rapid prototyping and medical device product design.
Training	Ranges from highly specific training in a discipline e.g. “spectroscopic fields” to more general or project management training aimed specifically at the life sciences sector
Recruitment	Includes “resourcing” on a direct to headcount (i.e. recruitment) or outsourced basis. Must be in the life sciences sector.
Investment companies	Venture capital firms with a predominant focus on life sciences, healthcare IP commercialisation.

11.3 Business Activity codes and descriptions

Level one description	Level two description	Definition
Research and development, including design	In-house	Companies which undertake research and development activities to support their own products. Includes: In-house product design and testing, intellectual property development and licensing, production of clinical trials materials.
Research and development, including design	Contract research, contract design	Companies which undertake research and development activities on a contract basis for other companies. Includes: contract product design and testing, contract research organisations, production of clinical trials materials.
Manufacturing	In-house	Companies which manufacture their own products. Includes: manufacture of products which are ready for market or sale to the end user or distributor. Excludes: components or sub-assemblies which do not constitute a product in their own right.
Manufacturing	Contract manufacturing	Companies which undertake manufacturing work on a contract basis for other companies. Includes: manufacture of products which are ready for market or sale to the end user or distributor. Excludes: components or sub-assemblies which do not constitute a product in their own right.
Service and supply chain	Service	Companies which provide a specialist service. Includes: specialist calibration, informatics and ICT, professional services & consultancy, education & training, sterilisation, gamma etc Excludes: after sales service
Service and supply chain	Supply chain	Companies which manufacture components or sub-assemblies which do not constitute a product in their own right. Includes: medical packaging, clean room moulding of plastic components, cell culture media.
Sales, distribution, after sales service, repair	Sales, distribution	Companies which sell or distribute products. Includes: assistive technology, single use technology, antibody distributors. Excludes: products which are not specialist to the sector but are used by NHS etc.
Service and supply chain	After sales service, repair	Companies which provide after sales service and repair for products and equipment. Includes: washer/steriliser maintenance, theatre lights service. Excludes: specialist calibration services

11. 4 Genomics codes and descriptions

Genomics level one activity	Definition	Genomics level two activities
Sampling	The process of collecting and packaging samples (e.g. saliva, blood). The kits used to collect DNA samples are fairly simple.	1. Consumables, 2. Patient acquisition, 3. Samples storage
Sequencing	Decoding the order of the nucleotides in a genome. DNA sequencing on a large scale is done by high-tech machines	1. Consumables, 2. Instruments, 3. Services
Analysis	The process to identify disease-causing variants, often run by bioinformatics software.	1. Data cleansing, 2. Variant analysis, 3. Database services
Interpretation	Taking analysed information and providing clinically useful interpretations and results	1. Reporting, 2. Link with Electronic Health Record (EHR), 3. Tailoring results
Application	The process of directly using genomic information to improve targeting of clinical services	1. Drug development, 2. Clinical services, 3. Diagnostics
Activities not elsewhere classified	A segment for companies that are clearly operating in genomics but are not easily assigned to the aforementioned level one activities. This category undergoes additional review if it becomes a large group.	N/A