Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Health Insurance
Barriers
Procurement & Tenders
Government & Association Links
FAQs
U.S. Commercial Service Contact Information
Tab Options
Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Health Insurance
Barriers
Procurement & Tenders
Government & Association Links
FAQs
U.S. Commercial Service Contact Information
Executive Summary The United Kingdom’s (UK) large and sophisticated healthcare system has a constant need for new and innovative technology. It has a large public healthcare segment, the National Health Service (NHS), which is financed primarily through tax and national insurance contributions. While most services are delivered to UK residents free at the point of delivery, service users are required to pay for certain services such a dental or eye care.
There is a small private healthcare segment, which is funded via private insurance, self-paying patients, or NHS funded referrals. Its strengths lie in the provision of secondary and tertiary care, fields not traditionally offered by the NHS (cosmetic surgery) or where public sector service is limited (dental care). The acute hospital sector is dominated by a handful of major hospital groups.
Pandemic Effects
Market Entry Companies should ensure their medical technology adheres to relevant legislation and regulations. There have been various changes since the United Kingdom left the European Union. Please see the information under Registration for additional information.
There are different procurement agencies and structures within the public health segment. For example, in England, NHS organizations or agencies have the option of procuring products individually, joining with other trusts to form consortia, or purchasing goods through centralized procurement bodies or hubs, such as NHS Supply Chain (www.supplychain.nhs.uk ). Opportunities can be identified within NHS Scotland, NHS Wales, and HSC Northern Ireland by approaching or visiting relevant agencies or online portals. Potential suppliers favoring a direct approach can contact potential buyers, such as NHS trusts or primary care organizations, register on supplier portals, or search for contracts and tenders on web sites such as Contracts Finder, which lists contacts over GBP 10,000 ($12,500) (www.gov.uk/contracts-finder ). Companies wishing to sell to the private sector can contact the relevant procurement team within the appropriate organization.
Various organizations help companies offering new and innovate technologies to navigate and enter the system. For example, England’s Health Technology Assessment (HTA) body, The National Institute of Health and Care Excellence (NICE) (www.nice.org.uk ) conducts medical technology appraisals, recommendations on the use of medicines, medical devices, procedures, or diagnostic techniques within the NHS. Within England, regional Academic Health Science Networks work with industry, academia, and other agencies to identify and aid adoption of innovative technologies.
As it can be challenging to sell directly from overseas, many U.S. exporters find it easier to form partnerships with well-established local companies, such as distributors or other suppliers. This enables new entrants to take advantage of their partner’s market expertise as well as their access to buyers and other decision makers across the healthcare system.
Current Market Trends Healthcare & Regulatory Reform
The UK regulator for medical devices, the Medicines and Healthcare products Regulatory Agency (MHRA), invited the public to offer their views on the future regulation of medical devices via a consultation in September 2021. The results are expected to be published sometime this year. Sustainability here .
Demographics
Best Prospects Digital Technology
The digital health sector is a very well developed and competitive market which plays host to numerous technology companies such as Cerner, IBM, Oracle, EMIS and BT. The market also offers a lot of opportunities for smaller companies and developers. Potential suppliers are advised to begin by gaining an in-depth understanding of their respective industry segment and building contacts to establish what is required within the market to determine the best method of entry. It will be necessary to adhere to relevant NHS as well as broader national compliance rules or regulations.
Market Size Healthcare spending (including investment)
$337 billion
.. as percent of GDP
12.8%
. of which spent on long-term care
$60.7 billion
… of which spent on outpatient services
$63.2 billion
Hospitals, Procedures, Healthcare Professionals
Number of hospitals
1325
Number of hospital beds (NHS)
169,000
… NHS available beds per capita
2.5 beds per 1,000
Number of surgical procedures
3,463,026 est.
…Top procedure Cataracts
470,500 est.
Physicians
328,582
Dentists Estimated
43,054 est.
Demographics
Population United Kingdom
67,081,000 million (England 56,550,000; Scotland 5,466,000; Wales 3,170,000; & Northern Ireland 1,896,000)
Life expectancy men/women
79/82.9
Infant mortality
Average 4 per 1000 live births
Percent of population older than 65
18% (2018)
…projection, 2036
23.4%
Annual deaths 2020
689,629- England & Wales
England and Wales caused by coronavirus
12.1% 10.5%
England and Wales caused by dementia/Alzheimer’s 11.5%
Sources: ONS, Fitch Solutions, NHS England, NHS Scotland, NHS Wales, HSC Northern Ireland, and The Kings Fund, Association of Optometrists, General Medical Council.
Main Competitors The country is home to a large segment of local and international small, medium sized, and large companies. Many of the leading U.S. medical device suppliers and technology providers have subsidiaries in the UK and well-established relationships with the NHS. They include companies such as Baxter Healthcare, Medtronic, GE Healthcare, Cerner, and Hyland.
Current Demand The NHS spends approximately $25 billion USD a year on goods and services. Most domestically produced medical products are exported, hence the need for imports. It is very open to early disease detection devices and technology that can tackle chronic diseases. Within the digital segment there’s demand for technology that can support interoperability, clinical efficiency tools, innovative apps and wearables, health analytics tools, remote consultation tools, and monitoring devices. The shift to an integrated, joined up model of care and elective care backlog will drive demand for related devices and technology. Although the private segment is smaller, opportunities exist for companies to supply private hospital, residential, and nursing facilities with equipment. The U.S. is an important overseas source of medical devices with an estimated 10% share of the import market. It’s a leading supplier of diagnostic, dental, orthopedic equipment, and high-quality wound care products to the UK.
Registration Process Manufacturers wishing to place a device on the market in Great Britain (England, Wales, and Scotland) need to ensure their product adheres to relevant legislation, register with the MHRA, and, if they are not established here, appoint a UK Responsible Person.
The CE mark will be valid in Great Britain until June 30, 2023. Since January 1, 2021, there has been a new route to market for devices being placed on the market in Great Britain in the form of the UKCA mark, which can be obtained by adhering to national legislation. Directive 90/385/EEC (active implantable medical devices), Directive 93/42/EEC (medical devices) and Directive 98/79/EC (in vitro diagnostic medical devices) apply in Great Britain under UK Medical Devices Regulations 2002. The most recent European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) did not go into effect during the Brexit transition period so do not apply in Great Britain.
The CE mark is still required in Northern Ireland where some rules differ. The EU MDR has applied in Northern Ireland since May 2021; the EU IVDR will apply there from May 26, 2022.
Additional information and guidance for Great Britain and Northern Ireland can be found on the Medicines and Health products Regulatory Agency (MHRA) website here .
Reimbursement Companies selling medical devices to the NHS are permitted to determine the price of their products; there are no specific product codes. However, NHS agencies are under intense pressure to cut costs and achieve savings, so pricing may be subject to negotiation.
Within the primary care market, certain products, such as stoma or incontinence appliances, are available to patients on prescription. Qualifying devices are listed within a monthly Drug Tariff which outlines what pharmacies will be reimbursed for devices, drugs, and their services. Suppliers can apply to NHS Prescription Services (https://www.nhsbsa.nhs.uk/ ) to have their products added to the Drug Tariff. Products must adhere to relevant regulatory requirements, fall within the qualifying categories, and already be on sale in the UK to qualify. Scotland, Wales, and Northern Ireland run similar systems.
In England, under the NHS national tariff system, secondary care providers, such as hospitals, are paid a fee by NHS healthcare commissioners (e.g., Integrated Care Boards) for providing patient care. Prices for consultations or treatments are predetermined, individually coded, and listed in the national tariff. Typically, any medical product or technology used during a procedure is incorporated into the price paid to the provider. Certain predetermined ‘high-cost’ devices are handled and paid for separately. The block contract system, where a provider is allocated a contract to undertake care within a specific area for a fixed period, remains the dominant system in NHS Scotland, Wales, and Northern Ireland.
Health Insurance Approximately 11% of the population has private health insurance; however, many policies stipulate upper spending limits or only cover specific medical conditions.
Barriers U.S. companies should not encounter any political or trade barriers to market entry. The UK currently conducts most buying through commercial negotiation.
Government & Association Links Government Health Plans:
Trade Associations:
FAQs What is BREXIT? How did it impact the UK healthcare market and medical devices segment?
U.S. Commercial Service Contact Information Name: Stephen Brown Stephen.Brown@trade.gov
