Europe Monkeypox Testing Market - Industry Outlook and Forecast 2023-2025

The Europe monkeypox testing market size was valued at USD 18.33 million in 2022 and is expected to reach USD 56.10 thousand by 2025. The market to register a CAGR of (85.48)% from 2022 to 2025. Monkeypox is an outbreak that has spread rapidly, from the first case identified on 7th May 2022 in London, UK. MPXV, a zoonotic orthopox DNA virus related to the virus that causes smallpox, was first described in humans in 1970 in the Democratic Republic of Congo. Since early May 2022, more than 78,900 MPXV infections have been reported in more than 100 countries across five regions, prompting the WHO to declare MPX an “evolving threat of moderate public health concern” on 23rd June 2022. The outbreak of monkeypox created a lucrative opportunity for the diagnostic market.

As of 9th November 2022, Europe has reported more than 25,300 confirmed cases. However, confirmed monkeypox infections have been declining since mid-August 2022. More than 30% of all cases worldwide are held by Europe alone, to date, of which more than 98% of men are the most infected target population alone. About 80% of the infected men are gay men, thereby contributing to the growth of the Europe monkeypox testing market. Globally, 96.9% of all cases with the available data are male, with a median age of 34 years. Males aged 18 to 44 are disproportionately affected by this outbreak, as they account for more than 79% of cases.

Until mid-July, Europe was the epicenter of the largest and geographically most widespread monkeypox outbreak ever reported outside of endemic areas in western and central Africa. Currently, it is the second-largest region with the highest number of cases. This is attributed to increasing initiatives taken by the government to slow the spread of infection by publishing strict guidelines and measures to prevent the spread of monkeypox, increasing awareness, and increasing testing. In July 2022, the government of France launched a ‘Monkeypox Info service’ to provide information and advice to people following the WHO’s classification of the virus as a global public health emergency. Patients are immediately informed that they can be vaccinated if reserved on a privately run website, Doctolib, that many French residents use to book medical appointments. The testing has been available to private and public laboratories, clinics, and hospitals. In July 2022, Gemeentelijke Gezondheidsdienst (GGD), a Municipal Health Service, a decentralized public health organization, set up/opened separate facilities with separate rooms where people can get tested for the monkeypox virus.

KEY MARKET INSIGHTS

• Syndromic tests for monkeypox detection are expected to witness strong growth because they can distinguish monkeypox from other harmful diseases, allowing for easier treatment. On 25th May 2022, Roche and its subsidiary TIB Molbiol announced that they had developed a unique LightMix Modular Virus kit that simultaneously detects orthopoxvirus and offers information on whether an MPXV is present or not, including all MPXV from both the West African and Central African forms of the virus.
• Rapid tests in the Europe monkeypox testing market are also expected to witness strong growth due to their rapid results and increasing consumer preference.
• Demand for MPXV testing kits is expected to decline during the forecast as the cases can be seen declining due to increased surveillance, contact tracing, and increasing vaccination across Europe.

MARKET TRENDS & DRIVERS

Increasing cases and testing are driving the growth of the Europe monkeypox testing market. The growing development of PCR kits as a standard gold method for monkeypox virus detection is propelling the growth of the market in the country. Also, increasing collaborations among In-Vitro Diagnostic (IVD) companies to develop and launch new monkeypox test kits is driving market growth. Surprisingly, the ease in medical device regulation only specific for monkeypox encouraged the IVD companies to bring new testing kits into the market and commercialize it, with PCR kits being the gold standard method. Confirmation of MPXV infection is based on nucleic acid amplification testing (NAAT), which uses conventional or real-time PCR to detect unique viral DNA sequences and is widely used as a standard method to detect MPXV. Increasing activities among vendors are driving the Europe monkeypox testing market growth, including the following:

• In July 2022, ELITechGroup, a France-based privately held manufacturer and distributor of IVD equipment, strategically partnered with Jiangsu Bioperfectus Technologies for monkeypox virus testing across Europe.
• In June 2022, Eurobio Scientific launched a CE-marked monkeypox screening test available for hospital use in France.
• On 8th June 2022, altona Diagnostics, a medical diagnostic company headquartered in Germany, announced the launch of the RealStar Zoonotic Orthopoxvirus PCR Kit 1.0, a real-time RT-PCR based reagent system for the detection of zoonotic (non-variola) Orthopoxvirus species-specific DNA – including MPVX DNA of the Central and West African strains.
• On 27th June 2022, Cepheid collaborated with the UK-based global molecular diagnostics company BioGX and announced a partnership between the two companies to provide a PCR test for MPX that will run on the GeneXpert system.
• In July, the altona Diagnostics company launched another monkeypox virus detection kit, Flexstar Monkeypox virus PCR Detection Mix 1.5, for research purposes.
• Bioactiva Diagnostica is another Germany-based company that offers PCR kits for monkeypox virus detection.

In addition, the growing product launches of lateral flow assay kits are expected to create lucrative opportunities for the Europe monkeypox testing market growth. Lateral flow assay is presently not preferred for monkeypox detection in the region because it may give false positive and negative results and because of its high cost. A number of rapid antibody and antigen test kits has been developed. Nanjing Synthgene Medical Technology, a China-based biomedical company, offers CE-certified rapid antibody and antigen tests at USD 1,253 and USD 438, respectively. In contrast, its MPXV Detection Kit (RT-PCR) costs around USD 144 with 24 tests, which means about USD 6 for each test.

The growing surveillance, contact tracing, and vaccine doses across the region are expected to impede market growth by a greater margin. However, it is unclear how much vaccine administrations have contributed to the slowdown in case numbers, and it is also unclear how long vaccine effects will last. In July 2022, the European Commission approved the MPX preventative vaccine, recommended by the European Medicines Agency (EMA).

Bavarian Nordic, a global leader in smallpox vaccines, has been a long-term supplier of the Imvanex vaccine to the US Government and has already supplied the vaccine in the European Union (EU) to many different, often unnamed, European countries. Bavarian Nordic is focused on developing, manufacturing, and commercializing human vaccines. Imvanex vaccine has been authorized to protect adults from MPX disease in the EU since 22nd July 2022.

Since the time of vaccine approval, the region has been ramping up to supply vaccine doses to every country dealing with the highest number of cases. Vaccine administration and contact tracing have rapidly increased in Spain, the second country after the US, with the highest number of confirmed cases since June 2022. On 20th October 2022, National Health Service (NHS) launched a new online vaccine site finder to make it easy for eligible people to vaccinate.

REGIONAL ANALYSIS

In 2022, EU-5 accounted for the largest share of 77.71% in the Europe monkeypox testing market. In EU-5, Spain accounts for the highest revenue share, followed by France, UK, Germany, and Italy, which can be attributed to increasing cases, and increased testing. More than 98% of cases are identified in men who have sex with men in EU-5. The Netherlands is vaccinating high-risk people against MPX using two doses of the Imvanex smallpox vaccine. Until 3rd August 2022, 1,976 people in the Netherlands received a preventive vaccination against the MPXV. 

In Berlin, Germany, vaccinations against the viral infection had begun in mid-July. In July, The Standing Commission on Vaccination (Stiko) recommended this for certain groups and people who have had close contact with infected persons. It sees an increased risk of infection, particularly among men who have same-sex sexual contact with changing partners. According to the Senate Department for Health, demand for the MPX vaccine is very high in Berlin; however, the vaccine is still in very short supply. The shortage in vaccine supply has increased the chances of spreading MPX, which implicitly increases the possibilities of the Europe monkeypox testing market growth. However, in the future, the growing number of vaccinations for monkeypox may hinder the growth of the MPX testing market. In addition, as the currently authorized vaccine, Imvanex is not authorized for children and pregnant women, the growth of MPX testing still holds growth opportunities during the forecast period. Also, an increase in risky behavior may cause a resurgence of the virus that may keep the opportunity for MPX testing market demand.