Global Rubella Diagnostic Testing Market - 2023-2030

Overview

Measles is highly contagious. Around 9 out of 10 people who are not protected will become infected following exposure to the measles virus. A pregnant woman infected with rubella in early pregnancy has up to a 90% chance of giving birth to a baby with congenital rubella syndrome (CRS). One person with measles can infect 12-18 people, making it the most infectious yet vaccine-preventable disease.

Around 9 out of 10 susceptible people (unvaccinated/have never had measles) who are exposed to measles will get sick. 33% of infants with congenital rubella syndrome die before one year. Rubella IgG serology testing should be used for assessing rubella immunity, including before, during, and after pregnancy suspecting congenital rubella syndrome. Rubella infection during pregnancy can lead to miscarriage (loss of the fetus within 20 weeks of conception) and stillbirth (death after 20 weeks).

Market Dynamics

Increasing measles outbreaks in certain parts of the world

The Reoccurrence of measles outbreaks in some parts of the world increases diagnostic testing. According to the Centers for Disease Control and Prevention, although measles was declared eliminated in the United States in 2000, almost 1,300 cases of measles were reported in 31 states in the U.S. in 2019, the most significant number since 1992. According to data, the World Health Organization said in early August 2023, India had the highest number of measles cases compared to the rest of the world, with 57,550 cases as of 2023. Yemen with 24,596 and Pakistan with 10,549 patients.

Measles vaccines saved more than 56 million lives worldwide between 2000-2021. However, the numbers are declining due to its reoccurrence. Diagnostic testing comes into play to treat the disease in individuals living in specific regions where measles outbreaks are observed. According to the United Nations International Children's Emergency Fund (UNICEF), global vaccination coverage has recovered in 2022. However, there are still 20.5 million children missing out on lifesaving vaccines globally, 2.1 million more than in 2019.

In 2022, India accounted for 1.6 million unvaccinated and under-vaccinated children despite achieving 93 percent coverage. These reducing numbers make the reoccurrence of the disease in a few regions and immediately spread to other regions as well because the disease is highly contagious. The outbreaks happen in those areas where the vaccination is at its lowest. Hence, the above factor is expected to drive the market in the forecast period.

Some of the other factors that drive the market are advancements in testing procedures, reoccurrence of rubella outbreaks, and decreased number of vaccinations are a few factors that are expected to drive the market in the forthcoming period.

False positive test results in pregnant women

Rubella IgM testing should be limited to suspected rubella cases. It is not recommended for screening asymptomatic people. The presence of rheumatoid factor can also result in a false positive IgM. Due to the possibility of false positive results, IgM should not be included in routine testing to determine evidence of prior rubella immunity. Rubella IgM testing in asymptomatic, unexposed pregnant people is inappropriate because false positive results can occur, which can be misleading.

Segment Analysis

The global rubella diagnostic testing is segmented based on diagnostic test, age group, end user, and region.

The enzyme immunoassay (EIA) is expected to hold the largest market share during the forecast period, owing to the rising incidences of rubella and the advantages of the enzyme immunoassay (EIA) method. For instance, the enzyme immunoassay is the most used as it is relatively inexpensive, technically easy to perform, rapid, and susceptible.

EIA is used to detect rubella-specific immunoglobulin G (IgG) antibodies. IgM testing is the most commonly performed technique using commercial enzyme immunoassay (EIA) kits. The blood test detects antibodies the immune system makes to kill the rubella virus, which remains in the bloodstream for years. The EIA is also suitable for diagnosing acute infections, as a significant increase in antibody levels was detected in all paired specimens tested from patients with acute rubella infection.

In July 2021, it reported that measles and rubella are two of the most globally critical vaccine-preventable diseases (VPD), and measuring antibodies to measles and rubella viruses in samples collected from serosurveys can play an important role in estimating population immunity and guiding immunization activities and enzyme immunoassay is the most convenient method and accessible approach for detecting the rubella virus. Hence, the efficacy is elevated if ELISA kits are used. This factor is expected to drive the market in the forecast period.

Geographical Analysis

Asia Pacific is expected to hold the largest segment in the market. According to information from the Centers for Disease Control and Prevention, India has the highest number of cases between April and September 2022. Pakistan stayed in 7th position with 3635 cases, while the US had 33 cases by the end of 2022.

Due to the increased number of cases in 2022, the Indian government has launched a scheme to improve the diagnostic services related to measles disease. For instance, in July 2022, the Pradhan Mantri Surakshit Matritva Abhiyan by the Ministry of Health & Family Welfare (MoHFW), Government of India, to improve the quality and coverage of antenatal care (ANC), including diagnostics and counseling services, as part of the Reproductive Maternal Neonatal Child and Adolescent Health (RMNCH + A) strategy.

COVID-19 Impact Analysis on Rubella Diagnostic Testing Market

COVID-19 negatively impacted the global market during the outburst because to prevent further COVID-19 infection, restrictions and regulations were imposed, making it difficult for people to perform rubella diagnoses affecting the sales of the rubella diagnostic kits. Furthermore, during the pandemic, regular vaccination programs were on hold, which according to NIH estimation, put 80 million infants at risk of infection by measles, polio, and diphtheria, negatively impacting the global market.

Market Segmentation

By Diagnostic Technique

• Latex Agglutination
• Liver Function Tests
• Enzyme Immunoassay (EIA)
• Radioimmunoassay (RIA)
• Fluorescent Immunoassay (FIA)
• Others

By Age Group

• Neonates
• Teenagers
• Adults

By End User

• Hospitals and Clinics
• Cancer Diagnostic Centers
• Ambulatory Surgical Centers
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico

• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe

• South America
  • Brazil
  • Argentina
  • Rest of South America

• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific

• Middle East and Africa

Competitive Landscape

The major global players in the rubella diagnostic testing market include: Siemens Healthineers AG, Bio Rad Laboratories Inc., Abbott Laboratories, BioMerieux SA, Thermo Fisher Scientific Inc., ZEUS, Scientific Inc., F. Hoffmann-La Roche Ltd, Ortho Clinical Diagnostics, InDevR, Inc., and Beckman Coulter Inc. among others.

Key Developments

• In 2023, The Immunization Agenda 2030 Measles & Rubella Partnership (M&RP), a partnership led by the American Red Cross, United Nations Foundation, Centers for Disease Control and Prevention (CDC), Gavi, the Vaccines Alliance, the Bill and Melinda French Gates Foundation, UNICEF and WHO, to achieve the IA2030 measles and rubella specific targets.
• In August 2022, Roche reported that the United States Food and Drug Administration (USFDA) has approved a label expansion for its Ventana MMR RxDx Panel that provides clinicians with access to a fully automated panel of mismatch repair (MMR) biomarkers tested by immunohistochemistry (IHC).
• In 2021, The United Kingdom Health Security Agency's Immunization and Vaccine-Preventable Diseases Division launched a new rash-fever surveillance scheme. The aim is to increase the number of samples tested for measles and rubella diagnostic testing. The program was initiated by the United Kingdom government, which distributed rubella diagnostic kits for rapid rubella testing.

Why Purchase the Report?

• To visualize the global rubella diagnostic testing segmentation based on diagnostic test, age group, end user, and region, as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of rubella diagnostic testing market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as Excel consisting of key products of all the major players.

The global rubella diagnostic testing market report would provide approximately 61 tables, 61 figures, and 185 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies