Toxoplasmosis Testing Market

Global Toxoplasmosis Testing Market Forecast

•   Global toxoplasmosis testing market size to reach US$3 Bn in 2031, up from US$1.9 Bn attained in 2024
• Market revenue projected to exhibit a remarkable rate of expansion, at an estimated CAGR of 6.7% during 2024 - 2031

Quick Report Digest

• Increasing awareness of toxoplasmosis and its complications, especially among pregnant women and immunocompromised individuals, drives market growth.
• Serological tests remain dominant, while PCR tests may see increased adoption.
• North America presently holds the largest market share, with Asia Pacific expected to exhibit the fastest growth due to rising disposable income and healthcare awareness.
• Market projected to maintain a healthy CAGR of 6.4% from 2024 to 2031, driven by continued public health efforts and research into the disease.
• Factors driving growth include rising awareness and diagnosis, increasing incidence of toxoplasmosis, and expanding veterinary applications.
• Limited access to healthcare services, regulatory challenges, and accuracy concerns pose major growth barriers.
• Technological advancements in testing methods, emphasis on One Health approach, and expansion of POCT solutions are key trends and opportunities.
• Regulatory scenario significantly shapes the industry, ensuring quality, accuracy, and patient data privacy.
• Top segments include serological testing, molecular testing (PCR), and POCT solutions, with North America leading the market and Asia Pacific as the fastest growing region.

A Look Back and a Look Forward - Comparative Analysis

The toxoplasmosis testing market witnessed a steady rise between 2019 and 2023, and this trend is expected to continue through 2031. Fuelled by factors like increasing awareness of toxoplasmosis and its potential complications, particularly for pregnant women and immunocompromised individuals, the market has seen a rise in demand for effective testing methods. Additionally, dietary habits in certain regions, with high consumption of meat like pork and mutton, contribute to the need for toxoplasmosis testing as these can be sources of infection. This growth is reflected in the rising adoption of toxoplasmosis tests by hospitals, diagnostic laboratories, and clinics. Serological tests, the most common type, are expected to maintain their dominance, while other methods like PCR tests might see increased use.

North America currently holds the largest market share, but the Asia Pacific region is anticipated to be the fastest growing market due to factors like rising disposable income and growing healthcare awareness. This trend is expected to be further bolstered by advancements in diagnostic technologies and the development of more efficient testing kits. Market growth is likely to be driven by continued public health efforts to raise awareness about toxoplasmosis, along with the increasing availability of diagnostic tests and ongoing research into the disease.

Key Growth Determinants

• Increasing Awareness and Diagnosis

Growing awareness about toxoplasmosis among healthcare professionals and patients is a key driver. As awareness spreads, more individuals seek testing, leading to increased demand for toxoplasmosis diagnostic products and services. Additionally, advancements in diagnostic technologies improve the accuracy and accessibility of testing, further driving market growth.

• Rising Incidence of Toxoplasmosis

The increasing prevalence of toxoplasmosis worldwide contributes significantly to market growth. Factors such as changes in climate, urbanisation, and population growth can lead to higher rates of toxoplasmosis infection. This surge in cases necessitates robust testing protocols for early detection and management, thereby boosting the demand for toxoplasmosis testing.

• Expanding Veterinary Applications

Toxoplasmosis is not just a concern for human health; it also affects animals, particularly livestock and pets. With the rising demand for food safety and animal health management, there's an increased need for toxoplasmosis testing in veterinary medicine. This expansion of testing applications into the veterinary sector opens new avenues for market growth, as veterinary clinics, laboratories, and livestock producers invest in diagnostic solutions for toxoplasmosis detection and control.

Major Growth Barriers

• Limited Access to Healthcare Services

In regions with inadequate healthcare infrastructure or limited access to medical facilities, the uptake of toxoplasmosis testing may be hindered. Lack of awareness, affordability issues, and geographic barriers can prevent individuals from seeking testing services, thereby restraining market growth.

• Regulatory Challenges and Approval Process

Regulatory hurdles, and lengthy approval processes for diagnostic tests can impede market growth. Manufacturers must navigate complex regulatory frameworks to obtain approvals for their toxoplasmosis testing products, which can delay market entry and increase costs. Additionally, stringent regulations regarding product quality, safety, and efficacy pose challenges for market players, especially smaller companies or those entering new markets.

• Risk of False Positives and Negatives

The accuracy of toxoplasmosis testing is critical for effective disease management. However, the risk of false positives or negatives can undermine confidence in testing methodologies and products. Inaccurate results may lead to unnecessary treatments, increased healthcare costs, and patient anxiety, thereby limiting the adoption of toxoplasmosis testing solutions. Ensuring the reliability and validity of testing methods is essential to overcoming this restraint.

Key Trends and Opportunities to Look at

• Technological Advancements in Testing Methods

Recent years have witnessed significant advancements in diagnostic technologies for toxoplasmosis testing. Novel molecular techniques, such as polymerase chain reaction (PCR) assays, offer increased sensitivity and specificity compared to traditional methods like serological testing. Furthermore, the emergence of point-of-care testing (POCT) platforms facilitates rapid and convenient on-site diagnosis, enabling timely intervention and management of toxoplasmosis cases. These technological innovations enhance the efficiency and accuracy of testing, driving market growth and improving patient outcomes.

• Growing Emphasis on One Health Approach

The concept of One Health, which recognises the interconnectedness of human, animal, and environmental health, is gaining traction globally. As toxoplasmosis affects both humans and animals, there's a growing emphasis on collaborative efforts among healthcare professionals, veterinarians, and environmental scientists to address the disease comprehensively. This holistic approach encompasses surveillance, prevention, and control measures across human and animal populations, thereby driving demand for toxoplasmosis testing solutions that cater to both clinical and veterinary settings.

• Expansion of Point-of-Care Testing (POCT) Solutions

The increasing demand for rapid and decentralised testing options presents a significant opportunity for market players to develop and commercialise POCT solutions for toxoplasmosis. POCT platforms offer advantages such as shorter turnaround times, reduced reliance on centralised laboratories, and enhanced accessibility, particularly in resource-limited settings or remote areas. By investing in the development of user-friendly POCT devices and assays, companies can tap into underserved markets and address unmet diagnostic needs, thereby gaining a competitive edge and expanding their market share.

How Does the Regulatory Scenario Shape this Industry?

The regulatory environment significantly impacts the toxoplasmosis testing market industry. Regulatory bodies like the US FDA and CE in Europe set strict guidelines for test approval, ensuring accuracy and reliability. This builds trust among healthcare providers and patients. Additionally, insurance reimbursement policies directly affect market growth. Wider insurance coverage for toxoplasmosis tests encourages more testing, thus influencing demand. Regulations also play a crucial role in maintaining quality standards. Regulatory bodies establish guidelines for test manufacturing and laboratory practices, ensuring consistent quality and minimizing inaccurate results. Standardised testing procedures also allow for better data comparison across studies and healthcare facilities.

Patient data privacy is another important aspect. Regulations like HIPAA and GDPR mandate secure storage and handling of patient information associated with toxoplasmosis testing. This builds trust in the testing process and encourages individuals to undergo testing. Finally, regulations can influence the development of new tests. Balancing innovation with stringent safety and efficacy measures is essential. The regulatory framework can incentivise research and development by streamlining approval processes for promising new tests, while ensuring patient safety. In essence, the regulatory landscape shapes the toxoplasmosis testing market by ensuring quality, accuracy, accessibility, and fostering trust in the testing process. It also plays a role in promoting innovation within the field.

Fairfield’s Ranking Board

Top Segments

• Serological Testing Retains the Dominant Position

Serological testing holds a dominant position in the toxoplasmosis testing market, representing a significant share due to its established reliability, and cost-effectiveness. This method, which detects antibodies produced in response to Toxoplasma gondii infection, is widely adopted in laboratory settings. Despite being a mature segment, continuous innovation drives its sustained relevance.

Manufacturers are constantly developing novel serological assays with improved sensitivity and specificity to cater to evolving healthcare needs. Serological testing finds versatile applications, from diagnosing acute infections in humans to screening pregnant women to prevent vertical transmission. Additionally, its role extends to veterinary medicine for detecting toxoplasmosis in animals, contributing to its ongoing market demand and growth prospects.

• Adoption Molecular Testing (PCR) Gains Momentum

Molecular testing, particularly PCR assays, is witnessing rapid adoption in the toxoplasmosis testing market owing to its superior sensitivity and specificity. Advances in molecular diagnostics have led to highly sensitive PCR assays capable of detecting Toxoplasma gondii DNA with minimal sample preparation and quick turnaround time. This technological progress drives demand for molecular testing solutions, expanding their clinical utility beyond traditional methods. PCR-based assays offer versatility in detecting Toxoplasma gondii DNA across various sample types, positioning molecular testing as a valuable tool for diagnosing toxoplasmosis in diverse patient populations, including immunocompromised individuals and neonates.

• Opportunities for POCT Solution Providers Grow Abundant

Point-of-care testing (POCT) solutions are gaining momentum in the toxoplasmosis testing market due to their ability to provide rapid and on-site results, facilitating timely diagnosis and management. These devices offer accessibility and convenience by eliminating the need for centralised laboratory facilities, enabling testing in non-traditional settings like clinics, emergency departments, and remote locations. The increasing emphasis on decentralised healthcare, and the demand for rapid diagnostic solutions in resource-limited settings create opportunities for POCT manufacturers to expand their market presence. By developing user-friendly and cost-effective POCT devices for toxoplasmosis testing, companies can tap into underserved markets and drive revenue growth.

Regional Frontrunners

• North America Takes up the Largest Market Share

North America holds the leading position in the toxoplasmosis testing market. This dominance is attributed to several factors. The region boasts a strong healthcare infrastructure with a high level of awareness about toxoplasmosis and its potential complications. Favorable reimbursement policies by insurance agencies encourage widespread testing. The prevalence of risk factors, such as the consumption of undercooked meat, further fuels the demand for toxoplasmosis testing in North America.

• Asia Pacific Emerges as the Fastest Growing Market

The Asia Pacific region is poised for the fastest growth in the toxoplasmosis testing market. This surge is driven by a combination of factors. Rising disposable income and increasing healthcare spending empower individuals to seek diagnostic services. Furthermore, growing awareness of toxoplasmosis and its associated complications is prompting more people to undergo testing. Additionally, the vast population base in this region increases the pool of individuals susceptible to infection, further propelling market growth.

• Europe to Register Robust Adoption

Europe presents a well-established market for toxoplasmosis testing. This is due in part to the presence of well-developed healthcare systems with robust regulatory frameworks that ensure the quality and accuracy of diagnostic tests. Additionally, European healthcare facilities demonstrate a high adoption rate for advanced diagnostic technologies, leading to more efficient and reliable testing methods. A growing focus on preventative healthcare within the region further emphasizes the importance of toxoplasmosis testing.

Fairfield’s Competitive Landscape Analysis

The competition landscape of the toxoplasmosis testing market is characterised by the presence of several prominent players striving to strengthen their market position through strategic initiatives. Leading players in the market include bioMérieux SA, Thermo Fisher Scientific Inc., Quest Diagnostics Incorporated, bioMérieux SA, Abbott Laboratories, and DiaSorin S.p.A. These companies adopt various growth strategies to maintain their competitive edge, including mergers and acquisitions, partnerships, product launches, and geographical expansions. Mergers and acquisitions enable companies to broaden their product portfolios, enhance technological capabilities, and expand their market reach. \

Partnerships and collaborations foster innovation and facilitate the development of advanced testing solutions. Furthermore, product launches focusing on novel technologies and improved diagnostic accuracy cater to evolving customer demands and contribute to market growth. Geographical expansions allow companies to capitalise on emerging markets and strengthen their global presence, thereby sustaining competitive advantage in the toxoplasmosis testing market.

Who are the Leaders in Global Toxoplasmosis Testing Space?

• Abbott Laboratories
• Bio-Rad Laboratories Inc.
• Affymetrix Inc.
• Beckman Coulter Inc.
• Biotest
• Cepheid Inc.
• GenBio
• Danaher Corporation
• Thermo Fisher Scientific
• Biomerica Inc.
• Biomerix

Significant Company Developments

August 2023: In August 2023, Thermo Fisher Scientific Inc. introduced a novel molecular assay for toxoplasmosis testing. The new PCR-based assay offers enhanced sensitivity and specificity, allowing for accurate detection of toxoplasma gondii DNA in various clinical specimens. This launch addresses the growing demand for advanced molecular testing solutions in the toxoplasmosis diagnostics market, empowering healthcare professionals with reliable tools for timely diagnosis and management of infections.

November 2023: November 2023 witnessed the release of a rapid point-of-care testing (POCT) device by Abbott Laboratories for toxoplasmosis detection. This compact and user-friendly device provides on-site results within minutes, enabling immediate diagnosis and facilitating prompt intervention. The introduction of this POCT solution marks a significant advancement in decentralised testing options for toxoplasmosis, catering to the need for rapid and convenient diagnostic solutions in diverse healthcare settings.

March 2024: In March 2024, DiaSorin S.p.A. announced a distribution agreement with a leading global healthcare distributor to expand the reach of its serological testing kits for toxoplasmosis. Under this agreement, the distributor will market and distribute DiaSorin's toxoplasmosis testing products across key regions, enhancing accessibility to reliable diagnostic solutions for healthcare providers and patients. This strategic partnership strengthens DiaSorin's market presence and facilitates broader market penetration, contributing to the advancement of toxoplasmosis testing initiatives globally.

An Expert’s Eye

• Increasing Awareness and Screening Programs: Growing awareness about the risks associated with toxoplasmosis, particularly during pregnancy, has led to an increase in screening programs worldwide. Pregnant women are routinely screened to detect the presence of the Toxoplasma gondii parasite, which can be transmitted to the foetus and cause severe complications. This heightened awareness and proactive screening approach have contributed to the expansion of the toxoplasmosis testing market.
• Technological Advancements: The toxoplasmosis testing market has benefited from ongoing advancements in diagnostic technologies. Polymerase Chain Reaction (PCR) and serological tests have become more sensitive, specific, and accessible, allowing for quicker and more accurate detection of Toxoplasma gondii infection. These technological improvements not only enhance diagnostic capabilities but also make testing more convenient for healthcare providers and patients, driving market growth.
• Prevalence of Toxoplasmosis: Toxoplasmosis is a globally prevalent parasitic infection, with an estimated one-third of the world's population affected. The infection is particularly common in regions with poor sanitation and hygiene standards, where contact with contaminated soil, water, or undercooked meat increases the risk of transmission. As awareness of toxoplasmosis grows and diagnostic testing becomes more widely available, the demand for testing services rises, contributing to the expansion of the toxoplasmosis testing market.

Global Toxoplasmosis Testing market is Segmented as Below:

By Test Type:

• Serological Test
• Dye Test
• Indirect Hemagglutination Assay
• Direct agglutination Assay
• ELISA
• PCR
• Ultrasound
• MRI
• Biopsy

By Sample:

• Blood Sample
• Amniotic Fluid
• Cerebrospinal Fluid

By End User:

• Hospitals
• Clinics
• Diagnostic Laboratories

By Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East & Africa