Johne’s Disease Diagnostics Market Size Analysis:

Johne’s Disease Diagnostics Market Size was valued at USD 652.6 million in 2023 and is expected to reach USD 1076.6 million by 2032, growing at a CAGR of 5.7% over the forecast period 2024-2032.

This report provides an overview of the Johne’s Disease Diagnostics market, detailing the key insights and trends, discusses the incidence and prevalence of Johne’s disease in the target audience characterized across the key regions, and provides projections. It also surveys the technology-wise rate of diagnostic adoption (ELISA, PCR, culture-based tests) and the growth of diagnostic kits & services. This report summarizes global trends in testing for Johne's Disease and the associated infrastructure for diagnosing the disease. It also looks at the disease's costs to the health system, covering public, private, and research spending. The report also provides insight into the evolving regulatory and compliance structure and highlights the approval of oat-based feed standards for livestock health and its effects on diagnostic practices globally.

The Johne’s Disease Diagnostics Market is driven by increasing awareness of Mycobacterium avium subspecies paratuberculosis (MAP) infections, which cause significant economic losses in the livestock industry. In 2023, the U.S. accounted for about 31% of the total market share in the world, with strong uptake of advanced diagnostic techniques like PCR and ELISA tests. Market growth has also been fuelled by government initiatives promoting sustainable farming and animal welfare, as producers increasingly adopt reliable methods for managing infected livestock. Johne’s disease is a chronic infection caused by a bacterium that typically affects cattle, sheep, and goats and is an international problem for the health of livestock. The disease leads to decreased milk production and weight loss which affects their productivity, highlighting the need for early and accurate diagnosis.

Johne’s Disease Diagnostics Market Dynamics

Drivers

• Advancements in diagnostic technologies like PCR and ELISA offer improved accuracy, sensitivity, and speed for early detection. This enhances disease control measures, reducing economic losses in the livestock industry.

Advancements in diagnostic technologies have significantly enhanced the detection and management of Johne's disease in livestock. Recent innovations include the development of molecular-based testing kits such as 'Johne-Find' and 'Johne-FindPRO' by the National Agriculture and Food Research Organization (NARO) and Nippon Gene Co., Ltd. Introduced in December 2023, 'Johne-Find' enables detection of infected cattle more than six months earlier than traditional antibody ELISA tests, while 'Johne-FindPRO' offers high specificity for confirmatory testing. ​In September 2023, diagnostics company MI:RNA unveiled an AI-powered testing method utilizing microRNA biomarkers, achieving 73% sensitivity and 71% specificity in identifying Johne’s disease. This approach holds promise for early-stage infection detection and outcome prediction. ​

Polymerase Chain Reaction (PCR) technology has also seen widespread adoption due to its high accuracy and sensitivity. In 2023, the PCR segment dominated the Johne’s disease diagnostics market, accounting for 45.3% of the market share. ​These advancements contribute to more effective disease control strategies, reducing economic losses in the livestock industry. For instance, Johne's disease leads to decreased milk production and weight loss in cattle, resulting in substantial financial impacts. Early detection through improved diagnostics enables timely intervention, mitigating these losses and enhancing overall herd health.

Restraint

• High costs of advanced diagnostic tests limit adoption, especially among small-scale farmers. Financial constraints in developing regions further hinder market expansion.

Some of the most significant obstacles to widespread approval by producers, especially small-scale livestock producers, are the high prices of diagnostic tests for Johne’s illness. To illustrate, a single ELISA test in the United States costs around $6.50 per sample, and PCR upwards of $50 per sample. UK pricing for serum ELISA tests, subject to volume discounts, is between £5.20 and £5.85 per sample. Costs can mount quickly, especially for farmers with large herds to manage, and regular testing can be prohibitively expensive. Moreover, developed regions have fewer LTD units as compared to new ones the poor availability of cheap diagnostic facilities in these backgrounds emerges as a challenge in these areas, limiting the management of diseases and control efforts. In conclusion, tackling the cost barriers outlined here is crucial to increase the uptake of diagnostic testing and decrease the economic burden of Johne’s disease on the global livestock industry.

Opportunity

• Growth in the livestock industry and rising disease awareness in emerging economies drive demand for effective diagnostics. Increased veterinary investments further support market expansion.

The growing livestock industry is an opportunity for Johne’s Disease Diagnostics Market especially in developing countries. With this increase comes a notable trend for developing accrete regions to focus more on animal husbandry. With growing larger livestock populations comes an increased risk of some pathogens, such as Johne's disease, a contagious infection that impacts cattle, sheep, and goats. For example, In the United States, approximately 68% of dairy herds have at least one cow that tests positive for Johne's disease, leading to economic losses due to reduced milk production and early culling. Although detailed data on infections in emerging economies is sparse, the international nature of livestock trade and movements indicates that the incidence of these infections could increase.

Particularly when it comes to Johne's disease, this challenge requires utilizing state-of-the-art diagnostic tools to identify and best manage the disease. Growing awareness among farmers and veterinarians about the economic impact of livestock diseases in these regions is creating demand for accurate diagnostic solutions. In addition, governmental campaigns on better animal health care and productivity, including India’s Rashtriya Gokul Mission and National Livestock Mission will provide further momentum towards the adoption of diagnostic technologies. The flourishing growth of the livestock segment in developing economies and increasing awareness levels along with supportive policies create a favorable climate for the growth of Johne’s Disease Diagnostics Market.

Challenge

• Genetic diversity of Mycobacterium avium subsp. paratuberculosis complicates diagnostic development. Different strains require tailored approaches, making universal detection difficult.

Mycobacterium avium subspecies paratuberculosis (MAP) is the etiological agent of Johne's disease whose high genetic diversity impacts the development of diagnostic tests. MAP strains can be broadly categorized into two major groups depending on their type: Type S (sheep-type) and C (cattle-type). These groups show significant genetic and phenotypic differences such as these differences in growth rates, colony morphology, and pathogenicity. For example, Type S lineages tend to grow more slowly and do not necessarily flourish on media formulations that allow Type C strains to thrive. Such diversity complicates the establishment of universal diagnostic tests, since assays that are optimal for one strain type may have poor performance for others. Therefore, early detection and surveillance for Johne's disease in various animal species is difficult, and different diagnostic techniques are required depending on the MAP strain. Knowledge of the genetic and phenotypic differences between MAP strains is important for the design of effective diagnostics and control measures.

Johne’s Disease Diagnostics Market Segment Analysis

By Animal Type

In 2023, the Johne’s Disease Diagnostics Market was led by the cattle segment as it represented over 86% of the revenue share. This is largely due to the high incidence of Johne’s disease in dairy and beef cattle globally. The herds harboring Mycobacterium avium subspecies paratuberculosis (MAP) the organism responsible for Johne’s disease which is responsible for a large number of economic losses, especially losses related to milk production, weight loss, and culling of infected animals with the USDA reporting nearly 68% average infection rate, for the U.S. dairy herd of MAP-infection through population-level estimates. The disease’s effect on productivity has made early and accurate diagnostics a global priority for cattle farmers.

Government initiatives have been key in driving diagnostic solution adoption in this segment. For instance, the USDA’s Voluntary Bovine Johne’s Disease Control Program encourages routine testing and biosecurity measures to reduce infection rates. For example, the Irish Johne's Control Programme (IJCP) strives to enhance herd health by encouraging regular diagnostic and management practices. These programs are familiarizing livestock owners with the importance of detection and prevention, and also prevention. The cattle segment has also benefited from technological advancements. Recent diagnostic strategies including enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) testing have high sensitivity and specificity and can detect human infection at an early stage when interventions are most valuable. Simultaneous diagnosis of multiple pathogens through multiplexed diagnostic tests is also growing in popularity among cattle farmers looking for holistic herd health solutions.

By Test Type

PCR (Polymerase Chain Reaction) segment has dominated the Johne's Disease Diagnostics Market in 2023. It contributed to over 37% revenue share for Johne's Code Diagnostics market, in 2023. This is due to PCR being able to identify MAP DNA in fecal samples as it is significantly more accurate and has greater sensitivity than conventional methods such as ELISA or AGID (Agar Gel Immunodiffusion). They can detect low levels of DNA from the bacterium, which makes them very useful for detecting the disease if clinical signs have not yet appeared. The fast and reliable results produced by PCR are one of the major factors behind its dominance. Unlike serological tests based on antibody responses, which might take time to get to a level that could be measured, PCR directly detects the presence of the MAP bacteria. This is especially useful for herd disease spread control. In addition, rapid developments in molecular diagnostics have facilitated the availability and affordability of PCR in veterinary diagnostics.

Another driver for the adoption of PCR-based diagnostics has been various government initiatives. In many countries, like Australia and Canada, Johne’s disease is notifiable and herds are regularly screened, which ensures that farmers are using sensitive diagnostic tools such as PCR. Additionally, molecular testing has been promoted through the USDA's Voluntary Bovine Johne's Disease Control Program. These economic advantages also bolster PCR in the market. PCR shows the infected animal before they are at the symptomatic stage, which enables the farmer to isolate their livestock and stop the cycle of infection that leads to productivity losses from late-stage infections. Additionally, multiplex PCR assays that can detect several pathogens at once are becoming more desirable to livestock producers looking for all-in-one diagnostic solutions.

By End-use

In 2023, veterinary hospitals & clinics dominated the johne's disease diagnostics market, commanding over 52% of the revenue share. This dominance can be associated with the fact that they offer expert-administered advanced diagnostic services such as ELISA and PCR testing. Veterinary practices have the specialized infrastructure to correctly diagnose and address Johne's disease in a timely fashion. Accessibility is one of the major drivers of growth in this segment. As primary contact points for livestock owners wanting their animals assessed for health Veterinarians care in hospitals and clinics Disease control strategies have made these facilities a necessary addition, as only trained veterinarians have the skills to interpret test results and advise on proper management practices.

The demand for diagnostic services at veterinary hospitals and clinics has been further supported by government initiatives. Because Johne’s disease is also a herd-specific and long-term chronic disease, no one program will work for all herds, so programs promoting testing routinely of Johne’s disease often farm with a network of veterinarians so they can reach farmers at the right time. Example programs include initiatives like the USDA’s Voluntary Bovine Johne’s Disease Control Program, which incentivizes flock owners to seek professional veterinary services for disease control. Such hospitals also have an importance role in educating farmers about biosecurity protocols to avoid contagious diseases spread among herds. They also help with follow-up testing and monitoring, which is critical for herd health over the long term.

Johne’s Disease Diagnostics Market Regional Insights

In 2023, North America led Johne’s Disease Diagnostics Market with a 33% market share due to the strong veterinary infrastructure, high level of awareness among livestock owners, and good government support for disease control programs. The U.S., which has a sizable share of global market share, has been a leader because of its sophisticated diagnostic technologies and broader acceptance of programs such as the USDA's Voluntary Bovine Johne's Disease Control Program. The programs encourage ongoing testing via methods like ELISA and PCR.

The Asia Pacific was the fastest growing region with a high CAGR during the forecast period 2024–2032 owing to rising meat consumption coupled with increasing prevalence rates in China and India. With increasing livestock herds in the region, demand for advanced diagnostics has increased as farmers seek solutions to combat the productivity losses caused by Johne’s disease. The initiatives taken by the government in Asia Pacific, have also contributed in a significant manner toward the growth of the market. India, fortunately, has initiated national programs to deal with animal health issues via screening and vaccination on a long-term basis to control zoonotic diseases. Moreover, the rise in investments in veterinary infrastructure across the developing economies has improved access to diagnostic services.

Johne’s Disease Diagnostics Market Key Players

• Zoetis Inc. (Vetscan Imagyst, Parachek)​

• IDEXX Laboratories, Inc. (Johne's ELISA Test, Johne's PCR Test)​

• Thermo Fisher Scientific Inc. (VetMAX MAP Real-Time PCR Kit, ELISA Test Kits)​

• PBD Biotech Ltd. (Actiphage Rapid, Actiphage Confirmatory)​

• IDvet (ID Screen Paratuberculosis Indirect Screening Test, ID Screen Paratuberculosis Indirect Confirmation Test)​

• VMRD, Inc. (Johne's Antibody Test Kit, Bovine Paratuberculosis ELISA)​

• bioMérieux SA (VIDAS Johne's Disease Assay, ELISA Kits)​

• INDICAL BIOSCIENCE GmbH (VetMAX MAP Real-Time PCR Kit, PathoProof Mastitis PCR Assay)​

• MV Diagnostics (Sure Farm Ltd) (ParaCheck Faecal Test, ParaCheck Blood Test)​

• Tetracore, Inc. (Johne's Disease Antibody Test Kit, Paratuberculosis PCR Test)​

• HiMedia Laboratories (HiPer Johne's Detection Kit, ELISA Test Kits)​

• Promega Corporation (Maxwell RSC Viral Total Nucleic Acid Purification Kit, GoTaq Probe qPCR Master Mix)​

• Pictor Diagnostics (Multiplexed ELISA Test, PictArray Technology)​

• Epitopix (Johne's Disease Vaccine, Diagnostic Test Kits)​

• Merck Animal Health (Paratuberculosis ELISA Kit, Johne's Disease PCR Test)​

• Randox Laboratories (Paratuberculosis ELISA Test, PCR Assays)​

• QIAGEN (QIAamp DNA Mini Kit, QuantiFERON)​

• Neogen Corporation (Para-D-Tec, Johne's Disease PCR Kit)​

• Bio-Rad Laboratories (ELISA Test Kits, PCR Detection Kits)​

• Agrolabo S.p.A. (Paratuberculosis Diagnostic Kits, ELISA Test Kits)

Recent Developments in the Johne’s Disease Diagnostics Market

• IDEXX Laboratories launched a PCR-based diagnostic test for early-stage MAP infections in September 2024.

• In October 2024, automated diagnostic devices with the intent to make test trying easier and quicker were introduced by Thermo Fisher Scientific.

• In November 2024, The USDA expanded funding for nationwide Johne’s disease eradication programs targeting rural farming communities across multiple states.