The Global Lateral Flow Assays Market in terms of revenue was estimated to be worth $20.5 billion in 2022 and is poised to reach $22.6 billion by 2027, growing at a CAGR of 2.0% from 2022 to 2027. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Increasing adoption of kits & reagents and lateral flow assay readers for infectious diseases testing, veterinary diagnostics, and drug of abuse testing, cardiac marker testing. Whereas most of lateral flow assays are having limitation of qualitative detection, lot to lot variation like factors may hinder the growth of global market during the forecast period.
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Lateral Flow Assays Industry Dynamics:
Drivers:
High prevalence of infectious diseases across the globe
Rapidly increasing geriatric population
Growing usage of home-based lateral flow assay devices
Growing demand for point-of-care testing
Need for rapid diagnostic testing for COVID-19
Restraints:
Inconsistent results of lateral flow assay tests
Opportunities:
Evolving applications of lateral flow assays
Rising demand for lateral flow assays in the food & beverage industry
Omicron – The new variant of concern is an opportunity for the lateral flow assays market
Government initiatives for omicron
Initiatives of Medical diagnostic companies for omicron
Challenges:
Limited reimbursements for lateral flow assay products
Difficulties in procuring quality raw materials for the development of lateral flow assay tests
Recent Developments:
In October 2022, F. Hoffmann-La Roche Ltd. (Switzerland) a next-generation portfolio of SARS-CoV-2 rapid antigen test 2.01, SARS-CoV-2 Rapid Antigen Test 2.0 Nasal2, and SARS-CoV-2 Rapid Antigen Test 2.0 Nasal3
In June 2021, Abbott Laboratories (US) received the CE approval for PanBio Rapid Antigen Self-test, opening access throughout Europe to fast, reliable COVID-19 testing
Regional Analysis:
1.1 LATERAL FLOW ASSAY MARKET
1.1.1.NORTH AMERICA
The presence of highly developed healthcare systems, rising geriatric population, increasing incidence of chronic diseases and infectious diseases such as COVID-19 and STIs, quick adoption of new and innovative products, and the strong presence of major players in the region are responsible for North America’s dominance in the lateral flow assays market. According to the CDC, 6 out of 10 Americans suffer from chronic diseases, and 868,000 Americans die of heart disease or stroke every year (one-third of all deaths). This can be attributed to the rising geriatric population and lifestyle changes among different population groups in the country.
The incidence of sexually transmitted diseases has also escalated drastically in the region over the years. According to the CDC, cases of syphilis have increased by 37% in women of childbearing age in the country between 2019 and 2020. This would drive the growth of lateral flow diagnostic testing for STIs in the region, especially in the home care settings segment.
Many academic and research laboratories are also located in this region, increasing the pace of technological progress in North America. The increased demand for effective solutions and focus on early disease diagnosis drives investments in healthcare technology development and new assay techniques. In North America, a major issue affecting market growth is the rising healthcare cost. According to National Health Expenditure projections for 2016–2025, US healthcare spending is projected to grow at an average rate of 5.6% per year. As a result, the US government focuses on implementing concrete initiatives and promoting technologies that will help curb the increasing healthcare cost/burden. In this regard, the proactive diagnosis of diseases with the help of lateral flow assay devices can be very effective, as these devices are priced lower than other techniques/products.
However, the North American lateral flow assays market faces challenges such as reimbursement cuts. In addition, the registration of lateral flow assay devices is a lengthy, expensive, and complex process, which delays product launches.
1.1.1.1 US
1.1.1.1.1 Largest market for lateral flow assays
Currently, the US is the largest regional market for lateral flow assay products. This is due to a large patient base and high per capita income, the high prevalence of infectious diseases, and the well-developed healthcare system in the country. Many lateral flow assay providers are also based in the US or have a significant presence in the country.
The US has been affected to a large extent by the influenza virus in the past few years and is currently one of the most severely affected countries by the COVID-19 pandemic. According to the CDC, in the 2019–2020 flu season, 38 million illnesses, 16.5 million hospital visits, 400,000 hospitalizations, and 22,000 deaths were associated with influenza. This surge in influenza and other infectious diseases in the US would increase the demand for rapid lateral flow testing in the forecast period.
Increasing R&D investments and venture capital funding from both large and small firms towards developing lateral flow assay diagnostics are also aiding the growth of the US market. The need for rapid results in clinical diagnostic procedures, especially in pregnancy and infectious disease testing, is also resulting in the greater adoption of lateral flow assay techniques in clinics and hospitals in the US.
According to the UN Department of Economic and Social Affairs, the above-65 age group constituted 16.25% of the total North American population in 2021. This figure is further expected to increase by 20% to exceed 56 million by 2030. This will drive the number of diagnostic procedures performed in the US, which, in turn, would contribute to the growth of the lateral flow assays market.
1.1.1.2 Canada
1.1.1.2.1 Availability of research funding and implementation of favorable government initiatives to drive market
The lateral flow assays market in Canada is estimated to grow at a relatively faster rate than in the US, primarily due to healthcare development in Canada over the past decade. However, several research institutes in Canada are collaborating with equipment manufacturers to improve the technical aspects of products and explore new application areas for lateral flow assay equipment. The availability of research funding, implementation of favorable government initiatives, new product launches, and the rising number of patients suffering from chronic diseases are the major factors driving the lateral flow assays market in Canada.
There are numerous local players in the lateral flow assays market in the country, such as Pro-Lab Diagnostics (Canada) and Cyto Diagnostics Inc. (Canada). These companies have been entering into agreements with other lateral flow test developers in different countries to expand their geographic reach.Regulatory processes act as a major restraint to the growth of the lateral flow assays market in the country. According to Alberta Health Services (the single health authority for Alberta), the number of laboratory tests performed across the province is increasing by ~6% per year. The increasing preference of patients for laboratory testing over rapid diagnosis due to the lack of reimbursement and awareness associated with the latter is hindering the growth of the lateral flow assays market in Canada.
1.1.2. TOP PLAYERS AND MNM VIEW
1.1.1.3 ABBOTT LABORATORIES
1.1.1.3.1 MNM VIEW
1.1.1.3.2 Right to win
Abbott Laboratories offers a strong portfolio for diagnostics. Abbott’s Rapid Diagnostics systems and tests provide real-time, lab-quality results at the point of care. The company is a world leader in diagnostic testing due to its rapid response, significant manufacturing scale, and affordable pricing strategy. During the pandemic, Abbott provided COVID-19 tests to more than 75,000 suppliers in 120 countries. Abbott’s worldwide rapid diagnostics sales increased to 112.3% in 2020 and 93.3% in 2021. Growth in 2021 was led by a high demand for Abbott’s portfolio of COVID-19 diagnostics tests, such as Abbott’s BinaxNOW, Panbio, and ID NOW rapid testing platforms.
1.1.1.3.3 Strategic choices
Abbott manufactures and markets diagnostic systems and tests to blood banks, hospitals, commercial laboratories, clinics, physicians’ offices, government agencies, alternate care testing sites, and plasma protein therapeutic companies. In August 2020, Abbott signed an agreement with the US government for 150 million BinaxNOW COVID-19 tests. The company also strengthened its diagnostics segment by increasing the manufacturing capacity for tests. It sold ~400 million tests in 2020.
1.1.1.3.4 Weaknesses and competitive threats
Abbott’s flexibility toward changing its business and economic condition and reducing funds available for working capital, capital expenditure, and acquisitions are likely to be affected due to significant indebtedness. For instance, in December 2021, Abbott’s consolidated indebtedness was ~USD 18.1 billion. Abbott’s businesses have experienced pressure on product pricing due to cost-containment efforts by government and private organizations. Some products listed on the site are available only in certain countries. For instance, Panbio Covid-19 Ag rapid test device is not approved for sale in the US.
Abbott’s products face intense competition from products that may be safer, more effective, more effectively marketed, or lower-priced. It also generated most of its revenue outside the US—62% in 2021
1.1.1.4 F HOFFMANN LA ROCHE
1.1.1.4.1 MNM VIEW
1.1.1.4.2 Right to win
The Diagnostics Division offers diagnostic tests and molecular testing systems that hospitals and healthcare providers widely adopt. The Diagnostics Division reported sales growth of 29% (USD 19.47 billion) due to its world-leading portfolio of COVID-19-related tests. The company has shown more interest in developing and launching products for COVID-19. For instance, in October 2022, the company launched SARS-CoV-2 Rapid Antigen Test 2.0 Nasal2, SARS-CoV-2 Rapid Antigen Test 2.01, and SARS-CoV-2 Rapid Antigen Test 2.0 Nasal3.
1.1.1.4.3 Strategic choices
In the COVID-19 scenario, the company has boosted its R&D activities to support the global response with high-quality tests to aid the healthcare system and individual patients. For instance, in September 2020, in collaboration with SD Biosensor, F. Hoffmann-La Roche Ltd. launched the SARS-CoV-2 Rapid Antigen Test for use on symptomatic people in markets accepting the CE Mark. Roche provides more than 90 tests on the WHO Essential Diagnostics List, which makes the Diagnostics Division of Roche a leader in the global market. The company has increased its R&D expenditure for the Diagnostics Division to USD 1.92 billion in 2021 from USD 1.66 billion in 2020.
1.1.1.4.4 Weaknesses and competitive threats
The product portfolio of the Diagnostics Division in the lateral flow assays market is not strong compared to its competitors. Hence, the sales of the Diagnostics Division may decrease. In 2020, Roche launched only two lateral flow assays related to COVID-19. The high level of competition in this market, especially during the pandemic, may affect its prospects
1.1.1.5 QUIDEL CORPORATION
1.1.1.5.1 MNM VIEW
1.1.1.5.2 Right to win
Quidel Corporation provides a wide range of diagnostic testing solutions in four segments for a large end-user base. Prominent among these end users are distributors, physician offices, hospitals, clinical laboratories, and reference laboratories, which it serves with a direct sales team.
1.1.1.5.3 Strategic choices
The company has reported strong R&D investments over the years. It spent USD 95.7 million, USD 84.3 million, and USD 52.6 million in 2021, 2020, and 2019 respectively, on R&D. Quidel has focused on developing technology platforms through both organic and inorganic growth. For instance, in December 2021, the company signed an agreement to acquire Ortho Clinical Diagnostics Holdings plc (US), which is one of the world’s largest in vitro diagnostic companies
In September 2020, it received Emergency Use Authorization for Sofia 2 Flu+ SARS Antigen FIA, a combination diagnostic assay for influenza A+B and COVID-19. Due to this, the company saw substantial revenue growth in COVID-19-related business in 2021. The sale of the company’s COVID-19 products accounted for 75% of the total revenue in 2021.
1.1.1.5.4 Weaknesses and competitive threats
Quidel sells and markets through direct sales, distributor organizations, and sales agents in Europe and the Asia Pacific. Direct sales were affected due to COVID-19, with an impact on its financial performance. Intense competition might lead to pricing pressure from major competitors, especially outside the US.
1.1.1.6 DANAHER CORPORATION
1.1.1.6.1 MNM VIEW
1.1.1.6.2 Right to win
Danaher Corporation has established itself as a strong player in the lateral flow assays market due to its innovative product portfolio and focus on organic and inorganic growth strategies. The company’s Diagnostics segment offers analytical instruments, reagents, consumables, software, and services that hospitals, physicians’ offices, reference laboratories, and other critical care settings use to diagnose diseases and make treatment decisions. Sales in 2021 for this segment by geographic destination (as a percentage of total sales in 2021) were: North America (44.3%), Western Europe (18.7%), other developed markets (4.9%), and high-growth markets (32.1%).
1.1.1.6.3 Strategic choices
Danaher comprises more than 20 operating companies leading in the life sciences, diagnostics, environmental, and applied sectors. Its business, R&D, manufacturing, sales, distribution, services, and administrative facilities are in more than 60 countries.
The company also acquires businesses and markets investments that either complement its existing business portfolio or expand its portfolio into new and attractive markets. Since Danaher’s acquisition of Cytiva on March 31, 2020, Cytiva’s core sales have grown by more than 30% compared to 2019, when it was owned by GE.
1.1.1.6.4 Weaknesses and competitive threats
Limited success outside the US could affect the growth of the company in the future. A limited number of product launches in response to the COVID-19 pandemic could result in competitors gaining the upper hand in the current scenario. Intense competition may lead to pricing pressure from established competitors, especially outside the US.
1.1.1.7 SIEMENS AG
1.1.1.7.1 MNM VIEW
1.1.1.7.2 Right to win
Siemens Healthineers’ Diagnostic business offers IVD products and services to healthcare providers in laboratory, molecular, and point-of-care diagnostics. The company mainly focuses on investments to enhance its competitiveness and innovation. Major capital expenditures made by the company were to expand manufacturing and technical capabilities, especially in the US and China. Growth in the company’s Diagnostics business in emerging markets is supported by rising government spending on healthcare, the promotion of the private segment, and wider access to healthcare services globally.
1.1.1.7.3 Strategic choices
Siemens Healthineers continuously focuses on updating its existing product portfolio. For instance, in October 2020, the company launched the CLINITEST Rapid COVID-19 Antigen Test for rapid antigen detection for COVID-19. It has also focused on joint ventures, agreements, and expansions to support business development in the US.
1.1.1.7.4 Weaknesses and competitive threats
Siemens has a limited product portfolio in the lateral flow assays market compared to its competitors. Other challenges include pressure on reimbursement systems, especially in the US, and extended equipment utilization at customer sites. Heavy reliance on a few suppliers may affect the company’s supply chain, especially in the current COVID-19 scenario, where logistics is problematic in certain regions. The company has seen less success in the international lateral flow assays market; most of its revenue comes from the US and Europe.
Lateral Flow Assays Industry Segmentation:
By Type
Kits & Reagents
Lateral Flow Readers
By Application
Clinical Testing
Veterinary Diagnostics
Food Safety & Environmental Testing
Drug Development & Quality Testing
By Technique
Sandwich Assays
Competitive Assays
Multiplex Detection Assays
By Sample Type
Blood Samples
Urine Samples
Saliva Samples
Other Samples
By End User
Hospitals & Clinics
Diagnostics Laboratories
Home Care Settings
Pharmaceuticals & Biotechnology Companies
Other End User
Report Link: ( Lateral Flow Assay Market )
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