At Home Testing Kits Market

At Home Testing Kits Market Distribution by Type of Test Format, Type of Biofluid Analyzed, Therapeutic Area and Key Geographical Regions (North America, Europe, Asia-Pacific, Africa and South America): Industry Trends and Global Forecasts, 2022-2035

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At Home Testing Kits Market

The global at home testing kits market size is estimated to grow from USD 14.8 billion in 2022 to USD 31.15 billion by 2035, representing a CAGR of 6% during the forecast period 2022-2035.

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Since the approval of the first over-the-counter test kits in the early 1976, there has been a substantial increase in the development initiatives focused on such products. In this context, it is worth highlighting that over 20 million at-home pregnancy test kits are being annually sold in the US. Companies have also developed at-home diagnostic kits for the detection and diagnosis of various diseases, such as human immunodeficiency virus (HIV) infection, diabetes, Hepatitis C, colon cancer and COVID-19. Specifically, post the onset of COVID-19, there has been an upsurge in the demand for self-testing kits. In fact, in 2021, more than 100 at-home self-testing kits were approved by the USFDA for the diagnosis of COVID-19. The popularity of these kits can be attributed to the fact that they are more reliable, efficient, high yielding, as well as compatible with a broad range of input samples, including blood, cells, tissues, plasma, saliva and microbes.

This image highlights the context of Self Testing Kits Market report. Upon realizing the potential of self-testing kits, industry stakeholders have initiated several R&D efforts focused on developing rapid at-home testing kits for detection, diagnosis and screening of various disease indications This image provides list of At-home Self-testing Kits. Over 510 at-home self-test kits have been developed for the screening, monitoring and diagnosis of a myriad of diseases, including diabetes, colon cancer and HIV This image presents the market overview of Self Testing Kits Market. Majority of the at-home self-testing strips are primarily being used for monitoring diabetes and have received approval from regulatory authorities, such as the USFDA, ISO and IVD

Given the extensive utilization of at-home testing kits / at home blood test in the diagnosis of a myriad of disease indications, there has been a significant rise in investments in at home testing kits market. Over USD 2.2 billion has been invested in this domain by various government institutions in the US, over the last five years. Further, the current market landscape is consolidated and primarily dominated by the kits being developed to detect pregnancies, monitoring glucose and ovulation patterns. We believe that, with an increase in the number of point-of-care test kits being developed across various therapeutic areas, such as infectious diseases and celiac diseases, and their subsequent commercialization, the opportunities for self-testing kit developers is likely to increase in the foreseen future. At present, efforts are also ongoing to connect at-home diagnostic tests with telemedicine; this is expected to enable a rapid turnaround time. The ongoing innovations in at home testing kits market are anticipated to bring a positive revolution in the healthcare domain. Given the continuous efforts being undertaken by industry players, the at home testing kits market is poised to witness healthy market growth over the forecast period.

Leading At Home Testing Companies Developing Kits

Examples of key companies engaged in the at home testing kits market (which have also been profiled in this market report; the complete list of companies is available in the full report) include ACON Laboratories, AdvaCare Pharma USA, Apex Biotechnology, i-SENS, Oak Tree Health, TaiDoc Technology and VivaCheck Laboratories. This market report includes an easily searchable excel database of all the at home testing companies developing at home medical tests, at home blood test and self-diagnostic test worldwide.

This image provides information on academic grants that have been awarded to various research institutes for conducting research focused on at-home self-testing kits. More than 1,130 academic grants have been awarded to industry players to support the ongoing efforts related to research and innovation of at-home self-testing kits, over the past few years This image highlights the competitive analysis of of at-home self-testing kit manufacturers. In order to gain competitive edge, firms continue to improve and benchmark their existing capabilities and capacities to offer a number of at-home self-testing solutions This image presents the Bowman's strategy clock framework to understand the pricing strategy of the at-home self-testing kits. Cost is a key determinant of the acceptance and adoption of assay kits; the pricing strategy matrix is likely to assist players in evaluating the competitive market prices for their offerings

Recent Developments in At Home Testing Kits Market

Several recent developments have taken place in the field of at home testing kits market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In July 2023, LifeCell International launched self-sampling test kits with an aim to allow people to collect cell swabs and tissue samples in the privacy of their homes which will be used for detecting Human Papillomavirus (HPV) which leading cervical cancer in women and sexually transmitted infections like syphilis or gonorrhea. 
  • In May 2023, Healthy.io collaborated with Boehringer Ingelheim Pharmaceuticals to support at-home testing and to provide educational information to patients at risk of chronic kidney disease (CKD) by transforming the smartphone camera into a medical device.
  • In January 2023, the National Institutes of Health in collaboration with the Administration for Strategic Preparedness and Response (ASPR) launched the Home Test to Treat program, an entirely virtual community health intervention, for the patients suffering from COVID-19.

Scope of the Report

The “At Home Testing Kits Market, Distribution by Type of Test Format (Strip, Stick, Cassette, and Others), Type of Biofluid Analyzed (Urine, Blood, and Stool), Therapeutic Area (Fertility and Reproductive Health, Metabolic Disorders, Infectious Diseases and Oncological Disorders) and Key Geographical Regions (North America (US, Canada and Rest of North America), Europe (UK, Germany, France, Italy, Spain and Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, Indonesia and Rest of Asia-Pacific), Africa (Nigeria, Ethiopia, Egypt and Rest of Africa) and South America (Argentina, Brazil and Rest of South America)): Industry Trends and Global Forecasts, 2022-2035” market report features an extensive study of the current market landscape, market size, market share, market forecast, market outlook and future opportunities associated with the at home testing kits market. The market research report also includes an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in at home testing kits market. Amongst other elements, the market report features:

  • A brief overview of at-home self-testing kits, highlighting the key steps involved while performing at-home self-tests. Further, it highlights the types of at-home tests available, and the types of assays used. The chapter also elaborates on the advantages offered by at-home self-testing kits along with the associated challenges. In addition, the chapter provides information on different regulatory authorities across key geographies which are involved in regulating the approval, safety, and sales of at-home self-testing kits and its future perspectives.
  • A detailed overview of the current market landscape of companies engaged in the development of at-home self-testing kits, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of testing procedure (manual and automatic), type of test format (strip, stick, cassette, and others), purpose of testing (cancer screening, pregnancy detection, diabetes monitoring, ketone monitoring, HIV diagnosis, ovulation monitoring, substance abuse monitoring and, others), target therapeutic area (fertility and reproductive health, metabolic disorders, oncological disorders, infectious diseases, hematological disorders, and others), wearability (wearable and non-wearable), analyte procurement method (invasive and non-invasive), biofluid analyzed (blood, saliva, urine, stool, and others), processing time (maximum processing time), kit components (diagnostic component, collection component, lancets, reagents, and other components), regulatory approvals / certifications (CE, ISO, FDA, IVD, and others), kit reusability, availability of data management tools, target analyte detected (hemoglobin, glucose, FSH, LH, hCG, cholesterol, and others), and follow-up consultation requirement.
  • A detailed analysis of academic grants that have been awarded to various research institutes for conducting research focused on at-home self-testing kits, during the period, pre-2019-2022, based on several parameters, such as year of grant award, amount awarded, support period, type of funding institute center, grant application, purpose of grant award, grant activity code, NIH spending category, study section involved, popular NIH departments, recipient organization, regional distribution of recipient organization. Further, the chapter also highlights the popular recipient organizations, (in terms of number of grants and amount awarded) and prominent program officers (in terms of number of grants).
  • A detailed competitiveness analysis of at-home self-testing kit manufacturers based on overall experience of the company (in terms of number of years since its establishment), product portfolio strength (in terms of number of at-home self-testing kits offered) and portfolio diversity (in terms of type of test format, type of biofluid analyzed, number of regulatory approvals, kit reusability, accessibility, and number of target analytes).
  • Elaborate profiles of prominent players engaged in offering at-home self-testing kits. Each profile includes a brief overview of the company, along with details related to its financial information (if available), information on product portfolio, recent developments and an informed future outlook.
  • A Bowman's strategy clock framework to understand the pricing strategy of the at-home self-testing kits offered by a company, along with its competitive position in the market. In addition, it presents the equation devised to calculate the likely price of the at-home self-testing kits based upon its characteristics.
  • An estimate of company’s intrinsic value by utilizing comparable company analysis of publicly listed companies based on their current share price, equity value, enterprise value, EBITDA, net income, and revenue.
  • An informed estimate of the annual demand (in terms of number of kits) for at-home self-testing kits, across various therapeutic areas, such as fertility and reproductive health, metabolic disorders, infectious diseases, and oncological disorders.
  • A detailed analysis based on a proprietary 2×2 representation, highlighting the current market scenario (in terms of existing competition and growth opportunities) across emerging and established market segments.
  • An overview of at-home self-testing kits, highlighting the key steps involved while performing at-home self-tests, types of home-tests and types of assays used. The chapter also elaborates on the advantages offered by at-home self-testing kits along with the associated challenges. In addition, the chapter provides information on different regulatory authorities across key geographies which are involved in regulating the approval, safety, and sales of at-home self-testing kits

The key objective of at home testing kits market report is to provide a detailed market analysis in order to estimate the existing market size, market value, statistics and future opportunity for at home testing kits market during the forecast period. We have provided informed estimates on the likely evolution of the market in the short to mid-term and long term, over the forecast period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] therapeutic area (fertility and reproductive health, metabolic disorders, infectious diseases, and oncological disorders), [B] type of biofluid analyzed (blood, urine, and stool), [C] type of test format (cassette, strip, stick and others), [D] key geographical regions (North America, Europe, Asia-Pacific, Africa, and South America). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market research report are in USD, unless otherwise specified.

This image provides estimate of company’s intrinsic value by utilizing comparable company analysis of publicly listed companies. Due to competitive pricing of products and rapid innovation being led by companies in this market, there are various lucrative opportunities for long term investments, with high possibility of positive return on investments This image highlights annual demand for at-home self-testing kits. The existing capacity is sufficient to meet the current global annual demand; we anticipate that players will continue to invest in building incremental capacity to meet the long-term expectations to meet the rising demand This image provides information on the future market growth of self-testing kits. In the long-term, the overall projected opportunity is likely to be segregated across various therapeutic areas, biofluids analyzed, test formats and key geographical regions

Frequently Asked Questions

Question 1: What are at home testing kits?

Answer: At home testing kits encompass a diverse array of tests that can be easily performed by the patients at their home. These tests can provide disease diagnosis and monitoring all at the convenience of the patient’s home.

Question 2: How big is the at home testing kits market?

Answer: The at home testing kits market size is estimated to be worth $14.8 billion in 2022.

Question 3: What is the projected market growth of the at home testing kits market?

Answer: The at home testing kits market is expected to grow at compounded annual growth rate (CAGR) of 6% during the forecast period 2022 - 2035.

Question 4: Who are the leading players in the at home testing kits market?

Answer: Examples of key companies engaged in the at home testing kits market (which have also been profiled in this market report; the complete list of companies is available in the full report) include ACON Laboratories, AdvaCare Pharma USA, Apex Biotechnology, i-SENS, Oak Tree Health, TaiDoc Technology and VivaCheck Laboratories.

Question 5: How many companies provide at home testing kits worldwide?

Answer: Currently, there are over 60 at home testing companies that claim to develop at home testing kits to enable disease diagnosis.

Question 6: How many at home testing kits are presently marketed / under development by industry stakeholders globally?

Answer: Over 510 at home testing kits are currently marketed / under development by key companies worldwide.

Question 7: Which geographies are key hubs for at home testing companies (kit developers)?

Answer: North America is the hub for at home testing companies (kit developers), with nearly 50% of the companies based in the region.

Question 8: When were at home pregnancy tests invented?

Answer: Home pregnancy testing is the most common at home testing kit used globally, with the first kit launched in 1976 after FDA approval.

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