At-home Self-testing Kits Market, 2022-2035

At-home Self-testing Kits Market, 2022-2035

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.

Given the extensive utilization of at-home testing kits in the diagnosis of a myriad of disease indications, there has been a significant rise in investments in this domain. 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 this market are anticipated to bring a positive revolution in the healthcare domain. Given the continuous efforts being undertaken by industry players, the at-home self-testing kits market is poised to witness healthy growth over the next decade.

SCOPE OF THE REPORT

The “At-home Self-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” report features an extensive study of the current market landscape and future potential associated with the at-home self-testing kits market. The study also includes an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. Amongst other elements, the 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

One of the key objectives of the report was to estimate the current opportunity and future size of at-home self-testing kits market. We have provided informed estimates on the likely evolution of the market in the short to mid-term and long term, over the 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 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 report are in USD, unless otherwise specified.

1.1. MARKET SEGMENTATION

At-home Self-testing Kits Market: Market Segmentations

Market Segments Details

Forecast Period 2022 - 2035

Key Therapeutic Areas Fertility and Reproductive Health

Infectious Diseases

Metabolic Disorders

Oncological Disorders

Type of Test Format Strip

Stick

Cassette

Others

Type of Biofluid Analyzed Blood

Stool

Urine

Key Geographical Regions North America

Europe

Asia-Pacific

Africa

South America

Source: Roots Analysis

1.2. RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we have conducted interviews with various experts in this domain (academia, industry, medical practice and other associations) in order to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions. Wherever possible, the available data has been validated from multiple sources of information.

The secondary sources of information include:

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market, gathered from various secondary and primary sources of information.

1.3. KEY QUESTIONS ANSWERED

Who are the leading players engaged in the manufacturing of at-home self-testing kits?

What is the most common diagnostic assay offered by at-home self-testing kit manufacturers?

What are the key regulatory frameworks for at-home self-testing kits across different geographical regions?

Which companies / institutes have received grants for the research and development of at-home self-testing kits?

What are the key factors influencing the price of at-home self-testing kits?

What is the likely valuation / net worth of companies engaged in this domain?

What is the current, global demand for at-home self-test kits?

How is the current and future market opportunity likely to be distributed across key market segments?

What is the current market scenario (in terms of existing competition and growth opportunities) across emerging and established market segments?

1.4. CHAPTER OUTLINES

Chapter 2 is an executive summary of the key insights captured during our research. It offers a high-level view on the current state of at-home self-testing kits market and its likely evolution in the mid to long-term.

Chapter 3 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.

Chapter 4 provides a detailed overview of the current market landscape of at-home self-testing kit developers, 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.

Chapter 5 presents an analysis on academic grants that have been awarded to various research institutes for projects focused on at-home self-testing kits, during the period, pre-2019-2022, based on several relevant parameters, such as year of grant award, amount awarded, support period, 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).

Chapter 6 provides an insightful competitiveness analysis of at-home self-testing kit manufacturers based on various relevant parameters, such as overall experience of the company (in terms of number of years since it was established), product portfolio strength (in terms of number of at-home self-testing kits offered) and portfolio diversity (in terms of type of test format, types of biofluid analyzed, number of regulatory approvals, kit reusability, availability of data management tools, and number of target analytes).

Chapter 7 provides elaborate profiles of prominent players engaged in this domain. Each profile includes a brief overview of the company, details related to its financial information (if available), information on product portfolio, recent developments, and an informed future outlook.

Chapter 8 presents a Bowman's strategy clock framework to understand the pricing strategy of the at-home self-test kits offered by a company, along with its competitive position. In addition, it presents the equation devised to calculate the likely price of the at-home self-test kits based upon different therapeutics areas, such as, fertility and reproductive health, metabolic disorders, infectious diseases, and oncological disorders.

Chapter 9 provides 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.

Chapter 10 provides an informed estimate of the annual demand for at-home self-testing kits, across various therapeutic areas such as, fertility and reproductive health, metabolic disorders, infectious diseases, and oncological disorders.

Chapter 11 presents an insightful market forecast analysis, highlighting the future potential of at-home self-testing kits market till 2035. We have segmented on the basis of therapeutic area (fertility and reproductive health, metabolic disorders, infectious diseases, and oncological disorders), type of biofluid analyzed (blood, urine, stool, and others), type of test format (cassette, strip, stick, and others), key geographical regions (North America, Europe, Asia-Pacific, Africa, and South America).

Chapter 12 presents 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.

Chapter 13 is a summary of the overall report, presenting the insights on the contemporary market trends and the likely evolution of the at-home self-testing kits market.

Chapter 14 contains the transcripts of interviews conducted with representatives from renowned organizations that are engaged in offering at-home self-testing kits. The chapter provides details of interviews held with (in alphabetical order) Ben Shen (Vice President – Sales and Marketing, Apex Biotechnology), Joy Chatterjee (Associate Vice President – Sales and Marketing, Mankind Pharma).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures in the report.

Chapter 16 is an appendix, which provides the list of companies and organizations mentioned in the report.