Infectious Disease Rapid Diagnostic Testing for HPV Market Size (2023-2030)

Global Infectious Disease Rapid Diagnostic Testing for HPV Market is estimated to be worth USD 2.78 Billion in 2022 and is projected to reach a value of USD 4.78 Billion by 2030, growing at a CAGR of 7.0% during the forecast period 2023-2030.

The widespread virus known as the human papillomavirus, or HPV for short, can cause harm to several bodily organs, including the genitals. About 100 different types of HPV exist, some of which cause warts to appear on various parts of the body while others can lead to more severe illnesses including cervical cancer. HPV is generally transmitted through skin-to-skin contact during sexual activity. Although many genital HPV strains are harmless and may cause genital warts, some high-risk types can progress to cancer if left untreated. HPV infections can affect anyone who engages in sexual activity, and it poses a greater risk to women in terms of cervical cancer. Regular Pap smears and HPV tests can help detect and prevent cervical cancer. Males have a lower risk of developing a worrying HPV infection than females, despite the likelihood of genital warts and other cancers. HPV is highly contagious and can be transmitted through various sexual activities, even without the exchange of body fluids. 

Healthcare providers have various tests and procedures to diagnose HPV infections. Visual examination can identify genital warts, but routine screenings are crucial since high-risk HPV strains often don't show symptoms. Pap smears are extensively used to screen for cervical cancer and detect precancerous cells (cervical dysplasia) linked to high-risk HPV, the primary cause of cervical cancer. HPV tests can identify high-risk strains that may lead to cervical cancer. However, due to the lower probability of malignant development in these areas, there are no FDA-approved HPV detection tests available for the vulva, vagina, penis, scrotum, rectum, or anus. Colposcopy involves using a colposcope to closely examine the cervix for abnormal cells, and a biopsy may be performed for further analysis. Visual inspection with acetic acid (VIA) is used in regions with limited access to Pap smears or HPV tests, where a vinegar-based solution is applied to the cervix to make abnormal cells more visible.

Global Infectious Disease Rapid Diagnostic Testing for HPV Market Drivers:

The rising incidence of HPV-related disease is fueling the growth of the global infectious disease rapid diagnostic testing for the HPV market.

A small DNA virus known as HPV harms cells in the skin and mucous membranes. Its circular genome consists of double-stranded DNA, around 8 kilobases long, containing genes for replication and structural proteins. Cervical cancer, anogenital malignancies, and head and neck cancers have been related to specific HPV genotypes. The most prevalent "high-risk" genotypes, HPV 16 and 18, contribute to about 70% of cervical cancer cases. HPV was responsible for around 500,000 cervical cancer cases and 250,000 deaths in 2002, predominantly in underdeveloped nations. HPV is highly contagious, often transmitted shortly after initiating sexual activity, and the majority of individuals acquire the infection at some point in their lives. Therefore, this factor drives the demand for rapid diagnostic testing for HPV disease.

The increasing demand for novel and effective diagnostic techniques is another factor contributing to the growth of the global infectious disease rapid diagnostic testing for the HPV market.

The rising incidence of HPV-related diseases among the population has created a growing need for the development of novel and effective diagnostic techniques. This need stems from the necessity to accurately and efficiently diagnose infectious diseases to facilitate timely treatment and containment measures. As a result, the demand for infectious disease rapid diagnostic testing has witnessed a significant surge, fueling the growth of the market. The development of innovative diagnostic techniques that can offer improved accuracy, sensitivity, and rapid results becomes crucial in addressing the rising population diagnosed with HPV-related diseases. Consequently, this increasing need for novel and useful diagnostic techniques acts as a market driver, propelling the growth of the infectious disease rapid diagnostic testing market during the forecast period.

Global Infectious Disease Rapid Diagnostic Testing for HPV Market Challenges:

The development of novel infectious disease testing kits has been hindered by stringent regulatory norms, particularly in the United States where diagnostic products undergo a rigorous clearance process by the FDA. These regulatory barriers limit the introduction of innovative diagnostic testing products, which can potentially restrict the revenue growth of the market. Moreover, limitations imposed on certain testing kits by regulatory bodies can impede the progress and introduction of advanced and innovative diagnostic testing products. These challenges about regulatory policies and restrictions pose obstacles to the overall revenue growth of the market.

COVID-19 Impact on the Global Infectious Disease Rapid Diagnostic Testing for HPV Market:

The outbreak of the COVID-19 pandemic substantially impacted the global infectious disease rapid diagnostic testing for the HPV market. The pandemic caused disruptions in supply chains and distribution of goods and services, which highly affected the supply of essential materials like reagents and testing equipment for rapid diagnostic testing for HPV disease. Moreover, the shifted focus of healthcare infrastructure resources and personnel to COVID-19 testing and treatment further declined the demand for rapid diagnostic testing for HPV disease. These factors negatively impacted the growth of the global infectious disease rapid diagnostic testing for the HPV market. Despite these challenges, the global infectious disease rapid diagnostic testing for the HPV market is projected to recover and grow in the coming years.

Global Infectious Disease Rapid Diagnostic Testing for HPV Market Recent Developments:

• In May 2023, Researchers at Brooke Army Medical Center developed HPV DeepSeq, an automated method for profiling the virome of human papillomavirus (HPV) associated with head and neck cancer. By utilizing a customized HPV genome database and next-generation sequencing (NGS) data analysis, the team achieved rapid and accurate results. This advancement has implications for HPV biomarker discovery, surveillance, diagnostics, and therapeutics. The researchers identified HPV viromes and genotypes linked to different levels of cervical abnormalities, aiming to translate their findings into a clinical tool for improved patient care. They are also exploring HPV mapping techniques to enhance understanding of viral-host integration sites and advance therapeutic interventions for HPV-related cancers.
• In November 2020, QIAGEN and BioNTech partnered to create a tissue-based companion diagnostic test. Squamous cell carcinoma of the head and neck (SCCHN) caused by specific types of human papillomavirus (HPV) infections will be identified utilizing this test and BioNTech's experimental cancer treatment, BNT113. The diagnostic test will utilize QIAGEN's RGQ MDx platform, which is part of their QIAsymphony product line, to detect the presence of HPV genotypes. This collaboration aims to improve the accuracy and effectiveness of treatment for SCCHN patients with HPV-related cancers.

INFECTIOUS DISEASE RAPID DIAGNOSTIC TESTING FOR HPV MARKET REPORT COVERAGE:

Global Infectious Disease Rapid Diagnostic Testing for HPV Market Segmentation:

Global Infectious Disease Rapid Diagnostic Testing for HPV Market Segmentation: By Product & Service

• Reagents & Kits
• Instruments
• Data Management Software
• Service

In 2022, the reagents and kits segment held the highest market share. The growth can be attributed to the rising demand for fast and accurate testing devices. The adoption of reagents and kits in both research and clinical settings is increasing owing to their ability to deliver consistent and precise results at a cost-effective price, which further supports the revenue growth of this segment.

The instruments segment is anticipated to expand at the quickest rate over the forecast period owing to the instruments being an essential tool utilized by laboratory technicians to perform diagnoses and connect reagents and samples.

Global Infectious Disease Rapid Diagnostic Testing for HPV Market Segmentation: By Technology

• Clinical Microbiology
• DNA Microassay
• Immunoassay
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• Polymerize Chain Reaction (PCR)
• Others

In 2022, the polymerized chain reaction (PCR) segment held the highest market share. The growth can be attributed to the rising adoption of PCR technology, which has shown high efficacy in detecting toxins and identifying various microorganisms such as bacteria, fungi, and viruses. Additionally, the growing utilization of state-of-the-art PCR technologies for coronavirus identification is anticipated to further propel the revenue growth of this segment.

The immunoassay segment is anticipated to expand at the quickest rate over the forecast period owing to the growing utilization of immunoassay techniques for detecting and identifying infectious microorganisms like fungi, bacteria, and viruses and the rising incidence of HPV cases and the development of more precise diagnostic equipment.

Global Infectious Disease Rapid Diagnostic Testing for HPV Market Segmentation: By End User

• Academic & Research Institutions
• Diagnostic Centers
• Hospitals & Clinical Laboratories
• Others

In 2022, the hospitals and clinical laboratories segment held the highest market share and will continue to expand at the quickest rate over the forecast period. They offer comprehensive healthcare facilities, with dedicated laboratory facilities and trained medical professionals for efficient infectious disease rapid diagnostic testing. Hospitals also have critical care units and emergency departments for the timely intervention and management of HPV-related disease patients. Additionally, HPV-related diseases often require hospitalization, and hospitals provide a suitable environment for continuous monitoring and intervention. Access to resources, including advanced diagnostic equipment and skilled personnel, further enables hospitals and clinical laboratories to perform a variety of infectious disease rapid diagnostic testing efficiently.

Global Infectious Disease Rapid Diagnostic Testing for HPV Market Segmentation: By Region

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

The region of North America held the largest share of the global infectious disease rapid diagnostic testing for HPV market in the year 2022. The rising incidence of HPV-related diseases, the presence of well-established healthcare infrastructure in nations, such as the United States and Canada, rapid advancements in clinical diagnostics, and the introduction of new and improved technologies that aid in the accurate and efficient detection of HPV-related diseases are some of the factors propelling the region's growth. Additionally, North America is home to several significant market players, including Abbott Laboratories, Becton, Dickinson and Company, Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., and Cepheid Inc.

The region of Europe is anticipated to expand at the quickest rate over the forecast period owing to the presence of well-established healthcare infrastructure in nations, such as Germany, the United Kingdom, and France, the growing awareness and emphasis on preventive healthcare, such as HPV vaccination and cervical cancer screening, and the strong presence of major market players, including QIAGEN, Fast Track Diagnostics, and Roche Holding AG.

Global Infectious Disease Rapid Diagnostic Testing for HPV Market Key Players:

1. QIAGEN (Germany)
2. Abbott Laboratories (United States)
3. Becton, Dickinson, and Company (United States)
4. Fast Track Diagnostics (Luxembourg)
5. Thermo Fisher Scientific Inc. (United States)
6. Bio-Rad Laboratories, Inc. (United States)
7. Cepheid Inc. (United States)
8. Roche Holding AG (Switzerland)
9. Hologic, Inc. (United States)
10. GenMark Diagnostics, Inc. (United States)