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Cervical dysplasia, also called as cervical intraepithelial neoplasia, a precancerous stage in which abnormal cell growth occurs on surface lining of the cervix, the opening between vagina and uterus.

Statistics:

The global cervical dysplasia market is estimated to account for US$ 784.8 Mn in terms of value by the end of 2027.

Global Cervical Dysplasia Market: Drivers

High prevalence of cervical cancer is expected to propel growth of the global cervical dysplasia market over the forecast period. For instance, according to the World Health Organization, cervical cancer is the fourth most frequent cancer in women with an estimated 570,000 new cases in 2018 representing 6.6% of all female cancers.

Moreover, increasing number of smokers is also expected to propel growth of the global cervical dysplasia market. For instance, according to the World Health Organization, 1.337 billion people smoked tobacco worldwide in 2018.

Statistics:

North America held dominant position in the global cervical dysplasia market in 2019, accounting for 54.5% share in terms of value, followed by Europe and Asia Pacific, respectively.

Figure 1: Global Cervical Dysplasia Market Share (%) Value, By Region, 2019

Global Cervical Dysplasia Market: Restraints

HPV vaccination recommendations are expected to hinder growth of the global cervical dysplasia market. Government organizations in the developed countries are taking initiation and recommending HPV vaccination to reduce the prevalence rate of cervical cancer. For instance, in the U.S., the Centers for Disease Control and Prevention (CDC) recommends HPV vaccine for preteen girls and boys at age 11 or 12. This in turn is expected to hamper growth of the global cervical dysplasia market.

Moreover, changes in government regulations is expected to hinder growth of the global cervical dysplasia market. Currently, to diagnose cervical cancer, various type tests such as Pap smear test, HPV test, and colposcopy are available in the market. Among all, HPV test and colposcopy are the prominent tests to confirm cervical dysplasia. Over the last few decades, physicians have been using Pap smear test for detecting the abnormalities in the cervix. However, doctors go for further tests such as HPV test to confirm cervical cancer due to false negatives results of Pap smear test. Hence, governments in the developed countries are changing the primary test for cervical cancer diagnosis.

Cervical Dysplasia Market Report Coverage Report Coverage Details Base Year: 2019 Market Size in 2019: US$ 447.7 Mn Historical Data for: 2016 to 2019 Forecast Period: 2020 to 2027 Forecast Period 2020 to 2027 CAGR: 7.3% 2027 Value Projection: US$ 784.8 Mn Geographies covered: North America: U.S., Canada

U.S., Canada Latin America: Brazil, Argentina, Mexico, Rest of Latin America

Brazil, Argentina, Mexico, Rest of Latin America Europe: Germany, U.K., France, Spain, Italy, Russia, Rest of Europe

Germany, U.K., France, Spain, Italy, Russia, Rest of Europe Asia Pacific: China, Japan, India, Australia, South Korea, ASEAN, Rest of Asia Pacific

China, Japan, India, Australia, South Korea, ASEAN, Rest of Asia Pacific Middle East: GCC Countries, Israel, Rest of Middle East

GCC Countries, Israel, Rest of Middle East Africa: North Africa, Central Africa, South Africa Segments covered: By Product Type: Diagnostic Test, Diagnostic Devices.

Diagnostic Test, Diagnostic Devices. By End User: Hospitals, Diagnostic Centers, Private Gynecologists’ Offices, Research & Academic institutes, Ambulatory Surgical Centers. Companies covered: F. Hoffmann La-Roche Ltd., QIAGEN N.V., Becton, Dickinson and Company, OncoHealth Corporation, Quest Diagnostics, Inc., Hologic, Inc., Abbott Laboratories, ASKA Pharmaceutical Co., Ltd., Asieris Pharmaceuticals, BetterLife Pharma Inc., and KinoPharma, Inc. Growth Drivers: Increasing prevalence of cervical cancer Restraints & Challenges: Stringent regulatory scenario

Global Cervical Dysplasia Market: Opportunities

Strengthening distribution network is expected to offer lucrative growth opportunities for players in the global cervical dysplasia market. Developing economies such as China, India, Brazil, and Singapore hold immense potential for cervical dysplasia market. MEA and Asia Pacific regions are characterized by poorly developed supply-side infrastructure such as inadequate number of laboratories and specialized diagnostic centers. Hence, such intrinsic characteristics provide a strong opportunity for Asia Pacific to strengthen distribution networks with the help of companies developing and supplying cervical dysplasia diagnostic testing products.

Moreover, initiatives of various organizations to eliminate cervical cancer are also expected to aid in growth of the global cervical dysplasia market. For instance, in 2018, the World Health Organization launched an ambitious global strategy to eliminate cervical cancer as a public health problem.

Statistics:

The global cervical dysplasia market was valued at US$ 447.7 Mn in 2019 and is forecast to reach a value of US$ 784.8 Mn by 2027 at a CAGR of 7.3% between 2020 and 2027.

Figure 2: Global Cervical Dysplasia Market Value (US$ Mn), 2016 – 2027

Market Trends/Key Takeaways

R&D in cervical dysplasia is expected to propel growth of the global cervical dysplasia market over the forecast period. For instance, in August 2020, researchers from Johns Hopkins University School of Medicine reported that women who received the HPV vaccine after surgical excision for high-grade cervical dysplasia had lower risk for recurrence than women who received placebo or surgery alone.

Major players in the global cervical dysplasia market are focused on adopting various strategies to enhance their market share. For instance, in July 2020, BetterLife Pharma Inc. indicated the finalization of its rebranding exercise for its wholly owned subsidiary, BLife Therapeutics, which has been publicly formalized through the launching of its new website.

Adoption of AI for predictive cancer is expected to propel growth of the global cervical dysplasia market over the forecast period. For instance, in September 2020, Google Cloud received a contract to supply Veterans Affairs hospitals and Defense Health Agency treatment facilities with AI for predictive cancer and disease diagnosis.

Moreover, development of advanced diagnostic tools is also expected to aid in growth of the global cervical dysplasia market. For instance, in June 2020, researchers from the Institute of Advanced Study in Science and Technology, India, reported development of a robust fully automated software-based solution using Pap smear images to detect abnormal growth or development of tissues in the cervix — the lower part of the uterus that connects to the vagina.

Regulations

Most cancer diagnostic tests are regulated through the in vitro diagnostics (IVD) regulations. Most recently, companion diagnostics used for selecting best therapy for a patient are also being overlooked by these regulations.

The manufacturers of cancer diagnostics can develop their tests and gain access to the U.S. market in three ways: as an analyte specific reagent (ASR), a laboratory-developed test (LDT), or an in vitro diagnostic (IVD). In the U.S., the agencies that regulate cancer diagnostics include the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).

The FDA regulates the sale and distribution of cancer diagnostics. It also regulates the safety and effectiveness of the test.

The CMS regulates the quality of clinical laboratories and the clinical testing process through the Clinical Laboratory Improvement Amendments of 1988

Major players operating in the global cervical dysplasia market include, F. Hoffmann La-Roche Ltd., QIAGEN N.V., Becton, Dickinson and Company, OncoHealth Corporation, Quest Diagnostics, Inc., Hologic, Inc., Abbott Laboratories, ASKA Pharmaceutical Co., Ltd., Asieris Pharmaceuticals, BetterLife Pharma Inc., and KinoPharma, Inc.

Global Cervical Dysplasia Market: Key Developments

Major players in the global cervical dysplasia market are focused on adopting collaboration and partnership strategies to expand their product portfolio. For instance, in January 2020, ASKA Pharmaceutical Co., Ltd. and KinoPharma, Inc. entered into an option agreement for an exclusive license for the development and commercialization of a candidate drug for cervical dysplasia under preclinical development by KinoPharma.