The global HPV associated disorders market size to be valued at USD 23.2 billion by 2026 and is expected to grow at a compound annual growth rate (CAGR) of 4.5% during the forecast period. The growing prevalence of HPV-related diseases and increasing penetration of treatment options are expected to drive the market. There are more than 100 strains of HPV, out of which 13 are high risk or cancerous. The degree of risk of each HPV strain is determined by the activated gene-E6 or E7. HPV causes a wide array of diseases, including Cervical Intraepithelial Neoplasia (CIN), cervical cancer, Anal Intraepithelial Neoplasia (AIN), anal cancer, vulvar cancer, oropharyngeal cancer, and genital warts.
Proactive government initiatives and increased funding for cancer research are expected to aid in significant growth in this market. For instance, the 2010 Affordable Care act provides the human papillomavirus vaccine, HPV testing, and Pap testing for most of the covered patients. Although the Healthy People 2020 goal in the U.S. sets a target of 80% vaccination coverage against HPV, a 2016 national survey estimated that only 50% of girls have completed all doses.
Lack of awareness about diagnosis & treatment of such diseases and high-cost of treatment are some factors impeding growth. There is a high unmet need for targeted drugs with improved clinical profile at reduced costs and convenient administration schedule. However, growing R&D expenditure on oncologic diseases offers a promising future for the market in the foreseeable future.
Most HPV associated disorders, especially cervical cancer, develop over a period of 15 to 20 years in women with normal immunity, giving them a significant window for prevention or treatment to limit disease progression. However, in women with low immunity or compromised immune system, disease manifestation generally takes only 5 to 10 years. Precancerous changes in women generally start between 20 and30 years of age, although the average age of diagnosis of most HPV-associated disorders in women is 50 years.
The market for human papillomavirus disorder is anticipated to be driven by an increase in the number of individuals infected with the virus, as well as growing familiarity with the disorder and the availability of new medicines for its treatment.
The global market is also anticipated to benefit from government initiatives and expanded financing for cancer research. The increased expenditure on R&D connected with oncologic disorders, on the other hand, presents significant potential growth for the market.
Furthermore, continuous innovation in healthcare increased consumer awareness and investments in medical infrastructure. Emerging and less developed countries are likely to generate several opportunities that will have an influence on market growth during the forecast period.
However, the absence of public awareness and understanding about the accessibility, usage of vaccines, and HPV, along with rising concerns about the side effects of therapies for a longer period and high cost of treatment alternatives are anticipated to act as significant restraining factors.
Cervical cancer remained the forerunner among all indications, capturing more than 40% share in 2018. The segment growth is driven by strong commercial performances of Avastin and Keytruda. Avastin’s near-term patent expiry and consequent penetration of biosimilars might alter the therapeutic landscape. Nevertheless, cervical cancer is projected to prevail as the leading segment over the forecast period.
CIN is positioned to demonstrate the fastest growth rate over the forecast period. CIN is a precancerous condition, which may progress into cervical cancer in case of untimely or lack of proper diagnosis & treatment. The segment’s high growth rate is fueled by a high disease prevalence due to growing cases of unprotected sex, people having multiple sex partners, and leading an unhealthy lifestyle.
The therapeutic focus has lately shifted towards taking preventive measures, thus driving the vaccine market for human papillomavirus. Currently, there are two commercial vaccines against HPV: Cervarix and Gardasil. In addition, an improvised, nonavalent version of Gardasil, Gardasil 9, was approved by the FDA in 2015. This label expansion gave Gardasil (quadrivalent and nonavalent) a distinct clinical advantage over Cervarix (bivalent).
The emergence of biologics and biosimilars has brought about a positive change in treatment regimens by increasing focus on targeted therapies. Targeted therapies are designed for identifying and counteracting specific disease cells. Avastin’s label expansion in 2014 for cervical cancer marked the introduction of biologics and targeted therapies for HPV associated disorders. Avastin had the monopoly of being the only approved biologic for cervical cancer, until Keytruda’s label expansion in 2018. These drugs have paved the way for more targeted therapies with improved safety and efficacy profiles.
Hospital pharmacies captured the largest share among distribution channels in 2018. Hospital pharmacies preserve the stock of products related to HPV associated disorders, mainly for cervical & anal cancer, for outpatients and inpatients. The segment will be driven by growing consumer awareness and increased investments in healthcare infrastructure across developing and underdeveloped economies.
Online pharmacies is the fast-growing segment due to its user-friendly interfaces and convenience in terms of access, prices, and delivery. Moreover, they have certain discounts on purchase of a certain amount or offer bundle pricing for cancer products. The segment will be driven by the increasing penetration of e-commerce.
North America accounted for more than 70% share in 2018, owing to strong commercial sales of biologics in the U.S. Other factors contributing to the market growth include proactive government initiatives, an increase in healthcare expenditure, and local presence of key manufacturers.
Asia Pacific is projected to observe the fastest growth throughout the forecast period. Swift economic development, improvements in healthcare infrastructure, increase in disposable income, and rise in consumer awareness are likely factors that contribute to regional growth. Emerging economies of China, India, South Korea, and others are expected to observe strong growth in the coming years.
Some key players in the HPV associated disorders market are Merck & Co., Inc.; GlaxoSmithKline plc; F. Hoffmann-La Roche Ltd; Pfizer, Inc.; Allergan plc; AstraZeneca plc; Biocon Ltd.; and Eli Lilly and Company. Merck & Co. led the competition and is expected to maintain its share, which is supported by the strong commercial performance of Gardasil and Keytruda. In addition, Mvasi (Amgen/Allergan) and Bevacirel (Reliance/Lupin) have marked the emergence of biosimilar in this market.
In May 2022, GSK plc agreed to buy Affinivax, Inc., a diagnostic biopharmaceutical firm established in Cambridge, Massachusetts, for $2.1 billion in cash and potentially $1.2 billion in possible growth milestones. Affinivax is leading the way in the creation of a next-generation pneumococcal vaccine
In September 2021, Eli Lilly and UNICEF have established a new partnership to help 10 million children and adolescents with severe non-communicable diseases (NCDs) improve their medical outcomes by 2025. Lilly has pledged $14.4 million to UNICEF's existing work in some countries to address NCD risk factors
Revenue forecast in 2026
USD 23.2 billion
CAGR of 4.5% from 2019 to 2026
Base year for estimation
2014 - 2017
2019 - 2026
Revenue in USD million/billion and CAGR from 2019 to 2026
Revenue forecast, company ranking, competitive landscape, growth factors, and trends
Indication, therapy, distribution channel, region
North America, Europe, Asia Pacific, Latin America, MEA
U.S., Canada, U.K., Germany, France, Italy, Spain, Mexico, Brazil, Argentina, Japan, China, India, South Korea, Australia, South Africa, UAE, Saudi Arabia
Key companies profiled
Merck & Co., Inc.; GlaxoSmithKline plc; F. Hoffmann-La Roche Ltd; Pfizer, Inc.; Allergan plc; AstraZeneca plc; Biocon Ltd.; Eli Lilly and Company. Merck & Co.
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This report forecasts revenue growth at global, regional, & country levels and provides an analysis on the latest industry trends in each of the sub-segments from 2014 to 2026. For the purpose of this study, Grand View Research has segmented the global HPV associated disorders market report on the basis of indication, therapy, distribution channel, and region:
Indication Outlook (Revenue, USD Million, 2014 - 2026)
Therapy Outlook (Revenue, USD Million, 2014 - 2026)
Distribution Channel Outlook (Revenue, USD Million, 2014 - 2026)
Regional Outlook (Revenue, USD Million, 2014 - 2026)
Middle East & Africa
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