The global Gastroesophageal Reflux Disease (GERD) therapeutics market size was valued at USD 5.66 billion in 2016 and by is estimated to be USD 4.34 billion by 2025, it is anticipated to observe a decrease in its revenue at a negative CAGR of -2.9%. Expiration of patented blockbuster drugs, which are indicated for the management of disorders of acid reflux is major restraining factors for this market.
With strong clinical pipelines and patent litigations, the market continues to experience significant changes. Proton pump inhibitors (PPI) and antagonists of histamine H2 receptor have the importance in current scenario of the market.
Upon loss of patent protection of formerly leading branded drugs, generic molecules with low-price can ingest the sales of the branded ones up to 90%. Rising number of companies being exposed to price scrutiny associated with shift in the focus of government on the promotion of consumer convenience will stimulate further reduction of drug prices. Although market turnover is affected by the expiration of major patents and the demand of drugs used to reduce acid, due to the increasing prevalence of heartburn, is anticipated to increase in the upcoming years.
The devices of GERD serves as a substitute for management of heartburn, because of low rate of success and failure in clinical trials. Hence, very limited acceptance of devices of GERD management contribute for the rising demand of drugs having acid neutralizing property, as the major therapy approach.
Nevertheless, the advent of devices which are minimally invasive to address anatomical defects are gaining popularity coupled with supportive evidence from clinical data for performing various procedures including trans oral fundoplication, which helps in preventing reflux of non-acid and acid contents. The adoption of these devices have been further reinforced in the U.S. in 2016 with the advent of a CPT code (43210) which helps in facilitating reimbursement process.
Drug Type Insights
In 2016, market was dominated by the antacids segment and is anticipated to keep its top position over the forecast period. Most preferred first-line therapy for infrequent and mild symptoms is antacids, as the therapy neutralize the secretion of gastric acid immediately. Convenient OTC (over-the-counter) accessibility various forms such as syrups, powders and tablets is accountable for the extreme adoption. Moreover, the AHFS (American Hospital Formulary services), amongst other countries, enlisted over 120 preparations too advocate.
In 2016, the second largest segment was found to be PPIs as it is the most common medication prescription type for the diseases such as heartburn. Generics inflow leading to the loss of exclusiveness of popular drugs, including Prilosec and Nexium, is estimated to negatively affect the sales of branded versions. A further decrease is appearing more with the expected expiration of other patented drugs, such as Dexilant.
In 2016, the largest region was found to be North America in terms of share for GERD market. Every year, GERD symptoms are experienced by more than 80 million people in the U.S., of which, approximately 25 million patients suffer from acid reflux and heartburn daily and approximately 60 million patients monthly.
Moreover, outpatient clinic visits for GERD disorder in the U.S. has been increased in the past few years because of the more prone geriatric population to develop acid reflux and heartburn. On the contrary, the Asia Pacific is estimated to witness the fastest growth rate. The increasing geriatric population and dietary and lifestyle risk factors such as diet with high fat and obesity, is anticipated to drive the growth. In developing countries, the inclination towards self-medication is quickly increasing because of the affordability and availability of OTC antacids as in China and India.
Competitive market, which is generics-driven is creating a pressure on the prices of drug with decreased retail sales, which will stimulate stationary growth in future. Companies producing them range from high to medium on the basis of competitive rivalry. Eisai Co., Ltd.; AstraZeneca PLC; GlaxoSmithKline PLC; Johnson & Johnson and Takeda Pharmaceutical Co., Ltd.; are some of the top key players. In addition, Daewoong Pharmaceutical Co., Ltd.; SRS Pharmaceuticals Pvt. Ltd.; SFJ Pharmaceuticals Group and Ironwood Pharmaceuticals, Inc. are some emerging companies.
Among others, RaQualia Pharma, Inc. and Ironwood Pharmaceuticals, Inc. are focusing more on development of new generic molecules, which involves novel and existing drug mechanisms as a part of the strategy to enter into the competition. Many generic players are also trying to focus on these spaces in an attempt to capture a larger share by the new version to replace the patent expired drugs.
GERD Therapeutics Drug Type Outlook (Revenue, USD Million, 2014 - 2025)
• H2 Receptor Blockers
• Proton Pump Inhibitors (PPIs)
• Pro-kinetic agents
GERD Therapeutics Regional Outlook (Revenue, USD Million, 2014 - 2025)
• North America
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)
• South Africa
Research Support Specialist, USA