Switch Sponsors Weigh Business Opportunities Against Regulatory Risk

In 2020, the U.S. market saw four new brands previously sold as prescription drugs enter the nonprescription market: 

  • Pataday allergy eye drops 
  • Voltaren Arthritis Pain topical NSAID 
  • Advil Dual Action ibuprofen and acetaminophen pain reliever 
  • Sklice lice treatment 

The new switch approvals have signaled a willingness on the part of regulators to be less conservative when it comes to OTC access to these medicines.  Nasal steroid switches, like Flonase and Rhinocort, along with the topical NSAID Voltaren Arthritis Pain and Sklice lice shampoo, are all in categories where switch activity was curtailed in the not-so-distant past due to concerns over systemic absorption of topically applied medicines. For in-depth profiles of recently approved FDA switches, subscribe to the all-new KlinePULSE Consumer Healthcare Industry Trends service. Continue reading

Healthcare Best of 2020

Evolving Consumer Healthcare Market Research in 2020

As 2020 concludes, we are reflecting on the priority of health and safety, and how drastically different our everyday lives are compared to just eight months ago.  We have seen major shifts toward the importance of immunity, with less emphasis on treatment of symptoms and more focus on prevention.  We have a new perspective on the evolving role consumer healthcare products play in keeping us healthy.  To help you put these major trends into perspective, below is a summary of our market studies and whitepapers that were published throughout the year. Continue reading

Nonprescription Drugs USA

Webinar Next Week: Key Issues Trending in the OTC Market

The U.S. OTC industry witnesses another year of growth with categories like topical analgesics, internal analgesics, herbal products, nasal allergy sprays, and contraceptive products all experiencing stronger than average sales growth.

What’s behind this growth? What are the latest developments? What is the impact of recently approved switches? We will reveal it all during this live webinar drawing upon highlights from our preeminent Nonprescription Drugs USA, Digestive Health, Immunity, and Probiotics: U.S. Market Analysis and Opportunities, and Rx-to-OTC Switch Forecasts USA: Next Frontier studies.Continue reading

Allergy Relief Products

Flonase Allergy Relief Drives the OTC Allergy Market

The U.S. OTC allergy relief market has seen a period of rapid growth over the past five years, and 2015 was no exception. GlaxoSmithKline’s Rx-to-OTC switch brand Flonase Allergy Relief entered the market in February 2015 and made a huge impact on the OTC market by adding previous prescription users to the category. The OTC allergy market has seen a steady influx of Rx-to-OTC switch brands, which has resulted in rather high growth for this market over a fairly sustained period of time. In fact, the allergy category has grown by a compound annual growth of over 11% from 2010-2015, finds the latest edition of our Nonprescription Drugs USA report. This healthy increase is well above the typical growth for the overall OTC market, which grows about 2% to 3% per year on average. Continue reading

Nonprescription Drugs USA

Top Three Drivers of the U.S. OTC Market

Estimated at over $24 billion at the manufacturers’ level in 2014, the U.S. nonprescription drugs market shows interesting opportunities for its players, posting growth in five out of the seven product classes tracked in Kline’s annual Nonprescription Drugs USA report. Let’s take a look at the top three drivers behind this market’s success:

  1. Rx-to-OTC switches – the big game changer

Rx-to-OTC switches represent the core driver of market growth as they involve large, popular brands, bringing former prescription users to the OTC market. According to our recently released Rx-to-OTC Switch Pipelines USA: Competitive Assessment, the increasingly favorable regulatory environment facilitated the approval of four new and important switches, in categories that five years ago would have been considered as challenging.Continue reading

Rx-to-OTC Switch Pipelines in the United States

Rx-to-OTC Switches – Game Changers for the U.S. OTC Drugs Market through 2019

Growth of the U.S. nonprescription market is primarily driven by Rx-to-OTC switches as they bring former prescription users to the OTC market. Due to an increasingly favorable regulatory environment, Kline forecasts robust Rx-to-OTC switch activity over the next five years with several all new OTC categories emerging along with many new brands entering the market into existing categories.

If all switches occur over the next five years (even those with low to moderate likelihood), the market is forecast to increase at a compound annual growth rate (CAGR) of 5% by 2019, according to the recently published report covering Rx-to-OTC Switch Pipelines in the United States. By contrast, if the only switches that come to market are those that are predicted to have moderate to high likelihood of approval and launch, the overall OTC market will expand by a CAGR of 3.6% over the next five years.Continue reading

Rx-to-OTC Switch Environment Heats Up

Rx-to-OTC Switch Environment Heats Up

With the publication of FDA’s NSURE (Nonprescription Safe Use Regulatory Extension) in February 2012, the pharmaceutical industry has been buzzing with potential for new switches, using unique approaches and technology to support the approval of new switches and safe use of consumer OTC medications.

“There is excitement and new Rx-to-OTC switch possibilities being evaluated in the United States like we have not seen in years,” says Laura Mahecha, Industry Manager, Healthcare. “Kline has been analyzing and forecasting switches for decades. Our most recent research, Rx-to-OTC Switch Pipelines USA: Competitive Assessment, has shown that we are at a crossroads where the industry is cautiously optimistic that new switches with real commercial potential will become a reality,” she adds.Continue reading

Rx-to-OTC Switch

Broader Opportunities in Rx-to-OTC Switch

There have been signs recently indicating that the environment is becoming ripe for more Rx-to-OTC switches. Since we last reported on this topic in August 2013, we saw the approval of two additional first-in-class switches in categories that would have been thought of as challenging five years ago. One is the first incontinence medication available for sale without a prescription, Merck’s Oxytrol for Women, and the other is the first nasal allergy steroid, Sanofi’s Nasacort Allergy 24HR.Continue reading

OTC Market Intelligence

50 Years Old and Still Bounding Over the Counter: Kline’s Healthcare Practice Continues to Deliver Unmatched OTC Market Intelligence

With over half a century of market insights on the U.S. consumer healthcare market, Kline & Company expects that new paradigm shifts in regulations, retail, and technology will create new opportunities for medications to move along the Rx-to-OTC continuum and more growth prospects for the U.S. OTC market. Additionally, with the OTC medication market in the United States nearing $23 billion in 2012 alone and with the FDA – through its recent NSURE (Nonprescription Safe Use Regulatory Expansion) initiative – showing encouraging indications that it is becoming more receptive to allowing more Rx-to-OTC switches, the U.S. OTC market is fast returning to pre-recession health.Continue reading