Oral contraceptives (OCs), known commonly as “the pill,” are prescription medications that prevent pregnancy. The most common brands of OCs contain hormone combinations of estrogen, progestin, and/or progesterone. These products have been used for years and were first launched on the U.S. prescription market in the 1960s. While OCs resulted in a new era of pregnancy protection for women, they were not without potential side effects to be considered, including risk of blood clots, heart attack, stroke, high blood pressure, and breast cancer (particularly for women who smoke). To date, OCs have proven to be one of the most popular forms of birth control, due to ease of use, efficacy, and their good safety profile for most women. Continue reading
The U.S. OTC market overall experienced 2.0% growth in 2017 with upper respiratory and topical products classes posting higher than average gains, according to Kline’s Nonprescription Drugs USA 2017 annual market study. “A strong cold and flu season in both Q1 and Q4 of 2017 drove the OTC cold and sinus market up 4.5% from 2016 levels,” says Laura Mahecha, Industry Manager for Kline’s Healthcare Practice. The topical products class posted 3.6% growth in 2017, driven by strong gains for OTC topical analgesics.Continue reading
Companies are being more selective in the Rx-to-OTC switches they pursue, according to new research just published by Kline & Company in the 13th study in its venerable syndicated series, Rx-to-OTC Switch Forecasts USA: Next Frontier.
Safety is paramount, and the sophistication of clinical studies required to gain approval has increased the cost burden and risk to switch sponsors. Most future switches will depend on a combination of market-driven forces and safety, as determined by regulators. Continue reading
Recently, the U.S. OTC market has been evolving, boosted by more prescription medications moving along the Rx-to-OTC continuum, as well as a number of changes in the market. Laura Mahecha, Industry Manager of Kline’s Healthcare Practice, reveals more about these changes in a recent interview about the trends and challenges affecting the U.S. OTC market.Continue reading
According to Kline’s Nonprescription Drugs USA study, the U.S. OTC market grew over 3.0% during 2013 to reach $23.5 billion at the manufacturers’ level. Driven by strong sales gains in analgesics, upper respiratory, nutritional, and topical products, the market appears to be showing signs of recovery. This is partly due to the long-awaited rejuvenation of several brands that have posted steep declines in the recent past as a result of supply disruptions and recalls. Brands such as Novartis’ Excedrin and Johnson & Johnson’s Tylenol and Motrin IB have experienced strong gains in 2013 thereby helping the analgesics category to post very strong gains this past year while Pfizer’s Advil, Bayer’s Aleve, and private-label analgesics also posted gains in 2013. Continue reading
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
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
Rx-to-OTC switch brands continue to be major game changers within the OTC market, whether promoting strong gains or causing steep declines. Aided by the launch of Rx-to-OTC switch brand Allegra (Sanofi-Aventis) and strong growth of private labels, allergy relief products grew 16.3% in 2011 to become the fastest growing category on the U.S. OTC drug market, according to the Nonprescription Drugs USA 2011 report by international consulting and research firm Kline & Company. The U.S. OTC drug market posted a gain of 2.4% reaching $21.4 billion in 2011 at the manufacturers’ level.
From 2010 to 2011, the U.S. OTC drug market posted a gain of 2.4% from $20.9 billion in 2010 to $21.4 billion in 2011 at the manufacturers’ level. The fastest growing categories include allergy relief products, which grew 16.3% in 2011 aided by the market launch of Rx-to-OTC switch brand Allegra (Sanofi-Aventis) and the strong growth of private-label allergy relief products. Past Rx-to-OTC switch brands continue to perform well with Rogaine (Johnson & Johnson) and Plan B (Teva Pharmaceutical), both posting strong gains in the hair regrowth products and contraceptives markets, respectively.