Despite increased penetration of biologics and small-molecules delivered via parenterally or in other routes, solid dosage products remain an important part of the overall drug market and among new molecular entities. So what has been the penetration of solid dosage products among new molecular entities and how does this compare to recent levels?DCAT Value Chain Insights (VCI) examines the key trends.

In looking at recent new drug approvals, in 2014, 46% of the new molecular entities (NMEs) approved by the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) were solid dosage products (tablets or capsules). So how is this trending with recent years? 

Solid dosage products in the pharma market 
In looking at recent trends, solid dosage products accounted for an important and fairly constant to slightly declining share of the industry’s top-selling products. Of the top 20 selling drugs on a global basis in 2014, six products or 30% were solid dosage products, down from eight products in 2013. In 2014, the global pharmaceutical market was valued at $936.5 billion (based on December 2014 estimates including prescription and certain over-the-counter products at manufacturers’ prices), according to IMS Health. Of this total, the six products that were solid dosage products (including products that may have been sold in both solid dosage and other dosage forms) accounted for $45.8 billion. This six products were Gilead Sciences’ Solvaldi (sofosbuvir), Bristol-Myers Squibb’s Abilify (aripiprazole); AstraZeneca’s Nexium (esomeprazole) and Crestor (rosovastatin); Pfizer’s Lyrica (pregabalin) and Merck & Co.’s Januvia (sitagliptin); 

Of the top 20 selling prescription drugs on a global basis in 2013, eight products, or 40%, were solid dosage products. Based on IMS estimates, the the global market accounted for$874.6 billion in sales (based on December 2013 estimates, calculated using US dollars with quarterly exchange rates and including direct and indirect pharmaceutical channels: wholesalers and manufacturers). Of this total, the eight products with solid dosage forms (which also included actives produced in solid dosage forms and other approved dosage forms) accounted for $48.04 billion (see Table I). These products were: AstraZeneca’s Nexium (esomeprazole) and Crestor (rosovastatiny); Bristol-Myers Squibb’s Abilify (aripiprazole); Eli Lilly’s Cymbalta (duloxetine); Gilead Sciences’ Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate); Merck & Co.’s Januvia (sitagliptin); Novartis’ Gleevec/Glivec (imatinib); and Pfizer’s Lyrica (pregabalin).

In looking at new drug approvals in 2014 and 2013, 46% of the new molecular entities (NMEs) approved CDER in 2014 were solid dosage products, and 63% of the NMEs approved in 2013 were solid dosage products (see Tables II and III at end of article). In 2014, 19 of the 41 NMEs were solid dosage products. Ten were approved as tablets and nine as capsules. In 2013, 17 of the 27 NMEs approved were solid dosage products. Twelve products were approved as tablets and five as capsules (see Tables II and III at end of article).

Among the large pharmaceutical companies, NME approvals in 2014 with solid dosage forms included: AbbVie’s Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat chronic hepatitis C virus infection; AstraZeneca’s Farxiga (dapaglifozin) for treating Type 2 diabetes, Movantik (naloxegel), a drug to treat opioid-induced constipation in adults with chronic non-cancer pain, and Lynparza (olaparib) for treating advanced ovarian cancer; Boehringer Ingelheim’s Ofev (nintedanib) for treating idiopathic pulmonary fibrosis and Jardiance (empagliflozin) for treating Type 2 diabetes, a drug which is part of Boehringer Ingelheim’s diabetes alliance with Eli Lilly; Gilead Sciences’ Harvoni (ledipasvir and sofosbuvir) for treating chronic hepatitis C virus genotype 1 infection and Zydelig (idelalisib) for treating three types of blood cancer; Merck & Co.’s Belsomra (suvorexant) for treating insomnia and Zontivity (vorapaxar), an antiplatelet; Novarti’s Zykadia (ceritinib), for treating a certain type of metastatic non-small cell lung cancer; Roche, through its acquisition of InterMune earlier in 2014, for Esbriet (pirfenidone) for treating idiopathic pulmonary fibrosis; and Sanofi’s Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type I form of Gaucher disease, a rare genetic disorder.

A drug’s product form is an important consideration in the drug’s marketability and commercialization, a point that was underscored by one of the top-selling drugs in 2014: Gilead Sciences’ Sovaldi (sofosbuvir), the company’s oral drug to treat chronic hepatitis C virus (HCV) infection. Sovaldi, which was approved by the FDA in December 2013 and in the European Union in January 2014, was the first drug that demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon, which is administered by injection. Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate, and that mechanism of action was considered an important advancement as well as the ability to administer the drug orally. Sovaldi was Gilead’s top-selling drug in 2014 and was one of the industry’s top-selling drugs with 2014 sales of $10.28 billion, making it one of the most successful first-year launches for a NME.