Market Overview

Tapentadol is an analgesic with a dual mode of action as a norepinephrine reuptake inhibitor and an agonist of the mu-opioid receptor. Its analgesic properties come into effect within few minutes of oral administration. Tapentadol is a new drug, being approved by the U.S. Food and Drug Administration (FDA) on the twenty sixth of August 2011, by the Therapeutic Goods Administration (TGA) of Australia on the twenty fourth of December 2010 and by the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK on the fourth of February 2011.

Tapentadol has been recognized as a step three analgesic on the World Health Organization (WHO) pain ladder. Tapentadol is utilized for the treatment of moderate to severe pain for chronic and acute musculoskeletal pain. Tapentadol is available in the U.S. in extended release formulations as Nucynta ER from Janssen Pharmaceuticals. Nucynta contains the (R,R) stereoisomer, which is a weak isomer in terms of opioid activity.

Tapentadol is often used to ease pain which cannot be managed with other types of analgesics. Tapentadol formulation is provided in 100 mg (red/orange), 75 mg (orange) and 50 mg (yellow) tablets to be used once every five hours as needed to control pain. In addition, tapentadol can be used for controlling the pain of diabetic neuropathy when round the clock analgesic is required.

Furthermore, tapentadol can be used to treat chronic depression, although it is not approved for this treatment. However, tapentadol is known to have adverse side effects. Tapentadol may impair cognitive and physical abilities and should not be used when operating heavy machinery, especially during initial treatment. Dizziness, nausea, constipation and central nervous system (CNS) sedation are common side effects of tapentadol. Tapentadol can increase the risk of seizure and should be administered carefully to epileptic patients.

The growth in the analgesic market is expected to increase the consumption of tapentadol. In addition, rising demand for over the counter painkillers in emerging economies of Asia Pacific is expected to boost demand for tapentadol. However, government regulations, availability of substitutes and adverse effects of tapentadol could hamper the growth of the market.

North America is the largest market for tapentadol followed by Europe and Asia Pacific. The U.S is the largest country market in North America followed by Canada. Ageing population represents the key growth driver for the US market. Growth-wise, Asia-Pacific is projected to be the fastest growing market for tapentadol.

China and India are expected to be the largest consumers of tapentadol in Asia Pacific due to growing population and rapid urbanization. Taiwan, Honk Kong, Japan, Republic of Korea, Malaysia and Indonesia are other major consumers of tapentadol in Asia Pacific. Increasing consumer awareness, better treatment and an increase in life expectancy is likely to propel future growth.

The market is dominated by large pharmaceutical companies with established brands. Some of the key players operating in this market are Johnson & Johnson Pharmaceutical Research & Development, L.L.C (U.S.), IPCA Laboratories Ltd (India), Lupin Laboratories Ltd (India), Ranbaxy Laboratories Ltd.(India), Aristo Pharmaceuticals Pvt Ltd (India), Cadila Pharmaceuticals Ltd (India), Tirupati Medicare Ltd (India) and Manus Aktteva Biopharma LLP (India) among others.

Companies are investing in research and development to develop new grades of Tapentadol. In addition, companies are using strategic acquisitions and mergers to remain competitive in market and increasing their presence in emerging economies of Asia Pacific and Latin America.