Today’s opportunity for Indian companies in biosimilars is not much different from that of the generics industry in 1984. According to Ministry of Commerce and Industry, India’s pharmaceutical export segment has more than doubled from $ 7.8 billion in 2008 to $ 16.5 billion in 2014. With biologic treatments introduced for diseases such as diabetes, cancer, multiple sclerosis, and rheumatoid arthritis, potentially lucrative biosimilar market could emerge as another growth driver of India’s pharmaceutical sector. India has a strong potential to emerge as a key player in the manufacture and marketing of biosimilars.
There are few Indian pharmaceutical companies substantially investing resources towards expanding their biosimilar portfolios. Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company, is one of the key players in the forefront of the biosimilar segment and has developed Reditux™, the world’s first biosimilar antibody. Biocon Ltd, which received its first approval for insulin glargine in a developed market (Japan) in March this year, is gearing up to submit application for approval in Europe and the US for its four products in FY17.
To increase global reach and market acceptance of their products, Indian companies are setting up manufacturing base overseas. For example, Biocon has reportedly invested $ 200 million on its just commissioned insulin plant in Malaysia. Similarly, Cipla is investing about Rs 600 crore (Rand 1.3 billion) in the new biosimilar manufacturing facility in South Africa, which the company intends to use to serve local as well export markets such as US, Europe and Asia.
Though biosimilars have emerged as important tool to treat cancer and autoimmune diseases, they are only used by about 8 percent of patients worldwide due to the high costs of these drugs. As more companies join the bio-generics race, prices are likely to fall resulting in higher usage. Although India does not have stringent regulations, it has a big potential for biosimilars. Most innovator biotherapeutics are unaffordable to the average patient in India, even though the price in the local market is usually lower than that in Western countries.
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VTE therapeutics & Atrial Fibrillation market was worth USD 4 billion in 2014 and USD 7.86 billion respectively. The VTE therapeutic market is expected to reach USD 5.5 billion by 2018 with a Compound Annual Growth Rate (CAGR) of 8.29% and Atrial Fibrillation market will reach on its peak value USD 13.28 billion by 2018 with compound annual growth rate (CAGR) of 14%, according to DelveInsight Analysis.
Anticoagulants reduce blood clotting in an artery, a vein or the heart. Clots can block the blood flow to heart muscle leading to heart attack. They can also block blood flow to brain, leading to stroke. Anticoagulants are given to prevent blood from clotting or prevent existing clots from getting larger.
Warfarin and Heparin were the only available anticoagulants since decades but now, the choice of anticoagulants is broadened by the approval of new oral anticoagulants bu U.S. Food and Drug Administration. The new oral anticoagulants include Dabigatran, Rivaroxaban, Edoxaban, and Apixaban. These novel oral anticoagulants are expected to replace older anticoagulants with their ease of use and favourable pharmacodynamic profiles.
Dabigatran and Rivaroxaban were the highest selling drugs in 2014 with the revenue generated ~1800 million and ~1700 million respectively. Dabigatran was the first oral direct thrombin inhibitor approved by U.S. FDA and Rivaroxaban was the first oral direct coagulation factor Xa inhibitor approved by U.S. FDA. The patent for Dabigatran is going to expire soon (in 2017) thus making way for generic drug in the market. Edoxaban is the newly approved (January 2015) factor Xa inhibitor for the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and the treatment and recurrence prevention of venous thromboembolism (VTE).
Despite novel anticoagulants are seen as replacements for heparin and warfarin, there are some adverse hemorrhagic events reported. Absence of any approved antidotes for oral anticoagulants limit their use. Though there are 3 antidotes in clinical development which can reverse the effects in case of major bleeding. These antidotes are 1.5 years away from being clinically available.
Since the patient compliance increases with the orally available drugs, the companies are focusing on developing such anticoagulants. The drugs in pipeline are mostly thrombin inhibitors or Factor Xa inhibitors unlike traditionally used warfarin which was Vitamin K reductase inhibitor.
Anticoagulants are prescribed for number of diseases such as Heart attack, stroke, deep venous thromboembolism, pulmonary embolism, Atrial fibrillation, Unstable angina, or for the prevention of Venous thromboembolism (VTE) after major orthopedic surgery. With such a wide usage, one must be familiar with anticoagulants, their pharmacological properties, pharmacodynamics, dosing, monitoring and toxicity.
Written by Rashi Aggarwal, Associate Analyst at DelveInsight
Report: Anticoagulants-Competitive Landscape, Market & Pipeline Analysis, Forecasted Market Size 2015-2018
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