Industry Themes

The launch of Remicade biosimilar in Dec-2014 in the Japan pharma market demonstrated its changing regulatory environment; it is faster than the U.S. in adapting to biosimilar use. After nine years of continuous efforts by the JP government to promote increased use of generics (started in 2006 by launching various benefits for GE use at Pharmacy, hospital level) – now in 2014, Generic penetration of small molecules is changing the trend line and moving towards faster market penetration. While for…

Novel approaches to treat infection is growing as the need is urgent! Misuse/overuse of antibiotics accelerated antimicrobial resistance (AMR) and has resulted in the emergence of “super bugs” which are posing life threatening challenges world wide. Many of the advances in medical treatment like cancer therapy; organ transplants etc. would go waste if the ability to fight infections during the treatment were not available. If that fails, the gains made in life-improving modern medical advantages will be lost creating a…

The increasing rate of chronic diseases has emphasized the need for Prevention over Intervention. These proactive health solutions include nutritional supplements which promise medical or health benefits and fall between the food and pharma chain – ‘Nutraceuticals’. Over the years, the nutraceutical market has experienced robust growth fueled by high consumer demand, product innovation, and low regulatory hurdles. The nutraceutical industry is already facing intense competitive pressure wherein companies are seeking new opportunities or geography expansion in functional food, beverage,…

Innovations have contributed to the availability of a range of new treatments for diseases resulting in improvement in the length and quality of life and reduced disease burden for individuals and society. However, the need for innovative therapies for unmet needs /challenging diseases continues to grow, accelerating the pace of drug development directly or through partnership/ in-licensing. We expect innovation and improved drugs therapies through novel target discovery and technology platforms to continue to flow from the backyards of small…

Indian companies are taking center stage in Complex Generics at US and EU markets. In Bio-similars, Indian companies will have perhaps the largest basket aimed at Emerging Countries in 2014-16 and later for Developed countries. Though few but is the beginning of NCE/mAb development by Indian companies is a sign of Indian Generics moving up in the chain. The uncertainty of clinical and regulatory pathways in the US helps Asian biopharma and biotech companies to be in the forefront of…

2014 will be marked as a transition year for the Japanese Pharma industry - the year is bound to be painful both for innovators and generic companies due to the new regulations. We find these regulations to be 'decisive' in spurring generic penetration significantly, with the main beneficiary being the Japanese government (or society) and not the generic companies. The implications of new price-reversions are going to have many facets and will change conventional business models. We expect many support…

Post Nycomed and Millenium acquisition, the new leadership of non-Japanese CEO/President Mr. Weber will transform Takeda in a truly global Japanese company in the coming years. It is however important to see how he fulfills the Japanese expectation from these acquisitions and fills the gap for Takeda due to the recent failure of its key late stage pipeline candidates (TAK-875, TAK-700 in chemo experienced Prostate Cancer). From its remaining late stage pipeline candidates (Table 2) Vedolizumab, Contrave (Naltoxone + buproprion,…

Dainippon Sumitomo (DSP) is one of those Japanese pharma companies which has changed its orbit by successful US launch of Latuda (Lurasidone, dopamine-2, serotonin-2 and serotonin-7 receptors agonist schizophrenia/bipolar disorder) in the last two years. But DSP’s expectation to generate $650m by FY2017 from its lead compound BBI-608 from mCRC is way unachievable. Pipeline Cancer Stem Cell Inhibitors- from OncoMed/Celgene (OMP-21M18, OMP-52M51) And Bionomics (BNC-101) also need a close watch. On M & A front (Table 11), DSP’s R &…

Strategy Diversification Divested: Productivity measurements, Divestment of non-core assets resulting in healthy Cash position- Will accelerate Next wave of targeted acquisition In recent years' several new therapies have been approved in the area of diabetes (SGLT-2, GLP-1 agonists), Multiple Sclerosis, HCV, melanoma, and breast cancer from major pharmaceutical companies. Many of them are expected to reach multi-billion dollars peak sales in the near-term which is likely to compensate the patent expiry loss in top-line revenue. Novel mechanisms like anti-PD1, anti-PCSK9,…

Positive sentiments for the biotech sector have prevailed in the last two to three years, and we expect this trend to continue for the next year too. Our optimism is based on the continuity in the flow of innovative products from their pipeline, implementation of strategic decisions to improve cost efficiency, strengthen therapeutic leadership, and hedge against generic threats – which all lend stability to the business model of the company. Focus and interest in Orphan diseases remain and Alexion…