Industry Themes

Innovative Therapies for treating diseases are being sought after with fresh vigor as new targets, approaches and biology is discovered. One field which is poised to bring a paradigm change in the way diseases are treated in the next decades is the Stem cell therapy/Regenerative Medicine space. The number of companies and products in the clinic have reached a critical mass warranting a close watch for those interested in keeping pace with the development of new medicines. The Regenerative medicine…

Invokana clean label thrills many on the street rising hopes that Invokana sales could cross $2.5b+ at peak. However we think that CV issues (dose dependent increase in LDL, CV events observed in first 30 days in CANVAS study), associated genital/UTI infections, compromised efficacy in renally impaired patients and long term safety study requirements by FDA (Table 1), should be seen in conjunction with the ‘clean label’. These issues will limit the initial uptake of Invokana to a small segment…

There are more than 1400 sustained or controlled release drugs have been approved all over the world. Revenues within the global generics market reached an estimated value of $265b in 2012, showing a growth of 9.3% throughout the year. The contribution of generics is approximately 20% of the overall international pharmaceutical market. The utilization of generic in terms of volume is higher in the US and lower in Japan, 89% and 24% respectively. The oral drug delivery market remains the…

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,…