miércoles, 26 de octubre de 2016

Visto en CPhI 2016 Barcelona (II): Genéricos, oportunidad de crecimiento.



Generic Medicines, The Opportunity For Growth
Alan Sheppard, IMS Health


For several years now the generic medicines market place has grown at a faster rate than the total pharmaceutical market. This growth was driven in recent history by what we all know as the ‘patent cliff’, whereby many blockbuster molecules lost protection, generating a huge opportunity for the generic medicine industry. 
This peaked in 2012 and since then there have been fewer major patent expiries with several of them being respiratory products associated with a device and of course the loss of exclusivity for biological molecules which has driven the biosimilar market. This has meant that companies required a much broader number of development candidates in order to push forward with the refreshing of product portfolios and maintenance of revenue growth. For some this has meant partnering with CROs and CMOs to meet the breadth and complexity required for the development of the new product pipeline. Procurement of external APIs rather than vertically integrated programmes has added to the challenge, at a time when cost controls are of paramount importance. 

Despite this the generic medicines industry has adapted its capabilities across formulation and innovative skills in delivery technology to open up new avenues of opportunities. At the same time, we have seen the introduction of several new molecules from R&D which has rejuvenated the pipeline of many major pharmaceutical companies; the return of the blockbusters as it has been said. Thus, the future development programmes for the generic industry look positive with significant opportunities across a wide range of therapies. Specialisation and technology will be required in certain areas in order to successfully deliver generic alternatives in the fields of oncology and hepatitis, but to date this has not presented an insurmountable barrier for the industry. 

For those companies where the focus has been on small chemical molecules the pharmerging markets continue to offer growth opportunities. In these markets, it is the legacy products for the treatment of infection, pain, cardiovascular disease and a host of other chronic primary care indications that are the foundation of a generic portfolio. 
This is in contrast to the developed markets where the focus is on speciality areas such as oncology, autoimmune disease and most recently hepatitis therapies. In these markets, the legacy products are under increasing competition surrounding pricing and new clinical alternatives. 

For the pharmerging markets affordability and access to medicines are key influencers and with the expansion of the availability of clinical support and insurance schemes we have seen new market opportunities open up for these older medicines. 

The future forecasts reflect a continuing trend as shown in the table below.

Legacy generic medicines continue to offer growth opportunities in pharmerging markets 

Spendieng by therapy area 2019




From the table it can be seen that in the developed market forecasts there is little or no growth in the therapy areas of pain, respiratory, anticoagulants and mental health, whereas oncology, diabetes and autoimmune therapies show a continued focus and expenditure on specialty medicines. It should be noted that the viral hepatitis market has sprung from a low base to a major contributor in a very short space of time and is expected to continue to grow. 
On a separate note, the importance of anti-diabetic therapy is relevant to all markets and the availability of generic medicines across the spectrum of alternative therapies will play a vital role in the cost effective management of this chronic indication.





The highest volume consumption is in the Asia/Australasia region, but this is also where the lowest revenue per unit is achieved.


Conclusion 

In conclusion, the growth opportunities for generic medicines remain strong and positive. The need for controlling healthcare costs remains a challenge for healthcare providers around the world. The availability of cost effective, safe generic alternatives offers a tool that can be used to balance access to and affordability of many of the major therapies required to maintain a healthy population of patients across multiple disease areas.

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