Horizon Discovery and LGC get £360,224

Horizon Discovery Group plc, the international life science supplying research tools to organisations engaged in genomics research and the development of personalised medicines, together with LGC, an international life sciences measurement and testing company have been offered a research grant of £360,224 ($608,000 USD) by the UK’s innovation agency, the Technology Strategy Board, of which Horizon will receive more than half of the funding. The grant is awarded under the Technology Strategy Board’s Collaborative Research and Development (CR&D) project ‘Improving Cell and Tissue Analysis for Stratified Medicine’ and will fund a joint project run by the Company’s Horizon Diagnostics division in partnership with LGC.

The project will fund the research and development of a portfolio of novel reference standard materials in order to serve a high need area of clinical diagnostics.  The programme will establish methods and cross platform data sets to standardise existing ‘liquid biopsy’ genetic diagnostic tests, to determine test sensitivity, and to help drive the development of new more sensitive systems as well as training and proficiency testing schemes for pathology laboratories.

Minimally invasive ‘liquid biopsies’ of tumour cells and tumour DNA from the bloodstream can enable earlier primary and secondary diagnosis compared to solid tumour biopsies, as well as detection of metastasis and/or residual disease, and ‘real time’ monitoring of treatment effectiveness that isn’t possible with solid biopsy methods. Standardisation within and between facilities and across geographies will enable the uptake of minimally invasive cancer diagnostics as a routine clinical procedure

India and other emerging markets

Economic Value derived above is based on dynamic assumptions which are likely to change during the course of development. Hence repeating this exercise at regular intervals is a prudent strategy.

Tornado  analysis is a tool used to identify the most impactful or most sensitive assumptions. Number of competitors in the market, probability of success, time to market launch and development costs are the key areas that companies should focus their energy on to maximize drug’s commercial potential.

Managing environmental challenges in India and other emerging markets, While the above process is fairly robust, the real challenge in developing drugs for emerging markets is the understanding of the local environmental and regulatory aspects.

 
Controlled pricing for patented products in India on the basis of procurement prices in UK, Canada, France, Australia, and NZ adjusted for per capita GDP ratio is under discussion by government authorities

Medicines Patents Pool (Gilead for HIV drugs) - voluntary patent licensing to generic companies in exchange for royalties is a new workaround to tackle stricter patent laws in India

Lack of clarity on Orphan status or Breakthrough designation viz-a-viz developed markets continues to be a challenge in designing clinical development strategy for emerging markets

Differential pricing both Inter and Intra country is a viable strategy being pursued for drug pricing in this part of the world. Compulsory Licensing of the patented drugs in countries like India, China, Brazil and Thailand is a known risk impacting the drug pricing.

Clinical trial cost escalations due to compensation issues, audio-visual informed consent and tighter pharmocovigilance cannot be undermined in expense estimations.

Biopharma - India Market

Industry experts are confident that there is no way for US to ignore India now. There is expertise, cost advantage and comprehension about biologics production which has led global pharma majors partner with many companies here, they point out.
For instance, till five years ago most biosimilar developing firms were contracting development of cell lines to USA and UK. Recently, however, this trend has changed with certain Indian firms, such as Reliance Lifesciences, Cipla and Biocon being able to develop cell lines in-house.

 

While the US depends on China and South East Asia for outsourcing, there is a clear sign that despite the Euro crisis, several companies are coming up in the European Union for the production of biosimilars and are looking at India. The European Medicines Agency guidelines are already in place for biosimilars and vaccines for Indian companies to initiate the process.
The demand for biosimilars is likely to increase as Indians are becoming more affluent and healthcare insurance coverage widens. Moreover, considering the cost advantages that India can provide, the country has a great potential for future growth in the biosimilars market.

The high cost of biologics has contributed to the increasing and unsustainable overall health expenses throughout the world. In the US, 43% of the drug budget for Medicare Part B is consumed by 6 biologic drugs. This immense burden has led many countries to develop a regulatory framework which can approve biosimilars to provide entry of low cost alternatives to originator drugs, according to Dr. Reddy’s Biologics Devpt Centre.

Pharma market - Growth

Majority of the Pharma market’s growth is driven by the urban markets,that is, areas that are classified as metros or tier I cities Tier II to tier VI is classified as per urban, while rural is the bottom of the pyramid, which constitutes 67% of India’s population (600,000 villages).

As per IMS Health, per-urban markets account for 38% of total industry sales, being valued at US$3.4 billion, while rural markets account for 17% of total industry sales, being valued at
US$2 billion, in 2010.
 

Over the next ten years, rural markets will grow at a CAGR ranging from a conservative
15% to an aggressive 20%, reaching an expected valuation of between US$8 billion and US$12 billion, depending on the implementation of growth drivers.

The opportunity

Around 742 million people reside in rural areas. There is a significant gap between the number of people residingin villages that require treatment, and quality treatment and medicines reaching these villages. Accessibility of medication in rural areas is very poor, with less than 20% of the population
having access.

This gap represents a huge opportunity for pharmaceutical companies to expand, and we believe that these markets will be the future volume drivers of the industry.