From The Summit Chair’s Desk

Cheers My Dear Friends,

While 2018 is slowly moving towards is “Good Bye”, come 2019, all of us are anxiously waiting for the general elections and of course the country waits for a “Miracle”. Our industry also wants the rainy days to get over soon and hope the sun shines brightly in 2019.

Let us the see the pharma kaleidoscope last year.

As reported by IBEF, the pharmaceutical sector was valued at US$ 33 billion in 2017. The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over 2015–20 to reach US$ 55 billion. India’s pharmaceutical exports stood at US$ 17.27 billion in 2017-18 and are expected to reach US$ 20 billion by 2020.Indian companies received 304 Abbreviated New Drug Application (ANDA) approvals from the US Food and Drug Administration (USFDA) in 2017. The country accounts for around 30 per cent (by volume) and about 10 per cent (value) in the US$ 70-80 billion US generics market.India’s biotechnology industry comprising bio-pharmaceuticals, bio-services, bio-agriculture, bio-industry and bioinformatics is expected grow at an average growth rate of around 30 per cent a year and reach US$ 100 billion by 2025. Biopharma, comprising vaccines, therapeutics and diagnostics, is the largest sub-sector contributing nearly 62 per cent of the total revenues at Rs 12,600 crore (US$ 1.89 billion).In 2017, Indian pharmaceutical sector witnessed 46 merger & acquisition (M&A) deals worth US$ 1.47 billion.The exports of Indian pharmaceutical industry to the US will get a boost, as branded drugs worth US$ 55 billion will become off-patent during 2017-2019. It has been quite an interesting year.

Going ahead, medicine spending in India is expected to increase at 9-12 per cent CAGR between 2018-22 to US$ 26-30 billion, driven by increasing consumer spending, rapid urbanisation, and raising healthcare insurance among others. Better growth in domestic sales would also depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as such as cardiovascular, anti-diabetes, anti-depressants and anti-cancers that are on the rise.The Indian government has taken many steps to reduce costs and bring down healthcare expenses. Ayushman Bharat Yojana attempts to do that.

Sometime back, I was happening to read an article by Goldman Sachs where the recent trends in Pharma were discussed. Few of these are –

a) Pharma emerging markets increase contributions to innovation.

The growing importance of emerging markets can be no longer ignored, in terms of where the pharmaceutical industry is turning for growth and profitability. The increased spending power of these so-called “pharmerging” markets means that new pharma products need to be launched on a more global scale than ever before. It is expected that this year’s pharmerging markets will increasingly influence the global strategy for the pharmaceutical industry.

These markets have become the fastest area of growth in Patent Cooperation Treaty (PCT) applications, with Russia and China outpacing the rest of Europe and North America. This trend will continue into 2018, with emerging markets turning their focus towards health issues particularly affecting their populations.

b) Collaborate to Innovate

Innovation will also be driven by an increase in collaboration across the pharma sector. To thrive in the increasingly competitive modern pharma market, companies will have to work together to develop innovative new products, services, and solutions, as well as share skills and expertise.

A great example of this type of collaboration in action is the recently announced collaboration between AbbVie, a research-based biopharmaceutical company, and the Google-backed life sciences firm Calico. By using Calico’s technical expertise to establish a new research and development facility, and with AbbVie using its scientific and clinical development support and commercial experience to bring discoveries to market, the two companies hope to discover, develop and market new therapies for patients with age-related diseases, such as cancer.

c) The era of smaller and more frequent product launches continues

According to IMS Health, nearly 200 new drugs are forecast to be launched in the next five years, with a high number of new molecular entities (NMEs) expected to be launched annually. This continuation is a second wave of innovation similar to levels seen in the mid-2000s.

There are currently over 2,000 products in late-stage clinical development, of which a quarter are oncology therapies. Furthermore, the growing number of medicines receiving the FDA’s Breakthrough Therapy Designation is contributing to an acceleration of approvals. Yet the global availability of these new medicines to patients varies significantly by country and disease, with less than half of new products available across all the major developed markets within five years of launch in the pharmaceutical industry. A lot needs to be done as currently it is only a drop in the ocean.

This year The Lex Witness 7th Annual Pharma Legal & Compliance Summit 2018 yet again comes with a basket of new areas of discussion trending in the pharma and healthcare space. We hope all of you enjoy the event and go back with newer insights, possibilities and solutional learnings.

See you soon.

Debolina Partap
VP Legal and General Counsel, Wockhardt Group
Summit Chair – PLCS 2018

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