Trends in Pharmaceutical R&D

8/12/2019 Trends in Pharmaceutical R&D

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Trends inPharmaceutical R&D

By

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Introduction

Research based Pharma industry: Unique role to play

Success rests on continuous innovation

Challenging business conditions Risky investm


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R&D process


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R&D pipeline Today cost of developing a single drug amount

billion USD compared to 138 million in 1975

High failure rates


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R&Dpipeline Rising R&D cost and stringent requirements is l

decline in drug approvals

No. of NCEs and NBEs launched on world mark149 in 2007-2011 from 196 in 1990-1995. Howthat it is increasing.

In 2012, the FDA approved 39 new molecular ehighest level in a decade


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R&Dspendingworld wide


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R&Dspendingworld wide

Global spending on Pharmaceutical R&D over theBillion)

- Global R&D spending to grow 3.8% in 2014


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R&Dspendingworld widebycompanies

Pharma Rank World Rank Company Country

1 6 ROCHE Switzerla

2 7 NOVARTIS Switzerla

3 8 MERCK US USA

4 9 JOHNSON & JOHNSON USA

5 10 PFIZER USA

6 15 SANOFI-AVENTIS France

7 20 GLAXOSMITHKLINE UK

8 26 ELI LILLY USA

9 33 ASTRAZENECA UK

10 35 ABBOTT LABORATORIES USA

11 36 BAYER Germany

12 40 BRISTOL-MYERS SQUIBB USA

13 41 TAKEDA PHARMACEUTICAL Japan

14 42 BOEHRINGER INGELHEIM Germany

15 47 AMGEN USA

16 67 OTSUKA Japan

17 68 DAIICHI SANKYO Japan

18 69 ASTELLAS PHARMA Japan

19 72 MERCK DE Germany

20 78 NOVO NORDISK Denmark
http://blogs.terrapinn.com/total-biopharma/?s=rochehttp://blogs.terrapinn.com/total-biopharma/?s=novartishttp://blogs.terrapinn.com/total-biopharma/?s=merckhttp://blogs.terrapinn.com/total-biopharma/?s=Johnson+and+johnsonhttp://blogs.terrapinn.com/total-biopharma/?s=pfizerhttp://blogs.terrapinn.com/total-biopharma/?s=sanofi+aventishttp://blogs.terrapinn.com/total-biopharma/?s=glaxosmithklinehttp://blogs.terrapinn.com/total-biopharma/?s=lillyhttp://blogs.terrapinn.com/total-biopharma/?s=astrazenecahttp://blogs.terrapinn.com/total-biopharma/?s=abbotthttp://blogs.terrapinn.com/total-biopharma/?s=bayerhttp://blogs.terrapinn.com/total-biopharma/?s=bristol%20myers%20squibbhttp://blogs.terrapinn.com/total-biopharma/?s=takedahttp://blogs.terrapinn.com/total-biopharma/?s=boehringer+ingelheimhttp://blogs.terrapinn.com/total-biopharma/?s=amgenhttp://blogs.terrapinn.com/total-biopharma/?s=OTSUKAhttp://blogs.terrapinn.com/total-biopharma/?s=daiichi+sankyohttp://blogs.terrapinn.com/total-biopharma/?s=astellas+pharmahttp://blogs.terrapinn.com/total-biopharma/?s=merckhttp://blogs.terrapinn.com/total-biopharma/?s=novohttp://blogs.terrapinn.com/total-biopharma/?s=novohttp://blogs.terrapinn.com/total-biopharma/?s=merckhttp://blogs.terrapinn.com/total-biopharma/?s=astellas+pharmahttp://blogs.terrapinn.com/total-biopharma/?s=daiichi+sankyohttp://blogs.terrapinn.com/total-biopharma/?s=OTSUKAhttp://blogs.terrapinn.com/total-biopharma/?s=amgenhttp://blogs.terrapinn.com/total-biopharma/?s=boehringer+ingelheimhttp://blogs.terrapinn.com/total-biopharma/?s=takedahttp://blogs.terrapinn.com/total-biopharma/?s=bristol%20myers%20squibbhttp://blogs.terrapinn.com/total-biopharma/?s=bristol%20myers%20squibbhttp://blogs.terrapinn.com/total-biopharma/?s=bristol%20myers%20squibbhttp://blogs.terrapinn.com/total-biopharma/?s=bayerhttp://blogs.terrapinn.com/total-biopharma/?s=abbotthttp://blogs.terrapinn.com/total-biopharma/?s=astrazenecahttp://blogs.terrapinn.com/total-biopharma/?s=lillyhttp://blogs.terrapinn.com/total-biopharma/?s=glaxosmithklinehttp://blogs.terrapinn.com/total-biopharma/?s=sanofi+aventishttp://blogs.terrapinn.com/total-biopharma/?s=sanofi+aventishttp://blogs.terrapinn.com/total-biopharma/?s=sanofi+aventishttp://blogs.terrapinn.com/total-biopharma/?s=pfizerhttp://blogs.terrapinn.com/total-biopharma/?s=Johnson+and+johnsonhttp://blogs.terrapinn.com/total-biopharma/?s=merckhttp://blogs.terrapinn.com/total-biopharma/?s=novartishttp://blogs.terrapinn.com/total-biopharma/?s=roche


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Drivers ofR&D

Access to market Access to local market

Better responses to local market requirements

More successful market introduction

Access to technologies More advanced innovation

Reduction of time to market

Complexity of diseases Evolving new and more complex diseases

According to statistics from the FDA, from authorization of the Orphan Drug Act in 1982013, Orphan Drug designations has been awacompounds, and of these, there have been 44for Orphan indications.


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Drivers ofR&D

Patent cliff The research-based pharmaceutical industry is

face a substantial drop in revenue in the near many of its patents on blockbustermedicine

expire. These challenges have not diminished tinnovative drive but have rather encouraged it tmodels of innovation.

Cost of R&D Around the world, much of the rising R&D

relates to the high cost of human clinical teaccounts for about two thirds of the entire c

development.

Against this backdrop, drug makers are pressure than ever to introduce new products trevenues


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Drivers ofR&D

Allocation of R&D investments by function and estimabringing NCE or NBE to market ($ Million)


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R&D trendsIndia

Expenditures on Research & Development (R&D) bIndian pharmaceutical companies have gone up sig19.7 per cent during the year ended March 20previous year.

The focus of R&D by these companies is on new cgeneric products in key therapeutic areas and not discoveries.

The R&D expenditure, on standalone basis, of Phaof 30 pharmaceutical companies increased to Rsduring 2012-13 fromRs.4,478 crore in the previous y

Despite rising investments in R&D the Indian comfailed to achieve any major success in disdevelopment of new molecules, new chemical endrug delivery systems during past several years

The overall limited success in finding new NCEs wothe high risks involved in their development is companies to look out for partnership. Several pharma companies are entering R&D partnershippharma companies.


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R&D trendsIndia

For instance, Biocon has entered partnership Sun Pharmaceutical with Merck and PanOsmotica Pharmaceutical.

R&D expenditure of Indian pharma companies2013

Company R D expenditure (Rs. Cr

Dr. Reddys Lab 690

Cadila 493Ranbaxy 449

Cipla 425

Sun Pharma 310


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Emerging R&Dstrategies in

Pharma sector

1. Contract research and manufacturing service It includes outsourcing arrangements for man

active pharmaceutical ingredients and fchemistry and biology research for new drug pre-clinical trials and clinical trials.

MNCs eye Eastern Europe, India, China, SouthAfrica for clinical trials to achieve cost savings.


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Pharma sector

Outsourcing by MNCs in India


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Pharma sector

Leading CROs in India


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Pharma sector

2. Mergers and acquisitions: Alliances between drug developers can save ea

significant R&D resources by providing it accessthat it does not have internally. This can development of drug candidates while containin

Mainly two types of such alliances takes place


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Pharma sector

Pharma- Pharma alliances Example - Bristol-Myers Squibb (BMS) and

entered into a collaboration to develop and cotwo BMS compounds for the treatment of diabe

In 2008, Merck and Ranbaxy to gather entered agreement to develop new anti-infectives.

Pharma- Biotech alliances 47% of pharma-biotech alliances pertain to initi

discovery and pre-clinical research

33% involve drugs and clinical development

14% involve marketable drugs

Example : Wyeth signed product development dbiotech firms a

A) Trubion Pharmaceuticals

B) Exelixis

C) Progenics Pharmaceuticals


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Pharma sector

3. Collaboration with academic institutions As pharma pipelines dwindle and internal R

diminish, Big Pharma is increasingly turning tlabs for innovative new medicines.

Pharma companies issue grants to academy wto foster R&D in institutions.


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Pharma sector

4. Internal refocusing

Internal refocusing to cut research and developmamong the most straightforward approaches

expenses as these initiatives may be implemwithin each drug makersown organization.

They are therefore among the first responses tocutting mandates and include management cha

Staff reductions,

Team consolidations,

Offshoring;Also shifts in product development strategy:

Lifecycle extension,

Repositioning.


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Future trendsin R&D

Drug discovery cost ballooned to USD 1-2 billiproductivity decreased by 60%. This indicatesblockbuster model.

Pharma industry is shifting from chemistry to40% of the drugs approved last year were biolo


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Future trendsin R&D


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Futuredirections for

R&D

A stronger market orientation in R&D is one of ttask for future R&D activities

Promoting comprehensive technologies to imprproductivity.

Team oriented approach in R&D

Breaking down silos to foster innovation

R&D has to adopt an increasingly internationalizstrategy. It is important to align R&D strategy wcorporate strategy

Strong collaborations with academic institutionscompanies and peers for R&D

Indias pharma market is now estimated to be Ubillion which is forecasted to increase to USD 52020. So, to achieve this goal one has to follow

A good pricing policy

Focus on extensive R&D

Strong IPR environment


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Thank

Documents

Trends in Pharmaceutical R&D