CPhI Report Warns Industry Must Actively Drive Process Improvements Itself to Meet Growing Global Demand

PR56589

AMSTERDAM, Apr. 24/PRN=KYODO JBN / --

    Improved process efficiency, with modern manufacturing techniques could

save billions and increase profits, improve quality and open up sales in

developing markets

    Girish Malhotra, CPhI expert panel view: "'Process centricity' has to

overtake the current 'regulation centricity' if pharma wants to see cost

reductions in new and existing processes."

    (Logo: http://photos.prnewswire.com/prnh/20130723/629764-a )

    Report highlights:

    - Manufacturing efficiencies must be driven by big pharma, not regulators as

      this will only increase costs

    - 'Improving product quality' and 'reducing manufacturing costs' are the

      industry's major priorities

    - 70% investing in manufacturing this year, with 59% also hiring more staff

    - 59% are increasing the use of outsourcing

    - Nearly 50% of the industry stated they introduced more than three products

      last year, with a further 41% adding 1-3 products

    - 'Improved efficiency' and 'improved safety' were highlighted as the most

      important manufacturing goals

    CPhI Worldwide [http://www.cphi.com ], part of UBM Live's Pharmaceutical

Portfolio, announce the findings of its Pharma Insights report on

Manufacturing. Overall the report indicates that the industry is aware of the

need to continue to improve manufacturing practices, processes and efficiencies

to dive down costs and improve profits and drug quality. However, the report

warns that industry must more actively take the lead if we are to see these

vital changes driven through- currently, the inertia of the existing model is

impeding innovation and preventing wide spread adoption.

    CPhI adds that most of the sector now states it is utilising continuous

process improvements to drive efficiency savings, but more could be done to

revolutionise practices. CPhI findings show that 26% are using 'statistical

process control', 21% using 'process capability analysis', 16% QbD, 12% 'six

sigma' and 11% using both 'lean/kaizen' and 'PAT'. Furthermore, many are

building for the future and making essential upgrades to existing equipment

with 70% actively investing in manufacturing.

    In the medium to long term, we should see a cross-pollination of process

improvements from generics (where costs savings can still be made) though CMOs

and ultimately into big pharma's patented products. The advantage here is that

lower cost patented products would open huge new markets, whilst reducing the

attractiveness of counterfeits.

    For cost savings to be made however, the report clearly states further

improvements must come from the industry itself and not the regulator, as this

will only increase costs.

    CPhI panel member and President of EPCOT International Girish Malhotra,

added: "Not much will change in the current processes as the needed regulatory

approval will come in the way of any improvement of existing processes. Success

to exceed regulations will only come from process inception stage along with

command of the process as they become commercial. 'Process centricity' has to

overtake the current 'regulation centricity' if pharma wants to see cost

reductions in new and existing processes."

    In terms of the industry's economic strength, the findings show the sector

is in good health with 59% planning to increase headcount this year and only 4%

planning reductions. In outsourcing we continue to see increases with 41%

outsourcing more of their manufacturing. Going forwards, if manufacturers want

to improve product quality, they must find a supplier that aligns with their

own GMP compliance expectation.

    Additionally, nearly 50% of the industry stated they introduced more than

three products last year, with a further 41% adding 1-3 products.

    The biggest manufacturing goals are to 'increase efficiencies' and 'safety'

and already 89% are testing raw material sourced- with 'compendial testing' by

far the most favoured method (81%).

    "With the majority of the industry now committed to process improvements

and increased product quality the next few years will hopefully see more new

manufacturing methods coming to market, with tighter process controls- these

should ultimately reduce costs and increase profits for the industry." Chris

Kilbee, Group Director Pharma.

    CPhI believes we may be at the cusp of a revolution and if one major pharma

company starts reaping the benefits of implementing process perfection from

initial development to commercialisation others will follow. Drawing all these

findings together the report concludes that the industry has made great strides

and with new efficient techniques drugs should be more available globally at

reduced cost, enabling developing countries increased

access.

    Chris Kilbee added: "The desire to modernise processes across the industry

is clearly there and taking a long term view we can see that the way we conduct

development work right through to commercialisation has the chance to

revolutionise the business model. Patented products will be opened up to a

wider number of the globe's seven billion inhabitants, which is a real human

goal, but also one that will see the industry become more sustainable and

increase profits. I believe that with these commitments we see a situation

where industry actively drives improvements and takes these new methods to the

regulator - cost savings and improved quality should go hand in hand".

    Full report:

http://www.cphi.com/documents/129623/1317492/CPhI+Pharma+Insights+Report-+Manufacturing.pdf/2fe19c18-9641-4a60-9846-4fbb561cb8a6

    About CPhI

    CPhI drives growth and innovation at every step of the global

pharmaceutical supply chain from drug discovery to finished dosage. Through

exhibitions, conferences and online communities, CPhI brings together more than

100,000 pharmaceutical professionals each year to network, identify business

opportunities and expand the global market. CPhI hosts events in Europe, China,

India, Japan, Korea, Southeast Asia, Istanbul, Russia and South America and

co-locates with ICSE for contract services, P-MEC for machinery, equipment &

technology, InnoPack for pharmaceutical packaging and BioPh for biopharma. CPhI

provides an online buyer & supplier directory at CPhI-Online.com.

    For more information visit: http://www.cphi.com

    The UBM Live annual schedule of Pharmaceutical events also includes CPhI

Russia and IPhEB (16-17 April, 2014 at the Lenexpo Exhibition Complex- St

Petersburg, Russia); CPhI, P-MEC and Innopack South East Asia (20-22 May, 2014

at the Jakarta International Expo- Jakarta, Indonesia); CPhI Istanbul (4-6

June, 2014, at the Lutfi Kirdar Convention and Exhibition Centre- Turkey);

CPhI, Hi and Fi, ICSE, P-MEC, BioPh and LabWorld China (26-28 June, 2014 at

SNIEC- Shanghai, China); CPhI South America (5-7 August 2014 at Expo Centre

Norte, Sao Paulo- Brazil); CPhI, ICSE Korea (2-3 September, 2014 at the COEX-

Seoul, South

Korea); CPhI, ICSE, P-MEC and InnoPack Worldwide (7-9 October 2014, Paris Nord

Villepinte- France); CPhI and P-MEC India (2-4 December, 2014 at the Bombay

Exhibition Centre- Mumbai); CPhI, ICSE, P-MEC, BioPh and Pharmatec Japan (22-24

April, 2015 at the Big Sight Exhibition Centre- Tokyo).

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    SOURCE: UBM Live