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The Pharmaceutical Fine Chemicals market was estimated at 70 billion dollars in 2008 (in a pharmaceutical market estimated at around 800 billion dollars) and which should grow to 106 billion in 2015. (Source Acmite Market Intelligence. March 2008)

Today PCAS is amongst the top fifteen world-wide players and works consistently with at least 15 of the top 20 world-wide pharmaceutical companies.

Several favourable trends in the coming years will favour the opening up of various segments supplied by PCAS.

 

trend n°1: The speeding-up of outsourcing pharmaceutical chemical production to the benefit of specialised chemical companies
The financial pressure on large innovative laboratories (« big pharma ») grew during 2009, forcing them to review their industrial organisation in order to reduce costs or to merge by selling or closing industrial
chemical facilities.
 
14 out of the top 20 world-wide laboratories announced the closure or sale of their manufacturing sites during 2007-2008.
(source : Lincoln International LLC, ChemOutsourcing conference, Sep. 2008)
 
The consequences of such a trend are:
• Increasingly resorting to subcontracting through strategic partnerships.
• Acquisition of molecules in clinical phase by emerging companies.
 
In the face of this trend, PCAS’ integrated services and the strengthening of its North American
cover respond perfectly to market needs.
 
 
trend n°2: The growth of the generic market.

This growth, which is set to continue, is fed by two powerful driving forces:
• The current rate of patents expiring is particularly noted in blockbusters: laboratories being exposed to patent expiry has gone from 17 billion dollars in 2007 to 20 billion in 2008.
(source Evaluate Pharma)

• Pressure from authorities in all countries in order to contain public deficit which favours an increase in generic power.

In 2007, the greatest spending element for generic manufacturers was « manufacture (API + formulation) » at 51%.
(source European Commission - July 2009)

Today PCAS has a significant and dynamic active ingredients catalogue for multi-customers, offering a guarantee with respect to the most strict standards in environmental matters, intellectual property and to the supply of competitive and green technologies such as biocatalyst through its brand.

 

Trend n°3: World-wide authorities start to take into account derivatives in terms of respect for quality standards for pharmaceutical substances

Around 50% of Conformity European Certificates (CEP*) issued to Asian producers having undergone inspections by European Authorities were withdrawn. One of the top three generic manufacturers in India was denied access to the American market.

Switching of API production to Asia is being questioned and today the trend is moving towards sharing out business between recognised players with closer cost structures, imposed through quality harmonisation.

PCAS, with its portfolio of more than 40 molecules for multi-customers ,enriched with new molecules every year, an irreproachable quality level and a perfectly adjusted cost structure, has regained significant market share of its main molecules to the detriment of companies weakened by an insufficient level of quality.

 

Trend n°4: The « big pharmas » speed up outsourcing of their R&D

This basic trend, initiated by laboratories such as ROCHE or GSK was accelerated in 2009, even within more conservative companies, to outsource like Sanofi-Aventis.

Large laboratories are looking to acquire more products in clinical phases from biotech structures/start-ups who thus regain a favourable financial environment after the financial crisis.

These emerging companies who have considerable acrued financial resources (Script: 2 billion dollars raised by US biotechs in 2009).
The United States far remains the first area with emerging biotechs who have a “100% outsourcing” model.

Expertise anchored in the production of active substances for clinical trials, the increase in power of multi-disciplinary scientific teams used to working on a « project mode » and GMP manufacturing laboratories in Europe and the United States, ideally position PCAS to become a favoured partner of emerging biotech companies.

« Innovation to active ingredients which have become generics »

“The API activity for multi-customers had to face a significant stock reduction programme by our major customers in the first quarter of 2009. Nevertheless, this activity within PCAS in 2009 was good and encouraging for the years to come. PCAS knew how to anticipate and confront the new trends and constraints of the generic market by developing new APIs according to innovative synthesis routes and with respect to intellectual property. To achieve this, we were supported by patent specialists who are directly integrated into the development team and at all stages of the project. We have thus continued our plan, putting strong emphasis on innovation in order to benefit our customers with access to original chemical or biocatalytic routes.

Moreover, in a market where quality and confidence are extremely important factors, all our sites dedicated to the production of APIs have been audited and approved by the FDA over the last two years and this taking place whilst a number of files have been submitted to the USA market, including some targeted blockbusters. PCAS is today an undisputed partner for its customers in both Europe and the USA and we are also involved in generic drugs of tomorrow, whilst working hand-in-hand as much as is possible with the originators”.

Laurent Alexandre
Sales & Marketing
Director Multi-client API