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The world HPAPIs (High Potent Active Pharmaceutical Ingredients) market

Settembre 2016

- theycarry out their pharmacological activity at or below 1 mg of daily dosage onpatients;

- theyhave an occupational exposure limit (OEL) at or below 10 micro-grams / m3of air as an 8-h time-weighted average (8-hr TWA).

The global HPAPIs market hasrisen faster than the global APIs market over the last past eleven – twelve years,at an average 7.9% yearly rate. Though biotech high potent APIs (mostly ADCs)are emerging at an astonishing 35% average yearly rate, currently syntheticAPIs by far still account for the largest share of the global HPAPIs business(more than 90%).

In addition to ADCs, other compounds in the HPAPIs segment arecorticosteroids, potent analgesics as well as different niche products.Currently the oncology sector accountsfor approximately 50% of HPAPIs applications, followed by diseases treated withcorticosteroids with another 26%. At the time being the majority of HPAPIs usedin the cancer therapy still are synthetic HPAPIs (vincristine derivatives,melphalan, etc), but an increasing number of ADCs are under clinical trials.

Currently there are more than 100companies worldwide engaged in HPAPIs development and manufacturing: only aselected number of these companies however (mostly located in Western Europeand North America) are eligible for an appropriate know – how.

In Asia, particularly India issensing the opportunity the HPAPIs business offers for competing in the globalAPIs market, and an increasing (albeit selected) number of Indiancompanies are partnering with Western companiesin order to perform their presence in this highly lucrative segment. The supplyof HPAPIs in China is more fragmented than in India: only a quite limitednumber of Chinese companies are entering the HPAPIs business with dedicatedexpertise and affordable know – how. For the time being however India and Chinaaltogether still account for a quite limited share of the global HPAPIs supply(less than 5%): with a few exceptions, their Western / North Americancompetitors are a long way ahead in terms of average quality standard, accessto funding, ability in exploring the more complex, sophisticated and riskybiotech segment and innovative therapy areas.

Japan dominates the Asian HPAPIsmarket in terms of both market share (accounting for nearly 60% of totalrevenues in the region) and quality standard. Other minor emerging competitorsin Asia are: Taiwan, South Korea and Australia.

Although currently the majorityof HPAPIs are manufactured in – house by pharmaceutical – biopharmaceuticalcompanies, there is an increasing tendency towards outsourcing HPAPIs R&Dand manufacturing activities to external selected CDMOs (Contract Developmentand Manufacturing Organizations), since the HPAPIs business is becoming everyday more capital intensive, demanding specialized expertiseas regards safety and handling requirements,engagement in developing innovative technologies, regulatory updating andspecialized personnel. The selected CDMO must demonstrate to have a series ofcharacteristics as key factors for success for being “a winner”in this highly competitive, but also highlylucrative market: the cost is generally considered one of the less important selectioncriteria in the choice of a CDMO: more important is the right balance betweenglobal affordability and competitive cost of the supplier.

In spite of a series ofchallenges a company faces in developing and manufacturing HPAPIs (among whichthe elevated cost of equipment due to stringent containment and handlingissues), there are however also a series of opportunities largely offsettingchallenges. Thus, opportunities will prevail on challenges in the future years,further pushing the HPAPIs global market, at an average 10.1% yearly growthover the next four years, as against an average 7.9% yearly growth during thelast past eleven – twelve years. The novel ADC technology for the developmentof next generation antibody therapeutics for cancer therapies will boost themarket. A number of therapeutic segments however are destined to see anincreasing use of HPAPIs in the future, also in innovative market niches, atthe moment still undiscovered.

Although pharmemerging countriesare increasing their manufacturing capabilities more quickly than otherregions, in the future medium term however Western countries – in particular theUS – will continue to be leaders in the global HPAPIs market . Amongpharmemerging countries India will be leader in expanding its market share inthe globalHPAPIs market, albeit from alow basis: outside Asia, Eastern European countries (particularly Poland, theCzech Republic, Slovakia and Hungary) are emerging as increasingly affordableHPAPIs sources (though still limited in terms of both number and revenues),though at generally average higher prices than their Asian competitors.

The trend towards outsourcingHPAPIs R&D and manufacturing activity to external selected CDMOs will grew wider in the future, with outsourced HPAPIs’market increasing at an average 13.9% yearly over the next four years asagainst an average 8.4% yearly increase of in-house manufacturing bypharmaceutical – biopharmaceutical companies.

The development ofthe HPAPIs market involves a parallel development of innovative manufacturingtechnologies, that are the specific “focus” of qualified players in the field

Indice dei contenuti

  • The global HPAPIs MARKET TRENDS over THE PERIOD 2004 - 2015
  • MAJOR THERAPEUTIC SEGMENTS
  • The SUPPLY of HPAPIs
  • FUTURE MARKET TRENDS
  • TECHNOLOGIES’ DEVELOPMENT

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