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CHALLENGES and OPPORTUNITIES of GROWTH in the STORMY APIs MARKET

October 2018

Last trends in the global APIs market in terms of demand, supply, new products and technological implementation

The traditional APIs market is facing a series of challenges, including: rising competition, Governments’ pressure on drug prices aiming at reducing healthcare spending, regulatory burden, enormous investments required for the launch of a NME, environmental, health and safety costs, and labor costs among others. In addition, the traditional generic APIs business is struggling, and many big generic APIs suppliers are changing their strategies, shifting from the traditional generic APIs field to emerging therapies, most of which in the biotech area.

The report highlights market size and trends of a number of such emerging therapies, including:

- antibody drug conjugates (ADCs);

- cell / gene therapies;

other nice therapies such as RNAi therapies, microbes or specialty therapeutic enzymes;

- biosimilar APIs;

- high potent APIs (HPAPIs),

opportunities and barriers to enter these markets.

Another promising area is that of therapeutic peptides, which are interesting pharmaceutical products to be classified between traditional small molecules made through chemical synthesis routes and large biological molecules through recombinant DNA technology in living systems. The transition towards synthetic peptides consists mainly in fewer regulatory burdens.

In addition, a series of strategic choices are being considered for competing in the global APIs market.

Although the personalization of therapies currently is still a small, reality, it has to be considered as the beginning of a history. Not only, but the number of FDA orphan drug approvals has risen for 14 in the year 2000 to over 50 in 2017.

Indeed, the APIs industry needs the implementation of innovative technologies, aiming to realize manufacturing processes compliant with high quality standards established by International Regulatory Agencies, coupled with cost containment, with a particular emphasis on: energy efficiency, eco – sustainability, synthesis simplification, final product quality, and waste reduction.

The manufacturing technology implementation, intended as a digitalization strategy will revolutionize the APIs / pharmaceutical industry in the near future, not differently from other industries. Thereby, for an APIs / pharmaceutical company’s survival, a crucial question is: “Are we ready for Industry 4.0?”. For answering this question, the management must examine the company’s culture and better understand its own business model, to begin with. A global overview on adoption of digitalization technologies by the APIs / pharmaceutical industry by geographical area / country is highlighted in the report.

In recent years much attention has been dedicated to Continuous Manufacturing Technology (CMT), since a continuous – flow process carried out in small reactors offers a series of advantages over traditional batch processes, in spite of a series of challenges, as there are often issues with converting batch work – up methods to continuous operations. The report shows a few examples of adoption of the CMT by the APIs / pharmaceutical industry and outlines the penetration of the continuous – flow chemistry process in the APIs / pharmaceutical industry by geographical area.

Another emerging technology is the nanotechnology: currently an application of the nanotechnology is in the field of delivery of APIs: therapeutically nanoparticles could be used as APIs carriers (vehicles) through dissolving, entrapping or adsorbing the API. A further development of the nanotechnologies applied to the medicine is the so – called “triggered response”, or the usage of nanoparticles in the field of neural regeneration.

The report shows nano-therapeutics currently approved, the state of the art of production technologies of nanosized APIs, market size and future trends of the nanotherapeutics’ market.

An increasing number of APIs / pharmaceutical companies are convinced that their pipeline can benefit from the use of biocatalytic methods: this also in consideration that in the field of drug discovery there is a trend towards molecules of higher complexity and higher specificity: typically such drugs require lower dosage to be efficacious in patients’ treatments, and have fewer side effects. Enzymes that have been designed for selective reactions are suitable for the rapid creation of libraries of such complex molecules

Index of contents

GENERAL OVERVIEW

THE ROLE OF EMERGING TECHNOLOGIES – THE CHALLENGES FOR THE FUTURE

COMPARISON of QUALITY / SAFETY AND LABOR COSTS between WESTERN – AND FAR EASTERN COUNTRIES

THE BURDEN OF cGMP INSPECTIONS AND IPRs RELATED ISSUES

THE FUTURE FRONTIER OF THE APIs INDUSTRY – THE IMPACT OF THE “EMERGING THERAPIES”

PEPTIDES

FUTURE TRENDS IN THE GLOBAL APIs MARKET

CONCLUSIONS

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