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APIs – Global market report - Edition 2019

Novembre 2019

The report analyzes global markettrends over the last past thirteen years, with focus on both synthetic APIs andbiotech APIs, and emphasizes the role of “emerging therapies” (including ADCs,biosimilars, ATMPs, HPAPIs, among other).

Trends in both captive use andmerchant APIs market, as well as trends of the generic APIs market areoutlined. The generic penetration markedly varies by geographical area (NorthAmerica, Western Europe, Central East Europe, Asia- Pacific, Latin America,Africa – Middle East).

The report also examines the worldAPIs consumption by major therapeutic classes. As of the year 2018 cardiovascularproducts held the highest market share, followed by CNS agents and oncologicproducts: these three therapeutic segments altogether accounted forapproximately 44% of the global synthetic APIs market. Rh proteins account forthe largest share of the global biotech APIs market, followed by monoclonalantibodies (mabs).

Oncology and autoimmune diseasesare expected to register the highest growth over the next few years.

The global APIs manufacturinglandscape is rapidly evolving, along with the pharmaceutical market, offeringboth opportunities and challenges. Also Indian and Chinese companies, thatuntil recently were on the up and up, are slowing their growth when compared toprevious years. Since now major efforts will focus on optimizing costs andaddressing APIs’ quality standards.

In terms of supply of APIs thecompetitive scenario is gradually changing, with new opportunities emerging forWestern APIs suppliers. New more stringent regulatory standards and qualityrequirements are pushing pharmaceutical formulators to be more carefully inchoosing their APIs suppliers. The report examines the trend of market sharesheld by major APIs producing countries on a worldwide scale and in the highlyregulated countries (US, Europe, Japan).

The generic APIs sector becomesevery day more competitive and crowded. Overall revenues deriving from genericdrugs’ sales have been increasing during the last past six years, but moreslowly when compared to previous years; the profitability of the traditionalgeneric sector is gradually flattening, with drastic prices’ fluctuations becomingevery day more common. This poses a risk to generic manufacturers, with delaysin manufacturing and shortages of APIs.

Key APIs market drivers over thenext few years include, among other, the increasing role of emerging therapies:biosimilars, ADCs, ATMPs, HPAPIs, RNAi therapies vaccines (both preventivetraditional vaccines and cancer vaccines), etc. Therapeutic peptides also areinteresting pharmaceutical products to be classified between traditional smallmolecules made through chemical synthesis routes and large biological moleculesthrough recombinant DNA technology in living organisms. In addition, orphandrugs are destined to play an emerging role in the global pharmaceuticalscenario.

The report also examines in detailthe Pharmaceutical Contract Research and Manufacturing services (PCRAMs)industry, with a business segmentation by major geographical areas; aparticular focus is dedicated to the Custom Synthesis of APIs. Overall, the PCRAMsindustry is predicted to experience substantial revenues’ growth over the nextyears, allowing the outsourcing company to save resources, cost, and time,additionally taking advantage from external technological input, becoming moreefficient and productive at the same time. In addition, since small-, medium-,and big – sized pharmaceutical companies are increasingly differentiating theirproducts’ portfolio in order to increase their competitiveness in the globalmarket, the outsourcing more and more becomes an obligated strategy forcompensating the eventual lack of internally available manufacturingtechnologies and R&D capabilities.

Increasing availability of low –cost outsourcing capabilities by well established CDMOs is also to be relatedto the M&A phenomenon. The PCRAMs industry is destined to continue toachieve consolidation via M&A: consolidation is expected to peak in thenext few years, with an increasing number of companies striving to provide afull range of services from APIs to finished dosage forms.

The future of the APIs /pharmaceutical industry cannot ignore the Industry 4.0 related technologies.Industry 4.0 is the term used to refer to the development process in themanagement of manufacturing and chain production; the term also refers to thefourth industry revolution. The target of Industry 4.0 is to create a socialnetwork where machines can communicate with each other – called the Internet ofThings (IoT) – and with people - called the Internet of People (IoP).

The Industry 4.0 offers a series ofbenefits, including, among other, improved productivity, product optimization,enhanced flexibility, increased demand of young adequate skill sets, costreduction. There are however also a series of barriers to overcome, that mightface Industry 4.0, such as initial high investment costs, general reluctance tochange by the stakeholders, still a lack of qualified employees in manycountries, and so on.

The report examinesthe penetration and adoption of I 4.0 – related technologies by the APIs / pharmaceutical industry inseveral countries overseas, and future predictable trends.

Indice dei contenuti

1.INTRODUCTION
1.A) Object and aim of the report
1.B) Definitions
1.C) Rates of exchange
1.D) Methodology used in carrying out the study – Sources of information
EXECUTIVE SUMMARY

1.GENERAL OVERVIEW – The global APIs – pharmaceutical landscape
1.1. Trends in the global APIs market 2005 – 2018
1.2. APIs DEMAND by MAJOR GEOGRAPHICAL AREA –
Generics’ penetration
1.3. World APIs CONSUMPTION BY THERAPEUTIC CLASSES
1.4. Biotech APIs
1.5. Peptides

2.FUTURE MARKET TRENDS
2.1. Key market drivers over the next few years
2.2. The future of generics
2.3. The role of emerging therapies
2.3.1. Biosimilars
2.3.2. Antibody drug conjugates
2.3.3. Advanced Therapeutic Medicinal Products (ATMPs)
2.3.4. HPAPIs
2.3.5. RNAi therapies
2.3.6. Specialty therapeutic enzymes
2.3.7. Vaccines
2.3.8. Microbes
2.3.9. Future trends in the global APIs market – Conclusions

3. COMPETITION in THE GLOBAL APIs MANUFACTURING LANDSCAPE
•A challenge for the EU APIs suppliers – The SPC question

4.THE GLOBAL PCRAMs INDUSTRY
4.1.Definition of Contract Manufacturing
4.2. The Pharmaceutical Contract Research and Manufacturing business
4.3.Business segmentation by geographical area
4.4.Future trends of the global PCRAMs industry
•The global CDMOS’ scenario

5. THE FACTORY of the FUTURE – THE PHARMACEUTICAL SMART FACTORY –
INDUSTRY 4.0 –
5.1. A challenge for the industry – The complexity of Industry 4.0 –
A wholly innovative concept
5.2. The Industry 4.0 and the pharmaceutical / APIs industry – How are APIs / pharmaceutical companies fully ready for this innovation
5.3.Investments in Industry 4.0 technologies by the pharmaceutical /
APIs industry
5.4. Future trends in investments in I 4.0 technologies by the pharmaceutical / APIs industry

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