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CHANGING TRENDS in the GLOBAL APIs MARKET - edition 2022
Giugno 2022
The study highlights the global market trends of the active pharmaceutical ingredients from 2008 up to 2021, the trend of the new molecules approved during the last past seventeen years, and offers a segmentation of the market itself among main APIs typologies (synthetic, biotech). In addition, the study analyses the main elements that will drive the market in the next future years: the global economic scenario, the impact of the patent expiries, the “emerging therapies”, the increasing importance of the “orphan drugs”, the biosimilars, the highly potent APIs (HPAPIs), the progressive shifting from treatment to prevention, the increasing importance of the “niche therapies”. The Pharmaceutical Contract Manufacturing and the Custom Synthesis as well are progressively gaining in importance; the study also supplies a breakdown of the Pharmaceutical Contract Manufacturing business by geographical area. Continues at a fast pace the Merger & Acquisition activity, mainly finalised to create synergies useful for sustaining the elevated expenses in the R&D activity for specific pharmaceutical products and treatments. Indeed, the expenses necessary for the launch onto the market of a new molecule, from initial research to experimentation up to the final approval by competent Authorities, have increased enormously during the past years; according to recent estimation, currently such expenses are in the range of 2.6 – 3.0 $ billion; in addition, only one every five – ten thousand molecules gets final approval. Currently North America is the largest market for Active pharmaceutical ingredients, followed by Asia – Pacific. Generic APIs account for approximately 56% of the global synthetic APIs market: the highest penetration of generics is in the pharmerging countries: Latin America, Middle east, Asian countries with the exception of Japan, where originator products dominate the market. On a global scale, captive market continues to account for the largest share, but the Custom Synthesis continues to gain in importance, especially for the manufacturing of more complex molecules. China continues to hold the leadership as manufacturer and supplier of active pharmaceutical ingredients and intermediates on a worldwide scale. This high dependence on China as APIs supplier has caused big problems during the last past two years of lockdown: a strong shortage of pharmaceutical raw materials, with heavy repercussions on the entire pharmaceutical supply chain. Many APIs that until twenty years ago were produced in Europe, are now exclusively produced in China. Conscious of this problem, many European APIs manufacturers have started to rebuild their facilities in Europe (the so-called “reshoring phenomenon); but it isn’t an easy matter due to a series of problems: environmental problems, authorizations, productive policies, and so on. In the year 2021 however the dependence on China of the European pharmaceutical companies for the supply of APIs and intermediates has diminished if compared with two years ago, though it remains still elevated (over 70%). In order to compete in the global changing context, APIs producers are gradually adopting innovative / revolutionary manufacturing technologies: digitalization / automation, continuous – flow processes, nanotechnologies, eco-friendly technologies (like biocatalysis). Only with a concrete reshoring policy, and with the adoption of innovative manufacturing technologies Western APIs producers can continue to recover market shares, considering that they only, and perhaps even more than in the past, hold the know – how and the capacities useful at this purpose.
Indice dei contenuti INTRODUCTION EXECUTIVE SUMMARY 1.MARKET TRENDS 2008 – 2021 2.KEY MARKET DRIVERS 2021 - 2025 2.1. Opportunities and challenges – The impact of COVID 19 2.2. The global scenario 3.THE EMERGING ROLE of the PCRAMS INDUSTRY 3.1. General overview 3.2. Market breakdown by business segment 3.3. Business breakdown by geographical area 4.CAPITAL FUNDING and M&A ACTIVITY 5.APIs DEMAND BY GEOGRAPHICAL AREA 6.APIs SUPPLY 6.1. Competitive landscape 6.2. Analysis of the supply by region 7. EVOLVING TRENDS in the GLOBAL APIs SUPPLY CHAIN 8. INNOVATIVE TECHNOLOGIES to be ADOPTED for COMPETING in the GLOBAL APIs ARENA 8.1. INDUSTRY 4.0 8.1.1. The concept of I 4.0 technology 8.1.2. The Pharma 4.0 8.1.3. Adoption of digitalization techniques in the different geographical areas 8.2. Microreactor – Continuous flow technology 8.2.1. What is the microreactor technology 8.2.2. Investments in the microreactor technology 8.3. Nanotechnologies 8.3.1. Nanoparticles in the pharmaceutical industry 8.3.2. The nanotherapeutics market 8.3.3. Production technologies of nanosized APIs 8.4. Green processes - Biocatalysis 9. EFPIA’s POLICY PROPOSALS to MINIMISE MEDICINE SUPPLY SHORTAGE in EUROPE 9.1. Lessons from COVID 19 crisis 9.2. EFPIA proposals 9.3. Best practices for national law measures designed to reduce the risk of supply shortage 10. CONCLUSION