Global generic, bioequivalent and API manufacturers Outlook: trends, opportunities and challenges

Source: shihuochuang's global pharmaceutical market continued to change on June 14, 2017 The main performance is that the market share and quantity of generic drugs continue to rise At present, the growth of global R & D expenditure is slowing down, the regulation is increasingly strict, the user payment is increasing, and the industrial integration is heating up again How should manufacturers deal with these problems? By analyzing the successful growth models and cases of pharmaceutical industry, this paper discusses how professional information can help enterprises transform to higher value products and services quickly and effectively? What information do they need to meet the changing needs of their new and different strategies? At present, the global annual drug cost for providing national medical insurance is more than 1 trillion US dollars It is expected that by 2018, the expenditure will increase at an average annual rate of 5.5%, but the growth rate in different regions will be significantly different Most European markets will grow by less than 2%, while many Asian, Middle East, Latin American and African countries will grow by more than 8% Now, the global generic market size is about US $435 billion, and the market share is expected to grow to 36% by 2017 Although generic drugs have reached a high market penetration rate of 50-60% in Europe, 45-50% in Asia and close to 80% in the United States, there is still a lot of room for growth However, the growth of generic drug costs is expected to keep pace with the growth of global health care costs, with single digit growth in mature markets in North America, Japan and Europe, and 10-20% growth in countries such as China, Brazil and India The global pharmaceutical market is constantly changing, and the most critical point is that at some time in the future, the generic pharmaceutical industry will continue to benefit from this change From 2016 to 2019, more than $100 billion of brand drug patents will expire and face the competition of generic drugs There are many reasons for the sustained growth of generic drugs, which not only creates opportunities for manufacturers, but also brings risks For example, the government, public institutions and private medical insurance companies will continue to rely heavily on generic drugs to control the medical insurance costs of patients, which also creates opportunities for the long-term development of the industry But at the same time, the most common practice of these institutions is to reduce budget and resources, coupled with the "low price wins" approach adopted in the bidding, which brings great pressure on manufacturers, requiring manufacturers to constantly reduce prices, but also to ensure the quality, safety, effectiveness or reliability of supply; the final result is often the continuous decline in product supply and profits At the same time, producers have to contend with other complex challenges Due to the increasingly strict regulation, the requirements of supply chain tracking and traceability, as well as the new and increasing payment of generic drugs, have increased the cost of ensuring compliance in various markets There is a backlog of more than 4000 andas in the US FDA generic approval process, with an estimated approval time of 40 months It is expected that in the next five years at least, the R & D expenses of the world's leading innovative companies will remain unchanged at about $75 billion per year, which means that there will not be a large number of new drugs approved for market in the next 8-10 years, and the opportunities for generic drugs will be reduced On the other hand, more and more CMC development outsourcing and large or small innovative companies' API and preparation production outsourcing also create new opportunities for customized synthesis and crams (customized R & D and production services) Finally, in many countries, biopharmaceuticals account for more than 40% of the drugs on the market and 37% of the drugs under development in the clinical development stage With the maturity of regulatory access and the acceptance of bioequivalent drugs by various stakeholders, whether manufacturers want to participate in the competition or not, they must have a clear strategy for bioequivalent drugs Before solving the above problems and challenges, it is valuable for the company's business strategy team to think about the feasibility model of the industry These reflections can be used as a measure of a company's current positioning and capabilities, as well as a tool to determine where to go next and what business capabilities are needed to achieve expectations and make decisions, and as well as the information needed to support these changes The industry growth pattern shown in Figure 1 can be used to help with assessment and decision making Jubilant Life Sciences in India is a good case, which shows how to combine its organic growth with merger and acquisition, and grow from a small pyridine chemical plant in the 1970s to a global life sciences company with annual income of billions of dollars This transformation requires the integration of complex intermediates and APIs with specialty and bioequivalent drugs In the process, the company spent $750 million on acquisitions at home and in Europe, the United States and Canada Let's take a look at the key strategic decisions that CMO companies or professional synthetic companies need to consider in order to strengthen their position or enter any other field to achieve growth: develop new technology platforms in local, regional or global markets, expand technological capabilities, transform from small molecular projects to bio pharmaceutical projects, expand production capacity or expand product pipelines From research and synthesis projects to generic APIs, and vice versa, to reduce costs, increase efficiency, quality, safety or supply chain support investment to replace or acquire competitors, acquire new capabilities and start integration: acquisition of growth strategies to be considered by generic distributors or producers in the same way as entering API production or crams: Expand the production of more complex dosage forms in local, regional or global markets, and expand the production capacity and product pipeline from non drug market to drug market, so as to drive market expansion, acquisition and promotion of small competition, brand, niche or specialty drug production, sales or cooperative sales of biological similar drugs Launch the "paragraph IV" patent challenge in the United States, cooperate with innovative companies, list and authorize generic drugs to replace or acquire competitors, acquire new capabilities and markets, and acquire API production through integration or acquisition While this is not an exhaustive list, it is clear that any of these strategic choices requires timely, accurate and reliable integrated information and tools to validate different approaches and make the right decisions For example, in order to expand new overseas markets, whether CMO or generic drug manufacturers, they need to have a thorough understanding of relevant national and global drug laws and regulations, so as to be able to compare and contrast the laws and regulations of different countries and differences, continuously monitor the changes of these laws and regulations, and be able to assess the impact of any changes in relevant laws and regulations on the business when entering the new market Often we will find that those companies that can successfully meet the above business challenges have clear growth strategies and adopt advanced business intelligence and information systems, including highly integrated data, covering key content such as research product lines, products, markets, companies, regulations and patent information Including the development of professional analysis functions, which can save time and energy, such as: estimating the generic drug launch date, without repeatedly considering the complex patent and market monopoly period Provide regional coverage that matches current and future business The search results can be sorted and analyzed flexibly, and visual tools are provided to test the strategy quickly and provide answers to complex business problems Here is an example, which is undoubtedly what many companies will face today: a generic pharmaceutical manufacturer in emerging markets, which only has experience in listing solid oral preparations in the local market, now has realized factory upgrading through large-scale investment, hoping to enter the lucrative sterile injection Market in Europe and America A strong and growing product portfolio and pipeline under development are important components of all manufacturers' successful development strategies At a minimum, a company's information solutions must be able to quickly retrieve and evaluate current, historical and future sales forecasts, listing information and price data, patent information and market monopoly period information, forecast the time to market of generic drugs, the supply of APIs, DMF status, litigation, effective transactions and more Professional information and tools should be able to answer representative questions such as portfolio development and product selection, generate a table in seconds with a list of candidate products that can be used for further detailed evaluation: "which products sell between $200 million and $400 million in the United States and Europe? The annual growth rate is less than 5% The dosage forms are vials, ampoules or injections The indications are cardiovascular, central nervous system and tumors At the same time, API supply is limited It is expected that generic drugs will be available in Germany, Italy or the United States from 2022 to 2028? " As a final example, once the product portfolio is determined, questions need to be asked about regulatory information and solutions to measure their impact on budgets and programs: what are market authorization (MA) fees, Ma renewal fees, renewal schedules, Ma extension fees and annual inspection fees in all European countries and the United States? What is the expected review time for market authorization (MA) applications in all European countries? How is it compared with the United States? With this information, companies can develop products with more confidence, submit applications on a schedule, determine the budget for each market, and learn at the earliest opportunity how much expected revenue the product will generate if it is approved successfully In the next few years, the prospect of the generic industry is bright, but it will also face fierce competition, stricter regulatory environment and other pressures However, through the above measures, the company will be able to continue to focus on strategic selection, verification and planning Companies that can leverage integrated intelligence and information will succeed and continue to grow sustainably.