According to IMS database statistics, the global generic pharmaceutical market reached 193 billion U.S. dollars in 2015, of which the total sales of generic drugs in the U.S. market was 71.9 billion U.S. dollars. It is estimated that in the next five years, the compound annual growth rate of the generic pharmaceutical market in the United States will reach 9.1%. In 2020, the sales of generic drugs will exceed 110 billion US dollars.
With huge market opportunities and direct or indirect promotional effects on other countries’ markets, more and more gold diggers have come to the United States in the “holy land” of generic drugs and have started a new journey. In recent years, domestic pharmaceutical companies represented by the four masters of “East Hengrui, Xirenfu, South China Sea, and North Qilu” have successively entered the US market. Whether it is Hengrui’s first generic injection of cyclophosphamide, the acquisition of RenFu, or the high number of Huahai’s ANDA logos, or Qilu’s 4 million injections.
However, it must be noted that the current competition in the US generic market is extremely fierce, with strong meat and food, mergers and acquisitions, and the constant downward pressure on generic drugs has become a helpless but inevitable trend. The big brothers and younger brothers of generic drugs took all the stops and made a decisive battle at the top of the Stars.
The author will make an inventory of the global generic drug giant active in the US market, hoping to help everyone further understand the global generic market pattern and development trend. This issue is about Teva’s introduction. The next issue will introduce Sandoz, so stay tuned.
Teva: Attack on the Israeli Giants
Teva originated in Israel, grew in Europe and America, and is located in the world. After more than a hundred years of continuous development and expansion, Teva has emerged an extraordinary road of his own, blossom everywhere, from the little-known rivers and lakes juniors turned into a profound global generic medicine brother. After the acquisition of the Allegan generics business, it has completed a gorgeous leap forward in the squid jump gantry to become the only generic drug giant in the global TOP10 pharmaceutical company.
As the saying goes, “I will mount a long wind some day and break the heavy waves, and set my cloudy sail straight and bridge the deep, deep sea.” The world of generic drugs can also be very exciting. The transformation of large generic drugs business, the continuous expansion of global mergers and acquisitions, and unremitting innovation are the troika of Teva’s success. Today, Teva is a combination of generic medicine and brand specialty medicine. Although “Epee has no front and no cleverness”, how to better digest the business, how to reintegrate existing resources and make a strategic layout will determine the future development of the company.
Founded in 1901, Teva is headquartered in Pektikawa, Israel. Currently it is the global TOP10 drug company, the largest generic drug giant with more than 46,000 employees in 36 countries, 68 production bases and 19 raw materials. Drug production base and more than 20 R & D centers. Founded in 1985, Teva USA is headquartered in North Wales, Pennsylvania. With more than 7,500 employees, Teva USA has a series of R&D centers, manufacturing sites, and distribution warehouses in various states throughout the United States.
Teva is committed to the development, production and sales of generic drugs, brand specialty drugs and APIs. The existing product line consists of more than 1,000 drugs (over 300 types of APIs), and the products cover more than 100 countries around the world, occupying a global footprint. The pharmaceutical market has an approximate 8% market share. The business is mainly divided into two major departments: the generic medicine department (including raw material medicine) and the specialist medicine department. The main areas of product treatment include the central nervous system, respiratory system, anti-tumor, and women’s health. Oral solid preparations and injections are its two main formulations.
Teva National Base List
Teva global production site layout
In 2015, Teva’s global revenue was 19.7 billion U.S. dollars (-3%); generic pharmaceuticals revenue was 9.546 billion U.S. dollars (-3%, including API business), accounting for 49% of the company’s total revenue, and net profit was 2.682 billion U.S. dollars. The U.S. dollar (+24%); specialty medicines have a total revenue of 8.338 billion U.S. dollars (-3%), accounting for 42% of the company’s total revenue, and a net profit of 4.361 billion U.S. dollars (-5%).
In terms of generics business, the United States has always been Teva’s largest market. In 2015, Teva’s generic pharmaceutical sales revenue in the US market was US$4,793 million (+8%), accounting for 51% of all generic pharmaceutical revenues; Europe was the second largest in the world. In the big market, revenue in 2015 was US$2.706 billion (-14%), accounting for 28% of all generic pharmaceutical revenues; other market revenues (mainly Japan, Canada, Venezuela, and Russia) were US$2.047 billion (-9%), occupying 21% of the total revenue of generic drugs.
By the end of 2015, Teva had more than 370 generic products in the US market and more than 1,100 specifications. In 2015, the total prescription volume in the US market was 473 million, of which Teva accounted for 13.1% of the total and there was one for every seven prescriptions. From Teva. In 2015, Teva’s US sales growth was mainly due to the availability of esomeprazole magnesium capsules and aripiprazole tablets, of which the esomeprazole magnesium capsule was first listed as a generic product. In addition, several products such as capecitabine tablets, budesonide inhaler and niacin tablets also contributed to the growth of the Teva generics business.
In the first half of 2016, Teva’s total revenue and profit were US$9.848 billion and US$3.702 billion, respectively, which was a slight decrease from the same period of last year. The generic pharmaceutical business revenue and profit were US$4.464 billion and US$1.198 billion, respectively. They were 45% and 32% respectively. Although the branded specialty medicine business is equal to the generic pharmaceutical business in terms of sales revenue, it contributes 66% to the profit of the company and wins the generic pharmaceutical business. Among them, the multiple sclerosis business contributed a 47% profit to Teva by virtue of the good performance of Copaxone. It is still Teva’s veritable tool for making money.
In the first quarter and second quarter of 2016, Teva’s generic pharmaceutical business revenue in the US market was US$976 million and US$892 million, respectively, which fell by 32% and 33% respectively over the same period. The decline in sales for two consecutive quarters was mainly due to the decline in sales revenue after the loss of the exclusive period protection of esomeprazole magnesium capsules, while the decline in income of the two main products of aripiprazole tablets and budesonide inhalers was further increased. Low total income.
Research and development
Teva’s R & D is divided into three parts: generic drugs, specialty drugs and new therapeutic entities (NTE). Different teams are responsible for the development of different types of products. Teva currently has 26 generic pharmaceutical R&D centers and 6 clinical centers worldwide, with 3,000 R&D personnel for generic drugs and R&D products covering almost all therapeutic areas.
Teva global generic pharmaceutical R&D center layout
The acquisition of Allergan has enabled Teva’s R&D capabilities to be further enhanced, enabling the seamless docking of both parties’ respective R&D dosage forms.
Teva and Actavis Mergers and Acquisitions Changes in Generic R&D Capabilities
As of September 7, 2016, Teva USA’s generic product line has 645 products, of which 325 are on-going products. The annual sales of branded drugs (2015.06-2016.06) for all product lines reached US$200 billion.
In 2015, Teva’s generic pharmaceutical R&D expense was US$ 513 million (+4%), accounting for 5.4% of the total generic pharmaceutical revenue. The R&D expenditure for specialist medicine was US$918 million (+5%), which accounted for 11% of the total revenue of generic drugs. In the first two quarters of 2016, the R&D expenses for generic drugs were US$136 million and US$125 million, respectively, which accounted for 6.3% and 5.4% of the total revenue of generic drugs in the quarter. The total R&D investment in the first half of the year increased by 6.5% compared to the same period of last year. .
In 2015, Teva had a total of 23 ANDA approvals, of which four were provisional approvals, and cumulative ANDA approvals exceeded 500; 26 generic pharmaceutical products were listed in the US, of which 5 were re-listed and 23 were listed. The withdrawal of the products will no longer be sold.
As of January 22, 2016, Teva had 107 products under review and awaiting final approval, including 28 provisional approvals, 76 patent-challenged products and 34 first declared products. After being incorporated into the Allergan generics business, the number of products in FDA review has reached 326.
In 2015, FDA’s official website recorded a total of 58 applications for ANDA for the first patent challenge for generic research products. Relying on strong R&D and litigation capabilities, Teva family occupied 25 of them, including 20 exclusive first filings and 5 first filings with other generic companies.
As of September 7, 2016, the FDA’s official website recorded a total of 27 applications for the first patent challenge for ANDA from various generic companies. Teva continued its good momentum last year and occupied 13 of the total, including 12 of them. Exclusive.
List of the first declarations of generic drugs in the US market in 2016
In 2015, Teva sold 4 of the top 10 products in the U.S. market for generic drugs, and 6 of them were brand specialty drugs, with sales exceeding US$300 million. Copaxone, the treasure of Zhenshan, continued its outstanding performance and continued to lead the race in the forefront. The sales share of 40mg/ml long-acting products already accounts for 70%, and the competition for 20mg/ml generic drugs that Sandoz launched in June 2015 is very limited.
From the therapeutic perspective, the respiratory system and nervous system products accounted for the largest proportion among the top ten products; from the dosage form, oral preparations have obvious advantages, followed by inhalants; in terms of share, the top ten products are in their respective generic pharmaceutical fields. In the field of branded drugs, it has shown strong strength; from the perspective of competition, competition from generic drugs for brand drugs due to patent protection and other factors is very limited. The competition of the four generic drugs is relatively fierce, but it has not yet reached its peak. degree.
Business Development Strategy
“Streamlined administration” has always been one of Teva’s long-term strategies. The longer the taller, the more difficult it is to avoid a slimming exercise. In order to achieve the target of slashing $2 billion in annual expenditures in 2017, Teva has closed many factories worldwide. After the acquisition of the Allegan generics business, Teva re-integrated the two companies’ generic products in the US market. Some of the products with limited profits were resolutely abandoned. In 2016, compared to 2015, dozens of products were sold out, including tablets. Capsules and capsules occupy the vast majority, covering a variety of therapeutic areas such as anti-infection, nervous system, and cardiovascular.
But to lose weight to lose weight, the body’s muscles still have to increase, as the lead brother, not a stick of scorpion meat how to make the following group of younger brother impressed? While cutting generics business, Teva is also actively seeking cooperation opportunities to strengthen its strength in specialty medicines, featured generics and biosimilars.
In terms of generic drugs, after receiving the third brother actavis, the big brother’s warehouse has been piled up. There are other brothers, basically, big brothers, even some difficult projects of NCE-1. When the younger brother decided to start R&D, it was very likely that Big Brother would have written more materials. Taking into account the way that a big brother is willing to go to a family-owned factory, it is certainly not realistic to talk about expanding the CMO business. Big Brother is really interested in what he wants to do but no technology, or high barrier projects that are too technically difficult to do. As long as you can make it, the lawsuit is handed to the big brother.
In respect of specialist medicine, Teva will continue to seek opportunities for external cooperation in the areas of respiratory medicine, central nervous system, anti-tumor and women’s health, with a view to further increasing profitability in the short term and consolidating its leading position in the existing advantageous areas. In the area of respiratory and central nervous diseases, as long as Big Brother feels good, even some early projects can be discussed. For the two areas of cancer and women’s health, Big Brother made it clear that they were only interested in some projects in the later stages of R&D. So the keyword of Big Brother is always “Quick! Quick! Quick!”
The rapid penetration of biosimilar drugs has become an inevitable trend in the development of the US market. The world of biological medicine is wonderful, but for most young people who have limited financial resources and started with small molecules, the world is also helpless. At present, Zarxio in Sandoz is recognized as the first biosimilar in the US market to be approved by the 351(k) approach. However, everyone may have ignored Teva’s Grastim (Filgrastim) landing the United States on the 351(a) route as early as 2012. The market became the second short-acting GCSF series product in the U.S. market after Amgen.
Biological medicine has always been a field that Teva vigorously developed. But overall, the number of products is still relatively limited, and most of them are based on prokaryotic expressions. The overall strength has been left behind by Sandoz, the second home owner who holds the imitation sword. Although having experienced parting ways with Lonza and Pidilizumab’s half-baking, the approval of Cinqair (reslizumab) was a shotgun for the elder brother who continued to thrive in the setbacks. The cooperation with Fusinumab on Fasinumab also put us on the list. The future performance of the field is full of expectations.
However, after reading the news that “Amgen Amjevita became the fourth FDA-approved biosimilar”, Big Brother silently turned off the cell phone, lit a cigarette, and started looking at the starry sky at a 45-degree angle.
2016-2019 Teva Global Sales Revenue Forecast
It is estimated that Teva’s sales revenue will be between 22 billion and 22.5 billion in 2016, and it is estimated to reach 27.8 billion in 2019, with a five-year compound growth rate of 9%.
- Consolidate the two core strengths of the central nervous system and respiratory system. Based on this, we will continue to expand and enrich generic and specialty drug product lines, especially complex and high barrier products, and maintain rapid growth.
- We will continue to expand the scope of our global business. While strengthening the traditional markets in Europe and the United States, we will attach importance to the rapid growth of emerging markets in the country, through acquisitions to enter the local market, and gradually grow stronger and bigger.
- Maintain and expand core specialty medicines, reduce the impact of patent protection of core specialty drugs such as Copaxone by improving existing products or launching new products in the same field, and maintaining the leading position of the company’s product line in relevant fields, striving to be in line with generic drugs. Advantages in the fierce competition of other branded drugs
- Seek strategic business cooperation, actively seek cooperation opportunities covering the company’s existing business areas on a global scale, establish strategic partnerships by establishing joint ventures or alliances, etc.
- Reduce operating costs gradually through institutional simplification and other measures to ensure maximum corporate profits