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Counterfeit medicines

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2022: Era of expensive drugs worth millions of dollars begins

On December 26, 2022, The Wall Street Journal reported on the onset of a new era of ultra-expensive drugs, the cost of which could be several million dollars.

We are talking about gene therapy drugs. Since August 2022, regulators USA Europe have approved the use of four new products designed to treat rare genetic diseases. These drugs relieve the disease in one course, but its cost is at least $2 million.

High price associated with efficacy of drugs to act on rare diseases

In particular, the price of Hemgenix the company's drug, CSL designed to combat hemophilia B, is $3.5 million, which is an absolute record. Skysona, developed by the company Bluebird and designed to treat a rare neurological disease in children, is estimated at $3 million. For a remedy (Zynteglo also created by Bluebird) to treat an inherited blood disease, you will have to pay $2.8 million. The cost of Zolgensma from for Novartis the treatment of a muscle wasting condition is $2.1 million.

The developers of these funds say that the high price is justified, since one dose is actually enough to treat a rare disease. At the same time, the patient is either completely cured, or for many years he can forget about his illness. In addition, such therapy in the long term will theoretically even save money, as it will save patients from the need to use outdated treatments throughout their lives. However, health insurers say they are not set up for such large payouts. They prefer to pay for older established treatments on a regular basis over a long period of time rather than give away a huge sum for a one-time course, despite the benefits of such an approach.^[1]

2021: Top 8 biggest players by prescription drug sales and R&D costs

Data for 2021

2020: Drug sales up 3% to $900.7 billion

In August 2021, Evaluate analysts released a study on the global drug market. Sales of drugs at the end of 2020 reached $900.7 billion, an increase of 3% compared to 2019. The top five producers accounted for almost a quarter of the market.

The Swiss company Roche took the first place in terms of revenue in the pharmaceutical market in 2020. In the immediate vicinity of it is Novartis. You can learn more about the balance of power among drug manufacturers from the illustration below.

World's largest drugmakers

According to experts, despite the fact that the COVID-19 coronavirus pandemic has affected all market players, it has affected pharmaceutical and biotechnology companies to varying degrees, depending on the assortment portfolio and business size. It is argued that the presence in the portfolio of drugs used in COVID-19 did not significantly affect the market capitalization of large manufacturers and large corporations. Their business remains the most stable even in economically difficult times.

Analysts note that the impact of the COVID-19 coronavirus on the pharmaceutical market is becoming more and more clear. In different countries, similar trends were noted against the background of a pandemic that suddenly hit the world. The researchers identified several main trends in the change in the global pharmaceutical market against the background of a difficult epidemiological situation.

Among them - the pronounced peak in the growth of pharmacy sales in the initial phase of morbidity observed in most countries with their subsequent fall. At the same time, the hospital sector grew more slowly than the commercial one. In the markets of the top 5 European countries, panic purchases of medicines were observed before the countries were quarantined. Both drugs for the treatment of chronic diseases and symptomatic agents for the auxiliary therapy of coronavirus infection, including painkillers and antipyretic drugs, were purchased.

Sales of pharmaceuticals at the end of 2020 increased by 3%, to $900.7 billion

According to experts, in recent years there have been more and more restrictions related to the promotion of medicines, and competition in the market continues to intensify. As a result of this situation, pharmaceutical companies are forced to change their promotion strategies, adapting them to a new reality.

Manufacturers are also concerned that the image of pharmaceuticals is often associated with negativity. To rectify the situation, they create new branding elements. In particular, they introduce into information materials and advertising campaigns provisions on the ethics of their business, the innovation of new drugs, on their investments in the economy of the host country, on free educational programs and services such as hotlines, create various "loyalty programs," that is, social benefits, discounts, promotions, etc.

New opportunities are leading pharmaceutical companies to face new risks and new forms of risks they already know that manufacturers have yet to learn how to manage:

• risk of theft of commercial information;
• risk of personal data leakage;
• reputational risks associated with the dissemination of negative information about the drug by competitors and third parties on the Internet;
• the risk of "enticing" the consumer with a competitor due to the introduction of remote drug trading, which expanded the range available to the buyer and presented customers with the opportunity to quickly compare drug prices at different sites;
• risks of non-compliance with compliance requirements and advertising laws.^[2]

2018

Top 50 pharmaceutical companies by global sales of prescription drugs in 2018

Pfizer topped the rankings with $45 billion in sales that boosted its leaders Prevnar 13, Lyrica and Enbrel.

Sales of Ibrance, a breast cancer treatment that was approved for use in men in April 2018, also boosted Pfizer's sales, according to Pharmaceutical Exec.

Pfizer has remained at the top of the rankings for the fourth consecutive year.

Cancer drugs are the main source of income for pharmaceutical companies

Cancer drugs are the main source of income for pharmaceutical companies

Cancer drugs in 2018 brought in $123 billion in revenue to pharmaceutical companies - with total revenues of 864 billion. In second place, with a lag of more than 2 times, there are drugs for rheumatism. On the third - from diabetes, but according to forecasts by 2024 they will change places.

We also expect an increase in revenues from vaccines by one and a half times, immunosuppresants by 2 and a half times, dermatological drugs by 2 times.

Top 10 best-selling drugs of the year

On March 21, 2019, it became known that the top 10 best-selling drugs were announced in 2018. Humira (adalimumab) from the company AbbVie remains the best-selling drug for the past 2 years, according to a bio-business review in Nature Reviews Drug Discovery. The world of sales this drug increased in 2017 by 18.4 billion, and in dol. USA 2018 - by 19.9 billion dollars.

As reported, at the end of 2018, the Food and Drug Administration (FDA) approved the biological analogue of Humira - Hyrimoz (Sandoz). However, due to patent protection, this drug will not appear on the market until 2023.

On the 2nd place in 2018, as a year earlier, there is a drug that is used for the treatment of blood cancer Revlimid (lenalidomide) from Celgene. Sales of this drug in 2018 amounted to $9.7 billion. compared to $8.2 billion. in 2017

3rd place is taken by the drug from Merck Keytruda (pembrolizumab), which is a programmed inhibitor of cell death of ligand-1 and is used to treat lung cancer and other types of oncological pathology. In 2017, with sales figures of 3.8 billion dollars. the drug Keytruda did not make it into the top ten best-selling drugs. However, in 2018, its sales reached $7.2 billion, which secured it 3rd place in this ranking.

The following 3 places, respectively, are occupied by drugs for treatment in the field of oncology from Roche: 4th place - Herceptin (trastuzumab), whose sales in 2018 amounted to $7.1 billion, which is equal to the indicators of 2017; 5th place - Avastin (bevacizumab) with sales in 2018 at $7 billion. compared to $6.8 billion. in 2017; 6th place - Rituxan (rituximab), its sales in 2018 amounted to $6.9 billion. compared to $7.5 billion. in 2017

As of March 2019, it is unclear how long these 3 drugs will hold a leading position in the global market, given the recent approval of their biosimilars in the United States.

Bristol-Myers Squibb Opdivo (nivolumab) monoclonal antibody drug, which is indicated for the treatment of various types of oncopathology, including lung cancer and melanoma, ranked 7th in this ranking. In 2018, sales of this drug amounted to $6.7 billion, which is $4.9 billion. more than in 2017

8th place is taken by the drug Eliquis (apixaban) again from Bristol-Myers Squibb. The drug is a direct factor Xa inhibitor that is used to treat venous thromboembolic complications and prevent stroke in patients with atrial fibrillation. In 2018, sales of the drug amounted to $6.4 billion. compared to $4.9 billion. in 2017

Pfizer's pneumococcal vaccine Prevnar 13 ranked 9th in this ranking with sales of $5.8 billion. in 2018 compared to $5.6 billion. in 2017

The top 10 drug from Johnson & Johnson Stelara (ustekinumab) completes - an inhibitor of interleukin-12 and interleukin-23, which is used to treat psoriasis, active psoriatic arthritis and moderately severe stage Crohn's disease. In 2018, sales of this drug amounted to $5.7 billion. against 4 billion dollars. a year earlier.^[4]

2017

Sales of $789 billion

Outlook to 2024 by analytics firm Evaluate Pharma, the global pharmaceutical industry continues to gain momentum in the wake of the financial crisis, according to a 2018 World Preview report. At the end of 2017, sales amounted to $789 billion.

In the period 2018-2024, the Compound Annual Growth Rate (CAGR) of the global prescription drug market will be 6.4%. By 2024, sales will reach $1.2 trillion thanks to increased global access to medicines, as well as the launch of new treatments that cover unmet medical needs (including drugs for gene and cell therapy). So, recently drugs for CAR-T-cell therapy entered the market. Also not USA so long ago, the Food and Drug Administration (FDA) for the first time approved an innovative gene therapy for the treatment of a rare inherited form of blindness.

Global Prescription Drug Sales 2010-2017 and Forecast 2018-2024

Analysts predict high rates of development in the segment of orphan drugs. It will develop faster than the market as a whole. Thus, in 2018-2024 the sales volume of this group of medicines will almost double and by 2024 will reach $262 billion, which will amount to about 20% of the global prescription drug market.

Evaluate Pharma analysts include the introduction of generics and biosimilars to the market. In the period 2018-2024. original drugs with current sales of $251 billion will be subject to competition from generics or biosimilars. Perhaps the industry will face a second patent cliff. During the forecast period, drugs such as Humira and Stelara will lose exclusivity. Nevertheless, in 2024 they will still be in the top 10 best-selling medicines.

Pfizer - No. 1, but Novartis is predicted to lead

It is expected that the leader in the volume of global sales of prescription drugs will be Novartis with $53.2 billion. It is expected that by 2024 the 3 of the drug of this company will be in the top 50 best-selling (Cosentyx, Entresto and Jakafi). To remain "on the front line," the company continues to make strategic investments. So, recently FDA the drug Kymriah (CAR-T therapy) received approval. In addition, the company acquired gene therapy developer AveXis for $8.7 billion. They will compete for 2nd and 3rd places (Pfizer the main growth drivers will be Ibrance, Bavencio, Xeljanz and Eucrisa, as well as (Roche Tecentriq, Ocrevus and Hemlibra).

The top 5 best-selling medicines on the global market in 2024 are expected to form Humira, Keytruda, Revlimid, Opdivo and Eliquis.

Biotechnological drugs are increasing their share

Share of biotechnological drugs in the structure of global sales of prescription and over-the-counter drugs in 2010-2017 and forecast for 2018-2024

Biotechnological drugs accumulate a significant share of global sales of prescription and over-the-counter drugs. According to Evaluate Pharma estimates, their market share will increase from 25% in 2017 to 31% by 2024, and in the top 100 best-selling drugs, half of sales will be provided by biotechnological drugs. Roche will remain the undeniable leader in the biotech drugs market.

Oncology and diabetes mellitus are the main therapeutic areas

The most promising segment remains the field of oncology. If at the end of 2017 the volume of sales of drugs of this group amounted to $104 billion, then by 2024 it will reach $233 billion, increasing annually by an average of 12.2%. The main growth drivers will be Keytruda, Tecentriq and Opdivo. The top five most promising therapeutic areas will also include drugs for the treatment of diabetes mellitus, rheumatism, as well as vaccines and antiviral drugs^[5]

2016

USA largest pharmaceutical market, Russia No. 14

According to the results of 2016, Russia ranks 14th in the world in terms of the size of the pharmaceutical market (8th place in 2011). According to the EIU forecast, in 2021 the volume of sales in the country will increase by 31.4%, and Russia will retain 14th place in the ranking.

Johnson & Johnson is the largest pharmaceutical company in the world

At the end of 2016, the first place in the global pharmaceutical market with sales of $71.8 billion was taken by the American company Johnson & Johnson.

Data: FiercePharma based on official reporting

Sales forecast - $761.8 billion

Sales of prescription medicines by 2020 will amount to $918.7 billion with an average annual growth rate (CAGR) of 4.8%, according to a report prepared by WhaTech business portal in September 2016. According to experts, in 2016 the global sales of prescription drugs will amount to $761.8 billion.

The report noted that one of the main drivers of growth in global sales of prescription drugs will be an increase in life expectancy, which will lead to further aging of the population. In addition, the spread of chronic diseases, including in developing countries, is an important factor.

Meanwhile, experts say, biosimilar lonches and changes in public policy in some countries will play a restraining role.

Analysts expect the highest growth in the volume of sales of prescription drugs in the countries of the Asia-Pacific region against the background of rising levels of income and well-being of the population, patient awareness and government investment in the healthcare sector.

According to the forecast, North America will remain the largest global pharmaceutical market due to stable demand for drugs.

Among the key participants in the global prescription drug market, analysts consider the companies:

• AstraZeneca,
• Bayer,
• Roche,
• Gilead Sciences,
• GlaxoSmithKline,
• Johnson & Johnson,
• Merck & Co (outside the United States and Canada - MSD),
• Novartis,
• Pfizer,
• Sanofi et al.

How tablets dissolve in the stomach

Notes