“Revolutionizing Healthcare: A Look at the Breathtaking Advances in the Medical Industry”

One of the major medical breakthroughs in 2023 was the approval of the first CRISPR gene-editing therapy by the U.S. Food and Drug Administration.

 This therapy, known as Casgevy, was developed to treat sickle cell disease by helping patients produce healthy hemoglobin. Patients with sickle cell disease have abnormal hemoglobin, leading to hard and crescent-shaped red blood cells that can block blood flow. The FDA is expected to make a decision by March 2024 on whether the same therapy can be used to treat beta-thalassemia, a disorder that reduces hemoglobin production.

Alzheimer's Progress:

 In July, the FDA granted full approval to the Alzheimer's drug lecanemab, also known as Leqembi. Similar to the 2021-approved drug aducanumab, lecanemab targets and removes amyloid plaques that accumulate in the brains of individuals with Alzheimer's disease. While the drug does not halt the progression of the disease, clinical trials demonstrated that lecanemab slowed cognitive decline by approximately 30% over an 18-month period compared to a placebo.

Muscular Dystrophy Gene Therapy:

In June, the FDA authorized the first gene therapy designed for children with Duchenne muscular dystrophy. This genetic disorder prevents the production of dystrophin protein due to a faulty gene, leading to muscle degeneration. The therapy aims to stimulate the body to generate a form of the missing protein.

 RSV Protection:

Throughout the year, various methods to guard against respiratory syncytial virus (RSV) emerged. In May, the FDA approved Arexvy, the initial RSV vaccine in the United States, for adults aged 60 and above. Subsequently, in August, a vaccine named Abrysvo was authorized for pregnant individuals. Additionally, a monoclonal antibody received approval in July to shield children aged 2 and under from RSV, a virus that annually causes numerous young children to be hospitalized in the U.S.

 Postpartum Depression Treatment:

 Until August, the sole medication specifically targeting postpartum depression in the U.S. necessitated a lengthy intravenous infusion in a hospital setting. With the FDA's approval of zuranolone, branded as Zurzuvae, individuals grappling with postpartum depression can now take an oral medication at home and potentially experience improvement within three days.

Over-the-Counter Birth Control:

 In July, the FDA decided that the oral contraceptive norgestrel, initially sanctioned in 1973, should be available without a prescription. This marked the introduction of the first over-the-counter daily birth control pill in the U.S. Some public health experts argue that reducing barriers to contraception is crucial for reproductive autonomy, particularly amidst state restrictions on abortion access.

Chikungunya Vaccine:

In November, the FDA greenlit the first vaccine against chikungunya virus, which can cause fever, severe joint pain, and pose a risk to newborns. Transmitted by mosquitoes, this virus is most prevalent in tropical regions but is increasingly spreading to new areas globally according to FDA warnings.

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The Pharmaceuticals industry

The Pharmaceuticals industry encompasses products used for the treatment, prevention, and diagnosis of diseases, including both small molecule drugs and biologic medical products known as drugs, medications, or medicines. This sector includes prescription and over-the-counter drugs, which are distributed through various channels such as pharmacies, hospitals, physicians, and drug stores. These medications can be administered in different forms like pills, capsules, gels, injections, and aerosols. The Pharmaceuticals market is segmented into categories based on specific medical fields or types of medicines, including original brands, biosimilars, generics, and orphan drugs. Additionally, there is an Other Pharmaceuticals segment that covers specialties not included in the main markets. Market values reflect the revenues generated from the sale of pharmaceutical products at manufacturer prices, excluding VAT. These revenues encompass spending by consumers, companies, and governments.

The Pharmaceuticals industry is projected to achieve a revenue of US$1,156.00 billion by 2024. Oncology Drugs are anticipated to be the leading segment, reaching a market volume of US$214.10 billion in the same year. Looking forward, this sector is predicted to grow at an annual rate of 6.19% from 2024 to 2028, resulting in a market volume of US$1,470.00 billion by 2028. The United States is expected to lead globally with a revenue of US$636.90 billion in 2024, attributed to its advanced healthcare infrastructure and robust research and development capabilities. The Pharmaceuticals market spans across various countries worldwide, with the United States standing out for its pharmaceutical innovation.

The Pharmaceuticals industry has experienced consistent growth recently, driven by innovative medications and a rising global need for pharmaceuticals and therapies.

 Consumer preferences:

 Customers in the Pharmaceuticals sector are increasingly seeking personalized and targeted treatments, emphasizing preventive healthcare. This has resulted in an increased demand for precision medicines, which are customized to individual genetic profiles and offer more efficient treatments with fewer adverse effects. While over-the-counter (OTC) pharmaceuticals have a limited impact compared to prescription drugs in terms of revenue, the market for prescription drugs is primarily dominated by original products. Nevertheless, there is a growing interest in OTC medications, which are readily available and can be purchased without a prescription.

The Pharmaceuticals industry has seen steady growth recently, propelled by advancements in medications and a growing global demand for pharmaceuticals and treatments.

 Changing consumer preferences:

 Customers in the Pharmaceuticals sector are increasingly looking for tailored and precise treatments, prioritizing preventative healthcare. This has led to a surge in the need for personalized medicines, which are tailored to individual genetic profiles and provide more effective treatments with fewer side effects. Although over-the-counter (OTC) pharmaceuticals play a smaller role in terms of revenue compared to prescription drugs, the prescription drug market is mainly dominated by original products. Nonetheless, there is a rising interest in OTC medications that are easily accessible and purchasable without a prescription.

Market trends:

 The Pharmaceuticals market is experiencing disruptions due to innovative drugs and patent expirations. Large pharmaceutical companies have traditionally dominated the market, investing heavily in research and development to introduce new drugs. However, there is an increasing presence of generic drug manufacturers offering more affordable alternatives to branded drugs, leading to heightened competition and a shift towards cost-effective healthcare solutions. In Europe, there is a strong emphasis on cost containment, prompting governments and healthcare providers to seek ways to reduce healthcare expenses. This has accelerated the adoption of biosimilars as cheaper substitutes for biologic drugs. In Asia, the Pharmaceuticals market is expanding rapidly due to growing healthcare demand and rising disposable incomes. Innovation is a key focus, with a surge in biotech startups and heightened interest in precision medicine. Additionally, there is a move towards online pharmacies and telemedicine services, providing enhanced convenience and accessibility for patients.

The Pharmaceuticals industry is typically subject to stringent regulations and patent laws, with approval processes varying across different countries. In Africa, challenges such as inadequate infrastructure and regulatory frameworks have impeded the growth of the Pharmaceuticals market. Despite these obstacles, there is increasing investment and collaboration with local firms in the region. Efforts are also being made to enhance healthcare accessibility through initiatives like mobile health clinics and community health workers.

The Pharmaceuticals industry is significantly impacted by macroeconomic factors like government regulations, healthcare expenditure, and demographic shifts. Developed nations have witnessed increased healthcare spending due to aging populations and higher prevalence of chronic illnesses. Developing countries are prioritizing healthcare accessibility through greater government funding and support from global entities. Furthermore, the industry is experiencing a shift towards digitalization and automation, enhancing operational efficiency and reducing costs in the pharmaceutical supply chain.

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THE PHARMACEUTICAL INDUSTRY:

A KEY ASSET TO THE EUROPEAN ECONOMY

As well as driving medical progress by researching, developing and bringing new medicines that improve health and quality of life for patients around the world, the research-based pharmaceutical industry is a key asset of the European economy. It is one of Europe’s top performing high-technology sectors.

Values in € million unless otherwise stated

MAIN TRENDS

The research-based pharmaceutical industry can play a critical role in restoring economic growth in Europe and ensuring future competitiveness in an advancing global economy. In 2022 it invested an estimated €44,500 million in R&D in Europe. It directly employs some 865,000 people and generates about three times more employment indirectly – upstream and downstream – than it does directly (PwC, Economic and societal footprint of the pharmaceutical industry in Europe, June 2019). However, the sector faces real challenges. Besides the additional regulatory hurdles and escalating R&D costs, the sector has been severely hit by the impact of fiscal austerity measures introduced by governments across much of Europe since 2010.

There is rapid growth in the market and research environment in emerging economies such as Brazil, China and India, leading to a gradual migration of economic and research activities from Europe   to these fast-growing   markets. During the period 2017-2022 the Brazilian, Chinese and Indian markets grew by 13.0%, 5.3% and 11.0% respectively compared to an average market growth  of 6.6% for the top 5 European Union markets and 7.1% for the US market (source: IQVIA MIDAS, May 2023).

In  2022  North  America  accounted   for  52.3% of  world  pharmaceutical  sales  compared  with 22.4%  for Europe.  According   to  IQVIA  (MIDAS May 2023), 64.4% of sales of new medicines launched during  the period 2017-2022 were on the US market, compared with 16.4% on the Eu- ropean market (top 5 markets).

The fragmentation of the EU pharmaceutical market has resulted in a lucrative parallel trade. This benefits neither social security nor patients and deprives the industry of additional resources to fund R&D. Parallel trade was estimated to amount to €6,280 million (value at ex-factory prices) in 2021

GEOGRAPHICAL BREAKDOWN (BY MAIN MARKETS) OF SALES OF NEW MEDICINES LAUNCHED DURING THE PERIOD 2017-2022

PHARMACEUTICAL PRODUCTION

According to EUROSTAT data, the pharmaceutical industry is the high technology sector with the highest added value per person employed, significantly higher than the average value for high tech and manufacturing industries. The pharmaceutical industry is also the sector with the highest ratio of R&D investment to net sales. According to the 2022 EU Industrial R&D Investment Scoreboard, health industries invested about €235.3 billion in R&D in 2021, accounting for 21.5% of total business R&D expenditure worldwide.

Source: EFPIA member associations (official figures)

PHARMACEUTICAL SALES

The world pharmaceutical (prescription) market was worth an estimated €1,222,921 million ($1,287,736 million) at ex-factory prices in 2022. The North American market (USA & Canada) remained the world’s largest market with a 52.3% share, well ahead of Europe, China and Japan.

BREAKDOWN OF THE WORLD PHARMACEUTICAL MARKET – 2022 SALES

 PHARMACEUTICAL MARKET VALUE

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