What is The Pharmaceutical Industry?

GCP-Mindset - All About Clinical Research
13 Jan 202203:58

Summary

TLDRThe pharmaceutical industry encompasses manufacturers that create drugs, including both original and generic manufacturers. Original manufacturers, also known as research-based companies, focus on developing new drugs and often lead in specific medical areas, investing heavily in branding and sales. In contrast, generic manufacturers produce drugs using expired patents, offering lower-cost alternatives without conducting research. The industry's product range is extensive, covering drugs for human and veterinary medicine, excluding medical devices. Pharmaceutical companies are subject to strict regulations, including pharmacovigilance, risk management, and adherence to good manufacturing practices. Notable industry leaders include Hoffmann-La Roche, Pfizer, Merck, Johnson & Johnson, Bristol-Myers Squibb, Sanofi, Advi, and GlaxoSmithKline, with a combined turnover exceeding $350 billion.

Takeaways

  • 💊 The pharmaceutical industry includes companies that manufacture drugs, known as pharmaceutical manufacturers.
  • 🔬 Pharmaceutical companies are involved in research and development, manufacturing, and marketing of drugs.
  • 🏭 There are two main types of manufacturers: original (research-based) manufacturers and generic manufacturers.
  • 🧪 Original manufacturers specialize in specific areas and invest heavily in branding and sales, while generic manufacturers offer drugs at lower prices after patent expiration.
  • 📈 Original manufacturers often work with subsidiaries or external manufacturers to produce generics and improve the value-added cycle.
  • 🐾 The industry's product range is vast, including drugs for human and veterinary medicine, but not medical devices.
  • 🏗️ Pharmaceutical companies can manufacture their products or use contract manufacturers like contract manufacturing organizations (CMOs).
  • 📜 Companies are subject to special pharmaceutical laws, including pharmacovigilance and risk management systems, and must adhere to good manufacturing practices.
  • 🌍 Each country has its own set of laws and regulations that pharmaceutical companies must follow.
  • 💰 The world's largest pharmaceutical manufacturers have a combined turnover of over 350 billion U.S. dollars.
  • 📊 The largest companies include Hoffmann-La Roche, Pfizer, Merck, Johnson and Johnson, Bristol-Myers Squibb, Sanofi, Advi, and GlaxoSmithKline.

Q & A

  • What is the pharmaceutical industry?

    -The pharmaceutical industry consists of manufacturers, also known as pharmaceutical companies, that produce drugs. This includes a range of activities from research and development of new active ingredients to the manufacturing and marketing of pharmaceuticals.

  • What are the two main groups pharmaceutical manufacturers can be divided into?

    -Pharmaceutical manufacturers can be divided into two main groups: original manufacturers, also known as research-based manufacturers, and generic manufacturers.

  • What characterizes original manufacturers in the pharmaceutical industry?

    -Original manufacturers are characterized by conducting pharmaceutical research and development of new drugs. They often specialize in selected indication areas where they are market leaders and invest heavily in branding and sales.

  • What is the primary difference between generic and original manufacturers?

    -Generic manufacturers typically do not conduct research but use active ingredients for which patent protection has expired. They can offer drugs of the same quality at significantly lower prices due to lower research and development costs.

  • How do original manufacturers work with generics?

    -Original manufacturers often work with subsidiaries that produce generics or cooperate with external generics manufacturers to improve the value-added cycle of their active ingredients.

  • What types of products are included in the pharmaceutical companies' product range?

    -The product range includes a wide variety of drugs for both human and veterinary medicine, such as finished drugs, blood preparations, serums, vaccines, in vivo diagnostics, allergen preparations, and drugs for novel therapies like gene therapeutics and biotechnologically processed tissue products.

  • What are some examples of novel therapies mentioned in the script?

    -Examples of novel therapies include gene therapeutics, somatic cell therapeutics, and biotechnologically processed tissue products.

  • What is not considered a medicine by pharmaceutical companies?

    -Medical devices such as bandages, catheters, or artificial joints are not considered medicines, even if some pharmaceutical companies manufacture them.

  • What are the special obligations that pharmaceutical companies are subject to?

    -Pharmaceutical companies are subject to special pharmaceutical law obligations, which include the implementation of a pharmacovigilance and risk management system, as well as a quality management system in accordance with good manufacturing practices for clinical trials.

  • What are the largest pharmaceutical manufacturers in the world?

    -The world's largest pharmaceutical manufacturers are currently Hoffmann La Roche, Pfizer, Merck, Johnson and Johnson, Bristol-Myers Squibb, Sanofi, Advi, and GlaxoSmithKline.

  • What is the combined turnover of the mentioned largest pharmaceutical manufacturers?

    -Together, these companies have a turnover of more than 350 billion U.S. dollars.

  • What are the different types of manufacturers that can produce medicines?

    -Medicines can be manufactured by the pharmaceutical company themselves or by contract manufacturers, such as a contract manufacturing organization.

  • What is the role of pharmacovigilance in the pharmaceutical industry?

    -Pharmacovigilance is a system that monitors the safety of drugs and ensures that the benefits of using a medicine outweigh any potential side effects or risks once it is available to patients.

Outlines

00:00

💊 Introduction to the Pharmaceutical Industry

This paragraph introduces the pharmaceutical industry, explaining that it is made up of companies that manufacture drugs. The industry encompasses a range of activities from research and development of new drugs to manufacturing and marketing. It differentiates between original manufacturers, who are involved in the development of new drugs and typically specialize in certain areas, and generic manufacturers, who produce drugs using expired patents, often at lower costs. The paragraph also touches on the various types of medicines produced, including human and veterinary medicines, and the regulatory requirements that pharmaceutical companies must follow. It concludes with a mention of the world's largest pharmaceutical companies and their combined turnover.

Mindmap

Keywords

💡Pharmaceutical Industry

The pharmaceutical industry is the sector of the economy that is involved in the research, development, production, and marketing of drugs. It includes both the creation of new medications and the manufacturing of existing ones. In the video, this industry is the central theme, as it discusses the various aspects and players within it.

💡Pharmaceutical Manufacturers

Pharmaceutical manufacturers are companies that produce drugs. They are a key component of the pharmaceutical industry and are responsible for the actual creation of medications. The script mentions that these manufacturers can be divided into original and generic manufacturers, highlighting the diversity within the industry.

💡Research and Development (R&D)

Research and development refers to the process of creating new drugs or improving existing ones. It is a critical aspect of the pharmaceutical industry and involves scientific inquiry and experimentation. The video emphasizes the importance of R&D in the context of original manufacturers, who are characterized by their pharmaceutical research and development of new drugs.

💡Original Preparations

Original preparations are drugs that are developed by pharmaceutical companies through extensive research and are protected by patents. These drugs are often the result of significant investment in R&D and are marketed under the manufacturer's own name. The script notes that original manufacturers specialize in selected indication areas and invest heavily in branding and sales.

💡Generics

Generic drugs are medications that are chemically equivalent to brand-name drugs but are sold under different names. They are typically produced after the patent protection of the original drug has expired. The video points out that generic manufacturers do not conduct research but offer drugs at significantly lower prices, making them accessible to a wider population.

💡Marketing Authorization Holder

A marketing authorization holder is an individual or company that has received permission from regulatory authorities to market a pharmaceutical product. The script mentions this term in the context of pharmaceutical manufacturers placing their products on the market under their own name as a marketing authorization holder.

💡Pharmacovigilance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems. It is a crucial part of the pharmaceutical industry's commitment to safety. The video script includes this term when discussing the obligations of pharmaceutical companies.

💡Good Manufacturing Practice (GMP)

Good Manufacturing Practice is a system for ensuring that products are consistently produced and controlled according to quality standards. It is a regulatory standard that pharmaceutical companies must follow to ensure the quality of their products. The script refers to GMP in the context of quality management systems for clinical trials.

💡Veterinary Medicine

Veterinary medicine involves the medical treatment of animals. It is a part of the pharmaceutical industry's scope, as companies also produce drugs for animals. The video script mentions that the product range of pharmaceutical companies includes drugs for both human and veterinary medicine.

💡Novel Therapies

Novel therapies refer to innovative medical treatments that are different from traditional ones. The script mentions gene therapeutics and somatic cell therapeutics as examples of novel therapies. These therapies represent the cutting edge of pharmaceutical research and are part of the industry's drive to develop new treatments for various conditions.

💡Contract Manufacturing Organization (CMO)

A Contract Manufacturing Organization is a company that provides contract manufacturing services for the pharmaceutical industry. Some pharmaceutical companies may choose to outsource the production of their drugs to CMOs. The script indicates that medicines can be produced by the pharmaceutical company themselves or by contract manufacturers like CMOs.

💡Regulations and Guidelines

Regulations and guidelines are the rules and standards set by governments and regulatory bodies that pharmaceutical companies must adhere to. These are in place to ensure the safety, efficacy, and quality of pharmaceutical products. The video script notes that every country has its own set of laws, guidelines, and regulations for pharmaceutical companies.

Highlights

The pharmaceutical industry includes companies that manufacture drugs.

Activities in the industry range from R&D of new drugs to manufacturing and marketing.

Pharmaceutical manufacturers are divided into original and generic manufacturers.

Original manufacturers are research-based and specialize in certain indication areas.

Original manufacturers invest heavily in branding and sales.

Generic manufacturers do not conduct research but use expired patent ingredients.

Generic drugs are offered at significantly lower prices than original drugs.

Most generic manufacturers are full range suppliers offering many different active ingredients.

Original manufacturers may work with subsidiaries or external manufacturers to produce generics.

The product range of pharmaceutical companies includes a variety of drugs for human and veterinary medicine.

Pharmaceuticals include finished drugs, blood preparations, serums, vaccines, and more.

Medicines do not include medical devices like bandages or artificial joints.

Pharmaceutical companies can manufacture their own products or use contract manufacturers.

Pharmaceutical companies are subject to special legal obligations including pharmacovigilance and quality management.

Different countries have their own laws, guidelines and regulations for the pharmaceutical industry.

The world's largest pharmaceutical manufacturers have a combined turnover of over 350 billion U.S. dollars.

The largest companies include Hoffmann La Roche, Pfizer, Merck, Johnson and Johnson, and others.

The video provides a comprehensive overview of the pharmaceutical industry and its key players.

Transcripts

play00:00

[Music]

play00:00

hi and welcome back to our gcp mindset

play00:03

channel and all topics on clinical

play00:05

research

play00:06

today we'll talk about the

play00:08

pharmaceutical industry to give you a

play00:10

small overview

play00:12

so what is the pharmaceutical industry

play00:14

more after the break

play00:16

[Music]

play00:22

let's dive right in

play00:24

pharmaceutical manufacturers also known

play00:26

as pharmaceutical companies and

play00:28

collectively referred to as the

play00:30

pharmaceutical industry are

play00:32

entrepreneurs or companies that

play00:34

manufacture drugs

play00:36

the spectrum of activities includes

play00:38

research and development for new active

play00:40

ingredients and dosage forms the

play00:42

manufacture of pharmaceuticals original

play00:45

preparations or generics and the placing

play00:48

on the market under one's own name as a

play00:51

marketing authorization holder or as a

play00:53

co-distributor

play00:54

in general pharmaceutical manufacturers

play00:57

can be divided into two groups original

play01:00

and generic manufacturers the original

play01:03

manufacturers are also referred to as

play01:05

research-based manufacturers and are

play01:08

characterized by pharmaceutical research

play01:10

and the development of new drugs

play01:13

original manufacturers usually

play01:15

specialize in selected indication areas

play01:17

in which they are market leaders

play01:19

they typically invest heavily in

play01:22

branding and sales generic manufacturers

play01:25

on the other hand usually do not conduct

play01:27

any research but use active ingredients

play01:30

for which patent protection has already

play01:32

expired

play01:33

due to the low research and development

play01:35

costs it is possible for generic drug

play01:38

manufacturers to offer drugs of the same

play01:41

quality at significantly lower prices

play01:44

than is possible for the researching

play01:45

manufacturers

play01:47

most generic manufacturers appear on the

play01:50

market as full range suppliers and offer

play01:53

as many different active ingredients as

play01:55

possible in many cases original

play01:57

manufacturers work with subsidiaries

play02:00

that produce generics or cooperate with

play02:02

external generics manufacturers in order

play02:05

to improve the value-added cycle of

play02:07

their active ingredients

play02:09

the product range of the pharmaceutical

play02:11

companies includes a wide variety of

play02:13

drugs for both human and veterinary

play02:16

medicine such as finished drugs blood

play02:19

preparations serums vaccines in vivo

play02:22

diagnostics allergen preparations and

play02:24

drugs for novel therapies for example

play02:27

gene therapeutics somatic cell

play02:29

therapeutics biotechnologically

play02:31

processed tissue products medicines do

play02:34

not include medical devices such as

play02:36

bandages catheters or artificial joints

play02:40

even if some of these are manufactured

play02:41

by pharmaceutical companies medicines

play02:44

are either manufactured by the

play02:46

pharmaceutical company themselves but

play02:48

they can also be produced by contract

play02:50

manufacturers like contract

play02:52

manufacturing organization

play02:55

pharmaceutical companies are subject to

play02:57

special pharmaceutical law obligations

play03:00

implementation of a pharmacovigilance

play03:02

and risk management system quality

play03:04

management system in accordance with

play03:06

good manufacturing practice for clinical

play03:09

and clinical trials in order to ensure

play03:12

the quality effectiveness and safety of

play03:14

their products

play03:16

every country has its own laws

play03:18

guidelines and regulations for

play03:20

pharmaceutical companies which the

play03:22

companies must adhere to the world's

play03:25

largest pharmaceutical manufacturers are

play03:27

currently hoffmann la raj naverties

play03:30

pfizer merck johnson and johnson

play03:32

bristol-myers squibb sanofi advi and

play03:36

glaxosmithkline

play03:38

together these companies have a turnover

play03:40

of more than 350 billion u.s dollars

play03:44

so much for our explanation of what

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pharmaceutical companies are

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we hope that we could give a good little

play03:51

overview

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Related Tags
Pharmaceutical IndustryDrug DevelopmentGeneric DrugsResearch-BasedActive IngredientsPharmacovigilanceQuality ManagementClinical TrialsHealthcare SectorMarket LeadersRegulatory Compliance