Overview of Pharmaceutical Industry
Pharmaceutical Industry plays a vital role in the in the healthy life in modern society. It is addressing so many issues that are related to human health. The industry is not only providing the medicines, but also became an important element in the new global economy.
The journey of the Pharmaceutical Industry
Over the past century, there has been a rapid growth in this field and the emergence of new technologies has taken the pharmaceutical industry to new heights. Available history reveals that the thought process of making medicines has taken a paradigm shift in the 19th century, which led to the innovation of modern techniques. In the early days, medicines were prepared traditionally from herbs i.e., botanical drugs such as morphine. Extracts from animals and some minerals were also used as medicines in olden days.
Manufacturing of medicines was industrialized in the 20th century with the advancement of chemical engineering. Organic chemical synthesis stood as a backbone of the industry. Scientist successfully implemented isolation and purification technologies to produce individual organic compounds with high quality.
Now drug discovery is entirely on a new plane. Computer-aided chemical technology influenced every facet of the research and development in the pharma industry. The computational approach in drug screening has sped up the new drug innovation process. There are so many software packages to quantify the potential drug properties within a minimum time.
Classification of Pharmaceutical Industry
The modern pharmaceutical industry can be classified into three types for the purpose of easy understanding of the industry. They are:
- Bulk Drugs
- Formulations
- Biotechnology
This classification provides a basis for the overview of the industry at all angles. Let us dive into the details of each segment.
Bulk Drugs
The bulk drug is a substance which is used in the manufacture of the pharmaceutical product, i.e., medicinal drug product such as tablets, ointments and syrups. This is also called as "Active Pharmaceutical Ingredient (API)" or "Drug Substance".
Manufacture of Bulk Drugs is a critical one and at the same time, it is expensive. It requires a lot of resources and technical knowledge. Developing a consistent process to manufacture a specific drug is not that much easy as we think. Meeting required quality while maintaining safety measures is a major challenge to the bulk drug industry.
As this is a chemical industry, naturally it is linked with environment protection also. Management of hazardous waste and maintaining the green environment are the key responsibilities of the industry along with the manufacturing of quality drugs.
The techniques used in this bulk drug industry are fermentation, organic synthesis, and natural extraction.
Formulations
The formulation is a process used for making medicinal products by combining Active Pharmaceutical Ingredients and inert substances (excipients) as per the predefined ratios. Finished dosage forms are prepared in this division of the pharmaceutical industry. Quality, safety and efficacy of the finished dosage form is the key challenge here.
Maintenance of manufacturing facility as per the regulatory norms and designing a robust process with the strong quality system are the main factors that decide the efficiency and performance of the formulations business.
As the finished dosage forms are final medicinal products and taken by the patients as such in the form of tablets, syrups etc., patient safety is the crucial thing. Implementation of good manufacturing practices and having a strong investigation system to investigate the failures are essential things to sustain in this business.
Biotechnology
Biotechnology mainly deals with the techniques that use in the manufacture of Biopharmaceuticals. Living microorganisms are the main resources for the preparation of Biopharmaceuticals. The process employed in this technique modifies the living organisms as per the requirements of human use.
This industry is showing a rapid growth in recent years. More than 270 products are now available for human consumption. Biotechnology is playing a key role in improving the healthier lives of people in the modern electronic age.
Getting funds for this segment is the biggest challenge. The cost of research and development is too high as 36% of the drugs fail before the preliminary stage itself during the development. That is why biotech drug price is too high compared with a common pill. Regulatory compliance also is a big challenge for this industry. A thorough scrutiny goes by regulatory agencies to avoid disasters in the future.
Regulation of the Pharmaceutical Industry
Who controls the industry? The pharmaceutical industry is directly controlled by the Governments. Every country has its own country-specific regulations and Health Ministries. WHO governs the industry at an international level.
Every country has its own Pharmacopoeia. The following are some examples.
| The Pharmacopoeia |
|---|
| 1. WHO - International Pharmacopoeia |
| 2. USA - United States Pharmacopeia (USP |
| 3. India - Indian Pharmacopoeia (IP) |
| 4. European Union - The European Pharmacopoeia (Ph. Eur.) |
| 5. Japan - Japanese Pharmacopoeia (JP) |
| 6. China - Chinese Pharmacopoeia (CP) |
| 7. United Kingdom - The British Pharmacopoeia (BP) |
Times are changing. New technologies are bringing new habits to the people. Lack of physical activity, mental stress, and environmental changes are ruining people's health. Now health is everybody's concern of living on the earth. Medicine became a basic need. Hence for safe consumption of medicines, regulation of the industry is must and inevitable.
Implementation of Good Manufacturing Practices (GMP) is mandatory in the manufacturing plants. Transparency and data integrity must be maintained at any cost. Violation of these rules may lead to severe consequences as per the law laid in their country. The majority of drugs are exported to the USA, as it is a profitable market. US FDA is taking strict measures against the violations of Drugs law.
You might have heard about the warning letters from US FDA for some companies in recent years. This is the result of GMP violations. The companies cannot do any business in the countries from where they received warning letters. Because public health is the topmost priority for the governments in any country. Ultimately, this leads to, business losses and sometimes imprisonment also.
Size of Pharmaceutical Business
As health is everybody's concern, availability of medication everywhere is a natural demand. So the supplying needs are high. Accordingly, the business size is also high. The pharmaceutical industry is spread significantly almost in all developed and developing countries. This is also one of the largest employment sources along with other major industries.
Advancement of computer technology brought enormous changes in the industry. Automation in manufacturing units increased the business volume and reduced the lead time of drug preparation. This fact is reflected in the revenues of the pharma sector at global level.
Pharmaceutical sector's revenue growth has been increased to a appreciable level during recent years. The revenues had surpassed one trillion US dollars for the first time in 2014.
This fast-growing, leading to the expectation that the industry has the potential to reach the overall $1.4 trillion market by 2022. This rise will be at a quicker rate amid 2018-2020.
Many patents are going to be expired after 2020. So the market analysts are expecting that the growth speed may decrease a little bit after 2020.
The key players in the industry are the United States, Switzerland and China. Many countries are importing raw materials from China in big volumes.
Top 10 Global Pharmaceutical companies
Thousands of pharma companies are there across the globe. Many reputed organizations conducted a survey to determine the top ten companies based on their turnovers. As per the survey's data, Pfizer is the largest company in this sector. The headquarter of this multination company is in Connecticut in the USA.
The following are the top ten international companies.
1 Pfizer |
2 Roche |
3 Abbvie |
4 Johnson & Johnson |
5 Sanofi |
6 Merck |
7 Novartis |
8 Gilead |
9 GSK |
10 Amgen |
Summary
Bulk drugs, Formulations, and Biotechnology are the three major divisions in the pharmaceutical industry. Bulk Drug is a substance which will be used in the drug product as an active ingredient and this is combined with excipients in a predefined proportion to make a finished dosage form. Living organisms are used as the source for the preparation of Biopharmaceuticals and modification of living organisms for human consumption is called biotechnology.
It is expected that the industry has the potential to reach $1.4 trillion markets by 2022. Advancement in computer technology and chemical engineering is pushing the industry's revenue growth upside. Government agencies such as US FDA are observing and monitoring the industry, to control fraudulent activities which may harm the patients. Safe drugs in a safe environment are the motto of the pharmaceutical industry.
If you feel this article is useful SHARE with your friends. It may help them if they are in need. Each one help one.
Author Profile
Ram Kumar Reddy
Ram Kumar Reddy is the founder of Pharma Times Now. Helping students of Pharmacy and Chemistry and employees in pharma industry in learning pharmaceutical scince. Ram Kumar Reddy has 24 years rich experience in Pharmaceutical industry and well versed in quality systems. He worked with Dr.Reddys and Sai Life Sciences. He lives in Hyderabad, India.
No comments