and Medicine Manufacturing
The pharmaceutical and medicine manufacturing industry develops and
produces a variety of medicinal and other health-related products that
save the lives of millions of people from various diseases and permits
many people suffering from illness to recover to lead productive lives.
pharmaceutical industry has achieved worldwide prominence through
research and development (R&D) on new drugs, and spends a relatively
high proportion of its revenue on R&D compared with other industries.
Each year, pharmaceutical industry testing involves millions of
compounds, yet may eventually yield fewer than 100 new prescription
For the majority of
firms in this industry, the actual manufacture of drugs is the last
stage in a lengthy process that begins with scientific research to
discover new products and to improve or modify existing ones. The R&D
departments in pharmaceutical and medicine manufacturing firms start
this process by seeking and rapidly testing libraries of thousands to
millions of new chemical compounds with the potential to prevent,
combat, or alleviate symptoms of diseases or other health problems.
Scientists use sophisticated techniques, including computer simulation,
combinatorial chemistry, and high-throughput screening (HTS), to hasten
and simplify the discovery of potentially useful new compounds.
firms devote a substantial portion of their R&D budgets to applied
research, using scientific knowledge to develop a drug targeted to a
specific use. For example, an R&D unit may focus on developing a
compound that will effectively slow the advance of breast cancer. If the
discovery phase yields promising compounds, technical teams then attempt
to develop a safe and effective product based on the discoveries.
To test new products
in development, a research method called "screening" is used. To screen
an antibiotic, for example, a sample is first placed in a bacterial
culture. If the antibiotic is effective, it is next tested on infected
laboratory animals. Laboratory animals also are used to study the safety
and efficacy of the new drug. A new drug is selected for testing on
humans only if it either promises to have therapeutic advantages over
drugs already in use or is safer. Drug screening is a laborious and
costly process—only 1 in every 5,000 to 10,000 compounds screened
eventually becomes an approved drug.
screening, firms conduct clinical investigations, or "trials," of the
drug on human patients. Human clinical trials normally take place in
three phases. First, medical scientists administer the drug to a small
group of healthy volunteers to determine and adjust dosage levels, and
monitor for side effects. If a drug appears useful and safe, additional
tests are conducted in two more phases, each phase using a successively
larger group of volunteers or carefully selected patients. The final
round of testing often involves a very large panel, sometimes upwards of
After a drug
successfully passes animal and clinical tests, the U.S. Food and Drug
Administration's (FDA) Center for Drug Evaluation and Research (CDER)
must review the drug's performance on human patients before approving
the substance for commercial use. The entire process, from the first
discovery of a promising new compound to FDA approval, can take over a
decade and cost hundreds of millions of dollars.
After FDA approval,
problems of production methods and costs must be worked out before
manufacturing begins. If the original laboratory process of preparing
and compounding the ingredients is complex and too expensive,
pharmacists, chemists, chemical engineers, packaging engineers, and
production specialists are assigned to develop a manufacturing process
economically adaptable to mass production. After the drug is marketed,
new production methods may be developed to incorporate new technology or
to transfer the manufacturing operation to a new production site.
pharmaceutical production plants are highly automated. Milling and
micronizing machines, which pulverize substances into extremely fine
particles, are used to reduce bulk chemicals to the required size. These
finished chemicals are combined and processed further in mixing
machines. The mixed ingredients may then be mechanically capsulated,
pressed into tablets, or made into solutions. One type of machine, for
example, automatically fills, seals, and stamps capsules. Other machines
fill bottles with capsules, tablets, or liquids, and seal, label, and
package the bottles.
Quality control and
quality assurance are vital in this industry. Many production workers
are assigned full time to quality control and quality assurance
functions, whereas other employees may devote part of their time to
these functions. For example, although pharmaceutical company sales
representatives, often called detailers, work primarily in marketing,
they engage in quality control when they assist pharmacists in checking
for outdated products.
The pharmaceutical and medicine manufacturing industry consists of over
2,500 places of employment, located throughout the country. R&D
laboratories perform the work of drug discovery and development, while
manufacturing plants produce the final drugs for consumers. Most R&D
laboratories are located separately from manufacturing plants, but some
labs and production plants are integrated.
There are three main
types of pharmaceutical companies. Large, or mainline, pharmaceutical
companies are established firms that have many approved drugs already on
the market. These companies often have significant numbers of R&D
laboratories and manufacturing plants throughout the Nation and around
the world. In contrast, smaller pharmaceutical companies are usually
newer firms that often do not have any approved drugs on the market. As
a result, these firms almost exclusively perform R&D. In addition to
developing their own drugs, some small pharmaceutical companies perform
contract research for other pharmaceutical companies. Finally, generic
pharmaceutical companies manufacture drugs that are no longer protected
by patents. Because their products are all established drugs, they
devote fewer resources to R&D and more to manufacturing.
in biotechnology are transforming drug discovery and development.
Bioinformatics, a branch of biotechnology using information technologies
to work with biological data like DNA, is a particularly dynamic new
area of work. Scientists have learned a great deal about human genes,
but the real work—translating that knowledge into viable new drugs—has
only recently begun. So far, millions of people have benefited from
medicines and vaccines developed through biotechnology, and several
hundred new biotechnologically-derived medicines are currently in the
pipeline. These new medicines, all of which are in human clinical trials
or awaiting FDA approval, include drugs for cancer, infectious diseases,
autoimmune diseases, neurologic disorders, and HIV/AIDS and related
Many new drugs are
expected to be developed in the coming years. Advances in technology and
the knowledge of how cells work will allow pharmaceutical and medicine
manufacturing makers to become more efficient in the drug discovery
process. New technology allows life scientists to test millions of drug
candidates far more rapidly than in the past. Other new technology, such
as regenerative therapy, also will allow the natural healing process to
work faster, or enable the regrowth of missing or damaged tissue. In
addition, technology based on the study of genes is being explored to
develop vaccines to prevent or treat diseases that have eluded
traditional vaccines, such as AIDS, malaria, tuberculosis, and cervical
in manufacturing processes are also impacting the industry. While
pharmaceutical manufacturers have long devoted resources to new drug
development as a source for future profits, firms are increasingly
realizing that improvements throughout the drug pipeline are needed to
stay competitive. Along with other manufacturing industries,
pharmaceutical manufacturers are realizing that quality products can
best be produced when quality improvements occur at all stages and when
processes are continually updated with the latest technologies and
methods. Controlling the product flow through the supply chain also
ensures that valuable resources do not sit idle but are put to work, and
that final products reach consumers without delay.
conditions in pharmaceutical plants are better than those in most other
manufacturing plants. Much emphasis is placed on keeping equipment and
work areas clean because of the danger of contamination. Plants usually
are air-conditioned, well lighted, and quiet. Ventilation systems
protect workers from dust, fumes, and disagreeable odors. Special
precautions are taken to protect the relatively small number of
employees who work with infectious cultures and poisonous chemicals.
With the exception of work performed by material handlers and
maintenance workers, most jobs require little physical effort.
Pharmaceutical and medicine manufacturing
provided 289,800 wage and salary jobs in 2008. Pharmaceutical and
medicine manufacturing establishments usually employ many workers. About
87 percent of this industry's jobs in 2008 were in establishments that
employed more than 100 workers. Over half of all jobs are in California,
New Jersey, Puerto Rico, Pennsylvania, and New York. Under the
North American Industry Classification System (NAICS), workers in
research and development (R&D) establishments that are not part of a
manufacturing facility are included in a separate industry—research
and development in the physical, engineering, and life sciences.
However, due to the importance of R&D work to the pharmaceutical and
medicine manufacturing industry, drug-related R&D is discussed in this
statement even though a large proportion of pharmaceutical
industry-related R&D workers are not included in the employment data.
Paths into this Industry
About 31 percent of all jobs in the pharmaceutical and medicine
manufacturing industry are in professional and related occupations,
mostly scientists and science technicians. About 27 percent of jobs are
in production occupations, including both low skilled and high skilled
jobs. The remaining jobs are primarily management, and office and
administrative support occupations.
engineers, and technicians conduct research to develop new drugs. Others
work to streamline production methods and improve environmental and
quality control. Life scientists are among the largest scientific
occupations in this industry. Most of these scientists are biological
and medical scientists who produce new drugs using biotechnology to
recombine the genetic material of animals or plants. Biological
scientists normally specialize in a particular area. Biologists and
bacteriologists study the effect of chemical agents on infected animals.
Biochemists study the action of drugs on body processes by analyzing the
chemical combination and reactions involved in metabolism, reproduction,
and heredity. Microbiologists grow strains of microorganisms that
produce antibiotics. Physiologists investigate the effect of drugs on
body functions and vital processes. Pharmacologists and zoologists study
the effects of drugs on animals. Virologists grow viruses, and develop
vaccines and test them in animals. Botanists, with their special
knowledge of plant life, contribute to the discovery of botanical
ingredients for drugs. Other biological scientists include pathologists,
who study normal and abnormal cells or tissues, and toxicologists, who
are concerned with safety, dosage levels, and the compatibility of
different drugs. Medical scientists, who also may be physicians, conduct
clinical research, test products, and oversee human clinical trials.
work of physical scientists, particularly chemists, also is important in
the development of new drugs. Combinatorial and computational chemists
create molecules and test them rapidly for desirable properties. Organic
chemists, often using combinatorial chemistry, then combine new
compounds for biological testing. Physical chemists separate and
identify substances, determine molecular structure, help create new
compounds, and improve manufacturing processes. Radiochemists trace the
course of drugs through body organs and tissues. Pharmaceutical chemists
set standards and specifications for the form of products and for
storage conditions; they also see that drug labeling and literature meet
the requirements of State and Federal laws. Analytical chemists test raw
and intermediate materials and finished products for quality.
such as biological and chemical technicians, play an important part in
research and development of new medicines. They set up, operate, and
maintain laboratory equipment, monitor experiments, analyze data, and
record and interpret results. Science technicians usually work under the
supervision of scientists or engineers.
account for a small fraction of scientific and technical workers, they
make significant contributions toward improving quality control and
production efficiency. Chemical engineers design equipment and devise
manufacturing processes. Bioprocess engineers, who are similar to
chemical engineers, design fermentation vats and various bioreactors for
microorganisms that will produce a given product. Industrial engineers
plan equipment layout and workflow to maintain efficient use of plant
At the top of the managerial group are executives who make policy
decisions concerning matters of finance, marketing, and research. Other
managerial workers include natural sciences managers and industrial
wholesale and manufacturing, describe their company's products to
physicians, pharmacists, dentists, and health services administrators.
These workers serve as lines of communication between their companies
Employment of wage and salary workers in pharmaceutical
and medicine manufacturing, 2008 and projected change,
(Employment in thousands)
business, and financial occupations
and related occupations
scientists, except epidemiologists
representatives, wholesale and manufacturing, technical and
do not add to total due to omission of occupations not
directly related to degrees in science, technology,
engineering, mathematics, or medicine. Original
Source: U.S. Bureau of Labor Statistics National Employment
According to the U.S. Department of Labor, Bureau of Labor Statistics,
eEmployment is expected to increase as demand for drugs continues to
grow. Prospects should be favorable, particularly for life scientists
with a doctoral degree.
Employment change. The
number of wage and salary jobs in pharmaceutical and medicine
manufacturing is expected to increase by 6 percent over the 2008-18
period, compared with 11 percent projected for all industries combined.
Even during fluctuating economic conditions, demand is expected to
remain strong for this industry's products, including the diagnostics
used in hospitals, laboratories, and homes, the vaccines used routinely
on infants and children, analgesics and other symptom-easing drugs;
antibiotics and other drugs for life-threatening diseases, and
"lifestyle" drugs for the treatment of nonlife-threatening conditions.
The use of drugs,
particularly antibiotics and vaccines, has helped to eradicate or limit
a number of deadly diseases, but many others, such as cancer,
Alzheimer's, and heart disease, continue to elude cures. Ongoing
research and the manufacture of new products to combat these and other
diseases will continue to contribute to employment growth. Demand also
is expected to increase as the population expands because many of the
pharmaceutical and medicine manufacturing industry's products are
related to preventive or routine healthcare, rather than just illness.
The growing number of older people, who tend to consume more of all
types of healthcare services, will further stimulate demand—along with
the growth of both public and private health insurance programs, which
increasingly cover the cost of drugs and medicines.
factor propelling demand is the increasing popularity of "lifestyle"
drugs. These drugs treat symptoms of chronic nonlife-threatening
conditions resulting from aging or genetic predisposition and can
enhance one's self-confidence or physical appearance. Other factors
expected to increase the demand for drugs include greater personal
income and the rising health consciousness and expectations of the
Despite the increasing
demand for drugs, several factors will limit employment growth in the
industry. Drug producers and buyers are placing more emphasis on cost
effectiveness, due to the extremely high costs of developing new drugs.
Competition from the producers of generic drugs also will put pressure
on many firms in this industry as more brand-name drug patents expire.
On the manufacturing side, continuing improvements in manufacturing
processes will improve productivity in pharmaceutical plants, while many
companies are also manufacturing more of their products overseas.
Strong demand is
anticipated for professional occupations—especially for life and
physical scientists engaged in R&D, the backbone of the pharmaceutical
and medicine manufacturing industry. Much of the basic biological
research done in recent years has resulted in new knowledge, including
the successful identification of genes. Life and physical scientists
will be needed to take this knowledge to the next stage, which is to
understand how certain genes function so that gene therapies can be
developed to treat diseases. Computer specialists such as systems
analysts, biostatisticians, and computer support specialists also will
be in demand as disciplines such as biology, chemistry, and electronics
continue to converge and become more interdisciplinary, creating demand
in rapidly emerging fields such as bioinformatics and nanotechnology.
Steady demand also is
projected for production occupations. Employment of office and
administrative support workers is expected to grow more slowly than the
industry as a whole, as companies streamline operations and increasingly
rely on computers.
Prospects should be
favorable, particularly for life scientists with a doctoral degree.
Unlike many other manufacturing industries, the pharmaceutical and
medicine manufacturing industry is not highly sensitive to changes in
economic conditions. Even during periods of high unemployment, work is
likely to be relatively stable in this industry, because consumption of
medicine does not vary greatly with economic conditions. Additional
openings will arise from the need to replace workers who transfer to
other industries, retire, or leave the workforce for other reasons.
Note: Some resources in this section are provided by the US Department
of Labor, Bureau of Labor Statistics.