Global Biogeneric Drugs Market Research Report 2023-Competitive Analysis, Status and Outlook by Type, Downstream Industry, and Geography, Forecast to 2029

Global Biogeneric Drugs Market Research Report 2023-Competitive Analysis, Status and Outlook by Type, Downstream Industry, and Geography, Forecast to 2029

Biogeneric Drugs are biologics that closely resemble already approved biologic drugs (called reference products) and are made from natural sources (living systems such as yeast, bacteria, or animal cells). Biogeneric Drugs must have no clinically significant differences from the reference product, and be the same in terms of drug action mechanism, strength, dosage, safety and effectiveness, high-standard manufacturing, etc. Minor differences are allowed in clinically inactive ingredients. Biogeneric Drugs, which must be approved by the FDA, can improve patient access to care by increasing the number of drug options and reducing research and manufacturing costs.

Market Overview:

The latest research study on the global Biogeneric Drugs market finds that the global Biogeneric Drugs market reached a value of USD 17961.1 million in 2022. It’s expected that the market will achieve USD 48664.2 million by 2028, exhibiting a CAGR of 18.07% during the forecast period.

Rising rates of cancer and diabetes

Diseases that biosimilars are currently used to treat include cancer, rheumatoid arthritis, infectious diseases, diabetes, and growth hormone disorders, among others. Therapeutic areas where biosimilars are being developed include oncology, autoimmune diseases, diabetes, and hepatitis. Cancer risk is rising due to smoking, alcohol consumption, unhealthy diet, sedentary lifestyle, and air pollution. Older adults are at higher risk of developing cancer due to less efficient cellular repair mechanisms. At the same time, women are more likely than men to suffer from cervical cancer, breast cancer, and ovarian cancer. According to the World Health Organization, cancer is the leading cause of death worldwide, killing nearly 10 million people in 2020, or nearly one in six deaths. Low- and middle-income countries are particularly vulnerable. The most common cancers are breast, lung, colon, rectal, and prostate. Cancer treatment is slowing down in developing countries due to underdeveloped medical infrastructure and a lack of knowledge about healthy living. Expanded government healthcare programs and improved healthcare infrastructure in Middle Eastern and African countries are helping to address cancer risk. An estimated 1.9 million new cancer cases will be diagnosed and 608,570 cancer deaths will occur in the United States in 2021. Promoted the expansion of the tumor biosimilar market. In addition to cancer, diabetes is one of the major diseases that endanger people's health in the world today. Due to the aggravation of the aging population, the improvement of living standards, and the negative impact of unhealthy lifestyles, the number of patients is increasing year by year. The fast-food diet in European and American countries and the carbohydrate diet in Asia have accelerated the rise in blood sugar after meals and also increased the prevalence of obese people. Biosimilars are gaining popularity among patients as they treat various chronic diseases at an affordable cost. FDA has demonstrated its commitment to helping the United States develop and maintain a healthy biosimilar market by promoting competition on a level playing field between original biologics and biosimilars. Therefore, the rising incidence of cancer and diabetes will increase the market demand for biosimilars.

Obvious cost advantage

Traditional medicines are chemically synthesized, while biologics are manufactured in living systems. The average price of biologics is much higher than that of small molecules due to differences in a therapeutic class and clinical use, payment policies, and limited competition. Biosimilars are highly similar versions of biologics and typically cost 10% - 30% less than similar drugs. Biosimilars can save costs for patients who benefit from biological medicines. By providing a more affordable option, biosimilars can reallocate resources to other areas of patient care. In addition, biosimilars may lead to earlier intervention with appropriate biologic drugs, potentially improving treatment outcomes. As the availability and familiarity of biosimilars increase, consumer acceptance will continue to increase. Moreover, companies will offer substantial discounts or rebates in the early stages of launching new drugs to compete. For example, when Amgen’s adalimumab (Humira) biosimilar came on the market, it was priced at $3,288 and $1,557 for a 2-week supply of the drug, discounts of 5% and 55%, respectively, compared to adalimumab. In addition to this, biosimilars also boost the profits of pharmaceutical wholesalers. By 2022, generics and biosimilars are estimated to account for only about 15% of wholesalers' U.S. drug distribution revenue, but 77% of total U.S. drug distribution gross profit, according to estimates. Therefore, the obvious cost advantage of biosimilars has made life-saving treatments affordable to more patients and helped the industry to develop rapidly.

Government incentives

Many countries are now encouraging doctors and pharmacy managers to turn to biosimilars for treatment. As the regulatory environment evolves, so does the opportunity for biosimilars in the US, Europe, China, and Japan. As of December 2022, the FDA has approved 40 biosimilar drugs. The FDA also issued biosimilar interchangeability guidance to provide biosimilar companies with clearer product development guidance. Clarity on legal and regulatory matters can help newly marketed biosimilars achieve faster promotion. More than 60 biosimilar products have been approved in Europe, accounting for half of the global biosimilar market value. The biosimilar market in Europe is supported by various initiatives. For example, the Priority Medicines Initiative launched by the European Medicines Agency aims to increase support for the development of medicines for unmet medical needs. Candidates selected for the program will receive benefits such as financial assistance, fee waivers, and marketing authorization guidance. The UK Government is investing £260 million in 2022 to support research and development and the manufacture of new medicines, devices, and diagnostics, enabling patients to benefit from cutting-edge medical advances and treatments. China's biosimilar drug market began to develop at the end of the last century, but it was difficult to obtain approval at that time. In 2019, the first four biosimilars were approved in China under a strict new framework established in 2015. There are major gaps in the use of therapeutic mAbs between China and the rest of the world. At present, among the approximately 70 monoclonal antibody therapeutic drugs approved in the United States, only 12 have been approved by the China Food and Drug Administration and put on the domestic market. The Japanese government promotes the development and use of biosimilar drugs and implements special treatment for patients who inject biosimilar drugs by themselves. When patients prescribe biosimilar drugs, a certain price will be added to the self-injection guidance management fee. The price of a new biosimilar drug is generally determined by multiplying the standard price by 70%. Overall, legal provisions, increased investment, and cost-saving initiatives adopted by the government encourage the use of biosimilars instead of branded biologics, thereby driving the demand for biosimilars.

Region Overview:

In 2022, the share of the Biogeneric Drugs market in Europe stood at 34.60%.

Company Overview:

Pfizer, Sandoz International, Teva pharmaceutical industries were the top 3 players in the Biogeneric Drugs market in 2023, taking up a market share of 30.36% together.

Segmentation Overview:

By type, Insulin segment accounted for the largest share of market in 2022.

Application Overview:

By application, the Hospital segment occupied the biggest share from 2018 to 2022.

Key Companies in the global Biogeneric Drugs market covered in Chapter 3:

Biogen
Pfizer
Shanghai Fosun Pharmaceutical
Viatris
Samsung Biologics
Amgen
Organon & Co
Celltrion
Sandoz International
Teva pharmaceutical industries
Biocon Biologics Ltd.
Coherus Biosciences

In Chapter 4 and Chapter 14.2, on the basis of types, the Biogeneric Drugs market from 2018 to 2029 is primarily split into:

Insulin
Growth Hormones
Monoclonal Antibodies
Others

In Chapter 5 and Chapter 14.3, on the basis of Downstream Industry, the Biogeneric Drugs market from 2018 to 2029 covers:

Hospital
Clinics
Research Centers

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2018-2029) of the following regions are covered in Chapter 8 to Chapter 14:

North America (United States, Canada)
Europe (Germany, UK, France, Italy, Spain, Russia, Netherlands, Turkey, Switzerland, Sweden)
Asia Pacific (China, Japan, South Korea, Australia, India, Indonesia, Philippines, Malaysia)
Latin America (Brazil, Mexico, Argentina)
Middle East & Africa (Saudi Arabia, UAE, Egypt, South Africa)